地榆消痔栓制备工艺优选

Optimization of Preparation Technology of Diyu Xiaozhi Suppository

目的:优选地榆消痔栓的提取工艺与成型性考察研究。方法:根据组方原则及方中药材的理化特性和各味药的药理作用,分为醇提、水煎煮和原生药直接入药三部分。以大黄素、虎杖苷含量为综合指标,采用正交试验法考察醇提工艺,选择乙醇浓度、加醇量、提取时间及提取次数为醇提考察因素;以鞣质含量及出膏率为综合指标,选择加水量、煎煮时间、煎煮次数为水提考察因素。将醇提及水煎煮浸膏喷雾干燥,所得干膏溶入基质,最后加入冰片。确定地榆消痔栓剂的最终制备工艺。结果:醇提最佳条件:80%乙醇,加6倍量,回流提取3次,每次1.5 h。水煎煮为10倍量水,煎煮3次,每次2 h。分别浓缩醇提液及水提液,喷雾干燥,所得干粉溶入基质,最后加入冰片,注模,脱模即得。结论:地榆消痔栓制备工艺稳定可靠,重现性好,为后续的生产开发和质量控制提供了依据。

Objective To optimize the extraction process and forming process of Diyu Xiaozhi Suppository.Methods According to the principle of composition,the physical and chemical properties of Chinese medicinal materials and the pharmacological effects of each flavor of medicine,it is divided into three parts:alcohol extraction,water decoction and direct introduction of original medicine.Taking the content of emodin and knotweed as comprehensive indexes,the orthogonal test method was used to investigate the alcohol extraction process,and the ethanol concentration,alcohol addition,extraction time and extraction times were selected as the factors for alcohol extraction investigation.Taking the tannin content and paste yield as the comprehensive indicators,the water added,decoction time and decoction frequency were selected as the water extraction factors.The alcohol decoction extract is spray dried,the resulting dry paste is dissolved into the substrate,and finally ice chips are added.By investigating the formability of the suppository,the final preparation process of Diyu Xiaozhi suppository was determined.Results The optimal conditions for alcohol extraction:80%ethanol was extracted 3 times with 6-fold reflux for 1.5 h each time.Decoction is 10 times the amount of water,decoction 3 times each for 2 hours.The alcohol is spray-dried with water decoction extract,the resulting dry paste is dissolved into the substrate,and finally ice chips are added.Conclusion The preparation process of Diyu Xiaozhi i suppository is stable and reliable,with good reproducibility,which provides a basis for industrial production.