CN111317713B - Preparation method of ofloxacin injection - Google Patents
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Abstract
The invention provides a preparation method of ofloxacin injection, which comprises the following steps: step S1: placing water for injection into a liquid preparation tank, adding ofloxacin and propylene glycol, stirring, adding concentrated hydrochloric acid, and continuously stirring until a clear yellow-green liquid is formed to form a solution A; step S2: adding mannitol and disodium ethylene diamine tetraacetate into water for injection, and stirring to dissolve to form a solution B; step S3: mixing and stirring the solution A and the solution B, and adjusting the pH to 3.5-5.0 by adopting a pH regulator to form a solution C; step S4: adding water for injection to constant volume, adding carbon for needle for decolorization, filtering, filling, sterilizing and packaging to obtain ofloxacin injection; in the preparation, the proportion of the usage amount of each medicine is as follows: every 1000ml of injection contains 50-100g of ofloxacin, 50-100ml of propylene glycol, 5-10ml of concentrated hydrochloric acid, 5-10ml of mannitol, 0.5-1.0g of disodium edetate, 20-50ml of pH regulator and the balance of water for injection. The invention provides a preparation method of ofloxacin injection with high stability and high product quality.
Description
Technical Field
The invention belongs to the technical field of medicine preparation, and particularly relates to a preparation method of ofloxacin injection.
Background
Ofloxacin has broad-spectrum antibacterial action, especially has high antibacterial activity to aerobic gram-negative bacillus, and has good antibacterial action in vitro to most of the bacteria in Enterobacteriaceae, including Enterobacter such as Citrobacter, Enterobacter cloacae, Enterobacter aerogenes, Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Vibrio, Yersinia, etc. It also has antibacterial activity against multiple drug-resistant bacteria. Has high antibacterial activity to penicillin-resistant Neisseria gonorrhoeae, enzyme-producing Bacillus influenzae and Moraxella. Has antibacterial effect on most strains of Pseudomonas such as Pseudomonas aeruginosa.
The ofloxacin injection has the problem of poor physical stability in the process of placing, namely, crystals can be separated out in the process of storage and placing, so that the clarity of the injection is reduced, the content of the medicine is reduced, and the safety and the effectiveness of the ofloxacin injection are seriously influenced. In addition, the ofloxacin injection is needed to treat bacterial infection of livestock, poultry and poultry, but due to the stability problem of the ofloxacin injection, the effective content in the injection is low, and the ofloxacin injection needs to be injected for many times, so that the livestock and poultry are easy to feel uncomfortable, and the remission of the illness state of the livestock and poultry is not facilitated.
Therefore, the research on the preparation method of the ofloxacin injection with high stability and high product quality has important significance for ensuring the clinical curative effect and the medication safety.
Disclosure of Invention
The invention aims to provide a preparation method of ofloxacin injection with high stability and high product quality.
The technical purpose of the invention is realized by the following technical scheme: a preparation method of ofloxacin injection comprises the following steps:
step S1: placing water for injection into a liquid preparation tank, sequentially adding ofloxacin and propylene glycol under stirring at a certain temperature, stirring for a period of time, adding concentrated hydrochloric acid, and continuously stirring until a clear yellow-green liquid is formed to form a solution A;
step S2: adding mannitol and disodium ethylene diamine tetraacetate into water for injection, and stirring to dissolve to form a solution B;
step S3: mixing and stirring the solution A and the solution B, and adjusting the pH to 3.5-5.0 by adopting a pH regulator to form a solution C;
step S4: adding water for injection to constant volume, adding carbon for needle for decolorization, filtering, filling, sterilizing and packaging to obtain ofloxacin injection;
in the preparation method, the proportion of the usage amount of each medicine is as follows: every 1000ml of injection contains 50-100g of ofloxacin, 50-100ml of propylene glycol, 5-10ml of concentrated hydrochloric acid, 5-10ml of mannitol, 0.5-1.0g of disodium edetate, 20-50ml of pH regulator and the balance of water for injection.
As a further configuration of the invention, step S1 further comprises galactomannan, wherein each 1000ml of injection comprises galactomannan 0.1-0.3g, and after ofloxacin and propylene glycol are added into water for injection, galactomannan is added.
As a further configuration of the invention, in step S2, the injection further comprises licorice antioxidant, wherein each 1000ml of the injection comprises 0.2-0.5g of licorice antioxidant, the licorice antioxidant is added into the water for injection together with mannitol and disodium ethylene diamine tetraacetate, and the solution is stirred to form solution B.
As a further configuration of the invention, the temperature in step S1 is 50-60 ℃.
As a further configuration of the invention, the pH adjusting agent is dilute hydrochloric acid.
As a further configuration of the present invention, the pH in step S3 is 4.0.
As a further configuration of the present invention, the amount of carbon charged in step S4 is 0.5-1 g.
