CN101897754B - Preparation method of polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation - Google Patents
Preparation method of polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation Download PDFInfo
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- CN101897754B CN101897754B CN2010102213061A CN201010221306A CN101897754B CN 101897754 B CN101897754 B CN 101897754B CN 2010102213061 A CN2010102213061 A CN 2010102213061A CN 201010221306 A CN201010221306 A CN 201010221306A CN 101897754 B CN101897754 B CN 101897754B
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Abstract
The invention discloses a method for preparing polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation. The preparation method comprises the following steps: adding water to 1500g of the root of red-rooted salvia and boiling for three times, the first time being 2h, the second time and the third time each being 1.5h, combining the boiled liquid, filtering, concentrating under decompression to 750ml, adding alcohol and precipitating twice, the alcohol content in the first time being 75% and in the second time being 85%, each all filtering after refrigerating, recovering the alcohol from filtrate and concentrating to 250ml, adding injection water to 400ml, blending, refrigerating, filtering, adjusting pH value to 6.8 by using 10% of sodium hydroxide solution, boiling for half an hour, filtering, adding 2.0g of polyethylene glycol 12-hydroxy stearate to the filtrate, and adding the injection water to 1000ml, mixing uniformly, adjusting the pH value to 6.8 by using the 10% of the sodium hydroxide solution, filtering, embedmenting, sterilizing and obtaining the product. The method of the invention solves the problems of easy precipitation and opacities during the storage and high temperature sterilization processes of the root of red-rooted salvia injection with satisfaction.
Description
Technical field
The present invention particularly, relates to a kind of Radix Salviae Miltiorrhizae medicine ejection preparation that contains polyethyleneglycol-12-hydroxy stearin in medical technical field.
Background technology
The Radix Salviae Miltiorrhizae Injection standard is recorded in health drug standard promulgated by the ministries or commissions of the Central Government (WS3-B-3766-98, the 20th in Chinese traditional patent formulation preparation), is the sterile water solution of extract through being processed into by red rooted salvia.Get Radix Salviae Miltiorrhizae 1500g, decoct with water three times, 2 hours for the first time, second and third time each 1.5 hours, collecting decoction filters, and filtrate decompression is concentrated into 750ml.Add the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 75%, make that to contain the alcohol amount be 85% for the second time, each all cold preservation is placed the back and is filtered, filtrate recycling ethanol, and be concentrated into about 250ml, add the injection water to 400ml, mixing, cold preservation is placed, filter, regulate pH value to 6.8 with 10% sodium hydroxide solution, boil half an hour, filter, add the injection water to 1000ml, embedding, sterilization, namely.
Radix Salviae Miltiorrhizae Injection has blood circulation promoting and blood stasis dispelling, the effect of freeing vessels and nourishing heart.Clinical uncomfortable in chest for coronary heart disease, angina pectoris.Usage and dosage is intramuscular injection, a 2～4ml, 1～2 time on the one; Intravenous injection, a 4ml (using with 50% glucose injection 20ml dilution back), 1～2 time on the one; Intravenous drip, a 10～20ml (using with 5% glucose injection, 100～500ml dilution back), 1 time on the one.Or follow the doctor's advice.
The main component Radix Salviae Miltiorrhizae extract that obtains according to Radix Salviae Miltiorrhizae Injection quality standard method for making contains ester soluble components such as TANSHINONES not soluble in water, causes Radix Salviae Miltiorrhizae Injection to be prone to problems such as precipitation, solution muddiness in storage and high temperature sterilize process.At present, use polyoxyethylene sorbitan monoleate as cosolvent in the Radix Salviae Miltiorrhizae Injection, but polyoxyethylene sorbitan monoleate becomes sour in storage and high temperature sterilize process easily, cause the impurity content height, easily and ingredient generation chemical change, product still has the problem of small amount of precipitate, solution muddiness to occur in storage process, causes the visible foreign matters inspection of product not meet the regulation of drug standard, makes troubles for clinical application and popularization.
Patent documentation 200710143306.2 discloses a kind of preparation method of Radix Salviae Miltiorrhizae Injection and the micelle ultrafiltration of bibliographical information prepares Radix Salviae Miltiorrhizae Injection (wangdan etc., the 25th the 6th phase of volume of Chinese patent medicine), mainly the macromole impurity of being removed in the medicinal liquid by the extracting solution employing ultrafiltration of 1500 parts of Radix Salviae Miltiorrhizaes (as tannin, protein) is made, precipitate in put procedure to solve Radix Salviae Miltiorrhizae Injection, problem such as muddiness, wherein literature method also adds tween 80 and makes cosolvent in medicinal liquid.Because of the TANSHINONES water solublity in this product principal agent composition very poor, and tween 80 has stronger hemolytic and anaphylaxis, so problems such as the solution Radix Salviae Miltiorrhizae Injection that adopts above method acquisition injection still can not be satisfied with precipitates in put procedure, muddiness can't satisfy the clinical practice needs.
