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目的研究温脾补肾片的最佳成型工艺。方法通过单因素重复试验,考察填充剂、润湿剂和润滑剂的种类及用量对本制剂成型性能的影响,以颗粒的吸湿性、片剂的外观、颗粒的流动性、片剂的硬度、片剂的崩解度等为指标,优选出最佳成型工艺。结果最佳成型工艺为选用淀粉为填充剂(浸膏粉与淀粉的配比为5:1),以90%乙醇(20%)为润湿剂制软材,并用硬脂酸镁(0.5%)为润滑剂。结论制得的片剂符合《中国药典》2010版有关项下的规定。
Objective To study the best forming process of Wenpi Bushen Tablet. Methods Through the single factor repeated test, the effects of the types and dosage of fillers, wetting agents and lubricants on the formability of the preparation were investigated. The moisture absorption of the granules, the appearance of the tablets, the fluidity of the granules, the hardness of the tablets, The degree of disintegration of the agent as an index, preferably the best forming process. Results The best forming process was that starch was used as filler (the ratio of extract powder to starch was 5: 1), soft material was made of 90% ethanol (20%) and wetting agent was made with magnesium stearate (0.5% ) As a lubricant. Conclusion The tablets obtained comply with the requirements of the 2010 edition of the Chinese Pharmacopoeia.