Study On Preparation Technology And Quality Standard Of Sihuang Zhitong Spray

ObjectSihuang powder is from Standards for Diagnosis and Treatment,which written by Wang kentang in the Ming Dynasty.It contains four kinds of Chinese medicine,rhizoma coptidis,cortex phellodendri,radix scutellariae,radix et rhizoma rhei.It can invigorate the circulation of blood,relieve swelling and pain,and is widely used in the treatment of soft tissue injuries,fractures etc.For further the development and utilization of the Chinese medicine preparation,according to the project requirements of document of approval for Pharmaceutical preparation of medical institutions,in accordance with the research method and scheme of new drugs,combined with traditional Chinese medicine advanced formulations,the topic studied the preparation technology and quality standard of the preparation,in order to lay the foundation for research into new hospital preparation.Methods1.Extraction Process:using U6*(64)uniform design method,respectively with the extraction rate of berberine,baicalin and emodin as index,the extraction was divided into two groups,rhizoma coptidis,cortex phellodendri as the extract group ?,radix scutellariae,radix et rhizoma rhei as extract group II,to optimize the best extraction technology of Sihuang Zhitong Spray.2.Forming process research:using the single factor investigation method,with the transfer rate of berberine,baicalin and emodin and preparation appearance as the index,the effects of ethanol concentration,solubilizer and dosage,pH were investigated on the forming process,optimizing the forming parameters of Sihuang Zhitong Spray.3.Quality standards research:HPLC method was used to control the quantitative of berberine,baicalin and emodin in the prescription;The TLC was used in the qualitative identification control of Coptis and Phellodendron;In addition,we maked a systematic study on methodology on the analysis me-thod,lay the foundation for establish quality standard of the preparation.4.Preliminary stability test:the changes of the characters,relative density,effective components and other factors of Sihuang Zhitong Spray were investigated by 3 months accelerated stability test and 3 months room temperature stability test.ResultlsThrough technology research,the optimal preparation process conditions of Sihuang Zhitong Spray were as follows:rhizoma coptidis and cortex phellodendri extracting 3 times with 4 times the amount of 56%ethanol,each time 105 min;radix scutellariae and radix et rhizoma rhei extracting 3 times with 4 times the amount of 67%ethanol,each time 105 min;merging two extracts,filtrating,let stand for 24h,filtrating,concentrating to 1g · mL-1 crude drug under reduced pressure,adding 0.5%of the total amount of preparation of span,adding 70%ethanol to constant volume,adjusting pH to 7.8 to 8.2,and let stand for overnight,filtering,packing into Sihuang Zhitong spray finished products.The result of TLC spots of Rhizoma Coptidis and Cortex Phellodendri showed good separation effect without negative interference,proving that the method is specific;The methodology of HPLC determining berberine,baicalin and emodin in content of the preparation was investigated systematically,the test results were in line with relevant requirements.According to the determination results of sample content,formulated the content limit of berberine hydrochloride,baicalin,emodin,the per milliliter of berberine hydrochloride,baicalin and emodin respectively not less than 0.13mg,0.25mg,5.73?g.The preliminary stability test of 3 batches of samples showed that the character,identification,pH,relative density,volume and content determina-tion of Sihuang Zhitong spray were in line with the requirements after 3 months,the products were basically stable in 3 months.ConclusionIn this study,we have maded a reasonable and feasible preparation technology and method,and established a reliable quality standard test method,which can guarantee the maximum clinical efficacy of Sihuang Zhitong spray.This experimental research method was simple,accurate,reproducible,accelerated stability and long-term stability tests conformed to the requirements,which can be used for the quality control of Sihuang Zhitong spray,providing experimental basis for the clinical application of new drugs.