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目的:研究黄连微生物检定法的适用剂量范围,建立标准曲线和它们对敏感菌株的剂量效应曲线,并且根据黄连量效曲线去测定不同厂家黄连上清丸的效价,从而建立黄连和黄连上清丸的质量标准。方法:采用菌敏试验考察黄连水提液对5种标准菌株(大肠杆菌CMCC(B)44103、金黄色葡萄球菌CMCC(B)26 003、枯草芽胞杆菌CMCC(B)63 501、藤黄微球菌CMCC(B)28001、白色念珠菌CMCC(F)98001)的抑菌性。利用黄连提取液对敏感菌的抑菌圈直径大小和浓度建立标准曲线,根据量效曲线测定不同厂家产地的黄连和黄连上清丸的效价。然后采用中国药典(2005版)一部黄连和黄连上清丸项下的薄层扫描法、HPLC法,对以上不同产地批次黄连及黄连上清丸中的盐酸小檗碱进行测定以验证以上效价结果。比较用生物检定法和药典传统方法作为质控指标的异同。结果:当黄连的浓度在0.0256g/m l~0.1526g/m l范围内时,黄连的对数剂量和反应效应呈线性关系,且相关性好(r=0.9912);生物检定法和HPLC法作为质控指标得出质量评价结果基本相同。结论:采用微生物检定法建立黄连、黄连上清丸的质量控制方法是可行的。它可以有效配合传统检验方法对黄连药材进行质量监控。
OBJECTIVE: To study the suitable dose range of the method for the determination of berberine and to establish a standard curve and their dose-response curves for the susceptible strains. According to the berberine dosage-effect curve, the potency of Coptis into different groups was determined, Quality Standard. Methods: The antibacterial activity test was used to investigate the effects of aqueous extract from Coptis chinensis Franch on five standard strains (Escherichia coli CMCC (B) 44103, Staphylococcus aureus CMCC (B) 26 003, Bacillus subtilis CMCC (B) 63 501, Micrococcus luteus CMCC (B) 28001, Candida albicans CMCC (F) 98001). Using the extract of Coptis chinensis to establish a standard curve for the diameter and concentration of the bacteriostatic zone of the susceptible bacteria, the potency of Coptis chinensis and Coptis Chinensis pill from different manufacturers was determined according to the dose-response curve. Then using the Chinese Pharmacopoeia (2005 Edition) a Coptis and Coptis Qingxuan pills under the TLC scanning, HPLC method above different origin Coptis and berberine hydrochloride berberine determination to verify the above titer result. Compare the similarities and differences between the traditional methods of bioassay and pharmacopoeia as quality control index. Results: When the concentration of Coptis was in the range of 0.0256g / ml ~ 0.1526g / ml, the logarithmic dose of Coptis chinensis had a linear relationship with the response effect (r = 0.9912). The bioassay and HPLC Control indicators come to the same quality evaluation results. Conclusion: It is feasible to establish the quality control method of Coptis chinensis and Huanglianshangqing pills by the method of microbial test. It can effectively cooperate with the traditional test methods for the quality control of Coptis.