CN102670523A - Method for preparing injection reduced glutathione freeze-dried powder - Google Patents
Method for preparing injection reduced glutathione freeze-dried powder Download PDFInfo
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- CN102670523A CN102670523A CN2011100720244A CN201110072024A CN102670523A CN 102670523 A CN102670523 A CN 102670523A CN 2011100720244 A CN2011100720244 A CN 2011100720244A CN 201110072024 A CN201110072024 A CN 201110072024A CN 102670523 A CN102670523 A CN 102670523A
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Abstract
The invention provides a method for preparing injection reduced glutathione freeze-dried powder widely used for auxiliary treatment of multi-system or multi-organ diseases such as liver or kidney injury and diabetes. According to the method, reduced glutathione is used as an active ingredient and added with a pH regulator and injection water, and the injection reduced glutathione freeze-dried powder is prepared by freeze-drying. For overcoming the defects of the conventional technology for preparing the injection reduced glutathione freeze-dried powder, the invention provides the method for preparing the injection reduced glutathione freeze-dried powder. The reduced glutathione freeze-dried powder is prepared by strictly controlling formulation selection, solution preparation and freeze-drying processes; and although the method is long in freeze-drying time, the reduced glutathione freeze-dried powder prepared by the method is high in stability and has a good freeze-dried effect.
Description
Technical field:
The present invention relates to field of medicine preparations, more particularly, is a kind of glutathione for injection method for preparing freeze-dried powder.
Background technology:
Reduced glutathion (GSH) is synthetic naturally a kind of tripeptides among the human cell; Form by glutamic acid, cysteine and glycine, contain sulfydryl and (SH), be distributed widely in each organ of human body; To keeping the cell biological function, the integrity of protection cell membrane has important function.Reduced glutathion is as regulatory metabolites matter important in a kind of cell; It is the prothetic group of Triose phosphate dehydrogenase; Be again the coenzyme of aldoketonutase and triose dehydrogenase, participate in tricarboxylic acid cycle and carbohydrate metabolism in the body, and can activate plurality of enzymes; As sulfydryl (SH) enzyme-coenzyme etc., thus promote saccharide, fat and protein metabolism.GSH molecule characteristics are to have sulfhydryl-group activity (SH) with the glutamy key.Sulfydryl is a GSH most important function group, can participate in the multiple important biochemical reaction of body, and not oxidized, the deactivation of important enzyme albumen sulfydryl in the protective guarantees energy metabolism, cell utilization.Through sulfydryl and intravital combined with radical, can directly make radical reduction, quicken the drainage of free radical, the infringement that also can resist the radical pair important organ simultaneously thereby make it to change into easy metabolic acid.GSH is the non-enzymatic antioxidant, is the synthetic antioxidant of cell, through its sulfhydryl oxidase-go back the conversion of ortho states, as reversible oxygen donator, mainly at intracellular water oxidation protection is provided.GSH can alleviate cell injury to whole body or local hypoxemia patient that anemia, poisoning or tissue inflammation cause, promotes to repair.Because its clinical effect is extensive, therefore be widely used in the auxiliary treatment of multisystems such as liver, renal damage and diabetes, many organ diseases.
At present; The glutathione for injection dosage form is an injectable powder; The powder pin mainly contains sterilized powder and freeze-dried powder, because there is more problem in sterilized powder in the preparation process, as: content uniformity, dissolubility and clarity be relatively poor, pollute easily; When particularly relating to biochemical drug, require higher to supplementary material and preparation technology.
And the preparation of freeze-dried powder, present existing freeze-dry process is divided into two kinds, and first kind is with the raw material lyophilizing; Under aseptic technique, carry out the powder fill through behind the crushing screening; Though its lyophilizing cost is lower,, be prone to decompose rotten through the easy moisture absorption of the glutathione for injection medicated powder of this method preparation; Influence drug safety, also be prone to cause loading amount not enough.Second kind is medicine to be mixed with directly carry out behind the liquid aseptic subpackagedly, carries out lyophilization then, and its advantage is that content uniformity is controlled easily; Can strengthen stability of drug; Shortcoming is that cost is higher, and especially for reduced glutathion, freeze dried condition is wayward; Cause percent defective higher, and even influence medicine stability before the deadline.Existing second method all thinks in the industry that for this product lyophilizing effect of reduced glutathion and bad this product is difficult to, and mainly is to cause in selection, the configuration of solution and the links such as control of freeze-drying process of writing out a prescription.
