CN102309440A - Method for producing ganciclovir glucose injection - Google Patents
Method for producing ganciclovir glucose injection Download PDFInfo
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- CN102309440A CN102309440A CN 201010211536 CN201010211536A CN102309440A CN 102309440 A CN102309440 A CN 102309440A CN 201010211536 CN201010211536 CN 201010211536 CN 201010211536 A CN201010211536 A CN 201010211536A CN 102309440 A CN102309440 A CN 102309440A
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- ganciclovir
- glucose injection
- value
- production method
- buffer agent
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Abstract
The invention belongs to the field of pharmaceutical preparations and in particular relates to a method for adjusting a pH value in the process of producing ganciclovir glucose injection. The method for producing the ganciclovir glucose injection is characterized by comprising the following steps: adding a pH value buffering agent in the process of preparing the ganciclovir glucose injection; adding the pH value buffering agent or corresponding weak acid according to the initially adjusted pH value of the ganciclovir glucose injection; and adjusting the pH value again to be within the required range. According to the ganciclovir glucose injection produced by using the method disclosed by the invention, the pH value of a finished product after being sterilized is slightly reduced; a few related substances are generated; and the quality is better.
Description
Technical field
The invention belongs to field of medicine preparations, be specifically related to produce the method for adjustment pH value in the ganciclovir glucose injection process.
Background technology
Generally behind high temperature sterilize, pH value all descends injection to some extent.The control of intermediate pH value is bad, and the finished product pH value often exceeds the scope of pharmacopeia regulation after sterilization, and product is defective.But the adjustment pH value generally carries out in solution preparation link, and fluid temperature is high, and preparing process wants seeking time short, and the pH value span of control is little, and this fast, accurately adjusts pH value just for manufacturer and brings certain difficulty.
In the existing patented technology data, the method for pH value adjustment is not disclosed.Like the patent No.: 200410012638.3, denomination of invention: ganciclovir injection and production method thereof and the patent No.: 02115931.9, denomination of invention: concrete method of adjustment all is not described in the disclosed technical data of ganciclovir injection and production method thereof.Current, in the actual production process, adopt the pH value of sodium hydroxide and hydrochloride adjusted solution, but the decline of the pH value of this kind method of adjustment finished product after sterilizing is bigger, the product quality of ganciclovir glucose injection is exerted an influence.
Summary of the invention
The object of the invention is exactly to the problems referred to above, proposes the method for adjustment pH value in a kind of ganciclovir glucose injection production process.
Technical scheme provided by the invention is:
A kind of production method of ganciclovir glucose injection; During preparation ganciclovir glucose injection; Add the pH value buffer agent earlier, the pH value according to first adjustment back ganciclovir glucose injection adds pH value buffer agent or corresponding weak acid then, adjusts pH value once more to the scope that requires.
Adding the pH value buffer agent first can be before adding ganciclovir, also can be after adding ganciclovir.
Added the pH value buffer agent first before adding ganciclovir.
Described pH value buffer agent is a strong base-weak acid salt.
Described pH value buffer agent is the arbitrary composition of a kind of or above-mentioned four kinds of materials in sodium acetate, sodium citrate, tertiary sodium phosphate, the sodium lactate.
The volume that adds the pH value buffer agent first accounts for the 0.001%-0.1% of ganciclovir glucose injection cumulative volume.
The volume that adds the pH value buffer agent first accounts for the 0.01%-0.02% of ganciclovir glucose injection cumulative volume.
The weak acid that sodium acetate is corresponding is acetic acid.The weak acid that sodium citrate is corresponding is citric acid, and the weak acid that tertiary sodium phosphate is corresponding is phosphoric acid, and the weak acid that sodium lactate is corresponding is lactic acid.
The compound method of ganciclovir glucose injection of the present invention is: when the ganciclovir high-capacity injection is prepared; With strong base-weak acid salt and corresponding weak acid adjustment pH value thereof; Because strong base-weak acid salt has stronger pH value buffer capacity; So with the ganciclovir glucose injection that this kind method is processed, the pH value of sterilization back finished product descends less, the related substance of generation is less, quality is better.
The specific embodiment
Embodiment 1
In adding the ganciclovir glucose injection preparation liquid of isotonic agent; Add the sodium acetate of 0.01% (in the preparation cumulative volume) and it is fully dissolved; Add ganciclovir then and it is fully dissolved; Measure pH value,, adjust pH value to suitable scope with sodium acetate or acetic acid if against regulation.
Embodiment 2
In adding the ganciclovir glucose injection preparation liquid of isotonic agent; Add ganciclovir and it is fully dissolved; Add the sodium acetate of 0.01% (in the preparation cumulative volume) then and it is fully dissolved; Measure pH value,, adjust pH value to suitable scope with sodium acetate or acetic acid if against regulation.
Embodiment 3
In adding the ganciclovir glucose injection preparation liquid of isotonic agent; Add the sodium citrate of 0.02% (in the preparation cumulative volume) and it is fully dissolved; Add ganciclovir then and it is fully dissolved; Measure pH value,, adjust pH value to suitable scope with sodium citrate or citric acid if against regulation.
