CN102793720A - Method for solving crystal substance precipitation of mixed sugar electrolyte injection after disinfection - Google Patents
Method for solving crystal substance precipitation of mixed sugar electrolyte injection after disinfection Download PDFInfo
- Publication number
- CN102793720A CN102793720A CN2012102946659A CN201210294665A CN102793720A CN 102793720 A CN102793720 A CN 102793720A CN 2012102946659 A CN2012102946659 A CN 2012102946659A CN 201210294665 A CN201210294665 A CN 201210294665A CN 102793720 A CN102793720 A CN 102793720A
- Authority
- CN
- China
- Prior art keywords
- injection
- mixed sugar
- active carbon
- disinfection
- electrolyte injection
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention provides a method for solving crystal substance precipitation of a mixed sugar electrolyte injection after disinfection, which comprises the following steps: step one, dissolving sodium chloride and anhydrous glucose in injection water which accounts for 20-40% of a prescription amount, adjusting the pH by a pH adjusting agent to obtain a mixed solution; step two, dissolving fructose, xylitol, sodium acetate and dipotassium hydrogen phosphate in the mixed solution, adding active carbon, stirring, filtering to obtain a filtrate; step three, mixing the filtrate with injection water dissolved with sodium bisulfite, zinc sulfate, magnesium chloride and calcium chloride, adding active carbon, supplementing injection water to obtain the prescription amount, stirring, standing, adjusting the pH by the pH adjusting agent, filtering, and performing disinfection. Through controlling the using amount of the pH adjusting agent, the method effectively prevents the defect of crystal precipitation of the injection after preparation and disinfection, reduces the production cost, and greatly reduces product energy productivity. The method is simple in process, and the prepared product is high in purity, good in appearance quality, and suitable for industrial production.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of method for preparing of mixed sugar electrolyte injection, particularly a kind ofly separate out the crystal method after being used to solve mixed sugar electrolyte injection sterilization.
Background technology
The mixed sugar electrolyte injection is formulated by special ratios by glucose, fructose, xylitol and multiple electrolyte, is the periphery nutrient of operation and non-patient with operation makeup energy, electrolyte and body fluid.Be particularly useful for all kinds of patients with severe symptoms of inside and outside section.This injection can with part medicine compatibility, have insulin-dependent for a short time, blood glucose fluctuation is few, is suitable for characteristics such as use under the metabolism obstacles of blood glucose state.This injection fluid power provides energy fast, fully, and the energy that uses glucose, fructose and xylitol component to provide more separately significantly improves, and every 100mL should inject the energy that fluid power provides 42 kilocalories of human bodies.Can promote effectively behind this injection to protein, lipogenesis, and multiple electrolyte (potassium, sodium, calcium, magnesium, zinc and chlorine etc.) can be provided that it is required in time to replenish multiple physiology, regulates acid-base balance.
Yet, in the method for preparing operation of existing mixed sugar electrolyte injection, after sterilization, can separate out more crystal, product is placed about 20 ~ 30 hours post crystallizations at constant temperature and is redissolved.Therefore, this is injected at when producing, logical produce to the head product after the sterilization need redissolve, operation such as lamp inspection, prolonged the production cycle, increased production cost, greatly reduce the product production capacity, cause output to satisfy not the market demand.
Summary of the invention
Technical problem to be solved: in order to solve the defective of sterilization back crystallize in the existing mixed sugar method for preparing; The invention provides a kind of method for preparing of mixed sugar electrolyte injection, concrete is a kind of method of separating out crystal after the mixed sugar electrolyte injection is sterilized that is used to solve.
Technical scheme: the invention provides a kind of method of separating out crystal after the sterilization of mixed sugar electrolyte injection that is used to solve, may further comprise the steps:
(1) sodium chloride and anhydrous glucose are dissolved in the water for injection of recipe quantity 20-40%, and use the pH regulator agent to regulate pH, get mixed solution;
(2) fructose, xylitol, sodium acetate and dipotassium hydrogen phosphate are dissolved in mixed solution, and add active carbon, stir, filter, must filtrate;
(3) will filtrate and mix with the water for injection that is dissolved with sodium sulfite, zinc sulfate, magnesium chloride and calcium chloride, and add active carbon, and add water for injection to recipe quantity, and stir, and use the pH regulator agent to regulate pH, and filter, it is canned to fill nitrogen, and sterilization promptly gets.
