The establishment of quality evaluation of traditional Chinese medicine system that not only accords with Chinese medicine function characteristics but also is recognized as international medical circles, is an arduous task in urgent need of solving the current modernization of traditional Chinese medicine in the process of internationalization. It is difficult to evaluate atraditional Chinese medicine by detection of single active components in traditional Chinesemedicinewiththe western medicine quality controlmethod due to the overall effects of traditional Chinese drugs, the components of the overall diversity, targets, and the complexity of the interaction between components of unpredictable make the Long-term since, domestic and foreign scholars continue to explore and put forward a series of quality evaluation of traditional Chinese medicine to promote the development of traditional Chinese medicine. This article summarized the related academic ideas and developments to, providea new thought and perspective for the quality control of traditional Chinese medicine.
Drug Evaluation ; methods ; standards ; Drugs, Chinese Herbal ; chemistry ; Humans ; Medicine, Chinese Traditional ; standards ; Quality Control

Quality control is one of the key scientific tissues in the modernization of traditional Chinese medicines (TCM). In order to overcome the deficiencies of assessment indexes, including little systematization and quantification, as well as loose association with clinical efficacy and dosage, a new integrated method named controllability pyramid ( CP) is first proposed in this paper. In addition, some study cases are used to explain how this model is constructed. We hope the establishment of CP could promote the clinical-orien- ted integrated innovation research of TCM, and provide control strategy and technology examples for improving the quality of Chinese medicines and clinical efficacy.
China ; Drug Evaluation ; methods ; standards ; Drug Therapy ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; standards ; Humans ; Medicine, Chinese Traditional ; standards ; Quality Control

The efficacy material base of traditional Chinese medicines (TCMs) is those constituents absorbed in blood and show the efficacy of TCMs after oral administration of a TCM formula. In TCM, formula consisted of more than one herbal drug is the clinical medication form which corresponding to TCM syndrome. The efficacy material base of TCMs had to be found in the condition of compatibility and efficacy of TCM formula. Therefore we take the biological characters of TCM syndrome as a research starting point, taking formula as object, through the integration of serum pharmacochemistry of TCM methods and metabolomics technologies, establish a system research methodology of the efficacy material basis in vivo--Chinmedomics. The use of metabolomics technology is used to fully understand nature biology on syndromes or disease, identify biomarkers for disease to bridging disease animal model, establishing the biological evaluation system of traditional Chinese medicine. On the basis of the validity of the premise, the use of serum pharmacochemistry of TCM to analysis in vivo directly substance after oral prescription and dynamic law, combined with changes law of the endogenous disease biomarkers (pharmacodynamic markers of TCM), Though establishing two variable correlation analysis method between Chinese chemical compositions in serum exogenous and endogenous biomarkers, to extract TCM compositions highly correlated with the endogenous marker as potential basis for traditional Chinese medicines, and to biological validation to determine the efficacy material basis of TCM.
Animals ; Biomarkers ; blood ; Drug Evaluation ; methods ; standards ; Drugs, Chinese Herbal ; pharmacokinetics ; Humans ; Metabolomics ; Phytotherapy

PURPOSE: The current methods used to evaluate the efficacy of drug products are inadequate. We propose a non-inferiority approach to prove the safety of drugs. MATERIALS AND METHODS: Traditional hypotheses for the evaluation of the safety of drugs are based on proof of hazard, which have proven to be inadequate. Therefore, based on the concept of proof of safety, the non-inferiority hypothesis is employed to prove that the risk of new drugs does not exceed a pre-specified allowable safety margin, hence proving that a drug has no excessive risk. The results from papers published on Vioxx(R) and Avandia(R) are used to illustrate the difference between the traditional approach for proof of hazard and the non-inferiority approach for proof of safety. RESULTS: The p-values from traditional hypotheses were greater than 0.05, and failed to demonstrate that Vioxx(R) and Avandia(R) are of cardiovascular hazard. However, these results cannot prove that both Vioxx(R) and Avandia(R) are of no cardiovascular risk. On the other hand, the non-inferiority approach can prove that they are of excessive cardiovascular risk. CONCLUSION: The non-inferiority approach is appropriate to prove the safety of drugs.
Biometry/*methods ; Confidence Intervals ; Controlled Clinical Trials as Topic ; Data Interpretation, Statistical ; Drug Evaluation/*methods/standards ; Drug Toxicity/prevention & control ; Humans ; Models, Statistical ; Research Design/standards

