CN103156808A - Gastrodin injection liquid and preparation method thereof - Google Patents
Gastrodin injection liquid and preparation method thereof Download PDFInfo
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- CN103156808A CN103156808A CN2011104238161A CN201110423816A CN103156808A CN 103156808 A CN103156808 A CN 103156808A CN 2011104238161 A CN2011104238161 A CN 2011104238161A CN 201110423816 A CN201110423816 A CN 201110423816A CN 103156808 A CN103156808 A CN 103156808A
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Abstract
The invention discloses gastrodin injection liquid and a preparation method thereof, in particular to gastrodin injection liquid containing gastrodin, water for injection, a metal ion complexing agent, and an injection liquid stabilizing agent and the preparation method thereof. The metal ion complexing agent is added to the injection liquid to avoid oxidization of the gastrodin. The stabilizing agent which is sodium chloride is added to the injection liquid to avoid precipitation of the gastrodin in the injection liquid, guarantee stability of the gastrodin injection liquid, prevent occurrence of white points and white blocks in the injection liquid, guarantee quality of products and safety and effects of medicine use for patients.
Description
Technical field
The present invention relates to a kind of gastrodine injection and preparation method thereof, belong to technical field of medicine.
Background technology
Gastrodine is the dried root extract of orchid Rhizoma Gastrodiae.Gastrodine has calmness preferably and soporific function, and neurasthenia, insomnia, headache symptom are had mitigation.Gastrodia elata can be treated dizzy, the numb limbs and tense tendons of pain, frightened pain is twitched.Clinical practice: treatment vertebra one basilar artery insufficiency; The treatment vestibular neuronitis; The treatment vertigo.
When gastrodine uses as injection clinically, existing route of administration is intramuscular injection or intravenous drip, and visible foreign matters is the emphasis that liquid drugs injection checks, if visible foreign matters is defective, be expelled in patient body, can bring pain to the patient, what have even can form granulation and various untoward reaction occur, has increased the risk of clinical use.Appearance how to avoid the endogenous visible foreign matters when therefore, preparing gastrodine injection is crucial.
Chinese patent application 200510067866.5(applicant Barrymore Medicine (Tonghua) company limited, publication number: CN1751691A, open day: on March 29th, 2006) disclose the vein small-volume injection, comprising gastrodine, water for injection, complexing of metal ion agent etc., its preparation method is also disclosed simultaneously; Chinese patent application 200910167315.4(publication number: CN1016232, open day: on January 13rd, 2010) disclose a kind of gastrodine injection and preparation method thereof, this gastrodine injection was comprised of active component gastrodine, adjuvant and water for injection.Adjuvant is only buffer salt, plays pH value and regulates and Stabilization.
Because the gastrodine aqueous solution is unstable, the gastrodine injection of producing tends to separate out a large amount of white points, white piece, and also can constantly increase in put procedure after sterilization in storage process, can not guarantee patient's drug safety, effectively.
Summary of the invention
A kind of gastrodine injection of the present invention and preparation method thereof, by add a kind of stabilizing agent in solution, the phenomenon that the rear white point of injection sterilization, white piece are separated out disappears, and no longer produces in storage process, guarantee product quality, improved the stability of gastrodine injection.
The object of the invention is to provide a kind of gastrodine injection and preparation method thereof; particularly contain the complexing of metal ion agent; can effectively protect the complexing of metal ion in gastrodine and solution; also contain solution stabilizer sodium chloride; play the dielectric constant effect of stabilizing solution; prevent that medicine from separating out, stoped the generation of white point, white piece in solution, adopt simultaneously the phosphate buffer of pH7.8 to regulate pH.The present invention writes out a prescription simply, the injection good stability, and clarity is high, clinical use safety, untoward reaction is little, is fit to suitability for industrialized production.
The present invention is easily oxidized under the condition that metal ion exists in order to prevent gastrodine; add the complexing of metal ion agent to play the effect of protection effective ingredient gastrodine; add solution stabilizer sodium chloride; make gastrodine more stable in solution; prevent that gastrodine from separating out, reduced the visible foreign matters percent defective of solution, be convenient to clinical use; reduce clinical risk, increased the stability of gastrodine injection in storage process.
Gastrodine injection of the present invention, prescription comprises gastrodine, complexing of metal ion agent, stabilizing agent, water for injection.
