CN1194698C - Puerarin injection and its prepn. process - Google Patents
Puerarin injection and its prepn. process Download PDFInfo
- Publication number
- CN1194698C CN1194698C CNB021263191A CN02126319A CN1194698C CN 1194698 C CN1194698 C CN 1194698C CN B021263191 A CNB021263191 A CN B021263191A CN 02126319 A CN02126319 A CN 02126319A CN 1194698 C CN1194698 C CN 1194698C
- Authority
- CN
- China
- Prior art keywords
- puerarin
- injection
- bottle
- adds
- excipient
- 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.)
- Expired - Fee Related
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a medicinal injection containing puerarin and a preparation technique thereof. The medicinal injection contains puerarin and pharmacologically allowed dissolution assisting substances; thus, the solubility of the puerarin is enhanced without changing the acidity and aikalinity of the puerarin, and the puerarin reaches the medicinal concentration required by clinical operation. The preparation method comprises the steps that puerarin powder and the pharmacologically allowed dissolution assisting substances are sufficiently and uniformly mixed to obtain clear liquid without a heat source, and the clear liquid is prepared into the injection containing puerarin by water needle technology or freeze-drying technology. The medicinal injection prepared by the method of the present invention has the advantages of reduced toxic and side effect, no salt generated by reaction, stable quality and accurate curative effect.
Description
Technical field
The present invention relates to a kind of drug injection and preparation technology thereof who contains puerarin.
Background technology
The puerarin injection of present clinical use is according to the national drug standards WS of National Drug Administration
1-(X-063)-preparation of 2000Z regulation, be colourless or little yellow clear liquid.Because dissolubility is less in the aqueous solution of puerarin below PH7, only is 4.63mg/ml, therefore, is difficult to reach corresponding drug level in the process for preparation of puerarin injection in limited volume.In order in the process for preparation of puerarin injection, to make it in limited volume, reach corresponding drug level, in puerarin injection, to add the propylene glycol of higher concentration as cosolvent, just can reach the desired drug level of this medicine like this.And the consumption of the puerarin injection of each course of treatment is all bigger clinically, and a large amount of propylene glycol injects in the human body, and human body is had certain toxic and side effects; And the viscosity of propylene glycol is bigger, and the loss of material medicine is also bigger in preparation process; Puerarin to the light and heat instability, easily decomposes variable color in water, pure mixed liquor, influence product quality, is difficult for long term storage.
Existing patent of invention " puerarin pharmaceutical composition and preparation thereof " discloses a kind of pharmaceutical composition and prescription that can reduce the propylene glycol toxic and side effects: under cleaning condition, powder of Radix Puerariae is suspended in the water for injection, add the alkaline matter that pharmacology allows, Jiao mixes dissolving, decolouring, ultrafiltration, obtain apyrogenic clear liquor, place cillin bottle, press the freeze-dry process lyophilizing, promptly get product.
Though the influence of propylene glycol organic cosolvent has been avoided in this invention, has added alkaline matter.The puerarin freeze-drying powder that uses clinically is white or little yellow lyophilizing block according to the preparation of national tentative standard WS-682 (X-594)-2000 (trying) regulation at present.Because puerarin contains two hydroxyls, show acid, the adding alkaline matter can improve the dissolubility of puerarin, though reach required drug level like this, but puerarin is with the alkali substance reaction salify simultaneously, this not only makes aqueous solution jaundice variable color, has influenced the quality of product, has also influenced the therapeutic effect of puerarin.
Summary of the invention
The object of the invention provides a kind of toxic and side effects that can reduce can not react salify again, and steady quality, curative effect are more definite, can treat the puerarin injection of coronary heart disease and cerebral embolism, wherein comprises puerarin injection and puerarin freeze-drying powder.
Another purpose of the present invention provides the preparation technology of above-mentioned puerarin injection.
Puerarin injection of the present invention is realized by following method: under cleaning condition, the abundant mix homogeneously of hydrotropy material with puerarin powder and pharmacology permission, add proper amount of water for injection, heated and stirred makes it to dissolve fully, coarse filtration, ultrafiltration obtains apyrogenic clear liquor, places ampoule bottle or control antibiotic bottle, presses the making of liquid drugs injection technology or freeze-dry process and promptly gets product.
The hydrotropy material that adds the pharmacology permission in the puerarin powder does not change the Acidity of Aikalinity of puerarin itself with the dissolubility that improves puerarin, make puerarin reach the drug level of clinical requirement.
The used hydrotropy material of the present invention is: nicotiamide, soluble poly vinylpyrrolidone (PVP) or hydroxypropyl beta cyclodextrin can be that wherein one or more mix use.
The ratio of puerarin of the present invention and hydrotropy material is: 1: 2-3.5.
In the injection of the present invention, can contain the excipient of 3-10%, excipient is mannitol, lactose, sorbitol or low molecular dextran.
