CN1989975A - Method for preparing composite injection of 12 vitamins - Google Patents
Method for preparing composite injection of 12 vitamins Download PDFInfo
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- CN1989975A CN1989975A CN 200510022449 CN200510022449A CN1989975A CN 1989975 A CN1989975 A CN 1989975A CN 200510022449 CN200510022449 CN 200510022449 CN 200510022449 A CN200510022449 A CN 200510022449A CN 1989975 A CN1989975 A CN 1989975A
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Abstract
The invention discloses a process for preparing compound injection of 12 kinds of vitamins, which comprises steps of mixing water soluble vitamins, fat soluble vitamins, solubilizing agent, auxiliary solvent, solvent and water for injection, stirring into colloidal solution state, charging activated charcoal for adsorbing, finally adjusting pH of the solution.
Description
Technical field
The present invention relates to a kind of preparation method of 12 kinds of composite vitamin injections.
Technical background
(parenteral nutrition PN) is bringing into play important support effect to parenteral alimentation on treatment of diseases.Need the patient of " rest " temporarily for functional gastrointestinal disease, cancer and those gastrointestinal tract, parenteral alimentation plays the important function that earns a bare living especially.Parenteral alimentation makes patient obtain the required various nutrients of metabolism, and (nutrition-associated complications, the hospital stays has been shortened in generation NAC) thereby avoided hunger, malnutrition to reach " nutrition related complication ".
Parenteral alimentation is widely used in following disease patient's treatment, as congenital malformation of the alimentary tract, middle severe malnutrition, digestive tract disease (serious diarrhoea, necrotizing enterocolitis, short bowel syndrome are early stage, intestinal obstruction, intestinal fistula, necrotizing pancreatitis), heavily danger neonate, the serious gastrointestinal reaction of caused by radiotherapy and chemotherapy that can not normally ingest, stress consume sick child's (severe infections, bigger operation, wound, burn etc.).
Parenteral alimentation also is widely used in peri-operation period patient's nutritional support.The surgical patient many places easily cause complication such as wound healing difficulty, infection in negative nitrogen balance, particularly stress, hunger makes clean nitrogen lose increase, can quicken each organ failure of whole body.To postoperative can not take food through digestive tract in a short time, the patient of nutriture difference, give total parenteral nutrition Supporting Therapy, suitably vitimin supplement, aminoacid, electrolyte etc. can improve nutriture, promote wound healing, make the rapid rehabilitation of patient.
In addition, parenteral alimentation also can be used for the treatment of wounded patient.Body is under the situation of severe trauma, and hypermetabolism is constantly lost body fluid and protein from wound surface, and digestive tract function is suppressed, and causes malnutrition, impaired, the immune function inhibition of organ dysfunction, and mortality rate obviously increases.Have to studies show that promptly giving regular parenteral alimentation in early days in wound treats, can improve nutritional status, improve immunologic function, reduce mortality rate.
Vitamin is the main component of parenteral alimentation as metabolic important cofactor.Different with protein, fat and carbohydrate, though vitamin participates in intravital energy metabolism, itself does not contain energy, so vitimin supplement can not cause overnutrition and obesity.
Because the vitamin kind is more, character is different, the vitamin preparation of therefore present domestic production is in the majority with separate constituent, and Cernevit-12 is less, and dosage form is based on tablet and capsular oral formulations.12 kinds of composite vitamin injections that are mixed with water soluble vitamins and fatsoluble vitamin are applicable to the patient's parenteral vitimin supplement that can not normally take food clinically, can be widely used in Supporting Therapy and other patient who needs vitimin supplement of critical illness, said preparation relies on import fully at present, the cosolvent that uses in the disclosed preparation method of import preparation is glycocholic acid, because this cost of supplementary product is high, so the finished product price is very expensive, retail price reaches 150 yuan/.
Summary of the invention
Purpose of the present invention has just provided the method for 12 kinds of composite vitamin injections of a kind of low-cost preparation, and this method has not only guaranteed safety, effectiveness and the controllability of medicine, and has reduced production cost significantly.