Summary of the invention
The objective of the invention is to replenish the deficiency of existing glutathione for injection preparation process thereof aspect; A kind of glutathione for injection method for preparing freeze-dried powder is provided; Improve from prescription selection, solution allocation and freeze-drying process control aspect respectively, be prone to tide to overcome reduced glutathion, be prone to decompose shortcomings such as rotten and lyophilizing weak effect.
The present invention is through with reduced glutathion and PH regulator mixed dissolution by a certain percentage, and regulates the PH of solution, and strictness prepares the reduced glutathion freeze-dried powder to freeze-drying process then.Freeze-dried powder content uniformity through this method makes is controlled easily, and stability of drug is good, and the product lyophilizing is effective.
The prescription of a kind of glutathione for injection freeze-dried powder provided by the invention consists of: (is unit with weight)
6～9 parts of reduced glutathions
The PH regulator is formed 0.8～1.5 part
Water for injection is an amount of
In the prescription that the present invention proposes, reduced glutathion and PH regulator consist of 6～9 parts of reduced glutathions, 0.8～1.5 part of PH regulator (is unit with weight).
In the prescription that the present invention proposes, the PH regulator can be one or both of sodium hydroxide or sodium bicarbonate, hydrochloric acid.
The present invention proposes the method for preparing of reduced glutathion, may further comprise the steps: 1. take by weighing an amount of PH regulator, stirring and dissolving makes it into 15% solution, and is subsequent use; 2. measure the 70% PH regulator solution for preparing, add reduced glutathion and stir, and with residue PH regulator solution drip make complete molten; Regulator solution PH is 4.9-5.5, supplies water for injection to full dose, stirs; Add 0.03% active carbon and stir, carbon removal is filtered, and subsequent use 3. get the filtrating fill in cillin bottle; By following freeze-drying curve lyophilizing: treat that the freeze dryer shelf temperature reduces to-10 ℃; The fill certified products are inserted on the freeze drying box shelf, be cooled to products temperature with the speed of 30 ℃/h and be-25 ℃, be incubated 2 hours; Shelf temperature is gone up, make products temperature rise to-5 ℃, be incubated 0.5 hour; Speed by 15～20 ℃/h makes shelf temperature reduce to-40 ℃ again, is incubated 2 hours; The beginning evacuation begins to be-22 ℃ with 5 ℃/h speed rise temperature to shelf temperature when treating the about 10pa of vacuum, is incubated 28 hours; Again shelf temperature is risen to 10 ℃, be incubated and after 3 hours shelf temperature risen to 40 ℃, treat that products temperature reaches 35 ℃ of insulations 8 hours, tamponade, outlet.
Technical characterstic of the present invention is to control the freeze-dried powder for preparing reduced glutathion through the strictness of prescription selection, solution allocation and freeze-dry process; Though this method freeze-drying time is long; But the reduced glutathion that makes through this method has good stable property, and the product lyophilizing is effective.
The specific embodiment
With by way of example the present invention is described further again below, provides the present invention and get implementation detail, but be not to be intended to limit protection scope of the present invention.
Embodiment 1:
The prescription of glutathione for injection freeze-dried powder consists of: (is unit with weight)
Reduced glutathion 900g
Sodium bicarbonate 120g
Water for injection is an amount of
Take by weighing the 120g sodium bicarbonate, stirring and dissolving makes it into 15% sodium bicarbonate solution, and is subsequent use; Measure 70% sodium bicarbonate solution for preparing, join in the 900g reduced glutathion and stir, and drip with residual sodium bicarbonate solution and to make complete dissolving; Regulator solution PH is 4.9-5.5, supplies water for injection to full dose, stirs; Add 0.03% active carbon and stir, carbon removal is filtered, and is subsequent use; Get the filtrating fill in cillin bottle, by following freeze-drying curve lyophilizing: treat that the freeze dryer shelf temperature reduces to-10 ℃, the fill certified products are inserted on the freeze drying box shelf, be cooled to products temperature with the speed of 30 ℃/h and be-25 ℃, be incubated 2 hours; Shelf temperature is gone up, make products temperature rise to-5 ℃, be incubated 0.5 hour; Speed by 15～20 ℃/h makes shelf temperature reduce to-40 ℃ again, is incubated 2 hours; The beginning evacuation begins to be-22 ℃ with 5 ℃/h speed rise temperature to shelf temperature when treating the about 10pa of vacuum, is incubated 28 hours; Again shelf temperature is risen to 10 ℃, be incubated and after 3 hours shelf temperature risen to 40 ℃, treat that products temperature reaches 35 ℃ of insulations 8 hours, tamponade, outlet gets final product.
