Study of Formulation and Preparation Technology of Compound Bingjia Cream
10.6039/j.issn.1001-0408.2015.22.34
- VernacularTitle:复方冰甲乳膏的配方与制剂工艺研究
- Author:
Hong QIU
;
Xudong TANG
;
Bing DAI
;
Hui WANG
;
Liping WANG
- Publication Type:Journal Article
- Keywords:
Compound Bingjia cream;
Metronidazole;
Borneol
- From:
China Pharmacy
2015;(22):3134-3136,3137
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To optimize the matrix formulation and preparation technological parameters of Compound Bingjia Cream. METHODS:To prepare water phase and oil phase matrix solutions respectively,and then the former was added into the lat-ter and well mixed together. The matrix formulation was optimized with the overall scores of appearance,high temperature,low temperature and oil and water stratification after centrifugal test as the evaluated indexes. High performance liquid chromatography was used to determine the content of metronidazole. Gas chromatography was adopted to determine the content of borneol. With the matrix temperature at the time of adding the main drug mixture,matrix quantity,emulsification method and emulsification time as observed factors,and the overall scores of metronidazole content,borneol content and the overall scores of preparation(the overall scores of appearance and stability tests) as the observed indexes,L9(34) orthogonal test was designed to optimize the preparation technological parameters of Compound Bingjia cream and verification for technology was conducted. RESULTS:The optimal oil phase matrix formulation was as follows as cetanol of 10 g,glyceryl monostearate of 16 g,stearic acid of 20 g,albolene of 8 g, while the optimal water oil matrix formulation as triethanolamine of 2 g,glycerinum of 24 g. The optimal preparation technological parameters were the matrix temperature of 50℃at the time of adding the main drug mixture,matrix of 300 g,emulsification meth-od of colloid emulsification,emulsification time of 30 min,where metronidazole content was 1.83%,borneol content 2.88%. The results of 3 verification tests showed the overall scores were all 25,with metronidazole content of 2.1%,2.1%,2.2%(RSD=2.71%,n=3),borneol content of 3.2%,3.3%,3.1%(RSD=3.12%,n=3). CONCLUSIONS:The optimal matrix formulation and technological parameters of the preparation are stable and feasible,and suitable for mass production.
