CN101623254A - Gastrodin injection and preparation method thereof - Google Patents

Gastrodin injection and preparation method thereof Download PDF

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Publication number
CN101623254A
CN101623254A CN200910167315A CN200910167315A CN101623254A CN 101623254 A CN101623254 A CN 101623254A CN 200910167315 A CN200910167315 A CN 200910167315A CN 200910167315 A CN200910167315 A CN 200910167315A CN 101623254 A CN101623254 A CN 101623254A
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injection
gastrodine
water
preparation
amount
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CN101623254B (en
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黄飞
龙娇
张志宏
邢贞凯
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Hainan Beite Pharmaceutical Co. Ltd.
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HAINAN LEVTEC PHARMACEUTICAL CO Ltd
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Abstract

The invention discloses a gastrodin injection and a preparation method thereof. The gastrodin injection comprises gastrodin which is an active constituent, an accessory and water for injection. A prescription process is simplified through a large number of experiments, and the accessory only consists of buffer salt which has the effects of pH regulation and stabilization. The gastrodin injection does not contain organic solvents, auxiliary solvents, antioxidants and metal ion complexing agents, thereby improving the safety of clinical medicines and reducing the cost. Proved by pharmacological experiments, the gastrodin injection does not have anaphylaxis, irritant reactions and hemolytic reactions and can guarantee the medicine safety. The gastrodin injection has the advantage of solving the problems of reduced content and unstable pH value of the gastrodin injection in the process of storage, has simple prescription, good stability, low production cost, guarantees of medicine quality and safety and can be stored for two years at normal temperature.

Description

A kind of gastrodine injection and preparation method thereof
Technical field
The present invention relates to a kind of gastrodine injection and preparation method thereof, belong to the technical field of pharmaceutical preparation.
Background technology
Gastrodine is the effective monomer in the rare Chinese medicine Rhizoma Gastrodiae, is used for diseases such as neurasthenia, neurasthenic syndrome and angioneurotic headache (as migraine, trigeminal neuralgia, occipital bone neuralgia etc.) and also can be used for make a noise traumatic syndrome, vertigo such as Meniere, medicinal vertigo, traumatic vertigo, vestibular neuronitis, vertebro-basilar artery insufficiency etc.
The gastrodine chemical name is: 4-methylol benzene-β-D-pyranglucoside semihydrate, and its chemical structural formula is:
Figure G2009101673154D00011
Because gastrodine aqueous solution instability, when being prepared into injection, gastrodine need add adjuvants such as a large amount of stabilizing agents, complexing of metal ion agent, but the interpolation of a large amount of adjuvants, not only increased the cost of gastrodine injection, and because the interpolation of multiple adjuvant, cause increasing of exogenous impurity in the injection, in the use of injection, cause injection pain or other untoward reaction easily, increase clinical unpredictable risk, be unfavorable for the use of injection.In addition, the storage-stable of existing gastrodine injection awaits further to improve.
Chinese patent application 200410016799.X (publication number: CN1559417A, open day: on January 5th, 2005) disclose a kind of gastrodine intravenous fluid, this medicine gastrodine intravenous fluid is made up of as active component and pharmaceutical carrier gastrodine, and pharmaceutical carrier has isoosmotic adjusting agent, cosolvent, antioxidant, stabilizing agent, complexing of metal ion agent and water for injection; Chinese patent application 200510067866.5 (applicant's 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, metal chelating agents etc. also disclose its preparation method simultaneously.
Summary of the invention
For solving the deficiencies in the prior art, the applicant is through a large amount of further investigations, be surprisingly found out that, by in gastrodine injection, adding a small amount of buffer salt, not only can reduce the interpolation of adjuvant in the gastrodine injection to greatest extent, make things convenient for the use of injection, and can ensure drug quality, improve the stability of injection greatly.
Therefore, the object of the present invention is to provide a kind of simple, stability and good gastrodine injection of safety of writing out a prescription.
