Live With Parasitic Pill And Granule Of Quality Control And Evaluation Research

Duhuojisheng Tang is a traditional prescription deriving from Valuable Prescription for Emergencies.It has the ability of expelling wind.removing damness,relieving pain,novishing kidney and liver,supplying qi and blood.So it can be used to treat rheumatic arthralgia,cold-pain of the loins and joints,limitation of movement.At present,the preparation of Chinese medicines which made from this prescription include Duhuojisheng Pill,Duhuojisheng Granules and Duhuojisheng mixture.The quality control standards of Duhuojisheng Pill and Granules are imperfect and not unified.So it is difficult to control the quality of Duhuojisheng Pill and Granules.,seriously affect the clinical efficacy and safety of this classical prescription.For this reason, they were listed in the study of national drug standards improve action plan.In this paper using qualitative and quantitative methods of index components, the quality standard of Duhuojisheng Pill and Duhuojisheng Granules had been systematically studied, which provide the standard’to the quality control of Duhuojisheng Pill and Duhuojisheng Granules.The main research contents are as follows:1.Basic research of Duhuojisheng Pill and Granules which relate to quality standard establishment.Basic research of Duhuojisheng Pill and Granules which relate to quality standard establishment has been done.To determine the establishment of identification and content determination of pharmaceutical based on analysis of prescription、 prescription composition and prescription dose. Study on quality standard of raw materials and accessories in order to ensure stable quality of raw material. Prescription medicinal research which provide basis to the selection of qualitative and quantitative index component. Preparation technology analysis,which confirmed the feasibility of index component selection. Preparations for Duhuojisheng Pill and Granules quality standard research, including raw materials, product, standards and negative control samples.2.Study on the quality standard of Duhuojisheng PillThis paper focus on the research of identification and content determination based on the full analysis of prescription composition, preparation method and the original standard of Duhuojisheng Pill.Microscopic identification of the original standard has been verified and TLC identification methods of the15medicinal materials involved in the presciption was researched in this paper. Finally the TLC identification methods of the Radix Angelicae Biseratae、Rhizoma Chuanxiong、Angelica Sinensis、Radix Paeoniae Alba、Radix Gentianae Marcrophyllae and Radix Rehmanniae Preparata have been established.The methods are accurate, sensitive, specific and reproducible, they can effectively identify the authenticity of preparation.The content determination method of osthole in Radix Angelicae Biseratae by HPLC has been established. Mobile phase consisted of acetonitrile-aquafer (43:57), detecting wavelength was at322nm,the result of this method showed a good linear relationship in the range of0.0503～4.024μg(r=0.9998), the rate of recovery was98.6%, RSD was1.44%; The content determination method of Gentiopicroside and Loganic acid in Radix Gentianae Marcrophyllae by HPLC has been established.Mobile phase consisted of acetonitrile-0.1%orthophosphoric acid (9:91), detecting wavelength was at236nm,the result of this method showed a good linear relationship in the range of0.6408～6.408μg(r=0.9994) for gentiopicroside, the rate of recovery was99.85%, RSD was0.24%, the result of this method showed a good linear relationship in the range of0.0384～1.9198μg (r=0.9993) for loganic acid, the rate of recovery was98.43%, RSD was1.4%; The content determination method of Paeoniflorin in Radix Paeoniae Alba by HPLC has been established. Mobile phase consisted of acetonitrile-0.1%orthophosphoric acid (12:88), detecting wavelength was at230nm,the result of this method showed a good linear relationship in the range of0.1274～5.096μg (r=0.9998), the rate of recovery was102.03%, RSD was1.8%. The methods are accurate, sensitive, specific and reproducible, they can effectively control the quality of Radix Angelicae Biseratae, Radix Gentianae Marcrophyllae and Radix Paeoniae Alba in Duhuojisheng pill.Meanwhile, this paper also provides the Method Validation information for inspection item of general rules for the preparation of pills.3. Study on the quality standard of Duhuojisheng GranulesThis paper focus on the research of identification and content determination based on the fall analysis of prescription composition, preparation method and the original standard of Duhuojisheng Granules:TLC methodology validation for original standard including the Radix Angelicae Biseratae、Rhizoma Chuanxiong、Angelica Sinensis、Radix Paeoniae Alba、 Glycyrrhizae and Pterostyrax Psilophyllus, TLC identification of Radix Gentianae Marcrophyllae had been added based on the systematic study of other medicinal ingredients.The methods are accurate, sensitive, specific and reproducible, can effectively identify the authenticity of preparation.The content determination method of Gentiopicroside and Loganic acid in Radix Gentianae Marcrophyllae by HPLC has been established.Mobile phase consisted of acetonitrile-0.1%orthophosphoric acid (9:91), detecting wavelength was at236nm,the result of this method showed a good linear relationship in the range of0.6408-9.612μg(r=0.9994) for gentiopicroside, the rate of recovery was99.98%, RSD was2.18%, the result of this method showed a good Linear relationship in the range ofD.0384～1.9198μg (r=0.9993) for loganic acid, the rate of recovery was101.29%, RSD was1.7%; The content determination method of Paeoniflorin in Radix Paeoniae Alba by HPLC has been established. Mobile phase consisted of acetonitrile-0.1%orthophosphoric acid (12:88), detecting wavelength was at230nm,the result of this method showed a good linear relationship in the range of0.1274～5.096μg (r=0.9998), the rate of recovery was100.22%, RSD was0.8%.The methods are accurate, sensitive, specific and reproducible, they can effectively control the quality of Radix Gentianae Marcrophyllae and Radix Paeoniae Alba in Duhuojisheng Granules.Meanwhile, this paper also provides the Method Validation information for inspection item of general rules for the preparation of Granules. 4. Duhuojisheng pill and Granules standards establishment and unityNew quality standards of Duhuojisheng pill and Granules were established based on fruitful results of Duhuojisheng pill and Granules quality standard research.Reviewed by Chongqing Institute for food and drug control,two quality standards are feasible, reproducible.They can effectively control the quality of preparation.In short,this paper used qualitative and quantitative methods of index components to improve and unify the quality standard of Duhuojisheng pill and Granules.TLC identification and content determination of Duhuojisheng pill were first used in the preparation. The standards established by this topic are accurately, accurate, feasible, specific and reproducible, can provide reliable basis for the quality control and standerd evaluation of Duhuojisheng Pill and Granules.