Analysis Of Chemical Composition And Stability Of Marsdenia Tenacissima And Its Preparation

Marsdenia tenacissima(Roxb.)Wight et Arn.aka Wuguteng,Tongguangteng,milk rattan,morrocoy plant,is widely distributed in tropical and subtropical regions of Asia.China’s Yunnan,Guizhou and other places also have a lot of distribution.Marsdenia tenacissima,s medicinal part is it,s dry rattan.Marsdenia tenacissima is sweet and slightly cold and taste bitter.It has the effect of expectorant and lactogenesis,heat clearing and detoxifying and it can reliev cough and asthmathe.There are many kinds of preparations such as Xiaoaiping tablets and Xiaoaiping injection etc that are extracted from Marsdenia tenacissima.It,s preparations are mainly used for the treatment of lung cancer,liver cancer,esophageal cancer,gastric cancer and other malignant tumors and the effection is good.This study established a reliable,sensitive and convenient UPLC/MS/MS method.The method could determine Tenacissosides A,H,I three active components of xiaoaiping tablet and Marsdenia tenacissima herbs simultaneously respectively.Another study examined the stability of xiaoaiping injection in three solvents from p H,insoluble particles,contents of tenacissoside A and I.The same time,the study established a HPLC method that could determine contents of Tenacissoside A and I on the same time respectively and determined the contents of Tenacissoside A and I eventually.This study provides reference for Marsdenia tenacissima and it,s preparation method for the quality control of the formulation.It also provides safe and stable reference data for clinical and Pharmacy Intravenous Admixture Services.Part one Study on the analysis method of Tenacissosides in Marsdenia tenacissima and xiaoaiping tabletObjective: To develop a UPLC-MS/MS method for the determination ofTenacissoside A 、H and I in xiaoaipin injection.Methods: Adopting the SPE-UPLC-MS/MS method.The chromatographic column was Phenomenex Kenetix C18(50mm×3mm,2.6μm),the mobile phase was acetonitrile-0.1% formic acid in water(gradient elution),the column temperature was 40℃,while the flow rate was 0.2 m L·min-1;The assay determination was carried out by using the MRM scanning mode,which was ESI model.The precursor-to-product ion paris of Tenacissoside A,H and I were 977.6/17.6,817.5/757.5,815.5/755.5。Results: The linearity range of the sample quantity of Tenacissoside A,H and I reached 0.025~10 ng·m L-1(r is 0.9997,0.9995,0.9989 respectively);LOD and LOQ were less ran 0.05 、 0.00125 、 0.00125;0.1 、 0.025 、0.025ng·m L-1respectively.RSD of the precision,stability,repetitive testing was less than 3.0 %.The range of the sample adding’s recovery rate of Marsdenia tenacissima herbs was 98.0%~103.3%,Tenacissoside A,H and I RSD(%)reached 0.53、1.4、2.8 respectively.The range of the sample adding’s recovery rate of xiaoaiping tablet was 98%~99.4%,while Tenacissoside A,H and I RSD(%)reached 0.53、1.97、0.44 respectively.Conclusion: This method is simple,rapid and sensitive,and can be used for determination of Marsdenia tenacissima herb and Xiaoaiping tablet in tenacissoside A,H,I content,and provides reference for Marsdenia tenacissima herb and related preparatio quality control of the preparation methods of formulation.Part Two The finished product infusions’ stability study of xiaoaiping injectionObjective: To investigate the stability of xiaoaiping injection with common solvents and provide reference datas to reference for clinic rational use of drugs.Methods: By solving xiaoaiping injection respectively with 5% glucose injection,10% glucose injection,0.9% sodium chloride injection,the appearance of mixed solution,p H and insoluble particles changes at room temperature(about 25℃)and high temperature(40℃)environment placed atdifferent times(≤ 48h)were investigated and a HPLC method for determination of xiaoaiping injection’s tenacissoside A and tenacissoside I content was established,and the contents of tenacissoside A and tenacissoside I were determined.Results: The contents of tenacissoside A and I had no obvious changes,the numbers of particles above 25 μm were within the Pharmacopoeia standard in 5% glucose injection,10% glucose injection and 0.9% sodium chloride injection under room temperature and high temperature.The particle numbers that diameter were from 10 to 25 μm were all more than 25 in 5%glucose injection,10% glucose injection and 0.9% sodium chloride injection.The color of the solution changed from brown to red brown in 0.9% sodium chloride injection at room temperature and high temperature in 24 h.The color had no obvious changes mixed with 5% and 10% glucose Injection at room temperature and high temperature within 48 h.Conclusion: Xiaoaiping injection were stable mixed with 5% glucose injection,10% glucose injection and 0.9% sodium chloride injection respectively within 24 hours.The manual does not put the 0.9% Sodium Chloride Injection as xiaoaiping injection solvent,this experiment suggests0.9% consider Sodium Chloride Injection as its common solvent.