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OBJECTIVE To evaluate the palatability and chewability of chewable tablets， and provide reference for the quality evaluation of various types of chewable tablets. METHODS Using self-made Glucosamine hydrochloride chewable tablets as the model drug， the quality test was conducted. The in vitro simulation system for chewable tablets was established by using a texture analyzer and rheometer， and an oral simulation experiment was conducted on chewable tablets. The texture analyzer was used to measure the force required for chewing and simulate the static disintegration process of chewable tablets； the rheometer was adopted to measure the viscoelasticity， thixotropy， and deformability of chewable tablets during the chewing process. RESULTS The disintegration time limit， principal component content， and dissolution of self-made Glucosamine hydrochloride chewable tablets all met the limit requirements. The in vitro simulation results of the texture analyzer showed that self-made chewable tablets were easy to chew in both axial and radial directions， and the force required for chewing was within the range of the chewing force of the teeth； chewable tablets could disintegrate at an appropriate time without being chewed and only taken in the oral cavity. The in vitro simulation results of the rheometer showed that the chewable tablets in the oral cavity exhibited a behavior of elasticity as the main factor and viscosity as the secondary factor through the continuous stirring of the tongue， and the viscosity of the chewable tablets gradually decreased with tongue stirring or tooth chewing； when chewing with teeth， the internal force of the chewing tablets decreased， causing plastic deformation and crushing. After being crushed， the shape couldn’t be restored， making it easy to chew and swallow. CONCLUSIONS The combination of texture analyzer and rheometer can be used to simulate the oral chewing process and evaluate the palatability and chewability of self-made Glucosamine hydrochloride chewable tablets. This model can provide reference for the evaluation of various chewable tablets.

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Taste masking is critical to improving the compliance of pediatric oral dosage forms. However, it is challenging for extremely bitter lisdexamfetamine dimesylate (LDX) with a long half-life and given in large dose. The present study aims to develop an immediate-release, taste-masked lisdexamfetamine chewable tablet. Lisdexamfetamine-resin complexes (LRCs) were prepared using the batch method. The molecular mechanism of taste masking was explored by PXRD, PLM, STA, and FT-IR. The results showed that taste masking was attributed to the ionic interaction between drug and the resin. The ion exchange process conformed to first-order kinetics. The rate-limiting step of drug release was the diffusion of ions inside the particles, and the concentration of H+ was the key factor for immediate release. The masking efficiency of the prepared LRCs in saliva exceeded 96%, and the drug could be completely released within 15 min in aqueous HCl (pH 1.2). Furthermore, the SeDeM expert system was used for the first time to comprehensively study the powder properties of LRCs and to quickly visualize their defects (compressibility, lubricity/stability, and lubricity/dosage). The selection of excipients was targeted rather than traditional screening, thus obtaining a robust chewable tablet formulation suitable for direct compression. Finally, the difference between chewable tablets containing LRCs and chewable tablets containing lisdexamfetamine dimesylate was compared by in vitro dissolution test, electronic tongue, and disintegration test. In conclusion, an immediate-released, child-friendly lisdexamfetamine chewable tablets without bitterness was successfully developed by the QbD approach, using the SeDeM system, which may help in further development of chewable tablets.

