CN1830433A - Preparation method of tanshinone IIA sodium sulphonate small volume injection - Google Patents
Preparation method of tanshinone IIA sodium sulphonate small volume injection Download PDFInfo
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- CN1830433A CN1830433A CN 200510051478 CN200510051478A CN1830433A CN 1830433 A CN1830433 A CN 1830433A CN 200510051478 CN200510051478 CN 200510051478 CN 200510051478 A CN200510051478 A CN 200510051478A CN 1830433 A CN1830433 A CN 1830433A
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Abstract
A low-dosage injection of tanshinone IIA-sodium sulfonate for treating coronary heart disease, angina pectoris, myocardial infarction and ventricular premature contraction is prepared from the tanshinone IIA-sodium sulfonate through depositing in water, cold storage, ultrafiltration, adding additives in dark condition, pouring in containers in Na atmosphere, sterilizing and lamp examining.
Description
Technical field
The present invention relates to a kind of preparation method of antianginal drug, specifically, relating to a kind of is the small-volume injection of Main Ingredients and Appearance with the sodium tanshinone IIA sulfate, after water precipitating, cold preservation, hyperfiltration technique processing, through the lucifuge preparation, fill the nitrogen fill, sterilization at last, lamp inspection, packing again, make small-volume injection, belong to the chemical preparation field.But this product intravenous drip, can coronary artery dilator, coronary blood flow increasing, improve the collateral circulation and the local blood supply of ischemic region cardiac muscle, improve the metabolism disorder of anoxia cardiac muscle, improve myocardial hypoxia tolerance, anticoagulant and antithrombotic form, and dwindle laboratory animal ischemic myocardium infarct size.Be mainly used in the treatment of coronary heart disease, angina pectoris, myocardial infarction and premature ventricular beat.
Background technology
Radix Salviae Miltiorrhizae is treatment cardiovascular diseases's an important Chinese herbal medicine, and another name Arisaema balansae Engl., Radix Salviae Miltiorrhizae, Herba Wedeliae Wallichii root etc. have good resisting coronary heart disease effect, and its effective ingredient is TANSHINONES and danshensu.Sodium tanshinone IIA sulfate is to extract tanshinone from Radix Salviae Miltiorrhizae, gets through sulfonation, and its water solublity is enhanced, better efficacy.Sodium tanshinone IIA sulfate can coronary artery dilator, and coronary blood flow increasing improves the collateral circulation and the local blood supply of ischemic region cardiac muscle, improve the metabolism disorder of anoxia cardiac muscle, improve myocardial hypoxia tolerance, anticoagulant and antithrombotic form, and strengthen myocardial contraction.At present, the preparation of sodium tanshinone IIA sulfate only has injection, but because of its preparation method difference, product quality has than big difference.Mainly exist constant product quality poor, clarity disqualification rate height, the medicinal liquid zest is strong, and pH value descends, and content descends, problems such as color burn.Its main cause is that sodium tanshinone IIA sulfate partial impurities such as protein, tannin, oxalates etc. in preparation process do not remove fully, and the unstability of adding sodium tanshinone IIA sulfate itself causes.New preparation method has solved the constant product quality problem preferably by special handling.
Summary of the invention
The object of the present invention is to provide a kind of preparation method of antianginal drug sodium tanshinone IIA sulfate injection.
Preparation method of the present invention comprises the steps: sodium tanshinone IIA sulfate, disodium edetate respectively after water precipitating, cold preservation, hyperfiltration technique are handled, get ultrafiltrate, then two kinds of ultrafiltrates are prepared under the lucifuge condition, fill the nitrogen fill, behind the sterilization lamp inspection, pack, make sodium tanshinone IIA sulfate injection finished product.
