CN105106111A - Safe medicine composition for compound gastrodin injection and preparation method of safe medicine composition - Google Patents
Safe medicine composition for compound gastrodin injection and preparation method of safe medicine composition Download PDFInfo
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Abstract
The invention discloses a safe medicine composition for a compound gastrodin injection and a preparation method of the safe medicine composition. The safe medicine composition used for injection is mainly prepared from a gastrodin extract, a Szechuan lovage rhizome extract, a carthamus tinctorius extract and 12-hydroxystearic acid-polyethylene glycol. The safe medicine composition has the advantages that a solubilizing agent with higher safety and a more obvious solubilizing effect is utilized for replacing polysorbate 80 in the conventional compound gastrodin injection; polysorbate 80 has a potential safety hazard and affects the quality of the conventional compound gastrodin injection, 12-hydroxystearic acid-polyethylene glycol has higher safety than polysorbate 80, and the dose of 12-hydroxystearic acid-polyethylene glycol is lower than that of polysorbate 80, so that the possibility and risk of an adverse medicine reaction are reduced, and the safety of clinical medication is improved.
Description
Technical field
The invention belongs to medical art, particularly, relate to a kind of preparation method improving the pharmaceutical composition of compound gastrodia elata element injection safety.
Background technology
Compound gastrodia elata element injection standard is recorded in health drug standard promulgated by the ministries or commissions of the Central Government (Traditional Chinese medicine historical preparation), and crude drug is gastrodine, Rhizoma Chuanxiong, Flos Carthami, belongs to Chinese medicine injection.There is promoting blood circulation to restore menstrual flow, effect of stasis-dispelling and pain-killing.Clinically be used for the treatment of dysmenorrhea, amenorrhea, injury from falling down, rheumatic arthralgia etc.
In China in wide clinical application for many years, clinical efficacy obtains the favorable comment of doctor and patient to compound gastrodia elata element injection.But in recent years, the Reporting of harms of Chinese medicine injection clinical practice is on the rise, and have impact on the development of the Chinese medicine injection with Chinese Medicine characteristic.Domestic experts and scholars have carried out large quantity research to the untoward reaction of Chinese medicine injection, and the cosolvent polyoxyethylene sorbitan monoleate (Tween 80) that there is potential safety hazard added in the generation of its untoward reaction of bibliographical information and Chinese medicine injection has very large relation.Due to Chinese medicine injection complicated component, affect clarity, solution ph storing and easily occur solute to separate out in autoclaving process and obviously descend degradation problem, therefore in such injection, add polyoxyethylene sorbitan monoleate (Tween 80) make cosolvent, the solubilization-aid effect adding other cosolvents is then not obvious.But polyoxyethylene sorbitan monoleate (Tween 80) due to process for refining immature, easily become sour in storage and autoclaving process, cause impurity content high, be difficult to reach injection standard, polyoxyethylene sorbitan monoleate (Tween 80) inherently has stronger hemolytic and anaphylaxis, is applied in injection the probability and risk that add and untoward reaction occurs.In addition, also there is in sterilizing and storage process itself problem that solution ph obviously declines in Chinese medicine injection, and polyoxyethylene sorbitan monoleate (Tween 80) easily becomes sour, and more accelerates the decline of the pH value of medicinal liquid.Also add polyoxyethylene sorbitan monoleate (Tween 80) in the compound gastrodia elata element injection of current domestic production and make cosolvent, be faced with same problem.
In view of the foregoing, finding the polyoxyethylene sorbitan monoleate (Tween 80) that safety is better, poor stability replaced by the more obvious cosolvent of solubilization-aid effect is this injection urgent problem.
Summary of the invention
Technical problem to be solved by this invention is to provide the preparation method that a kind of safety is better, solubilization-aid effect more obviously improves the pharmaceutical composition of compound gastrodia elata element injection safety.
The present invention solves the problems of the technologies described above adopted technical scheme: a kind of pharmaceutical composition improving the safety of compound gastrodia elata element injection, primarily of the injection pharmaceutical composition that gastrodin, Rhizoma Chuanxiong extract, Flos Carthami extract and polyethyleneglycol-12-hydroxy stearin are made.
Described medicine composition dosage form is injection, powder pin or lyophilizing.