As a further configuration of the present invention, in step S4, the filtration is performed by using a 0.20-0.22 μm microporous membrane.
The invention has the beneficial effects that:
1. the invention can effectively increase the sensitivity of ofloxacin to temperature and effectively improve the solubility of ofloxacin in water for injection by adding propylene glycol and galactomannan, thereby reducing the crystallization of ofloxacin due to the reduction of the solubility and effectively improving the stability of ofloxacin injection.
2. The mannitol is added in the ofloxacin formula, can improve the osmotic pressure of blood plasma, relieves the edema of local tissues when the ofloxacin acts on focuses, is added in the injection for diuresis, expands renal blood vessels, has the protection effect on the kidney, is convenient for removing toxins, can reduce the damage influence of the ofloxacin on the kidney, and improves the medication safety of the product.
3. The disodium ethylenediamine tetraacetate and the licorice antioxidant are added, the disodium ethylenediamine tetraacetate and the licorice antioxidant can improve the stability of the ofloxacin in the injection, the licorice antioxidant can promote the conversion of the dextrofloxacin in the ofloxacin into the levofloxacin, the ratio of the levofloxacin is improved, the antibacterial activity of the ofloxacin injection is improved, the stability of the levofloxacin is higher than that of the dextrofloxacin, the stability of the ofloxacin injection is also improved, and the medication curative effect and the safety of the ofloxacin are effectively ensured.
Detailed Description
The technical solutions in the examples will be clearly and completely described below. It is to be understood that the described embodiments are merely a few embodiments of the invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without any inventive step, are within the scope of the present invention.
Example 1
A preparation method of ofloxacin injection comprises the following steps:
step S1: placing water for injection into a liquid preparation tank, sequentially adding ofloxacin, propylene glycol and galactomannan under stirring at 50 deg.C, stirring for a while, adding concentrated hydrochloric acid, and stirring to obtain clear yellowish green liquid to obtain solution A;
step S2: adding mannitol, disodium ethylene diamine tetraacetate and licorice antioxidant into water for injection, stirring and dissolving to form solution B;
step S3: mixing and stirring the solution A and the solution B, and adjusting the pH to 3.5 by adopting a pH regulator diluted hydrochloric acid to form a solution C;
step S4: adding water for injection to constant volume, adding 0.5g of needle carbon for decolorization, filtering with 0.20 μm microporous membrane, bottling, sterilizing, and packaging to obtain ofloxacin injection;
in the preparation method, the proportion of the usage amount of each medicine is as follows: each 1000ml of injection contains 50g of ofloxacin, 50ml of propylene glycol, 5ml of concentrated hydrochloric acid, 5ml of mannitol, 0.5g of ethylene diamine tetraacetic acid disodium, 20ml of pH regulator and the balance of water for injection.
Example 2
A preparation method of ofloxacin injection comprises the following steps:
step S1: placing water for injection into a liquid preparation tank, sequentially adding ofloxacin, propylene glycol and galactomannan under stirring at 60 deg.C, stirring for a while, adding concentrated hydrochloric acid, and continuously stirring to form clear and yellowish green liquid to form solution A;
step S2: adding mannitol, disodium ethylene diamine tetraacetate and licorice antioxidant into water for injection, stirring and dissolving to form solution B;
step S3: mixing and stirring the solution A and the solution B, and adjusting the pH to 5.0 by adopting a pH regulator diluted hydrochloric acid to form a solution C;
step S4: adding water for injection to constant volume, adding 1g of needle carbon for decolorization, filtering with 0.22 μm microporous membrane, bottling, sterilizing, and packaging to obtain ofloxacin injection;
in the preparation method, the proportion of the usage amount of each medicine is as follows: each 1000ml of injection contains 100g of ofloxacin, 100ml of propylene glycol, 10ml of concentrated hydrochloric acid, 10ml of mannitol, 1.0g of ethylene diamine tetraacetic acid, 50ml of pH regulator and the balance of water for injection.
Example 3
A preparation method of ofloxacin injection comprises the following steps:
step S1: placing water for injection into a liquid preparation tank, sequentially adding ofloxacin, propylene glycol and galactomannan under stirring at 55 deg.C, stirring for a while, adding concentrated hydrochloric acid, and continuously stirring to form clear and yellowish green liquid to form solution A;
step S2: adding mannitol, disodium ethylene diamine tetraacetate and licorice antioxidant into water for injection, stirring and dissolving to form solution B;
step S3: mixing and stirring the solution A and the solution B, and adjusting the pH to 4.0 by adopting a pH regulator diluted hydrochloric acid to form a solution C;
step S4: adding water for injection to constant volume, adding 0.7g of needle carbon for decolorization, filtering with 0.21 μm microporous membrane, bottling, sterilizing, and packaging to obtain ofloxacin injection;
in the preparation method, the proportion of the usage amount of each medicine is as follows: each 1000ml of injection contains 80g of ofloxacin, 80ml of propylene glycol, 8ml of concentrated hydrochloric acid, 8ml of mannitol, 0.8g of ethylene diamine tetraacetic acid, 40ml of pH regulator and the balance of water for injection.
