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目的研究乳癖内消片的制备工艺及质量标准。方法采用半浸膏片的生产工艺制成制剂,使用显微和薄层色谱法进行鉴别,通过加速试验对其初步稳定性进行预测。结果各项检查均符合药典要求;薄层鉴别图谱斑点清晰,分离度好。成品置于温度37℃～40℃、相对湿度75%环境,分别于0,1,2,3月对其外观性状、鉴别、检查等稳定性项目进行测定,各项检测指标均无明显变化,表明该产品质量稳定。结论制备工艺成熟稳定可行,操作简便;质量可控。
Objective To study the preparation technology and quality standard of Rupi Neixiao. Methods The preparation process of the preparation was made by using the technology of semi-extract patch and identified by microscopic and TLC. The preliminary stability of the preparation was predicted by accelerated test. Results of the tests are in line with the requirements of pharmacopoeia; TLC identification spots clear, good resolution. The finished products were placed in the environment of temperature 37 ℃ ~ 40 ℃ and relative humidity 75%, and their appearance, identification, inspection and other stability items were measured in January, January, February and March, respectively. There was no obvious change in each index, Shows that the product quality and stability. Conclusion The preparation process is mature, feasible and easy to operate with quality controllable.