Fufang Yikangzuo Yanghuaxin Safen
Compound Econazole Nitrate Powder
This product contains econazole nitrate (C18H15Cl3N2O · HNO3) and zinc oxide (ZnO) should be 90.0% to 110.0% of the marked amount.
ã€Prescription】 Econazole Nitrate 10g
250g zinc oxide
Calcined alum 50g
Borneol 10g
Talc powder
Made 1000g
ã€Manufacturing method】 Dry and crush each powder separately, pass through No. 6 sieve, mix well.
ã€Properties】 This product is a kind of white powder with the smell of borneol.
[Identification] (1) Take an appropriate amount of this product (about 10mg of borneol), add 5ml of ethanol, shake to dissolve, filter, concentrate the filtrate on a water bath to about 1ml, let cool, add freshly prepared 1% vanillin sulfuric acid 1 to 2 drops of the solution will appear purple.
(2) Take an appropriate amount of this product (approximately equivalent to 100mg of calcined alum), add 10ml of water, shake for 5 minutes, filter, the filtrate is divided into 2 parts, add ammonia test solution to a white colloidal precipitate, add alizarin After a few drops of sodium sulfonate indicator solution, the precipitate is cherry red; another test solution is added with barium chloride, and a white precipitate is generated, which is separated.
(3) Take an appropriate amount of this product (about 0.25g of zinc oxide), add 10ml of dilute hydrochloric acid, shake to dissolve, filter, and add potassium ferrocyanide test solution to the filtrate to produce a white precipitate.
(4) In the chromatogram recorded under the content determination item, the retention time of the main peak of the test product should be consistent with the retention time of the econazole nitrate reference product.
[Inspection] The inspection of the loading volume according to the minimum loading inspection method (Appendix XX F of the Chinese Pharmacopoeia 2000 Edition, Part II) shall comply with the regulations.
Other than drying weightlessness, it should meet the relevant regulations under the powder (Chinese Pharmacopoeia 2000 Edition Appendix II P).
[Determination of content] Econazole nitrate is determined by high-performance liquid chromatography (Chinese Pharmacopoeia 2000 Edition, Appendix â…¤ D).
Chromatographic conditions and system suitability tests use octadecylsilane-bonded silica gel as a filler; methanol-water-triethylamine (85: 15: 0.1) (with glacial acetic acid to adjust the pH to 6.0) as the mobile phase; detection wavelength It is 230nm. The number of theoretical plates calculated according to the peak of econazole nitrate should not be less than 1500.
Determination of appropriate amount of this product (approximately equivalent to 10 mg of econazole nitrate), accurately weighed, placed in a 100ml measuring bottle, add appropriate amount of methanol, shake to dissolve, then add methanol to the mark, shake, filter, precision Measure 20μl of the continuous filtrate into a liquid chromatograph and record the chromatogram; take another econazole nitrate reference substance, accurately weigh it, dissolve with methanol and quantitatively dilute to make a solution containing 0.1mg per 1ml, and determine by the same method. According to the external standard method, the area formed by the baseline is called the peak area. A = × σ × h = 2.507σh = 1.064 Wh / 2h> Peak area calculation.
Take the appropriate amount of zinc oxide (approximately equivalent to 75mg of zinc oxide), weigh it accurately, place it in an Erlenmeyer flask, add 5ml of dilute hydrochloric acid, shake to dissolve the zinc oxide, add 20ml of water, 1 drop of 0.025% methyl red ethanol solution, Add ammonia test solution dropwise until the solution is micro yellow, add 25ml of water, 10ml of ammonia-ammonium chloride buffer (pH10.0) and 1.5g of tartaric acid, shake to dissolve, add a little chrome black T indicator, use ethylenediamine tetrachloride Disodium acetate titration solution (0.05mol / L) is titrated until the solution turns from purple to pure blue. Per 1ml EDTA disodium titration solution (0.05mol / L
This article comes from the compound econazole zinc oxide dusting powder | Scientific Instrument Online Original Link: http: //
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