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目的:初步探讨不同物料参数及配比与中药丸剂有效性关系,通过改变物料配比改变中药丸剂的生物有效性。方法:选取不同物料的代表药物并测定其物料参数,以均匀设计法自拟12个处方并制备模型丸剂,用HPLC法测定处方中苦参碱含量,根据Weibull分布提取溶出参数,用SPSS 20.0处理数据。结果:不同物料配比的模型丸剂中苦参碱在不同时间点的溶出百分率不同,如2 min时处方1的溶出百分率最低(2.78%),处方12的溶出百分率最高(39.00%);240 min时处方1的溶出百分率最低(82.90%),处方12的溶出百分率最高(99.26%)。结论:纤维类、淀粉类、矿物类对丸剂溶出有明显促进溶出作用,树脂类、油脂类、蛋白类对丸剂溶出有明显的阻滞作用,而多糖类对丸剂溶出影响不显著。吸湿率、吸水率、吸水膨胀率、比黏度等物料参数与体外溶出也有相关性。
OBJECTIVE: To explore the relationship between different material parameters and the ratio of traditional Chinese medicine pills, and to change the bioavailability of traditional Chinese medicine pills by changing the ratio of materials. Methods: The representative drugs of different materials were selected and their material parameters were determined. Twelve prescriptions were prepared by self-designed method and the model pills were prepared. The content of matrine in prescription was determined by HPLC. The dissolution parameters were extracted by Weibull distribution and treated with SPSS 20.0 data. Results: The percentages of dissolution of matrine at different time points were different in different formulations. For example, the dissolution percentage of prescription 1 was the lowest (2.78%) at 2 min, the dissolution percentage of prescription 12 was the highest (39.00%) at 240 min The dissolution percentage of prescription 1 was the lowest (82.90%), while that of prescription 12 was the highest (99.26%). CONCLUSION: Fibers, starches and minerals can obviously promote the dissolution of pellets. The resins, lipids and proteins have a significant retardation effect on the dissolution of pellets, while polysaccharide has no significant effect on pellet dissolution. Moisture absorption, water absorption, water swelling, specific viscosity and other material parameters and in vitro dissolution are also relevant.