Wherein, described complexing of metal ion agent is: disodiumedetate, and content is preferably 0.01%-0.03%;
The stabilizing agent of described injection is sodium chloride, and content is preferably 0.8%～0.9%.
The proportioning of gastrodine and water for injection is 0.1:1.
The preparation method of a kind of gastrodine injection of the present invention, comprise the steps: fresh water for injection is cooled to 35～40 ℃, then add the complexing of metal ion agent, the gastrodine raw material added wherein stirring and dissolving is complete, add again the injection stabilizing agent, at last regulate pH qualified after, filtration, embedding, sterilization, obtain gastrodine injection.
The preparation method of gastrodine injection of the present invention specifically comprises the steps:
Get the fresh water for injection of amount of preparation 70%, be cooled to 35～40 ℃, complexing of metal ion agent with 0.01%～0.1% is dissolved in cooling good fresh water for injection, then, add the gastrodine raw material in solution, after dissolve complete, add 0.8%～0.9% sodium chloride in solution, until completely dissolved, then reconcile pH5.0～7.0 with phosphate buffer, add 0.1% active carbon, stirred standing adsorption 15 minutes, the completion water yield, inflated with nitrogen, embedding was sterilized 15 minutes, and was namely got gastrodine injection for 121 ℃.
The pH of gastrodine injection of the present invention is pH5.0～7.0, is preferably pH6.2～6.4, and pH adjusting agent is the phosphate buffer of pH7.8.
Described sterilization can be adopted normal sterilizing installation and the technique that adopts of those skilled in the art.Use the water-bath sterilization, sterilization is 15 minutes under 121 ℃.
The preparation method of gastrodine injection of the present invention comprises the steps:
A) first fresh water for injection is cooled to 35～40 ℃, then in cooling good water for injection, adds 0.01%～0.03% complexing of metal ion agent, after waiting it to dissolve fully, add the gastrodine raw material of 0.1:1 in the solution.
B) add the sodium chloride of 0.8%-0.9% in the mentioned solution, regulate pH6.2～6.4 with the phosphate buffer of pH7.8, then add 0.1% medicinal charcoal, stirred standing adsorption 15 minutes, filtering decarbonization.
Again through the micropore filter element aseptic filtration of 0.22um, after filtration, inflated with nitrogen, fill through 121 ℃ of water-bath sterilizations 15 minutes, namely gets gastrodine injection.
Gastrodine injection stable in properties of the present invention can not separated out white point, white piece, can guarantee patient's drug safety, effective.
The specific embodiment
Only the present invention is described further for following examples, should not be understood as further restriction of the present invention.
Embodiment 1
Prescription: gastrodine 100g
EDTA-2Na 0.1g
NaCL 8g
Water for injection adds to 1000ml
Make 500
First prepare the phosphate buffer of pH7.8, standby.getting 70% fresh water for injection adds in dense preparing tank, be cooled to 35～40 ℃, the EDTA-2Na of recipe quantity is added wherein, stirring makes its dissolving, then the gastrodine that adds recipe quantity, stirring is dissolved it fully, add again the sodium chloride of recipe quantity in the solution, after mixing, phosphate buffer with pH7.8 is regulated pH value to 6.2, claim the medicinal charcoal of its amount of preparation 0.1% to add dense preparing tank, benefit adds to the full amount of water for injection, after stirring, standing adsorption is 15 minutes, filter decarburization to dilute preparing tank, again through the micropore filter element filtration sterilization of 0.22um, then embedding, through 121 ℃ of water-bath sterilizations 15 minutes, lamp inspection, packing, namely get gastrodine injection.
Embodiment 2
Prescription: gastrodine 100g
EDTA-2Na 0.2g
NaCL 8g
Water for injection adds to 1000ml
——————————————————
Make 500
First prepare the phosphate buffer of pH7.8, standby.getting 70% fresh water for injection adds in dense preparing tank, be cooled to 35～40 ℃, the EDTA-2Na of recipe quantity is added wherein, stirring makes its dissolving, then the gastrodine that adds recipe quantity, stirring is dissolved it fully, add again the sodium chloride of recipe quantity in the solution, after mixing, phosphate buffer with pH7.8 is regulated pH value to 6.3, claim the medicinal charcoal of its amount of preparation 0.1% to add dense preparing tank, benefit adds to the full amount of water for injection, after stirring, standing adsorption is 15 minutes, filter decarburization to dilute preparing tank, again through the micropore filter element filtration sterilization of 0.22um, then embedding, through 121 ℃ of water-bath sterilizations after 15 minutes, lamp inspection, packing, namely get gastrodine injection.
