傣药保肝Ⅰ号颗粒制剂的研究

Study on the Granule Preparation of Dai Medicine Baogan Ⅰ

保肝Ⅰ号为傣医院院内制剂,作为一种针对治疗肝损伤的复方药物,在临床上有着广泛需求.但保肝Ⅰ号浸膏粉(BGYH)易吸湿、不易制粒及其服用剂量较大等特点限制了其在临床上的进一步应用.研究了保肝Ⅰ号的颗粒制剂的制剂工艺,根据《药典》要求考察辅料A、辅料B、玉米淀粉、微晶纤维素、木糖醇、甘露醇6种辅料的不同添加比对颗粒剂性质的影响,并进行了小试放大研究.结果表明:BGYH,辅料A,辅料B的质量比为5∶6∶1时有较好颗粒剂性质,BGYH的颗粒剂临界相对湿度(CRH)为69.66%,BGYH的生产和贮存不得高于此湿度.经过小试放大,成功地制备了含药量为125 g的保肝Ⅰ号颗粒剂一批.为保肝Ⅰ号5类新药申报提供重要数据及理论依据.

Baogan No. 1（ BGYH） is a preparation produced in Dai hospital,taken as a compound medicament to cure the liver trauma. There is a lot of demand in clinic application. Due to some problems of the Baogan No. 1,i. e. moisture absorption of its powder,hardness of its grain production,big dosage,and so on characteristics restrict its more application in clinic. In this paper,the granule preparation procedure of Baogan No. 1（ BGYH） was optimized. According to pharmacopoeia, six pharmaceutic necessities were analyzed,including pharmaceutic necessity A,B,cornstarch,microlite fibrin,xylitol and amrita,to get the effects of different accession ratio of pharmaceutic necessities on the property of the prepared granule. A magnified test was taken to study the effect exactly. The results show that,when the component ratio of BGYH,pharmaceutical necessities A and B is 5 ∶ 6 ∶ 1,the property of granular preparation is better. And the critical relative humidity（ CRH） of the granule prepared with this ratio is 69. 66%. This means that the humidity should not exceed 69. 66% in production and reserving. Some important data and theoretics are provided,and a batch of 125 g granular preparation is produced for further research.