Preparation method detailed process of the present invention is as follows:
A) get the fresh water for injection of 10%～30%60 ℃～80 ℃ of amount of preparation, lucifuge adds the sodium tanshinone IIA sulfate in the prescription, fully stirring and dissolving, be placed to room temperature, shading is airtight, 0 ℃～10 ℃ cold preservation 12～48 hours, with molecular cut off is 10,000 ultrafilter membrane ultrafiltration, ultrafiltrate I.
B) get the fresh water for injection of 10%～30%60 ℃～80 ℃ of amount of preparation, add the disodium edetate dissolving in the prescription, regulate pH value 3.8～5.0, be placed to room temperature, 0 ℃～10 ℃ cold preservation 12～48 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, ultrafiltrate II.
C) with above-mentioned ultrafiltrate I, II mix homogeneously, standardize solution is transferred pH value 3.8～5.0, and intermediate products after the terminal aseptic filtration, fill the nitrogen fill with medicinal liquid after the assay was approved under the lucifuge condition, sterilization, and lamp inspection, packing promptly gets sodium tanshinone IIA sulfate injection finished product.
More preferred manufacturing procedure comprises the steps:
A) get the fresh water for injection of 20%70 ℃ of amount of preparation, lucifuge adds the sodium tanshinone IIA sulfate in the prescription, and fully stirring and dissolving is placed to room temperature, and shading is airtight, and 4 ℃～8 ℃ cold preservation 24 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, must ultrafiltrate I.
B) get the fresh water for injection of 15%70 ℃ of amount of preparation, add the disodium edetate dissolving in the prescription, regulate pH value 4.0～4.5, be placed to room temperature, 4 ℃～8 ℃ cold preservation 24 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, gets ultrafiltrate II.
C) with above-mentioned ultrafiltrate I, II mix homogeneously, standardize solution is transferred pH value 4.0～4.5, and intermediate products after the terminal aseptic filtration, fill the nitrogen fill with medicinal liquid after the assay was approved under the lucifuge condition, sterilization, and lamp inspection, packing promptly gets sodium tanshinone IIA sulfate injection finished product.
In the above-mentioned preparation method, for making constant product quality, the temperature of used water for injection is 70 ℃, and refrigerated storage temperature is 4～8 ℃, and cold preservation time is 24 hours, and pH value is strict controlled in 4.0～5.0.
In the above-mentioned preparation method, adopting the molecular weight that dams is 10,000 ultrafilter membrane ultrafiltration, is the controlled step of invalid components in institute's preparating liquid, and used ultrafilter membrane is the commercially available prod.Its manufacturer should be the production unit of industry approval.
In the above-mentioned preparation method, lucifuge condition and medicinal liquid fill the committed step that the nitrogen fill is the medicinal liquid process for preparation.
Intramuscular injection during anti-anginal drug sodium tanshinone IIA sulfate injection clinical practice of the present invention, 1 40～80mg, 1 time on the one; Intravenous injection, 1 40～80mg dilutes with 25% glucose injection 20ml; Intravenous drip, 1 40～80mg is with 5% glucose injection, 250～500ml dilution, 1 time on the one.
Anti-anginal drug sodium tanshinone IIA sulfate injection of the present invention, can coronary artery dilator, coronary blood flow increasing, improve the collateral circulation and the local blood supply of ischemic region cardiac muscle, improve the metabolism disorder of anoxia cardiac muscle, improve myocardial hypoxia tolerance, anticoagulant and antithrombotic form, and dwindle laboratory animal ischemic myocardium infarct size.Be mainly used in the treatment of coronary heart disease, angina pectoris, myocardial infarction and premature ventricular beat.
The present invention adopts water precipitating, cold preservation, hyperfiltration technique to handle; and take lucifuge, fill protective measures such as nitrogen; guaranteed that invalid components is removed fully; avoided the degraded of sodium tanshinone IIA sulfate; reduced the related substance in the preparation, the preparation stability of making is increased, zest reduces; improved clarity, curative effect is more stable.
The specific embodiment
Further describe the present invention with embodiment below, but described embodiment only is used to illustrate the present invention rather than restriction the present invention.