Embodiment 3
Prescription: gastrodine 100g
EDTA-2Na 0.2g
NaCL 8.5g
Water for injection adds to 1000ml
——————————————————
Make 500
First prepare the phosphate buffer of pH7.8, standby.getting 70% fresh water for injection adds in dense preparing tank, be cooled to 35～40 ℃, the EDTA-2Na of recipe quantity is added wherein, stirring makes its dissolving, then the gastrodine that adds recipe quantity, stirring is dissolved it fully, add again the sodium chloride of recipe quantity in the solution, after mixing, phosphate buffer with pH7.8 is regulated pH value to 6.3, claim the medicinal charcoal of its amount of preparation 0.1% to add dense preparing tank, benefit adds to the full amount of water for injection, after stirring, standing adsorption is 15 minutes, filter decarburization to dilute preparing tank, again through the micropore filter element filtration sterilization of 0.22um, then embedding, through 121 ℃ of water-bath sterilizations after 15 minutes, lamp inspection, packing, namely get gastrodine injection.
Embodiment 4
Prescription: gastrodine 100g
EDTA-2Na 0.3g
NaCL 9g
Water for injection adds to 1000ml
——————————————————
Make 500
First prepare the phosphate buffer of pH7.8, standby.getting 70% fresh water for injection adds in dense preparing tank, be cooled to 35～40 ℃, the EDTA-2Na of recipe quantity is added wherein, stirring makes its dissolving, then the gastrodine that adds recipe quantity, stirring is dissolved it fully, add again the sodium chloride of recipe quantity in the solution, after mixing, phosphate buffer with pH7.8 is regulated pH value to 6.4, claim the medicinal charcoal of its amount of preparation 0.1% to add dense preparing tank, benefit adds to the full amount of water for injection, after stirring, standing adsorption is 15 minutes, filter decarburization to dilute preparing tank, again through the micropore filter element filtration sterilization of 0.22um, then embedding, through 121 ℃ of water-bath sterilizations after 15 minutes, lamp inspection, packing, namely get gastrodine injection.
Embodiment 5
Prescription: gastrodine 100g
EDTA-2Na 0.2g
NaCL 9g
Water for injection adds to 1000ml
——————————————————
Make 500
First prepare the phosphate buffer of pH7.8, standby.getting 70% fresh water for injection adds in dense preparing tank, be cooled to 35～40 ℃, the EDTA-2Na of recipe quantity is added wherein, stirring makes its dissolving, then the gastrodine that adds recipe quantity, stirring is dissolved it fully, add again the sodium chloride of recipe quantity in the solution, after mixing, phosphate buffer with pH7.8 is regulated pH value to 6.2, claim the medicinal charcoal of its amount of preparation 0.1% to add dense preparing tank, benefit adds to the full amount of water for injection, after stirring, standing adsorption is 15 minutes, filter decarburization to dilute preparing tank, again through the micropore filter element filtration sterilization of 0.22um, then embedding, through 121 ℃ of water-bath sterilizations after 15 minutes, lamp inspection, packing, namely get gastrodine injection.
Embodiment 6
Prescription: gastrodine 100g
EDTA-2Na 0.3g
NaCL 9g
Water for injection adds to 1000ml
——————————————————
Make 500
First prepare the phosphate buffer of pH7.8, standby.getting 70% fresh water for injection adds in dense preparing tank, be cooled to 35～40 ℃, the EDTA-2Na of recipe quantity is added wherein, stirring makes its dissolving, then the gastrodine that adds recipe quantity, stirring is dissolved it fully, add again the sodium chloride of recipe quantity in the solution, after mixing, phosphate buffer with pH7.8 is regulated pH value to 6.3, claim the medicinal charcoal of its amount of preparation 0.1% to add dense preparing tank, benefit adds to the full amount of water for injection, after stirring, standing adsorption is 15 minutes, filter decarburization to dilute preparing tank, again through the micropore filter element filtration sterilization of 0.22um, then embedding, through 121 ℃ of water-bath sterilizations after 15 minutes, lamp inspection, packing, namely get gastrodine injection.