Another object of the present invention provides a kind of simple, low production cost of writing out a prescription, is convenient to gastrodine injection of industrialized mass and preparation method thereof.
Gastrodine injection provided by the invention is made up of gastrodine, buffer salt, water for injection.
The kind and the consumption of buffer salt are not particularly limited, and be preferred 5.5~6.5 as long as buffer salt makes the pH of this injection reach 5.0~7.0 after adding gastrodine injection, is preferably about 6.0 especially and gets final product.
As preferred version, the content of buffer salt preferably accounts for 0.001%~5.0% of injection percentage composition (m/v), and more preferably 0.005%~3.0%, more preferably 0.05%~2.0%.
The buffer salt that uses among the present invention is meant and is suitable for medicinal any buffer system, as long as it can realize making gastrodine injection to reach above-mentioned pH scope.Suitable buffer salt includes but not limited to, for example can be acetic acid-sodium acetate, acetic acid-ammonium acetate, sodium hydrogen phosphate-sodium dihydrogen phosphate, citric acid-sodium citrate or citric acid-sodium hydrogen phosphate, buffer salt can use separately, also can mix use by any way, in use can be mixed with buffer earlier, add then in the gastrodine aqueous solution, also can be directly buffer salt solid and gastrodine be directly added the injection water and be mixed with injection of the present invention.When direct use buffer salt solid, the content of above-mentioned buffer salt in injection is meant percentage composition (m/v); When using buffer solution, above-mentioned content is meant the percentage composition (m/v) of buffer salt and injection.
The content of active component gastrodine also is not particularly limited in the gastrodine injection of the present invention, can be to be suitable for medicinal any specification, contain 10~500g gastrodine in for example every 1000ml gastrodine injection, preferably contain 50~200g, more preferably contain 80~100g, most preferably contain the 100g gastrodine, if be converted into unit dose, then contain 10mg~500mg gastrodine in per unit dosage (for example every 1ml injection) gastrodine injection of the present invention, preferred 50~200mg, more preferably 80~100mg, most preferably 100mg gastrodine.
In the gastrodine injection of the present invention, except that active component gastrodine and aqueous solvent, only select for use buffer salt to regulate pH value, and do not add adjuvants such as antioxidant, stabilizing agent, complexing of metal ion agent, can not only guarantee the quality of medicine, save production cost, satisfy the big needs of producing, and reduced and be difficult to the risk expected in the clinical application, no anaphylaxis, zest and hemolytic react, thereby reduce the injection pain, make things convenient for medication.Simultaneously, gastrodine injection of the present invention has extraordinary storage-stable.Be suitable for commercial production in enormous quantities.
Another object of the present invention is to provide the preparation technology of described gastrodine injection.
The preparation method of gastrodine injection of the present invention may further comprise the steps: a, an amount of buffer of preparation, and standby; B, in an amount of water for injection, add the gastrodine of recipe quantity, be stirred to dissolving fully; C, add prepare buffer, mix; D, in above-mentioned solution, be incorporated as the active carbon (preferred 0.1%~0.5% of solution weight 0.05%~1.0%, more preferably 0.1%~0.3%, most preferably 0.2%), benefit adds to the full amount of water for injection, recirculation stirs after stirring certain hour, filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization; E, embedding, 121 ℃ of pressure sterilizings 15 minutes promptly get gastrodine injection.
Particularly, preparation technology may further comprise the steps: a, an amount of buffer of elder generation's preparation, and standby; B, get proper amount of water for injection and drop in the dense preparing tank, add the gastrodine of recipe quantity, be stirred to dissolving fully; C, add prepare buffer, mix; D, 0.2% the active carbon that takes by weighing amount of liquid add dense preparing tank, and benefit adds to the full amount of water for injection, and stir after 20 minutes the recirculation stirring 10 minutes, and filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization; E, get fine straining liquid and carry out intermediate and detect; F, the embedding of qualified back, 121 ℃ of pressure sterilizings 15 minutes, lamp inspection, quality inspection is qualified, promptly gets gastrodine injection.