A preparation method for the pharmaceutical composition of above-mentioned raising compound gastrodia elata element injection safety, comprises the steps: (1) compound gastrodia elata element injection raw medicinal material gastrodine 100g, Rhizoma Chuanxiong 100g, Flos Carthami 100g, cosolvent 2.0g, described cosolvent is made up of polyethyleneglycol-12-hydroxy stearin and polyoxyethylene sorbitan monoleate, and wherein the content of polyethyleneglycol-12-hydroxy stearin is 0.005g ~ 1.9g, and surplus is polyoxyethylene sorbitan monoleate, (2) gastrodine, Rhizoma Chuanxiong decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume to relative density is 1.27 ~ 1.30(80 DEG C), let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.30(80 DEG C), add 3 times of water gagings, fully stir, cold preservation 48 hours, filter, filtrate reduced in volume is about 1.15(80 DEG C to relative density), medicinal liquid is for subsequent use, Flos Carthami decocts with water secondary, each 1 hour, collecting decoction, filter, it is 1.25 ~ 1.30(80 DEG C that filtrate is concentrated into relative density), let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, filtrate reduced in volume to relative density is 1.20(80 DEG C), add ethanol make containing amount of alcohol be 70%, hold over night, filter, it is 1.30(80 DEG C that filtrate is concentrated into relative density), add 3 times of water gagings, abundant stirring, cold preservation 48 hours, filter, it is 1.15(80 DEG C that filtrate is concentrated into relative density), merge with above-mentioned medicinal liquid, add 2 times of water gagings, abundant stirring, cold preservation 24 hours, filter, filtrate adds cosolvent and water for injection is mixed with 1000ml solution.Stir evenly.(3) regulate solution ph to 6.5-8.5 with 20% sodium hydroxide solution.(4) above-mentioned solution is filtered through microporous filter membrane.(5) fill, sterilizing, to obtain final product.
The present invention, by a large amount of experimentatioies, finds a kind of Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (SolutolHS-15
?) be the desirable substitute products of polyoxyethylene sorbitan monoleate.Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (SolutolHS-15
?) recorded in European Pharmacopoeia (EP5.5), Deutscher Arzneibucs and British Pharmacopoeia, can be used for the solubilizing agent of ejection preparation.The pharmacological toxicology experimental data of bibliographical information shows that its toxicity is starkly lower than polyoxyethylene sorbitan monoleate (Tween 80).We be experimental studies have found that by a large amount of in addition, Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (SolutolHS-15 when reaching identical solubilization-aid effect
?) amount ratio polyoxyethylene sorbitan monoleate (Tween 80) low, more improve Drug safety.
To sum up, the invention has the beneficial effects as follows: provide that a kind of safety is better, the more obvious cosolvent of solubilization-aid effect replaces in compound gastrodia elata element injection the cosolvent polyoxyethylene sorbitan monoleate (Tween 80) that there is potential safety hazard and affect product quality; Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (SolutolHS-15
?) safety higher and consumption is lower than polyoxyethylene sorbitan monoleate (Tween 80), reduce probability and the risk of medicine generation untoward reaction, improve the safety of clinical application.
Detailed description of the invention
embodiment 1
Gastrodine 100g
Rhizoma Chuanxiong 100g
Flos Carthami 100g
SolutolHS-15
?2.0g
Preparation method: gastrodine, Rhizoma Chuanxiong decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume to relative density is 1.27 ~ 1.30(80 DEG C), let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.30(80 DEG C), add 3 times of water gagings, fully stir, cold preservation 48 hours, filter, filtrate reduced in volume is about 1.15(80 DEG C to relative density), medicinal liquid is for subsequent use, Flos Carthami decocts with water secondary, each 1 hour, collecting decoction, filter, it is 1.25 ~ 1.30(80 DEG C that filtrate is concentrated into relative density), let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, filtrate reduced in volume to relative density is 1.20(80 DEG C), add ethanol make containing amount of alcohol be 70%, hold over night, filter, it is 1.30(80 DEG C that filtrate is concentrated into relative density), add 3 times of water gagings, abundant stirring, cold preservation 48 hours, filter, it is 1.15(80 DEG C that filtrate is concentrated into relative density), merge with above-mentioned medicinal liquid, add 2 times of water gagings, abundant stirring, cold preservation 24 hours, filter, filtrate adds Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (SolutolHS-15
?) make cosolvent and water for injection is mixed with 1000ml solution.Stir evenly.Regulate solution ph to 6.5-8.5 with 20% sodium hydroxide solution.Above-mentioned solution is filtered through microporous filter membrane.Fill, sterilizing, to obtain final product.
