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To enhance the quality evaluation and control of traditional Chinese medicine (TCM) and ensure the safety and efficacy of clinical medication, it is imperative to establish a comprehensive quality assessment method aligned with TCM efficacy. This study uses a representative Chinese medicine with multi-origin and multi-efficacy, Paris polyphylla var. yunnanensis (PY), as an illustrative example. Surprisingly, despite the high fingerprint similarity among the 12 batches of PY samples collected from various regions in Yunnan, a notable variation in the composition and content of components was observed. The chromatographic analysis identified seven common peaks, namely, polyphyllin I, polyphyllin II, polyphyllin V, polyphyllin VI, polyphyllin VII, polyphyllin H, and polyphyllin D. In the bioactivity evaluation, an in vitro antiplatelet aggregation model induced by adenosine diphosphate was established, showcasing excellent stability. The maximum antiplatelet aggregation inhibition rate for all PY samples consistently remained stable at 73.1%-99.1%. However, the 50% inhibitory concentration (IC50 ) values exhibited a range from 1.615 to 18.200 mg/mL. This approach not only meets high-throughput screening requirements but also demonstrates remarkable discrimination. The results of chemical and bioactivity evaluations were analyzed using hierarchical cluster analysis and canonical correlation analysis. Polyphyllin I, polyphyllin II, polyphyllin VII, polyphyllin H, and polyphyllin D were identified as the Q-markers for antiplatelet aggregation in PY samples. Validation of the bioactivity for these monomer components aligned with the previously mentioned findings. Notably, this study established a spectrum-effect model for PY samples, enhancing the scientific robustness of the quality evaluation method. Furthermore, these findings offer valuable research insights for improving the quality assessment of other TCMs.

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This study aimed to develop a streamlined method for evaluating the dilution ratio of drug dose-response plates created by automated liquid handlers in the early stages of drug discovery. The quantitative techniques commonly used for this purpose have restrictions due to their limited linear dynamic range and inaccuracies in assessing serial dilution performance. To address this challenge, we describe a method based on acoustic ejection mass spectrometry (AEMS). The method involves using standard compounds and an internal standard to evaluate each dilution point in quality control (QC) plates. The samples are transferred to a chromatography-free tandem mass spectrometry system through an acoustic source, enabling the analysis of one sample per three seconds from a microtiter plate. This approach provides precise, accurate, label-free, and rapid data acquisition to support high-throughput screening efforts.

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Chuanxiong Rhizoma is a traditional Chinese medicine (TCM) that is used to promote blood circulation. We set out to improve Chuanxiong Rhizoma quality standards using a bioassay-based Effect-constituent Index (ECI). We performed high performance liquid chromatography (HPLC) analysis to determine the chemical constituents of 10 Chuanxiong Rhizoma samples from different locations. We then constructed a direct bioassay method to investigate each sample's antiplatelet aggregation effects. To screen for active ingredients that promote antiplatelet aggregation, we carried out Pearson correlation analyses between biopotency and compounds identified in the HPLC data. We developed an ECI of platelet aggregation inhibition using a multi-indicator synthetic evaluation method based on the integration of biopotency and active constituents. To further assess the biopotency-based Chuanxiong Rhizoma quality evaluation result accuracy, we compared the ECI with the chemical indicator' method. Eight common chemical fingerprints peaks indicated notable content variation among samples. Biological evaluation showed that all 10 samples could inhibit platelet aggregation, although they had significantly different biological potencies. Using spectrum-effect relationships, we determined that Ligustilide was the significant active constituent responsible for antiplatelet aggregation. Using correlation analysis, we found that ECI correlated with the Chuanxiong Rhizoma extract's platelet aggregation inhibitory effect. Additionally, ECI proved to be a good indicator of Chuanxiong Rhizoma quality, whereas chemical indicators failed to distinguish and predict the biopotency-based quality grade. This work indicates that ECI is a useful tool for associating sample quality with chemical markers linked to TCM clinical effects. ECI also provides a paradigm for improving the quality control of other TCMs that invigorate blood circulation.

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Citrate anticoagulant concentration affects the results of coagulation tests. Until now, the end user had no direct insight into the quality of evacuated blood collection tubes. By introducing an easy-to-perform UV spectrometric method for citrate determination on a purified water model, we enabled the evaluation of (1) the accuracy of the anticoagulant amount added into the tubes by a producer, (2) the accuracy of the volume of anticoagulant solution in the tube at the instant of examination, (3) the anticoagulant concentrations at a draw volume. We examined the Vacuette®, Greiner BIO-ONE, Vacutube, LT Burnik d.o.o., and BD Vacutainer® tubes. The anticoagulant amount added into the tubes during production had a relative bias between 3.2 and 23.0%. The anticoagulant volume deficiency at the instant of examination expressed as a relative bias ranged between -11.6 and -91.1%. The anticoagulant concentration relative bias after the addition of purified water in a volume that equalled a nominal draw volume extended from 9.3 to 25.7%. Draw-volume was mostly compliant during shelf life. Only Vacutube lost water over time. Contamination with potassium, magnesium, or both was observed in all the tubes but did not exceed a 0.21 mmol/L level. This study enables medical laboratories to gain insight into the characteristics of the citrate blood collection tubes as one of the preanalytical variables. In situations that require anticoagulant adjustment for accurate results, this can help make the right decisions. The methodology gives producers additional means of controlling the quality of their production process.