The solution pH value can effectively avoid crystallization separate out through control pH in step (1) and (3) 4.50 ~ 5.00 to sterilizing back medicinal liquid crystallize influence significantly.
Wherein, said pH regulator agent is a citric acid.
In the step (1), the amount ratio of pH regulator agent and recipe quantity water for injection is (0.50-0.55) g:500ml.
In the step (2), the amount ratio of active carbon and recipe quantity water for injection is (0.25 ± 0.10) g:500ml.
In the step (3), the amount ratio of active carbon and recipe quantity water for injection is (0.10 ± 0.05) g:500ml.
In the step (3), pH is 4.50-5.00; Preferably, be 4.8-4.9.
Beneficial effect: provided by the invention be used to solve separate out crystal after the sterilization of mixed sugar electrolyte injection method through control pH regulator agent consumption; Effectively avoided this injection to prepare the defective of sterilization back crystallize in the process; Thereby reduced the preparation section of this injection; Shorten the production cycle, reduced production cost, greatly reduced the product production capacity.This method technology is simple, and the product purity of preparation is high, presentation quality is good, is fit to suitability for industrialized production.
The specific embodiment
According to following embodiment, the present invention may be better understood.Yet, those skilled in the art will readily understand that the described concrete material proportion of embodiment, process conditions and result thereof only are used to explain the present invention, and the present invention that should also can not limit in claims to be described in detail.
The mixed sugar electrolyte injection, write out a prescription as follows:
30 parts of anhydrous glucose, 15 parts in fructose, 7.5 parts of xylitol, 0.730 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.00074 part in zinc sulfate, 0.21 part of sodium sulfite, 500 parts of waters for injection.
The preparation of embodiment 1 mixed sugar electrolyte injection.
(1) gets 30 parts of anhydrous glucose and 0.730 part of sodium chloride, add 150 parts of waters for injection, mix, and be heated to little 15min of boiling, be cooled to 75 ± 5 ℃; Through the control solution temperature, further reduced the production cycle;
(2) above-mentioned solution is incubated and adds 0.545 part of citron acid for adjusting pH, stirring and dissolving for 75 ± 5 ℃; Reduce to room temperature;
(3) add 15 parts of fructose, 7.5 parts of xylitol, 0.41 part of sodium acetate and 0.87 part of dipotassium hydrogen phosphate, the dissolving back adds 0.25 ± 0.10 part of active carbon, stirs, filters;
(4) with 0.07 part of sodium sulfite, 0.00074 part of zinc sulfate, 0.255 part of magnesium chloride and 0.185 part of calcium chloride are added in the above-mentioned filtrating with water for injection dissolving back, add 0.1 ± 0.05 part of active carbon again; Add water for injection to 500 part, stir, leave standstill, it is 4.72 that sampling detects pH value of solution; Transfer pH to 4.80 with citric acid soln; Filter after adding 0.14 part of sodium sulfite nitrogen filled protection again, it is canned to fill nitrogen, 121 ℃ of sterilization 30min.
Be lamp inspection after the sterilization, do not have crystal to separate out, it is 4.69 that pH is measured in the sterilization back.
The preparation of embodiment 2 mixed sugar electrolyte injections.
(1) gets 30 parts of anhydrous glucose, 0.730 part of sodium chloride, add 150 parts of waters for injection, mix, and be heated to little 15min of boiling, be cooled to 75 ± 5 ℃;
(2) 75 ± 5 ℃ of insulations of above-mentioned mixed solution add 0.532 part of citron acid for adjusting pH, stirring and dissolving; Reduce to room temperature;
(3) add 15 parts of fructose, 7.5 parts of xylitol, 0.41 part of sodium acetate and 0.87 part of dipotassium hydrogen phosphate, the dissolving back adds 0.25 ± 0.10 part of active carbon, stirs, filters;
(4) with 0.07 part of sodium sulfite, 0.00074 part of zinc sulfate, 0.255 part of magnesium chloride and 0.185 part of calcium chloride are added in the above-mentioned filtrating with water for injection dissolving back, add 0.1 ± 0.05 part of active carbon again; Add water for injection to 500 part, leave standstill after the stirring, it is 4.84 that sampling detects pH value of solution; With citric acid soln pH is transferred to 4.90; Filter after adding 0.14 part of sodium sulfite nitrogen filled protection again, canned towards nitrogen, 121 ℃ of sterilization 30min.Sterilization back lamp inspection does not have crystal to separate out, and it is 4.76 that pH is measured in the sterilization back.