Contain fat-soluble in 12 kinds of composite vitamin injections and water solublity two biostearins, this two biostearin can not dissolve each other, and fatsoluble vitamin does not dissolve at aqueous solution, therefore need to select appropriate solubilizing agent and cosolvent guaranteeing that two biostearins can mix homogeneously, and guarantee can dissolve fully when using clinically, stable in properties.Selected solubilizing agent is soybean phospholipid or Ovum Gallus domesticus Flavus lecithin, cosolvent is a kind of in cholic acid or its pharmaceutically acceptable property salt, deoxycholic acid or its pharmaceutically acceptable property salt, dehydrocholic acid or its pharmaceutically acceptable property salt, and the weight ratio of solubilizing agent and cosolvent is 1.0-2.5: 1, be preferably 1.2-1.8: 1.Solubilizing agent is an ethanol with the alcohol dissolving preferably, and solvent load is 0.4-1.2%.
Key step of the present invention is made solution with water dissolution for fatsoluble vitamin being dissolved in the alcoholic solution of solubilizing agent respectively with cosolvent, water soluble vitamins; Above three kinds of solution are mixed, be stirred to clarification.Add activated carbon adsorption, filter, regulator solution pH regulator pH value of solution to 6.0, preparation technology makes injection routinely.
Product and 12 kinds of compound vitamines of import injection (Shi Niweita) by the present invention's preparation are compared, and two kinds of products have all guaranteed safety, effectiveness and the controllability of medicine; And the cosolvent-glycocholic acid of the cosolvent that the product by the present invention preparation adopts and imported product has gap greatly on price, so preparation cost significantly reduces.
Product by the present invention's preparation is carried out necessary inspection, and the result is as follows:
1, product and the imported product (Shi Niweita) to the present invention's preparation carries out the comparison of character, clarity and color, content, and the result shows that two kinds of products all meet the quality standard regulation.
2, heat stability is investigated
Get each 40 bottles of product by the present invention preparation and imported products (Shi Niweita), put in the airtight clean container, under 40 ℃ of temperature, placed 10 days, in the 5th day and sampling in the 10th day, by the investigation of investigation project.
The assay result:
| Condition | Time | Outward appearance | Acidity | Clarity | |
| High temperature | 0 day | 030901 | Orange-yellow lyophilizing block | 6.02 | Up to specification |
| Shi Niweita | Orange-yellow lyophilizing block | 6.17 | Up to specification | ||
| 5 days | 030901 | Orange-yellow lyophilizing block | 6.04 | Up to specification | |
| Shi Niweita | Orange-yellow lyophilizing block | 6.17 | Up to specification | ||
| 10 days | 030901 | Orange-yellow lyophilizing block | 6.08 | Up to specification | |
| Shi Niweita | Orange-yellow lyophilizing block | 6.22 | Up to specification | ||
Above result proof is stable under 40 ℃ of hot conditionss by the 12 kinds of composite vitamin injections and the Shi Niweita of the present invention's preparation.
The present invention will be described with embodiment below, but the present invention is not limited to these embodiment.
1,12 kinds of complex vitamin freeze-dried powder injections
| Prescription 1 | Prescription 2 | ||
| Retinyl palmitate is equivalent to retinol cholecalciferol racemization alpha-tocopherol and is equivalent to alpha-tocopherol ascorbic acid four hydration thiamine monophosphates and is equivalent to the thiamine Riboflavine sodium phosphate and is equivalent to the riboflavin Pyridoxine Hydrochloride and is equivalent to the how hot cyanocobalamin folic acid of pyrrole Dexpanthenol is equivalent to pantothenic acid Bio niacinamide glycine cholic acid sodium soybean lecithin ethanol NaOH, hydrochloric acid water for injection adds to | 3,500,000 IU, 220,000 IU 10.2g, 1.12 ten thousand IU 125g 5.8g 3.51g 5.67g 4.14g 5.5g 4.53g 0.006g 0.414g 16.15g 17.25g 0.069g 46g 250g 120.0g 112.5g 40ml transfer pH5.7-6.3 5000ml | Retinyl palmitate is equivalent to retinol