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目的:通过对海布玻璃胶囊原料的选用及制备中间体(浸膏)的稳定性研究,进一步确定中间体的技术考量参数。方法:按照吉林省食品药品监督管理局批准的制剂工艺标准,选择原料来源及制备中间体,并在20℃,RH65﹪的条件下,对3个生产批次的浸膏相对密度、pH值试验,并以此为标准进行单味药提取液与相互混合液的相对密度、pH值等项测据的试验。结果:海布玻璃胶囊的原料来源很重要;把中间体的相对密度1.176～1.185、pH值4.7作为考量浸膏的内控指标。结论:控制好原料,加强对相对密度1.176～1.185之间的pH值检测,可以有效的控制中间体的质量。
OBJECTIVE: To further determine the technical parameters of intermediates through the selection of raw materials and preparation of intermediates (extract) stability. Methods: According to the preparation process standard approved by Food and Drug Administration of Jilin Province, the sources of raw materials and the preparation of intermediates were determined. The relative density and pH of the three batches were tested at 20 ℃ and RH65% , And use this as a standard test for the relative density, pH, etc. of the single herb extract and the mixed liquid. Results: The origin of raw materials of Hyblo capsule was very important. The relative density of intermediate 1.176 ~ 1.185 and pH 4.7 were taken as the internal control indexes of the extract. Conclusion: Control of raw materials, to strengthen the relative density of 1.176 ~ 1.185 between the pH value can effectively control the quality of intermediates.