CN108210451B - Stable breviscapine injection and preparation process thereof - Google Patents
Stable breviscapine injection and preparation process thereof Download PDFInfo
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- 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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Abstract
The invention discloses a stable breviscapine injection and a preparation method thereof, wherein each 1L of the injection contains: 2-4g of breviscapine, 0.05-0.15g of disodium ethylene diamine tetraacetate, 0.5-2g of sodium bicarbonate, 0.1-0.5g of alkaline L-type amino acid, 0.005-0.02g of antioxidant, 0.01-0.05g of disodium hydrogen phosphate, 0.0005-0.005g of sodium dihydrogen phosphate and 55-75g of propylene glycol; the preparation method comprises adding disodium ethylene diamine tetraacetate into a small part of injection water, adding breviscapine, stirring the solution to suspend, adding alkaline L-type amino acid and sodium bicarbonate to dissolve the raw materials completely to be clear, keeping the pH of the liquid medicine at 7.0-7.9, adding antioxidant, using disodium hydrogen phosphate and sodium dihydrogen phosphate alone or in combination, refrigerating the liquid medicine at low temperature, filtering the refrigerated liquid medicine with a cylindrical filter, ultrafiltering with an ultrafilter, adding propylene glycol into the ultrafiltered liquid medicine, mixing, and adding injection water to full dose according to the content of the liquid medicine. The breviscapine injection prepared by the invention meets the standard requirements through 6-month acceleration and 36-month long-term stability inspection, and has stable quality.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to a stable breviscapine injection and a preparation process thereof.
Background
The breviscapine is extracted and separated from erigeron breviscapus of Compositae. At present, the preparation prepared by taking the raw materials comprises tablets, dripping pills, injection and freeze-dried powder injection. It is used clinically in treating cerebral collateral obstruction, apoplexy, hemiplegia, heart vessel obstruction, thoracic obstruction, cardiac pain, apoplexy sequelae and coronary heart disease angina pectoris.
The breviscapine injection is collected in the pharmaceutical standard promulgated by the Ministry of health, and has the standard number of WS 3-B-3822-98. The Chinese medicine injection is directly injected into the blood circulation of human body in the form of liquid, and is especially suitable for rescuing critical patients, and the administration mode does not pass through the digestive tract and the liver, and can also avoid the influence of a plurality of factors of the digestive tract on the action of the medicine, so that the Chinese medicine injection has accurate dosage, reliable action and definite curative effect, and is a better quick-acting preparation formulation for clinically treating critical severe diseases in traditional Chinese medicine. However, the traditional Chinese medicine injection has some problems due to the complexity of the raw material components of the traditional Chinese medicine injection, the uncertainty of the traditional Chinese medicine variety, the production place and the contained components, the particularity of the prescription components and the dosage, the non-standardization of the preparation process and the analysis technology and the like. At present, breviscapine injection on the market generally has the phenomena of unstable quality, continuously reduced content in an effective period, darkened color, and unqualified visible foreign matters such as precipitation, white spots, white blocks and the like. Therefore, how to provide a stable breviscapine injection and a preparation process thereof becomes a problem which is urgently needed to be solved at present.
Disclosure of Invention
The invention aims to solve the technical problem of providing a stable breviscapine injection and a preparation process thereof, and solving the stability problem of the breviscapine injection.
In order to solve the technical problems, the invention adopts the following technical scheme:
a stable breviscapine injection contains, per 1L:
breviscapine 2-4g
0.05-0.15g of disodium ethylene diamine tetraacetate
Sodium bicarbonate 0.5-2g
Basic L-amino acid cosolvent 0.1-0.5g
Antioxidant 0.005-0.02g
0.01-0.05g of disodium hydrogen phosphate
Sodium dihydrogen phosphate 0.0005-0.005g
55-75g of propylene glycol
Wherein the disodium hydrogen phosphate and the sodium dihydrogen phosphate are used singly or in combination.
Furthermore, the L-type amino acid cosolvent adopts any one of L-arginine, L-lysine or L-histidine.