The preparation of embodiment 3 mixed sugar electrolyte injections.
(1) gets 30 parts of anhydrous glucose, 0.730 part of sodium chloride, add 200 parts of waters for injection, mix, and be heated to little 15min of boiling, be cooled to 75 ± 5 ℃;
(2) above-mentioned mixed solution is incubated and adds 0.532 part of citron acid for adjusting pH, stirring and dissolving for 75 ± 5 ℃; Reduce to room temperature;
(3) add 15 parts of fructose, 7.5 parts of xylitol, 0.41 part of sodium acetate and 0.87 part of dipotassium hydrogen phosphate, the dissolving back adds 0.25 ± 0.10 part of active carbon, stirs, filters;
(4) with 0.07 part of sodium sulfite, 0.00074 part of zinc sulfate, 0.255 part of magnesium chloride and 0.185 part of calcium chloride are added in the above-mentioned filtrating with water for injection dissolving back, add 0.1 ± 0.05 part of active carbon again; Add water for injection to 500 part, leave standstill after the stirring, it is 4.95 that sampling detects pH value of solution; With citric acid soln pH is transferred to 5.00; Filter after adding 0.14 part of sodium sulfite nitrogen filled protection again, canned towards nitrogen, 121 ℃ of sterilization 30min.Sterilization back lamp inspection does not have crystal to separate out, and it is 4.85 that pH is measured in the sterilization back.
The preparation of embodiment 4 mixed sugar electrolyte injections.
(1) gets 30 parts of anhydrous glucose, 0.730 part of sodium chloride, add 100 parts of waters for injection, mix, and be heated to little 15min of boiling, be cooled to 75 ± 5 ℃;
(2) above-mentioned mixed solution is incubated and adds 0.550 part of citron acid for adjusting pH, stirring and dissolving for 75 ± 5 ℃; Reduce to room temperature;
(3) add 15 parts of fructose, 7.5 parts of xylitol, 0.41 part of sodium acetate and 0.87 part of dipotassium hydrogen phosphate, the dissolving back adds 0.25 ± 0.10 part of active carbon, stirs, filters;
(4) with 0.07 part of sodium sulfite, 0.00074 part of zinc sulfate, 0.255 part of magnesium chloride and 0.185 part of calcium chloride are added in the above-mentioned filtrating with water for injection dissolving back, add 0.1 ± 0.05 part of active carbon again; Add water for injection to 500 part, leave standstill after the stirring, it is 4.46 that sampling detects pH value of solution; With citric acid soln pH is transferred to 4.50; Filter after adding 0.14 part of sodium sulfite nitrogen filled protection again, canned towards nitrogen, 121 ℃ of sterilization 30min.
Sterilization back lamp inspection does not have crystal to separate out, and it is 4.41 that pH is measured in the sterilization back.
Embodiment 5 existing methods prepare the mixed sugar electrolyte injection.
(1) gets 30 parts of anhydrous glucose, 0.730 part of sodium chloride, add 150 parts of waters for injection, mix to dissolving fully;
(2) add 15 parts of fructose, 7.5 parts of xylitol, 0.41 part of sodium acetate and 0.87 part of dipotassium hydrogen phosphate to above-mentioned mixed solution again, the dissolving back adds 0.25 ± 0.10 part of active carbon, stirs, filters;
(3) with 0.07 part of sodium sulfite, 0.00074 part of zinc sulfate, 0.255 part of magnesium chloride and 0.185 part of calcium chloride are added in the above-mentioned filtrating with water for injection dissolving back, add 0.1 ± 0.05 part of active carbon again; Add water for injection to 500 part; Leave standstill after the stirring, it is 4.63 that sampling detects pH value of solution, filters after adding 0.14 part of sodium sulfite nitrogen filled protection again; Canned towards nitrogen, 121 ℃ of sterilization 30min.
Have a large amount of crystallizations to separate out after the sterilization, after constant temperature was placed and redissolved in 28 hours, crystallization was all dissolved, and pH is 4.61 behind the bacterium of having gone out.
Embodiment 6 existing methods prepare the mixed sugar electrolyte injection.