Example 4
A preparation method of ofloxacin injection comprises the following steps:
step S1: placing water for injection into a liquid preparation tank, sequentially adding ofloxacin and propylene glycol under stirring at 55 ℃, stirring for a period of time, adding concentrated hydrochloric acid, and continuously stirring until a clear yellow-green liquid is formed to form a solution A;
step S2: adding mannitol, disodium ethylene diamine tetraacetate and licorice antioxidant into water for injection, stirring and dissolving to form solution B;
step S3: mixing and stirring the solution A and the solution B, and adjusting the pH to 4.0 by adopting a pH regulator diluted hydrochloric acid to form a solution C;
step S4: adding water for injection to constant volume, adding 0.7g of needle carbon for decolorization, filtering with 0.21 μm microporous membrane, bottling, sterilizing, and packaging to obtain ofloxacin injection;
in the preparation method, the proportion of the usage amount of each medicine is as follows: each 1000ml of injection contains 80g of ofloxacin, 80ml of propylene glycol, 8ml of concentrated hydrochloric acid, 8ml of mannitol, 0.8g of ethylene diamine tetraacetic acid, 40ml of pH regulator and the balance of water for injection.
Example 5
A preparation method of ofloxacin injection comprises the following steps:
step S1: placing water for injection into a liquid preparation tank, sequentially adding ofloxacin, propylene glycol and galactomannan under stirring at 55 deg.C, stirring for a while, adding concentrated hydrochloric acid, and continuously stirring to form clear and yellowish green liquid to form solution A;
step S2: adding mannitol and disodium ethylene diamine tetraacetate into water for injection, and stirring to dissolve to form a solution B;
step S3: mixing and stirring the solution A and the solution B, and adjusting the pH to 4.0 by adopting a pH regulator diluted hydrochloric acid to form a solution C;
step S4: adding water for injection to constant volume, adding 0.7g of needle carbon for decolorization, filtering with 0.21 μm microporous membrane, bottling, sterilizing, and packaging to obtain ofloxacin injection;
in the preparation method, the proportion of the usage amount of each medicine is as follows: each 1000ml of injection contains 80g of ofloxacin, 80ml of propylene glycol, 8ml of concentrated hydrochloric acid, 8ml of mannitol, 0.8g of ethylene diamine tetraacetic acid, 40ml of pH regulator and the balance of water for injection.
Example 6
A preparation method of ofloxacin injection comprises the following steps:
step S1: placing water for injection into a liquid preparation tank, sequentially adding ofloxacin and propylene glycol under stirring at 55 ℃, stirring for a period of time, adding concentrated hydrochloric acid, and continuously stirring until a clear yellow-green liquid is formed to form a solution A;
step S2: adding mannitol and disodium ethylene diamine tetraacetate into water for injection, and stirring to dissolve to form a solution B;
step S3: mixing and stirring the solution A and the solution B, and adjusting the pH to 4.0 by adopting a pH regulator diluted hydrochloric acid to form a solution C;
step S4: adding water for injection to constant volume, adding 0.7g of needle carbon for decolorization, filtering with 0.21 μm microporous membrane, bottling, sterilizing, and packaging to obtain ofloxacin injection;
in the preparation method, the proportion of the usage amount of each medicine is as follows: each 1000ml of injection contains 80g of ofloxacin, 80ml of propylene glycol, 8ml of concentrated hydrochloric acid, 8ml of mannitol, 0.8g of ethylene diamine tetraacetic acid, 40ml of pH regulator and the balance of water for injection.
Experimental part
1. And (3) accelerated test: the ofloxacin injections of examples 1 to 6 were each tested according to the method specified under the accelerated test of pharmaceutical preparations in the second part of pharmacopeia 2005 edition (appendix XIX C) guidelines for drug stability tests. Standing at 40 deg.C + -2 deg.C and relative humidity of 75% + -5% for 6 months, sampling once at 0 month, 3 months, and 6 months during the test period, and detecting appearance color, pH, solution color, clarity, and content. Wherein, the appearance color change of the preparation is observed by an appearance color visual method; the pH value is detected according to the standard of pharmacopoeia appendix (VI H); taking appropriate amount of the product for the color of the solution, and measuring absorbance at 450nm wavelength, which should be less than 0.03, according to the appendix of spectrophotometry (IVA); the clarity is checked according to the law of 'clarity inspection rules and judgment standards' in pharmacopoeia of edition; the content is determined according to the content determination method under the quality standard of the product.