Gastrodine injection of the present invention can also be by following method preparation, and preparation technology comprises the steps: a, adds the gastrodine of recipe quantity in proper amount of water for injection, is stirred to dissolving fully; B, the buffer salt of getting recipe quantity are dissolved in the proper amount of water for injection, and it is added in step a gained solution, stir; C, be incorporated as the active carbon of aforesaid liquid weight 0.05%~1.0%, benefit adds to the full amount of water for injection, stir certain hour after recirculation stir, filtering decarbonization, again through 0.22 μ m micropore filter element filtration sterilization d, embedding, 121 ℃ of pressure sterilizings 15 minutes promptly get gastrodine injection.
Particularly, preparation method comprises the following steps: a, gets in the proper amount of water for injection input dense preparing tank, adds the gastrodine of recipe quantity, is stirred to dissolving fully; B, the buffer salt (acid and/or salt) of getting recipe quantity are dissolved in proper amount of water for injection, add in " a " solution, 0.2% the active carbon that stir c, takes by weighing amount of liquid adds dense preparing tank, benefit adds to the full amount of water for injection, stirring after 20 minutes recirculation stirred 10 minutes, filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization; D, get fine straining liquid and carry out intermediate and detect; E, the embedding of qualified back, 121 ℃ of pressure sterilizings 15 minutes, lamp inspection, quality inspection is qualified, promptly gets gastrodine injection.
Prescription of the present invention is simple, easy and simple to handle, has reduced production cost, and product stability is good, and by the pharmacological toxicology test, no anaphylaxis, zest and hemolytic reaction can guarantee the safety of medication.
The specific embodiment
Following examples only are further detailed the present invention, and should not be construed as is to further restriction of the present invention.
1 1000 of embodiment
Prescription: gastrodine 100g
Acetic acid-sodium-acetate buffer 15ml
Water for injection adds to 1000ml
Make 1000
An amount of acetic acid-the sodium-acetate buffer of preparation is standby earlier.Get proper amount of water for injection and drop in the dense preparing tank, add the 100g gastrodine, be stirred to dissolving fully.Add prepare acetic acid-sodium-acetate buffer, mix.0.2% the active carbon that takes by weighing amount of liquid adds dense preparing tank, and benefit adds to the full amount of water for injection, and stirs after 20 minutes the recirculation stirring 10 minutes, and filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization.Get fine straining liquid and carry out the intermediate detection.The embedding of qualified back, 121 ℃ of pressure sterilizings 15 minutes, lamp inspection, packing promptly gets the gastrodine injection finished product.
2 1000 of embodiment
Prescription: gastrodine 100g
Citric acid 0.15g
Sodium hydrogen phosphate 0.36g
Water for injection adds to 1000ml
Make 1000
Get proper amount of water for injection earlier and drop in the dense preparing tank, add the 100g gastrodine, be stirred to dissolving fully.The citric acid and the sodium hydrogen phosphate that take by weighing recipe quantity are dissolved in proper amount of water for injection, after the stirring and dissolving, add in the dense preparing tank, stir.0.2% the active carbon that takes by weighing amount of liquid adds dense preparing tank, and benefit adds to the full amount of water for injection, and stirs after 40 minutes the recirculation stirring 10 minutes, and filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization.Get fine straining liquid and carry out the intermediate detection.The embedding of qualified back, 121 ℃ of pressure sterilizings 15 minutes, lamp inspection, packing promptly gets the gastrodine injection finished product.