Claims (6)
1. gastrodine injection and preparation method thereof, comprise gastrodine, water for injection, it is characterized in that, also contains complexing of metal ion agent and a kind of solution stabilizer of total amount 0.01%～0.1%.
2. a kind of gastrodine injection according to claim 1 and preparation method thereof, is characterized in that, described complexing of metal ion agent is disodiumedetate, and its content is preferably 0.01%～0.03%.
3. a kind of gastrodine injection according to claim 1 and preparation method thereof, is characterized in that, described a kind of solution stabilizer is sodium chloride, and its content is preferably 0.8%～0.9%.
4. a kind of gastrodine injection according to claim 1 and preparation method thereof, is characterized in that, the proportioning of gastrodine and water for injection is 0.1:1.
5. a kind of gastrodine injection according to claim 1 and preparation method thereof, it is characterized in that, comprise the steps: first fresh water for injection to be cooled to uniform temperature, then add the complexing of metal ion agent, gastrodine added wherein stirring and dissolving is complete, add again stabilizing agent, at last regulate pH value qualified after, embedding, sterilization, lamp inspection, make gastrodine injection.
6. the preparation method of gastrodine injection according to claim 5, it is characterized in that, comprise the steps: A) first fresh water for injection is cooled to 35～40 ℃, then in cooling good water for injection, add 0.01%～0.03% complexing of metal ion agent, after dissolving fully Deng it, add the gastrodine of 0.1:1 in the solution; B) count 0.8%～0.9% sodium chloride in mentioned solution, phosphate buffer with pH7.8 is regulated pH6.2～6.4, then add 0.1% medicinal charcoal, stirred standing adsorption 15 minutes, filtering decarbonization, fill after the micropore degerming membrane filtration of 0.22um through 121 ℃ of water-bath sterilizations 15 minutes, gets gastrodine injection.
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| CN2011104238161A CN103156808A (en) | 2011-12-18 | 2011-12-18 | Gastrodin injection liquid and preparation method thereof |
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| CN2011104238161A CN103156808A (en) | 2011-12-18 | 2011-12-18 | Gastrodin injection liquid and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103126980A (en) * | 2013-03-04 | 2013-06-05 | 扬州中宝制药有限公司 | Gastrodin injection preparation and preparation method |
| CN112190545A (en) * | 2020-11-16 | 2021-01-08 | 安徽宏业药业有限公司 | Gastrodin injection and preparation method thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1559417A (en) * | 2004-03-05 | 2005-01-05 | 嵩 张 | Gastrodin venous injection liquid, and its prepn. method |
| CN1634091A (en) * | 2004-11-26 | 2005-07-06 | 巴里莫尔制药（通化）有限公司 | Injectio of gastrodine, its preparing process and usage |
| CN1751691A (en) * | 2004-11-26 | 2006-03-29 | 巴里莫尔制药（通化）有限公司 | Small volume intravenous injection of gastrodine and its prepn. method |
| CN101623254A (en) * | 2009-08-13 | 2010-01-13 | 海南利能康泰制药有限公司 | Gastrodin injection and preparation method thereof |
-
2011
- 2011-12-18 CN CN2011104238161A patent/CN103156808A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1559417A (en) * | 2004-03-05 | 2005-01-05 | 嵩 张 | Gastrodin venous injection liquid, and its prepn. method |
| CN1634091A (en) * | 2004-11-26 | 2005-07-06 | 巴里莫尔制药（通化）有限公司 | Injectio of gastrodine, its preparing process and usage |
| CN1751691A (en) * | 2004-11-26 | 2006-03-29 | 巴里莫尔制药（通化）有限公司 | Small volume intravenous injection of gastrodine and its prepn. method |
| CN101623254A (en) * | 2009-08-13 | 2010-01-13 | 海南利能康泰制药有限公司 | Gastrodin injection and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103126980A (en) * | 2013-03-04 | 2013-06-05 | 扬州中宝制药有限公司 | Gastrodin injection preparation and preparation method |
| CN112190545A (en) * | 2020-11-16 | 2021-01-08 | 安徽宏业药业有限公司 | Gastrodin injection and preparation method thereof |
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Application publication date: 20130619 |