Résumé
The present invention provides a new composition for treating pain-associated sleep disturbances, especially shortened sleep duration, comprising ibuprofen and diphenhydramine hydrochloride. In the present work the soft gelatin capsules were formulated comprising 25 mg diphenhydramine hydrochloride and 200 mg ibuprofen using polyethylene glycol 400, propylene glycol, potassium hydroxide and purified water. The prepared soft gelatin capsules were evaluated for weight variation test, assay, dissolution and disintegration. The capsules had a fill weight of 550 ± 5%, Disintegration time of 5-6 minutes and showed 97.00% to 99.50% of labeled amount of ibuprofen and diphenhydramine hydrochloride indicating uniformity in drug contents. The capsules containing 75 mg/capsule of propylene glycol released 99.40% of diphenhydramine hydrochloride and 99.70% of ibuprofen at the end of 60 minutes. Thus, it may be concluded that soft gelatin capsules of diphenhydramine hydrochloride and ibuprofen could be successfully prepared with existing technology and machinery which have a commercial viability and enhance patient compliance with improved bioavailability.
Résumé
OBJECTIVE:To study the relationship between various composition factors and the dissolution rates of the soft gelatin capsule shell.METHOD:The gelatin disk and gelatin shaped mass method were used by the current CP rotating-basket dissolution apparatus.The effects of shell compositions on the capsule shell dissolution rate were illustrated and discussed.RESULTS:With the increase in the ratio of gelatin glycerol in soft gelatin shell,the dissolution rate of the shell changed irregularly.After storage of 21 days at 40℃，the dissolution rate of the shell decreased at different extent.The dissolution rate of the shaped gelatin mass increased slightly by adding some polymers (pvp,starch).CONCLUSION:Am investigation of these factors and their influence on dissolution may be of assistance in the formulation of soft gelatin capsule shells for various purposes,THE SOFT gelatin capsules should be stored at relatively low temperature.
Résumé
Objective To investigate the effects of Yifuning soft gelatin capsules(YSGC)on immune function in ovariectomized (OVX) rats.Methods Fifty female mature Sprague-Dawley rats were randomized into 5 groups:normal control, model control, diethylstilbestrol tablets(DT)and YSGC(high-and low-dose). After 4-week treatment,the serum E2 and IL-2 levels were detected by radioimmunoassay. The estrogen receptor(ER)level in spleen were detected with method of radioligand receptor assay(RRA).The pathologic changes of thymus were observed under light microscope and the body weight,thymus index and spleen index were detected too.Results YSGC could obviously increase the serum levels of E2 and IL-2,increase spleen index and ER content in the spleen of OVX rats (P