Preparation and Quality Standard Formulation of Compound Bupleurum Suppository
10.3870/j.issn.1004-0781.2025.09.017
- VernacularTitle:复方柴胡栓的制备与质量标准
- Author:
Zhizhen YU
1
;
Zegan LIU
;
Libo WANG
;
Liangyong HUANG
;
Fang YE
;
Haitao ZHU
;
Ziyan XU
;
Shiming DU
Author Information
1. 湖北医药学院药学院,十堰 442000
- Publication Type:Journal Article
- Keywords:
Compound Bupleurum suppository;
Volatile oil of Bupleurum;
Taurine;
Preparation technology;
Quality standard
- From:
Herald of Medicine
2025;44(9):1482-1489
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the prescription and preparation technology of compound Bupleurum suppository and draft its quality standard.Methods The volatile oil of Bupleurum was extracted by steam distillation,and the compound Bupleurum-based suppository was prepared by mixing the volatile oil with taurine using the melting method.The quality standard of the preparation was formulated according to the quality inspection items of the general rule 0107 of the Pharmacopoeia of the People's Republic of China(2020 Edition,Volume IV);The contents of n-hexanoic acid and n-heptanoic acid in the preparation were determined by gas chromatography-mass spectrometry(GC-MS).The content of taurine in the preparation was determined by high-performance liquid chromatography(HPLC).Results The optimized distillation time of the volatile oil was 1.5 h,The linear ranges of n-hexanoic acid,n-heptanoic acid and taurine are 23.175 0-115.875 0 μg·mL-1(R2=0.999 4),4.590 0-68.850 0 μg·mL-1(R2=0.998 9)and 15-125 μg·mL-1(R2=0.999 6),respectively.The average recoveries are 99.83%,101.96%,98.89%with RSDs of 2.84%,1.36%,2.88%,respectively.The RSDs of precision,stability,and repeatability tests are less than 5%.The properties,mass difference,melting time,microbial limit,and stability assessment of the preparationwere all in accordance with the Pharmacopoeia of the People's Republic of China.Conclusion Compound Bupleurum suppository preparation technology is reasonable and feasible,which meets the quality standard.
