CN101837009A - Sodium selenite vitamin injection and preparation method thereof - Google Patents

Sodium selenite vitamin injection and preparation method thereof Download PDF

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Publication number
CN101837009A
CN101837009A CN201010184550A CN201010184550A CN101837009A CN 101837009 A CN101837009 A CN 101837009A CN 201010184550 A CN201010184550 A CN 201010184550A CN 201010184550 A CN201010184550 A CN 201010184550A CN 101837009 A CN101837009 A CN 101837009A
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vitamin
injection
sodium selenite
water
castor oil
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岳奎忠
张翔
徐志辉
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Northeast Agricultural University
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Northeast Agricultural University
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Abstract

The invention discloses sodium selenite vitamin injection and a preparation method thereof and belongs to the technology of veterinary medicaments. The vitamin injection is water-soluble injection which is prepared from active ingredients of vitamin A, vitamin D3, vitamin E and sodium selenite through a solubilizer Tween, span, polyoxyethylenated castor oil (35), a preservative 2, and 6-ditertiary butyl paracresol. The sodium selenite vitamin injection has the effects of improving the nutritional conditions of cows, enhancing the cow body physique, accelerating the oestrous period, improving the artificial fertilization and conception rate, preventing hysteritis and retained fetal membranes of the cows, promoting healthy development of calves, and preventing white muscle disease of the calves.