Embodiment 4
In adding the ganciclovir glucose injection preparation liquid of isotonic agent; Add the tertiary sodium phosphate of 0.02% (in the preparation cumulative volume) and it is fully dissolved; Add ganciclovir then and it is fully dissolved; Measure pH value,, adjust pH value to suitable scope with tertiary sodium phosphate or phosphoric acid if against regulation.
Embodiment 5
In adding the ganciclovir glucose injection preparation liquid of isotonic agent; Add the sodium lactate of 0.02% (in the preparation cumulative volume) and it is fully dissolved; Add ganciclovir then and it is fully dissolved; Measure pH value,, adjust pH value to suitable scope with sodium lactate or lactic acid if against regulation.
Embodiment 6
In adding the ganciclovir glucose injection preparation liquid of isotonic agent; Add 0.01% (in the preparation cumulative volume) sodium acetate and 0.01% (in the preparation cumulative volume) sodium citrate and make sodium acetate and sodium citrate fully dissolves; Add ganciclovir then and it is fully dissolved; Measure pH value,, adjust pH value to suitable scope with sodium acetate or acetic acid if against regulation.
Should be noted that at last: above embodiment is only in order to technical scheme of the present invention to be described but not to its restriction; Although with reference to preferred embodiment the present invention has been carried out detailed explanation, the those of ordinary skill in affiliated field is to be understood that: still can specific embodiments of the invention make amendment or the part technical characterictic is equal to replacement; And not breaking away from the spirit of technical scheme of the present invention, it all should be encompassed in the middle of the technical scheme scope that the present invention asks for protection.
Claims (9)
1. a kind of production method of ganciclovir glucose injection; It is characterized in that; During preparation ganciclovir glucose injection; Add the pH value buffer agent earlier, the pH value according to first adjustment back ganciclovir glucose injection adds pH value buffer agent or corresponding weak acid then, adjusts pH value once more to the scope that requires.
2. according to a kind of production method of the said ganciclovir glucose injection of claim 1, it is characterized in that adding the pH value buffer agent first can be before adding ganciclovir, also can be after adding ganciclovir.
3. according to a kind of production method of claim 1 or 2 said ganciclovir glucose injections, it is characterized in that, added the pH value buffer agent first before adding ganciclovir.
4. according to a kind of production method of the said ganciclovir glucose injection of claim 1, it is characterized in that described pH value buffer agent is a strong base-weak acid salt.
5. according to a kind of production method of the said ganciclovir glucose injection of any one claim in the claim 1 to 4; It is characterized in that described pH value buffer agent is the arbitrary composition of a kind of or above-mentioned four kinds of materials in sodium acetate, sodium citrate, tertiary sodium phosphate, the sodium lactate.
6. according to a kind of production method of the said ganciclovir glucose injection of claim 1, it is characterized in that the volume that adds the pH value buffer agent first accounts for the 0.001%-0.1% of ganciclovir glucose injection cumulative volume.
7. according to a kind of production method of the said ganciclovir glucose injection of claim 6, it is characterized in that the volume that adds the pH value buffer agent first accounts for the 0.01%-0.02% of ganciclovir glucose injection cumulative volume.
8. according to a kind of production method of the said ganciclovir glucose injection of claim 5, it is characterized in that the weak acid that sodium acetate is corresponding is acetic acid.
9. according to a kind of production method of the said ganciclovir glucose injection of claim 5, it is characterized in that the weak acid that sodium citrate is corresponding is citric acid, the weak acid that tertiary sodium phosphate is corresponding is phosphoric acid, and the weak acid that sodium lactate is corresponding is lactic acid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010211536 CN102309440B (en) | 2010-06-29 | 2010-06-29 | Method for producing ganciclovir glucose injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010211536 CN102309440B (en) | 2010-06-29 | 2010-06-29 | Method for producing ganciclovir glucose injection |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102309440A true CN102309440A (en) | 2012-01-11 |
| CN102309440B CN102309440B (en) | 2013-04-10 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 201010211536 Expired - Fee Related CN102309440B (en) | 2010-06-29 | 2010-06-29 | Method for producing ganciclovir glucose injection |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1403084A (en) * | 2002-06-06 | 2003-03-19 | 武汉华龙生物制药有限公司 | Ganciclovir injection and its production process |
| CN1726917A (en) * | 2005-07-26 | 2006-02-01 | 湖北丽益医药科技有限公司 | Ganciclovir lactated ringer solution and preparation method |
-
2010
- 2010-06-29 CN CN 201010211536 patent/CN102309440B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1403084A (en) * | 2002-06-06 | 2003-03-19 | 武汉华龙生物制药有限公司 | Ganciclovir injection and its production process |
| CN1726917A (en) * | 2005-07-26 | 2006-02-01 | 湖北丽益医药科技有限公司 | Ganciclovir lactated ringer solution and preparation method |
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| CN102309440B (en) | 2013-04-10 |
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