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目的:探讨符合中医药特点的中药固体制剂质量控制与评价的化学-生物联合评价模式。方法:以金银花颗粒为模型药,采用菌敏试验(最小抑菌浓度和最小杀菌浓度的测定)考察金银花提取液对4种标准菌株(金黄色葡萄球菌、变形链球菌、大肠埃希菌、铜绿假单胞菌)的抑菌性。建立敏感菌抑菌圈直径与不同浓度金银花提取液之间的相关曲线,计算不同厂家金银花颗粒的生物效价,并将测定结果与HPLC法测定(以绿原酸计)的结果相比较。结果:抑菌实验表明,金银花对金黄色葡萄球菌、变形链球菌、大肠埃希菌、铜绿假单胞菌敏感,其中金黄色葡萄球菌的抑菌圈边缘清晰、敏感度较高。当金银花的质量浓度在0.0142~0.0680 g·ml~(-1)范围内时,对数浓度与反应效应呈线性关系,且相关性好(r=0.990 9)。结论:以生物活性为导向的效价评价方法有望成为评价中药固体制剂有效成分含量的手段之一,可配合传统检验方法对中药材及其制剂进行质量监控。
Objective: To explore the chemical-biological joint evaluation model of quality control and evaluation of Chinese traditional medicine in line with the characteristics of traditional Chinese medicine. Methods: With honeysuckle granules as model drug, the effects of honeysuckle extract on four standard strains (Staphylococcus aureus, Streptococcus mutans, Escherichia coli, patina Pseudomonas) bacteriostasis. The correlation curve between the diameters of bacteriostatic zone and the extracts of honeysuckle was established. The biological potency of the honeysuckle particles from different manufacturers was calculated. The results were compared with those obtained by HPLC (chlorogenic acid). Results: The bacteriostasis experiments showed that honeysuckle was sensitive to Staphylococcus aureus, Streptococcus mutans, Escherichia coli and Pseudomonas aeruginosa. The bacteriostatic circle of S. aureus was clear and sensitive. When the concentration of honeysuckle was in the range of 0.0142 ~ 0.0680 g · ml -1, the logarithmic concentration had a linear relationship with the response effect, and the correlation was good (r = 0.990 9). CONCLUSION: Bioactive-based titer evaluation method is expected to become one of the means to evaluate the content of active ingredients in traditional Chinese medicine. It can be used in combination with traditional test methods to monitor the quality of traditional Chinese medicines and their preparations.