CN104940149A - Compound aminopyrine antipyrine barbital injection freeze-dried powder injection and preparation method thereof - Google Patents
Compound aminopyrine antipyrine barbital injection freeze-dried powder injection and preparation method thereof Download PDFInfo
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- CN104940149A CN104940149A CN201510310408.3A CN201510310408A CN104940149A CN 104940149 A CN104940149 A CN 104940149A CN 201510310408 A CN201510310408 A CN 201510310408A CN 104940149 A CN104940149 A CN 104940149A
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Abstract
The invention discloses compound aminopyrine antipyrine barbital injection freeze-dried powder injection and a preparation method thereof. The compound aminopyrine antipyrine barbital injection freeze-dried powder injection comprises aminopyrine, antipyrine, barbital, mannitol, propylene glycol, sodium sulfite, lactose and dextran. Compared with the prior art, the compound aminopyrine antipyrine barbital injection freeze-dried powder injection is good in redissolving property, and stable in quality, and can relieve pain caused by intramuscular injection, the preparation process provided by the invention is simple and easy to control, the production efficiency is high and production energy consumption is low.
Description
Technical field
The present invention relates to a kind of compound recipe ammonia woods barbital frozen powder for injection injection being used for the treatment of acute high fever and preparation method thereof, belong to field of medicine preparations.
Background technology
Components In Antongding Injectate, also known as compound Anlin Babituo injection, is colourless or yellowish clear liquid.Promptly bringing down a fever when being mainly used in acute high fever, also has mitigation to the headache syndromes of adstante febre.Be used for the treatment of tablet, the injection medicine of the bringing down a fever of urgent adstante febre, the headache of adstante febre, arthralgia, neuralgia, the disease such as rheumatalgia and dysmenorrhea.For compound preparation, wherein aminophenazone and phenazone belong to pyrazolone antipyretic analgesic, can suppress synthesis and the release of hypothalamus prostaglandin, recover the orthocrasia of thermotaxic centre receptive neuron and play antipyretic effect; Also play analgesic activity by suppressing the synthesis of prostaglandin etc. simultaneously.Aminophenazone also can the synthesis of prostaglandin and release in inflammation-inhibiting local organization, stablizes lysosome membrane, affect cytophagous phagocytosis and play antiinflammatory action.Share barbital, can Postoperation effect.
Compound Anlin Babituo injection disclosed in Chinese patent literature CN101129328A consists of aminophenazone, phenazone, barbital, disodiumedetate and water for injection.Disclosed in CN104324034A, the pharmaceutical composition of injection use compound aminophenazone consists of aminophenazone; Phenazone, barbital, PLGA, PEG, PVP, mannitol, glycine, poloxamer, ethylene glycol.Although above-mentioned injection has, solubility is good, good stability, the features such as drug loading is high, safety of clinical trials is good, overcomes that solubility in prior art is poor, the weak point of poor stability, and it exists the myalgia problem that intramuscular injection causes and can not be ignored.The muscle of the intramuscular injection initiation of antondin, skeleton pain, buttocks are red and swollen, abscess, and the untoward reaction such as acral necrosis have many sections of bibliographical informations.
For this problem, although numerous document has been reported in " improving the discussion (Huang Yingying, etc., southern nursing magazine volume the 3rd phase May the 5th in 1998) that intramuscular injection method alleviates local pain ", by operator during adjustment intramuscular injection
method meeting portionpoint alleviate patient's local pain, but the method cannot be releived to myalgia from the angle of preparation itself, can only alleviate from very slight degree because medicine forms the problem causing muscular injury pain of the preparation existence brought itself.Thus, self studying for antondin preparation, alleviate at all or avoid the untoward reaction such as the pain that its intramuscular injection causes from preparation angle, has been the urgent technical problem continuing to solve.
Summary of the invention
Therefore, technical problem to be solved by this invention is the technological deficiency overcoming the myalgia that existing compound recipe ammonia woods barbital injection easily causes, thus proposes that a kind of muscular injury pain sense is low and the compound recipe ammonia woods barbital frozen powder for injection injection that product is stablized, solubility is good and preparation method.
For this reason, the invention provides a kind of compound recipe ammonia woods barbital frozen powder for injection injection being used for the treatment of acute high fever, comprise aminophenazone, phenazone, barbital, mannitol, propylene glycol, sodium sulfite, lactose, dextran,
Wherein each composition consists of:
The compound recipe ammonia woods barbital frozen powder for injection injection raw material composition that the present invention is used for the treatment of acute high fever is preferably:
The compound recipe ammonia woods barbital frozen powder for injection injection raw material composition that the present invention is used for the treatment of acute high fever is preferably:
The compound recipe ammonia woods barbital frozen powder for injection injection raw material composition that the present invention is used for the treatment of acute high fever is preferably:
The preparation method of the compound recipe ammonia woods barbital frozen powder for injection injection of acute high fever is used for the treatment of described in present invention also offers:
A. get the raw materials ready by production prescription, supplementary material takes by recipe quantity respectively, for subsequent use;
B. the mannitol of recipe quantity, propylene glycol, lactose are dissolved in the water for injection of 60% 60 ± 5 DEG C, add 0.1% active carbon, filter to obtain A1 liquid;
C. aminophenazone, phenazone, barbital, sodium sulfite, dextran are dissolved in the water for injection of 60 ± 5 DEG C of 60% successively, add 0.1% active carbon, filter to obtain B1 liquid;
D. get the A liquid 1 that step B obtains, be added to the B1 liquid that step C obtains, after mix homogeneously, filtering with microporous membrane;
E: pre-freeze 7 hours at the solution after filtration in step D is placed in-55 DEG C; Then the sublimation drying 30 hours when temperature-15 DEG C; Temperature being risen to 25 DEG C carries out dry again again, and the time is 15 hours; Jump a queue, gland, packaging.