Further, the antioxidant sodium sulfite and sodium thiosulfate are used singly or in combination. The preparation method of the stable breviscapine injection comprises the following steps:
adding disodium ethylene diamine tetraacetate into a small part of injection water, adding breviscapine, stirring the solution to suspend, adding cosolvent alkaline L-type amino acid and sodium bicarbonate to completely dissolve the raw materials until the raw materials are clear, wherein the pH value of the liquid medicine is 7.0-7.9, adding antioxidant, and singly or jointly using disodium hydrogen phosphate and sodium dihydrogen phosphate, refrigerating the liquid medicine at low temperature, filtering the refrigerated liquid medicine through a cylindrical filter, performing ultrafiltration through an ultrafilter, adding propylene glycol into the ultrafiltered liquid medicine, uniformly mixing, and adding the injection water to the full amount according to the content of the liquid medicine. And further, adding the water for injection to full dose, then performing fine filtration, filling and sealing, sterilizing, detecting leakage and performing light inspection.
Further, disodium edetate is added into 7-15% of the preparation amount of water for injection.
Further refrigerating the medicinal liquid at 0-7 deg.C for 20-30 hr.
Further, the cartridge filter is a cartridge filter of 0.3-0.5 μm, and the ultrafilter is an ultrafilter of 8000-10000 molecular weight.
By adopting the technical scheme, the invention at least has the following advantages:
1. in the prescription of the injection, the cosolvent adopts sodium bicarbonate and an alkaline L-type amino acid cosolvent to be used together, so that the breviscapine injection is more stable in a stability period.
2. In the preparation process, firstly, in the material dissolution, breviscapine is dissolved in a solution containing disodium ethylene diamine tetraacetate, which has the function of removing heavy metal ions in raw materials, and then sodium bicarbonate and other cosolvents are added to fully dissolve the materials. Secondly, the invention confirms that the dissolved liquid medicine needs to be refrigerated to separate impurities, large impurities are removed by barrel filtration, and macromolecular substances, heat sources and the like are intercepted by the ultrafiltration of the ultrafilter. The preparation method does not need to use active carbon with the function of adsorbing impurities, can well control the heat source and endotoxin of the product only by using ultrafiltration of an ultrafilter, and avoids the defect that the active carbon is easy to cause pollution due to large dust and poor control of the production process.
3. The invention firstly adds the disodium ethylene diamine tetraacetate into a small part of injection water with preparation amount, preferably 7-15%, prepares concentrated liquor, adopts ultrafiltration to the concentrated liquor, and is mainly based on the adsorbability of materials of an ultrafilter, and the content of the liquor can be reduced in different degrees after the liquor is ultrafiltered by the ultrafilters with different molecular weights, so that the ultrafiltration to the concentrated liquor is safer and controllable compared with the final liquor ultrafiltration, and the process can be ensured to be reproducible. The amount of water for dilution can be calculated according to the content of the liquid medicine after ultrafiltration and the content of the finished liquid medicine expected to be achieved, so that the content of the finished product is better controlled within a standard range.
4. The breviscapine injection is respectively placed under the conditions of 40 +/-2 ℃ and 75 +/-5% of relative humidity for 6 months and 25 +/-2 ℃ and 60 +/-10% of relative humidity for 36 months for temperature property examination, and the content and the pH of the breviscapine injection meet the standard specification under the test conditions, if the content of the breviscapine injection is 95-105% specified by the standard specification, the content of the breviscapine injection can reach over 100%, the content degradation speed is slow, and at most, the content is only reduced by 0.23 percent.
Detailed Description
The invention uses breviscapine as raw material, uses disodium ethylene diamine tetraacetate as auxiliary material, uses sodium bicarbonate and alkaline L-amino acid cosolvent (one of L-arginine, L-histidine and L-lysine) as cosolvent, uses sodium sulfite and sodium thiosulfate as antioxidant singly or jointly, and uses disodium hydrogen phosphate and sodium dihydrogen phosphate singly or jointly.
The breviscapine injection has the dosage of 1000ml of breviscapine 2-4g, ethylenediamine tetraacetic acid disodium 0.05-0.15g, sodium bicarbonate 0.5-2g, L-arginine, L-lysine or L-histidine 0.1-0.5g, sodium sulfite, sodium thiosulfate 0.005-0.02g, disodium hydrogen phosphate 0.01-0.05g, sodium dihydrogen phosphate 0.0005-0.005g and propylene glycol 55-75 g.
