CN103191052A - L-alpha-glycerol phosphorylcholine injection composition and preparation method thereof - Google Patents
L-alpha-glycerol phosphorylcholine injection composition and preparation method thereof Download PDFInfo
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- CN103191052A CN103191052A CN2013101078386A CN201310107838A CN103191052A CN 103191052 A CN103191052 A CN 103191052A CN 2013101078386 A CN2013101078386 A CN 2013101078386A CN 201310107838 A CN201310107838 A CN 201310107838A CN 103191052 A CN103191052 A CN 103191052A
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Abstract
The embodiment of the invention discloses an L-alpha-glycerol phosphorylcholine injection composition. The L-alpha-glycerol phosphorylcholine injection composition comprises the active pharmaceutical ingredient, namely 1.0kg of L-alpha-glycerol phosphorylcholine per 1000 injections and 4L of water for injection per 1000 injections. The invention further discloses a preparation method of the L-alpha-glycerol phosphorylcholine injection composition, which comprises the following steps of: weighing the active pharmaceutical ingredient, namely the L-alpha-glycerol phosphorylcholine according to the formula amount, adding part of the water for injection according to the formula amount, stirring and dissolving; adding activated carbon for injection, adsorbing and filtering to remove the carbon; adding the remaining water for injection into a solution, and performing fine filtration by using a sterile microporous filter membrane; inspecting a semi-finished product, and filling and sealing after the semi-finished product is inspected to be qualified; performing hot pressing and sterilization; and inspecting a finished product and packaging. The formula and the preparation method have the advantages of reasonable parameters, maturity, stability, good reproducibility and stable product quality, and are suitable for large-scale production.
Description
Technical field
The present invention relates to a kind of injecta composition field, relate in particular to a kind of L-α-glyceryl phosphoryl choline injecta composition and preparation method thereof.
Background technology
Glyceryl phosphoryl choline can deserve to be called " transporter " and " adventurous headman " in the phosphate choline in the choline.It has the potential ability that prevents and treat for various biochemical pathological changes.People find that from the various factors that causes nervous tissue's decline syndrome it has the peculiar effect that reduces somatotonia and change phosphate lipoid compound structure in the neuron film.The chemical constitution of L-α-glyceryl phosphoryl choline (containing 40.5% choline) and the physicochemical characteristics that connects each other, guaranteed it become a kind of that cerebral tissue is highly profitable, can protect the metabolic material of cerebral tissue at any time.The result of preclinical pharmacology test and clinical research are all verified, and L-α-glyceryl phosphoryl choline choline is without benefits to cognition and the memory function of brain, especially very helpful for the emotion that causes because of the brain degeneration disease and behavior disorder.
Summary of the invention
Embodiment of the invention technical problem to be solved is, provides a kind of workable, is easy to control, L-α-glyceryl phosphoryl choline injecta composition that product stability is high and preparation method thereof.
Described L-α-glyceryl phosphoryl choline injecta composition, the medicine active ingredient is: the water for injection of per thousand 1.0kgL-α-glyceryl phosphoryl cholines and 4L.
The preparation method of described L-α-glyceryl phosphoryl choline injecta composition comprises the steps:
(1) takes by weighing above-mentioned recipe quantity medicine active ingredient L-α-glyceryl phosphoryl choline, add the water for injection stirring and dissolving of part recipe quantity;
(2) add needle-use activated carbon, absorption filters takes off charcoal;
(3) remaining water for injection is added solution, with aseptic microporous filter membrane fine straining;
(4) inspection of semifinished product, qualified back embedding;
(5) water-bath sterilization; 121 ℃ of sterilizations in 15 minutes
(6) product inspection, packing.
Part recipe quantity water for injection 80%-90% in the described step (1).
The consumption of needle-use activated carbon is 0.1% of amount of liquid medicine in the described step (2).
Described step (2) is middle to be 20 minutes with the needle-use activated carbon adsorption time.
The aperture of aseptic microporous filter membrane is 0.22um described in the described step (3).
The temperature of described step (5) pressure sterilizing is 121 ℃, and the time is 15 minutes.
Implement the embodiment of the invention, have following beneficial effect:
By investigating the dosing Temperature Influence, show that the temperature of water for injection does not have obviously influence to preparation in the embodiment of the invention, this production technology is fit to suitability for industrialized production, selects for use commonly used 0.1% consumption that this product is not had obvious absorption, can reach production requirement; Sterilization process research aspect adopts the first-selected sterilising conditions of excessively killing (121 ℃ of 15min), and result of study shows, this product good thermal stability can tolerate and excessively kill condition, has guaranteed the sterilized water product of this product; This prescription and preparation technology parameter are reasonable, and be mature and stable, and repeatability is good, and constant product quality is fit to large-scale production.
The specific embodiment
For making the purpose, technical solutions and advantages of the present invention clearer, below with the present invention is described in further detail.
Present embodiment L-α-glyceryl phosphoryl choline injecta composition preparation method is as follows: the thing active ingredient of getting it filled earlier, and specific as follows;
Preparation method:
1. take by weighing the L-α-glyceryl phosphoryl choline of recipe quantity, add stirring and dissolving in about 90% the water for injection.
2. add the needle-use activated carbon of amount of liquid medicine 0.1%, adsorbed 20 minutes, filter and take off charcoal.
3. benefit adds to the full amount of water for injection, with the aseptic microporous filter membrane fine straining of 0.22 μ m.
4. the inspection of semifinished product, qualified back embedding.
5. in 121 ℃ of water-bath sterilization 15min.
6. product inspection, packing.
In order to verify the feasibility of formulation and technology, the formulation and technology according to determining feeds intake by 1000 amount of preparation, the preparation sample.