Description

A kind of sodium selenite vitamin injection and preparation method thereof
Technical field
The invention belongs to the veterinary drug technology, relate generally to a kind of sodium selenite vitamin injection and preparation method thereof.
Background technology
Selenium and vitamin A, D, E are that milch cow is kept normal physiological activity, promotes growth promoter, improves breeding and the special organic and inorganic elements of the necessary class of fertility performance.Milch cow if lack that above-mentioned substance can cause that ovarian agenesis, non-estrus, nonfertilization, stillborn fetus, calf white muscle disease, growth promoter are complete, puerperal a series of reproductions, growth disease such as placenta retention, metritis incidence rate height, influence greatly the fertility performance of milch cow, bring great loss to cattle-raising.The mode of general supplement trace material is oral and injection, oral vitamin degraded can take place in cud and the long-acting fruit of soak time bad, should be vitimin supplement and selenic best way so inject.Vitamin A, D, E are liposoluble substance, the inorganic matter sodium selenite of selenium supplement is a water-soluble substances, on the market sodium selenite vitamine E injection and vitamin AD E injection are arranged now, and sodium selenite and vitamin A, D, E are made the research that a kind of compound water soluble parenteral solution need adopt pharmaceutical technologies such as solubilising, emulsifying, also there is not product on the market now.
Summary of the invention
The object of the present invention is to provide a kind of sodium selenite vitamin injection and preparation method thereof, by solubilizing agent Tween 80, sorbester p17, polyoxyethylene castor oil (35) fat-soluble vitamin is dissolved in the water and makes the water preparation injection with sodium selenite, reach selenium and vitamin A, D, E with mending the reproduction of prevention milch cow, growth property disease, stable performance, bioavailability height, easy to use.
Technical scheme of the present invention is:
Sodium selenite vitamin injection is prepared from by following materials of weight proportions: vitamin A 1,000 ten thousand-8,000 ten thousand units, vitamin D 31,000 ten thousand-8,000 ten thousand units, vitamin E 1-10g, sodium selenite 0.5-10g, Tween 80 1-400g, sorbester p17 1-400g, polyoxyethylene castor oil (35) 1-400g, benzyl alcohol 5-50g, 2,6 ditertiary butyl p cresol 1-5g, water for injection 400-800g.
The present invention also provides the preparation method of sodium selenite vitamin injection, comprises the steps:
Take by weighing the raw material that contains above-mentioned weight ratio; With vitamin A, vitamin D 3, vitamin E, benzyl alcohol, 2,6 ditertiary butyl p cresol mix, and places 60 ℃ of water-baths to make its dissolving evenly, adding part water for injection and sorbester p17, Tween 80, polyoxyethylene castor oil (35) stir and make dissolving, sodium selenite is added wherein with a small amount of water for injection dissolving, stir evenly, add to the full amount of water for injection, stir evenly, get faint yellow clear and bright solution, filter packing, sterilization, promptly.
Advantage of the present invention and beneficial effect are: selenium and vitamin A, D, E are with mending the reproduction of prevention milch cow, growth property disease, efficacy stability, bioavailability height, easy to use.
The specific embodiment
Describe the present invention for example below.
Embodiment 1:
Take by weighing vitamin A 2,000 ten thousand units, vitamin D by weight 32,000 ten thousand units, vitamin E 5g, sodium selenite 1g, Tween 80 150g, sorbester p17 50g, polyoxyethylene castor oil (35) 50g, benzyl alcohol 10g, 2,6 ditertiary butyl p cresol 2g; With vitamin A, vitamin D 3, vitamin E, benzyl alcohol, BHT mix, put to make in 60 ℃ of water-baths and dissolve evenly, adding part water for injection and sorbester p17, Tween 80, polyoxyethylene castor oil (35) stir and make dissolving, with sodium selenite with a small amount of water for injection dissolving adding wherein, stir evenly, add to the full amount of water for injection, stir evenly, get faint yellow clear and bright solution, filter, packing, sterilization, promptly.Water for injection is to 1000ml.
Embodiment 2:
Take by weighing vitamin A 8,000 ten thousand units, vitamin D by weight 31,000 ten thousand units, vitamin e1 0g, sodium selenite 10g, Tween 80 100g, sorbester p17 100g, polyoxyethylene castor oil (35) 20g, benzyl alcohol 50g, 2,6 ditertiary butyl p cresol 4g; With vitamin A, vitamin D 3, vitamin E, benzyl alcohol, BHT mix, put to make in 60 ℃ of water-baths and dissolve evenly, adding part water for injection and sorbester p17, Tween 80, polyoxyethylene castor oil (35) stir and make dissolving, with sodium selenite with a small amount of water for injection dissolving adding wherein, stir evenly, add to the full amount of water for injection, stir evenly, get faint yellow clear and bright solution, filter, packing, sterilization, promptly.Water for injection is to 1000ml.
Embodiment 3:
Take by weighing vitamin A 1,000 ten thousand units, vitamin D by weight 38,000 ten thousand units, vitamin E 2g, sodium selenite 1g, Tween 80 50g, sorbester p17 50g, polyoxyethylene castor oil (35) 200g, benzyl alcohol 30g, 2,6 ditertiary butyl p cresol 5g; With vitamin A, vitamin D 3, vitamin E, benzyl alcohol, BHT mix, put to make in 60 ℃ of water-baths and dissolve evenly, adding part water for injection and sorbester p17, Tween 80, polyoxyethylene castor oil (35) stir and make dissolving, with sodium selenite with a small amount of water for injection dissolving adding wherein, stir evenly, add to the full amount of water for injection, stir evenly, get faint yellow clear and bright solution, filter, packing, sterilization, promptly.Water for injection is to 1000ml.
Sodium selenite vitamin injection is carried out following test:
1, content of effective determination test:
The sodium selenite vitamin injection effective ingredient is sodium selenite, vitamin A, vitamin D 3, vitamin E.The present invention uses from intending quality standard above-mentioned effective ingredient is detected continuous three batches of product contents by atomic absorption instrument, ultraviolet spectrophotometer, high performance liquid chromatograph, gas chromatography respectively.Content should be the 90.0%-110.0% of labelled amount.
Lot number Sodium selenite (labelled amount %) Vitamin A (labelled amount %) Vitamin D 3(labelled amount %) Vitamin E (labelled amount %)
