Study on quality standard of Dengzhan Shengmai soft capsule
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AIM Through research on entire quality standard of Dengzhan Shengmai soft capsule, to establish the quality standard which will meet the criteria of the application requirement for new Chinese patent medicine. METHODS Quantity of scutellarin was determined by HPLC through measuring the main effective ingredients of Dengzhan and quality identifying methods for three meteria medica was established by TLC. RESULTS Method of quantity determination of scutellarin was set up, outcoming with the minimum content of each capsule had not to be less than 15.0 mg; and thus also established the identification method for Herba erigerontis, Ginseng, Fructus Schisandrae Chinensis, and there was no interference with the negative references. CONCLUSION The establishment of quality standard of Dengzhan Shengmai soft capsule is scientificial and practical, which is superior than quality standard of Dengzhan Shengmai capsule, and further ensures the quality and stability of Dengzhan Shengmai soft capsule.Keywords:
Quality standard
Capsule
Scutellarin
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Objective To explore the prescription and preparation technology of Miganning Capsule and establishing the quality standard.Methods Capsule was prepared with semi-extract granulation method.Qualitative identification between phellodendron amure and radices cyathulae was conducted with thin-layer chromatography(TCL).HPLC was applied for content determination for desmodium and sculellaria barbata.Results TCL detected phellodendron amure,radices cyathulae,and was suitable for the identification for the two after investigation on the specificity and repetitiveness.The HPLC provided that kaempferide content in Miganning Capsule should be over 40μg/g,which offered an effective control to the product quality.Conclusion The prescription is reasonable.The preparation method is accorded with conventional TCM rule.The established method is simple and feasible and suitable for quality control for the Miganning Capsule.
Capsule
Quality standard
Granulation
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OBJECTIVETo establish the optimal extraction technology for Dengzhan Shengmai Granules.METHODSThe orthogonal test was employed for selecting the optimum of extraction technology.The investigation factors were the volume of alcohol and concentration,the time and time of extraction.The extraction technology of Dengzhan Shengmai Granules was screened by the transfer rate of scutellarin in asarum herb and yield of extraction.RESULTSThe best extraction condition was as follow:10times of 70% alcoho1,extracted twice,each time was 3 hours.CONCLUSIONThe above mentioned extraction technology was feasible,stable,reasonable and replicable,the optimized extraction process of Dengzhan Shengmai Granules was obtained.
Scutellarin
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OBJECTIVE Study on prescription constitutes,the preparation method and the standard of the quantity controls of Qinggan Capsule.METHODSAfter being extracted volatile oil,mint,schizonepeta can be decocted two times with scutellaria,honeysuckle,forsythia,burdock-seed,and concentrating decoction liquides.Platycodon root,angelica root and liquoric root was mixed with the decoction liquid after being grounded to thin powder,then drying,grounding and making into grain,spraying the volatile oil and filling the capsule.RESULTSProducing technique is scientific,reasonable,discriminating and quantitative analysis method can effectively control the quality of the product.CONCLUSIONThe method is stable and dependable to control the quantity of the baicalin.
Decoction
Baicalin
Capsule
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Objective:Improving the standard identification method for Danshen and establishing an identification and determination method for Shanqi.Methods:TLC.Results:The identification methods for Dansen and Sanqi are feasible.Conclusion:Test results show the revised methods are applicable in the quality control.
Identification
Quality standard
Gold standard (test)
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Chinese medical preparation has complicated chemical constituents. Consequently, the proper quality control methods for these Chinese medical preparations have been great challenges to the traditional Chinese medicine modernization and internationalization. What components should be chosen for quality control is a big challenge in the development of traditional Chinese medicine. A new concept of “Quality Marker” was proposed by Liu et al. to solve this problem and established a new research paradigm for traditional Chinese medicine quality study. Several strategies were proposed by the researchers in traditional Chinese medicine, here, we used Shengmai injection as an example to discuss a strategy for selecting “Quality Markers” of Chinese medical preparation by the components transfer process analysis in the Shengmai injection manufacturing process. Firstly, a total of 87 compounds were identified or partially characterized in shengmai injection. Secondly, referenced to the quality control method in China pharmacopeia and considered the biomarkers in the original medicines and representative components in the manufacturing process, four ginsenosides in Panax ginseng (Hongshen), two compounds in Schisandra chinensis (Wuweizi), and a sugar from Ophiopogon japonicas (Maidong) were quantified. As a result, these seven representative compounds exhibited an acceptable transitivity throughout the Shengmai injection manufacturing process. Finally, combined with the active ingredients, components transfer process analysis, and comprehensive evaluation by “Spider-web” analysis, six compounds were selected as the quality markers for the quality control of Shengmai injection. Through this strategy of optimization for quality markers of Shengmai injection, we found that these six compounds could represent the main bioactive substances and be easily detected in the whole process of production. Furthermore, the quality control method was developed for quality assessment and control of these six quality markers in the Shengmai injection. The total content range of the selected quality markers in the 10 batches of the Shengmai injection is 13.844-22.557 mg/mL.
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