复方颠茄合剂的工艺改进

目的 改进复方颠茄合剂的配制工艺,解决其出现絮状沉淀的问题.方法 复方颠茄合剂中的絮状沉淀主要来源于颠茄酊中的醇溶性的树脂类等杂质,由于溶稍系统的改变在水溶液中慢慢析出而形成的.针对这个主要原因,先将颠茄酊中有效成分莨菪类生物碱成盐,再加适量的蒸馏水,加热除去乙醇,使有效成分溶于水,杂质不溶于水而析出,滤除杂质后再加复方樟脑酊配制成复方颠茄合荆.结果 新工艺配制的复方颠茄合剂,不仅外观清澈透明,3个月内无任何沉淀,而且主药成分莨菪碱稳定,药品质量和稳定性得到大大提高.结论 新工艺制法简单、实用,有效的解决了复方颠茄合剂絮状沉淀的问题.

Improvement of the preparation techniques of Compound Belladonna Mixture

OBJECTIVE To solve the problem of the flocule appearing in Compound Belladonna Mixture in period of validity,the preparation technics was studied. METHODS The floccule came from the impurities of Belladonna Tincture which were composed of the alcohol soluble resin,etc. These impurities were seperated out when the solvent system changed from ethanol into water. For this reson, belladonna alkloids in Belladonna Tincture were firstly changed into the salts, suitable amounts of distilled water was added and the ethanol was removed by heating Thus, the efficiency components were dissolved while the alcohol soluble impurities were separated out and eliminated by filtration, After the adding of Compound Camphor Tincture, the preparation of Compound Belladonna Mixture was completed. RESULTS Compound Belladonna Mixture prepared by new technics was clear without any floccule and the content of hyoscyamine was stable in period of validity. The quality and stability of Compound Belladonna Mixture were greatly improved. CONCLUSION The method of new technics was simple and practical, which well solved the problem of the floccule appearing in Compound Belladonna Mixture.