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OBJECTIVE:To optimize the extraction technology of Baiyi rectal solution. METHODS:The effects of water amount and extraction time on extraction technology were investigated by central composite design-response surface method using OD value of berberine hydrochloride and ferulic acid and the extract yield as index. Validation test was also conducted. RESULTS:The optimal extraction technology was as 11-fold water,decocting 70 min for the first time;5-fold water,decocting 30 min for the second time. In validation test,OD value of first extraction was 0.940 0,and the bias between observed and predicted values was -2.07%;that of second extraction was 0.851 8,and the bias was -2.41%. CONCLUSIONS:The extraction technology of Baiyi rectal solution is reasonable,feasible and suitable for industrial production.
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Objective:To prepare and evaluate Shenhuang vaginal thermosensitive in situ gels. Methods:Shenhuang vaginal ther-mosensitive in situ gels( SHV-TISG)were prepared with poloxamer 407 and poloxamer 188 as the materials. The viscosity change at different temperatures and the gelation temperature of SHV-TISG and SHV-TISG diluted by stimulant vaginal fluid were measured,the in vitro drug release of the preparation was evaluated by a membraneless diffusion method,and the safety of SHV-TISG was detected by vaginal irritation test. Results:The preparation showed the vaginal injectability and gelationability in vivo without vaginal irritation. Gel erosion was the principal mechanism of the drug release from the gels. Conclusion:The preparation of SHV-TISG is feasible in tech-nique,and the properties meet the requirements of vaginal topical use.
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Objective:To establish an HPLC method for the determination of gallic acid and berberine hydrochloride in Dihuang sprays. Methods:A ZORBAX SB-C18 column (250 mm × 4. 6 mm,5 μm) was used, the mobile phase was acetonitrile-0. 1% phos-phoric acid with gradient elution. The flow rate was 1. 0 ml·min-1 , the column temperature was 30℃, and the detection wavelength wassetat270nm.Results:Thelinearrangeofgallicacidandberberinehydrochloridewas20.36-305.40 μg·ml-1(r=0.9996) and 20.08-301.20 μg·ml-1(r=0.999 8), respectively. The average recovery was 98.9%(RSD =1.3%) and 98.5%(RSD =1. 5%) , respectively. Conclusion:The method is simple, reliable and accurate, which can be used in the determination of gallic acid and berberine hydrochloride of Dihuang sprays.