论文部分内容阅读
目的:制备补骨咀嚼片并优化其处方工艺。方法:采用单因素试验对填充剂、矫味剂、润湿剂和润滑剂进行筛选;以外观、口感、风味为指标,采用模糊数学评价法和响应面法进一步优化填充剂和矫味剂用量,并对最优处方所制制剂进行验证。结果:最优处方(1 000片)为:杜仲333.3 g,骨碎补166.7 g,D-氨基葡萄糖盐酸盐250.0g,硫酸软骨素33.3 g,柠檬酸钙250.0 g,甘露醇204.2 g,木糖醇58.3 g,乳糖52.5 g,阿斯巴甜2.9 g,硬脂酸镁9.1g,制粒润湿剂为95%乙醇。所制咀嚼片表面光滑,色泽均匀,口感良好,片重差异、硬度、脆碎度等各项指标均符合咀嚼片相关质量要求。结论:优选的处方工艺稳定、可行,可用于制备补骨咀嚼片。
Objective: To prepare chewable tablets and optimize its prescription process. Methods: The filler, flavoring agent, wetting agent and lubricant were screened by single factor test. The appearance, taste and flavor were used as indices to evaluate the effect of filler and flavoring agent by fuzzy mathematics evaluation and response surface methodology , And the formulation of the best prescription to verify. Results: The optimal prescription (1 000 tablets) was: 333.3 g of Eucommia ulmoides, 166.7 g of drynaria, 250.0 g of D-glucosamine hydrochloride, 33.3 g of chondroitin sulfate, 250.0 g of calcium citrate, 204.2 g of mannitol, 58.3 g of sugar alcohol, 52.5 g of lactose, 2.9 g of aspartame, 9.1 g of magnesium stearate and 95% of granulating wetting agent. The prepared chewable tablet has the advantages of smooth surface, uniform color, good taste, different tablet weight, hardness, friability and other indexes conforming to the quality requirements of the chewable tablet. Conclusion: The preferred prescription process is stable and feasible, which can be used to prepare bone-augmented chewable tablets.