CN1709349A - Corydalis amabilis injection agent, and its preparation and quality control method - Google Patents
Corydalis amabilis injection agent, and its preparation and quality control method Download PDFInfo
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- CN1709349A CN1709349A CN 200510031641 CN200510031641A CN1709349A CN 1709349 A CN1709349 A CN 1709349A CN 200510031641 CN200510031641 CN 200510031641 CN 200510031641 A CN200510031641 A CN 200510031641A CN 1709349 A CN1709349 A CN 1709349A
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- rhizoma corydalis
- injection
- corydalis decumbentis
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Abstract
The present invention discloses a decumbent corydalis tuber injection and its preparation and quality control method. It is a decumbent corydalis tuber powder injection of freeze-dried powder injection whose main component is extract of decumbent corydalis tuber. Said invention also provides the concrete steps of its preparation method, and its quality control method adopts a content assaying method.
Description
Technical field:
The present invention relates to a kind of Chinese medicine and preparation method thereof and method of quality control, relate in particular to injection Rhizoma Corydalis Decumbentis powder pin or freeze-dried powder and preparation method thereof and method of quality control.
Background technology:
Powder pin or freeze-dried powder, change dosage form and manage as new drug research according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.Rhizoma Corydalis Decumbentis has injection now, and lists the national drug standards in.
The Rhizoma Corydalis Decumbentis Injection of existing collateral dredging promoting blood circulation and stopping pain is a kind of Rhizoma corydalis decumbenti Injection, and it is the sterile water solution of Rhizoma Corydalis Decumbentis extract.
All multifactor influences such as the Rhizoma corydalis decumbenti Injection of existing collateral dredging promoting blood circulation and stopping pain is subject to make, stores, transportation, the difficult control of quality influences clinical therapeutic efficacy.
Summary of the invention:
The purpose of this invention is to provide a kind of Rhizoma Corydalis Decumbentis Injection and preparation thereof and method of quality control, overcome the above-mentioned disadvantage of prior art Rhizoma corydalis decumbenti Injection, improve the quality and the curative effect of product, satisfy the needs of medical treatment better.
Technical solution of the present invention is a kind of Rhizoma Corydalis Decumbentis Injection, and it is that main component is the injection Rhizoma Corydalis Decumbentis powder pin or the freeze-dried powder of Rhizoma Corydalis Decumbentis.
The preparation method of injection Rhizoma Corydalis Decumbentis powder pin or freeze-dried powder is: the extract of getting Rhizoma Corydalis Decumbentis adds the injection water, add an amount of stabilizing agent, proppant after, stir it dissolved fully, add active carbon, stir, boiled 5-20 minute, put coldly, leave standstill, filter, filtrate is regulated pH value to 1.0-5.0, leaves standstill, and filters, must not have the clear and bright solution of thermal source, dry must not have the thermal source powder, will not have the packing of thermal source powder, gland promptly gets injection Rhizoma Corydalis Decumbentis powder pin; Maybe will there be the clear and bright solution of thermal source, packing, lyophilization, gland promptly gets injection Rhizoma Corydalis Decumbentis freeze-dried powder.
Its stabilizing agent is one or more mixture or other proper auxiliary materials of following material: disodiumedetate, citric acid (sodium), sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, vitamin C or nitrogen.
Its proppant is mixture or other proper auxiliary materials of following one or more: mannitol, dextran, lactose or glucose.
Its method of quality control is: content assaying method, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test, with octadecylsilane chemically bonded silica is filler, 0.02-0.08mol/L potassium dihydrogen phosphate-acetonitrile-(58-98: 2-42) be mobile phase, the detection wavelength is 260-350nm, and number of theoretical plate is pressed the protopine peak and calculated, and should be lower than 1000; The preparation of reference substance solution, it is an amount of to get 105 ℃ of protopine reference substances that are dried to constant weight, puts in the 10ml measuring bottle, adds methanol and makes dissolving and be diluted to scale, shakes up, and making reference substance solution concentration is 0.2-0.6mg/ml; This product 2g is got in the preparation of need testing solution, and accurate the title decides, and adds methanol and makes dissolving, puts in the 10ml measuring bottle, adds methanol and is diluted to scale, shakes up, promptly;
Algoscopy, accurate respectively reference substance solution and each 5 μ l of need testing solution of drawing inject liquid phase color instrument, measure, promptly.