The preparation method of the breviscapine injection comprises the following steps: adding disodium ethylene diamine tetraacetate into 7-15% of injection water, adding breviscapine, stirring the solution to suspend, adding cosolvent L-arginine, L-lysine and L-histidine and sodium bicarbonate to dissolve the raw materials completely to be clear, enabling the pH of the liquid medicine to be 7.0-7.9, using sodium sulfite and sodium thiosulfate singly or jointly, using disodium hydrogen phosphate and sodium dihydrogen phosphate singly or jointly, refrigerating the liquid medicine at 0-7 ℃ for 20-30 hours, filtering the refrigerated liquid medicine through a 0.3-0.5 mu m cylindrical filter, performing ultrafiltration through an ultrafilter with molecular weight of 8000-10000, adding propylene glycol into the ultrafiltered liquid medicine, mixing uniformly, supplementing the injection water to full amount according to the content of the liquid medicine, performing fine filtration, filling and sealing, sterilizing, detecting leakage, and performing light inspection to obtain the injection.
Example 1: 75L injection
Dissolving disodium ethylene diamine tetraacetate in 5.3L of water for injection, adding breviscapine, stirring the solution to suspend, adding L-arginine solution and sodium bicarbonate solution to dissolve the raw materials completely to be clear, adding a mixed solution of sodium sulfite and disodium hydrogen phosphate, refrigerating the liquid medicine for 24 hours at the temperature of 2 ℃ after uniformly mixing, filtering the refrigerated liquid medicine by a 0.3 mu m cylinder filter, performing ultrafiltration by an ultrafilter with the molecular weight of 8000, adding propylene glycol into the ultrafiltered liquid medicine, uniformly mixing, adding water for injection according to the content of the liquid medicine to full volume, performing fine filtration, filling and sealing, sterilizing, detecting leakage, and performing light inspection to obtain the injection.
Example 2: 75L injection
Dissolving disodium ethylene diamine tetraacetate into 8L of water for injection, adding breviscapine, stirring the solution to suspend, adding L-lysine solution and sodium bicarbonate solution to dissolve the raw materials completely to be clear, adding a mixed solution of sodium sulfite, sodium thiosulfate and sodium dihydrogen phosphate, refrigerating the liquid medicine for 22 hours at 0 ℃ after uniformly mixing, filtering the refrigerated liquid medicine by a 0.5 mu m cylinder filter, performing ultrafiltration by an ultrafilter with a molecular weight of 8000, adding propylene glycol into the ultrafiltered liquid medicine, uniformly mixing, adding water for injection according to the content of the liquid medicine to full amount, performing fine filtration, filling and sealing, sterilizing, detecting leakage, and performing light inspection to obtain the injection.
Example 3: 75L injection
Dissolving disodium ethylene diamine tetraacetate into 11.25L of water for injection, adding breviscapine, stirring the solution to suspend, adding L-histidine solution and sodium bicarbonate solution to dissolve the raw materials completely to be clear, adding a mixed solution of sodium sulfite, disodium hydrogen phosphate and sodium dihydrogen phosphate, refrigerating the medicine liquid for 28 hours at 7 ℃ after uniformly mixing, filtering the refrigerated medicine liquid by a 0.3 mu m cylinder filter, performing ultrafiltration by an ultrafilter with the molecular weight of 10000, adding propylene glycol into the ultrafiltered medicine liquid to be uniformly mixed, supplementing the water for injection to full amount according to the content of the medicine liquid, performing fine filtration, filling and sealing, sterilizing, detecting leakage, and performing light inspection to obtain the injection.
Example 4: 75L injection
Dissolving disodium ethylene diamine tetraacetate into 11.25L of water for injection, adding breviscapine, stirring the solution to suspend, adding L-lysine solution and sodium bicarbonate solution to dissolve the raw materials completely to be clear, adding a mixed solution of sodium thiosulfate and disodium hydrogen phosphate, refrigerating the liquid medicine for 26 hours at 4 ℃ after uniformly mixing, filtering the refrigerated liquid medicine by a 0.3 mu m cylindrical filter, performing ultrafiltration by an ultrafilter with a molecular weight of 10000, adding propylene glycol into the ultrafiltered liquid medicine, uniformly mixing, supplementing the water for injection to full amount according to the content of the liquid medicine, performing fine filtration, filling and sealing, sterilizing, detecting leakage, and performing light inspection to obtain the injection.
