保利尔胶囊处方替代质量标准研究

Study on Quality Standard for Prescription Replacement of Baolier Capsule

摘要: 目的：为了产业的可持续发展，保利尔胶囊立题研究减去处方中濒危药材，并对处方替代后产品的质量可控性进行研究。方法：采用显微、TLC及气相色谱等方法对处方多味药材进行定性控制，采用高效液相色谱法对方中丹参的有效成分丹参酮IIA、丹酚酸B进行定量控制。结果：丹参酮IIA在0.020064~0.40128 g范围内呈良好的线性关系(r = 0.9993)；丹酚酸B在0.0683~1.3660 g范围内呈良好的线性关系(r = 0.9996)。结论：本法灵敏，准确，专属性强，重现性好，可作为该制剂的质量控制方法。

Abstract: Objective: In order to promote the sustainable development of the industry, Polyl Capsules was selected to subtract the endangered medicinal materials from the prescriptions and to study the quality control of the substituted products. Methods: Microscopic, TLC and gas chromatography were used to qualitatively control the MULTI-INGREDIENTS of the prescription. Tanshinone IIA and Salvianolic acid B in the prescription were quantitatively controlled by high performance liquid chromatography. Results: Tanshinone IIA showed a good linear relationship in the range of 0.020064 - 0.40128 g (r = 0.9993); Salvianolic acid B showed a good linear relationship in the range of 0.0683 - 1.3660 g (r = 0.9996). Conclusion: The method is sensitive, accurate, specific and reproducible, and can be used for the quality control of this preparation.