In the drug regimen material of the present invention, can contain antioxidant, antioxidant is nitrogen, carbon dioxide gas, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, disodiumedetate.
The clinical using method of pharmaceutical composition of the present invention is: puerarin injection is dissolved in 5% glucose solution or 0.9% sodium chloride solution, intravenous drip is used for the treatment of diseases such as coronary heart disease, various angina pectoris, myocardial infarction, retina arteriovenous obstruction, sudden deafness.
Because pharmaceutical composition of the present invention does not contain propylene glycol, thereby the toxic and side effects of having avoided a large amount of propylene glycol that human body is produced,
Avoid adding alkaline matter simultaneously and cause the variable color of puerarin salify, influence drug effect.Drug regimen amount of the present invention is more stable, and toxic and side effects is lower, has kept the former effective in cure of puerarin.
The specific embodiment
Embodiment 1
Under cleaning condition, 10g puerarin powder is fully mixed with the 25g nicotiamide, add 200ml water for injection, heating Jiao mixes and makes it to dissolve fully, adds 0.5% antioxidant again, through coarse filtration, ultrafiltration, get apyrogenic settled solution, place ampoule bottle, make the product of 0.1g bottle by liquid drugs injection technology.
Embodiment 2
Under cleaning condition, 10g puerarin powder is fully mixed with the 25g nicotiamide, add 200ml water for injection, heating Jiao mixes and makes it to dissolve fully, the mannitol that adds 6g again through coarse filtration, ultrafiltration, gets apyrogenic settled solution, place the control antibiotic bottle, make the product of 0.1g/ bottle, 0.2g/ bottle, 0.4g/ bottle by freeze-dry process.
Embodiment 3
Under cleaning condition, 10g puerarin powder is fully mixed with the 20g nicotiamide, add 200ml water for injection, heating Jiao mixes and makes it to dissolve fully, adds 0.5% antioxidant again, through coarse filtration, ultrafiltration, get apyrogenic settled solution, place ampoule bottle, make the product of 0.1g bottle by liquid drugs injection technology.
Embodiment 4
Under cleaning condition, 10g puerarin powder is fully mixed with the 20g polyvinylpyrrolidone, add 200ml water for injection, heating Jiao mixes and makes it to dissolve fully, add the 6g sorbitol again,, get apyrogenic settled solution through coarse filtration, ultrafiltration, place the control antibiotic bottle, make the product of 0.1g/ bottle, 0.2g/ bottle, 0.4g/ bottle by freeze-dry process.
Embodiment 5
Under cleaning condition, 10g puerarin powder is fully mixed with the 30g hydroxypropyl beta cyclodextrin, add 200ml water for injection, heating Jiao mixes and makes it to dissolve fully, add 0.5% antioxidant again, through coarse filtration, ultrafiltration, apyrogenic settled solution, place ampoule bottle, make the product of 0.1g bottle by liquid drugs injection technology.
Embodiment 6
Under cleaning condition, 10g puerarin powder is fully mixed with the 30g hydroxypropyl beta cyclodextrin, add 200ml water for injection, heating Jiao mixes and makes it to dissolve fully, add the 10g lactose again,, get apyrogenic settled solution through coarse filtration, ultrafiltration, place the control antibiotic bottle, make the product of 0.1g/ bottle, 0.2g/ bottle, 0.4g/ bottle by freeze-dry process.
Embodiment 7
Under cleaning condition, 10g puerarin powder, 20g hydroxypropyl beta cyclodextrin, 10g nicotiamide are fully mixed, add 200ml water for injection, heating Jiao mixes and makes it to dissolve fully, add 0.5% antioxidant again, through coarse filtration, ultrafiltration, apyrogenic settled solution, place ampoule bottle, make the product of 0.1g bottle by liquid drugs injection technology.
Embodiment 8
Under cleaning condition, 10g puerarin powder, 20g hydroxypropyl beta cyclodextrin, 10g nicotiamide are fully mixed, add 200ml water for injection, heating Jiao mixes and makes it to dissolve fully, add the 10g lactose again,, get apyrogenic settled solution through coarse filtration, ultrafiltration, place the control antibiotic bottle, make the product of 0.1g/ bottle, 0.2g/ bottle, 0.4g/ bottle by freeze-dry process.
Claims (2)
1. a puerarin injection is characterized in that, is the hydrotropy material that contains puerarin and pharmacology permission; Hydrotropy material wherein is nicotiamide, soluble poly vinylpyrrolidone or hydroxypropyl beta cyclodextrin; Can be that one or more mix use; The ratio of described puerarin and hydrotropy material is: 1: 2-3.5; The excipient that also contains 3-10%; Described excipient is mannitol, lactose, sorbitol or low molecular dextran.