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BACKGROUND: Mosquitoes serve as the vector of canine heartworm (Dirofilaria immitis), which represents a significant and persistent threat to canine health. A reduction in the longevity and/or reproductive success of mosquitoes that take a blood meal from fluralaner-treated dogs may consequently reduce the local transmission of heartworm and prevent new infections. A novel secondary effect of an oral formulation of the ectoparasiticide fluralaner (Bravecto®) against a laboratory strain of the mosquito Aedes aegypti, a potential major vector of canine heartworm, was investigated in this study. METHODS: Six dogs were administered a single dose of fluralaner orally in the form of Bravecto® Chews (at the labeled fluralaner dose of 25 mg/kg body weight), while six control dogs received no treatment. Mosquitoes were fed on blood that was collected from each dog prior to treatment and weekly for 15 weeks post-treatment to assess the continued effects of fluralaner as its serum level decreased. Mosquito fitness was assessed by three parameters: rate of successful blood-feeding, survival, and egg laying. RESULTS: Successful blood-feeding rate was similar between control and treatment groups. In the fluralaner treatment, mosquito survival was significantly reduced within the first 24 h after blood-feeding, for the first 12 weeks post-treatment of the dogs (efficacy range = 33.2-73.3%). Survival of mosquitoes up until a potentially heartworm-infective timepoint (14 days post-blood-feeding) was significantly reduced in the fluralaner-treated group at several timepoints (1, 2, 5, 11, 12, 13, 14, and 15 weeks post-treatment; efficacy range = 49.4-91.4%), but was less consistently reduced at the other timepoints. Egg laying by mosquitoes was almost completely suppressed for the first 13 weeks following treatment of the dogs with fluralaner (treatment efficacy ≥ 99.8%). CONCLUSIONS: Mosquitoes fed blood from fluralaner-treated dogs experienced a significant reduction in survival and fecundity. These findings support the potential for a reduction in heartworm transmission directly by lethal effects on the vector and indirectly through a reduction of the local vector population when mosquitoes are exposed to animals treated with fluralaner.

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Repaglinide (RPG), a monotherapy insulin secretagogue used to treat diabetes mellitus-type II yet, it suffers from poor water solubility and variable bioavailability (∼ 50%) due to hepatic first pass metabolism. In this study, 2FI I-Optimal statistical design was employed to encapsulate RPG into niosomal formulations using cholesterol,span 60 and peceolTM. The optimized niosomal formulation (ONF) showed particle size 306.60 ± 84.00 nm, zeta potential -38.60 ± 1.20 mV, polydispersity index 0.48 ± 0.05 and entrapment efficiency 92.00 ± 2.60%. ONF showed > 65% RPG release that lasted for 3.5 h, and significantly higher sustained release compared to Novonorm® tablets after 6 h (p < 0.0001). TEM for ONF showed spherical vesicles with dark core and light-colored lipid bilayer membrane. RPG peaks disappeared in FTIR confirming successful RPG entrapment. To eliminate dysphagia associating conventional oral tablets, chewable tablets loaded with ONF were prepared using coprocessed excipients; Pharmaburst® 500, F-melt® and Prosolv® ODT. Tablets showed friability <1%, hardness 3.9 ± 0.423-4.7 ± 0.410 Kg, thickness 4.1 ± 0.045-4.4 ± 0.017 mm and acceptable weight.All tablets showed robust RPG release at 30 min compared to Novonorm® tablets. At 6h, chewable tablets containing only Pharmaburst® 500 and F-melt® showed sustained and significantly increased RPG release compared to Novonorm® tablets (p < 0.05). Pharmaburst® 500 and F-melt® tablets showed rapid in vivo hypoglycemic effect with 5 and 3.5 fold significant reduction in blood glucose compared to Novonorm® tablets (p < 0.05) at 30 min. Also, at 6h the same tablets showed 1.5 and 1.3 fold significant extended reduction in blood glucose compared to the same market product (p < 0.05). It could be concluded that chewable tablets loaded with RPG ONF represent promising novel oral drug delivery systems for diabetic patients suffering from dysphagia.