3 1000 of embodiment
Prescription: gastrodine 100g
Sodium hydrogen phosphate-phosphate sodium dihydrogen buffer solution 10ml
Acetic acid-sodium-acetate buffer 10ml
Water for injection adds to 1000ml
Make 1000
An amount of sodium hydrogen phosphate-phosphate sodium dihydrogen buffer solution and the acetic acid-sodium-acetate buffer of preparation is standby earlier.The water for injection of getting 100g drops in the dense preparing tank, adds the 100g gastrodine, is stirred to dissolving fully.Add prepared phosphoric acid disodium hydrogen-phosphate sodium dihydrogen buffer solution and acetic acid-sodium-acetate buffer, mix.0.2% the active carbon that takes by weighing amount of liquid adds dense preparing tank, and benefit adds to the full amount of water for injection, and stirs after 30 minutes the recirculation stirring 15 minutes, and filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization.Get fine straining liquid and carry out the intermediate detection.The embedding of qualified back, 121 ℃ of pressure sterilizings 15 minutes, lamp inspection, packing promptly gets the gastrodine injection finished product.
4 1000 of embodiment
Prescription: gastrodine 100g
Acetic acid 0.03g
Sodium acetate 1.36g
Citric acid 0.02g
Sodium citrate 0.12g
Water for injection adds to 1000ml
Make 1000
Get proper amount of water for injection earlier and drop in the dense preparing tank, add the 100g gastrodine, be stirred to dissolving fully.The sodium hydrogen phosphate, sodium dihydrogen phosphate, citric acid and the sodium citrate that take by weighing recipe quantity are dissolved in an amount of water for injection, after the stirring and dissolving, stir.0.2% the active carbon that takes by weighing amount of liquid adds dense preparing tank, and benefit adds to the full amount of water for injection, and stirs after 20 minutes the recirculation stirring 10 minutes, and filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization.Get fine straining liquid and carry out the intermediate detection.The embedding of qualified back, 121 ℃ of pressure sterilizings 15 minutes, lamp inspection, packing promptly gets the gastrodine injection finished product.
5 1000 of embodiment
Prescription: gastrodine 200g
Acetic acid-ammonium acetate buffer 25ml
Water for injection adds to 1000ml
Make 1000
An amount of acetic acid-the ammonium acetate buffer of preparation is standby earlier.Get proper amount of water for injection and drop in the dense preparing tank, add the 200g gastrodine, be stirred to dissolving fully.Add prepare acetic acid-ammonium acetate buffer, mix.0.1% the active carbon that takes by weighing amount of liquid adds dense preparing tank, and benefit adds to the full amount of water for injection, and stirs after 45 minutes the recirculation stirring 25 minutes, and filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization.Get fine straining liquid and carry out the intermediate detection.The embedding of qualified back, 121 ℃ of pressure sterilizings 15 minutes, lamp inspection, packing promptly gets the gastrodine injection finished product.
6 1000 of embodiment
Prescription: gastrodine 50g
Citric acid-sodium hydrogen phosphate buffer 5ml
Water for injection adds to 1000ml
Make 1000
An amount of citric acid-sodium hydrogen phosphate the buffer of preparation is standby earlier.Get proper amount of water for injection and drop in the dense preparing tank, add the 50g gastrodine, be stirred to dissolving fully.Add prepare citric acid-sodium hydrogen phosphate buffer, mix.0.5% the active carbon that takes by weighing amount of liquid adds dense preparing tank, and benefit adds to the full amount of water for injection, and stirs after 15 minutes the recirculation stirring 10 minutes, and filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization.Get fine straining liquid and carry out the intermediate detection.The embedding of qualified back, 121 ℃ of pressure sterilizings 15 minutes, lamp inspection, packing promptly gets the gastrodine injection finished product.
Gastrodine injection dopant species of the present invention is few, and impurity content is extremely low, and not only stability is high, and drug safety.By every detection, its index is higher than existing gastrodine injection far away.Meet the medication requirement.
Table 1: the testing result of gastrodine injection of the present invention
Figure G2009101673154D00051
Figure G2009101673154D00061
With official method gastrodine injection of the present invention has been carried out study on the stability, and the gastrodine injection of itself and prior art contrasted, as a comparison case, according to Chinese patent application 200510067866.5 disclosed prescriptions, through 121 ℃ of pressure sterilizings 15 minutes, prepare corresponding gastrodine injection, the results are shown in Table 2.