Technique scheme of the present invention has the following advantages compared to existing technology, by the kind of adjuvant and the consumption of supplementary material in screening lyophilized injectable powder, the invention provides the compound recipe ammonia woods barbital frozen powder for injection injection that a kind of adopt simple preparation technology to reach solubility is good, steady quality, intramuscular injection cause pain is light.Product stability prepared by the present invention is good, the stability of projects indexs such as impurity is significantly better than existing product, the myalgia pain significantly caused is almost nil, and preparation technology provided by the invention simply, is easily controlled, production efficiency is high, energy consumption is low.
Detailed description of the invention
In the present invention, if not refer in particular to, all parts, percentage ratio are weight or volume unit, and all equipment and raw material etc. all can be buied from market or the industry is conventional.Method in following embodiment, if no special instructions, is the conventional method of this area.
Embodiment 1: the compound recipe ammonia woods barbital frozen powder for injection injection being used for the treatment of acute high fever
Embodiment 2: the compound recipe ammonia woods barbital frozen powder for injection injection being used for the treatment of acute high fever
Embodiment 3: the compound recipe ammonia woods barbital frozen powder for injection injection being used for the treatment of acute high fever
Embodiment 1-3 all adopts following methods to be prepared:
A. get the raw materials ready by production prescription, supplementary material takes by recipe quantity respectively, for subsequent use;
B. the mannitol of recipe quantity, propylene glycol, lactose are dissolved in the water for injection of 60% 60 ± 5 DEG C, add 0.1% active carbon, filter to obtain A1 liquid;
C. aminophenazone, phenazone, barbital, sodium sulfite, dextran are dissolved in the water for injection of 60 ± 5 DEG C of 60% successively, add 0.1% active carbon, filter to obtain B1 liquid;
D. get the A liquid 1 that step B obtains, be added to the B1 liquid that step C obtains, after mix homogeneously, filtering with microporous membrane;
E: pre-freeze 7 hours at the solution after filtration in step D is placed in-55 DEG C; Then the sublimation drying 30 hours when temperature-15 DEG C; Temperature being risen to 25 DEG C carries out dry again again, and the time is 15 hours; Jump a queue, gland, packaging.
Comparative example 1: be prepared by CN101129328A embodiment 1 method
Comparative example 2: be prepared by CN104324034A embodiment 1 method
Experimental example 1 stability comparative study result
Product prepared by the compound recipe ammonia woods barbital frozen powder for injection injection in the embodiment of the present invention 3 and CN101129328A, CN104324034A embodiment 1 is carried out the investigation of dissolution degree, measure indices, the results are shown in
table 1.
table 1
By
table 1result is known, under the reference indexs such as clarity, dissolution velocity, insoluble particles be how many, is all obviously better than the product of comparative example, illustrates that the quality of the product that the present invention obtains is more stable, controlled in the sample that the present invention obtains.
Experimental example 2 stability comparative study result
Product prepared by the compound recipe ammonia woods barbital frozen powder for injection injection in the embodiment of the present invention 3 and CN101129328A, CN104324034A embodiment 1 is carried out accelerated stability test research, measures indices, the results are shown in
table 2,
table 3.
table 2
| Sample time | Embodiment 3 | Comparative example 1 | Comparative example 2 |
| 0 day | Clarify, without granule | Basic clarification, slightly granule | Clarify, without granule |
| Accelerate January | Clarify, without granule | Basic clarification, slightly granule | Clarify, without granule |
| Accelerate February | Clarify, without granule | Basic clarification, granule increase | Clarify, substantially without granule |
| Accelerate March | Clarify, without granule | Basic clarification, granule increase | Clarify, substantially without granule |
By
table 2result is known, and under accelerated test condition, the aspects such as the sample appearance that the present invention obtains obviously have more advantage than comparative example 1 product, more excellent or suitable compared with comparative example 2, illustrates that the quality of the product that the present invention obtains is more stable, controlled
Experimental example 3 pain degree comparative study result
Injection process is operated by special messenger, pushes away medicine even, and speed is consistent, gets rid of the factor that injector's level height differs, and injects at the medicine of same patient different experiments example, get rid of the factor that different Principle of Pain threshold value is different.Inquire the pain degree of the person of being injected immediately after injection, according to main suit very pain (++), comparatively pain (+), not (-) three kinds of standard recordings bitterly, carry out check analysis, the results are shown in
table 3.
table 3
By
table 3result is visible, the myalgia pain of the lyophilized injectable powder generation of the injection embodiment of the present invention 3 is obviously lighter than the myalgia pain of comparative example 1 or comparative example 2 generation, namely preparation of the present invention is alleviating in this untoward reaction of myalgia caused due to preparation itself, creates ideal effect.
