CN1390550A - Freeze-dried minocycline hydrochloride powder injection and its preparing process - Google Patents
Freeze-dried minocycline hydrochloride powder injection and its preparing process Download PDFInfo
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- CN1390550A CN1390550A CN 02132673 CN02132673A CN1390550A CN 1390550 A CN1390550 A CN 1390550A CN 02132673 CN02132673 CN 02132673 CN 02132673 A CN02132673 A CN 02132673A CN 1390550 A CN1390550 A CN 1390550A
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- minocycline hydrochloride
- freeze
- dried
- powder injection
- injection
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Abstract
A freeze dried minocycline hydrochloride powder as antibacterial injection is prepared from minocycline hydrochloride (0.05-10 wt.portions), freeze dried power supporting agent (10-100) and pH regulator. Its advantages are broad antibacterial sprectrum, high stability to light, heat, oxygen and water, and no pollution.
Description
Technical field:
The invention belongs to broad spectrum antibiotic, the preparation method of particularly a kind of freeze-dried minocycline hydrochloride powder injection and this injection.
Background technology:
Other microbial diseases such as inflammation that gram positive bacteria and gram negative bacteria cause and multiple drug resistance staphylococcus, chlamydia, pseudomonas fluorescens, Flavobacterium, health is caused very big harm, and the patient with severe symptoms often is difficult to treatment with other class antimicrobial drug, minocycline hydrochloride is powerful broad-spectrum antibiotic, and multiple fastbacteria is had good antibacterial ability.This product preparation is a tablet at present, and compared following shortcoming with injectable powder: 1, onset is slow in the tablet use; 2, has extremely strong gastrointestinal reaction; 3, require great quantity of water drinking; 4, range of application is narrow, and tablet is difficult to swallow to having swallowed the obstacle patient, is difficult for treatment in time.
Summary of the invention;
The object of the present invention is to provide a kind ofly to stable performances such as light, heat, oxygen, water, pollution-free, and be convenient to operation, transportation and storage, applied range, be fit to the freeze-dried minocycline hydrochloride powder injection of large-scale production.
Another object of the present invention is to provide the preparation method of this injection.
The object of the present invention is achieved like this: the present invention forms and comprises minocycline hydrochloride, lyophilized powder proppant and pH regulator agent, and parts by weight are: minocycline hydrochloride 0.05-10 part; Lyophilized powder proppant 0-100 part; The pH regulator agent is an amount of.
The present invention is a lyophilized injectable powder, pH value between 0-7.5, between the optimum pH 2-3.5, its purposes widen into: to how sharp drug resistance staphylococcus, chlamydia, the infection that acinetobacter calcoaceticus etc. cause has fine therapeutical effect, but the feeder vessels external administration.Wherein the lyophilized powder proppant is the water solublity proppant, and is soluble in water, and dissolving rapidly is selected from mannitol, glucose, NaCl, dextran, gelatin hydrolysate in clinical use.Osmotic pressure regulator refers to mineral acids such as hydrochloric acid, sulphuric acid, phosphoric acid, organic acid such as acetic acid, lactic acid.
The preparation method of freeze-dried minocycline hydrochloride powder injection provided by the invention is: get recipe quantity minocycline hydrochloride and lyophilized powder proppant and add water for injection, stirring makes dissolving, transfer pH to proper range with the pH regulator agent, the pin activated carbon that adds 0.1%～1% (W/V), filter de-carbon, degerming, after-teeming is penetrated water to capacity, crosses the 0.2um microporous filter membrane, after measuring content, fill; At first pre-freeze is incubated 1～5 hour to-50 ℃～-35 ℃, and evacuation in 15～30 hours, rises to temperature-10～-3 ℃, at 2～10 hours temperature is risen 15～50 ℃ again, continues to keep 3～10 hours, and gland promptly.