Embodiment 2
The prescription of glutathione for injection consists of: (is unit with weight)
Reduced glutathion 600g
Sodium hydroxide 90g
Water for injection is an amount of
Take by weighing the 90g sodium hydroxide, stirring and dissolving makes it into 15% sodium hydroxide solution, and is subsequent use; Measure 70% sodium hydroxide solution for preparing, join in the 600g reduced glutathion and stir, and drip with the residual hydrogen sodium hydroxide solution and to make complete dissolving; Regulator solution PH is 4.9-5.5, supplies water for injection to full dose, stirs; Add 0.03% active carbon and stir, carbon removal is filtered, and is subsequent use; Get the filtrating fill in cillin bottle, by following freeze-drying curve lyophilizing: treat that the freeze dryer shelf temperature reduces to-10 ℃, the fill certified products are inserted on the freeze drying box shelf, be cooled to products temperature with the speed of 30 ℃/h and be-25 ℃, be incubated 2 hours; Shelf temperature is gone up, make products temperature rise to-5 ℃, be incubated 0.5 hour; Speed by 15～20 ℃/h makes shelf temperature reduce to-40 ℃ again, is incubated 2 hours; The beginning evacuation begins to be-22 ℃ with 5 ℃/h speed rise temperature to shelf temperature when treating the about 10pa of vacuum, is incubated 28 hours; Again shelf temperature is risen to 10 ℃, be incubated and after 3 hours shelf temperature risen to 40 ℃, treat that products temperature reaches 35 ℃ of insulations 8 hours, tamponade, outlet gets final product.
After having read above-mentioned teachings of the present invention, those skilled in the art can make various changes or modification to the present invention, and these equivalent form of values fall within the application's appended claims institute limited range equally.
Claims (5)
1. a glutathione for injection method for preparing freeze-dried powder is characterized in that, may further comprise the steps:
1.1 take by weighing an amount of PH regulator, stirring and dissolving makes it into 15% solution, and is subsequent use;
1.2 measure the 70% PH regulator solution for preparing, add reduced glutathion and stir, and with residue PH regulator solution drip make complete molten; Regulator solution PH is 4.9-5.5, supplies water for injection to full dose, stirs; Add 0.03% active carbon and stir, carbon removal is filtered, and is subsequent use;
1.3 get the filtrating fill in cillin bottle, by following freeze-drying curve lyophilizing: treat that the freeze dryer shelf temperature reduces to-10 ℃, the fill certified products are inserted on the freeze drying box shelf, be cooled to products temperature with the speed of 30 ℃/h and be-25 ℃, be incubated 2 hours; Shelf temperature is gone up, make products temperature rise to-5 ℃, be incubated 0.5 hour; Speed by 15～20 ℃/h makes shelf temperature reduce to-40 ℃ again, is incubated 2 hours; The beginning evacuation begins to be-22 ℃ with 5 ℃/h speed rise temperature to shelf temperature when treating the about 10pa of vacuum, is incubated 28 hours; Again shelf temperature is risen to 10 ℃, be incubated and after 3 hours shelf temperature risen to 40 ℃, treat that products temperature reaches 35 ℃ of insulations 8 hours, tamponade, outlet gets final product.
2. the method for preparing freeze-dried powder of reduced glutathion as claimed in claim 1; It is characterized in that: to join the ratio of reduced glutathion and PH regulator in the solution be that the amount of reduced glutathion is 6～9 parts, the PH regulator consists of 0.8～1.5 part (is unit with weight).
3. the method for preparing freeze-dried powder of reduced glutathion as claimed in claim 1 is characterized in that: the PH regulator is selected a kind of or two kinds of mixing of sodium hydroxide or sodium bicarbonate, hydrochloric acid for use.
4. the method for preparing freeze-dried powder of reduced glutathion as claimed in claim 1, it is characterized in that: PH regulator institute wiring solution-forming concentration is 15%.