Specific embodiments:
The present invention further specifies as follows in conjunction with specific embodiments:
A kind of Rhizoma Corydalis Decumbentis Injection and preparation thereof and method of quality control, it is that main component is the injection Rhizoma Corydalis Decumbentis powder pin or the freeze-dried powder of Rhizoma Corydalis Decumbentis.
Rhizoma Corydalis Decumbentis powder pin of the present invention or freeze-dried powder are mainly used in treatment hypertension hemiplegia, poliomyelitis sequela, sciatica, rheumatic arthritis, traumatic injury.
Embodiment one:
The extract 1500g of Rhizoma Corydalis Decumbentis adds the injection water, stirs it is dissolved fully, adds 1% active carbon, stirs, boiled 10 minutes, and filtered, add the injection water, regulate pH to 2.5～3.0, packing, lyophilization, gland promptly gets injection Rhizoma Corydalis Decumbentis freeze-dried powder goods.
Embodiment two:
The extract 1500g of Rhizoma Corydalis Decumbentis adds the injection water, stirs it is dissolved fully, adds active carbon, stir, boiled 5-20 minute, put cold, leave standstill, filter, add the injection water, regulate pH value to 2.5-3.0, leave standstill, filter, must not have the clear and bright solution of thermal source, dry must not have the thermal source powder, will not have the packing of thermal source powder, gland promptly gets injection Rhizoma Corydalis Decumbentis powder pin.
Embodiment three:
The extract 1500g that gets Rhizoma Corydalis Decumbentis adds the injection water, and the sodium sulfite of adding 0.1% or sodium pyrosulfite or both mixture used as stabilizers, the mannitol with 3% are as proppant, and stirring is dissolved it fully, add 1% active carbon, stir, boiled 10 minutes, filter, add the injection water, regulate pH value to 2.5～3.0, packing, lyophilization, gland promptly gets injection Rhizoma Corydalis Decumbentis freeze-dried powder.
Embodiment four:
The extract 1500g that gets Rhizoma Corydalis Decumbentis adds the injection water, and the sodium sulfite of adding 0.1% or sodium pyrosulfite or both mixture used as stabilizers, the mannitol with 3% are as proppant, and stirring is dissolved it fully, add 1% active carbon, stir, boiled 10 minutes, filter, add the injection water, regulate pH value to 2.5～3.0, leave standstill, filter, must not have the clear and bright solution of thermal source, dry must not have the thermal source powder, to not have the packing of thermal source powder, gland promptly gets injection Rhizoma Corydalis Decumbentis powder pin.
Embodiment five:
The extract 1500g that gets Rhizoma Corydalis Decumbentis adds the injection water, and the sodium sulfite of adding 0.05% or dimension C or both mixture or inflated with nitrogen used as stabilizers, the dextran with 3% are as proppant, and stirring is dissolved it fully, add 1% active carbon, stir, boiled 10 minutes, filter, add the injection water, regulate pH value to 2.5～3.0, packing, lyophilization, gland promptly gets injection Rhizoma Corydalis Decumbentis freeze-dried powder.
Embodiment six:
The extract 1500g that gets Rhizoma Corydalis Decumbentis adds the injection water, add 0.02% sulphuric acid sodium thiosulfate used as stabilizers and with 5% lactose or glucose or both mixture as proppant, stirring is dissolved it fully, add 1% active carbon, stir, boiled 10 minutes, filter, add the injection water, regulate pH value to 2.5～3.0, packing, lyophilization, gland promptly gets injection Rhizoma Corydalis Decumbentis freeze-dried powder.
The method of quality control of injection Rhizoma Corydalis Decumbentis powder pin of the present invention or freeze-dried powder is:
Assay, according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test, with octadecylsilane chemically bonded silica is filler, 0.05mol/L potassium dihydrogen phosphate-acetonitrile-(78: 20) are mobile phase, the detection wavelength is 290nm, and number of theoretical plate is pressed the protopine peak and calculated, and should be lower than 1000;
105 ℃ of protopine reference substances that are dried to constant weight are got in the preparation of reference substance solution, and accurate the title decides, and puts in the measuring bottle, adds methanol and makes dissolving, makes the solution that every ml contains protopine reference substance 0.4mg, shakes up, promptly;
This product 1.5g is got in the preparation of need testing solution, and accurate the title decides, and puts in the 10ml measuring bottle, adds methanol and is diluted to scale, shakes up, promptly;
Algoscopy, accurate respectively reference substance solution and each 5 μ l of need testing solution of drawing inject liquid phase color instrument, measure.