Summary of the invention
Technical problem to be solved by this invention provides a kind of Radix Salviae Miltiorrhizae medicine ejection preparation that contains polyethyleneglycol-12-hydroxy stearin, it could be that Chinese medicine extract is obtaining to improve clarity of injection in the maxima solubility making active component that this Radix Salviae Miltiorrhizae medicine ejection preparation uses certain density polyethyleneglycol-12-hydroxy stearin, solves Radix Salviae Miltiorrhizae Injection satisfactorily and be prone to problems such as precipitation, muddiness in storage and high temperature sterilize process.
The present invention addresses the above problem the technical scheme that adopts: a kind of polyethyleneglycol-12-hydroxy stearin (Solutol that contains
) Radix Salviae Miltiorrhizae medicine ejection preparation, mainly be dissolved in the injection medicine that water for injection is made by Radix Salviae Miltiorrhizae extract with for the polyethyleneglycol-12-hydroxy stearin that improves clarity of injection, the consumption of described polyethyleneglycol-12-hydroxy stearin is 0.1g～1.0g/100ml.
Particularly, the consumption of polyethyleneglycol-12-hydroxy stearin is the arbitrary value among 0.1g～1.0g/100ml, based on obtain solution cumulative volume meter, as 0.1g/100ml, 0.2g/100ml, 0.5g/100ml, 1.0g/100ml etc.; Preferable amount is 0.2g-0.5g/100ml.
In the above-mentioned Radix Salviae Miltiorrhizae medicine ejection preparation, the consumption of Radix Salviae Miltiorrhizae extract can be that every 100ml solution contains and is equivalent to the 100g-200g red rooted salvia and extracts Radix Salviae Miltiorrhizae extract with the process for refining preparation according to injection.
Described Radix Salviae Miltiorrhizae medicine ejection preparation dosage form can be made pharmaceutically acceptable regular dosage forms such as injection, freeze-dried powder.
A kind of above-mentioned preparation method that contains the Radix Salviae Miltiorrhizae medicine ejection preparation of polyethyleneglycol-12-hydroxy stearin comprises the steps:
(1) gets raw medicinal material Radix Salviae Miltiorrhizae 1000～2000 weight portions; Polyethyleneglycol-12-hydroxy stearin 1.0～10.0 weight portions;
(2) red rooted salvia extracts the Radix Salviae Miltiorrhizae extract for preparing with process for refining according to injection, adds polyethyleneglycol-12-hydroxy stearin and water for injection and is mixed with 1000ml solution;
(3) regulator solution pH value to 5.0～9.0, solution filters through microporous filter membrane; Fill, sterilization, namely.
Perhaps
(1) gets raw medicinal material Radix Salviae Miltiorrhizae 1000-2000 weight portion; Solutol
1.0-10.0 weight portion;
(2) Radix Salviae Miltiorrhizae decocts with water three times, and 2 hours for the first time, second and third time each 1.5 hours, collecting decoction filters, and filtrate decompression is concentrated into 750ml.Add the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 75%, make that to contain the alcohol amount be 85% for the second time, each all cold preservation is placed the back and is filtered, filtrate recycling ethanol, and be concentrated into about 250ml, add the injection water to 400ml, mixing, cold preservation is placed, filter, regulate pH value to 6.8 with 10% sodium hydroxide solution, boil half an hour, filter, filtrate adds the Polyethylene Glycol 12-hydroxy stearic acid ester, and adds the injection water to 1000ml, stirs evenly.
(3) regulate pH value to 6.8 with 10% sodium hydroxide solution, filter, embedding, sterilization, namely.
In step (2) and step (3), further optimize as follows:
(2) Radix Salviae Miltiorrhizae decocts with water three times, and 2 hours for the first time, second and third time each 1.5 hours, collecting decoction filters, and filtrate decompression is concentrated into 750ml.Add the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 75%, make that to contain the alcohol amount be 85% for the second time, each all cold preservation is placed the back and is filtered, filtrate recycling ethanol, and be concentrated into about 250ml, add the injection water to 400ml, mixing, cold preservation is placed, filter, regulate pH value to 6.8 with 10% sodium hydroxide solution, boil half an hour, filter, filtrate adds the Polyethylene Glycol 12-hydroxy stearic acid ester, and adds the injection water to 1000ml, stirs evenly.
