The Pharmaceutical Research Of Compound Rhodiola Capsule

Compound Rhodiola capsule composes of two herbals including Rhodiola crenulata and Scrophularia ningpoensis,which mainly was used in the treatment of ischemic stroke.Because of its simple prescription,easy to control,it has broad prospects for development and application.This topie studied the extraction and purification process of Rhodiola and Scrophularia to prepare the effective parts of them.The quality standards of intermediate of Rhodiola and Scrophularia were investigated to ensure the stability and homogeneity of intermediate quality.The research of compound Rhodiola capsule quality standard ensured the quality of the preparation stability and controllability.By studying the composition ratio of optimal efficacy of Rhodiola and Scrophularia composition,established the foundation for development of the evident effect and natural medicine compound preparation.1.the preparation of compound Rhodiola capsuleTaking the content of Salidroside as the index,study the technics of the extraction of Radix et Rhizoma Rhodiolae Kirilowii,and finally definite it as following:Radix et Rhizoma Rhodiolae Kirilowii was extracted for 3 times and 2 hour for each with 8 times 70%ethanol,filtered,combined filtrate,and concentrated the filtrate to 1.0g crude drug per ml(d=1.08,50?)under vacuum(70?,-0.08MPa),then put it into D101 macroporous resin column,eluted with 5 times column volume waters,abandoned the elution,then eluted with 5 times column volume 20%ethanol,collect ethanol eluent,and concentrated the filtrate to relative density is about 1.30(50?)under vacuum(70?,-0.08MPa),and dried under vacuum(60?,-0.08MPa),shattered,standby.Taking the content of Harpagide,Harpagoside,Angoroside C as index,extraction and purification of process parameters on Scrophularia was inspected to identify the extraction technology:Radix Scrophulariae was extracted for 2 times and 3 hour for each with 10 times 50%ethanol,filtered,combined them,and concentrated the filtrate to relative density 1.10(50?)under vacuum(70?,-0.08MPa),added ethanol to 80%alcohol content standing 48h,concentrated the supermatant to 0.5g crude drug per ml(d=1.05,50?)under vacuum(70?,-0.08MPa),then put it into D101 macroporous resin column,eluted with 2 times column volume waters,abandoned the elution,then eluted with 25%and 70%ethanol,collected 4 times column volume elution,respectively,combined them,and concentrated them to relative density is about 1.30(50?)under vacuum(70?,-0.08MPa),dried under vacuum(55?,-0.08MPa).shattered,standby.The efficacy experiment is adopted to validate the effects of the formula,taking angle of repose and moisture percentage as index,studied the forming technics,choose microcrystalline cellulose as diluent,the ratio of powdered extract and microcrystalline cellulose was 5:1,the characteristics of contents of capsules compliance with the requirements,the stability and homogeneity of the finally products were good.2.Compound Rhodiola capsule quality standard researchTaking character,identification,moisture,total ash,Salidroside,Tyrosol and Crenulatin as index,initially established the quality standard of intermediate of Radix et Rhizoma Rhodiolae Kirilowii as following:the content of water should not exceed 4.0%,of the total ash should not exceed 0.9%,establish content determination methods of Salidroside,Tyrosol,Crenulatin.Taking character,identification,moisture,total ash,Harpagide,Harpagoside,Angoroside C as index,initially established the quality standard of intermediate of Radix Scrophulariae as following:the content of water should not exceed 5.0%,of the total ash should not exceed 0.8%,establish content determination method of Harpagide,Harpagoside,Angoroside C.According to the relevant requirements of the 2010 edition of "Chinese Pharmacopoeia"General preparation in capsules,we did research on the quality standard for compound Rhodiola capsule including characteristics,identification,moisture,the load difference,disintegration time,content determination.initially established the indicator standard(draft)as following:the product is capsule,the contents of capsule is a reddish-brown to brown fine powder,mildly bitter flavor,moisture,the load difference and disintegration time compliance with the above relative requirements,the content of Salidroside,Harpagide,Harpagosideis not less than 25.1 mg?21.6 mg?18.5 mg per capsule.3.Compound Rhodiola capsule of preliminary stability studyAccording to the preparation process to prqPare three batches of compound Rhodiola capsule,according to the product quality standard and the related requirements of stability test of new drug of TCM,we respectively made study the room temperature testing(the temperature is 25?±2?,the relative humidity is 60%±10%)and the accelerated stability testing(the temperature is 40?±2?,the relative humidity is 75%±5%),the results show that all indicators come up to thestandards and quality is stable within three months.4.Formula ratio of Rhodiola intermediate and Scrophularia intermediate researchThis research identify the optimum ratio of HX as 1:1 by in vitro active screening.The internal carotid artery suture method was adopted to establish the model of focal cerebral ischemia to observe the influence of HX(1:1)on action,cerebral infarction area and cerebral water content of model rats.The result show that,the medium and high dose group of HX(1:1)can significantly reduce the infarction area of the cerebral ischemia-reperfusion rats,decrease the rate of infarction,has certain regulatory effect on cerebral edema caused by cerebral ischemia,and also can significantly improved the behavioral symptoms of cerebral ischemia of the rats 72 h after modeling,which all shows that formula of Rhodiola intermediate and Scrophularia intermediate have protective effect on foeal cerebral ischemiain-reperfusion rat.