| Objective:To optimize the conditions of the extraction technique for sidiming(SDM),and prepare the SDM capsules;To study the quality of SDM capsules and establish the standard for its quality control;To study the effects of SDM capsules on morphine metabolism in morphine dependent rats in vivo.Methods:The optimum procedures in two-step process water extracting and ethanol precipitation were selected by the orthogonal text design L9(34) respectively.The yield of the dry ointment was used as the assessment in the water extracting,and the catalpol was used as the assessment in ethanol precipitation.The content of catalpol was determined by HPLC.The magnesium stearate was added after the extractive of SDM was shattered into powder,then the SDM capsules were prepared after the mixture was dried and sifting.The Rehmannia glutinosa libosch.,Coptis chinensis Franch.and Eucommia Ulmoides Oliv.were identified by TLC.The contents of catalpol,berberine and chlorogenic acid were determined by HPLC.The rats were randomly divided into the SDM capsules-treated group,the untreated group,the morphine-treated group,the SDM capsules control group,and the normal sodium(NS)control group.A morphine dependent model of rats was established in the former 3 groups by subcutaneous injection(s.c.)of morphine in gradually increasing dosages within 7 days,and the treated drugs were administered to each group respectively from the 8th day(d8).Meanwhile the SDM and NS were administered to the latter 2 groups respectively by intragastric administration (i.g.)from d1.The rat blood was collected from d8 to d11,and the rat urine was collected from d8 to d13.Morphine was extracted from serum and urine by ethyl acetate,and determined by HPLC-UV,and the excreted quantity of morphine in the urine within the 24 h was calculated.Results:The optimum condition was that the crude drugs were decocted for 2 times with 8-fold water(with 9-fold water for the first time),1h each time.The water extract was filtered and concentrated to 1.0 g.ml-1(the proportion of crude drugs to water extract),and then precipitated by ethanol. The ethanol concentration for precipitation was 75%,and the time for precipitation was 24h.Then the supernatant was centrifugated,concentrated and dried by microwave vacuum concentration dryer to dry ointment,the magnesium stearate was added after the dry ointment was shattered into powder, then the SDM capsules were prepared after the mixture was dried and sifting. The Rehmannia glutinosa libosch.,Coptis chinensis Franch.and Eucommia Ulmoides Oliv.were identified successfully by TLC.The linear curve of catalpol concentration within the range of 0.4～2.4μg was ideal(r=0.9998). The retrieve rate was 99.75%,RSD=0.53%.The linear curve of berberine concentration within the range of 1.0～10.0μg was ideal(r=1.000).The retrieve rate was 98.12%,RSD=0.02%.The linear curve of chlorogenic acid concentration within the range of 0.1～0.7μg was ideal(r=0.9998).The retrieve rate was 100.08%,RSD=1.43%.Compared with the untreated group, morphine content in the serum within the d8 and d9 was significantly higher after the treatment with SDM capsules in the morphine withdrawal rats,but lower within the d10 and d11.The excreted quantity of morphine in the urine within the d8～d10 was significantly higher,but significantly lower within the d11～d13.Morphine content in the serum and urine of the morphine-treated group was significantly higher than those in other groups.Morphine was not detected in both NS control and SDM capsules control groups.Conclusions:The optimum extraction procedure is stable and reliable,it can be used in the extraction procedure of SDM capsules.The quality control method is accurate,stable and reliable,it can be used in the quality control of SDM capsules.SDM capsules can accelerate the metabolism and excrete of morphine in the morphine dependent rats,which may be one of the mechanisms related to detoxification and habilitation by SDM capsules.
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