进出口的风温也是比较关键的因素,是影响颗粒成品率及颗粒的含水量的一对矛盾。进风口温度太高,则浸膏来不及与辅料形成颗粒即被干燥成细小颗粒,颗粒成品率低;温度太低则粘壁、干燥速率慢,颗粒含水量高,达不到中国药典关于颗粒剂含水量的要求〔1〕。因此,如何筛选进出口的风温,既要提高颗粒的成品率又要使颗粒的含水量达标需要通过试验来解决。
辅料的配比则应根据有效成份的性质及疗效而定,因本制剂是用来治疗胃病,含糖量太高会影响药物的疗效发挥,因此宜选用含蔗糖量低的辅料配比,并且一部分乳糖取代蔗糖也利于颗粒的干燥,降低成品的含水量〔2〕。
药材的提取工艺应根据处方选用,一般来说,经过醇沉后的浸膏容易喷雾,不易堵塞喷头,但易损失多糖、蛋白质类有效成分;若不经过醇沉有时则易堵塞喷头,给喷雾操作带来困难;纯粹用醇提法制备浸膏则成本太高。因本处方中含糖类等粘性物质不多,为最大限度地保留处方中的有效成份,故选用水提法,以提高经济效益和节省生产成本。
参考文献
[ 1 ] 国家药典委员会1中国药典1二部1北京:化学工业出版社, 2000:附录161
[ 2 ] 罗明生,高天惠主编1药剂辅料大全1成都:四川科学技术出版社, 1995: 50425081
Study on Spray2Dr ier Prepara tion Technology ofWe ita i Granules Using Orthogona l Exper imen ts
QU Cai2hong1 , YANG L i2 , CHEN Zhi2liang2
(11 Department of Pharmacy, The Third Affiliated Hosp ital of Sun Yat2sen University, Guangzhou 510630, China; 21 Department of
Pharmacy, The Nanfang Hosp ital of the South medicalUniversity, Guangzhou 510630, China1)
Abstracts Objective: To screen p reparntion tchnique in order to raise the end2p roduct and economical efficiency of sp ray2drierp reparation technology ofweitai granules. Methods: Newly Fluid2bed2sp ray2drier2granulation technique was adoped and taken extracting technique, temperature of exit and entry and the matching of accessories as inspecting factors, two levels of each factors, end2p roduct and the water content of semi2finished weitai granules as inspecting marker, the best p reparation technique of weitai granules was screened by orthogonal desing1 Results: Among the 3 factors, the matching of accessorieswasmost notalbe ( P < 0101) , nextwas the temperature of exit and entry ( P < 0105) 1 However, the extracting technique was of little importance ( P > 0105) 1 Conclusion: The optimum sp ray2drier granulation technique of weitai granules is A3B1C3。
KeyWords Sp ray2Drier; Granules; Preparation Technology; Orthogonal Experiments |
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