Study Of Preparation Process And Quality Standard Of Xiaoerjinchen Granules

The prescription takes Hypericum perforatum L.as the monarch drug,takes Bupleurum,honeysuckle,plaster and Scutellaria as the ministerial drug,takes Ephedra sinica Stapf,Semen Armeniacae Amarum,and dried tangerine peel as adjuvant drug and takes Licorice as the conductant drug.aiming at the pneumonia for children.It not only maintains advantages of Traditional Chinese Medicine on overall recuperation,fever relieving,pain easing,cough relieving and phlegm eliminating,but also enhances antiviral and antiseptic effect.In addition to the Bupleurum,honeysuckle,plaster,dried tangerine peel and Scutellaria with antiviral and antiseptic effect,the Hypericum perforatum L.,which is recognized as the drug for resisting virus at home and abroad,is added into the prescription.That's why the prescription has outstanding antiviral and antiseptic effect.The objective of the study is to find out the traditional Chinese medicine preparation with good curative effect,less adverse reaction and ideal comprehensive regulation effect for the pneumonia for children and the upper respiratory tract infection,relieving the pain of children.Thus,the experiment confirms the feasibility of the scheme of Xiaoerjinchen Granules through the investigation of preparation process,quality standard and initial stability.It takes the content of hypericin,the content of hesperidin and the content of alcohol extract as indexes and carries out the single factor investigation for the factors influencing the effect of extraction,the extraction frequency,the alcohol concentration,the extraction time and the alcohol content.Besides,it investigates the alcohol concentration,the extraction time and the alcohol content with the orthogonal test under fixed extraction times based on the single factor investigation,optimizing the alcohol extraction process.The process conditions for alcohol extraction on Hypericum perforatum,Bupleurum and dried tangerine peel are 8 times'70%ethanol and two-time extraction.Each extraction will cost 1 hour.It takes the content of Baicalin,the content of total polysaccharide and the content of water extract as indexes and carries out the single factor investigation for the extraction frequency,the extraction time and water quantity which will influence the extraction effect.Then,it investigates the extraction time and water quantity with the uniform test under fixed extraction frequency,optimizing the water extraction process.The best water extraction process are 12 times' water and 3-times decoction.Each decoction will cost 1.5 hours.It compares the impacts of four impurity removal processes,including natural set'tlement,high speed centrifugation,alcohol precipitation and ZTC1+1-? clarifier,on the content of Baicalin,the content of total polysaccharide and the content of water extract,and determines the impurity removal process suitable for industrial production through the comprehensive scoring.The impurity removal process is confirmed as the ZTC1+1-II clarifier accounting 4%of medicine used for removing impurities,such as protein,tannin,and wax.For preventing the destruction of the effective components due to the excessive heating time,the concentration experiment in the paper is carried out through the decompression and concentration equipment.According to the drug properties,equipment performance and operating conditions,the alcohol extraction of clear paste of Hypericum perforatum L.can realize the best efficiency with the relative density of 1.18-1.22 at 60?.Besides,the clear paste of Scutellaria,honeysuckle and other drugs ith the relative density of 1.25?1.28 are tested at 60?.According to the comprehensive evaluation of hygroscopicity,formability and solubility of the granule made by excipients and extract powder,it chooses appropriate excipients.It investigates the sucrose,starch,dextrin,lactose and mannitol through the single factor test,taking the hygroscopicity,formability and solubility as indexes and considering the cost and the taste of children.It confirms that sucrose is the best excipient.For effectively control the quality of the drugs,it establishes HPLC measurement method of hypericin,the HPLC chromatographic identification of Hypericum perforatum L.and the TLC identification of Bupleurum,Honeysuckle,dried tangerine peel and licorice.Besides,it also carries out corresponding studies on quality standards according to the requirements of traditional Chinese medicine for granules.Considering the sources of medicinal materials,the production and storage of drugs and other factors,it is temporarily confirmed the component of hypericin,counting with the content of hypericin.The hypericin should not less than 70 ?g/bag.It tests the pilot sample of each batch under the prescribed humidity,temperature and time according to the requirements of preliminary stability.The results show that there are no obvious changes,indicating that the quality of Xiaoerjinchen Granules n is stable.