embodiment 2
Gastrodine 100g
Rhizoma Chuanxiong 100g
Flos Carthami 100g
SolutolHS-15
?1.0g
Tween 80 1.0
Preparation method: gastrodine, Rhizoma Chuanxiong decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume to relative density is 1.27 ~ 1.30(80 DEG C), let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.30(80 DEG C), add 3 times of water gagings, fully stir, cold preservation 48 hours, filter, filtrate reduced in volume is about 1.15(80 DEG C to relative density), medicinal liquid is for subsequent use, Flos Carthami decocts with water secondary, each 1 hour, collecting decoction, filter, it is 1.25 ~ 1.30(80 DEG C that filtrate is concentrated into relative density), let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, filtrate reduced in volume to relative density is 1.20(80 DEG C), add ethanol make containing amount of alcohol be 70%, hold over night, filter, it is 1.30(80 DEG C that filtrate is concentrated into relative density), add 3 times of water gagings, abundant stirring, cold preservation 48 hours, filter, it is 1.15(80 DEG C that filtrate is concentrated into relative density), merge with above-mentioned medicinal liquid, add 2 times of water gagings, abundant stirring, cold preservation 24 hours, filter, filtrate adds Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (SolutolHS-15
?) and tween 80 makes cosolvent and water for injection is mixed with 1000ml solution.Stir evenly.Regulate solution ph to 6.5-8.5 with 20% sodium hydroxide solution.Above-mentioned solution is filtered through microporous filter membrane.Fill, sterilizing, to obtain final product.
embodiment 3
Gastrodine 100g
Rhizoma Chuanxiong 100g
Flos Carthami 100g
SolutolHS-15
?2.0g
Preparation method: gastrodine, Rhizoma Chuanxiong decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume to relative density is 1.27 ~ 1.30(80 DEG C), let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.30(80 DEG C), add 3 times of water gagings, fully stir, cold preservation 48 hours, filter, filtrate reduced in volume is about 1.15(80 DEG C to relative density), medicinal liquid is for subsequent use, Flos Carthami decocts with water secondary, each 1 hour, collecting decoction, filter, it is 1.25 ~ 1.30(80 DEG C that filtrate is concentrated into relative density), let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, filtrate reduced in volume to relative density is 1.20(80 DEG C), add ethanol make containing amount of alcohol be 70%, hold over night, filter, it is 1.30(80 DEG C that filtrate is concentrated into relative density), add 3 times of water gagings, abundant stirring, cold preservation 48 hours, filter, it is 1.15(80 DEG C that filtrate is concentrated into relative density), merge with above-mentioned medicinal liquid, add 2 times of water gagings, abundant stirring, cold preservation 24 hours, filter, filtrate adds Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (SolutolHS-15
?) make cosolvent and water for injection is mixed with solution.Stir evenly.Regulate solution ph to 6.5-8.5 with 20% sodium hydroxide solution.Above-mentioned solution is filtered through microporous filter membrane.Be distributed into 1000, lyophilization, obtain final product.
Embodiment 4:
Gastrodin of the present invention, Rhizoma Chuanxiong extract, Flos Carthami extract and Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (SolutolHS-15
?) the injection pharmaceutical composition made realizes by following technical scheme:
(1) compound gastrodia elata element injection raw medicinal material gastrodine 100g, Rhizoma Chuanxiong 100g, Flos Carthami 100g, Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (SolutolHS-15
?) 2.0g;
(2) gastrodine, Rhizoma Chuanxiong decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume to relative density is 1.27 ~ 1.30(80 DEG C), let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.30(80 DEG C), add 3 times of water gagings, fully stir, cold preservation 48 hours, filter, filtrate reduced in volume is about 1.15(80 DEG C to relative density), medicinal liquid is for subsequent use, Flos Carthami decocts with water secondary, each 1 hour, collecting decoction, filter, it is 1.25 ~ 1.30(80 DEG C that filtrate is concentrated into relative density), let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, filtrate reduced in volume to relative density is 1.20(80 DEG C), add ethanol make containing amount of alcohol be 70%, hold over night, filter, it is 1.30(80 DEG C that filtrate is concentrated into relative density), add 3 times of water gagings, abundant stirring, cold preservation 48 hours, filter, it is 1.15(80 DEG C that filtrate is concentrated into relative density), merge with above-mentioned medicinal liquid, add 2 times of water gagings, abundant stirring, cold preservation 24 hours, filter, filtrate adds Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester (SolutolHS-15
?) make cosolvent and water for injection is mixed with 1000ml solution.Stir evenly.
