瑰及乳膏的制备与质量控制

Preparation and Quality Control of Guiji Cream

目的制备瑰及乳膏并建立质量标准。方法以当归提取物和白及胶为主要成分,以霍霍巴油、乳化硅油、十二烷基硫酸钠为乳膏基质制备瑰及乳膏,建立性状、鉴别、含量测定质量标准,考察该制剂稳定性。结果以200r·min^-1速度搅拌、80℃温度乳化制备的乳膏细腻、涂展性好;以HPLC法测定阿魏酸含量,在0.64-64.00μg·mL^-1范围内线性关系良好（r=0.9993）,平均回收率为98.92%,RSD=1.29%。结论该制剂工艺可行,性质稳定,质量可控。

Objective To prepare Guiji cream and establish the quality standard.Methods Take the Chinese angelica extraction and the baiji rubber as the principal constituent,take the sound of sword Pakistan oil,the emulsified silicone oil,the dodecane alkyl sulfate sodium as the cream base to prepare Guiji cream;establish the quality specification of character,identifiability and determination;inspect the stability of this preparation.Results Agitating at the pace of 200r·min^-1 and emulsifying at the temperature of 80℃,then the cream was exquisite.Determine the content of asafoetida acid in the skin cream by HPLC.The linearity relationship was good in 0.64～64.00μg·mL^-1（r=0.9993）;the average recovery ratio was 98.92%,RSD=1.74%.Conclusion This preparation craft is feasible;the nature is stable;the quality is controllable.