CN106389326A - Gastrodin injection and preparation method and application thereof - Google Patents
Gastrodin injection and preparation method and application thereof Download PDFInfo
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- CN106389326A CN106389326A CN201611054150.6A CN201611054150A CN106389326A CN 106389326 A CN106389326 A CN 106389326A CN 201611054150 A CN201611054150 A CN 201611054150A CN 106389326 A CN106389326 A CN 106389326A
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- gastrodin
- gastrodine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- Proteomics, Peptides & Aminoacids (AREA)
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Abstract
The invention discloses a gastrodin injection. The gastrodin injection comprises gastrodin, injection water and a metal complexing agent. Meanwhile, the invention further discloses a preparation method and application. The gastrodin is treated by water sedimentation, refrigeration and ultra-filtration technologies, and is sterilized, invalid ingredients are completely removed, related substances in a preparation are reduced, the preparation is good in stability, the related substances and pyrogen items comfort to quality standard, the curative effect is stable, clarity is improved, and clinical experiments prove that intravenous injection can be implemented. The gastrodin injection is used for preparing drugs for treating diseases such as debilitated spirit, neurasthenic syndrome, cerebral trauma syndrome, vertigo including meniere, medicinal vertigo, traumatic vertigo, sudden deafness, vestibular neuronitis and vertebro-basilar artery insufficiency, neuralgia including trigeminal neuralgia, sciatica and great occipital neuralgia, and headache including vascular headache, migraine, neurasthenia and neurasthenic syndrome.
Description
Technical field
The present invention relates to a kind of Injectio of gastrodine and its production and use, belong to chemical medicine.
Background technology
Gastrodin is the main effective ingredient in orchid family perennial parasitic plant rhizoma Gastrodiae (Gastrodia elata BL.).
Gastrodin (Gastrodin), chemistry is entitled to adjoin food in one's mouth glucoside (P-hydroxymethylPhenyl- to methylol benzene-β-D- grape
β-D-glucopyranoside), white, needle-shaped crystals, 154 DEG C -156 DEG C of fusing point, i.e. gastrodin.
Pharmacological evaluation shows that Gastrodin can recover the excited dysequilibrium and between process of inhibition of cerebral cortex, have calmness,
Sleeping and analgesia etc. central inhibitory action.Shown by acute toxicity testing and sub-acute toxicity test：Gastrodin is to hematopoiesis system
System, Liver and kidney function and blood fat all no affect.
At present, having of clinic is applied to for main active with Gastrodin：Gastrodini, rhizoma Gastrodiae cellulose capsule, Gastrodin
Parenteral solution, gastrodia-tuer powder injection and Rhizoma gastrodiae extract drop pill etc..
Application No. 02134016, invention entitled gastrodia-tuer powder injection, is medicinal with water for injection dissolubility by Gastrodin
The mixture composition of auxiliary material or water or water for injection dissolubility pharmaceutic adjuvant and water, wherein, when Gastrodin is water-soluble with injection
Property pharmaceutic adjuvant or water for injection dissolubility pharmaceutic adjuvant and water mixture combination when, the percentage by weight of Gastrodin is 30～
99.9%, the percentage by weight of the mixture of its water for injection dissolubility pharmaceutic adjuvant or water for injection dissolubility pharmaceutic adjuvant and water
Content is 0.1～70%；When Gastrodin is combined with water, the percentage by weight of Gastrodin is 85～99.9%, the weight of its moisture
Amount degree is 0.1～15%, this powder-injection with Gastrodin as active component, have calm, sleeping, analgesia, combating vertigo,
Anticonvulsion, anti-epileptic, improve cardio and vascular function, promote myocardial cell energy metabolism and anti-ageing effect waited for a long time.
Application No. 03143337, invention entitled Rhizoma gastrodiae extract drop pill and preparation method thereof, by apply ultramicro grinding and
The Rhizoma gastrodiae extract drop pill that pill production Technology is made, can reach raising disintegration and leach speed, onset is rapid, improves medicine
Stability, reduces supplementary product consumption, reduces production cost, purpose easy to carry and use.Compliance is good, is particularly suitable for
Child, the elderly, bed patient and dysphagia patients are taken.
When Gastrodin clinically uses as injection, existing method of administration is intramuscular injection.Warp after intramuscular injection
Cross skin absorption to play a role to after blood, onset is slow；And the problem that intramuscular injection exists is patient injection site's pain and length
Phase injection is likely to occur local redness, extravasated blood, lump, the even bad reaction such as muscular death；In production raw materials used due to system
Standby technological problemses have that purity is not high, there is also certain potential safety hazard.
