CN102525905A - Tinidazole and sodium chloride injection and preparation method thereof - Google Patents
Tinidazole and sodium chloride injection and preparation method thereof Download PDFInfo
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- CN102525905A CN102525905A CN2012100302623A CN201210030262A CN102525905A CN 102525905 A CN102525905 A CN 102525905A CN 2012100302623 A CN2012100302623 A CN 2012100302623A CN 201210030262 A CN201210030262 A CN 201210030262A CN 102525905 A CN102525905 A CN 102525905A
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Abstract
The invention relates to a tinidazole and sodium chloride injection and a preparation method thereof. The injection is prepared from the following raw materials in percentage by weight/volume: 0.4 percent of tinidazole, 0.9 percent of sodium chloride, 0.005 to 0.5 percent of stabilizer, 0.01 to 0.05 percent of activated carbon, a proper amount of pH value regulator (the pH value is 3.5 to 5.5), and the balance of water for injection. The preparation method comprises the following steps of: putting the sodium chloride into a thick mixing tank, stirring the sodium chloride and water and dissolving to form a solution at the concentration of between 20 and 22 percent (g/ml), adding 50 percent of the activated carbon, stirring, boiling, cooling, performing pressure filtration, performing internal circulation for 10 minutes, and transferring into a thin mixing pot; putting the tinidazole into a container, adding water, stirring and dissolving, and transferring into the thin mixing pot; putting the stabilizer into the thin mixing pot, adding water, adding the residual activated carbon, adding water until the mixture reaches certain volume, stirring, refluxing for 15 minutes, and regulating the pH value to be 3.5 to 5.5 by using the pH value regulator; sampling, detecting the sodium chloride and the tinidazole, and cooling to 20 to 40 DEG C after the content of the sodium chloride and the tinidazole is qualified; and sequentially performing four-stage filtration and filling, sterilizing at the temperature of 121 DEG C, and warehousing after the product is proved to be qualified through light inspection. The problems that a tinidazole and sodium chloride injection is low in clarity qualification rate and is easy to crystallize in winter are solved.
Description
One, technical field
The present invention relates to a kind of tinidazole sodium chloride injection and preparation method thereof.
Two, background technology
Tinidazole is the later stage in the sixties by the nitro glyoxaline compound of new generation of U.S. Pfizer company exploitation, is the anti-trichomonal medicine of the curative effect height that behind metronidazole, is developed into, short treating period, better tolerance.The tinidazole sodium chloride injection can be used for various anaerobic infections, like septicemia, osteomyelitis, abdominal cavity infection, pelvic infection, the infection of pulmonary branches trachea, pneumonia, sinusitis, skin cellulitis, oral cavity infection and postoperative wound infection; Be used for the preceding prophylactic of art of colorectum operation, obstetrics and gynecology operation and operation on oral cavity etc.In process of production, find that tinidazole sodium chloride injection clarity qualification rate is low, be prone to crystallization winter in the storage process, directly influenced product yield and selling market.
Three, summary of the invention
The objective of the invention is to disclose a kind of tinidazole sodium chloride injection and preparation method thereof, solve that present tinidazole sodium chloride injection clarity qualification rate is low, be prone to crystalline problem winter.Technical scheme easy operating provided by the invention, stability is strong, and effect is obvious.
The present invention seeks to realize through following technical scheme:
A kind of tinidazole sodium chloride injection, raw material form by weight/and percent by volume is:
Tinidazole 0.4%;
Sodium chloride 0.9%;
Stabilizing agent 0.005%～0.5%;
Activated carbon 0.01%～0.05%;
The pH regulator agent is an amount of, and making the pH value range of accommodation is 3.5～5.5;
Surplus is a water for injection.
The implication of said " raw material is formed by weight/percent by volume " is: the ratio of the weight numerical value of tinidazole, sodium chloride, stabilizing agent and active carbon and water for injection volume numerical value.
Concrete, stabilizing agent is: a kind of in disodium edetate, calcium disodium edetate, the trisodium citrate.
Preferably, stabilizing agent is a calcium disodium edetate.
Concrete, the pH regulator agent is: a kind of in citric acid, acetic acid, citric acid-sodium citrate buffer, the acetic acid-sodium-acetate buffer.
Preferably, the pH regulator agent is: citric acid.
Concrete, the pH regulator scope is 3.8～4.2.