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This research aimed to develop innovative self-nanoemulsifying chewable tablets (SNECT) to increase oral bioavailability of tadalafil (TDL), a nearly insoluble phosphodiesterase-5 inhibitor. Cinnamon essential oil, PEG 40 hydrogenated castor oil (Cremophor® RH 40), and polyethylene glycol 400 served as the oil, surfactant, and cosurfactant in the nanoemulsifying system, respectively. Primary liquid self-nanoemulsifying delivery systems (L-SNEDDS) were designed using phase diagrams and tested for dispersibility, droplet size, self-emulsifying capability, and thermodynamic stability. Adsorption on a carrier mix of silicon dioxide and microcrystalline cellulose was exploited to solidify the optimum L-SNEDDS formulation as self-nanoemulsifying granules (SNEG). Lack of crystalline TDL within the granules was verified by DSC and XRPD. SNEG were able to create a nanoemulsion instantaneously (165 nm), a little larger than the original nanoemulsion (159 nm). SNECT were fabricated by compressing SNEG with appropriate excipients. The obtained SNECT retained their quick dispersibility dissolving 84% of TDL within 30 min compared to only 18% dissolution from tablets of unprocessed TDL. A pharmacokinetic study in Sprague−Dawley rats showed a significant increase in Cmax (2.3-fold) and AUC0−24 h (5.33-fold) of SNECT relative to the unprocessed TDL-tablet (p < 0.05). The stability of TDL-SNECT was checked against dilutions with simulated GI fluids. In addition, accelerated stability tests were performed for three months at 40 ± 2 °C and 75% relative humidity. Results revealed the absence of obvious changes in size, PDI, or other tablet parameters before and after testing. In conclusion, current findings illustrated effectiveness of SNECT to enhance TDL dissolution and bioavailability in addition to facilitating dose administration.

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The demand for personalized medicine has received extensive attention, especially in pediatric preparations. An emerging technology, extrusion-based 3D printing, is highly attractive in the field of personalized medicine. In this study, we prepared propranolol hydrochloride (PR) gummy chewable tablets tailored for children by semisolid extrusion (SSE) 3D printing technology to meet personalized medicine needs in pediatrics. In this study, the effects of critical formulation variables on the rheological properties and printability of gum materials were investigated by constructing a full-factorial design. In addition, the masticatory properties, thermal stability, and disintegration time of the preparations were evaluated. Bitterness inhibitors were used to mask the bitterness of the preparations. The results of the full-factorial design showed that the amount of gelatin and carrageenan were the key factors in the formulation. Gelatin can improve printability and masticatory properties, carrageenan can improve thermal stability, and accelerate the disintegration of preparations; therefore, a reasonable combination of both could satisfactorily meet the demand for high-quality 3D printing. γ-Aminobutyric acid can reduce the bitterness of gummy chewable tablets to improve medication compliance and the determined formulation (F7) met the quality requirements. In conclusion, the gum material has excellent potential as an extrusion material for 3D printing. The dosage can be adjusted flexibly by the model shape and size. 3D printing has broad prospects in pediatric preparations.

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Currently, there are a few or none marketed gabapentin veterinary products, leading to treatment with compounded dosage forms or off-label use of human-marketed products. With the said approaches, there are significant risks of preparation errors, rendering these practices suboptimal. A new manufacturing technique to accurately and rapidly prepare veterinary dosage forms close to the point-of-care is needed. However, a current hurdle in developing small-dose gabapentin dosage forms is the quantification of the gabapentin molecule. UV-Vis spectrophotometric quantification possesses suitable properties for implementation at small production sites, but quantifying gabapentin with the said technique has proven to be challenging as the small molecule lacks chromophores. This study aimed at thoroughly assessing UV-Vis spectrophotometric gabapentin quantification methods with the intent of finding a reliable method. Excellent linearity (R2 = 0.9998) in a broad and useful concentration range (0.5-40 µg/mL) was detected for the ascorbic acid derivatization method at a wavelength of 376 nm. The method was successfully applied to determine the drug content in the prepared semi-solid extrusion 3D-printed dosage forms. This study proved that pet-friendly tailored gabapentin dosage forms could easily be manufactured by semi-solid extrusion 3D printing and UV-Vis spectrophotometrically analyzed with the ascorbic acid derivatization method.

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Semisolid extrusion (SSE) 3D printing is an emerging technology in personalized medicine. To address clinical multi-dose requirements, SSE has been explored to manufacture new preparations. In this study, amlodipine besylate (AMB) was the model drug, and SSE was the pharmaceutical strategy. We developed semisolids suitable for SSE and AMB chewable tablets with six strengths (1.5-5 mg) to meet the needs of 2-16-year-old patients. First, the semisolid extrudability was evaluated by texture analyzer, and then the amounts of carboxymethyl cellulose sodium, sodium starch glycolate, and glycerin were optimized by full factorial design. Then, rheological tests were performed to evaluate the properties of the semisolid and the effect of starch sodium glycolate on printability. Finally, the amount of corrigents was optimized using the electronic tongue. Laboratory amplified semisolids and 3D printed tablets can be stored for a few months, and the whole SSE process had no effect on crystal type. This study validated the feasibility of SSE 3D printing, and tablets with appropriate taste and cartoon appearance can meet or even exceed the traditional preparations. Our study provides a new strategy for multi-dose solid preparations and effectively meet the need for personalized amlodipine medicine.