cholecalciferol racemization alpha-tocopherol and is equivalent to alpha-tocopherol ascorbic acid four hydration thiamine monophosphates and is equivalent to the thiamine Riboflavine sodium phosphate and is equivalent to the riboflavin Pyridoxine Hydrochloride and is equivalent to the how hot cyanocobalamin folic acid of pyrrole Dexpanthenol is equivalent to pantothenic acid Bio niacinamide glycine neocholan egg yolk lecithin ethanol NaOH, hydrochloric acid water for injection adds to | 3,500,000 IU, 220,000 IU 10.2g, 1.12 ten thousand IU 125g 5.8g 3.51g 5.67g 4.14g 5.5g 4.53g 0.006g 0.414g 16.15g 17.25g 0.069g 46g 250g 112.5g 112.5g 60ml transfer pH5.7-6.3 5000ml |
Process example: the recipe quantity cosolvent is added an amount of water for injection be dissolved into 20% solution; Recipe quantity ethanol is joined in the recipe quantity solubilizing agent, and the following 55 ℃ of heating in water bath stirring and dissolving of nitrogen protection add the recipe quantity fatsoluble vitamin and stir miscible; Recipe quantity water soluble vitamins, glycine are dissolved in stirring and dissolving in an amount of water for injection.More than three parts of solution mix, stir to clarify, add 0.3% needle-use activated carbon, stirring and adsorbing 15 minutes, filtering decarbonization is regulated pH value 5.3, the inspection of semifinished product with 1.0mol/L hydrochloric acid solution and 1.0mol/L sodium hydroxide solution then.Replenish water for injection to full dose, after stirring, 0.22um microporous filter membrane fine straining, fill is in brown cillin bottle, and every bottle of fill 5ml delivers to lyophilization in the freeze drying box after the content uniformity passed examination, gland, sealing.
2,12 kinds of compound vitamin injection with small volume
| Prescription 1 | Prescription 2 | ||
| Retinyl palmitate is equivalent to retinol cholecalciferol racemization alpha-tocopherol and is equivalent to alpha-tocopherol ascorbic acid four hydration thiamine monophosphates and is equivalent to the thiamine Riboflavine sodium phosphate and is equivalent to the riboflavin Pyridoxine Hydrochloride and is equivalent to the how hot cyanocobalamin folic acid of pyrrole Dexpanthenol is equivalent to pantothenic acid Bio niacinamide Glycocine deoxycholic acid soybean lecithin ethanol NaOH, hydrochloric acid water for injection adds to | 3,500,000 IU, 220,000 IU 10.2g, 1.12 ten thousand IU 125g 5.8g 3.51g 5.67g 4.14g 5.5g 4.53g 0.006g 0.414g 16.15g 17.25g 0.069g 46g 250g 120.0g 300g 20ml transfer pH5.7-6.3 5000ml | Retinyl palmitate is equivalent to retinol cholecalciferol racemization alpha-tocopherol and is equivalent to alpha-tocopherol ascorbic acid four hydration thiamine monophosphates and is equivalent to the thiamine Riboflavine sodium phosphate and is equivalent to the riboflavin Pyridoxine Hydrochloride and is equivalent to the how hot cyanocobalamin folic acid of pyrrole Dexpanthenol is equivalent to pantothenic acid Bio niacinamide glycine cholic acid soybean lecithin ethanol NaOH, hydrochloric acid water for injection adds to | 3,500,000 IU, 220,000 IU 10.2g, 1.12 ten thousand IU 125g 5.8g 3.51g 5.67g 4.14g 5.5g 4.53g 0.006g 0.414g 16.15g 17.25g 0.069g 46g 250g 112.5g 170g 40ml transfer pH5.7-6.3 5000ml |
Process example: the recipe quantity cosolvent is added an amount of water for injection be dissolved into 20% solution; Recipe quantity ethanol is joined in the recipe quantity solubilizing agent, and the following 55 ℃ of heating in water bath stirring and dissolving of nitrogen protection add the recipe quantity fatsoluble vitamin and stir miscible; Recipe quantity water soluble vitamins, glycine are dissolved in stirring and dissolving in the water for injection.More than three parts of solution mix, stir to clarify, add 0.3% needle-use activated carbon, stirring and adsorbing 15 minutes, filtering decarbonization is regulated pH value 5.3, the inspection of semifinished product with 1.0mol/L hydrochloric acid solution and 1.0mol/L sodium hydroxide solution then.Replenish water for injection to full dose, after stirring, 0.22um microporous filter membrane fine straining fills the nitrogen packing, envelope bottle, sterilization, promptly.