Table 2: gastrodine injection of the present invention is investigated the result through stability (Chinese Pharmacopoeia 2005 version two ones):
Figure G2009101673154D00062
Figure G2009101673154D00071
The The pharmacological results that is used for the gastrodine injection of preparation method acquisition of the present invention is:
(1) gastrodine injection solution hemolytic test
1.1 test material
(1) the big white male rabbit of ear of experimental animal Japan is 1, body weight 2.0kg, and Changsha Kaifu District east wound laboratory animal science service portion provides.Laboratory animal production licence number: SCXK (Hunan) 2006-0001.
(2) trial drug gastrodine injection of the present invention (being embodiment 1 injection), specification: 1ml:0.1g (lot number: 0602151); Provide by Hainan Levtec Pharmaceutical Co., Ltd..Face with preceding and be diluted to every ml with 0.9% sodium chloride injection as required and contain gastrodine 8mg.
1.2 test method
The preparation of (1) 2% Sanguis Leporis seu oryctolagi cell suspension: get rabbit cardiac blood 20ml, remove fibrin with bead, make into defibrinated blood, move in the graduated centrifuge tube, add normal saline, shake up, centrifugal, lose supernatant, till being washed till supernatant and being water white transparency with normal saline, press the snowball volume, it is diluted to 2% suspension with 0.9% sodium chloride injection.
(2) hemolytic test: get 7 in test tube, press table 3 and add various liquid, the 6th pipe does not add need testing solution, makes blank with normal saline, and the 7th effective distilled water replaces normal saline, as hemolytic positive control.Send in 37 ℃ of constant water bath box after each pipe shakes up gently and hatch record 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h result.
1.3 result of the test
Gastrodine injection solution hemolytic result of the test see the following form (table 3):
Figure G2009101673154D00081
Annotate: "+" expression haemolysis among the result; "-" represents not haemolysis.
Gastrodine injection of the present invention as seen from Table 3,0.1,0.2,0.3,0.4, the 0.5ml pipe, 37 ℃ of insulation 4h,
Do not see haemolysis and agglutination are arranged.Upper strata liquid achromatism and clarity, erythrocyte all sinks, and shows that gastrodine injection of the present invention does not have haemolysis.
(2) gastrodine injection irritation test:
2.1 test material
(1) the big ear of experimental animal Japan is from rabbit, and male and female are regardless of (female rabbit does not have pregnant) 2.0~2.5kg, and Changsha Kaifu District east wound laboratory animal science service portion provides.Laboratory animal production licence number: SCXK (Hunan) 2006-0001.
(2) same 1.1 (2) of trial drug descends.
2.2 test method
(1) rabbit auricular vein vascular stimulation test
Take consubstantiality bilateral relative method to test, get 3 of rabbit, every day, every rabbit one edge vein of picking up the ears was the gastrodine injection 10ml/kg of 8mg/ml by sterile working's method intravenous drip concentration respectively, side gives isopyknic 0.9% sodium chloride injection in addition, once a day, and continuous 3d, in the 4d sacrificed by exsanguination, the medicine-feeding part perusal has no abnormal, and gets the auricular vein blood vessel and make the pathology tissue examination, observes to have or not significance irritant reaction such as tissue degeneratiaon or necrosis.
(2) rabbit quadriceps femoris irritant test
Take consubstantiality bilateral relative method to test, get 2 of rabbit, every is the gastrodine injection 0.5ml of 100mg/ml by sterile working's method implantation concentration in a side quadriceps femoris meat, opposite side is injected isopyknic 0.9% sodium chloride injection, sacrificed by exsanguination behind the 48h is observed the irritant reaction of being tried thing.
