無(wú)水葡萄糖形成藥典標(biāo)準(zhǔn)形成因素
來(lái)源：http://www.nttdr.com 日期：2019-05-27 發(fā)布人：admin
本品為無(wú)色結(jié)晶或白色結(jié)晶性或顆粒性粉末；無(wú)臭，味甜。
This product is colorless crystalline or white crystalline or granular powder; odorless and sweet.
本品在水中易溶，在乙醇中微溶。
This product is soluble in water and slightly soluble in ethanol.
比旋度
Specific rotation
取本品約10g，精細(xì)稱(chēng)定，置50ml量瓶中，加水適量與氨試液2.0ml溶解后，用水稀釋至刻度，搖勻，放置60分鐘，在25℃時(shí)依法測(cè)定（2010年版藥典二部附錄Ⅵ E），比旋度為+52.6°至+53.2°。
Take this product about 10g, weigh it carefully, put it in a 50ml measuring bottle, add water and dissolve 2.0ml ammonia test solution, dilute it with water, shake it well and put it for 60 minutes. Measure it at 25 C according to law (Appendix VI E of 2010 Pharmacopoeia II). The specific curl is +52.6 to +53.2.
鑒別
Identify
（1）取本品約0.2g,加水5ml溶解后，緩緩滴入微溫的堿性酒石酸銅試液中，即生成氧化亞銅的紅色沉淀。
(1) The product is about 0.2g, dissolved with water for 5ml, and then slowly dripped into the slightly warm alkaline copper tartrate test solution to form the red precipitation of cuprous oxide.
（2）本品的紅外光吸收?qǐng)D譜應(yīng)與對(duì)照的圖譜（《藥品紅外光譜集》702圖）分歧。
(2) The infrared absorption spectra of the product should be different from those of the control (702 in the Infrared Spectra of Drugs).
檢查
inspect
酸度
acidity
取本品2.0g，加水20ml溶解后，加酚酞指示液3滴與氫氧化鈉滴定液（0.02mol/L）0.20ml，應(yīng)顯粉紅色。
After 2.0g of this product is dissolved with 20 ml of water, 3 drops of phenolphthalein indicator solution and 0.20ml of sodium hydroxide titration solution (0.02mol/L) should be pink.
溶液的廓清度與顏色
Clearance and colour of solution
取本品5.0g，加熱水溶解后，放冷，用水稀釋至10ml，溶液應(yīng)廓清無(wú)色；如顯混濁，與1號(hào)濁度規(guī)范液（2010年版藥典二部附錄Ⅸ B）比擬，不得更濃；如顯色，與對(duì)照液（取比色用氯化鈷液3.0ml、比色用重鉻酸鉀液3.0ml與比色用硫酸銅液6.0ml，用水稀釋成50ml）1.0ml用水稀釋至10ml比擬，不得更深。
Take 5.0g of this product, dissolve it in hot water, cool it, dilute it with water to 10ml, the solution should be clear and colorless; if turbidity appears, it should not be more concentrated than turbidity standard solution No. 1 (Appendix IX B of Pharmacopoeia No. 2, 2010 edition); if colour develops, it should be diluted with water 1.0ml compared with control solution (cobalt chloride solution 3.0ml for colour comparison, potassium dichromate solution 3.0ml for colour comparison, copper sulfate solution 6.0mL for colour comparison and water dilution to 50ml for colour comparison). Release to 10 ml, not deeper.
乙醇溶液的廓清度
Clearance of Ethanol Solution
取本品1.0g，加乙醇20ml，置水浴上加熱回流約40分鐘，溶液應(yīng)廓清。
Take 1.0g of this product, add 20ml ethanol, put it in a water bath, heat and reflux for about 40 minutes, the solution should be clear.
氯化物
chloride
取本品0.60g，依法檢查（2010年版藥典二部附錄Ⅷ A），與規(guī)范氯化鈉溶液6.0ml制成的對(duì)照液比擬，不得更濃（0.01%）。
Take 0.60g of this product and inspect it according to law (Appendix_A of the second part of Pharmacopoeia 2010 edition). Compared with the control solution of 6.0mL sodium chloride solution, it should not be more concentrated (0.01%).
硫酸鹽
sulfate
取本品2.0g，依法檢查（2010年版藥典二部附錄Ⅷ B），與規(guī)范硫酸鉀溶液2.0ml制成的對(duì)照液比擬，不得更濃（0.01%）。
Take 2.0g of this product and inspect it according to law (Appendix_B of the second part of Pharmacopoeia 2010 edition). Compared with the control solution of 2.0ml standard potassium sulfate solution, it should not be more concentrated (0.01%).
亞硫酸鹽與可溶性淀粉
Sulfite and soluble starch
取本品1.0g，加水10ml溶解后，加碘試液1滴，應(yīng)即顯黃色。
Take 1.0g of this product, add 10 ml of water to dissolve, add 1 drop of iodine test solution, it should be yellow.
枯燥失重
Dull and weightlessness
取本品，在105℃枯燥至恒重，減失重量不得過(guò)1.0%（2010年版藥典二部附錄Ⅷ L）。
Take this product, dry to constant weight at 105 (L, Appendix II, 2010 edition of Pharmacopoeia) and lose no more than 1.0% (weight).