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ObjectiveTo explore the regulatory effect of Gouqi chewable tablets on innate and adaptive immunity in normal mice and its antioxidant activity in vitro and in vivo. MethodThe effects of low-， medium-， and high-dose groups （0.25， 0.5， 1.5 g·kg-1） on the immune function of normal mice were observed by carbon clearance test， immune organ index test， serum hemolysin test， ConA-induced splenic lymphocyte proliferation test， and natural killer cell （NK cell） activity test. The effects of Gouqi chewable tablets on the antioxidant capacity in vivo were determined by detecting the content of superoxide dismutase （SOD）， glutathione peroxidase （GSH-Px）， and malondialdehyde （MDA） in mice serum. The in vitro antioxidant activity of Gouqi chewable tablets was detected by 2，2'-azino-bis（3-ethylbenzothiazoline-6-sulfonic acid） diammonium salt （ABTS）， 2，2-diphenyl-1-picrylhydrazyl （DPPH）， and hydroxyl radical scavenging tests. ResultCompared with the blank control group， the low-， medium-， and high-dose groups of Gouqi chewable tablets improved the viability of NK cells， the proliferation of splenic lymphocytes， and the level of serum hemolysin antibody in mice （P<0.05）. The high-dose group increased the thymus index， spleen index， and phagocytic function of macrophages （P<0.05， P<0.01）. As compared with the blank control group， the activity of GSH-Px in mice serum in the medium-dose group was increased （P<0.05）， and the content of MDA in mice serum in the high-dose group was decreased （P<0.05）. In in vitro antioxidant tests， the median inhibitory concentration （IC50） values of Gouqi chewable tablets were 1.64±0.20， 2.04±0.03， and 10.27±0.03 g·L-1 by the DPPH， ABTS， and OH- free radical method， respectively. Those results indicated that Gouqi chewable tablets have good antioxidant effects in vitro. ConclusionGouqi chewable tablets can enhance the immune function of mice with good antioxidant effects.

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Gastroretentive raft-forming formulations were developed in liquid and chewable tablet dosage forms to achieve prolonged delivery of quercetin in the stomach. The formulations contained a solid dispersion of quercetin and polyvinylpyrrolidone (PVP K 30) at a 1:10 w/w ratio to improve the solubility of the flavonoid. The formulations also contained sodium alginate as a gel forming agent, calcium carbonate as a calcium source and carbon dioxide producer and hydroxypropyl methylcellulose K100M as a drug release retarding polymer. The chewable tablets incorporated mannitol as a diluent. Both liquid and chewable tablet formulations exhibited rapid floating behaviour (lag time < 1 min) and long floating duration (>24 h) in 0.1 N HCl. The optimized liquid formulation showed superior characteristics based on high raft strength (10.4 g) and sustained release of quercetin (93 % over 8 h) whereas the optimized chewable tablet formulation exhibited lower raft strength (7.2 g) and lower drug release (79 % in 8 h). The optimized liquid and chewable tablet formulations were found to induce anti-inflammatory activity in cell culture using RAW 264.7 cells macrophages and enhance the migration of human gastric adenocarcinoma (AGS) epithelial cells in vitro, indicating wound healing potential for treatment of gastric ulcers.