5. the method for preparing freeze-dried powder of reduced glutathion as claimed in claim 1, it is characterized in that: the freeze drying process of the freeze-drying curve of being selected for use may further comprise the steps:
(1), treat that the freeze dryer shelf temperature reduces to-10 ℃, the fill certified products are inserted on the freeze drying box shelf, be cooled to products temperature with the speed of 30 ℃/h and be-25 ℃, be incubated 2 hours;
(2), shelf temperature is gone up, make products temperature rise to-5 ℃, be incubated 0.5 hour; Speed by 15～20 ℃/h makes shelf temperature reduce to-40 ℃ again, is incubated 2 hours;
(3), the beginning evacuation, begin to be-22 ℃ when treating the about 10pa of vacuum with 5 ℃/h speed rise temperature to shelf temperature, be incubated 28 hours;
(4), again shelf temperature is risen to 10 ℃, be incubated and after 3 hours shelf temperature risen to 40 ℃, treat that products temperature reaches 35 ℃ of insulations 8 hours, tamponade, outlet.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011100720244A CN102670523A (en) | 2011-03-18 | 2011-03-18 | Method for preparing injection reduced glutathione freeze-dried powder |
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| CN2011100720244A CN102670523A (en) | 2011-03-18 | 2011-03-18 | Method for preparing injection reduced glutathione freeze-dried powder |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106310244A (en) * | 2016-08-19 | 2017-01-11 | 广州白云山明兴制药有限公司 | Freeze-drying process of asparaginase for injection |
| CN108567970A (en) * | 2018-05-25 | 2018-09-25 | 福安药业集团湖北人民制药有限公司 | High stable glutathione for injection |
| CN113912671A (en) * | 2021-11-26 | 2022-01-11 | 江西诚志生物工程有限公司 | Glutathione separating and purifying process |
| CN115671060A (en) * | 2022-11-18 | 2023-02-03 | 无锡福祈制药有限公司 | Glutathione freeze-dried preparation for eyes and preparation method thereof |
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| CN1970075A (en) * | 2005-11-24 | 2007-05-30 | 山东绿叶制药有限公司 | Lyophilized powder injection of glutathione and preparation process thereof |
| CN1994461A (en) * | 2006-01-06 | 2007-07-11 | 上海复旦复华药业有限公司 | Lyophilization process of glutathione for injection |
| CN101074202A (en) * | 2006-05-16 | 2007-11-21 | 重庆药友制药有限责任公司 | Production of injecting reductive glutathione |
| CN101647783A (en) * | 2009-07-24 | 2010-02-17 | 上海复旦复华药业有限公司 | Prefreezing method in preparing injection-used reduced glutathione with freeze drying method |
-
2011
- 2011-03-18 CN CN2011100720244A patent/CN102670523A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1970075A (en) * | 2005-11-24 | 2007-05-30 | 山东绿叶制药有限公司 | Lyophilized powder injection of glutathione and preparation process thereof |
| CN1994461A (en) * | 2006-01-06 | 2007-07-11 | 上海复旦复华药业有限公司 | Lyophilization process of glutathione for injection |
| CN101074202A (en) * | 2006-05-16 | 2007-11-21 | 重庆药友制药有限责任公司 | Production of injecting reductive glutathione |
| CN101647783A (en) * | 2009-07-24 | 2010-02-17 | 上海复旦复华药业有限公司 | Prefreezing method in preparing injection-used reduced glutathione with freeze drying method |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106310244A (en) * | 2016-08-19 | 2017-01-11 | 广州白云山明兴制药有限公司 | Freeze-drying process of asparaginase for injection |
| CN108567970A (en) * | 2018-05-25 | 2018-09-25 | 福安药业集团湖北人民制药有限公司 | High stable glutathione for injection |
| CN108567970B (en) * | 2018-05-25 | 2021-09-24 | 福安药业集团湖北人民制药有限公司 | Preparation method of reduced glutathione for injection |
| CN113912671A (en) * | 2021-11-26 | 2022-01-11 | 江西诚志生物工程有限公司 | Glutathione separating and purifying process |
| CN113912671B (en) * | 2021-11-26 | 2024-04-19 | 江西诚志生物工程有限公司 | Glutathione separation and purification process |
| CN115671060A (en) * | 2022-11-18 | 2023-02-03 | 无锡福祈制药有限公司 | Glutathione freeze-dried preparation for eyes and preparation method thereof |
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Application publication date: 20120919 |