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我地区某药厂生产的黄连上清丸(水丸),一度崩解时限大为延长(达2～5小时),不符合药典规定。经分析处方。发现该丸剂中大黄和白芷共占30.5%,此两味药材中均含有大量淀粉,故疑系湿丸干燥温度过高、淀粉糊化硬结所致。笔者将制成的湿丸,分成数份,各以不同温度烘干。测定其崩解时限与含水量,结果见附表。
The Huanglian Shangqing Pill (Shuiwan) produced by a certain pharmaceutical company in my area was greatly prolonged (up to 2 to 5 hours) in disintegration time and did not meet the requirements of the Pharmacopoeia. After analysis of prescriptions. Rhubarb and white peony in the pill were found to account for 30.5% of the total. Both herbs contained a large amount of starch. Therefore, it was suspected that the drying temperature of the wet pill was too high and the starch gelatinized induration. The author made the wet pill into several parts, each drying at different temperatures. The disintegration time and water content were measured. The results are shown in the attached table.