Advantage of the present invention is:
Use, easy to carry, quality controllability, good stability conveniently transport, can be mass-produced.
Claims (5)
1, a kind of Rhizoma Corydalis Decumbentis Injection is characterized in that it is that main component is the injection Rhizoma Corydalis Decumbentis powder pin or the freeze-dried powder of Rhizoma Corydalis Decumbentis.
2, a kind of preparation method of Rhizoma Corydalis Decumbentis Injection, it is the preparation method of injection Rhizoma Corydalis Decumbentis powder pin or freeze-dried powder, it is characterized in that: the extract of getting Rhizoma Corydalis Decumbentis adds the injection water, add an amount of stabilizing agent, proppant after, stir it dissolved fully, add active carbon, stir, boiled 5-20 minute, put cold, leave standstill, filter, filtrate is regulated pH value to 1.0-5.0, leaves standstill, filter, get the clear and bright solution of apyrogeneity, the dry apyrogeneity powder that gets is with the packing of apyrogeneity powder, gland promptly gets injection Rhizoma Corydalis Decumbentis powder pin; Or with the clear and bright solution of apyrogeneity, packing, lyophilization, gland promptly gets injection Rhizoma Corydalis Decumbentis freeze-dried powder.
3,, be characterised in that its stabilizing agent is mixture or other proper auxiliary materials of following one or more: disodiumedetate, citric acid (sodium), sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, vitamin C or nitrogen according to the described method of claim 2.
4, preparation method according to claim 2 is characterized in that its proppant is mixture or other proper auxiliary materials of following one or more: mannitol, dextran, lactose or glucose.
5, a kind of method of quality control of Rhizoma Corydalis Decumbentis Injection, it is the method for quality control of injection Rhizoma Corydalis Decumbentis powder pin or freeze-dried powder, it is characterized in that:
High effective liquid chromatography for measuring content, octadecylsilane chemically bonded silica is a filler, and 0.02-0.08mol/L potassium dihydrogen phosphate-acetonitrile-(58-98: 2-42) be mobile phase, the detection wavelength is 260-350nm, number of theoretical plate is pressed the protopine peak and is calculated, and should be lower than 1000;
105 ℃ of protopine reference substances that are dried to constant weight are got in the preparation of reference substance solution, and accurate the title decides, and puts in the measuring bottle, adds methanol and makes dissolving, makes the solution that every ml contains protopine reference substance 0.2-0.6mg, shakes up, promptly;
Get this product 1-2g, the accurate title, decide, and adds methanol and make dissolving, puts in the 10ml measuring bottle, adds methanol and be diluted to scale, shakes up, promptly;
Algoscopy, accurate respectively reference substance solution and each 5 μ l of need testing solution of drawing inject liquid phase color instrument, measure, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510031641 CN1709349A (en) | 2005-06-01 | 2005-06-01 | Corydalis amabilis injection agent, and its preparation and quality control method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510031641 CN1709349A (en) | 2005-06-01 | 2005-06-01 | Corydalis amabilis injection agent, and its preparation and quality control method |
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| Publication Number | Publication Date |
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| CN1709349A true CN1709349A (en) | 2005-12-21 |
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| CN 200510031641 Pending CN1709349A (en) | 2005-06-01 | 2005-06-01 | Corydalis amabilis injection agent, and its preparation and quality control method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110715987A (en) * | 2019-10-23 | 2020-01-21 | 张璐 | Quality control method for Yujiang corydalis amabilis |
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2005
- 2005-06-01 CN CN 200510031641 patent/CN1709349A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110715987A (en) * | 2019-10-23 | 2020-01-21 | 张璐 | Quality control method for Yujiang corydalis amabilis |
| CN110715987B (en) * | 2019-10-23 | 2022-05-03 | 张璐 | Quality control method for Yujiang corydalis amabilis |
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