(3) regulate solution ph to 6.5-8.5 with 20% sodium hydroxide solution.
(4) above-mentioned solution is filtered through microporous filter membrane.
(5) fill, sterilizing, to obtain final product.
In the present invention, cosolvent can be polyethyleneglycol-12-hydroxy stearin, and its consumption is the arbitrary value in 0.005g ~ 5.0g/100ml, as 0.005g/100ml, 0.01g/100ml, 0.05g/100ml, 1.0g/100ml, 5.0g/100ml etc.; Cosolvent also can be made up of polyethyleneglycol-12-hydroxy stearin and polyoxyethylene sorbitan monoleate, and its usage ratio is 0.005g ~ 5.0g/100ml:0.001g ~ 2.0g/100ml.
Claims (3)
1. improve a preparation method for compound gastrodia elata element injection safety pharmaceutical composition, it is characterized in that, comprise the steps:
(1) compound gastrodia elata element injection raw medicinal material gastrodine 100g, Rhizoma Chuanxiong 100g, Flos Carthami 100g, cosolvent 2.0g;
(2) gastrodine, Rhizoma Chuanxiong decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume is 1.27 ~ 1.30 to relative density, lets cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, decompression filtrate recycling ethanol to be concentrated into relative density be 1.30, adds 3 times of water gagings, fully stirs, cold preservation 48 hours, filter, filtrate reduced in volume is about 1.15 to relative density, and medicinal liquid is for subsequent use, Flos Carthami decocts with water secondary, each 1 hour, collecting decoction, filter, it is 1.25 ~ 1.30 that filtrate is concentrated into relative density, let cool, add ethanol make containing amount of alcohol be 65%, hold over night, filter, filtrate reduced in volume to relative density is 1.20, add ethanol make containing amount of alcohol be 70%, hold over night, filter, it is 1.30 that filtrate is concentrated into relative density, add 3 times of water gagings, abundant stirring, cold preservation 48 hours, filter, it is 1.15 that filtrate is concentrated into relative density, merge with above-mentioned medicinal liquid, add 2 times of water gagings, abundant stirring, cold preservation 24 hours, filter, filtrate adds cosolvent and water for injection is mixed with 1000ml solution, stir evenly, the relative density of above-mentioned each filtrate is relative density when 80 DEG C,
(3) regulate solution ph to 6.5-8.5 with 20% sodium hydroxide solution;
(4) above-mentioned solution is filtered through microporous filter membrane;
(5) fill, sterilizing, to obtain final product.
2. want a kind of preparation method improving compound gastrodia elata element injection safety pharmaceutical composition described in 1 according to right, it is characterized in that, in described step (1), cosolvent is made up of polyethyleneglycol-12-hydroxy stearin and polyoxyethylene sorbitan monoleate.
3. want a kind of preparation method improving compound gastrodia elata element injection safety pharmaceutical composition described in 1 according to right, it is characterized in that, the content of described polyethyleneglycol-12-hydroxy stearin is 0.005g ~ 1.9g, and surplus is polyoxyethylene sorbitan monoleate.
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CN106361813A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Drug composition for improving safety of compound ginseng injection |
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CN106361813A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Drug composition for improving safety of compound ginseng injection |
CN106361914A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Preparation method of drug composition for improving safety of compound crocus sativus injection |
CN106474206A (en) * | 2016-11-06 | 2017-03-08 | 成都先先先生物科技有限公司 | A kind of preparation method improving compound recipe Dinggongteng Injection safety pharmaceutical composition |
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Application publication date: 20151202 |