Study On The Improvement Of Quality Standard And Production Process Validation Of Siji Ganmao Tablets (Capsules)

Objective:To improve the quality standard of Siji Ganmao Tablets(capsules),establish the quality evaluation and control method of the preparation,and optimize the production process from the perspective of quality improvement to improve the overall quality level of the preparation.Methods:There are many manufacturers of Siji Ganmao tablets(capsules),but there is no unified national drug quality standard at present.All enterprises control the drug quality by registered standards or ministerial standards.The key test items of the current standard are missing,and the indicators for effective control of the internal quality of the preparation are lacking,which can not effectively control the product quality.In this study,the TLC method was used to establish the specific identification method of 8 medicinal materials in Siji Ganmao Tablets(capsules),including platycodon grandiflorum,perilla leaf,orange peel,schizonepeta,folium isatidis,forsythia suspensa,licorice,Cyperus,and Fangfeng,by optimizing the extraction solvent,extraction method,and developing agent.The fingerprint of Siji Ganmao Tablets(capsules)was established by HPLC;A method for the determination of the content of seven active ingredients in Si jiganmao tablets was established.The safety of Siji Ganmao Tablets(capsules)was studied.The four heavy metals of lead,cadmium,copper and chromium and 9 common pesticide residues were determined by atomic absorption spectrophotometry and gas chromatography respectively.According to the improved quality standard,the production process of the preparation was optimized and verified.Results:1.Taking the reference material and the reference material as the reference material,through optimizing the parameters,the identification method of eight medicinal materials in Siji Ganmao Tablets(capsules)was established,including platycodon grandiflorum,perilla leaf,tangerine peel,schizonepeta,folium isatidis,forsythia suspensa,licorice,Cyperus,fangfeng,etc;2.The fingerprint of Sijiganmao Tablet(capsule)was established by HPLC with the standard reference preparation as the reference,and 7 substances as the common reference peak,namely,cimetin,forsythrin A,glycyrrhizin,5-0-methylvisamin,hesperidin,rosmarinic acid and forsythrin;3.HPLC method was used to determine the content of cimetin,glycyrrhizin,5-0-methylvisamin,hesperidin,rosmarinic acid,forsythrin,glycyrrhizic acid α-The content of 8 components of Cyperhydanone was determined,and the content analysis method of 7 effective components in Sijiganmao tablets was established,and the reasonable content limit was worked out;4.The four heavy metals of lead,cadmium,copper and chromium and 9 common pesticide residues were determined by atomic absorption spectrophotometry and gas chromatography respectively,and the safety of Siji Ganmao tablets(capsules)was comprehensively studied;5.The quality standard of Siji Ganmao tablets(capsules)has been comprehensively improved;6.With reference to the improved quality standard,the production process of Siji Ganmao Tablets(capsules)was optimized and verified by orthogonal test to ensure the conversion rate of the effective ingredients of the nine medicinal materials.Conclusion:1.The TLC identification method of Siji Ganmao Tablets(capsules)in this paper has no interference with the negative control.On the corresponding position of the chromatogram of the sample,there are spots of the same color as the chromatogram of the reference medicine and the reference substance.2.The established fingerprint method of Siji Ganmao Tablets(capsules)can be used for overall and comprehensive evaluation of the quality of the preparation.3.A method for determining the content of mμlti-index components has been established,and through methodological validation,it can be used for the specific analysis of the effective components of seven medicinal materials in Sijiganmao tablets(capsules).4.The safety of Siji Ganmao tablet(capsule)was comprehensively studied and evaluated from the aspects of heavy metal pollution and pesticide residue;5.The quality standard of Siji Ganmao tablets(capsules)has been comprehensively improved;6.The production process of Siji Ganmao tablets(capsules)was optimized and verified by orthogonal test,and the reasonable parameters were determined.