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Due to its low solubility, carbamazepine (CBZ) exhibits slow and incomplete release in the gastrointestinal tract and, hence, variable pharmacokinetics and pharmacodynamic effect. Lots of methods have been devised to improve its solubility, the large number of proposed solutions being a sign that the problem is not yet satisfactorily solved. The persistent problem is that predictable release kinetics, an increased rate but within defined limits, are required to avoid high absorption variability. This paper presents a synthesis of a carbamazepine-ß-cyclodextrin inclusion complex (CBZ-ß-CD), the characterization of the physical mixture, CBZ, ß-CD and the CBZ-ß-CD inclusion complex using Fourier transform infrared spectroscopy, scanning electron microscopy, simultaneous thermal analysis and X-ray diffraction, formulation of chewable tablets, determination of the dissolution of carbamazepine in medium containing 1% sodium lauryl sulfate (LSS), and in simulated saliva (SS), mathematical modeling of release kinetics. The kinetics of total CBZ release from tablets containing CBZ-ß-CD and super-disintegrant F-Melt in both SS and LSS followed two steps: a burst release in the first minutes and a slower release in intervals up to 60 min. The release in the second phase has been well described by the Higuchi and Peppas models, which advocate a controlled release by combined diffusion and with some phenomena of swelling and relaxation of the matrix generated by the crospovidone component of the F-Melt excipient.

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BACKGROUND: Oral drug delivery is the most preferred route for drug administration in the world, with tablets being one of the most common dosage forms. However, some people, particularly children and the elderly, have difficulty swallowing the tablets. Chewable tablets are the dosage form that can address the issue while also providing a valuable masking effect on drug taste, allowing patients to swallow the drugs more easily. MATERIALS AND METHODS: In this study, the chewable tablets were manufactured using the melt granulation method, which resulted in tablets with a chewy texture. The tablets contained paracetamol as well as Arabic gum, starch, agar, and mannitol. RESULTS: The drug release profiles for the fragmented form showed that 50% of the drug was released within 4 min and 100% was released within 30 min of the dissolution process. The intact form released nearly 90% of the drug within 2 h. CONCLUSION: Formulation 2 was determined as the best formulation. This tablets' formulation had passed all characterization tests and displayed a moderate hardness and chewy texture.

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Objective:To evaluate the efficacy of Jiedu-Huaban Decoction combined with montelukast sodium chewable tablets in the treatment of children with henoch schonlein purpura (HSP). Methods:A total of 80 children with HSP and blood heat syndrome who met the inclusion criteria, from January 2017 to December 2019, were randomly divided into two groups by random number table method, 40 in each group. The control group took montelukast sodium chewable tablets at night, and the study group took Jiedu-Huaban Decoction on the basis of the control group. Both groups were treated for 2 weeks. The disappearance time of gastrointestinal disease, skin purpura, kidney disease, joint swelling and pain were observed. The improvement score of skin purpura was evaluated before and after treatment. The serum levels of IL-6, IL-4, interferon-γ (IFN-γ) and TNF-α were detected by ELISA, and the levels of IgG, IgA and IgM. The T lymphocyte subsets (CD4 + and CD8 +) were measured by nephelometry, and the CD4 +/CD8 +values were calculated. The clinical efficacy was evaluated. Results:The total effective rate was 87.5% (35/40) in the study group and 67.5% (27/40) in the control group, with significant difference between the two groups ( χ2 =4.588, P=0.032). The disappearance time of gastrointestinal disease, skin purpura, kidney disease and joint swelling and pain in the study group were significantly earlier than those in the control group ( t=7.802, 12.167, 7.309, 9.365, all Ps<0.001). After treatment, the serum levels of IL-6, IL-4, IFN-γ and TNF-α in the study group were significantly lower than those in the control group ( t=9.319, 6.738, 8.221, 6.553, all Ps<0.001). The improvement score of skin purpura at 1 week after treatment (2.75 ± 0.69 vs. 3.92 ± 0.83, t=6.856) and 2 weeks after treatment (0.41 ± 0.15 vs. 1.55 ± 0.37, t=18.095) in the study group were significantly lower than those in the control group ( P<0.01). After treatment, the level of IgG, CD4 +, CD4 +/CD8 + in the study group were significantly higher than those in the control group ( t=5.160, 4.558, 3.442, all Ps<0.01), the level of IgA, IgM, CD8 + in the study group were significantly lower than those in the control group ( t=2.614, 6.712, 5.468, all Ps< 0.05). During the treatment, the incidence of adverse reactions in the control group was 17.5% (7/40), and that of the study group was 15.0% (6/40), wherer there was no statistical difference between the two groups ( χ2=0.092, P=0.762). Conclusion:Jiedu-Huaban Decoction combined with montelukast sodium chewable tablets can improve the clinical symptoms of children with HSP and blood heat syndrome, reduce the body inflammatory reaction, improve immunity, with good safety.

