Solution Preparation for Aerosol Inhalation of Carbocisteine, and Preparation Method Therefor

[0071]1000 mL of a solution preparation for aerosol inhalation of carbocisteine was prepared according to the proportion of Prescription 1.

[0072]70% of the total amount of water for injection, which was 700 mL, was added into a liquid preparation apparatus, the water temperature was controlled at 30° C., nitrogen was filled into the water for injection for protection until the liquid preparation was finished, a positive nitrogen pressure was kept in the liquid preparation apparatus, and the next operation was carried out after the residual oxygen content was measured to be 1.6 mg / L.

[0073]Then, 20 mg of disodium edetate (manufactured by Chengdu Huayi Pharmaceutical Excipient Manufacturing Co., Ltd.) was weighed and slowly added into the above water for injection, and the mixture was stirred until the disodium edetate was completely dissolved.

[0074]Next, 4 g of carbocisteine (manufactured by Sinopharm Shantou Jinshi Pharmaceutical Co., Ltd.) was slowly added, and the mixture was stirr...

[0078]A solution preparation for aerosol inhalation of carbocisteine was prepared in the same manner as in Example 1, except that the proportions of Prescriptions 2 to 13 were used in place of that of Prescription 1.

[0081]The single-dose solution preparations for aerosol inhalation of carbocisteine obtained in Examples 5, 8 and 9 (the solution preparations for aerosol inhalation of carbocisteine were prepared according to the formulas of Prescriptions 5, 8 and 9) were left to stand for one year. The content of carbocisteine in the single-dose solution preparations for aerosol inhalation of carbocisteine obtained in Examples 5, 8 and 9 were determined by the following method for determining the content of carbocisteine after one year, and the color and clarity of the preparations were observed by visual observation. The results were shown in Table 1.

Determination of the Content of Carbocisteine

[0082](1) Octadecylsilane-bonded silica gel was used as a filler (4.6×150 mm, 5 μm), a 20 mM sodium octane sulfonate solution and a 20 mM potassium dihydrogen phosphate solution (pH was adjusted to 2.5 with phosphoric acid) were used as the mobile phase, the detection wavelength was 210 nm, the column temp...