Study On The Preparation Technology And Quality Evaluation Of Baitouweng Decoction Dropping Pills

Ulcerative colitis is a common difficult disease in the department of gastroenterology.However,the pathogenesis has not been fully elucidated,the current treatment effect to the disease is not ideal,and difficult to cure,the recurrence rate remains high,with a high cancer rate,so it is listed as one of the most difficult treated diseases by the world health organization.Baitouweng decoction is an effective treatment medicine of hot dysentery,its treatment of ulcerative colitis has been proved for many times,and has certain advantages.However,the traditional decoction of Pulsatilla chinensis is short for large volume of liquid,bitter tasting,unconvenient to take and carry.In addition,its raw materials are easy to mold,and affect the medical efficacy.Therefore,how to obtain the rapid absorption and high bioavailability of Baitouweng decoction dropping pills preparation is particularly important.Based on the study of Baitouweng decoction formula in Zhang Zhongjing’s treatise on pathogenic cold,this study aimed to prepare a new dosage form of Baitouweng decoction,investigated the optimal extraction conditions of the active ingredients in the pharmaceutical components of Baitouweng decoction,determined the preparation process of Baitouweng decoction dropping pills,and established the quality evaluation draft of Baitouweng decoction.On this basis,the stability of the prepared Baitouweng decoction dropping pills was verified,which will provid the theoretical and technical basis for the development and utilization of this new dosage form.This study was carried out through the single factor and orthogonal experiment design,with Baitouweng decoction formula,pharmacopoeia requirements and clinical medicine as reference,Baitouweng decoction was prepared according to the ratio of Pulsatilla chinensis 150 g,Coptis chinensis 60 g,Phellodendron 120 g,Cortex fraxini 120 g.Before decoction of medicine,soaking the herbs for 1.5 h was optimum extraction process.Then,12 times the amount of water was added for decoction,after 1h,the decotion was subjected to extraction for three times.Then the filtrate was combied and the reduced pressure concentration and drying of the filtrate dry extract was obtained.The dry extract was afterward smash through 80 mesh sieves,and ultimately get the extract powder.Under the optimal extraction conditions of medicinal materials,with polyethylene glycol PEG4000 to PEG6000 ratio of 1:1 for dropping pill matrix,taking medicinal herbs extract powder according to the ratio of 1:3 in matrix,water bath is heated to80℃,immersion,pour liquid into dropping pill machine,keep the solution temperature is 80℃,200 m Pa s.dimethyl silicone oil as a condensing agent,with 30 drops/min speed drops into the20℃condensing agent,drop distance was kept at 8 cm,condensing agent 50 cm in height,the finished dropping product can be obtained.In terms of quality evaluation,dropping pill three batch of pulsatilla decoction on the preparation of the finished product through the character,general examination of thin layer identification,and content determination,etc,with reference to the China pharmacopoeia（2015edition）has established the Baitouweng decoction dropping pill preparation of fingerprint and quality evaluation of the draft,finally determined the character of this product is brown to black,gas micro,taste bitter,dropping to 180 mg/g standard pellets,difference in weight limit for plus or minus 10%,the content of dropping pill limit per 1 g pill contains saponins B₄ shall not be less than 17.0 mg;Through accelerated test and long-term test,the preliminary stability of Baitouweng decoction dropping pills was studied,which indicated that the parameters of Baitouweng decoction dropping pills were in accordance with the provisions of pharmacopoeia,and the stability of the pills was good.This study shows that the preparation process of Baitouweng decoction dropping pills is stable and feasible,and the quality evaluation research is comprehensive for large scall production.