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A recently published FDA guidance on chewable tablets has addressed the quality attributes of this class of dosage forms. This study evaluated disintegration as a quality attribute for a number of commercially available chewable antacid tablets. Additionally, acid-neutralizing-capacity values were evaluated. A number of the products exhibited prolonged disintegration times-which were far longer than those of conventional immediate-release tablets. The mean disintegration times ranged from 6 to more than 60 min in distilled water and from 9 to over 60 min in 0.1 N HCl. The products with longer disintegration times had higher breaking force and tensile strength values. Despite the range in disintegration times, all products met the criteria for acid-neutralizing capacity. These results indicate a need for patients to be aware of the need to thoroughly chew antacid tablets upon administration. Given these considerations, disintegration testing would be a useful quality control test in evaluating these dosage forms as the implicit assumption by the manufacturer that patients will chew the product sufficiently may not be met in every case.

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Objective: To optimize the formulation and preparation process of compound Shenzao chewable tablets, and establish a method for the determination of the active ingredient spinosin. Methods: Using the wet granulation process, the types, dosages and adding manners of diluents, wetting agents, sweeteners and lubricants were optimized, and three batches of the compound Shenzao chewable tablets were prepared. An HPLC method for the determination of spinosin in the tablets was established and the HPLC conditions were as follows: ZORBAX SB-C 18 column(4.6 mm×250 mm, 5 μm)was adopted. The mobile phase was the acetonitrile-water solution in a gradient elution. The flow rate was 1.0 ml/min, the column temperature was 25℃ and the detection wavelength was 335 nm. Results: In the wet granulation process, the dry Lepidium meyenii (Maca)powder and 20% mannitol were used as diluents, the 80% ethanol as wetting agent, and the 0.50% aspartame as sweetener. In the tabletting process, the 1.0% magnesium stearate was used as lubricant. The prepared tablets showed smooth surface, moderate sweetness, and a stable and controllable quality. The HPLC method for the determination of spinosin showed a good linearity within the concentration range of 5~100 μg/ml (r=0.9995)and the average recovery was 98.55%. Conclusion: The optimized formulation and preparation process are stable and feasible for the preparation of the compound Shenzao chewable tablets. The determination of spinosin by the HPLC method is accurate and reliable, which might be used for the quality control of the preparation.

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OBJECTIVE: The main objective of this research is to formulate, optimize, and evaluate raft-forming chewable tablets of Nizatidine. Various raft-forming agents were used in preliminary screening. Sodium alginate showed maximum raft strength, so tablets were prepared using sodium alginate as the raft forming agent, along with calcium carbonate (CaCO3) as antacid and raft strengthening agent, and sodium bicarbonate (NaHCO3) as a gas generating agent. RESEARCH DESIGN AND METHODS: Raft forming chewable tablets containing Nizatidine were prepared by direct compression and wet granulation methods, and evaluated for drug content, acid neutralization capacity, raft strength, and in-vitro drug release in 0.1 N HCl. Box-Behnken design was used for optimization. RESULTS: Two optimized formulations were predicted from the design space. The first optimized recommended concentrations of the independent variables were predicted to be X1 = 275.92 mg, X2 = 28.60 mg, and X3 = 202.14 mg for direct compression technique and the second optimized recommended concentrations were predicted to be X1 = 253.62 mg, X2 = 24.60 mg, and X3 = 201.77 mg for wet granulation technique. Optimized formulations were stable at accelerated environmental testing for six months at 35 °C and 45 °C with 75% relative humidity. X-Ray showed that the raft floated immediately after ingestion and remained intact for ∼3 h. CONCLUSION: Raft was successfully formed and optimized. Upon chewing tablets, a raft is formed on stomach content. That results in rapid relief of acid burning symptoms and delivering the drug into systemic circulation with enhanced bioavailability.