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This study aimed to identify the antiplatelet aggregation quality markers of Salvia yunnanensis (SY) based on an integrated approach. The effects of SY methanol extracts on platelet aggregation were measured to evaluate their in vitro biological activity. Chemical composition differences were determined by HPLC. Molecular docking methods were used to assess the action mechanism of the potential active compounds and target proteins in SY. The results showed that 12 batches of SY samples inhibited platelet aggregation. Sodium danshensu, protocatechuic aldehyde, rutin, rosmarinic acid, salvianolic acid B, dihydrotanshinone I, tanshinone I, cryptotanshinone, and tanshinone IIA components were identified using chemical fingerprints. Multivariate statistical analysis indicated that cryptotanshinone, dihydrotanshinone I, tanshinone I, tanshinone IIA, and rosmarinic acid may have been the active components for antiplatelet aggregation, and molecular docking showed that these five components could combine with P2Y12 protein on platelets. Furthermore, platelet aggregation inhibition activity of the five monomers was verified separately and it was obvious that cryptotanshinone and rosmarinic acid inhibited platelet aggregation. Therefore, cryptotanshinone and rosmarinic acid may be the quality markers of SY. This report describes a comprehensive, scientific, and feasible method for SY quality evaluation and provides a preliminary scientific basis for applying the antithrombotic activity of SY.

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Currently, an increasing number of patients are seriously affected by acute thrombotic events. In China, Polygonum multiflorum (PM) is commonly used to treat diseases associated with thrombosis. Our previous work showed that PM could inhibit the platelet aggregation that plays a key role in the pathogenesis of thrombosis. However, the constituents of PM are complicated, and quality control methods cannot completely ensure the quality and clinical efficacy. In an attempts to explore this problem, we constructed a direct bioassay method to evaluate the antiplatelet aggregation effects of PM. To ensure the precision and reliability of this bioassay, we optimized and standardized the experimental conditions and then tested the standardized bioassay by analyzing 10 PM samples. Additionally, we combined chemical and biological evaluation methods to identify antiplatelet aggregation markers. The evaluation indicated that 10 samples of PM could inhibit platelet aggregation and there was a notable difference in biopotency between the different PM groups. Chemical fingerprints revealed variations in the contents of the 7 main peaks. Trans-2,3,5,4'-tetrahydroxy-stilbene-2-O-ß-d-glucoside and catechin might be active constituents of antiplatelet aggregation as determined by spectrum-effect relationships. This work indicates that bioassay and spectrum-effect relationships are useful tools to associate sample quality with the potential chemical markers linked to the clinical effects of Traditional Chinese Medicines.

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Objective: To establish a method of quantitative analysis of multi-components by single marker (QAMS) for determining the flavonoids in Epimedii Herba and improve the level of quality control of Epimedii Herba by applying multi-index components control. Methods: To detect a relative correction factor (RCF) of epimendin A, epimendin B, epimendin C, and icariin at detection wavelength of 270 nm by HPLC in the range of a linear, to investigate the reproducibility of RCF in different chromatographic columns and different instruments as well, to consider icariin as an internal standard, to calculate the contents of epimendin A, epimendin B, and epimendin C in Epimedii Herba by using RCF; Meanwhile, to analyze the content of the four components in 100 Epimedii Herba by external standard method (ESM) and verify the accuracy and scientificalness of QAMS. Results: The RCF had a good reproducibility, which were 1.352, 1.384, and 1.340. The values of RSD were less than 5%; No significant differences were found in the quantitative results of epimendin A, epimendin B, and epimendin C determined by using RCF and ESM. Conclusion: This method could be accurate and reliable, simple and feasible, which could save the reference and costs of testing. It further validates that this approach can be used as a quality control method for the determination of multi-component index in Epimedii Herba.

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This paper reported TLC identification of various Chinese medicines in Renshensinitang Oral Liq- uid,limit dose detection and content determination of aconitine.These methods could be available for internal quality control of Renshensinitang Oral Liquid.

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This article reviews the study on Compound Danshen Tablets. Based on collecting and analyzing literatures, about the pharmacological actions, preparation procedure, quality control methods, dosage improvement, etc. of Compound Danshen Tablets, it is considered that Compound Danshen Tablets has been extensively studied mrecent years, but quality control methods should be improved further and basic research should attract attention.