2 English reference pantocrin injection
3. Standard issued by the Ministry of Traditional Chinese Medicine 3. 1 Pinyin Name Lu Rongjing Injection
3.2 standard number WS3B223496
This product is a sterile aqueous solution made from sika deer antler by extraction and processing.
3.3 Methods Take 65438 000 g pilose antler (peeled and hairy), slice or pulverize it into coarse powder, add 5 times of 50% ethanol, reflux extract for 4 times, each time for 4 hours, combine the extractive solutions, recover ethanol, concentrate under reduced pressure into fluid extract, add 5 times of 80% ethanol, fully stir, stand for more than 65438 02 hours, and filter and precipitate. Concentrate under reduced pressure until every 65438+/-0g concentrated solution contains 2g of the original medicinal materials, then add 7 times of ethanol, fully stir, stand for 65438+/-02h, filter, wash the precipitate with ethanol, combine the washing liquid and filtrate, recover ethanol, concentrate under reduced pressure until every 65438+/-0g concentrated solution contains 2g of the original medicinal materials, carry out alcohol precipitation until there is no precipitation according to the above method, recover ethanol, and add water to dilute it into 60% pilose antler liquid. Take out, thaw, filter, repeatedly heat and freeze until there is no precipitation, adjust the pH value to 6.4-6.8 with 10% sodium hydroxide solution, filter until it is clear, dilute with water for injection to obtain pilose antler liquid containing 10%, add10% activated carbon, fully stir and stand/kloc-.
3.4 Characteristics This product is a colorless or yellowish clear liquid.
3.5 Identification (1) Take this product 1ml, add 3 drops of ninhydrin test solution, and heat it in a water bath, showing blue purple.
(2) Take 4ml of this product, dry it in a water bath, add 0.2ml of water to the residue to make it dissolve, add 0.8ml of anhydrous ethanol, and shake it well as the test solution. According to the thin-layer chromatography test (Appendix ⅵ b), suck 20μl of the test solution, spot it on the silica gel G thin-layer plate, spread 16cm with n-butanol glacial acetic acid water (3: 1: 1) as the developing agent, take it out, dry it, and spray the ninhydrin test solution at 65438+. In the chromatogram of the sample, there are four obvious purple-red stripes in the Rf value range of 0.2 ~ 0.6.
(3) Accurately measure 2ml of this product, dry it in a water bath, add water to dissolve the residue, transfer it to a 25ml volumetric flask, dilute it to scale with water, shake it evenly, put it in a 65438±0cm time pool, and take water as a blank, and perform wavelength scanning determination within the range of 190 ~ 400 nm. There are two peaks at 253±2nm and 253±3nm.
3.6 Check that the pH value should be 5.6 ~ 6.8 (Appendix VII g).
Take 65438 0 ml of protein, add 65438 0 ml of newly prepared 30% sulfosalicylic acid solution, 5min well, and let stand for 5 minutes without turbidity. Take this product 10ml of heavy metal, evaporate it to dryness, and check it according to law (appendix ⅸ e, second method), and it shall not exceed 2ppm.
Accurately absorb 2ml of this product, put it in an evaporating dish, evaporate it in a water bath, dissolve the residue in water, quantitatively transfer it to a 25ml volumetric flask, dilute it to scale with water, shake it evenly, and determine it by spectrophotometry (Appendix ⅴ a). The absorbance at the wavelength of 253±2nm shall be not less than 0.5.
Others shall comply with the relevant provisions under injections (Appendix I U).
3.7 Functions and indications can enhance vitality and promote cell metabolism. Can be used for neurasthenia, anorexia, malnutrition, sexual hypofunction and amnesia.
3.8 Administration and dosage: intramuscular or subcutaneous injection, 1 ~ 2ml once,/kloc-0 once a day.
3.9 specifications each containing 2ml.
3. 10 Storage is sealed, protected from light and placed in a cool place.
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