2 English reference naproxen sodium tablets
3 Pharmacopoeia standard of naproxen sodium tablets 3. 1 name 3. 1. 1 Chinese name naproxen sodium tablets
3. 1.2 Chinese Pinyin Napson Tablet
3. 1.3 English name naproxen sodium tablets
3.2 The content or potency of naproxen sodium (C 14H 13NaO3) in this product should be 93.0% ~ 107.0% of the labeled amount.
3.3 Characteristics This product is white or white-like.
3.4 Identification (1) Take a proper amount of fine powder of this product (about 0.25g of naproxen sodium), add water 12ml, shake well, and add hydrochloric acid 1ml, that is, white precipitate is produced, and the filtrate shows the identification reaction of sodium salt (Appendix III of Pharmacopoeia II, 20 10 edition).
(2) Take the sediment to be identified (1), wash it with water until it is neutral, dry it at 105℃ 1 hour, take about 30mg fine powder, add methanol to make a solution containing 30μg per 1ml, and observe the ultraviolet-visible spectrophotometry (20/kloc)
3.5 Check the dissolution rate of 3.5. 1 Take this product, and use phosphate buffer (pH 7.4) (take 2.28g of sodium dihydrogen phosphate, disodium hydrogen phosphate11.) according to the dissolution determination method. The rotating speed is 50 revolutions per minute, and the operation is carried out according to the law. After 30 minutes, take 10ml solution, filter it, take a proper amount of continuous filtrate, and dilute it with dissolution medium to make a solution containing about 0. 1mg of naproxen sodium per 1ml as the test solution. Accurately weigh another naproxen sodium reference substance, dissolve it in the dissolution medium, and dilute it quantitatively to prepare a solution containing 0. 1ml as the reference substance solution. Take the above two solutions, respectively, and measure the absorbance at the wavelength of 332nm according to the ultraviolet-visible spectrophotometry (Appendix Ⅳ a of Pharmacopoeia II, 20 10), and calculate the dissolution of each tablet. The limit is 80% of the marked quantity, which should meet the requirements.
3.5.2 Others shall comply with the relevant provisions under tablets (Appendix 1A of Pharmacopoeia Part II, 20 10).
3.6 Content determination Take this product 10 tablet, accurately weigh it, grind it, accurately weigh an appropriate amount (about 275mg of naproxen sodium), put it in a 100ml volumetric flask, add about 70ml of methanol, shake it well for 30 minutes, dissolve naproxen sodium, dilute it to scale with methanol, shake it well, filter it, and accurately measure 2ml. According to the ultraviolet-visible spectrophotometry (Appendix Ⅳ a of Pharmacopoeia II, 20 10), the absorbance was determined at the wavelength of 332nm. In addition, accurately weigh the reference substance of naproxen sodium, add methanol to dissolve it and dilute it quantitatively to make a solution containing about 55μg per 1ml, and determine and calculate it by the same method.
3.7 antipyretic, anti-inflammatory and analgesic drugs.
3.8 Specification (1)0. 1g (equivalent to naproxen 9 1mg) (2)0.275g (equivalent to naproxen 250mg).
3.9 Store in a dark place, sealed and kept in a dry place.
Version 3. 10