2. And (3) long-term test: the ofloxacin injections of examples 1 to 6 were each tested according to the method specified in the long-term test under the conditions of 25 ℃ and 60% relative humidity in the pharmaceutical preparation of the second part of pharmacopoeia 2005 edition (appendix XIX C) guidelines for drug stability tests, and samples were taken every three months to determine the appearance color, pH, color, clarity, and content of the solution.
3. Determination of dextroisomer: the mobile phase is methanol-chiral reagent solution (taking 0.33g of L-phenylalanine and 0.25g of copper sulfate, adding 1000ml of water for dissolving, and shaking up) (13: 87); the detection wavelength is 293nm, the number of theoretical plates is not less than 2500 according to levofloxacin, and the separation degree between the levorotatory isomer and the dextrorotatory isomer meets the specification.
TABLE 1 results of accelerated test of ofloxacin injection of each example
The following are the results in the long-term test:
TABLE 2 Long-term test results of ofloxacin injection of each example
Claims (7)
1. A preparation method of ofloxacin injection is characterized in that: the method comprises the following steps:
step S1: placing water for injection into a liquid preparation tank, sequentially adding ofloxacin, propylene glycol and galactomannan under stirring at a certain temperature, stirring for a period of time, adding concentrated hydrochloric acid, and continuously stirring until a clear and yellowish green liquid is formed to form a solution A;
step S2: adding mannitol and disodium ethylene diamine tetraacetate into water for injection, and stirring to dissolve to form a solution B;
step S3: mixing and stirring the solution A and the solution B, and adjusting the pH to 3.5-5.0 by adopting a pH regulator to form a solution C;
step S4: adding water for injection to constant volume, adding carbon for needle for decolorization, filtering, filling, sterilizing and packaging to obtain ofloxacin injection;
in the preparation method, the proportion of the usage amount of each medicine is as follows: every 1000ml of injection contains 50-100g of ofloxacin, 50-100ml of propylene glycol, 0.1-0.3g of galactomannan, 5-10ml of concentrated hydrochloric acid, 5-10ml of mannitol, 0.5-1.0g of disodium edetate, 20-50ml of pH regulator and the balance of water for injection.
2. The process for preparing an ofloxacin injection according to claim 1, wherein: in the step S2, the injection solution also comprises licorice antioxidant, wherein each 1000ml of the injection solution comprises 0.2-0.5g of the licorice antioxidant, mannitol and disodium ethylene diamine tetraacetate are added into the water for injection, and the solution is stirred to form a solution B.
3. The process for preparing an ofloxacin injection according to claim 1, wherein: the temperature in the step S1 is 50-60 ℃.
4. The process for preparing an ofloxacin injection according to claim 1, wherein: the pH regulator is dilute hydrochloric acid.
5. The process for preparing an ofloxacin injection according to claim 1, wherein: the pH in step S3 was 4.0.
6. The process for preparing an ofloxacin injection according to claim 1, wherein: the amount of the carbon used in step S4 is 0.5-1 g.
7. The process for preparing an ofloxacin injection according to claim 1, wherein: in the step S4, the filtration is carried out by adopting a 0.20-0.22 mu m microporous membrane.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1074604A (en) * | 1993-01-01 | 1993-07-28 | 苏州长征制药厂 | The rota-enzyme restrainer that contains rotatory enzyme inhibitor |
| CN101693008A (en) * | 2009-10-16 | 2010-04-14 | 蚌埠丰原涂山制药有限公司 | Ofloxacin injection and preparation process thereof |
| CN103655467A (en) * | 2013-11-18 | 2014-03-26 | 河南迪冉生物科技有限公司 | Ofloxacin injection and preparation method thereof |
| CN110755374A (en) * | 2019-11-22 | 2020-02-07 | 南京知和医药科技有限公司 | Levofloxacin injection and preparation process thereof |
-
2020
- 2020-04-28 CN CN202010348412.XA patent/CN111317713B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1074604A (en) * | 1993-01-01 | 1993-07-28 | 苏州长征制药厂 | The rota-enzyme restrainer that contains rotatory enzyme inhibitor |
| CN101693008A (en) * | 2009-10-16 | 2010-04-14 | 蚌埠丰原涂山制药有限公司 | Ofloxacin injection and preparation process thereof |
| CN103655467A (en) * | 2013-11-18 | 2014-03-26 | 河南迪冉生物科技有限公司 | Ofloxacin injection and preparation method thereof |
| CN110755374A (en) * | 2019-11-22 | 2020-02-07 | 南京知和医药科技有限公司 | Levofloxacin injection and preparation process thereof |
Non-Patent Citations (1)
| Title |
|---|
| 氧氟沙星注射液制备工艺的改进;徐根连等;《医药导报》;20011130;第21卷(第11期);第696页 * |
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