The evaluation on clinical efficacy of traditional Tibetan medicine (TTM) is an important scientific subject during the development of TTM. Firstly, the authors introduced the current situations and problems in evaluation on clinical efficacy of traditional Tibetan medicine both at home and abroad in this study. Secondly, they compared the similarities and differences between TTM and traditional Chinese medicine (TCM) in evaluation on clinical efficacy, define their differences in details but not in nature, and proposed that TTM could selectively learn TCM's experiences in clinical research and build a specific methodology system for evaluation on clinical efficacy according to its own characteristics. Thirdly, they discussed the methodological challenges in evaluation on clinical efficacy of TTM, including the pending clinical research guidelines and disease diagnosis standards according to its own characteristics. Finally, they propound some suggestions for promoting the evaluation on clinical efficacy of TTM, including the comprehensive application of multiple research methods, overall research-based evaluation on efficacy of TTM complex intervention and selection of accepted and objective outcome indexes for efficacy evaluation.
Biomedical Research ; Clinical Trials as Topic ; Drug Evaluation ; methods ; standards ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Medicine, Tibetan Traditional ; Treatment Outcome

OBJECTIVETo establish a new quality evaluation method for Chinese herbal medicine, using one chemical reference substance to calculate multi-components simultaneously.

METHODRelative correction factors (RCF) of mutongsaponin B and C to saponin PJ1, a characteristic component as marker, were calcalated in The chromatographic conditions for determination of the three saponins in Caulis Akebiae akebiae as a research model. The contents of saponin PJ1 were determined by external standard method, and those of mutongsaponin B and C were calculated by saponin PJ1 and their RCF. The accuracy of the new method was evaluated by comparing the calculated contents with the determined contents.

RESULTThe analysis procedures were validated. There has been no significant difference between the calculated contents and the determined contents, according to the angle cosine value, and the calcalated RCF have confidence value.

CONCLUSIONThe method of multi-components quantitation by one marker has been verified in caulis akebiae and it is to be a new quality evaluation pattern for Chinese herbal medicines.

Animals ; Chromatography, High Pressure Liquid ; methods ; Drug Evaluation, Preclinical ; methods ; Drugs, Chinese Herbal ; analysis ; standards ; Humans ; Magnoliopsida ; chemistry ; Plant Stems ; chemistry ; Plants, Medicinal ; chemistry ; Reproducibility of Results ; Saponins ; analysis

OBJECTIVETo probe into the feasibility of screening anti-HIV compounds by using HIV-1 p24 detection kit made by Hebei Medical University.

METHODSThe sensitivity, reproducibility and efficacy of the Hebei p24 kit were evaluated compared with the commercially available Vironostika HIV-1 Antigen Microelisa System (Biomerieux).

RESULTSHebei p24 kit had high sensitivity and good reproducibility. In vitro screening demonstrated that there was no statistically significant difference (P greater than 0.05) between these two kits in assessing anti-HIV compounds.

CONCLUSIONHebei p24 kit could be used as an easily affordable alternative method for detection of HIV-1 in screening anti-HIV compounds.

Anti-HIV Agents ; isolation & purification ; pharmacology ; Cell Line ; Drug Evaluation, Preclinical ; instrumentation ; methods ; Feasibility Studies ; HIV Core Protein p24 ; analysis ; HIV-1 ; drug effects ; growth & development ; immunology ; Humans ; Reagent Kits, Diagnostic ; standards ; Reproducibility of Results