Embodiment 1
A) get the fresh water for injection of 25%80 ℃ of amount of preparation, lucifuge adds the sodium tanshinone IIA sulfate in the prescription, and fully stirring and dissolving is placed to room temperature, and shading is airtight, and 8 ℃ of cold preservation 12 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, must ultrafiltrate I.
B) get the fresh water for injection of 10%80 ℃ of amount of preparation, add the disodium edetate dissolving in the prescription, regulate pH value 3.8, be placed to room temperature, 6 ℃ of cold preservation 12 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, gets ultrafiltrate II.
C) with above-mentioned ultrafiltrate I, II mix homogeneously, standardize solution is transferred pH value 3.8, and intermediate products after the terminal aseptic filtration, fill the nitrogen fill with medicinal liquid after the assay was approved under the lucifuge condition, sterilization, and lamp inspection, packing promptly gets sodium tanshinone IIA sulfate injection finished product.
Embodiment 2
A) get the fresh water for injection of 15%60 ℃ of amount of preparation, lucifuge adds the sodium tanshinone IIA sulfate in the prescription, and fully stirring and dissolving is placed to room temperature, and shading is airtight, and 4 ℃ of cold preservation 24 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, must ultrafiltrate I.
B) get the fresh water for injection of 20%60 ℃ of amount of preparation, add the disodium edetate dissolving in the prescription, regulate pH value 5.0, be placed to room temperature, 4 ℃ of cold preservation 24 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, gets ultrafiltrate II.
C) with above-mentioned ultrafiltrate I, II mix homogeneously, standardize solution is transferred pH value 5.0, and intermediate products after the terminal aseptic filtration, fill the nitrogen fill with medicinal liquid after the assay was approved under the lucifuge condition, sterilization, and lamp inspection, packing promptly gets sodium tanshinone IIA sulfate injection finished product.
Embodiment 3
A) get the fresh water for injection of 10%70 ℃ of amount of preparation, lucifuge adds the sodium tanshinone IIA sulfate in the prescription, and fully stirring and dissolving is placed to room temperature, and shading is airtight, and 6 ℃ of cold preservation 36 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, must ultrafiltrate I.
B) get the fresh water for injection of 30%70 ℃ of amount of preparation, add the disodium edetate dissolving in the prescription, regulate pH value 4.5, be placed to room temperature, 10 ℃ of cold preservation 36 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, gets ultrafiltrate II.
C) with above-mentioned ultrafiltrate I, II mix homogeneously, standardize solution is transferred pH value 4.5, and intermediate products after the terminal aseptic filtration, fill the nitrogen fill with medicinal liquid after the assay was approved under the lucifuge condition, sterilization, and lamp inspection, packing promptly gets sodium tanshinone IIA sulfate injection finished product.
Embodiment 4
A) get the fresh water for injection of 30%75 ℃ of amount of preparation, lucifuge adds the sodium tanshinone IIA sulfate in the prescription, and fully stirring and dissolving is placed to room temperature, and shading is airtight, and 8 ℃ of cold preservation 48 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, must ultrafiltrate I.
B) get the fresh water for injection of 25%75 ℃ of amount of preparation, add the disodium edetate dissolving in the prescription, regulate pH value 5.3, be placed to room temperature, 8 ℃ of cold preservation 48 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, gets ultrafiltrate II.
C) with above-mentioned ultrafiltrate I, II mix homogeneously, standardize solution is transferred pH value 5.3, and intermediate products after the terminal aseptic filtration, fill the nitrogen fill with medicinal liquid after the assay was approved under the lucifuge condition, sterilization, and lamp inspection, packing promptly gets sodium tanshinone IIA sulfate injection finished product.
Embodiment 5
A) get the fresh water for injection of 10%65 ℃ of amount of preparation, lucifuge adds the sodium tanshinone IIA sulfate in the prescription, and fully stirring and dissolving is placed to room temperature, and shading is airtight, and 6 ℃ of cold preservation 12 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, must ultrafiltrate I.