Content of the invention
It is an object of the invention to provide a kind of Injectio of gastrodine, this parenteral solution contains metal chelating agent, can effectively protect
Shield Gastrodin, utilizes more than filter technology simultaneously and parenteral solution is processed, and the Injectio of gastrodine bioavilability of gained is high, steady
Qualitative good, clarity is high, and Clinical practice is convenient, bad reaction is little, curative effect is rapid.
It is still another object of the present invention to provide a kind of preparation method of Injectio of gastrodine.
Another object of the present invention is to providing, a kind of Injectio of gastrodine declines in preparation treatment god, god declines syndrome and brain
The application of the disease medicaments such as traumatic syndrome, vertigo, neuralgia, headache.
The present invention, in order to prevent Gastrodin easily oxidized under conditions of metal ion presence, adds complexing of metal ion agent
Play the effect of protection effective ingredient Gastrodin, and utilize more than filter technology and parenteral solution is processed, the invalid one-tenth of its macromolecular
Divide and be removed completely, the product biological availability of gained is high, Clinical practice is convenient, bad reaction is little, curative effect is rapid, improves 10%
Left and right, can give full play to the pharmacological action of Gastrodin.
A kind of Injectio of gastrodine of the present inventionly, including Gastrodin, water for injection it is characterised in that also containing total
The metal chelating agent of weight 0.01%～0.1%, described Injectio of gastrodine forms through hyperfiltration technical finesse.
Wherein, metal complex agent content is preferably 0.03%～0.05%.
Described metal chelating agent can be：Ethanedioic acid four acetic acid disodium or ethanedioic acid four acetic acid.
Gastrodin is 0.1: 1～1: 0.1, preferably 1: 4～4: 1 with the proportioning of water for injection.
Described hyperfiltration is to carry out 1～3 classified filtering using intercepting ultrafiltration apparatus below 100,000 for the molecular weight.Described
Classified filtering be exactly using retention different molecular weight filter multiple times of filtration, with reach progressively remove invalid components mesh
's.Such as, first ultrafiltration obtains Gastrodin solution below 100,000 for the molecular weight, then through multiple times of filtration, final that bioavilability is high, clear
The high Gastrodin solution of lightness.
A kind of preparation method of Injectio of gastrodine of the present invention, comprises the steps：Gastrodin is heavy, cold through water
Hide, hyperfiltration technique process, obtain Gastrodin ultrafiltrate, after through adjust pH value, sterilizing make Injectio of gastrodine.
The preparation method of Injectio of gastrodine of the present invention, specifically includes following steps：
First by Gastrodin and water for injection mixed dissolution at 80～90 DEG C according to the above ratio, place to room temperature, at 0～10 DEG C
Refrigeration 12～48 hours, through 1～3 progressively filtration, ultrafiltration, adds 0.01%～0.1% metal chelating agent, finally adjusts pH value
For 5.0～7.0, and sterilized form Injectio of gastrodine.
Filtration of the present invention can be filtered through 1～3 time, preferably 1～2 time, can carry out pretreatment filtration using paper pulp,
Then first ultrafiltration obtains Gastrodin solution below 100,000 for the molecular weight, then ultrafiltration obtains Gastrodin solution below 5000 for the molecular weight, excellent
Choosing is the ultrafilter using retention less than 3000 molecular weight.
Furtherly, the preparation method of Injectio of gastrodine of the present invention, comprises the steps：
A) first by Gastrodin and water for injection with 0.1: 1～1: 0.1 ratio mixed dissolution at 80～90 DEG C, place to room
Temperature, 0～10 DEG C refrigerates 12～48 hours, after ultrafilter ultrafiltration below 100,000 for the molecular cut off, then uses molecular cut off
Less than 5000 ultrafilter ultrafiltration, obtains Gastrodin ultrafiltrate；
B in ultrafiltrate) add 0.01%～0.1% metal chelating agent, adjust pH5.0～7.0, sterilize to obtain Gastrodin injection
Liquid.
The pH of Injectio of gastrodine of the present invention is 5.0～7.0, preferably pH5.8～6.2, and pH value regulator can
From conditioning agent commonly used in the art, such as 10% NaOH or 10% hydrochloric acid solution.
Sterilizing installation and technique that described sterilizing can be commonly used using those skilled in the art.For example, using water-bath sterilization
Or steam sterilizing, sterilize 30～45 minutes at 100～110 DEG C.