2.3 result of the test
(1) tame rabbit ear edge vascular stimulation experimental rabbits auricular vein every day instillation concentration is: the gastrodine injection 10ml/kg of 8mg/ml, side gives isopyknic 0.9% sodium chloride injection in addition, every day 1 time, continuous 3 days, observe the injection site blood vessel behind the last administration 24h and do not see obvious hyperemia and edema, vessel boundary is clear, and pathological changes such as metaplasia and necrosis are not seen in the pathological tissue inspection.
(2) the gastrodine injection 0.5ml of rabbit quadriceps femoris irritant test rabbit one side quadriceps femoris injection 100mg/ml, isopyknic 0.9% sodium chloride injection of side injection in addition, 48h after the administration, get the quadriceps femoris observation and there is no the obvious stimulation reaction, the reaction score value is 0, and pathological changes such as tissue degeneratiaon and necrosis are not seen in the pathological tissue inspection.
(3) gastrodine injection systemic allergy test
3.1 test material
(1) experimental animal albefaction Cavia porcellus, male and female dual-purpose (female Cavia porcellus does not have pregnant), body weight 300~360g, wound laboratory animal science service portion provides by Changsha Kaifu District east.Laboratory animal production licence number: SCXK (Hunan) 2006-0001.
(2) trial drug gastrodine injection of the present invention, specification: 1ml:0.1g (lot number: 0602151); Provide by Hainan Levtec Pharmaceutical Co., Ltd..Face with preceding and be diluted to every ml with 0.9% sodium chloride injection as required and contain gastrodine 8mg, 16mg.
3.2 test method
Get albefaction and do not have 24 of the Cavia porcelluss of wound, divide equally 4 groups, every gastrodine injection 0.5ml/ sensitization that lumbar injection concentration is 8mg/8ml next day of getting the 1st group of (being made as low dose group) Cavia porcellus by the sterile working, continuous 3 times, every gastrodine injection 0.5ml/ sensitization that lumbar injection concentration is 16mg/ml next day of getting the 2nd group of (being made as high dose group) Cavia porcellus by the sterile working, continuous 3 times.1st, 2 groups of 10d after the last injection, intravenous injection gives to excite attack for 1ml/ gastrodine injection only; Every lumbar injection 0.9% sodium chloride injection 0.5ml/ only totally 3 times, gives 0.9% sodium chloride injection 1ml/ in last injection back 10d intravenous injection and only excites attack next day of getting the 3rd group of (being made as negative control group) Cavia porcellus; Every lumbar injection 100ml/L Ovum Gallus domesticus album solution 0.5ml/ only totally 3 times, gives 100ml/L Ovum Gallus domesticus album solution 1ml/ in last injection back 10d intravenous injection and only excites attack next day of getting the 4th group of (being made as positive controls) Cavia porcellus.Each is organized the Cavia porcellus injection and excites in the 30min of attack back, the observed and recorded result.
3.3 result of the test
Gastrodine injection whole body initiatively hypersensitive test the results are shown in following table (table 4):
Figure G2009101673154D00101
Show that through stability study this product quality assurance, mature preparation process is feasible, prescription is simple, can satisfy the demand of big production, and pharmacological experiment study shows that gastrodine injection of the present invention does not have anaphylaxis, zest and hemolytic reaction.

Claims (10)

1, a kind of gastrodine injection is characterized in that: described gastrodine injection is made up of gastrodine, buffer salt and water for injection.
2,, it is characterized in that the percentage composition (m/v) of buffer salt in the injection is 0.001%~5.0% according to the gastrodine injection described in the claim 1.
3, cannabinoid injection according to claim 2 is characterized in that the percentage composition (m/v) of buffer salt in the injection is 0.05%~2.0%.
4, according to any described gastrodine injection in the claim 1 to 3, it is characterized in that described buffer salt is selected from a kind of or its mixing in acetic acid-sodium acetate, acetic acid-ammonium acetate, sodium hydrogen phosphate-sodium dihydrogen phosphate, citric acid-sodium citrate or the citric acid-sodium hydrogen phosphate.