B) get the fresh water for injection of 10%65 ℃ of amount of preparation, add the disodium edetate dissolving in the prescription, regulate pH value 4.2, be placed to room temperature, 6 ℃ of cold preservation 12 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, gets ultrafiltrate II.
C) with above-mentioned ultrafiltrate I, II mix homogeneously, standardize solution is transferred pH value 4.2, and intermediate products after the terminal aseptic filtration, fill the nitrogen fill with medicinal liquid after the assay was approved under the lucifuge condition, sterilization, and lamp inspection, packing promptly gets sodium tanshinone IIA sulfate injection finished product.
Experimental example 1
The detection of relevant every gainer under character, pH value and the injection item of this experimental example for the prepared antianginal drug sodium tanshinone IIA sulfate injection of the present invention.
Character: this product is red clear liquid, and is up to specification.
PH value: get this product, measure (two appendix VIH of Chinese Pharmacopoeia version in 2000) in accordance with the law, pH value is 3.5～5.5, and is up to specification.
Other: meet every regulation relevant under the injection item (two appendix IB of Chinese Pharmacopoeia version in 2000).
Experimental example 2
This experimental example is the qualitative determination of the prepared antianginal drug sodium tanshinone IIA sulfate injection of the present invention.
(1) gets this product 0.1ml, put in the water-bath behind the evaporate to dryness, add 1～2 in sulphuric acid, promptly show navy blue and gradual change bottle green.
(2) get this product 1ml, put in the water-bath behind the evaporate to dryness, blazingly make ashing, add 1mol/l hydrochloric acid solution 5ml.Filter, filtrate adds barium chloride test solution 5ml, promptly generates white precipitate.
(3) get solution under the assay item, measure, absorption maximum is arranged at wavelength 226nm and 271nm place according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000), up to specification.
(4) this product shows the identification (two appendix III of Chinese Pharmacopoeia version in 2000) of sodium salt, and is up to specification.
Contain definite component in the prepared antianginal drug sodium tanshinone IIA sulfate injection of above description of test the present invention.
Experimental example 3
This experimental example is the assay of the prepared antianginal drug sodium tanshinone IIA sulfate injection of the present invention.
Assay: it is an amount of that precision is measured this product, and dilute with water is made the solution that contains sodium tanshinone IIA sulfate 5ug among every 1ml, according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000), measures trap at wavelength 271nm place, presses C
19H
17NaO
6The absorptance of S (E) is 767 calculating, promptly.
Standard code: contain sodium tanshinone IIA sulfate (C
19H
17NaO
6S) should be 90.0%～110.0% of labelled amount, the assay by three batches the results are shown in following table:
| Lot number | Labelled amount (%) |
| 20040501 | 100.3 |
| 20040502 | 101.2 |
| 20040503 | 99.8 |
Experimental example 4
This experimental example is the security inspection of the prepared antianginal drug sodium tanshinone IIA sulfate injection of the present invention.
Aseptic: press two appendix XIE of Chinese Pharmacopoeia version in 2000 and check, up to specification.
Pyrogen: press two appendix XID of Chinese Pharmacopoeia version in 2000 and check, up to specification.
Long term toxicity is measured: successive administration was observed the hematuria inspection in three months, pathologic finding there is no unusually.
Safety by the prepared antianginal drug sodium tanshinone IIA sulfate injection of above description of test the present invention meets the injection requirement, does not have any toxic action, uses human body safety.
Comparative example 1
The clarity of the antianginal drug sodium tanshinone IIA sulfate injection that this comparative example explanation the present invention is prepared is better than producing with conventional preparation method.
The clarity criterion:
(1) finds no foreign body or only be with micro-white point person, the lattice theory of making a match.
(2) every bottle contains the hair that is shorter than 0.5cm and the white point of 0.1～0.2mm, white piece or color dot sum above 5 persons, the lattice theory of making a match.