(1) gets 30 parts of anhydrous glucose, 0.730 part of sodium chloride, add 150 parts of waters for injection, mix to dissolving fully;
(2) add 15 parts of fructose, 7.5 parts of xylitol, 0.41 part of sodium acetate and 0.87 part of dipotassium hydrogen phosphate to above-mentioned mixed solution again, the dissolving back adds 0.25 ± 0.10 part of active carbon, stirs, filters;
(3) with 0.07 part of sodium sulfite, 0.00074 part of zinc sulfate, 0.255 part of magnesium chloride and 0.185 part of calcium chloride are added in the above-mentioned filtrating with water for injection dissolving back, add 0.1 ± 0.05 part of active carbon again; Add water for injection to 500 part; Leave standstill after the stirring, it is 4.92 that sampling detects pH value of solution, filters after adding 0.14 part of sodium sulfite nitrogen filled protection again; Canned towards nitrogen, 121 ℃ of sterilization 30min.
Have a large amount of crystallizations to separate out after the sterilization, constant temperature is placed after 22 hours and is redissolved, and crystallization is dissolved fully, and it is 4.83 that pH is measured in the sterilization back.
Claims (4)
1. one kind is used to solve the method for separating out crystal after the mixed sugar electrolyte injection is sterilized, it is characterized in that: may further comprise the steps:
(1) sodium chloride and anhydrous glucose are dissolved in the water for injection of recipe quantity 20-40%, and use the pH regulator agent to regulate pH, get mixed solution;
(2) fructose, xylitol, sodium acetate and dipotassium hydrogen phosphate are dissolved in mixed solution, and add active carbon, stir, filter, must filtrate;
(3) will filtrate and mix, and add active carbon, add water for injection, and stir, leave standstill, and use the pH regulator agent to regulate pH, filtration, sterilization, promptly get to recipe quantity with the water for injection that is dissolved with sodium sulfite, zinc sulfate, magnesium chloride and calcium chloride.
2. a kind of being used to according to claim 1 solves the method for separating out crystal after the mixed sugar electrolyte injection is sterilized, and it is characterized in that: said pH regulator agent is a citric acid.
3. a kind of being used to according to claim 1 solves the method for separating out crystal after the mixed sugar electrolyte injection is sterilized, and it is characterized in that: in the step (1), pH regulator agent and water for injection amount ratio are (0.50-0.55) g:500ml.
4. a kind of being used to according to claim 1 solves the method for separating out crystal after the mixed sugar electrolyte injection is sterilized, and it is characterized in that: in the step (3), pH is 4.50-5.00.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012102946659A CN102793720A (en) | 2012-08-17 | 2012-08-17 | Method for solving crystal substance precipitation of mixed sugar electrolyte injection after disinfection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012102946659A CN102793720A (en) | 2012-08-17 | 2012-08-17 | Method for solving crystal substance precipitation of mixed sugar electrolyte injection after disinfection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102793720A true CN102793720A (en) | 2012-11-28 |
Family
ID=47193189
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2012102946659A Pending CN102793720A (en) | 2012-08-17 | 2012-08-17 | Method for solving crystal substance precipitation of mixed sugar electrolyte injection after disinfection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102793720A (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103385889A (en) * | 2013-07-22 | 2013-11-13 | 珠海经济特区生物化学制药厂 | Carbohydrate and electrolyte mixed injection and preparation method thereof |
| CN103405473A (en) * | 2013-08-27 | 2013-11-27 | 山东齐都药业有限公司 | Mixed carbohydrate-electrolyte injection and preparation method thereof |
| CN105560281A (en) * | 2014-10-08 | 2016-05-11 | 华仁药业股份有限公司 | Mixed saccharide electrolyte injection and preparation method thereof |
| CN108113998A (en) * | 2016-11-28 | 2018-06-05 | 华仁药业股份有限公司 | A kind of preparation method of parenteral solution |
| CN112603888A (en) * | 2020-12-30 | 2021-04-06 | 中国大冢制药有限公司 | Preparation method of mixed sugar electrolyte injection and prepared mixed sugar electrolyte injection |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3684435B2 (en) * | 1997-08-22 | 2005-08-17 | 味の素株式会社 | Glucose-containing preparation |
| CN101947240A (en) * | 2010-09-13 | 2011-01-19 | 海南本创医药科技有限公司 | Mixed sugar electrolyte drug composite injection |
