CN101897756B - Preparation method of silver yellow medicinal preparation containing polyethylene glycol 12-hydroxy stearate - Google Patents
Preparation method of silver yellow medicinal preparation containing polyethylene glycol 12-hydroxy stearate Download PDFInfo
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- CN101897756B CN101897756B CN2010102212745A CN201010221274A CN101897756B CN 101897756 B CN101897756 B CN 101897756B CN 2010102212745 A CN2010102212745 A CN 2010102212745A CN 201010221274 A CN201010221274 A CN 201010221274A CN 101897756 B CN101897756 B CN 101897756B
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Abstract
The invention discloses a silver yellow medicinal preparation containing polyethylene glycol 12-hydroxy stearate and a preparation method thereof. The silver yellow medicinal preparation is an injection medicament which is mainly prepared by dissolving a honeysuckle flower extract, a baical skullcap root extract and the polyethylene glycol 12-hydroxy stearate for enhancing the clarity of injection in water for injection, wherein the dosage of the polyethylene glycol 12-hydroxy stearate is between 0.1 and 1.0 g/100ml. Under the condition that the silver yellow medicinal preparation is stored for a long time (more than 24 months), the clarity of the silver yellow medicinal preparation can be enhanced, the detection of visible foreign matters of the injection can be stably kept in accordancewith the specification of medicament quality standard, the problems of a small number of small white points, white blocks and solution turbidness of the injection occurring under the condition that the silver yellow medicinal preparation is stored by using the conventional cosolvent (Twain-80) for a long time are solved, the detection of the visible foreign matters of the injection can be ensuredin accordance with the specification of the medicament quality standard, and convenience is brought to clinical administration and popularization.
Description
Technical field
The present invention particularly, relates to a kind of silver yellow pharmaceutical preparation that contains polyethyleneglycol-12-hydroxy stearin in medical technical field.
Background technology
The YINHUANG ZHUSHEYE standard is recorded in health drug standard promulgated by the ministries or commissions of the Central Government (WS3-B-3691-98, Chinese traditional patent formulation preparation), and crude drug is Radix Scutellariae extract 20.0g (in baicalin), Flos Lonicerae extract 12.5g (in chlorogenic acid).More than two flavors, add an amount of dissolving of injection water and 80% sodium hydroxide solution respectively after, mixing, add the injection water to about 980ml, regulate pH value to 7.2 with 80% sodium hydroxide solution, it is an amount of to add active carbon, puts in the water-bath and heats 1 hour, put cold, add benzyl alcohol 10ml, be adjusted to 1000ml, filter with water for injection, embedding, sterilization.Promptly.
YINHUANG ZHUSHEYE has the effect of heat clearing away, detoxifcation, sore-throat relieving.Clinical be used for the treatment of wind-heat invading the lung and cause heating, the cough, diseases such as pharyngalgia, upper respiratory tract infection, acute tonsillitis, pharyngitis see above-mentioned patient all available it.
The complicated component of Flos Lonicerae extract, Radix Scutellariae extract, baicalin are poorly soluble in water, cause YINHUANG ZHUSHEYE to be prone to problems such as small particles, precipitation and solution muddiness in storage and high temperature sterilize process.At present, use benzyl alcohol as cosolvent in the YINHUANG ZHUSHEYE, product still has the problem of a small amount of small particles, precipitation and 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 CN200410091534.6A discloses a kind of honey suckle and baikal skullcap root freeze dried injection and preparation method thereof, adopt the HP-beta-schardinger dextrin-as cosolvent, but the hydrotropy principle and the benzyl alcohol of HP-beta-schardinger dextrin-is different, may influence medicine pharmacological action in vivo.Bibliographical information (crown canopy hero etc., the research that 2006 the 18th volumes of Strait Pharmaceutical Journal the 2nd phase YINHUANG ZHUSHEYE preparation process is selected the pH optimum) YINHUANG ZHUSHEYE is because of the chlorogenic acid facile hydrolysis, baicalin easily precipitation is separated out, it is undesirable often to occur chlorogenic acid content decline or clarity in process of production, in order to address this problem the screening of having carried out optimal pH.But 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 silver yellow pharmaceutical preparation that contains polyethyleneglycol-12-hydroxy stearin, it could be when Chinese medicine extract is obtaining maxima solubility, to solve YINHUANG ZHUSHEYE satisfactorily and be prone to problems such as small particles, precipitation and solution muddiness in storage and high temperature sterilize process making active component that certain density polyethyleneglycol-12-hydroxy stearin is used in this silver yellow pharmaceutical preparation.
