Study On Preparation Technology And Quality Standard Of Compound Xianhecao Enteritis Tablets

Purpose:The preparation process of Compound Xianhe Enteritis Tablets agrimoniae enteritis piece of research,establishment of quality stanard and stability test for the period of validity.Method:The best production technology for Compound Xianhe Enteritis Tablets was finally determined on the basis of the study to extraction,concentration and drying process,and the dosage of complementary makings and flow aid making,as well as the mobility of the particles,hygroscopicity.Using HPLC to determine the product composition for the content of berberine hydrochloride and the validity of Compound Herba Agrimoniae Enteritis,and.Using TLC for the qualitative of rhizoma and platgcodon grandiflorum,and the heavy metal content were determined,so that to determine the preparation process of quality standards.ResuLts:1.Its determined the best extracting method of the essential oil of combination by orthgonal test and acorus tatarinowii :eight times in the original medicinal water,soak for one hour and distillation for seven hours;By the quantity of cream as a indicator for decoction process selection,determine the parameters for the water extraction process:the liquid after the extraction of oil and the aqueous solution with the characteristics of four linds,boiling water for 3 times,the first time to join the herbs in 10 times the amount of water,decoction for 90 min,the second and third time to join in 8times the amount of water of medicinal materials,decoction time respectively for 60 min;Through enrichment and dry conditions’ inspection,determined to take atmospheric concentration(80 ℃),enrichment and relative density of 1.30 ~ 1.35(25 ℃)of the thick paste with auxiliary again after blending and ambient pressure;Dosage of flow aid in selection and determination of particles liquidity,so as to determine the amount of flow aid magnesium stearate was 1%,the relative humidity below 58% for tablet.Through the above inquiry and investigation to determine the best production technology of Compound Xianhe Enteritis Tablets.2.Using the HPLC determination of main efficacy components in this product,the content of berberine hydrochloride standard curve in the range not only was a good linear relationship,precision,stability,repeatability and sample recovery rate meet to the standard required,using this method can accurately determine the efficacy of Compound Herba Agrimoniae Enteritis;Using the method of TLC for qualitative identification of rhizoma coptidis and radix platycodi,the test solution and referrence solution for the apots were clear,good separation effect,could accurate identification;More over the heavy metal content of this product has carrried on the investigation and meet the prescribed standards.3.Compound Xianhe Enteritis Tablets according to the simulation of commercial packaging for the accelerated test and room temperature stability test,and the insection results meet to all the rules,the stability is good so that the period of validity can be tentatively for 3 years.ConcLusions:By means of Compound Xianhe Enteritis Tablets preparation process design,and make the best production process for Compound Xianhe Enteritis Tablets;Established to determine this product of effective component berberine hydrochloride by HPLC method,this method could accurately control the effective composition content;By the study for the stability of Compound Herba Agrimoniae Enteritis,its stability and period of validity was determined.The research for the development and application of Compound Xianhe Enteritis Tablets with more sufficient basis for the product laid a solid foundation.