2. the preparation technology of the described puerarin injection of claim 1, it is characterized in that, under cleaning condition, the abundant mix homogeneously of hydrotropy material of puerarin powder and pharmacology permission, add proper amount of water for injection, heated and stirred makes it to dissolve fully, adds excipient again, through coarse filtration, ultrafiltration, obtain apyrogenic clear liquor, place ampoule bottle or control antibiotic bottle, press the freeze-dry process making and promptly get product of the present invention; The hydrotropy material that adds is nicotiamide, soluble poly vinylpyrrolidone or hydroxypropyl beta cyclodextrin, can be that wherein one or more mix use; The puerarin that adds and the ratio of hydrotropy material are: 1: 2-3.5, the excipient that adds 3-10% is mannitol, lactose, sorbitol or low molecular dextran.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021263191A CN1194698C (en) | 2002-07-18 | 2002-07-18 | Puerarin injection and its prepn. process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021263191A CN1194698C (en) | 2002-07-18 | 2002-07-18 | Puerarin injection and its prepn. process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1389211A CN1389211A (en) | 2003-01-08 |
| CN1194698C true CN1194698C (en) | 2005-03-30 |
Family
ID=4745740
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB021263191A Expired - Fee Related CN1194698C (en) | 2002-07-18 | 2002-07-18 | Puerarin injection and its prepn. process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1194698C (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007014B (en) * | 2006-01-24 | 2010-10-13 | 程高楼 | A compound puerarin preparation |
| CN102488649B (en) * | 2011-11-27 | 2013-07-10 | 辽宁海神联盛制药有限公司 | Puerarin sodium chloride injection and preparation method thereof |
| CN104042602A (en) * | 2014-05-28 | 2014-09-17 | 西北农林科技大学 | Application of sodium glutamate in puerarin injection |
| CN104042603B (en) * | 2014-05-28 | 2019-11-05 | 西北农林科技大学 | Application of the γ-aminobutyric acid on the drug for the intravascular hemolysis that preparation prevention and treatment puerarin injection induces |
| CN104940190A (en) * | 2015-07-13 | 2015-09-30 | 江苏天晟药业有限公司 | Application of puerarin to preparing pain easing medicine |
| CN105125485A (en) * | 2015-09-23 | 2015-12-09 | 成都艾比科生物科技有限公司 | Preparation method of injecting drug improving stability of puerarin drug injection preparation |
| CN105106110A (en) * | 2015-09-23 | 2015-12-02 | 成都艾比科生物科技有限公司 | Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition |
-
2002
- 2002-07-18 CN CNB021263191A patent/CN1194698C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN1389211A (en) | 2003-01-08 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| RU2260429C2 (en) | Sodium chloride-containing moxifloxacin compositions | |
| EP3505161B1 (en) | Sublingual pharmaceutical composition of edaravone and (+)-2-borneol | |
| CN101322682A (en) | Preparation of indissoluble medicament nano granule | |
| KR20090104811A (en) | Use of High Osmotic Liquid Composition in Manufacturing Medicament for Enhancing Wound Healing | |
| AU610134B2 (en) | Use of metformin in the preparation of medicines | |
| CN1194698C (en) | Puerarin injection and its prepn. process | |
| CN112386572B (en) | Gamithromycin injection and preparation method thereof | |
| KR20040063913A (en) | Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid | |
| KR100629326B1 (en) | Dermatological formulations | |
| US7091336B2 (en) | Lyophilized powder of lentinan and the process of preparation thereof | |
| CN112402371B (en) | Rudesiwei injection and preparation method thereof | |
| CN1074673C (en) | Traditional Chinese medicine compositions contg. pueraria root extract | |
| CN1344541A (en) | Water soluble Azithromycin salt and its eye drop | |
| CN1663615A (en) | Fructose injection of antibiotic medicine | |
| CN100467024C (en) | Lornoxicam composition for injection and preparation process thereof | |
| US20060094669A1 (en) | Method for treating bacterial infections in horses or pigs with tilmicosin | |
| CN100396289C (en) | Scutellarin injection preparation and its preparing method | |
| CN1131039C (en) | Kelamycin injection and its preparing process | |
| RU2524651C1 (en) | Pharmaceutical composition in form of solution for injection and method for production thereof | |
| RU2313346C2 (en) | Pharmaceutical composition | |
| CN100391447C (en) | Freeze dried powder injection of coenzyme Q10 and its preparation process | |
| CN1552449A (en) | Baicalin cyclodextrin clathrate compound, preparation and preparing method thereof | |
| CN1285335C (en) | Pyrithioxine hydrochloride freeze-dried composition and its preparing method | |
| CN106074398A (en) | A kind of freeze dried lentinan holoside powder injecta and preparation method thereof | |
| CN1287776C (en) | Process for preparing houttuyninum sodium injection |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20050330 Termination date: 20160718 |