2 English reference naproxen sodium
3 Pharmacopoeia standard of naproxen sodium 3. 1 name 3. 1. 1 Chinese name naproxen sodium
3. 1.2 Chinese Pinyin Naipushengna
3. 1.3 English name naproxen sodium
3.2 structural formula 3.3 molecular formula and molecular weight c 14h 13ao 3 252.25
3.4 Source (name) and content (potency) This product is (S) sodium α-methyl -6- methoxy -2- naphthylacetate. Calculated by dry product, the content of C 14H 13NaO3 should be 98.0% ~ 102.0%.
3.5 Properties This product is white or white-like crystalline powder; Tasteless; Slightly hygroscopic.
This product is soluble in water, methanol, ethanol, acetone and hardly chloroform or toluene.
3.5. 1 specific rotation Take 0.5g of this product, add 6ml of water, add 2.4ml of hydrochloric acid solution 1mol/L dropwise, shake well while adding, precipitate out, wash the precipitate with water until it is neutral, dry it to constant weight at 105℃, weigh it accurately, and add chloroform to make it about/kloc-.
3.6 Identification (1) Take about 0.25g of this product, add 10ml water to dissolve it, and add a few drops of dilute hydrochloric acid, that is, white precipitate appears, and the filtrate shows sodium salt identification reaction (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) Take this product and dry it at 65438 005℃ for 3 hours, and its infrared absorption spectrum should be consistent with that of the reference substance (Figure 433: Infrared spectrum collection of drugs).
3.7 Check the related substances in 3.7. 1. Take this product, add methanol to make a solution containing 20mg per 1 ml as the test solution. Accurately measure an appropriate amount and dilute it quantitatively with methanol into a solution containing 0. 1ml as a control solution. According to the test of thin-layer chromatography (appendix ⅴ b of Pharmacopoeia Part II, 20 10), respectively absorb the above two solutions 10μl, spread them on the same silica gel GF254 thin-layer plate with toluene-tetrahydrofuran-glacial acetic acid (30: 3: 1) as developing agent, dry them, and place them in an ultraviolet lamp.
3.7.2 Take 5.0g of free naproxen, accurately weigh it, put it in a separatory funnel, add 25ml of water to dissolve it, shake it evenly, extract it with chloroform for three times, each time with 65438±05ml, combine chloroform solutions, put it in a water bath to dry, dissolve the residue with 50ml of 75% neutral methanol (neutral to phenolphthalein indicator), add 3 drops of phenolphthalein indicator, and titrate with sodium hydroxide.
3.7.3 loss on drying takes this product and dries it to constant weight at 105℃, and the weight loss shall not exceed 1.0% (Appendix VIII L of Pharmacopoeia Part II, 20 10).
3.7.4 Take 1.0g heavy metal, put it in a separatory funnel, add 20ml water to dissolve it, add 5ml 1mol/L hydrochloric acid solution, extract it with dichloromethane for three times (20ml, 20ml, 10ml), discard the dichloromethane layer, and check the water layer according to law.
3.8 Content determination Take about 0.2g of this product, weigh it accurately, add 30ml glacial acetic acid to dissolve it, add 1 drop crystal violet indicator, titrate with perchloric acid until the solution turns blue-green, and correct the titration result with blank test. Every 1ml perchloric acid titration solution (0. 1mol/L) is equivalent to 25.22mg c 14 13 nao 3.
3.9 antipyretic, anti-inflammatory and analgesic drugs.
3. 10 Store away from light, sealed and stored in a dry place.
3. 1 1 Preparation of Naproxen Sodium Tablets
Version 3. 12