安肠浓缩丸制备工艺研究

Study on Preparation Technology of Anchang Concentrated Pills

摘要: 目的：研究并确立安肠浓缩丸的最佳制备工艺。方法：验证隔山消、陈皮、太子参、石菖蒲、酢浆草的提取工艺，同时以小肠推进率、浸出物得率、橙皮苷含量为指标，采用正交试验法，考察提取时间、提取次数、提取水量等因素对安肠浓缩丸水取工艺的影响，从而确定安肠浓缩丸最佳水提工艺。通过单因素试验法，考察不同烘干时间对成型效果的影响，优选安肠浓缩丸的最佳制备工艺。结果：隔山消、陈皮、太子参、石菖蒲、酢浆草粗粉以10倍水量，提取3次，每次煎煮1 h提取工艺稳定。滤液浓缩至稠膏相对密度为1.22~1.24，置于真空干燥箱中干燥成干浸膏粉，加入1.1倍淀粉，充分混合均匀后，膏粉与淀粉总量的2.2%低取代羟丙纤维素为崩解剂，充分混合均匀后，加入17%醋液作为润湿剂，制成软硬适中的软材，制丸真空65℃烘干14 h条件下制得的浓缩丸效果最佳。结论：制得的丸剂圆整光滑、色泽一致，符合2020年版《中华人民共和国药典：四部》丸剂项下规定，该成型工艺制备浓缩丸稳定可靠，简单易行，为工业化生产提供依据。

Abstract: Objective: To study and establish the best preparation technology of Anchang concentrated pills. Methods: The extraction technology of Geshanxiao, Tangerine peel, Radix pseudostellariae, gladiolus and oxalis was verified. At the same time, the effect of extraction time, extraction times and extraction water amount on the water extraction technology of Anchang concentrated pills was inves-tigated by orthogonal test with small intestine advancing rate, extraction yield and hesperidin con-tent as indexes, so as to determine the best water extraction technology of Anchang concentrated pills. The influence of different drying time on the forming effect was investigated by single factor test, and the best preparation technology of Anchang concentrated pills was selected. Results: The crude powder of Geshanxiao, Tangerine peel, Radix pseudostellariae, calamus and oxalis was extracted 3 times with 10 times of water and decocted for 1 h each time. The filtrate was concentrated until the relative density of the thick paste was 1.22~1.24, which was dried into dry extract powder in a vacuum drying oven, and 1.1 times starch was added. After fully and evenly mixed, 2.2% of the paste powder and starch were low-substituted hydroxypropyl cellulose as disintegrating agent. Af-ter fully and evenly mixed, 17% vinegar was added as wetting agent to make soft material with moderate hardness. The best pellet was prepared under vacuum drying at 65 ˚C for 14 h. Conclusions: The prepared pills are round, smooth and consistent in color, in accordance with the provisions of the pill section of the Fourth Part of the Pharmacopoeia of the People’s Republic of China (2020 edition). The preparation of concentrated pills by the forming process is stable, reliable, simple and feasible, and provides a basis for industrial production.