中药浓缩丸溶散时限影响因素的探讨

The exploration of the influence factors of Chinese concentrated pills dissolution time

通过前期对6个厂家的20个中药浓缩丸品种进行溶散时限的考察,发现部分中药浓缩丸品种存在溶散时限不合格的问题。考察样品中,有近30%的中药浓缩丸品种,其溶散时限超过了120 min,还有近20%的中药浓缩丸品种,其溶散时限接近120 min,而溶散时限是评价中药浓缩丸质量、药物生物利用度以及临床疗效的重要指标之一。为此,本文结合中药制剂理论,对中药浓缩丸溶散时限的影响因素进行了深入的分析与探讨,为合理设计中药浓缩丸制备工艺、增强其临床疗效奠定理论基础。

Through the previous investigation of dissolution time of 20 varieties of Chinese concentrated pills from six different manufacturers, the research finds that some Chinese concentrated pills have the problem of dissolution disqualifications. The results show that dissolution time of nearly 30 percent of Chinese concentrated pills samples exceed 120 minutes. Meanwhile, the dissolution time of about 20 percent of Chinese concentrated pills samples close to 120 minutes. The dissolution time is one of the important factors which directly influence the qualifications, the bioavailability and clinical effects of the drug. Therefore, combining with the theory of Chinese medicine, the affecting factors of the dissolution time of Chinese concentrated pills are analyzed and discussed to provide reference for the rational design of Chinese concentrated pills preparation process and enhancement of clinical effects.