Example 5: 112.5L injection
Dissolving disodium ethylene diamine tetraacetate into 8L of water for injection, adding breviscapine, stirring the solution to suspend, adding L-histidine solution and sodium bicarbonate solution to dissolve the raw materials completely to be clear, adding a mixed solution of sodium thiosulfate and sodium dihydrogen phosphate, refrigerating the liquid medicine for 22 hours at 0 ℃ after uniformly mixing, filtering the refrigerated liquid medicine by a 0.5 mu m cylinder filter, performing ultrafiltration by an ultrafilter with a molecular weight of 8000, adding propylene glycol into the ultrafiltered liquid medicine, uniformly mixing, adding water for injection according to the content of the liquid medicine to full volume, encapsulating, sterilizing, detecting leakage, and performing light inspection to obtain the traditional Chinese medicine.
Example 6: 112.5L injection
Dissolving disodium ethylene diamine tetraacetate in 16.9L of water for injection, adding breviscapine, stirring the solution to suspend, adding L-arginine solution and sodium bicarbonate solution to dissolve the raw materials completely to be clear, adding a mixed solution of sodium sulfite, disodium hydrogen phosphate and sodium dihydrogen phosphate, refrigerating the medicine liquid for 30 hours at 7 ℃ after uniformly mixing, filtering the refrigerated medicine liquid by a 0.5 mu m cylinder filter, performing ultrafiltration by an ultrafilter with a molecular weight of 8000, adding propylene glycol into the ultrafiltered medicine liquid to be uniformly mixed, supplementing the water for injection to full amount according to the content of the medicine liquid, performing fine filtration, filling and sealing, sterilizing, detecting leakage, and performing light inspection to obtain the injection.
Example 7: 150L injection
Dissolving disodium ethylene diamine tetraacetate in 10.5L of water for injection, adding breviscapine, stirring the solution to suspend, adding L-lysine solution and sodium bicarbonate solution to dissolve the raw materials completely to be clear, adding a mixed solution of sodium sulfite, sodium thiosulfate, disodium hydrogen phosphate and sodium dihydrogen phosphate, refrigerating the liquid medicine for 26 hours at 4 ℃ after uniformly mixing, filtering the refrigerated liquid medicine by a 0.3 mu m cylinder filter, performing ultrafiltration by an ultrafilter with the molecular weight of 10000, adding propylene glycol into the ultrafiltered liquid medicine to be uniformly mixed, supplementing the water for injection to full amount according to the content of the liquid medicine, performing fine filtration, filling and sealing, sterilizing, detecting leakage, and performing light inspection to obtain the injection.
Example 8: 150L injection
Dissolving disodium ethylene diamine tetraacetate in 22.5L of water for injection, adding breviscapine, stirring the solution to suspend, adding L-arginine solution and sodium bicarbonate solution to dissolve the raw materials completely to be clear, adding a mixed solution of sodium thiosulfate and disodium hydrogen phosphate, refrigerating the liquid medicine for 24 hours at the temperature of 2 ℃ after uniformly mixing, filtering the refrigerated liquid medicine by a 0.5 mu m cylinder filter, performing ultrafiltration by an ultrafilter with the molecular weight of 10000, adding propylene glycol into the ultrafiltered liquid medicine, uniformly mixing, adding water for injection according to the content of the liquid medicine to the full amount, performing fine filtration, filling and sealing, sterilizing, detecting leakage, and performing light inspection to obtain the injection.
The samples are respectively placed under the conditions of the temperature of 40 +/-2 ℃ and the relative humidity of 75 +/-5% for 6 months and the temperature of 25 +/-2 ℃ and the relative humidity of 60 +/-10% for 36 months to carry out temperature investigation, and the samples are detected according to a standard method, wherein the key data of stability are as follows:
table 1 example 1 stability test results
Table 2 example 2 stability examination results
Table 3 example 3 stability test results
Table 4 example 4 stability test results
Table 5 example 5 stability test results
Table 6 example 6 stability test results
Table 7 example 7 stability test results
Table 8 example 8 stability test results
According to the stability examination results, the breviscapine injection disclosed by the invention is yellow clear liquid in properties, the content of active substances can reach more than 100%, the content degradation speed is low, the content is reduced by only 0.21 percentage point (accelerated for 6 months) and 0.23 percentage point (long-term 36 months) at most, the quality indexes of pH value, visible foreign matters, insoluble particles, related substances and the like which are very critical to the stability also meet the standard regulation, and the product quality is stable.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the present invention in any way, and it will be apparent to those skilled in the art that the above description of the present invention can be applied to various modifications, equivalent variations or modifications without departing from the spirit and scope of the present invention.