The present invention addresses the above problem the technical scheme that is adopted: a kind of polyethyleneglycol-12-hydroxy stearin (Solutol that contains
) silver yellow pharmaceutical preparation, main by Flos Lonicerae extract, Radix Scutellariae extract and the polyethyleneglycol-12-hydroxy stearin that is used to improve clarity of injection be dissolved in the injection medicine that water for injection is made, 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 silver yellow pharmaceutical preparation, the consumption of Flos Lonicerae extract, Radix Scutellariae extract can be that every 100ml solution contains and is equivalent to Radix Scutellariae extract 1.5～2.5g (in baicalin), Flos Lonicerae extract 1.0～1.5g (in chlorogenic acid).The usage ratio of Radix Scutellariae extract and Flos Lonicerae extract is 8: 5.
Described silver yellow medicament form of pharmaceutical preparation is injection or freeze-dried powder.The silver yellow medicament form of pharmaceutical preparation can be made pharmaceutically acceptable regular dosage forms such as injection, freeze-dried powder.
A kind of above-mentioned preparation method that contains the silver yellow pharmaceutical preparation of polyethyleneglycol-12-hydroxy stearin comprises the steps:
(1) in baicalin get Radix Scutellariae extract 15～25 weight portions, in chlorogenic acid extracting honeysuckle extract 10～15 weight portions, polyethyleneglycol-12-hydroxy stearin 1.0～10.0 weight portions;
(2) Radix Scutellariae extract, Flos Lonicerae extract add polyethyleneglycol-12-hydroxy stearin and water for injection and are mixed with solution after extraction and process for refining are handled;
(3) regulator solution pH value to 5.0～9.0, solution filters through microporous filter membrane; Fill, sterilization, promptly.
Perhaps
(1) gets Radix Scutellariae extract 15～25 weight portions (in baicalin), Flos Lonicerae extract 10～15 weight portions (in chlorogenic acid), polyethyleneglycol-12-hydroxy stearin 1.0～10.0 weight portions;
(2) above two flavors, after adding an amount of dissolving of injection water and 80% sodium hydroxide solution respectively, mix, add the injection water to about 980ml, regulate pH value to 7.2 with 80% sodium hydroxide solution, it is an amount of to add active carbon, put in the water-bath and heated 1 hour, put coldly, add polyethyleneglycol-12-hydroxy stearin, be adjusted to 1000ml with water for injection;
(3) regulate pH value to 7.2 with 80% sodium hydroxide solution, solution filters through microporous filter membrane, embedding, sterilization.Promptly.
In step (2) and step (3), further optimize as follows:
(2) above two flavors, after adding an amount of dissolving of injection water and 80% sodium hydroxide solution respectively, mix, add the injection water to about 980ml, regulate pH value to 7.2 with 80% sodium hydroxide solution, it is an amount of to add active carbon, put in the water-bath and heated 1 hour, put coldly, add polyethyleneglycol-12-hydroxy stearin, be adjusted to 1000ml with water for injection;
(3) regulate pH value to 7.2 with 80% sodium hydroxide solution, solution filters through microporous filter membrane, embedding, sterilization.Promptly.
Still more preferably, adopt raw material Radix Scutellariae extract 20g (in baicalin), Flos Lonicerae extract 12.5g (in chlorogenic acid), polyethyleneglycol-12-hydroxy stearin 2.0g;
The present invention discovers by experiment, at a kind of above-mentioned polyethyleneglycol-12-hydroxy stearin (Solutol that contains
) silver yellow pharmaceutical preparation in, polyethyleneglycol-12-hydroxy stearin (Solutol
) consumption the YINHUANG ZHUSHEYE 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 polyethyleneglycol-12-hydroxy stearin (Solutol that contains of the present invention
) silver yellow pharmaceutical 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 silver yellow pharmaceutical preparation detect the regulation that meets drug standard, improve the clarity of silver yellow pharmaceutical preparation, solved becoming sour easily that the existing cosolvent of silver yellow pharmaceutical 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 the solubilization-aid effect sketch map of variable concentrations polyethyleneglycol-12-hydroxy stearin to silver yellow pharmaceutical 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 silver yellow pharmaceutical preparation that contains polyethyleneglycol-12-hydroxy stearin, main by Flos Lonicerae extract, Radix Scutellariae extract and the polyethyleneglycol-12-hydroxy stearin that is used to improve clarity of injection be dissolved in the injection medicine that water for injection is made, the consumption of described polyethyleneglycol-12-hydroxy stearin is 0.1g～1.0g/100ml.
