jiāo náng yòng míng jiāo
2 English referencegelatinum pro capsulae [Xiangya Medical Dictionary]
3 Gelatin for Capsules Pharmacopoeia Standard 3.1 Name 3.1.1 Chinese NameGelatin for Capsules
3.1.2 Chinese PinyinJiaonangyong Mingjiao
3.1.3 English NameGelatin for Capsules
3.2 Source and contentThis product is the animal skin, bone, tendon and ligament collagen incomplete acid hydrolysis, alkaline hydrolysis or enzymatic degradation of the purified products, or for the above three different gelatin products of the mixture.
3.3 PropertiesThe product is a yellowish to yellow, transparent or translucent slightly glossy flakes or powder; odorless, tasteless; when immersed in water, it will swell and soften, and can absorb 5 to 10 times its own mass of water.
The product is soluble in hot water, soluble in acetic acid or glycerin and water hot mixture, insoluble in ethanol.
3.4 Identification(1) take 0.5g of this product, add 50ml of water, heat to dissolve, take 5ml of the solution, add potassium dichromate test solution - dilute hydrochloric acid (4:1) a few drops, that is, the production of orange-yellow flocculent precipitate.
(2) take 1ml of the solution remaining under the identification (1), add 100ml of water, shake well, add a few drops of tannic acid test solution, which produces turbidity.
(3) take the product, add sodium lime, heating, that is, ammonia odor.
3.5 Check 3.5.1 Freezing strengthTake two copies of this product each 7.50g, respectively, placed in a freezing bottle, add water to make 6.67% of the gum liquid, cover, placed 1 ~ 4 hours later, at 65 ℃ ± 2 ℃ in a water bath stirring and heating for 15 minutes to make the sample dissolved uniformly, placed at room temperature for 15 minutes, placed the freezing bottle horizontally at 10 ℃ ± 0.1 ℃ in the thermostatic water bath with a rubber plug tightly plugged insulation 17 ± 2 ℃, the sample dissolved uniformly. After 17±1 hours of heat preservation with rubber stopper, quickly remove the bottle, dry the outer wall, and put it on the test bench of freezing force apparatus, calculate the average of two results, and the freezing force strength should not be less than 180Bloom g.
3.5.2 pHTake 1.0g of this product, heat 100ml of water, shake it well to make it dissolve, cool it down to 35℃, and then determine according to the law (Appendix VI H, Pharmacopoeia 2010), and determine the pH. Appendix VI H), the pH value should be 4.0-7.2.
3.5.3 TransmittanceTake 2.0g of this product, add 50-60℃ water to dissolve and dilute to make a 6.67% solution, then cool it to 45℃, and then measure the transmittance at 450 nm and 620 nm according to the method of ultraviolet-visible spectrophotometry (2010 Pharmacopoeia Part II, Appendix VI A), and determine the transmittance at the wavelength of 620 nm and 450 nm respectively. According to the UV-visible spectrophotometric method (2010 version of the Pharmacopoeia II Appendix VI A), respectively, at 450nm and 620nm wavelength to determine the transmittance, shall not be less than 50% and 70%.
3.5.4 ConductivityTake 1.0g of this product, add not more than 60 ℃ water to dissolve and dilute to make 1.0% of the solution, as a test solution, and another 100ml of water as a blank solution, the test solution and the blank solution placed in 30 ℃ ± 1 ℃ of the water bath insulation for 1 hour, measured by a conductivity meter, platinum-black electrode as a measurement of the electrode, the first rinse electrode with the blank solution. After 3 times, determine the conductivity of the blank solution, the conductivity value should not be more than 5.0 μS/cm. remove the electrode, and then rinse the electrode with the test solution 3 times, determine the conductivity of the test solution, it should not be more than 0.5 mS/cm.[1]
3.5.5 Sulfite (SO2)Take 10.0g of this product, put it into a long-necked round-bottomed flask, add 150ml of water. After 1 hour, in 60 ℃ water bath heating to dissolve, add 5 ml of phosphoric acid and sodium bicarbonate 1g, instantly connected to the condenser tube (produce excessive foam, you can add an appropriate amount of antifoaming agent, such as silicone oil, etc.), heating and distillation, 15ml of 0.05mol/L iodine solution as the receiving solution, collect the distillate of 50 ml, dilute with water to 100 ml, shaking, measure 50 ml, placed on a water bath evaporation, always add water appropriate Evaporation on the water bath, at any time to supplement the appropriate amount of water, evaporate until the solution is almost colorless, dilute with water to 40 ml, according to the sulfate check method (2010 version of the Pharmacopoeia II Appendix VIII B) check, such as showing turbidity, and the control solution made of 7.5ml of the standard solution of potassium sulfate, shall not be more concentrated (0.01%).
