鹿青胶囊缓控释制剂的处方及制备工艺研究..docVIP

鹿青胶囊缓控释制剂的处方及制备工艺研究 【摘要】目的：为了研究鹿青胶囊缓控释制剂的处方及制备工艺，提高依从性和临床效果。方法：应用正交实验设计方法进行处方筛选，通过测定青藤碱标准品的溶出得到浓度-吸光面积回归方程，计算正交实验九个批次的累计溶出度，最够根据2010版药典标准进行处方合理性判断。结果：青藤碱标准品回归方程为C=6.49A×10-5+0.071（R=0.9995，线性范围为1.10ug/mL-105.6 ug/mL），正交实验筛选出的最优处方是羟苯甲纤维素、乳糖和酒精浓度分别为110g，20 g和40%，经制粒和装填后制得的鹿清胶囊缓控释制剂的拟合度符合药典要求。结论：鹿青胶囊缓控释制剂能延缓释药时间，维持血药浓度，增加了患者的用药依从性。 【关键词】鹿青胶囊，处方，制备工艺 Lu Qing Capsule controlled release preparation and preparation process [Abstract] Objective: To study Lu Qing Capsule controlled release preparation and preparation process, improve the compliance and clinical effect. Methods: using the orthogonal design method of prescription screening, through the determination of sinomenine standard solution concentration - absorption area of the regression equation, the calculation of nine batches of orthogonal experiment and the cumulative release, the prescription was reasonable enough judgment according to the Chinese Pharmacopoeia 2010 Edition standard. Results: the sinomenine standard regression equation was C=6.49A (R=0.9995 × 10-5+0.071, linear range of 1.10ug/mL-105.6 ug/mL), the optimal formulation by orthogonal experiment selected is hydroxyl benzene methyl cellulose, lactose and alcohol concentration were 110g, 20 g and 40%, pelletizing and filling of deer Qing Capsule controlled release preparations the fit of the Pharmacopoeia requirements. Conclusion: Lu Qing Capsule controlled release preparation can delay the release time, maintaining blood concentration, increased the medication compliance of patients. [keyword] Lu Qing Capsule, prescription, preparation technology 鹿清胶囊是一种主要用来治疗类风湿性关节炎的中成药，在临床上的应用比较广泛[1]，鹿清胶囊的中药方剂组成成分是包括青风藤、鹿衔草和穿山龙等在内的十七味植物药，具有明显的养血活络、强肝荣筋、壮阳益肾和增强免疫的效果。很多临床研究结果显示[2-3]，鹿清胶囊在治疗类风湿性关节炎方面具有疗效明确和不良反应低等特点，能在很大程度上缓解患者疼痛等临床表现。但在长期的临床应用过程中，人们发现鹿清胶囊服药后释药速度较快，而且在体内的消除速度很快，半衰期较短，患者需要通过多次给药的方式才能维持有效的血药浓度，这大大降低了患者的用药依从性，也在一定程度上增大了鹿清胶囊的不良反应发生率[4]。从这个角度出发，笔者通过研究鹿青胶囊缓控释制剂的处方及制备工艺，旨在提高药物的用药依从性和临床治疗效果，现将研究结果报道如下： 1资料与方法 1.1一般资料 鹿清胶囊缓控释制剂的辅料包括羟丙甲纤维素（HPMC,购自北京华金盛科技科技有限