??080201 ??99.71 ??94.45 ??98.21 ??92.39
??080202 ??99.58 ??96.28 ??98.50 ??94.11
??080203 ??99.64 ??98.41 ??99.43 ??92.78
Above-mentioned three batches of preparations are same preparation technology embodiment product, and the production inventory is 105% of a recipe quantity, and vitamin and airborne oxygen generation oxidative degradation have a certain amount of loss to belong to normal phenomenon in process of production.But reasonable, stable by above-mentioned data product technology, can produce in batches.
2, stability test: three batches of products are packaged in by finished product under the condition of 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10% and placed 12 months, sampling in per 3 months once detected by stable high spot reviews project respectively at 0 month, 3 months, 6 months, 9 months, 12 months.After 12 months, carry out outward appearance, content detection respectively at sampling in 18 months, 24 months.
Figure GSA00000135646900041
Conclusion: character of the present invention, content detection, sterility test are all qualified, meet " People's Republic of China's veterinary drug allusion quotation 2005 editions " related request.
4, safety testing
(1) hypersensitive test: get 18 of healthy guinea pigs, be divided into 3 groups every group 6 at random: sodium selenite vitamin injection group, 0.9% sodium chloride injection group, 5% Ovum Gallus domesticus album normal saline positive controls.Use 0.5 milliliter of above 3 kinds of reagent intraperitoneal injection/only respectively.Each group is divided 2 groups again then, and 3 every group, the 1st group in injecting back 14 days first, by the hind leg saphena inject respectively 2.0 milliliters/only; The 2nd group in injecting back 21 days first, by the hind leg saphena inject respectively 2.0 milliliters/only.There is useless pawl to scratch reactions such as nose, sneeze, perpendicular hair, tic, dyspnea, gatism, shock and death after observing injection.The result: sodium chloride injection group Cavia porcellus is attacked in the 15min of injection back, nose do not occur grabbing, tremble or erects anaphylaxiss such as hair, dyspnea, shock.5% Ovum Gallus domesticus album normal saline group Cavia porcellus dysphoria, ear scratch, sneeze, dyspnea, spasm symptom occur after attacking injection, and successively all dead in 3min.Sodium selenite vitamin injection was attacked in the 14th day and 21 days does not all have any symptom, does not have irritated reaction, and sodium selenite vitamin injection Cavia porcellus hypersensitive test feminine gender is described.
(2) hemolytic test: get the fresh Sanguis Leporis seu oryctolagi 5ml of family, put in the clean triangular flask, stir the removal fibrin with Glass rod, then defibrinated blood is moved in the graduated centrifuge tube, add an amount of sodium chloride injection, shake up the back with the centrifugal 5min of 2000r/min, then the gained erythrocyte is pressed its volume, be diluted to 2% suspension with sodium chloride injection.In 2% Sanguis Leporis seu oryctolagi red blood cell suspension, add sodium selenite vitamin injection 0.1-0.5ml respectively, not seeing has obvious haemolysis or agglutination to erythrocyte.
(3) vascular stimulation test: get 6 of rabbits, divide 3 groups, 2 every group.The 1st group of sodium selenite vitamin injection 1ml/kg; The 2nd group of sodium selenite vitamin injection 2ml/kg; The 3rd group of 0.9% sodium chloride injection 2ml/kg.With sterile working's method, every rabbit ear edge vein is slowly injected, and every day 1 time, injects continuously 6 days.Put to death animal, perusal ear injection site blood vessel has or not abnormal responses such as hyperemia, blood stasis, itemized record, and get the auricular vein proximal part 2cm of vascular tissue and do the pathology cut sections for microscopic examination.The result: the large and small dosage of 0.9% sodium chloride injection matched group, sodium selenite vitamin injection injection 6 days, duct of Arantius intracavity skin is complete, and smooth muscle and adventitia do not have and thicken, and fibrous connective tissue does not have edema, no cell infiltration around the blood vessel.
(4) intramuscular injection test: get 4 of rabbits, respectively at and arranged on left and right sides hind leg quadriceps femoris position injection Lian Bizhi sodium chloride injection 1mL, negative control group injection sodium chloride injection, cut skin behind the 48h, the perusal injection site has or not hyperemia, edema, degeneration or necrosis, and does the pathology cut sections for microscopic examination.The result: medicine-feeding part does not have significant change.
Conclusion: sodium selenite vitamin injection does not have irritated reaction to Cavia porcellus.The Sanguis Leporis seu oryctolagi erythrocyte there are not obvious haemolysis or cohesion.Behind the rabbit ear edge intravenous drip sodium selenite vitamin injection, endothelium is complete, smooth, and tube wall is not seen inflammatory reaction, and not seeing in the tube chamber has thrombosis, so this medicine does not have the obvious stimulation effect to local vein blood vessel.Do not see the local excitation reaction behind this medicine of intramuscular injection yet.
5, effect test
The inventor has carried out nearly 1 year application test in Fructus Pruni forestry and animal husbandry cattle farm, Harbin with homemade sodium selenite vitamin injection.Adopt the method for random packet that 150 milch cows that situation is close separately are divided into 2 groups, matched group does not deal with, each intramuscular injection 25ml sodium selenite vitamin injection before the test group breeding, in antenatal 60 days, 30 days, 1 hour puerperal.The result: compare with matched group, the test group postpartum paralysis reduces 5 times; Placenta retention has lacked 8 times; The average birth weight of calf has increased by 1.4 kilograms; The calf white muscle disease reduces 2 times; The sickness rate of calf descends 27.3% in 30 ages in days.The recover of uterus time average shortens 2.8 days.The milch cow calving is on average shortened 4.5 days with the adaptive interval of oestrusing.
Conclusion: sodium selenite vitamin injection can improve the dairy cow nutrition situation, strengthens milch cow body constitution, promotes to oestrus, and can improve artificial fertilization's conception rate; Prevention milk cattle metritis and puerperal placenta retention; Promote the calf healthy development, the generation of prevention calf white muscle disease.