Table 1 lab scale sample preparation result
Conclusion: prepare sample by the formulation and technology of determining, workable, be easy to control, preparation process is smooth, in order further to verify the stability of formulation and technology, this batch sample is carried out the influence factor test investigation.
Factors influencing
1. sample message
Own product: sample lot number: 101101
Specification: 4ml:1.0g
Commercially available product: trade name: GLIATILN
Specification: 4ml ﹕ 1.0g
Lot number: 06001
Manufacturer: the ITALFARMACO S.p.A.ITALY(big pharmaceutical factory of big general Marko of anticipating)
2. investigation project: character, pH value, visible foreign matters, color, related substance, content.
3. investigation purpose: investigate stability and the packaging material compatibility of this product, ad hoc meter this product is in the stability of illumination, hot conditions and freeze thawing.
4. content of the test
4.1 exposure experiments to light
With own product and commercially available product, placing intensity of illumination is under 4500 ± 500Lx condition, places ten days, respectively at the 0th, 5, the 10 day every index of sampling and measuring, the results are shown in following table.
4.2 hot test (60 ℃)
With own product and commercially available product, place under 60 ℃ of constant temperatures, placed ten days, respectively at the 0th, 5, the 10 day every relevant index of sampling and measuring, the results are shown in following table.
4.3 freezing-thawing test
Own product was placed 2 days at-10～-20 ℃, placed 2 days under 40 ℃ of acceleration environments then, the every relevant index of sampling and measuring after 3 times that so circulates the results are shown in following table.
4.4 result of the test
Table 2L-α-glyceryl phosphoryl choline injection (own product) exposure experiments to light result
Table 3L-α-glyceryl phosphoryl choline injection (Yuan grinds product) exposure experiments to light result
Table 4L-α-glyceryl phosphoryl choline injection (own product) hot test result
Table 5L-α-glyceryl phosphoryl choline injection (Yuan grinds product) hot test result
Table 6L-α-glyceryl phosphoryl choline injection freezing-thawing test result
4.5 conclusion
1. own product and Yuan grind product (4500 ± 500Lx) irradiations ten days, Yuan grind the zero no significant change in sky of product and the every index of own product through illumination.
2. own product and Yuan grind product and placed ten days in high temperature (60 ℃) environment, and every index is all than no significant change in zero day.
3. after the freezing-thawing test, the every index of sample is compared with zero day measurement result and there is no significant change.
Each condition test of combined influence factor and freezing-thawing test by the test that own product and Yuan are ground product, show the quality of the pharmaceutical preparations level that my company produces, and are not less than the Yuan triturate.Influence factor's test and long-time stability are investigated, and this product is answered shading, airtight preservation.
Trial production and process certification
On the basis of above-mentioned test, form and preparation technology according to the prescription of determining, carry out continuous 3 batches of trial productions, simultaneously to the critical process in the technology: dosing, embedding, sterilization process carry out process certification.The process certification data is seen Appendix.
The trial production result
This product is produced three batches as a trial continuously, its inventory, output and yield is added up result such as following table:
Table 7 pilot scale sample preparation result
Conclusion: pilot scale shows that the prescription of this product is stable, technical maturity, and good reproducibility is fit to large-scale production.
Above disclosed is a kind of preferred embodiment of the present invention only, can not limit the present invention's interest field certainly with this, and therefore the equivalent variations of doing according to claim of the present invention still belongs to the scope that the present invention is contained.
Claims (7)
1. L-α-glyceryl phosphoryl choline injecta composition is characterized in that the medicine active ingredient is: the water for injection of per thousand 1.0kgL-α-glyceryl phosphoryl cholines and 4L.
2. the preparation method of L-α as claimed in claim 1-glyceryl phosphoryl choline injecta composition is characterized in that, comprises the steps:
(1) takes by weighing above-mentioned recipe quantity effective ingredient L-α-glyceryl phosphoryl choline, add the water for injection stirring and dissolving of part recipe quantity;
(2) add needle-use activated carbon, absorption filters takes off charcoal;
(3) remaining water for injection is added solution, with aseptic microporous filter membrane fine straining;
(4) inspection of semifinished product, qualified back embedding;
(5) pressure sterilizing;
(6) product inspection, packing.
3. the preparation method of L-α as claimed in claim 2-glyceryl phosphoryl choline injecta composition is characterized in that, the part recipe quantity water for injection 80%-90% in the described step (1).
4. the preparation method of L-α as claimed in claim 2-glyceryl phosphoryl choline injecta composition is characterized in that, the consumption of needle-use activated carbon is 0.1% of amount of liquid medicine in the described step (2).
5. the preparation method of L-α as claimed in claim 4-glyceryl phosphoryl choline injecta composition is characterized in that, described step (2) is middle to be 20 minutes with the needle-use activated carbon adsorption time.
6. the preparation method of L-α as claimed in claim 2-glyceryl phosphoryl choline injecta composition is characterized in that, the aperture of aseptic microporous filter membrane is 0.22um described in the described step (3).
7. the preparation method of L-α as claimed in claim 2-glyceryl phosphoryl choline injecta composition is characterized in that, the temperature of described step (5) water-bath sterilization is 121 ℃, and the time is 15 minutes.
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| CN2013101078386A CN103191052A (en) | 2013-03-29 | 2013-03-29 | L-alpha-glycerol phosphorylcholine injection composition and preparation method thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102213698A (en) * | 2010-04-07 | 2011-10-12 | 四川科伦药物研究有限公司 | Detection method of glycerin phosphoryl choline injecta related material |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102213698A (en) * | 2010-04-07 | 2011-10-12 | 四川科伦药物研究有限公司 | Detection method of glycerin phosphoryl choline injecta related material |
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Application publication date: 20130710 |