The Preparation And Quality Standard Of Microcapsules Aerosol For Treating Lung Cancer

Kangaisan anticancer agents, developed based on Zhang Dezhong chief physician of ancestral secret recipe on the document number: Hubei: pharmaceutical(2001) BZ44-005. Kangaisan from Hedyotis diffusa, Fructus polygoni orientalis, three seven, Paris(seven leaf flower), American ginseng, bupleurum six Traditional Chinese medicine formula composition, rigorous, evil are taken into account, playeda total of heat clearing and detoxicated promoting circulation of Qi and blood, phlegm, relieving pain, nourishing Qi Gong, for lung cancer, can not only significantly improve the symptoms of cancer patients and can dissipate, extend life, but also can control the transfer and relieve the pain, improve the quality of life. Has a strong anti-lungumor activity, can improve the immune function of organism. Mainly used for the treatment of lung cancer, but also for the treatment of liver cancer.Previous research laboratory: screening of anticancer powder prescription. Anticancer powder formula. Pharmacological study on Kangaisan effective parts of the fingerprint of Kangaisan. Effective parts of ethyl acetate on Kangaisan; chemical constituents of petroleum ether extraction, anticancer powder extract and single herb extracts from analysis and comparison of the content of the main active ingredients. Anti-tumor mechanism research and new formulations of anticancer active components dispersed nanoparticles research.But the existing research mostly concentrated in the direction of such components, no dosage form for Fructus Polygon oriental is: Hedyotis diffusa, Paris, three seven, American ginseng, bupleurum six kinds of traditional Chinese medicine. Therefore, on the basis of existing research, in view of the characteristics of lung cancer, respiratory disease, cancer powder prepared into aerosol formulations, can make the medicinal ingredients directly to lesions, so as to better inhibition, remission and cure of lung cancer.The purpose of this project is to develop micro encapsulated aerosol for treating lung cancer and to study the quality standard of the preparation. Using modern science and technology such as chromatography to compound Chinese medicine extraction, purification to obtain effective parts, design manufacturing process, and quality standard of experimental research.According to the research purpose, the research content is divided into four sections: To further clarify the effective part, determine the optimum conditions for the extraction separation of flavonoids. Material selection, a new method of inclusion compound traditional Chinese medicine active sites into particles, preparation of nanometer microcapsules, and connecting with folic acid, tumor cell targeting. Preparation of quantitative aerosol. Formulate quality standard were anticancer powder aerosol.Based on the experimental design of orthogonal test method, the raw material for heat reflux extraction ethanol extraction, extraction conditions were selected by orthogonal table, alcohol extraction were determined by quantitative yield of extract liquid can be dried to powder quantitative preparation of sample solution, the HPLC method for determination of the content of ursolic acid, in order to study the main factors affecting the extraction process of effective anticancer component of anticancer compound powder, the ratio of mobile phase: phase 72%A(Yi Jing), 28%B(0.1% phosphoric acid solution), isocratic elution. Finally using the content of ursolic acid in extraction rate and sample as the index, to optimize the extraction process of compound anticancer powder.The anticancer powder as capsule core, Arabia gelatin and gum as the sealing material, using complex coacervation microencapsulated drug package into the pharmacy store. To explore the main influence factors of the microcapsule preparation process and the optimum process conditions and the establishment of the method for the determination of. The microcapsules by microscope and electron microscope; UV spectrophotometry was used to determine the content; using distilled water as dissolution medium on the in vitro dissolution system. With the entrapment efficiency as the main quality index, the formulation was optimized by single factor test and orthogonal test process.With the method of spray drying(physical and mechanical method for curing), using two methyl ether as propellant, made quantitative aerosol, tentative specifications 25mg/ bottles, each press 0.1mg. In accordance with the requirements of Pharmacopoeia of cancer powder microcapsule type aerosol study the quality standard of review.The experimental design of orthogonal test, the optimized compound anticancer powder extraction process was 12 times the amount of solvent, extraction time 1.5 h, ethanol concentration 80%. The average diameter of the preparation of Kangaisan microcapsules is 6.403?m, and in accordance with the orthogonal distribution. The entrapment efficiency was 84.63%, with the 2010 edition of "Chinese Pharmacopoeia" requirements. The optimum process conditions are encapsulated ratio of gelatin glue: Arabia. anticancer powder =2:2:1.Speed of 400 r/min and a temperature of 35, encapsulated pH 4. According to the Circular of the microcapsules were prepared and smooth, high encapsulation rate.