Claims (2)

1. sodium selenite vitamin injection, it is characterized in that: it is to be prepared from by following proportion raw material: vitamin A 1,000 ten thousand-8,000 ten thousand units, vitamin D 31,000 ten thousand-8,000 ten thousand units, vitamin E 1-10g, sodium selenite 0.5-10g, Tween 80 1-400g, sorbester p17 1-400g, polyoxyethylene castor oil (35) 1-400g, benzyl alcohol 5-50g, 2,6 ditertiary butyl p cresol 1-5g, water for injection 400-800g.
2. an a kind of sodium selenite vitamin injection preparation method as claimed in claim 1 is characterized in that this method comprises the steps: to take by weighing the raw material of weight ratio; With vitamin A, vitamin D 3, vitamin E, benzyl alcohol, 2,6 ditertiary butyl p cresol mix, and places 60 ℃ of water-baths to make its dissolving evenly, adding part water for injection and sorbester p17, Tween 80, polyoxyethylene castor oil (35) stirring and dissolving obtain solution, to join in the above-mentioned solution with the sodium selenite after a small amount of water for injection dissolving, stir evenly, will remain water for injection and all add in the solution, stir evenly, get faint yellow clear and bright solution, filter packing, sterilization, promptly.
CN201010184550A 2010-05-27 2010-05-27 Sodium selenite vitamin injection and preparation method thereof Pending CN101837009A (en)

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102715128A (en) * 2012-07-02 2012-10-10 扬州大学 Method for preventing fetal membrane of dairy cow from retaining
CN103006692A (en) * 2012-12-14 2013-04-03 江苏恒丰强生物技术有限公司 Sodium selenite vitamin e injection and preparation method thereof
CN105663144A (en) * 2016-01-06 2016-06-15 施维雅(青岛)生物制药有限公司 Fat-soluble vitamin water-based preparation for animals and preparing method and use method thereof
CN105663145A (en) * 2016-01-06 2016-06-15 施维雅(青岛)生物制药有限公司 Fat-soluble vitamin injection liquid for animals and preparing method and use method thereof
CN108042564A (en) * 2017-12-15 2018-05-18 合肥中龙神力动物药业有限公司 A kind of sodium selenite vitamin C parenteral solutions and its manufacturing method
CN111228298A (en) * 2020-01-15 2020-06-05 开封嘉骏生物科技有限公司 Medicine for preventing and treating cattle and sheep flaccid paralysis and preparation method thereof
CN111781042A (en) * 2020-07-08 2020-10-16 青海省畜牧兽医科学院 Eperythrozoon detection kit and sample processing method

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
《养殖技术顾问》 20100205 马丽红等 提高猪鲜精人工授精受胎率的技术 50 1-2 , 2 *
《药用辅料手册》 20050131 郑俊民主译 药用辅料手册 64、548-558、678-683、773 1-2 , 1 *

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102715128A (en) * 2012-07-02 2012-10-10 扬州大学 Method for preventing fetal membrane of dairy cow from retaining
CN103006692A (en) * 2012-12-14 2013-04-03 江苏恒丰强生物技术有限公司 Sodium selenite vitamin e injection and preparation method thereof
CN103006692B (en) * 2012-12-14 2015-03-11 江苏恒丰强生物技术有限公司 Sodium selenite vitamin e injection and preparation method thereof
CN105663144A (en) * 2016-01-06 2016-06-15 施维雅(青岛)生物制药有限公司 Fat-soluble vitamin water-based preparation for animals and preparing method and use method thereof
CN105663145A (en) * 2016-01-06 2016-06-15 施维雅(青岛)生物制药有限公司 Fat-soluble vitamin injection liquid for animals and preparing method and use method thereof
CN108042564A (en) * 2017-12-15 2018-05-18 合肥中龙神力动物药业有限公司 A kind of sodium selenite vitamin C parenteral solutions and its manufacturing method
CN111228298A (en) * 2020-01-15 2020-06-05 开封嘉骏生物科技有限公司 Medicine for preventing and treating cattle and sheep flaccid paralysis and preparation method thereof
CN111781042A (en) * 2020-07-08 2020-10-16 青海省畜牧兽医科学院 Eperythrozoon detection kit and sample processing method
CN111781042B (en) * 2020-07-08 2023-07-07 青海省畜牧兽医科学院 Eperythrozoon detection kit and sample processing method

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