The present invention is with the injectable sterile powder of lyophilization principle preparation compared with prior art, is lyophilized injectable powder, and pH value has the following advantages between 0～7: be convenient to operation, be fit to large-scale production; The north and extremely frigid zones transportation in winter and storage problem have been solved; Solved esophagus by obstacle person medication.Shortened drug effect onset time.Reduced amount of drinking water.Reduced volume and weight, reduced the cost of transportation of process of operation greatly with dose product.Applied range, but feeder vessels external administration.
The specific embodiment: be described in further detail the present invention below by embodiment
Embodiment 1:
(1) preparation prescription:
Minocycline hydrochloride 108g
Mannitol 210g
0.1mol/l hydrochloric acid is an amount of
Water for injection adds to 3000ml
Make 1000
(2) preparation technology: get recipe quantity minocycline hydrochloride and mannitol and add water for injection 2500ml, stirring and dissolving, transfer pH2.0～3.5 with 0.1ml/l hydrochloric acid, add solution amount 0.1% pin activated carbon, stirring at room 15min filters after-teeming and penetrates water to 3000ml, cross the 0.2um microporous filter membrane, after measuring content, fill in the 7ml glass tube vial, every 3ml.After fill is good, insert in the freezer dryer, reduce earlier temperature, be incubated 2 hours to-45 ℃, evacuation then, and, after temperature reaches-5 ℃, be warming up to 25 ℃ by 5 ℃/hour by about 2 ℃ of/hour intensifications, and be incubated 2 hours, add plug, Zha Gai, quality inspection is cased.
Embodiment 2:
(1) preparation prescription:
Minocycline hydrochloride 108g
The intoxicated 210g of dextrose
Acetic acid is an amount of
Water for injection adds to 3000ml
Make 1000
(2) preparation technology: with embodiment 1.
Embodiment 3:
Minocycline hydrochloride 108g
Gelatin hydrolysate 210g
Phosphoric acid is an amount of
Water for injection adds to 3000ml
Prepare 1000
Preparation technology: with embodiment 1.
Claims (7)
1, a kind of freeze-dried minocycline hydrochloride powder injection is characterized in that: this lyophilized injectable powder is formed and is comprised minocycline hydrochloride, lyophilized powder proppant and pH regulator agent, and parts by weight are: minocycline hydrochloride 0.05-10 part; Lyophilized powder proppant 0-100 part; The pH regulator agent is an amount of.
2, freeze-dried minocycline hydrochloride powder injection according to claim 1 is characterized in that this injection belongs to the broad-spectrum antimicrobial drug, but the feeder vessels medicine for external use.
3, according to the preparation method of the described freeze-dried minocycline hydrochloride powder injection of claim 1, it is characterized in that: get recipe quantity minocycline hydrochloride and lyophilized powder proppant and add water for injection 2000ml, stirring makes dissolving, transfer pH to proper range with the pH regulator agent, add the pin activated carbon of 0.1%～1% (W/V), filter de-carbon, degerming, after-teeming is penetrated water to capacity, cross the 0.2um microporous filter membrane, behind the mensuration content, fill; At first pre-freeze is incubated 1～5 hour to-50 ℃～-35 ℃, and evacuation in 15～30 hours, rises to temperature-10～-3 ℃, at 2～10 hours temperature is risen 15～50 ℃ again, continues to keep 3～10 hours, and gland promptly.
4,, it is characterized in that its pH value is between 0.1～7.5 according to claim 1 or 3 described freeze-dried minocycline hydrochloride powder injection and preparation methoies.
5, according to claim 1 or 3 described freeze-dried minocycline hydrochloride powder injection and preparation methoies, it is characterized in that: described lyophilized powder proppant is the water solublity proppant, is selected from mannitol, glucose, NaCl, dextran, lactose, gelatin hydrolysate.
6, freeze-dried minocycline hydrochloride powder injection according to claim 1 and preparation method is characterized in that: described PH regulator is meant mineral acids such as hydrochloric acid, sulphuric acid, phosphoric acid, organic acid such as acetic acid, lactic acid.