Claims (7)
1, a kind of preparation method of 12 kinds of composite vitamin injections comprises water soluble vitamins, fatsoluble vitamin, solubilizing agent, cosolvent, solvent, water for injection are stirred to the colloid solution state, adds activated carbon adsorption, regulator solution pH.
2, the method for claim 1, wherein said solubilizing agent is selected to soybean phospholipid, Ovum Gallus domesticus Flavus lecithin.
3, the method for claim 1, wherein said cosolvent are selected to cholic acid or its pharmaceutically acceptable property salt, deoxycholic acid or its pharmaceutically acceptable property salt, dehydrocholic acid or its pharmaceutically acceptable property salt.
3, the method for claim 1, the ratio of wherein said solubilizing agent and cosolvent are 1.0-2.5: 1.
4, the method for claim 1, wherein said for solvent be C
nH
2n+1OH.
5, C as claimed in claim 4
nH
2n+1OH is an ethanol
6, ethanol as claimed in claim 5, its concentration are 0.4-1.2%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510022449 CN1989975A (en) | 2005-12-30 | 2005-12-30 | Method for preparing composite injection of 12 vitamins |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510022449 CN1989975A (en) | 2005-12-30 | 2005-12-30 | Method for preparing composite injection of 12 vitamins |
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| CN1989975A true CN1989975A (en) | 2007-07-04 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101564384B (en) * | 2008-07-14 | 2012-03-07 | 烟台绿叶动物保健品有限公司 | Multivitamin aqueous solution preparation |
| CN102499939A (en) * | 2011-11-29 | 2012-06-20 | 海南美大制药有限公司 | Pharmaceutical compositions of fat-soluble vitamins for injection and water-soluble vitamins for injection and preparation method thereof |
| CN102652744A (en) * | 2011-03-03 | 2012-09-05 | 西藏海思科药业集团股份有限公司 | Modified injection containing 13 compound vitamins and preparation method thereof |
| CN104337829A (en) * | 2014-05-29 | 2015-02-11 | 西安力邦肇新生物科技有限公司 | Bottled grease micro emulsion freeze-dried preparation with 13 composite vitamins |
| CN104688762A (en) * | 2013-12-05 | 2015-06-10 | 天津汉瑞药业有限公司 | Medicinal composition containing 12 vitamins and used for intravenous injection |
-
2005
- 2005-12-30 CN CN 200510022449 patent/CN1989975A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101564384B (en) * | 2008-07-14 | 2012-03-07 | 烟台绿叶动物保健品有限公司 | Multivitamin aqueous solution preparation |
| CN102652744A (en) * | 2011-03-03 | 2012-09-05 | 西藏海思科药业集团股份有限公司 | Modified injection containing 13 compound vitamins and preparation method thereof |
| CN102652744B (en) * | 2011-03-03 | 2014-06-18 | 西藏海思科药业集团股份有限公司 | Modified injection containing 13 compound vitamins and preparation method thereof |
| CN102499939A (en) * | 2011-11-29 | 2012-06-20 | 海南美大制药有限公司 | Pharmaceutical compositions of fat-soluble vitamins for injection and water-soluble vitamins for injection and preparation method thereof |
| CN102499939B (en) * | 2011-11-29 | 2013-03-20 | 海南美大制药有限公司 | Pharmaceutical compositions of fat-soluble vitamins for injection and water-soluble vitamins for injection and preparation method thereof |
| CN104688762A (en) * | 2013-12-05 | 2015-06-10 | 天津汉瑞药业有限公司 | Medicinal composition containing 12 vitamins and used for intravenous injection |
| CN104337829A (en) * | 2014-05-29 | 2015-02-11 | 西安力邦肇新生物科技有限公司 | Bottled grease micro emulsion freeze-dried preparation with 13 composite vitamins |
| CN104337829B (en) * | 2014-05-29 | 2018-07-27 | 西安力邦肇新生物科技有限公司 | The one bottled compound 13 kinds of vitamin freeze-dried preparations of fat micro emulsion |
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