Study On Preparation Technology And Quality Standard Of Ruyi Zhenbao Tablets

Objective: To solve the problems of low yield and backward quality standards in the production process through the research on the preparation technology and quality standards of Ruyi Zhenbao Tablets,in order to reduce the production cost of medicines and improve the quality control level of tablets.Through the research on the quality standards of Xianghanqin and Huangkuzi medicinal materials,establish and improve the standards of medicinal materials,and provide inspection basis for storage.Methods: Under the guidance of the instructor,use modern pharmacy and quality control methods,combined with medical statistics knowledge to carry out research from the following three aspects.1.Research on the preparation process of Ruyi Zhenbao Tablets.According to the traditional medicine characteristics of Tibetan medicine and modern pharmaceutical technology,this subject uses a full-powder tableting process to crush the drug into a fine powder,add appropriate auxiliary materials,and granulate and press it into tablets.First,a single factor inspection method was used to study the effects of crushing time,granulation screen size,tablet type,binder type,wetting agent content,and tablet press pressure.On the basis of the former,we selected the amount of wetting agent,tablet diameter,and tablet press pressure that have a great influence on the tablet formability to do an orthogonal experiment of 3 factors and 3 levels,and screened out the best preparation process and repeated Sexual verification experiment.The particle moisture content,particle size distribution,particle yield,particle angle of repose,compression degree,etc.under the best process conditions were investigated,which provided a basis for the quality control of Ruyi Zhenbao tablet semi-finished products(particles).2.Research on the quality standards of Ruyi Zhenbao Tablets.Through literature review combined with experimental research,a new thin layer chromatography(TLC)identification method for the four medicinal materials of frankincense,balsam,woody and clove in the prescription was newly established;the main effective component of safflower was established by high performance liquid chromatography HPLC method for determination ofsafflower yellow pigment A and long pepper's main active ingredient piperine.In accordance with the requirements of the Pharmacopoeia General Requirements for Preparations,quality analysis was conducted on 6 batches of Ruyi Zhenbao Tablets,and their appearance,differences in tablet weight,tablet hardness,friability,disintegration time limit and other items were checked and met the regulations.3.Study on the quality standards of Xianghanqin and Huangkuzi.This study is based on the existing standards of Tibetan medicinal and Chinese medicinal materials.By consulting the literature and combining six batches of medicinal materials experiments,we study the photos of powder microscopic identification,cross-sectional microscopic identification items,thin layer chromatography identification,alcohol Items such as determination of soluble leachables.Result:1.The best preparation process and parameters: add 40% warm water(about 40 ~ 60 ?)as a wetting agent to dissolve the licorice paste,mix it with the rest of the fine powder of Ruyi Zhenbao tablets,then granulate with a 24 mesh sieve It is dried and granulated,and compressed into tablets under the condition of a tablet press pressure of 35 KN and a tablet diameter of 10 mm.According to the general rules of the preparation,the evaluation of the drugs showed that the surface of the prepared tablets was smooth and brown,with an average tablet weight of 0.5g and an average hardness of 35.9N.The friability and disintegration time limit met the regulations.2.The TLC spots of frankincense,balsam,woody,and clove in Ruyi Zhenbao tablets are clear,the Rf value is moderate,and the negative is no interference,which can be used as the quality standard under thin layer identification.According to the results of Agilent 1160 high performance liquid chromatography(HPLC),the content of hydroxysafflor yellow A in Ruyi Zhenbao tablets is 0.37 mg / g ~ 0.755 mg / g,the average value between groups is 0.567 mg / g;the content of piperine From 0.26 mg / g to 0.37 mg / g,the average value between groups is 0.325 mg / g.Finally,a new quality standard for Ruyi Treasure Tablets was drafted.3.The basic source of Xianghanqin and Huangkuzi is clear,and the appearance is easy to identify.The microscopic identification of Xianghanqin is characterized by vascular bundles,oil tubes,cotyledons,calcium oxalate cubic crystals,stone cells,oil droplets,andthreaded ducts;the microscopic identification of okra seeds is composed of palisade cells,pigment cell groups,cotyledons,endosperm,Embryo,outer epidermal villi,and calcium oxalate cluster crystals.In terms of thin layer chromatography(TLC)identification,both can show spots of the same color and position compared with the control medicinal materials,with good reproducibility.Through the determination of alcohol-soluble extractives of 6batches of medicinal materials,the average extractive content of the medicinal material Xiangxianqin was found to be 21.82%,the highest value was 25.16%,and the lowest value was 18.62%.The average extract content of the medicinal material Huangkuzi is 10.67%.The highest content of the six batches of medicinal materials is 11.52%,and the lowest value is 9.79%.In the end,new quality standards of Xiangxianqin and Huangkuzi were drafted.Conclusion: The preparation process of Ruyi Zhenbao Tablets is stable and feasible,and meets the production specifications.The quality standard of finished products has been significantly improved compared with before,which can better control the quality of drugs.The quality standards of Xianghanqin and Huangkuzi added cross-sectional microscopy,thin-layer chromatography,alcohol-soluble extract supplements,and became more complete.