7, freeze-dried minocycline hydrochloride powder injection according to claim 4 and preparation method is characterized in that: its optimum pH is between 2.0-3.5.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02132673 CN1390550A (en) | 2002-07-25 | 2002-07-25 | Freeze-dried minocycline hydrochloride powder injection and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02132673 CN1390550A (en) | 2002-07-25 | 2002-07-25 | Freeze-dried minocycline hydrochloride powder injection and its preparing process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1390550A true CN1390550A (en) | 2003-01-15 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 02132673 Pending CN1390550A (en) | 2002-07-25 | 2002-07-25 | Freeze-dried minocycline hydrochloride powder injection and its preparing process |
Country Status (1)
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1858488A1 (en) | 2005-03-14 | 2007-11-28 | Wyeth a Corporation of the State of Delaware | Tigecycline compositions and methods of preparation |
| JP2013529201A (en) * | 2010-05-12 | 2013-07-18 | レンペックス・ファーマシューティカルズ・インコーポレイテッド | Tetracycline composition |
| US20160279151A1 (en) * | 2008-03-28 | 2016-09-29 | Paratek Pharmaceuticals, Inc. | Oral and injectable formulations of tetracycline compounds |
-
2002
- 2002-07-25 CN CN 02132673 patent/CN1390550A/en active Pending
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9694078B2 (en) | 2005-03-14 | 2017-07-04 | Wyeth Llc | Tigecycline compositions and methods of preparation |
| JP2008533146A (en) * | 2005-03-14 | 2008-08-21 | ワイス | Tigecycline composition and method of preparation |
| US7879828B2 (en) | 2005-03-14 | 2011-02-01 | Wyeth Llc | Tigecycline compositions and methods of preparation |
| CN102512429A (en) * | 2005-03-14 | 2012-06-27 | 惠氏公司 | Tigecycline compositions and methods of preparation |
| EP1858488A1 (en) | 2005-03-14 | 2007-11-28 | Wyeth a Corporation of the State of Delaware | Tigecycline compositions and methods of preparation |
| KR101354093B1 (en) * | 2005-03-14 | 2014-01-24 | 와이어쓰 엘엘씨 | Tigecycline compositions and methods of preparation |
| US8975242B2 (en) | 2005-03-14 | 2015-03-10 | Wyeth Llc | Tigecycline compositions and methods of preparation |
| US10588975B2 (en) | 2005-03-14 | 2020-03-17 | Wyeth Llc | Tigecycline compositions and methods of preparation |
| US9254328B2 (en) | 2005-03-14 | 2016-02-09 | Wyeth Llc | Tigecycline compositions and methods of preparation |
| EP3348258A1 (en) * | 2008-03-28 | 2018-07-18 | Paratek Pharmaceuticals, Inc. | Oral and injectable formulations of tetracycline compounds |
| US20160279151A1 (en) * | 2008-03-28 | 2016-09-29 | Paratek Pharmaceuticals, Inc. | Oral and injectable formulations of tetracycline compounds |
| JP2013529201A (en) * | 2010-05-12 | 2013-07-18 | レンペックス・ファーマシューティカルズ・インコーポレイテッド | Tetracycline composition |
| US9744179B2 (en) | 2010-05-12 | 2017-08-29 | Rempex Pharmaceuticals, Inc. | Tetracycline compositions |
| US9278105B2 (en) | 2010-05-12 | 2016-03-08 | Rempex Pharmaceuticals, Inc. | Tetracycline compositions |
| US9084802B2 (en) | 2010-05-12 | 2015-07-21 | Rempex Pharmaceuticals, Inc. | Tetracycline compositions |
| US11944634B2 (en) | 2010-05-12 | 2024-04-02 | Melinta Subsidiary Corp. | Tetracycline compositions |
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