Preferably, the preparation method of Injectio of gastrodine of the present invention, comprises the steps：
A) first by Gastrodin and water for injection with 1: 4～4: 1 ratio mixed dissolution at 80～90 DEG C, place to room temperature, 0～
10 DEG C refrigerate 24～32 hours, after ultrafilter ultrafiltration below 100,000 for the molecular cut off, then with molecular cut off below 5000
Ultrafilter ultrafiltration, obtain Gastrodin ultrafiltrate；
B in ultrafiltrate) add 0.03%～0.05% metal chelating agent, adjust pH5.8～6.2, sterilize to obtain Gastrodin note
Penetrate liquid finished product.
Using Injectio of gastrodine obtained by preparation method of the present invention, proterties is colourless clear liquid, and specification can
Think 1ml：50mg、2ml：200mg、5ml：500mg、10ml：2g, most preferred specification is 2ml：200mg、5ml：500mg.
During Injectio of gastrodine clinical practice of the present invention not only can intramuscular injection, can be quiet with intravenous injection
Arteries and veins injection can avoid pain during intramuscular injection and the issuable bad reaction of long-term intramuscular injection.Intramuscular injection, every time
200mg, 1～2 time on the one.Drip-feed, 500～1000mg every time, once a day, with 250～500ml 5% glucose injection
Use after liquid or the dilution of 0.9% sodium chloride injection.Parenteral solution of the present invention can long term administration.
Gastrodin can recover the excited dysequilibrium and between process of inhibition of cerebral cortex, has calm, sleeping and analgesia etc.
Central inhibitory action.Syndrome that Injectio of gastrodine of the present invention declines for preparation treatment god, god declines and brain traumatic are comprehensive
Close disease；Vertigo：Meniere's disease, medicinal vertigo, traumatic vertigo, sudden deafness, vestibular neuronitis, Vertebral-basilar artery
Blood supply insufficiency etc.；Neuralgia：Trigeminal neuralgia, sciatica, occipital bone neuralgia etc.；Headache：Vascular headache, inclined head
Bitterly, neurasthenia and god decline the application of syndrome disease medicine.
Metal chelating agent is with the addition of, Gastrodin is under conditions of metal ion presence by easily by oxygen in the parenteral solution of the present invention
Change, add complexing of metal ion agent to play the effect of protection effective ingredient Gastrodin.And the researcher of the present invention is through excessive
The experimental study of amount and analysis, it is believed that highly purified Gastrodin, can make the product quality of Injectio of gastrodine effectively improve,
Can reach higher level in terms of the safety indexes such as pyrogen, acute toxicity test, be less than especially with intercepting molecular weight
After 5000 ultrafilter ultrafiltration, its macromolecular invalid components is removed completely, and the product biological availability of gained is high, Clinical practice
Facilitate, bad reaction is little, curative effect is rapid, improve 10% about, the pharmacological action of Gastrodin can be given full play to.
Gastrodin is sunk by the researcher of the therefore present invention through water, refrigeration, hyperfiltration technique are processed, and sterilizing is it is ensured that invalid
Composition is completely removed, and decreases the relevant material in preparation, the better stability of preparation made, clarity is high, compares common process
Improve 5% about, and curative effect is stable, Injectio of gastrodine drip-feed is administered, and solves and makes injection site during intramuscular injection
Local redness that pain and long term injections are likely to occur, extravasated blood, lump, the even bad reaction such as muscular death, drip-feed is given
After medicine, blood can be directly entered and onset, effect is rapid.
Specific embodiment
Example below further describes the present invention, but described embodiment is merely to illustrate the present invention rather than limits this
Bright.
Embodiment 1
A) take 80 DEG C of fresh water for injection, Gastrodin added with 1: 4 ratio, is sufficiently stirred for making to be completely dissolved, places to room temperature,
10 DEG C refrigerate 12 hours, after ultrafilter ultrafiltration below 100,000 for the molecular cut off super below 5000 with molecular cut off
Filter ultrafiltration, obtains Gastrodin ultrafiltrate, samples detection level.
B in ultrafiltrate) add the ethanedioic acid four acetic acid disodium of gross weight 0.03%, according to the content constant volume of Gastrodin,
Adjust pH5.3, intermediate products after the assay was approved, by liquid through end-filtration filling in ampoule, using water-bath sterilization, 108
Sterilize 30 minutes at DEG C, lamp inspection, clarity is 98%, and packaging obtains final product Injectio of gastrodine finished product.
