Dextran Factory, Producing Dextran Injection, Medicine Product

• Customization: Available
• Application: All
• Usage Mode: Injection
• Model NO.: Dextran SLL-007
• State: Liquid
• Shape: Oral Liquid
• Type: Biological Products
• Pharmaceutical Technology: Chemical Synthesis
• pH: 5.2~6.5
• Transport Package: Box
• Specification: 5vial/10vial/tray
• Trademark: UK
• Origin: UK
• HS Code: 2928000090
• Production Capacity: 5000000000000000000000PC/Year

Product Description

Dextran factory ,producing dextran injection,medicine product
Medicine, this product is a dark brown colloidal solution. It is used to treat iron deficiency anemia.

Examination :
Take 3.0ml(Specification 1 or specification 2) or 1.5ml(Specification 3) of this product, dilute it to 15ml with water, add 50μl hydrochloric acid, shake, put it in a water bath for 30 minutes, cool it, 24 hours later, filter it, take 25μl of further filtrate and inject it into the liquid chromatograph for determination according to the method of iron dextranhydride. The weight average molecular weight (Mw) of dextran in this product should be 5000~7500, and the distribution width (Mw/Mn) should be less than 2.0. Heavy metals take 2ml of this product, according to the method under dextran iron check, heavy metals must not exceed 15 parts per million. Arsenic salt Take 1ml of this product, according to the method of dextran iron item check, arsenic salt shall not exceed 0.0002%. At least 2 healthy rabbits were selected, the hair on the inside of the right hind leg was cut off, and after the injection site was disinfected, the needle was inserted from the distal end of the semitendinosus muscle and injected into the medial femoris muscle through the sartor muscle, at a dose of 0.4ml per 1kg body weight. After 7 days of administration, the animals were killed, and the skin of the right hind leg was cut open and dissected. Take out the colored femoris muscle at the injection site, homogenate it, pour it into a 1000ml beaker, add 75ml 2mol/L sodium hydroxide solution and appropriate amount of water, cover and boil until no solid exists, cool it, carefully add 50ml concentrated sulfuric acid, heat to boil, add about 10ml nitric acid in batches, until no carbides appear. Heat to remove excess nitric acid, cool, transfer to 250ml bottle, dilute to scale with water. Accurately measure the above solution 5.0ml, add 3ml concentrated sulfuric acid, heat until the solution is smoky, add appropriate amount of nitric acid, continue heating until the solution is colorless, cool, add 20ml water, boil for 3 minutes, cool, add 10ml 20% citric acid solution, 1ml mercaptoacetic acid solution, drip-add concentrated ammonia solution until the purple color is no longer deepened, transfer to a 100ml measuring bottle. Dilute with water to scale as test solution. An equal amount of the internal femur muscle of the right hind leg of another rabbit injected with this product was prepared by the same method as A control solution. The control solution was used as A blank, and the absorbance was determined as A at the wavelength of 530nm by spectrophotometry (Appendix IV A). The standard solution series containing 0μg, 1μg, 2μg, 3μg and 4μg of iron in each 1ml were prepared by accurately absorbing standard iron reserve liquid 0ml, 1.0ml, 2.0ml, 3.0ml and 4.0ml, which were placed in 100ml measuring bottles, added water to the scale and shaken well. The standard solution series containing 0μg, 1μg, 2μg, 3μg and 4μg of iron in each 1mL was obtained. Add 10% citric acid solution and 1ml mercaptoacetic acid solution respectively, add concentrated ammonia solution to purple color without deepening, transfer to 100ml measuring bottle, dilute to scale with water. With 0 tube as blank, the absorption was measured at the wavelength of 530nm, and the regression equation was calculated with the iron content (μg) to the corresponding absorption. The Fe content corresponding to A is calculated from the regression equation. Corresponding iron content at the injection site did not absorb Fe content % = ─ ─ ─ ─ ─ ─ ─ ─ ─ ─ x 50 x 100% (Fe) injection quantity at the injection site did not absorb the Fe content shall not be greater than 20%. With abnormal toxicity, 10 healthy mice weighing 18~22g were injected with 5mg(Fe) from the tail vein, and the death number of mice should not exceed 3 within 5 days. If there are more than 3 mice, another 20 mice need to be taken, repeated experiment, combined with the results of two experiments, the total number of mice should not exceed 10. Bacterial endotoxin Take this product, check according to law (Appendix XI E), the amount of endotoxin per 1mg of iron should be less than 0.5EU. Other requirements under injections shall be complied with, except for clarity inspection (Appendix I B).