(3) disqualification rate surpasses 5%, this batch product lattice theory of making a match.
Relevant notion:
White piece: mean with the inspection method of regulation, can see the whiteness that tangible plane or corner angle are arranged.
White point: can not differentiate plane or corner angle by white point.
Trace white point: in official hour, only see 3 or 3 following white point persons.
Foreign body: comprise chips of glass, fiber, color dot, color lump and other external foreign body.
Inspection method:
Get respectively and adopt prepared antianginal drug sodium tanshinone IIA sulfate injection of the present invention and each 200 of the products that adopts the common process preparation,, the results are shown in following table by " clarity test detailed rules and regulations and criterion " and above standard inspection.
| Group | The trace white point | White point | White piece | Foreign body | Number of non-compliances | Disqualification rate | Qualification rate | Conclusion |
| The invention group | 6 bottles | 2 bottles surpass 5 | 0 | 0 | 2 bottles | 1％ | 99％ | Qualified |
| Conventional group | 52 bottles | 5 bottles surpass 5 | 5 bottles surpass 5 | 0 | 10 bottles | 5％ | 95％ | Qualified |
Clarity by the prepared antianginal drug sodium tanshinone IIA sulfate injection of above description of test the present invention obviously is better than producing with conventional preparation method.
Comparative example 2
This comparative example illustrates that the prepared antianginal drug sodium tanshinone IIA sulfate injection zest when clinical practice of the present invention is less.
| Group | The invention group | Conventional group |
| Usage and dosage | Intramuscular injection, 1 40～80mg, 1 time on the one; Intravenous injection, 1 40～80mg dilutes with 25% glucose injection 20ml; Intravenous drip, 1 40～80mg is with 5 % glucose injections, 250～500ml dilution, 1 time on the one. | Intramuscular injection, 1 40～80mg, 1 time on the one; Intravenous injection, 1 40～80mg dilutes with 25% glucose injection 20ml; Intravenous drip, 1 40～80mg is with 5 % glucose injections, 250～500ml dilution, 1 time on the one. |
| Clinical practice | Treat 55 routine angina pectoriss | Treat 48 routine angina pectoriss |
| Zest is observed | No pain phenomenon | There is the pain phenomenon 20 routine injection sites, and the erythra reaction appears in 5 examples |
Comparative example 3
The prepared antianginal drug sodium tanshinone IIA sulfate injection of this comparative example explanation employing the present invention compares with the stability of the antianginal drug sodium tanshinone IIA sulfate injection that adopts conventional preparation method to produce by six months accelerated tests, the results are shown in following table.
Standard code:
Content: this product contains sodium tanshinone IIA sulfate (C
19H
17NaO
6S) should be 90.0%～110.0% of labelled amount
PH value: should be 3.5～5.5
Clarity: qualification rate should be not less than 95%
Color: should be red clear liquid
By above experiment as can be seen, the invention group was passed through accelerated tests after six months, significant change does not take place in its content, pH value, clarity, color, and content, the pH value of conventional group all have obvious reduction, clarity, color are all against regulation, show that the prepared antianginal drug sodium tanshinone IIA sulfate injection of the present invention obviously is better than adopting conventional preparation method to be produced.
Claims (8)
1. the preparation method of an antianginal drug sodium tanshinone IIA sulfate injection, described preparation method detailed process is as follows:
A) get fresh water for injection, lucifuge adds the sodium tanshinone IIA sulfate dissolving in the prescription, and is airtight, cold preservation, and ultrafiltration gets ultrafiltrate I;
B) get fresh water for injection, add the disodium edetate dissolving in the prescription, regulate pH value, cold preservation, ultrafiltration gets ultrafiltrate II;
C) with above-mentioned ultrafiltrate I, II mix homogeneously, standardize solution is transferred pH value, and intermediate products behind end-filtration, fill the nitrogen fill with medicinal liquid after the assay was approved under the lucifuge condition, sterilization, and lamp inspection, packing promptly gets sodium tanshinone IIA sulfate injection finished product.
