乙酰半胱氨酸片的制备及处方优化

金鑫; 戴艳群; 倪牡丹; 汪雪君

doi:10.13748/j.cnki.issn1007-7693.20240735

乙酰半胱氨酸片的制备及处方优化

Preparation and Formulation Optimization of Acetylcysteine Tablets

摘要

摘要:
目的对比乙酰半胱氨酸N-乙酰基-L-半胱氨酸(N-acetyl-L-cysteine，NAC)片不同制备工艺，优化NAC片剂处方。
方法根据参比制剂信息和先验知识确定初处方，然后筛选出较优工艺，并进行处方筛选和实验设计，以溶出度、脆碎度和产品稳定性为考察指标，优化处方。
结果确定粉末直压法为较优工艺，NAC的粒度分布对产品质量有显著影响，筛选得到较优的NAC粒度分布范围为150~400 μm。
结论粉末直压工艺适用于NAC片的制备，工艺重现性好、产品适口性佳，关键质量符合要求。

Abstract:
OBJECTIVE To compare different preparation processes of acetylcysteine(N-acetyl-L-cysteine, NAC) tablets and optimize the formulation.
METHODS Initial prescription was determined based on reference formulation information and prior knowledge. Then the optimal process was selected, the prescription was screened, and design of experiments was carried out to optimize the prescription, with dissolution, friability, and stability as the evaluation indexes.
RESULTS Direct powder compression method was determined as the optimal process. The particle size distribution of NAC had a significant effect on product quality. The optimal particle size distribution range of NAC obtained from screening was 150–400 μm.
CONCLUSION The direct powder compression method is suitable for preparation of NAC tablets, which has good reproducibility and palatability, and meets the key quality requirements.

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