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Objective To study the efficacy of Liangxue-Zhuyu decoction combined with montelukast in the treatment of henoch schonlein purpura (HSP) and its influence on immunologic function. Methods A total of 95 HSP children treated in department of pediatrics from February 2014 to December 2016 were enrolled, and then were randomly divided into observation group (n=48) and control group (n=47), meanwhile another 48 healthy children admitted to a medical examination were selected as the healthy group. The patients in the control group were given the treatment of oral montelukast sodium chewable tablets before sleeping (the dose:2-6 years old 4 mg/d, 6-14 years old 5 mg/d), and the patients in the observation group accepted the therapy of Liangxue-Zhuyu decoction based on the treatment of the control group.The course of the treatment in the two groups were 30d. The time of clinical symptom regression and adverse reactions were recorded, and the clinical efficacy was evaluated. Monoclonal antibody immunofluorescence method and Enzyme-linked immunosorbent assay (ELISA) were used to detect the levels of serum T lymphocyte subsets and INF-γ and IL-10 before and after treatment, and their differences among three groups were compared. Results The effective rates of the observation group was 95.8% (46/48), which was significantly higher than 76.6% (36/47) of control group (x 2=7.441,P<0.05).The subsided time of the symptoms,including purpura(5.0 ± 1.3 d vs.6.6 ± 2.6 d,t=3.816), abdominal pain(3.1 ± 2.1 d vs.4.1 ± 2.6 d,t=2.139),joint pain(4.3 ± 1.5 d vs.5.4 ± 1.9 d,t=3.416),fecal occult blood(4.5 ± 1.5 d vs.6.1 ± 1.9 d,t=4.404)of the observation group were significantly shorter than those of the control group(P<0.05).After the treatment,the CD4(45.14% ± 9.32% vs.41.02% ± 9.97%),CD8(25.10% ± 4.69% vs.21.52% ± 5.71%)of the observation group was significantly higher than those of the control group, and the CD4/CD8(1.62 ± 0.32 vs.1.95 ± 0.35)and IL-10(33.07 ± 1.86 pg/ml vs.53.92 ± 2.98 pg/ml)of the observation group was significantly lower than this of the control group (P<0.05). Conclusions The efficacy of the Liangxue-Zhuyu decoction combined with montelukast for HSP was definite,and the effect was rapid with little side effects. The mechanism might be related to regulating the secretion of T lymphocyte and IL-10, thereby to correct Th1/Th2 cell balance and disturbance of immune function.

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BACKGROUND: The clinical efficacy of fluralaner chewable tablets (Bravecto™, MSD Animal Health) against naturally acquired Linognathus setosus infestations on dogs was evaluated compared with permethrin (Exspot®, MSD Animal Health) treatment. METHODS: Privately-owned dogs naturally infested with L. setosus from 21 different households were randomly allocated to two treatment groups. Fourteen dogs were treated once orally with fluralaner and ten dogs were treated once topically with permethrin, at the recommended label dose. Live L. setosus on all dogs were counted before treatment and 1, 7, 28 (both groups) and 84 (fluralaner group) days post-treatment according to a coat parting technique at pre-specified locations and lice species were confirmed microscopically. At the same time points, a veterinary dermatology severity score and an owner's perceived pruritus score were recorded. RESULTS: Percentage reduction in geometric mean L. setosus counts, comparing post- with pre-treatment counts within each group, were 85.7% (day 1), 96.8% (day 7) and 100% (days 28 and 84) for the fluralaner (two-sided two-sample t-test, P ≤ 0.0088 for days 1-84) and 67.5% (day 1), 90.3% (day 7) 99.1% (day 28) for the permethrin group (two-sided two-sample t-test, P ≤ 0.0014 for days 7-28). No lice were seen on fluralaner-treated dogs 28 and 84 days post-treatment. In contrast, two permethrin-treated dogs were re-treated at 7 and 28 days after initial treatment because of observed lice. Owner's perceived pruritus scores were reduced compared to pre-treatment levels by 23.8% (day 1), 31.1% (day 7), 70.4% (day 28) and 99.5% (day 84) after fluralaner treatment and 21.3% (day 1), 45.8% (day 7), and 78.1% (day 28) after permethrin treatment. Dermatological signs were improved compared to pre-treatment levels in both treatment groups. CONCLUSIONS: Single oral fluralaner treatment eliminated natural L. setosus infestation on dogs within 28 days and led to complete dermatological recovery that was maintained until the study end on day 84. Single topical permethrin treatment reduced the number of L. setosus by 99.1% at day 28 although two animals required unscheduled re-treatment.