Claims (7)
1. A preparation method of a stable breviscapine injection is characterized in that each 1L of the breviscapine injection contains:
breviscapine 2-4g
0.05-0.15g of disodium ethylene diamine tetraacetate
Sodium bicarbonate 0.5-2g
Basic L-amino acid cosolvent 0.1-0.5g
Antioxidant 0.005-0.02g
0.01-0.05g of disodium hydrogen phosphate
Sodium dihydrogen phosphate 0.0005-0.005g
55-75g of propylene glycol
Wherein the disodium hydrogen phosphate and the sodium dihydrogen phosphate are used singly or jointly;
the preparation method comprises the following steps:
adding disodium ethylene diamine tetraacetate into a small part of injection water, adding breviscapine, stirring the solution to suspend, adding cosolvent alkaline L-type amino acid and sodium bicarbonate to dissolve the raw materials completely to be clear, enabling the pH value of the liquid medicine to be 7.0-7.9, adding an antioxidant, singly or jointly using disodium hydrogen phosphate and sodium dihydrogen phosphate, refrigerating the liquid medicine at low temperature, filtering the refrigerated liquid medicine through a cylindrical filter, performing ultrafiltration through an ultrafilter, adding propylene glycol into the ultrafiltered liquid medicine, uniformly mixing, and supplementing the injection water to the full amount according to the content of the liquid medicine.
2. The method for preparing the stable breviscapine injection as claimed in claim 1, wherein the injection water is added to full dose, and then fine filtration, encapsulation, sterilization, leak detection and light inspection are carried out.
3. The method for preparing a stable breviscapine injection as claimed in claim 1, wherein disodium edetate is added to 7-15% of the amount of water for injection.
4. The method for preparing a stable breviscapine injection as claimed in claim 1, wherein the liquid medicine is refrigerated at 0-7 deg.C for 20-30 hr.
5. The method for preparing a stable breviscapine injection solution as claimed in claim 1, wherein the cartridge filter is a cartridge filter of 0.3-0.5 μm, and the ultrafilter is an ultrafilter of 8000-10000 molecular weight.
6. The method for preparing the stable breviscapine injection as claimed in claim 1, wherein the basic L-amino acid cosolvent is any one of L-arginine, L-lysine or L-histidine.
7. The method for preparing the stable breviscapine injection as claimed in claim 1, wherein the antioxidant is sodium sulfite or sodium thiosulfate used singly or in combination.
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Citations (1)
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| CN1830451A (en) * | 2005-03-08 | 2006-09-13 | 阿尔贝拉医药控股(通化)有限公司 | Preparation method of erigeron breviscapus glucese injection |
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| CN1062161C (en) * | 1997-01-08 | 2001-02-21 | 大连弘丰制药厂 | Stable prescription and process of fleabane extract injection |
| CN1231223C (en) * | 2002-12-19 | 2005-12-14 | 上海博泰医药科技有限公司 | Breviscapine infusion preparation and its preparing method |
| CN1672687A (en) * | 2004-03-23 | 2005-09-28 | 杭州民生药业集团有限公司 | Transfused breviscapine prepn |
| CN1732970A (en) * | 2005-08-13 | 2006-02-15 | 杭州民生药业集团有限公司 | Breviscapine injection liquid and its preparing process |
| CN102198092A (en) * | 2011-05-27 | 2011-09-28 | 吉林龙泰制药股份有限公司 | Breviscapine injection and preparation method thereof |
| KR20150101162A (en) * | 2014-02-26 | 2015-09-03 | 바이오스펙트럼 주식회사 | Composition for ameliorating inflammation comprising Erigeron annuus (L.) Pers. extract or breviscapine or salts thereof |
| CN106236710A (en) * | 2016-08-29 | 2016-12-21 | 上海颂露医药科技有限公司 | Breviscapini injection and preparation method thereof |
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| CN1830451A (en) * | 2005-03-08 | 2006-09-13 | 阿尔贝拉医药控股(通化)有限公司 | Preparation method of erigeron breviscapus glucese injection |
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