Embodiment 2
A) take 90 DEG C of fresh water for injection, add Gastrodin with 2: 5 ratios, be sufficiently stirred for making to be completely dissolved, place to room temperature,
5 DEG C refrigerate 24 hours, after ultrafilter ultrafiltration below 100,000 for the molecular cut off, then the ultrafiltration below 3000 with molecular cut off
Device ultrafiltration, obtains Gastrodin ultrafiltrate, samples detection level.
B in ultrafiltrate) add the ethanedioic acid four acetic acid disodium of gross weight 0.04%, according to the content constant volume of Gastrodin,
Adjust pH5.9, intermediate products after the assay was approved, by liquid through end-filtration filling in ampoule, using steam sterilizing, 110
Sterilize 35 minutes at DEG C, lamp inspection, clarity is 99%, and packaging obtains final product Injectio of gastrodine finished product.
Embodiment 3
A) take 85 DEG C of fresh water for injection, Gastrodin added with 1: 1 ratio, is sufficiently stirred for making to be completely dissolved, places to room temperature,
0 DEG C refrigerates 48 hours, after ultrafilter ultrafiltration below 100,000 for the molecular cut off, then the ultrafiltration below 5000 with molecular cut off
Device ultrafiltration, obtains Gastrodin ultrafiltrate, samples detection level.
B in ultrafiltrate) add 0.05% ethanedioic acid four acetic acid, according to the content constant volume of Gastrodin, adjust pH7.0,
Intermediate products after the assay was approved, by liquid through end-filtration filling in ampoule, water-bath sterilization 30 minutes at 108 DEG C, lamp inspection, clear
Lightness is 98%, and packaging obtains final product Injectio of gastrodine finished product.
Claims (8)
1. a kind of Injectio of gastrodine, including Gastrodin, water for injection it is characterised in that also contain gross weight 0.01%～
0.1% metal chelating agent, described Injectio of gastrodine forms through hyperfiltration technical finesse.
2. a kind of Injectio of gastrodine according to claim 1 is it is characterised in that described metal complex agent content is preferred
For 0.03%～0.05%.
3. a kind of Injectio of gastrodine according to claim 1 and 2 is it is characterised in that described metal chelating agent is second
Diacid four acetic acid disodium or ethanedioic acid four acetic acid.
4. according to any one Injectio of gastrodine in claims 1 to 3 it is characterised in that the joining of Gastrodin and water for injection
Than for 0.1: 1～1: 0.1, preferably 1: 4～4: 1.
5. according to any one Injectio of gastrodine in Claims 1 to 4 it is characterised in that described hyperfiltration is to adopt to cut
Ultrafiltration apparatus below 100,000 for the molecular weight is taken to carry out 1～3 classified filtering.
6. a kind of method of the Injectio of gastrodine prepared described in claim 1 is it is characterised in that comprise the steps：First will
Gastrodin and water for injection mixed dissolution at 80～90 DEG C according to the above ratio, place to room temperature, refrigerate 12 at 0～10 DEG C～
48 hours, through 1～3 time progressively filter, ultrafiltration, add 0.01%～0.1% metal chelating agent, finally adjust pH value be 5.0～
7.0, and sterilized form Injectio of gastrodine.
7. the preparation method of Injectio of gastrodine according to claim 6 is it is characterised in that described filtration is through 1～3 time
Filter, pretreatment filtration can be carried out using filter paper, then first ultrafiltration obtains Gastrodin solution below 100,000 for the molecular weight, then ultrafiltration obtains
Gastrodin solution below 5000 for the molecular weight.
8. the preparation method of Injectio of gastrodine according to claim 6 is it is characterised in that comprise the steps：
A) first by Gastrodin and water for injection with 0.1: 1～1: 0.1 ratio mixed dissolution at 80～90 DEG C, place to room
Temperature, 0～10 DEG C refrigerates 12～48 hours, after ultrafilter ultrafiltration below 100,000 for the molecular cut off, then uses molecular cut off
Less than 5000 ultrafilter ultrafiltration, obtains Gastrodin ultrafiltrate；
B in ultrafiltrate) add 0.01%～0.1% metal chelating agent, adjust pH5.0～7.0, sterilize to obtain Gastrodin injection
Liquid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611054150.6A CN106389326A (en) | 2016-11-25 | 2016-11-25 | Gastrodin injection and preparation method and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611054150.6A CN106389326A (en) | 2016-11-25 | 2016-11-25 | Gastrodin injection and preparation method and application thereof |
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| CN106389326A true CN106389326A (en) | 2017-02-15 |
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| CN201611054150.6A Withdrawn CN106389326A (en) | 2016-11-25 | 2016-11-25 | Gastrodin injection and preparation method and application thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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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2016
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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: 20170215 |