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BACKGROUND: The efficacy of fluralaner for the treatment of Otodectes cynotis infestations in dogs and cats was evaluated after oral (dogs) or topical administration (dogs and cats). Twenty-four dogs and sixteen cats were experimentally infested with O. cynotis and randomly allocated to equal sized groups (n = 8/group). Dog groups were treated once, either orally with fluralaner at a minimum dose of 25 mg/kg body weight, topically with fluralaner at a dose of 25 mg/kg body weight or topically with saline solution (control). Cat groups were treated once, either topically with fluralaner at a dose of 40 mg/kg body weight or topically with saline solution. Ears of all animals were examined otoscopically for live visible mites and the amount of debris and cerumen before, and 14 and 28 days after treatment. Twenty-eight days after treatment, animals were sedated and both ears were flushed to obtain the total number of live mites per animal. The efficacy was calculated, based on the results of the ear flushing, by comparing mean live mite counts in the fluralaner treated groups versus the saline solution treated group. RESULTS: A single topical treatment of cats with fluralaner reduced the mean mite counts by 100% (P < 0.001) at 28 days after treatment. Similarly, a single oral or topical treatment of dogs with fluralaner reduced the mean mite counts by 99.8% (P < 0.001) at 28 days after treatment. Cats treated topically with fluralaner had no mites visible during otoscopic examination at either 14 or 28 days after treatment. All dogs treated orally or topically with fluralaner had no mites visible during otoscopic examination at 28 days after treatment. At 14 days after treatment, only 1-2 mites were visible in three dogs (oral treatment: 2 dogs, topical treatment: 1 dog). All fluralaner-treated animals showed improvement in the amount of cerumen exudation compared with observations performed before treatment. No treatment related adverse events were observed in any dogs or cats enrolled in these studies. CONCLUSIONS: In this study, fluralaner administered topically to cats and orally or topically to dogs was highly effective against Otodectes cynotis mite infestations.

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OBJECTIVE:To establish the method for the content determination of 4 active components in Compound xiaosuanzao chewable tablets.METHODS:HPLC-ELSD method was adopted.The determination was performed on a Grace Brava C18-BDS column with mobile phase consisted of acetonitrile-water (gradient elution) at the flow rate of 1.0 mL/min.The column temperature was 25 ℃,and sample size was 20 μL.The drift tube temperature is 100 ℃,and the carrier gas flow rate is 2.9 L/min.RESULTS:The linear ranges of betulic acid,betulinol,pachymic acid and glycyrrhizic acid were 44.50-890.0 μg/mL (r=0.999 3),20.28-405.6 μg/mL (r=0.999 7),20.50-656.0 μg/mL(r=0.999 7) and 10.50-336.0 μg/mL(r=0.999 6),respectively.RSDs of precision,stability and reproducibility were all lower than 3.0％.The recoveries were 99.44％-101.12％ (RSD=0.57％,n=6),99.41％-100.39％ (RSD=0.34％,n=6),99.31％-100.46％ (RSD=0.51％,n=6),98.96％-101.19％ (RSD=0.84％,n=6),respectively.CONCLUSIONS:The method is simple,precise,stable and reproducible,and can be used for simultaneous determination of 4 active components in Compound xiaosuanzao chewable tablets.