Development Of New Type Of Traditional Chinese Medicine Aerosol

Since the Freon’s destruction of the ozone layer, the Chinese herb aerosol which used freon as propellant has been fully disabled in 2013, earlier products can be in circulation until the deadline. Foreign countries have an early research on the alternative of Freon. Currently, the available alternative substances are DME, HFA 134a and HFA 227ea. But domestic research in this aspect is still in its infancy.A new type of Chinese herb aerosol was prepared, which used Yunnan Baiyao aerosol liquid as a main drug, DME and HFA 134a as propellant, combined with solubilizing agents, film formers and penetration agents. The prepared aerosol was nonflammable, safe, clear and had a high stability. Particle size distribution was measured by a laser particle size analyzer, and the drive with suitable aperture was screened. besides, the aerosol was sealed in the aerosol cans, the leakage rate and the corrosion of the tank were both in line with the requirements. The injection rate of the preparation, the total discharge, ethanol content and active ingredient content of the preparation were studied, which all meet the requirements of the company.1, Prescription screening of Yunnan Baiyao Aerosol and Insurance LiquidPropellants alternative of Yunnan Baiyao aerosol liquid and Yunnan Baiyao aerosol insurance liquid have been studied by this paper. First of all, the components of two Chinese herb liquid were measured, as a result, the ethanol content of Yunnan Baiyao aerosol liquid was 88.9%, the moisture content was 7.84%, the ethanol content of Yunnan Baiyao aerosol insurance liquid was 92.8%,the moisture content was 2.61%. Then the intersolubility between Chinese herb liquid and DME, HFA 134a was examined, DME and HFA 134a were mixed with two different Chinese herb liquid respectively at the same mass fraction, the prescription which DME mixing with Chinese herb liquid only produced a small amount of precipitation, the other produced lots of yellow flocculent precipitate, so DME was chosen as the main propellant. After adding 3-9% glycerol, the prescription was clear and transparent. Considering the high ethanol content of two herb liquid and high flammable of DME, a small amount of non-combustible material HFA 134a was added to ensure the safety of using process,, which reduced the flammable of preparation, and there was no precipitation and stratification by the preparation. To ensure the effect of using, 1-3% PVP K30 was screened as film former,1-2% azone was screened as penetration enhancers. Finally, the amount of two materials was determined and evaluate in preparation for further optimization.2, Security evaluation of Yunnan Baiyao Aerosol and Insurance Liquid homemade prescriptionThe security of the prescription was studied with the method of testing the ignited distance of dangerous aerosol, flammability of Yunnan Baiyao aerosol and Yunnan Baiyao insurance liquid were studied under different proportions HFA 134a, it was concluded that the flammability of homemade prescription is as same as the sales of products on sales and the aerosol is safe to use when DME proportion was 15% and the propor of HFA 134a was 10% in the research of Yunnan Baiyao aerosol formulation. It was also concluded that the flammability of homemade prescription is as same as the sales of products on sales and the aerosol is safe to use when DME proportion was 35% and the propor of HFA 134a was 10% in the research of Yunnan Baiyao insurance liquid aerosol formulation.3, Formulation characteristics evaluation of Yunnan Baiyao Aerosol and Insurance Liquid homemade prescriptionFirstly, the stability of the Yunnan Baiyao aerosol formulation and Yunnan Baiyao aerosol insurance formulation were researched in the process of preparation quality evaluation, when formulations were placed at temperature 4℃,for 24 hours, then the formulations were moved at temperature 40℃ and humidity 75% for 24 hours, after five times of hot and cold cycles, it was investigated that the formulation was clear and transparent. Droplet size distribution of homemade prescription and commercial products were measured by using a laser particle size analyzer,0.5 millimeter aperture drive was chosen as homemade prescription drive, and homemade prescription particle size distribution was consistent with the commercial product. The amounts of discharge and injection rate of two different prescriptions were researched, the total discharge of Yunnan Baiyao aerosol homemade prescription was 88.6%, injection rate was 0.87g/s, the total discharge of Yunnan Baiyao aerosol insurance liquid homemade prescription was 95.1%, injection rate was 0.85g/s, two kinds of prescriptions were both meet the requirements of China Pharmacopoeia which injection rate was more than 0.80g/s and total discharge was more than 85%. Leakage rate and corrosion of the tank by liquid were both studie, the results showed that the leak rate of prescription was less than 3.5%, there was no tank corrosion when the formulations were placed at room temperature for 6 months. According to the quality standards of Yunnan Baiyao aerosol, the ethanol content tested by gas chromatography was 83.2%, the corporate standards of which is 74%-88%, and the main active ingredient personal saponins Rgl measured by high performance liquid chromatography was 1.11mg/mL, meeting the standard which was more than 0.3mg/mL. As a result, both met the relevant requirements of quality standard.The aerosol this thesis made met the requirements of China Pharmacopoeia and the company, sealed the aerosol in the aluminum cans, the aerosol was convenient to use, had a high stability, clean, environmental friendly and had a high value.