A kind of tinidazole chloride injection liquid and preparation method thereof is following:
Take by weighing each raw material for standby by prescription;
The sodium chloride of getting formula ratio places the dense preparing tank that is placed with an amount of water for injection, and stirring and dissolving makes sodium chloride become the concentrated solution of 20%～22% (g/ml); For the first time add 50% of needle-use activated carbon total amount, stirring and evenly mixing boiled 15 minutes; Be cooled to 70～90 ℃; With the pressure filtration of titanium rod filter, and internal recycle changed rare joining in the pot over to after 10 minutes;
The tinidazole of getting formula ratio adds the water for injection of 5-10 times of volume numerical value of tinidazole weight numerical value in clean container, stir 10～15 minutes fully after the dissolving, is transferred to rare joining in the pot;
Stabilizing agent is placed rare pot of joining, rare join add to the full amount of water for injection in the pot 80%, add for the second time the needle-use activated carbon of surplus, and mend and add to the full amount of water for injection, after stirring, refluxing 15 minutes, using the pH regulator agent to regulate pH value is 3.5～5.5;
From taking a sample rare joining the pot; Survey sodium chloride content and be 95.0%～105.0% (by weight/percent by volume calculate) of labelled amount; Tinidazole content is 95.0%～105.0% (by weight/percent by volume calculate) of labelled amount, up to specification after, be cooled to 20～40 ℃;
Filter through titanium rod filter, 0.45 μ m membrane cartridge, 0.22 μ m membrane cartridge, 0.01 μ m ultrafilter membrane filter element level Four successively at last; Fill is to 100ml infusion bottle or transfusion bag then; Sterilized 8～10 minutes in 121 ℃ of water-baths according to sterilizing program; Sample after the sterilization after lamp inspection is qualified, labeling, packing, warehouse-in.
Concrete, using the pH regulator agent to regulate pH value is 3.8～4.2.
Tinidazole added in rare joining in the process, rather than added in dense joining in the process, had reduced the adsorption of activated carbon, made the stable content of tinidazole.Simple acid-alkali accommodation is used in the pH regulator agent, and pH value often is difficult to balance, and the buffer that the pH regulator agent selects for use organic acid or organic acid salt to be made into makes pH value comparatively stable; Citric acid has chelation to metal ion simultaneously, so pH value is more stable.The stabilizing agent that the present invention selects for use all is complexing of metal ion agent, makes solution more stable.
Fill is filtered in rare dosing at a lower temperature, and filtering is diffluent impurity under higher temperature, and issuable nucleus under the low temperature has been played preventive effect.
The present invention prescription and preparation method thereof has solved the low problem of tinidazole sodium chloride injection clarity qualification rate, and has well solved these article easy crystalline polamer in cryopreservation or winter transportation, and its related substance has also obtained better controlled.The stability of this prescription and technology obviously is superior to commercially available prescription, and related substance and clarity have obtained effective control, has solved these article crystallisation problems in production and storage.
Stability obviously is superior to commercially available prescription under product pH value of the present invention and the low temperature situation, has solved these article and has produced and preserving instability problem in the transportation.Test shows, the prescription of tinidazole sodium chloride injection of the present invention and technology can effectively improve medicine stability and clinical drug safety property, effectiveness.
Four, the specific embodiment
Embodiment 1:
Take by weighing each raw material for standby by prescription.The sodium chloride of formula ratio is inserted in the dense preparing tank that is placed with an amount of water for injection, and stirring and dissolving becomes by weight/20% concentrated solution of volume metering sodium chloride.For the first time add needle-use activated carbon 0.1g, stirring and evenly mixing boiled 15 minutes, put and was chilled to 80 ℃.With the pressure filtration of titanium rod filter, internal recycle 10 minutes changes rare joining in the pot over to.
The tinidazole of formula ratio is inserted in the clean container, adds the water for injection of 40ml, stir it was fully dissolved in 15 minutes after, change rare joining in the pot over to.Then calcium disodium edetate 0.1g is inserted rare joining in the pot, rare join add to the full amount of water for injection in the pot 80%.For the second time add needle-use activated carbon 0.1g, benefit adds to the full amount of water for injection, and stirs, refluxes 15 minutes.Using 10% citric acid 0.2ml to regulate pH value is 4.10.From taking a sample rare joining the pot, survey sodium chloride content and be 95.0%～105.0% (by weight/percent by volume calculate) of labelled amount, tinidazole content is 100.5% (by weight/percent by volume calculate) of labelled amount.After up to specification; Be cooled to 30 ℃; Filter through titanium rod filter, 0.45 μ m membrane cartridge, 0.22 μ m membrane cartridge, 0.01 μ m ultrafilter membrane filter element level Four, filter fill to the 100ml infusion bottle, sterilized 10 minutes in 121 ℃ of water-baths according to sterilizing program; Sample after the sterilization after lamp inspection is qualified, labeling, packing, warehouse-in.