(3) regulate pH value to 6.8 with 10% sodium hydroxide solution, filter, embedding, sterilization, namely.
The present invention discovers by experiment, at a kind of above-mentioned polyethyleneglycol-12-hydroxy stearin (Solutol that contains
) Radix Salviae Miltiorrhizae medicine ejection preparation in, polyethyleneglycol-12-hydroxy stearin (Solutol
) consumption the Radix Salviae Miltiorrhizae Injection composition is had good solute effect when being 0.1g～1.0g/100ml, and prove by concrete experimental data hereinafter, and preferable amount cost is relatively low when being 0.2g～0.5g/100ml, product quality is better, safety is higher relatively.Polyethyleneglycol-12-hydroxy stearin (Solutol
) recorded in European Pharmacopoeia (EP5.5), Deutscher Arzneibucs and British Pharmacopoeia, can be used for the solubilizing agent of ejection preparation.
In sum, the invention has the beneficial effects as follows: the present invention discovers by experiment, is containing polyethyleneglycol-12-hydroxy stearin (Solutol
) Radix Salviae Miltiorrhizae medicine ejection preparation in, polyethyleneglycol-12-hydroxy stearin (Solutol
) consumption can be stable in high temperature and storage process when being 0.1g～1.0g/100ml the visible foreign matters of maintenance injection detect the regulation that meets drug standard, improve the clarity of Radix Salviae Miltiorrhizae medicine ejection preparation, solved becoming sour easily that the existing cosolvent of Radix Salviae Miltiorrhizae medicine ejection preparation employing occurs in storage and high temperature sterilize process, cause the impurity content height, easily and ingredient generation chemical change, product still has a small amount of small particles in storage process, white piece, the problem of solution muddiness occurs, can guarantee that the visible foreign matters inspection of product meets the regulation of drug standard, is convenient to clinical application and popularization.
Description of drawings
Fig. 1 is that the variable concentrations polyethyleneglycol-12-hydroxy stearin is to the solubilization-aid effect sketch map of Radix Salviae Miltiorrhizae medicine ejection preparation.
The specific embodiment
The present invention is described in further detail below in conjunction with embodiment, but embodiments of the present invention are not limited thereto.
A kind of Radix Salviae Miltiorrhizae medicine ejection preparation that contains polyethyleneglycol-12-hydroxy stearin, mainly be dissolved in the injection medicine that water for injection is made by Radix Salviae Miltiorrhizae extract with for the polyethyleneglycol-12-hydroxy stearin that improves clarity of injection, the consumption of described polyethyleneglycol-12-hydroxy stearin is 0.1g～1.0g/100ml.
The concrete preparation method of present embodiment is as follows:
Radix Salviae Miltiorrhizae 1500g
Solutol
2.0g
Radix Salviae Miltiorrhizae decocts with water three times, and 2 hours for the first time, second and third time each 1.5 hours, collecting decoction filters, and filtrate decompression is concentrated into 750ml.Add the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 75%, make that to contain the alcohol amount be 85% for the second time, each all cold preservation is placed the back and is filtered, filtrate recycling ethanol, and be concentrated into about 250ml, add the injection water to 400ml, mixing, cold preservation is placed, and filters, and regulates pH value to 6.8 with 10% sodium hydroxide solution, boil half an hour, filter, filtrate adds the Polyethylene Glycol 12-hydroxy stearic acid ester, and adds the injection water to 1000ml, stir evenly, regulate pH value to 6.8 with 10% sodium hydroxide solution, filter embedding, sterilization, namely.
Radix Salviae Miltiorrhizae 1000-2000g
Solutol
1.0-10.0g
Radix Salviae Miltiorrhizae decocts with water three times, and 2 hours for the first time, second and third time each 1.5 hours, collecting decoction filters, and filtrate decompression is concentrated into 750ml.Add the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 75%, make that to contain the alcohol amount be 85% for the second time, each all cold preservation is placed the back and is filtered, filtrate recycling ethanol, and be concentrated into about 250ml, add the injection water to 400ml, mixing, cold preservation is placed, and filters, and regulates pH value to 6.8 with 10% sodium hydroxide solution, boil half an hour, filter, filtrate adds the Polyethylene Glycol 12-hydroxy stearic acid ester, and adds the injection water and be mixed with certain density solution, stir evenly, regulate pH value to 6.8 with 10% sodium hydroxide solution, filter packing, freeze-dried powder is made in lyophilization, namely.