熾灼殘?jiān)?/div>
Scorching residue
不得過(guò)0.1%（2010年版藥典二部附錄Ⅷ N）。
No more than 0.1% (Appendix_N of the 2010 edition of the Pharmacopoeia).
蛋白質(zhì)
Protein
取本品1.0g，加水10ml溶解后，加磺基水楊酸溶液（1→5）3ml，不得發(fā)作混濁或沉淀。
Take 1.0g of this product, add 10 ml of water to dissolve, add sulfosalicylic acid solution (1 5) 3 ml, no turbidity or precipitation.
鋇鹽
Barium salt
取本品2.0g，加水20ml溶解后，溶液分紅兩等份，一份中加稀硫酸1ml，另一份中水1ml，搖勻，放置15分鐘，兩液均應(yīng)廓清。
Take 2.0g of this product, add 20 ml water to dissolve, the solution dividends into two equal parts, one with dilute sulfuric acid 1ml, the other with water 1ml, shake well, put for 15 minutes, both liquids should be cleared.
鈣鹽
Calcium salt
取本品1.0g，加水10ml溶解后，加氨試液1ml與草酸銨試液5ml，搖勻，放置1小時(shí)，如發(fā)作混濁，與規(guī)范鈣溶液[精細(xì)稱(chēng)取碳酸鈣0.1250g，置500ml量瓶中，加水5ml與鹽酸0.5ml使溶解，用水稀釋至刻度，搖勻。每1ml相當(dāng)于0.1mg的鈣（Ca）]1.0ml制成的對(duì)照液比擬，不得更濃（0.01%）。
Take 1.0 g of this product, add 10 ml of water to dissolve, add 1 ml of ammonia test solution and 5 ml of ammonium oxalate test solution, shake well, place for 1 hour, such as turbidity, and standard calcium solution [fine weigh calcium carbonate 0.1250 g, put 500 ml measuring bottle, add 5 ml of water and 0.5 ml of hydrochloric acid to dissolve, dilute water to scale, shake well. The control solution made of 1.0 ml of calcium (Ca) equivalent to 0.1 mg per ml should not be more concentrated (0.01%).
鐵鹽
Ferric salt
取本品2.0g，加水20ml溶解后，加硝酸3滴，遲緩煮沸5分鐘，放冷，用水稀釋制成45ml，加硫氰酸銨溶液（30→100）3.0ml，搖勻，如顯色，與規(guī)范鐵溶液2.0ml用同一辦法制成的對(duì)照液比擬，不得更深（0.001%）。
Take 2.0g of this product, add 20 ml of water to dissolve, add 3 drops of nitric acid, slow boil for 5 minutes, cool down, dilute with water to make 45 ml, add ammonium thiocyanate solution (30 100) 3.0ml, shake well, such as color rendering, compared with the reference solution of 2.0ml of standard iron solution, no deeper (0.001%).
重金屬
heavy metal
取本品5.0g，加水23ml溶解后，加醋酸鹽緩沖液（pH 3.5）2ml，依法檢查（2010年版藥典二部附錄Ⅷ H一法），含重金屬不得過(guò)百萬(wàn)分之四。
Take 5.0g of this product, add water 23ml to dissolve, add acetate buffer (pH 3.5) 2ml, and inspect according to law (Appendix_H first method of 2010 edition of Pharmacopoeia II), containing no more than four parts per million of heavy metals.
砷鹽
Arsenic salt
取本品2.0g，加水5ml溶解后，加稀硫酸5ml與溴化鉀溴試液0.5ml，置水浴上加熱約20分鐘，使堅(jiān)持稍過(guò)量的溴存在，必要時(shí)，再補(bǔ)加溴化鉀溴試液適量，并隨時(shí)補(bǔ)充蒸散的水分，放冷，加鹽酸5ml與水適量使成28ml，依法檢查（2010年版藥典二部附錄Ⅷ J一法），應(yīng)契合規(guī)則（0.0001%）。
Take 2.0g of this product and dissolve it with 5 ml of water, add 5 ml of dilute sulfuric acid and 0.5 ml of potassium bromide test solution, heat it in water bath for about 20 minutes, so as to persist in the existence of slightly excessive bromide. If necessary, add appropriate amount of potassium bromide test solution, and at any time add evaporated water, cool it, add 5 ml of hydrochloric acid and water to make it 28 ml, and check it according to law (Appendix J1of 2010 edition of Pharmacopoeia II). (0.0001%).
微生物限度
microbial limit
取本品10g，用pH 7.0無(wú)菌氯化鈉－蛋白胨緩沖液制成1: 10的供試液。
10 g of this product was used to prepare 1:10 test solution with pH 7.0 sterile Sodium Chloride Peptone buffer.
相信看了本文的無(wú)水葡萄糖http://www.nttdr.com介紹后，對(duì)這方面也會(huì)有自己的一番認(rèn)識(shí)，以后針對(duì)的等問(wèn)題也能很好的解決。
I believe that after reading the introduction of anhydrous glucose http://www.nttdr.com in this article, I will have my own understanding of this aspect, and other problems can be solved well in the future.
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