Product of the present invention and commercially available article according to embodiment 1 preparation carry out long-term and accelerated test according to two XIXC methods of Chinese Pharmacopoeia version in 2010, and the result is following:
Table 1 long term test is investigated the result
Table 2 accelerated test is investigated the result
Temperature adaptability test is carried out in product of the present invention and commercially available prod according to the embodiment of the invention 1 preparation, and its result is following:
Table 3 temperature adaptability test result
Embodiment 2
Take by weighing each raw material for standby by prescription.The sodium chloride of formula ratio is inserted in the dense preparing tank that is placed with an amount of water for injection, and stirring and dissolving becomes by weight/20% concentrated solution of volume metering sodium chloride.For the first time add needle-use activated carbon 0.1g, stirring and evenly mixing boiled 15 minutes, put and was chilled to 80 ℃.With the pressure filtration of titanium rod filter, internal recycle 10 minutes pumps into rare pot of joining.
The tinidazole of formula ratio is poured in the clean container, is added the water for injection of 40ml, stir made abundant dissolving in 15 minutes after, join rare joining in the pot.Then trisodium citrate 0.2g is dropped into rare joining in the pot, rare join add to the full amount of water for injection in the pot 80%.For the second time add needle-use activated carbon 0.1g, benefit adds to the full amount of water for injection, and stirs, refluxes 15 minutes.Using commercially available medicinal acetic acid 0.1ml to regulate pH value is 3.9.From taking a sample rare joining the pot, survey sodium chloride content and be 95.0%～105.0% (by weight/percent by volume calculate) of labelled amount, tinidazole content is 99.8% (by weight/percent by volume calculate) of labelled amount.After up to specification, be cooled to 20 ℃.Filter through titanium rod filter, 0.45 μ m membrane cartridge, 0.22 μ m membrane cartridge, 0.01 μ m ultrafilter membrane filter element level Four, filter fill to the 100ml infusion bottle.According to sterilizing program in 121 ℃ of water-baths sterilization 8 minutes, the sample after the sterilization after lamp inspection is qualified, labeling, packing, warehouse-in.
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 (8)
1. a tinidazole sodium chloride injection is characterized in that, and raw material forms by weight/and percent by volume is:
Tinidazole 0.4%;
Sodium chloride 0.9%;
Stabilizing agent 0.005%～0.5%;
Activated carbon 0.01%～0.05%;
The pH regulator agent is an amount of, and making the pH value range of accommodation is 3.5～5.5;
Surplus is a water for injection.
2. according to the said a kind of tinidazole sodium chloride injection of claim 1, it is characterized in that stabilizing agent is: a kind of in disodium edetate, calcium disodium edetate, the trisodium citrate.
3. according to claim 1 or 2 said a kind of tinidazole sodium chloride injections, it is characterized in that stabilizing agent is a calcium disodium edetate.
4. according to the said a kind of tinidazole sodium chloride injection of claim 1, it is characterized in that the pH regulator agent is: a kind of in citric acid, acetic acid, citric acid-sodium citrate buffer, the acetic acid-sodium-acetate buffer.
5. according to claim 1 or 4 said a kind of tinidazole sodium chloride injections, it is characterized in that the pH regulator agent is: citric acid.
6. according to the said a kind of tinidazole sodium chloride injection of claim 1, it is characterized in that the pH regulator scope is 3.8～4.2.
7. tinidazole chloride injection liquid and preparation method thereof is characterized in that:
1), takes by weighing each raw material for standby by prescription;
2), the sodium chloride of getting formula ratio places the dense preparing tank that is placed with an amount of water for injection, stirring and dissolving makes sodium chloride become the concentrated solution of 20%～22% (g/ml); For the first time add 50% of needle-use activated carbon total amount, stirring and evenly mixing boiled 15 minutes; Be cooled to 70～90 ℃; With the pressure filtration of titanium rod filter, and internal recycle changed rare joining in the pot over to after 10 minutes;
3), get formula ratio tinidazole in clean container, add the water for injection of 5-10 times of volume numerical value of tinidazole weight numerical value, stir 10～15 minutes fully after the dissolving, be transferred to rare joining in the pot;
4), stabilizing agent is placed rare pot of joining, rare join add to the full amount of water for injection in the pot 80%, add the needle-use activated carbon of surplus for the second time, and mend and add to the full amount of water for injection, after stirring, refluxing 15 minutes, using the pH regulator agent to regulate pH value is 3.5～5.5;
5), from taking a sample rare joining the pot; Survey sodium chloride content, for labelled amount by weight/percent by volume calculate 95.0%～105.0%, tinidazole content be labelled amount by weight/percent by volume calculate 95.0%～105.0%; After up to specification, be cooled to 20～40 ℃;
6) filter through titanium rod filter, 0.45 μ m membrane cartridge, 0.22 μ m membrane cartridge, 0.01 μ m ultrafilter membrane filter element level Four successively at last; Fill is to 100ml infusion bottle or transfusion bag then; Sterilized 8～10 minutes in 121 ℃ of water-baths according to sterilizing program; Sample after the sterilization after lamp inspection is qualified, labeling, packing, warehouse-in.