Obviously, above-described embodiment is only for clearly example being described, and the restriction not to embodiment.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here exhaustive without the need to also giving all embodiments.And thus the apparent change of extending out or variation be still among the protection domain of the invention.
Claims (5)
1. be used for the treatment of a compound recipe ammonia woods barbital frozen powder for injection injection for acute high fever, it is characterized in that comprising aminophenazone, phenazone, barbital, mannitol, propylene glycol, sodium sulfite, lactose, dextran,
Wherein each composition consists of:
2. the compound recipe ammonia woods barbital frozen powder for injection injection being used for the treatment of acute high fever according to claim 1, is characterized in that each composition consists of:
3. the compound recipe ammonia woods barbital frozen powder for injection injection being used for the treatment of acute high fever according to claim 1, is characterized in that each composition consists of:
4. the compound recipe ammonia woods barbital frozen powder for injection injection being used for the treatment of acute high fever according to claim 1, is characterized in that each composition consists of:
5. the preparation method being used for the treatment of the compound recipe ammonia woods barbital frozen powder for injection injection of acute high fever that one of claim 1-4 is described, is characterized in that, comprise the following steps
A. get the raw materials ready by production prescription, supplementary material takes by recipe quantity respectively, for subsequent use;
B. the mannitol of recipe quantity, propylene glycol, lactose are dissolved in the water for injection of 60% 60 ± 5 DEG C, add 0.1% active carbon, filter to obtain A1 liquid;
C. aminophenazone, phenazone, barbital, sodium sulfite, dextran are dissolved in the water for injection of 60 ± 5 DEG C of 60% successively, add 0.1% active carbon, filter to obtain B1 liquid;
D. get the A liquid 1 that step B obtains, be added to the B1 liquid that step C obtains, after mix homogeneously, filtering with microporous membrane;
E: pre-freeze 7 hours at the solution after filtration in step D is placed in-55 DEG C; Then the sublimation drying 30 hours when temperature-15 DEG C; Temperature being risen to 25 DEG C carries out dry again again, and the time is 15 hours; Jump a queue, gland, packaging.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510310408.3A CN104940149A (en) | 2015-06-08 | 2015-06-08 | Compound aminopyrine antipyrine barbital injection freeze-dried powder injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510310408.3A CN104940149A (en) | 2015-06-08 | 2015-06-08 | Compound aminopyrine antipyrine barbital injection freeze-dried powder injection and preparation method thereof |
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| CN104940149A true CN104940149A (en) | 2015-09-30 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11406598B2 (en) | 2019-09-20 | 2022-08-09 | Nivagen Pharmaceuticals, Inc. | Lyophilized compositions of phenobarbital sodium salt |
| US11878076B2 (en) | 2019-09-20 | 2024-01-23 | Nivagen Pharmaceuticals, Inc. | Lyophilized compositions of phenobarbital sodium salt |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101129328A (en) * | 2007-09-13 | 2008-02-27 | 天津药业集团新郑股份有限公司 | Compound aminophenazone barbital Injection and method of producing the same |
| CN102716067A (en) * | 2011-11-14 | 2012-10-10 | 河南润弘制药股份有限公司 | Vinpocetine injection and production method thereof |
| CN104324034A (en) * | 2014-11-04 | 2015-02-04 | 重庆泰通动物药业有限公司 | Compound aminopyrine pharmaceutical composition for injection |
-
2015
- 2015-06-08 CN CN201510310408.3A patent/CN104940149A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101129328A (en) * | 2007-09-13 | 2008-02-27 | 天津药业集团新郑股份有限公司 | Compound aminophenazone barbital Injection and method of producing the same |
| CN102716067A (en) * | 2011-11-14 | 2012-10-10 | 河南润弘制药股份有限公司 | Vinpocetine injection and production method thereof |
| CN104324034A (en) * | 2014-11-04 | 2015-02-04 | 重庆泰通动物药业有限公司 | Compound aminopyrine pharmaceutical composition for injection |
Non-Patent Citations (2)
| Title |
|---|
| 罗远鸿: "复方氨基比林注射液的制造经验", 《药学通报》 * |
| 袁松范: "注射剂中应用的辅料", 《国外医药——合成药生化药制剂分册》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11406598B2 (en) | 2019-09-20 | 2022-08-09 | Nivagen Pharmaceuticals, Inc. | Lyophilized compositions of phenobarbital sodium salt |
| US11878076B2 (en) | 2019-09-20 | 2024-01-23 | Nivagen Pharmaceuticals, Inc. | Lyophilized compositions of phenobarbital sodium salt |
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