Study on Dissolution in vitro of Cyclosporine Soft Capsules from 3 Domestic Manufacturers
- VernacularTitle:国内3厂家环孢素软胶囊的体外溶出评价研究
- Author:
Ting SUN
1
;
Jianguo JIANG
1
;
Jing ZHANG
2
;
Xiru ZHANG
3
;
Yanmei XU
4
;
Liu WANG
1
Author Information
1. Dept. of Quality Consistency Evaluation，Hebei Institute for Drug Control，Shijiazhuang 050011，China
2. Dept. of Director of Quality Management，Hebei Institute for Drug Control，Shijiazhuang 050011，China
3. Dept. of Cosmetics，Hebei Institute for Drug Control，Shijiazhuang 050011，China
4. Dept. of Chemical，Hebei Institute for Drug Control，Shijiazhuang 050011，China
- Publication Type:Journal Article
- Keywords:
Cyclosporine soft capsules;
Similarity;
Dissolution in vitro;
Generic drugs;
Original drugs
- From:
China Pharmacy
2019;30(17):2332-2336
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To investigate the similarity of in vitro dissolution curve between the generic drugs and the reference preparation （original drugs） of the domestic Cyclosporine soft capsules in 6 dissolution mediums. METHODS： The dissolution test was performed with paddle method. 2％ SDS water solution， 2％ SDS pH 1.2 hydrochloric acid solution， 2％ SDS water solution， 2％ SDS pH 4.5 acetate buffer solution， 2％ SDS pH 5.5 acetate buffer solution， 2％ SDS pH 6.8 phosphate buffer solution and 2％ SDS simulated gastric fluid were used as the dissolution medium， and the rotation speed was 50 r /min. HPLC method was used. The determination was performed on Agilent Eclipse XDB-C18 column with mobile phase consisted of acetonitrile phosphate solution （73 ∶ 27 ∶ 0.25，V/V/V），the flow rate was 1.0 mL/min. The detection wavelength was set at 226 nm， the column temperature was 60 ℃， and sample size was 20 μL. The dissolution curves in 6 medium were drawn and the similarity factor （f2） was used to investigate the similarity between the samples from 3 domestic manufacturers （5 batches） and a batch of original drugs. RESULTS： The linear range of cyclosporine was 5-250 μg/mL （r＝0.999 6-0.999 9）； RSDs of precision， stability （12 h） and reproducibility tests were lower than 2.0％ （n＝6 or 7）； the recoveries were 98.4％-99.7％ （RSD＜2.0％， n＝9）. The cumulative dissolution of 6 batches of samples within 15 min reached 85％ in 2％ SDS pH 1.2 hydrochloric acid solution and 2％ SDS simulated gastric juice. f2 of the dissolution curve of 5 batches of generic and original drugs of Cyclosporine soft capsules were 75， 45， 57， 42， 83 in 2％ SDS water solution and 44， 76， 38， 32， 76 in 2％ SDS pH 4.5 acetate buffer solution 76， 47， 49， 40， 79 in 2％ SDS pH 5.5 acetate buffer solution and 52， 49， 55， 48， 80 in 2％ SDS pH 6.8 phosphate buffer solution， respectively. CONCLUSIONS： There have differences in the similarity of the dissolution curve between the domestic generic and the original drugs of 5 batches of Cyclosporin soft capsule from 3 domestic manufacturers.