8. according to the said a kind of tinidazole chloride injection liquid and preparation method thereof of claim 7, it is characterized in that using the pH regulator agent to regulate pH value is 3.8～4.2.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103110574A (en) * | 2013-03-05 | 2013-05-22 | 扬州中宝制药有限公司 | Tinidazole injection preparation and preparation method thereof |
| CN106377561A (en) * | 2015-10-17 | 2017-02-08 | 李秉清 | External liquid medicine |
| CN107137347A (en) * | 2017-06-02 | 2017-09-08 | 兰西哈三联制药有限公司 | A kind of preparation method of Tinidazole sodium chloride injection |
| CN108066338A (en) * | 2017-12-26 | 2018-05-25 | 金华智济药物科技合伙企业（有限合伙） | New antibiotic composition when prevention and treatment aerobic bacteria and anaerobic bacteria mixed infection and preparation method thereof |
| CN110227063A (en) * | 2019-06-18 | 2019-09-13 | 石药银湖制药有限公司 | A kind of preparation method of Linezolid Injection |
| CN110314133A (en) * | 2019-06-28 | 2019-10-11 | 石家庄四药有限公司 | A kind of metronidazole injection and preparation method thereof |
| CN115737546A (en) * | 2022-11-19 | 2023-03-07 | 华夏生生药业(北京)有限公司 | Tinidazole and sodium chloride injection and production process thereof |
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| CN101991589A (en) * | 2009-08-11 | 2011-03-30 | 四川科伦药物研究有限公司 | Glycerol fructose injection and preparation method thereof |
| CN102274170A (en) * | 2011-07-27 | 2011-12-14 | 安徽环球药业股份有限公司 | Method for preparing tinidazole and sodium chloride injection |
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| CN1973837A (en) * | 2006-12-11 | 2007-06-06 | 常州康恒医药科技有限公司 | Concentrated Tinidazole solution injection and its prepn process |
| CN101991589A (en) * | 2009-08-11 | 2011-03-30 | 四川科伦药物研究有限公司 | Glycerol fructose injection and preparation method thereof |
| CN102274170A (en) * | 2011-07-27 | 2011-12-14 | 安徽环球药业股份有限公司 | Method for preparing tinidazole and sodium chloride injection |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103110574A (en) * | 2013-03-05 | 2013-05-22 | 扬州中宝制药有限公司 | Tinidazole injection preparation and preparation method thereof |
| CN106377561A (en) * | 2015-10-17 | 2017-02-08 | 李秉清 | External liquid medicine |
| CN107137347A (en) * | 2017-06-02 | 2017-09-08 | 兰西哈三联制药有限公司 | A kind of preparation method of Tinidazole sodium chloride injection |
| CN108066338A (en) * | 2017-12-26 | 2018-05-25 | 金华智济药物科技合伙企业（有限合伙） | New antibiotic composition when prevention and treatment aerobic bacteria and anaerobic bacteria mixed infection and preparation method thereof |
| CN108066338B (en) * | 2017-12-26 | 2020-04-24 | 磐安县道地磐药中药研究所 | Antibiotic composition and preparation method thereof |
| CN110227063A (en) * | 2019-06-18 | 2019-09-13 | 石药银湖制药有限公司 | A kind of preparation method of Linezolid Injection |
| CN110227063B (en) * | 2019-06-18 | 2021-06-15 | 石药银湖制药有限公司 | Preparation method of linezolid injection |
| CN110314133A (en) * | 2019-06-28 | 2019-10-11 | 石家庄四药有限公司 | A kind of metronidazole injection and preparation method thereof |
| CN115737546A (en) * | 2022-11-19 | 2023-03-07 | 华夏生生药业(北京)有限公司 | Tinidazole and sodium chloride injection and production process thereof |
| CN115737546B (en) * | 2022-11-19 | 2023-08-22 | 华夏生生药业(北京)有限公司 | Tinidazole sodium chloride injection and production process thereof |
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Application publication date: 20120704 |