5, according to any described gastrodine injection in the claim 1 to 4, it is characterized in that: contain gastrodine 10g~500g in every 1000ml injection.
6,, it is characterized in that containing gastrodine 50g~200g in every 1000ml injection according to the gastrodine injection of claim 5.
7,, it is characterized in that containing gastrodine 80g~100g in every 1000ml injection according to the gastrodine injection of claim 6.
8, according to any described gastrodine injection in the claim 1 to 4, it is characterized in that containing gastrodine 10mg~500mg in the per unit dosage injection.
9, the preparation method of any described gastrodine injection of claim 1~8 is characterized in that comprising the following steps:
A, an amount of buffer of elder generation's preparation, standby; B, in an amount of water for injection, add the gastrodine of recipe quantity, be stirred to dissolving fully; C, add prepare buffer, stir; D, be incorporated as the active carbon of solution weight 0.05%~1.0% in above-mentioned solution, benefit adds to the full amount of water for injection, stir certain hour after recirculation stir, filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization; E, embedding, 121 ℃ of pressure sterilizings 15 minutes promptly get gastrodine injection.
10, the preparation method of any described gastrodine injection in the claim 1~8 is characterized in that this method comprises the following steps:
A, in proper amount of water for injection, add the gastrodine of recipe quantity, be stirred to dissolving fully; B, the buffer salt of getting recipe quantity are dissolved in the proper amount of water for injection, and it is added in step a gained solution, mix; C, be incorporated as the active carbon of aforesaid liquid weight 0.05%~1.0%, benefit adds to the full amount of water for injection, stir certain hour after recirculation stir, filtering decarbonization is again through 0.22 μ m micropore filter element filtration sterilization; D, embedding, 121 ℃ of pressure sterilizings 15 minutes promptly get gastrodine injection.
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* Cited by examiner, † Cited by third party
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CN102648895A (en) * 2012-04-16 2012-08-29 丁丽曼 Application of gastrodin injection in preparing medicine for treating chronic gastritis
CN103126980A (en) * 2013-03-04 2013-06-05 扬州中宝制药有限公司 Gastrodin injection preparation and preparation method
CN103156808A (en) * 2011-12-18 2013-06-19 山东方明药业集团股份有限公司 Gastrodin injection liquid and preparation method thereof
CN103224539A (en) * 2013-05-23 2013-07-31 湖北济生医药有限公司 Gastrodine compound and pharmaceutical composition thereof
CN103961313A (en) * 2014-05-30 2014-08-06 成都苑东药业有限公司 Ibandronate sodium injection medicine composition and preparation method thereof
CN105079067A (en) * 2015-09-23 2015-11-25 成都艾比科生物科技有限公司 Pharmaceutical composition for improving safety of compound gastrodin injection

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103156808A (en) * 2011-12-18 2013-06-19 山东方明药业集团股份有限公司 Gastrodin injection liquid and preparation method thereof
CN102648895A (en) * 2012-04-16 2012-08-29 丁丽曼 Application of gastrodin injection in preparing medicine for treating chronic gastritis
CN102648895B (en) * 2012-04-16 2013-08-14 丁丽曼 Application of gastrodin injection in preparing medicine for treating chronic gastritis
CN103126980A (en) * 2013-03-04 2013-06-05 扬州中宝制药有限公司 Gastrodin injection preparation and preparation method
CN103224539A (en) * 2013-05-23 2013-07-31 湖北济生医药有限公司 Gastrodine compound and pharmaceutical composition thereof
CN103224539B (en) * 2013-05-23 2015-09-09 湖北济生医药有限公司 A kind of Gastrodine compound and pharmaceutical composition thereof
CN103961313A (en) * 2014-05-30 2014-08-06 成都苑东药业有限公司 Ibandronate sodium injection medicine composition and preparation method thereof
CN105079067A (en) * 2015-09-23 2015-11-25 成都艾比科生物科技有限公司 Pharmaceutical composition for improving safety of compound gastrodin injection

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