Embodiment 3
Polyoxyethylene sorbitan monoleate and Solutol
The Radix Salviae Miltiorrhizae Injection stability comparative test of solubilising
Utilize the stability of solution of the prepared Radix Salviae Miltiorrhizae Injection of the present invention fine, solved Radix Salviae Miltiorrhizae Injection and in storage and high temperature sterilize process, be prone to problems such as precipitation, solution muddiness.Utilize the prepared Radix Salviae Miltiorrhizae Injection of the present invention according to the related request of two appendix XI of Chinese Pharmacopoeia version in 2005 XC pharmaceutical preparation stability test guideline, investigated respectively at 25 ℃ and placed 6 months, 60 ℃ medicine stabilities of placing 20 days of 36 months, 40 ℃ placements, the result is constant product quality under above-mentioned experimental condition, and each detects the regulation that index meets this product quality standard.
The pharmacological results shows: utilize the prepared Radix Salviae Miltiorrhizae Injection of the present invention not have hemolytic, no anaphylaxis, nonirritant, meet the requirement of drug administration by injection.
Table 1 Radix Salviae Miltiorrhizae Injection contains different amounts Solutol
End product quality is investigated the result
25 ℃ of study on the stability results of table 2
60 ℃ of study on the stability results of table 3
40 ℃ of study on the stability results of table 4
According to The above results as can be known, the polyethyleneglycol-12-hydroxy stearin (Solutol that contains of the present invention
) Radix Salviae Miltiorrhizae medicine ejection preparation under the long situation of period of storage (more than 24 months), can improve the clarity of Radix Salviae Miltiorrhizae medicine ejection preparation, the visible foreign matters of maintenance injection that can be stable detects the regulation that meets drug standard, having solved the problem that injection that Radix Salviae Miltiorrhizae medicine ejection preparation adopts existing cosolvent (tween 80) to occur under the long situation of period of storage has a small amount of small particles, white piece, solution muddiness occurs, can guarantee that the visible foreign matters inspection of product meets the regulation of drug standard, is convenient to clinical application and popularization.
As mentioned above, just can realize the present invention preferably.
Claims (1)
1. a preparation method that contains the Radix Salviae Miltiorrhizae medicine ejection preparation of polyethyleneglycol-12-hydroxy stearin is characterized in that, is undertaken by following step:
Get Radix Salviae Miltiorrhizae 1500g, polyethyleneglycol-12-hydroxy stearin 2.0g, Radix Salviae Miltiorrhizae decoct with water three times, 2 hours for the first time, second, three times each 1.5 hours, collecting decoction, filter, filtrate decompression is concentrated into 750ml, adds the ethanol precipitation secondary, make for the first time that to contain the alcohol amount be 75%, make that to contain the alcohol amount be 85% for the second time, each all cold preservation is placed the back and is filtered, filtrate recycling ethanol, and be concentrated into 250ml, add the injection water to 400ml, mixing, cold preservation is placed, and filters, and regulates pH value to 6.8 with 10% sodium hydroxide solution, boil half an hour, filter, filtrate adds the Polyethylene Glycol 12-hydroxy stearic acid ester, and adds the injection water to 1000ml, stir evenly, regulate pH value to 6.8 with 10% sodium hydroxide solution, filter embedding, sterilization, namely.
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| CN2013103179076A Division CN103417623A (en) | 2010-07-08 | 2010-07-08 | Salvia miltiorrhiza drug injection preparation containing polyethylene glycol 12 hydroxy stearic acid ester (Solutol HS 15, registered) and preparation method thereof |
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| 张永恒，等."丹参注射液".《医院制剂学》.人民卫生出版社,1986,第155页. |
| 张永恒,等."丹参注射液".《医院制剂学》.人民卫生出版社,1986,第155页. * |
| 易红，等."几种注射用表面活性剂的质量标准及安全性概述".《中国实验方剂学杂志》.2010,第16卷(第1期),第115-119页. |
| 易红,等."几种注射用表面活性剂的质量标准及安全性概述".《中国实验方剂学杂志》.2010,第16卷(第1期),第115-119页. * |
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Denomination of invention: Preparation method of polyethylene glycol 12-hydroxy stearate-containing danshen root medicament injection preparation Effective date of registration: 20141120 Granted publication date: 20130814 Pledgee: China Huarong Asset Management Limited by Share Ltd Sichuan branch Pledgor: Sichuan Sunnyhope Pharmaceutical Co., Ltd. Registration number: 2014510000035 |
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Date of cancellation: 20180209 Granted publication date: 20130814 Pledgee: China Huarong Asset Management Limited by Share Ltd Sichuan branch Pledgor: Sichuan Sunnyhope Pharmaceutical Co., Ltd. Registration number: 2014510000035 |