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药品说明书翻译样例

发布者:鑫达医学翻译 发布时间:2012-11-19阅读:

Drug discrimination:
(1). Transfer 2 gram of the powder into the test tube which was sealed by a cork. Water droplet was noted in the tubal wall after ignition.
(2). 0.2 g powder was dissolved into 10 ml diluted hydrochloric acid. The mixture was cooled at room temperature. Subsequently, 1 ml filtrate was neutralized with NaOH solution (2%). Then white precipitate was generated after adding 1 ml ammonium oxalate. The white precipitate could be dissolved in hydrochloric acid other than acetic acid. Additionally, 1 ml barium chloride solution was added to 1 ml filtrate, resulted in white precipitate that was not dissolved in hydrochloric acid and acetic acid.

(3). 1 g powder was heat until it reached the sublimation temperature. Then the sublimate was collected, and was dissolved in ethanol (1~2 drops). After fresh vanillin/sulphuric acid reagent (1~2 drops) was added, the mixture was in a color of purple.
Inspection: The content of water should not >21.0% (appendix IX H, method II).
Other ingredients should be consistent with the standard methods (Appendix IL).
Content determination: Gas chromatography (Appendix VI E).

Chromatographic condition and system suitability test: Silicone was used as the stationary liquid. The coating concentration was 9%. The column temperature was set at 150℃. The theoretical plate number was calculated according to the peak value of borneol (it should be ~1500). The resolution of the peaks of borneol and impurity was according to the standard methods.

The determination of correction factor: N-tetradecane was dissolved in ethyl acetate with a final concentration of 50 mg/ml. The solution was set as the internal standard. After that, 20 mg borneol reference substance was added to a 10 ml volumetric flask. Subsequently, 1.0 ml internal standard was added, and was diluted with ethyl acetate. Then 1 μl solution was transferred to the gas chromatographic column. The correlation factor was calculated according to the averaged peak area.


 


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