Above-mentioned silver yellow preparation of pharmaceutical formulations method is as follows:
Radix Scutellariae extract 20.0g (in baicalin)
Flos Lonicerae extract 12.5g (in chlorogenic acid)
More than two the flavor, after adding an amount of dissolving of injection water and 80% sodium hydroxide solution respectively, mix, add the injection water to about 980ml, regulate pH value to 7.2 with 80% sodium hydroxide solution, it is an amount of to add active carbon, put in the water-bath and heated 1 hour, put coldly, add polyethyleneglycol-12-hydroxy stearin, be adjusted to 1000ml with water for injection.Regulate pH value to 7.2 with 80% sodium hydroxide solution, solution filters through microporous filter membrane, embedding, sterilization.Promptly.
Radix Scutellariae extract 20.0g (in baicalin)
Flos Lonicerae extract 12.5g (in chlorogenic acid)
More than two the flavor, after adding an amount of dissolving of injection water and 80% sodium hydroxide solution respectively, mix, add the injection water to about 500ml, regulate pH value to 7.2 with 80% sodium hydroxide solution, it is an amount of to add active carbon, put in the water-bath and heated 1 hour, put coldly, add polyethyleneglycol-12-hydroxy stearin, be adjusted to the solution of certain volume with water for injection.Regulate pH value to 7.2 with 80% sodium hydroxide solution, solution filters through microporous filter membrane.Packing, lyophilization, promptly.
Embodiment 3
Polyoxyethylene sorbitan monoleate (being Tween 80) and Solutol
The YINHUANG ZHUSHEYE stability comparative test of solubilising
Utilize the stability of solution of the prepared YINHUANG ZHUSHEYE of the present invention fine, solve YINHUANG ZHUSHEYE and in storage and high temperature sterilize process, be prone to small particles, problems such as precipitation and solution muddiness, utilize the related request of the prepared YINHUANG ZHUSHEYE of the present invention according to two appendix XI of Chinese Pharmacopoeia version in 2005 XC pharmaceutical preparation stability test guideline, investigated respectively at 25 ℃ and placed 36 months, placed 6 months for 40 ℃, 60 ℃ of medicine stabilities of placing 20 days, the result is constant product quality under above-mentioned experimental condition, and every detection index all meets the regulation of this product quality standard.
The pharmacological results shows: utilize the prepared YINHUANG ZHUSHEYE of the present invention not have hemolytic, no anaphylaxis, nonirritant, meet the requirement of drug administration by injection.
Table 1 YINHUANG ZHUSHEYE 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 that contains of the present invention
Silver yellow pharmaceutical preparation under the long situation of period of storage (more than 24 months), can improve the clarity of silver yellow pharmaceutical 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 silver yellow pharmaceutical 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 silver yellow pharmaceutical preparation of polyethyleneglycol-12-hydroxy stearin is characterized in that, is undertaken by following step:
Get Radix Scutellariae extract 20.0g, in the Flos Lonicerae extract 12.5g of chlorogenic acid, polyethyleneglycol-12-hydroxy stearin 2.0g in baicalin; After Radix Scutellariae extract, Flos Lonicerae extract add injection water and the dissolving of 80% sodium hydroxide solution respectively, mix, add the injection water to 980ml, regulate pH value to 7.2 with 80% sodium hydroxide solution, it is an amount of to add active carbon, puts in the water-bath and heats 1 hour, puts cold, add polyethyleneglycol-12-hydroxy stearin, be adjusted to 1000ml with water for injection; Regulate pH value to 7.2 with 80% sodium hydroxide solution, solution filters through microporous filter membrane, embedding, and sterilization, promptly.
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| CN101518617B (en) * | 2009-04-02 | 2010-09-08 | 四川升和制药有限公司 | Pharmaceutical composition for improving safety of Shenmai injection and method for preparing same |
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Non-Patent Citations (4)
| Title |
|---|
| 中华人民共和国卫生部药典委员会."银黄注射液".《中华人民共和国卫生部药品标准中药成方制剂（第十九册）》.1998,第197页. |
| 中华人民共和国卫生部药典委员会."银黄注射液".《中华人民共和国卫生部药品标准中药成方制剂(第十九册)》.1998,第197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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Address after: No. 3 high tech Zone Gaopeng road in Chengdu city of Sichuan Province in 610000 Applicant after: Sichuan Sunnyhope Pharmaceutical Co., Ltd. Address before: High tech Zone Gaopeng road in Chengdu city of Sichuan province 610041 3 block A No. 9 Applicant before: Sichuan Sunnyhope Pharmaceutical Co., Ltd. |
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Denomination of invention: Preparation method of silver yellow medicinal preparation containing polyethylene glycol 12-hydroxy stearate Effective date of registration: 20141120 Granted publication date: 20130731 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: 20130731 Pledgee: China Huarong Asset Management Limited by Share Ltd Sichuan branch Pledgor: Sichuan Sunnyhope Pharmaceutical Co., Ltd. Registration number: 2014510000035 |