| CN102451187A (en) * | 2010-10-28 | 2012-05-16 | 四川科伦药物研究有限公司 | High-energy nutrient infusion solution and preparation method thereof |
| CN102552320A (en) * | 2010-12-07 | 2012-07-11 | 西藏海思科药业集团股份有限公司 | Preparation method for invertose electrolyte injection |
-
2012
- 2012-08-17 CN CN2012102946659A patent/CN102793720A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3684435B2 (en) * | 1997-08-22 | 2005-08-17 | 味の素株式会社 | Glucose-containing preparation |
| CN101947240A (en) * | 2010-09-13 | 2011-01-19 | 海南本创医药科技有限公司 | Mixed sugar electrolyte drug composite injection |
| CN102451187A (en) * | 2010-10-28 | 2012-05-16 | 四川科伦药物研究有限公司 | High-energy nutrient infusion solution and preparation method thereof |
| CN102552320A (en) * | 2010-12-07 | 2012-07-11 | 西藏海思科药业集团股份有限公司 | Preparation method for invertose electrolyte injection |
Non-Patent Citations (1)
| Title |
|---|
| 倪少云等: "高效液相色谱法测定混合糖电解质注射液中乙酸盐的含量", 《中国新药与临床杂志》 * |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103385889A (en) * | 2013-07-22 | 2013-11-13 | 珠海经济特区生物化学制药厂 | Carbohydrate and electrolyte mixed injection and preparation method thereof |
| CN103405473A (en) * | 2013-08-27 | 2013-11-27 | 山东齐都药业有限公司 | Mixed carbohydrate-electrolyte injection and preparation method thereof |
| CN103405473B (en) * | 2013-08-27 | 2015-11-18 | 山东齐都药业有限公司 | Carbohydrate-electrolyte solution and preparation method thereof |
| CN105560281A (en) * | 2014-10-08 | 2016-05-11 | 华仁药业股份有限公司 | Mixed saccharide electrolyte injection and preparation method thereof |
| CN108113998A (en) * | 2016-11-28 | 2018-06-05 | 华仁药业股份有限公司 | A kind of preparation method of parenteral solution |
| CN112603888A (en) * | 2020-12-30 | 2021-04-06 | 中国大冢制药有限公司 | Preparation method of mixed sugar electrolyte injection and prepared mixed sugar electrolyte injection |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102793720A (en) | Method for solving crystal substance precipitation of mixed sugar electrolyte injection after disinfection | |
| CN103405473B (en) | Carbohydrate-electrolyte solution and preparation method thereof | |
| CN101455631B (en) | Meglumine cyclic adenosine injection and preparation technique thereof | |
| CN106822175A (en) | A kind of sodium acid carbonate ringer's injection and preparation method thereof | |
| CN109432123A (en) | A kind of compound electrolyte glucose injection and preparation method thereof | |
| CN106309448A (en) | Novel cefoperazone sodium and sulbactam sodium pharmaceutical composition for injection | |
| CN101947240A (en) | Mixed sugar electrolyte drug composite injection | |
| CN102145009A (en) | Octadeca compound amino acid injection and preparation method thereof | |
| CN103110574A (en) | Tinidazole injection preparation and preparation method thereof | |
| CN103110640B (en) | Pharmaceutical composition of injection ceftizoxime sodium and compound amino acid injection | |
| CN103239442A (en) | Preparation method of compound amino acid injection (18AA-V) | |
| CN103385889B (en) | Carbohydrate and electrolyte mixed injection and preparation method thereof | |
| CN103989705B (en) | Sugar electrolyte injection liquid and preparation method thereof | |
| CN105560281A (en) | Mixed saccharide electrolyte injection and preparation method thereof | |
| CN103463094B (en) | Medicine composition of cefpiramide sodium and infant compound amino acid injection (19AA-I) | |
| CN102949413B (en) | Method for preparing invert sugar and electrolytes injection | |
| CN102258507A (en) | Ibuprofen-containing pharmaceutical composition and its preparation method and application | |
| CN104721223B (en) | A kind of injection pharmaceutical composition of compound electrolyte and preparation method thereof | |
| CN101601647B (en) | Riboflavine sodium phosphate composition injection and preparation method thereof | |
| CN103483262A (en) | Stable edaravone trihydrate and pharmaceutical compositions thereof | |
| CN103393689B (en) | Pharmaceutical composition of cefotiam hydrochloride for injection and compound amino acid injection | |
| CN105037195A (en) | Aceglutamide, and injection and preparation method thereof | |
| CN102008461A (en) | Ibuprofen drug composite for injection | |
| CN108440372A (en) | A kind of process of extraction high-purity medicine rank tryptophan | |
| CN101721424A (en) | Bicarbonate physiological balanced solution and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C12 | Rejection of a patent application after its publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20121128 |