复方白及乳膏的质量控制

Studies on Quality Standard of Compoud Baiji Cream

目的建立复方白及乳膏的质量控制方法。方法观察性状;以a-萘酚硫酸法鉴别白及多糖;以硫酸铜显色法鉴别尿素;以蒽酮染色法测定白及多糖含量;以苯甲醛染色法测定尿素含量。结果复方白及乳膏为白色的乳膏;α-萘酚硫酸鉴别显白及多糖的阳性反应;硫酸铜显色鉴别显尿素的阳性反应;白及多糖在1.88~33.75μg·mL^-1范围内呈良好的线性关系,y=0.039X-0.0069（r=0.9998）,平均回收率为98.3%,RSD为1.81%,平均含量应为4.0mg·g^-1（±10%）;尿素在10.0~120.0μg·mL^-1范围内呈良好的线性关系,Y=0.0077X＋0.0019（r=0.9995）,平均回收率为99.1%,RSD为1.49%,平均含量应为0.1g·g^-1（±10%）。结论所建立质量控制方法可操作性强,结果重现性好,适用于复方白及乳膏的质量控制。

OBJECTIVE To establish the quality standard of Compound Baiji cream.METHODS Observe character、was observed,to identify the polysaccharide was identified by α-naphthol sulfuric acid method; the urea was identified by cupric sulfate chromogenic method.The polysaccharide content was determined by anthrone staining method and the urea content was determined by benzaldehyde staining method.RESULTS Compound Baiji cream was a white cream.The result of a-naphthol sulfuric acid idehtification was positive identification of polysaccharide.The result of cupric sulfate chromogenic identification was positive identification of urea.It had a good linear relationship.The linear range of polysaccharide was 1.88 ~ 33.75μg·mL^-1,y=0.039x-0.0069（r=0.9998）.The liner range of urea was 10.0 ~ 120.0μg·mL^-1,y=0.0077 x ＋ 0.0019（r=0.9995）.The average recovery of polysaccharide and urea was 98.3% and 99.1% with RSD 1.81% and 1.49% respectively.The average content should be 4.0mg·g^-1（± 10%） and 0.1g·g^-1（± 10%） respectively.CONCLUSION The established methods are accurate,reproducible and can be used for the quality control of compound Baiji cream.