3.5.6 PeroxideTake 10g of this product, placed in a 250ml stoppered flask, add 140ml of water, placed in a water bath at 50 ℃ to heat to dissolve, and immediately cooled, add sulfuric acid solution (1 → 5) 6ml, potassium iodide 0.2g, 1% starch solution 2ml and 0.5% ammonium molybdate solution 1ml, tightly corked, shaking, placed in the dark for 10 minutes, the solution should not show blue. The solution shall not show blue color.
3.5.7 Loss of weight on dryingTake the product, dry at 105 ℃ for 15 hours, the weight loss should not be more than 15.0% (2010 version of the Pharmacopoeia II Appendix VIII L).
3.5.8 Residue of cauterizationTake 1.0g of the product, check according to law (2010 version of the Pharmacopoeia II Appendix VIII N), the residue left should not be more than 2.0%.
3.5.9 ChromiumTake 0.5g of this product, placed in a PTFE digestion tank, add 5-10ml of nitric acid, mix well, soak overnight, cover the inner lid, tighten the jacket, placed in a suitable microwave digestion furnace, digestion. After complete dissolution, cancel the dissolution of the inner tank placed on the hot plate slowly heated to the reddish-brown vapor evaporation and nearly dry, with 2% nitric acid transferred to 50 ml measuring flask, and diluted with 2% nitric acid to the scale, shaking, as a test solution; the same method of preparation of reagent blank solution; the other chromium single-element standard solution, diluted with 2% nitric acid to make every 1 ml of chromium containing chromium 1.0 μg of chromium standard reserve solution, ready to use, were precise! At the time of use, respectively, measure the appropriate amount of chromium standard reserve solution, diluted with 2% nitric acid solution to make each 1ml containing chromium 0-80ng of the control solution. Take the test solution and the control solution, use graphite furnace as atomizer, according to the atomic absorption spectrophotometry (2010 version of the Pharmacopoeia II Appendix Ⅳ D the first method), measured at the wavelength of 357.9nm, calculated, that is, obtained. Containing chromium shall not exceed two parts per million.
3.5.10 Heavy metalsTake the residue left under the blazing residue, check according to law (2010 version of the Pharmacopoeia, Part II, Appendix VIII H, the second method), containing heavy metals shall not be more than 30 parts per million.
3.5.11 Arsenic saltTake 2.0g of this product, add 0.5g of starch and calcium hydroxide 1.0g, add a small amount of water, mix well, dry, first burn with a small fire to make charcoal, and then blaze at 500 ~ 600 ℃ to make the ashing completely, cool, add 8ml of hydrochloric acid and 20ml of water to dissolve, according to the law, check (2010 version of the Pharmacopoeia, Part II, Appendix VIII J, first law), it should be in line with the regulations (0.0001%).
3.5.12 Microbial limitTake the product, according to the law check (2010 version of the Pharmacopoeia II Appendix Ⅺ J), the number of bacteria per 1g of the test product shall not be more than 1,000, the number of molds and yeasts shall not be more than 100, Escherichia coli shall not be detected; Salmonella shall not be detected per 10g of the test product.
3.6 CategoryPharmaceutical excipients, used in the preparation of hollow capsules.
3.7 StorageSealed, stored in a cool and dark place.
3.8 Versions