The Bioassay Method Used For Quality Control Of Blood Circulation Category Of Tcm Injections

Anti-Stasis Chinese Herbal Injections (ASCHI) are commonly used in the treatment of cardiovascular and cerebrovascular diseases. And the quality of these injections is very important for patients'lives. But it is difficult to control the quality and characteristics of TCM by the currently used models and methods on TCM quality control guided by the theory of "several compound only", let alone to reflect the efficiency and safety of TCM. Therefore, it is necessary to bring in a bioassay for Anti-Stasis Chinese Herbal Injections, so that to control the quality of ASCHI by the comprehensive evaluation of both the bioassay and the currently used models.This thesis, doublely guided by theories of Traditional Chinese Medicine and bioassay statistics, was a exploratory research on the bioassay of ASCHI by activated partial thromboplastin time (APTT). The main contents and results were shown as follow:1 The establishment of an APTT-based biological assayWith heparin as a model drug, the difference among the APTT-based bioassay, the rabbit blood method of ChP2005 and the sheep plasma method of USP32 had been investigated. And both the test system evaluation and the methodological study of APTT-based biological assay had been done in this part. The results showed that (1) The APTT-based bioassay was coincided with rabbit blood method and the sheep plasma method in the result (P>0.05). (2) Fresh rabbit plasma and frozen sheep plasma were more suitable than others as the heparin APTT-based bioassay test system for their better stability. (3) There was a good linear relationship (r=0.9965) between heparin and the log clotting time in the concentration of 0.7-3IU·ml-1. (4) When sample potency was in the 80-120% range of standard preparation, the APTT-based bioassay was reliable (the regression was significant, P<0.01; the deviation from parallel, the quadratic curve and the inverse quadratic curve was not significant, P>0.05). The result has both good reproducibility (RSD=1.45%, n=6) and good intermediate precision (RSD=1.61%, n=6). But beyond this range, it was necessary to re-estimate sample potency, and to retest.2 Methodological study of the APTT-based bioassay on 3 Kinds of Anti-Stasis Chinese Herbal InjectionsTo investigate the application perspective of APTT-based bioassay on Anti-Stasis Chinese Herbal Injections, Danshen injection, Safflower injection and Shuxuening injection had been studied as representative drugs. The results showed that the percent concentration of Danshen injection, safflower injection and Shuxuening injection showed respectively good linear relationship with the 3 times log conversion of APTT in a certain range (r=0.9971, 0.9972 and 0.9964); APTT-based bioassay on the 3 injections were all reliable, accurate and good reproducibility (RSD<5%). The results proved the feasibility of the APTT-based bioassay on Anti-Stasis Chinese Herbal Injections.3 Study on the quality control of Shuxuening injection by APTT-based bioassayWith Ginkgo biloba leaf extract injection as the standard reference material, to establish a APTT-based bioassay for Relative Biological Potency (RBP) of Shuxuening injection. The methodological study showed that, when sample potency was in the 80-120% range of standard reference material, the bioassay was reliable, the result has both good reproducibility (RSD=4.40%, n=6), and good intermediate precision (RSD=1.90%, n=6). According to this method,24 groups Shuxuening injections of 8 manufactories had been measured by RBP. And the result had been analyzed related with the content determination, the security test and the finger print. It had been found that the samples of which the relative potency deviated far from the standard reference material, its content determination or security test results could not meet the requirement, too. And conversely, the samples'content determination or security test results were qualified. The verified rate is 87.5%. So it seemed that the APTT-based bioassay was coincided with the currently quality control models on Shuxuening injection. By controlling the RBP range, it had a bright perspective to control the quality of Shuxuening injection, or even of the ASCHI, quickly, conveniently, sensitively and accurately.