2. according to claims 1 described preparation method, it is characterized in that comprising the steps:
A) get the fresh water for injection of 10%～30%60 ℃～80 ℃ of amount of preparation, lucifuge adds the sodium tanshinone IIA sulfate in the prescription, fully stirring and dissolving, be placed to room temperature, shading is airtight, 0 ℃～10 ℃ cold preservation 12～48 hours, with molecular cut off is 10,000 ultrafilter membrane ultrafiltration, ultrafiltrate I;
B) get the fresh water for injection of 10%～30%60 ℃～80 ℃ of amount of preparation, add the disodium edetate dissolving in the prescription, regulate pH value 3.8～5.0, be placed to room temperature, 0 ℃～10 ℃ cold preservation 12～48 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, ultrafiltrate II;
C) with above-mentioned ultrafiltrate I, II mix homogeneously, standardize solution is transferred pH value 3.8～5.0, and intermediate products after the terminal aseptic filtration, fill the nitrogen fill with medicinal liquid after the assay was approved under the lucifuge condition, sterilization, and lamp inspection, packing promptly gets sodium tanshinone IIA sulfate injection finished product.
3. according to claims 1 described preparation method, it is characterized in that comprising the steps:
A) get the fresh water for injection of 20%70 ℃ of amount of preparation, lucifuge adds the sodium tanshinone IIA sulfate in the prescription, and fully stirring and dissolving is placed to room temperature, and shading is airtight, and 4 ℃～8 ℃ cold preservation 24 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, must ultrafiltrate I;
B) get the fresh water for injection of 15%70 ℃ of amount of preparation, add the disodium edetate dissolving in the prescription, regulate pH value 4.0～4.5, be placed to room temperature, 4 ℃～8 ℃ cold preservation 24 hours is 10,000 ultrafilter membrane ultrafiltration with molecular cut off, gets ultrafiltrate II;
C) with above-mentioned ultrafiltrate I, II mix homogeneously, standardize solution is transferred pH value 4.0～4.5, and intermediate products after the terminal aseptic filtration, fill the nitrogen fill with medicinal liquid after the assay was approved under the lucifuge condition, sterilization, and lamp inspection, packing promptly gets sodium tanshinone IIA sulfate injection finished product.
4. according to claims 1,2 or 3 described preparation methoies, the temperature that it is characterized in that the used water for injection of formulated product is 60 ℃～80 ℃.
5. according to claims 1,2 or 3 described preparation methoies, it is characterized in that refrigerated storage temperature is 0 ℃～10 ℃, cold preservation time is 12～48 hours.
6. according to claims 1,2 or 3 described preparation methoies, it is characterized in that the employed ultrafilter membrane of ultrafiltration is that molecular cut off is 10,000 ultrafilter membrane.
7. according to claims 1,2 or 3 described preparation methoies, it is characterized in that preparing, the condition in the pouring process is lucifuge, fills nitrogen.
8. according to claims 1,2 or 3 described preparation methoies, it is characterized in that used pH value regulator is 10% sodium hydroxide solution or 10% hydrochloric acid solution, pH value is controlled at 4.0～4.5.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510051478 CN1830433A (en) | 2005-03-08 | 2005-03-08 | Preparation method of tanshinone IIA sodium sulphonate small volume injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510051478 CN1830433A (en) | 2005-03-08 | 2005-03-08 | Preparation method of tanshinone IIA sodium sulphonate small volume injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106806393A (en) * | 2015-11-30 | 2017-06-09 | 湖南恒生制药股份有限公司 | Ginsenoside vein small-volume injection and preparation method thereof |
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2005
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106806393A (en) * | 2015-11-30 | 2017-06-09 | 湖南恒生制药股份有限公司 | Ginsenoside vein small-volume injection and preparation method thereof |
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