l Drugs, reagents and instruments acetylspiramycin national standard (batch No. 347-9501). Acetylspiramycin tablets and capsules (commercially available).
Methanol, ethanol, dipotassium hydrogen phosphate, potassium dihydrogen phosphate, and hydrochloric acid were all analytically pure, and water was double distilled water.
Japan Shimadzu UV-240 can be seen outside the spectrophotometer.
2 Experimental method Precision parts Take 2 samples of acetylspiramycin national standard; a 25.8mg, set in a 10mL volumetric flask, add methanol to dissolve and add to the scale, shake well, accurately measure 2mL in a 25mL volumetric flask, add Methanol solution (1 → 5) to the scale, shake well, accurately measure 5mL into a 50mL volumetric flask, add methanol solution (1 → 5) to the scale, shake well, that is, obtain a standard methanol solution of 20.64μg / mL; A 24.1mg, placed in a l0ml volumetric flask, add ethanol to dissolve and add to the mark, shake well, accurately measure 3 parts of 2mL separately placed in a 25mL volumetric flask, and then separately use water, hydrochloric acid solution (diluted hydrochloric acid 24 → 1000), Phosphate buffer (pH 7.8) was quantitatively diluted to a standard aqueous solution of 19.28 μg/mL, lysine hydrochloride and phosphate buffer. Taking the above four solutions, the ultraviolet absorption spectrum was plotted at a wavelength of 200 to 300 nm, and the absorbance value of (232 ± 2) nm was measured. The acetylspiramycin tablets (solution concentration of about 16 μg/m1) and capsules (solution concentration of about 15 μg/mL) were measured in the same manner.
3 Results and Discussion Results Four different solvents had no effect on the large absorption wavelength and UV absorption spectrum of acetylspiramycin. When the concentration of the standard methanol solution is converted to the concentration of the standard solution, the absorbance is 0.586. The 95% confidence interval for the overall mean value of the four values ​​of the four solutions of the standard was [0.593, 0.584], indicating that the solvent had no effect on the large absorbance value of the acetyl spiromycin.
The ultraviolet identification solvent of acetylspiramycin tablets and capsules is dissolved in a small amount of ethanol, and then diluted with water to form an aqueous solution of about 15-20 μg/mL, and the large absorption value of zui is about 0.4 to 0.6, which can reduce waste. Reduce pollution to the environment.
references
1 Ministry of Health (95) Wei Medicine Mark No. 02, Acetylspiramycin Tablet Quality Standard
2 Ministry of Health {95} medicinal medicinal standard No. 03, acetylspiramycin capsule quality standard
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