CN105079067A - Pharmaceutical composition for improving safety of compound gastrodin injection - Google Patents
Pharmaceutical composition for improving safety of compound gastrodin injection Download PDFInfo
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- CN105079067A CN105079067A CN201510616522.9A CN201510616522A CN105079067A CN 105079067 A CN105079067 A CN 105079067A CN 201510616522 A CN201510616522 A CN 201510616522A CN 105079067 A CN105079067 A CN 105079067A
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Abstract
The invention discloses a pharmaceutical composition for improving the safety of a compound gastrodin injection. The pharmaceutical composition is mainly prepared from gastrodin extract, extract of chuanxiong rhizome, safflower extract and Solutol HS-15 for injections. According to the pharmaceutical composition for improving the safety of the compound gastrodin injection, cosolvent of polysorbate 80 which can cause potential safety hazards and affect product quality is replaced with cosolvent with better safety and a more obvious hydrotropy effect in the compound gastrodin injection, the safety of the Solutol HS-15 is higher than that of the polysorbate 80, the dosage of the Solutol HS-15 is lower than that of the polysorbate 80, the occurrence probability of untoward effects and risks of pharmaceuticals 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 pharmaceutical composition improving the safety of compound gastrodia elata element injection.
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 pharmaceutical composition that a kind of safety is better, solubilization-aid effect more obviously improves the safety of compound gastrodia elata element injection.
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.
In order to realize the present invention better, further, every 100ml solution is containing gastrodin, the Rhizoma Chuanxiong extract of 5-15g Ligusticum chuanxiong Hort, the Flos Carthami extract of 5-15g flos carthami of 5-15g gastrodine medical material, and the usage ratio of gastrodine, Rhizoma Chuanxiong, flos carthami is 1:1:1.
In order to realize the present invention better, further, the consumption of described polyethyleneglycol-12-hydroxy stearin is 0.005g ~ 5.0g/100ml.
In order to realize the present invention better, further, the consumption of described polyethyleneglycol-12-hydroxy stearin is 0.05g ~ 1.0g/100ml.
In order to realize the present invention better, further, also comprise polyoxyethylene sorbitan monoleate in described pharmaceutical composition, the usage ratio of polyethyleneglycol-12-hydroxy stearin and polyoxyethylene sorbitan monoleate is 0.005g ~ 5.0g/100ml:0.001g ~ 2.0g/100ml.
In order to realize the present invention better, further, described medicine composition dosage form is injection, powder pin or lyophilizing.
The preparation method of 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 ~ 2.0g, 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), 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 (80 DEG C), adds 3 times of water gagings, fully stirs, cold preservation 48 hours, filter, filtrate reduced in volume to relative density is about 1.15 (80 DEG C), 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 (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
the desirable substitute products of polyoxyethylene sorbitan monoleate.Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester
record 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 when reaching identical solubilization-aid effect
amount ratio polyoxyethylene sorbitan monoleate (Tween 80) low, more improve Drug safety.
The pharmacological toxicology experimental data of bibliographical information shows Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester
safety higher than polyoxyethylene sorbitan monoleate (Tween 80), its toxicity is starkly lower than polyoxyethylene sorbitan monoleate (Tween 80) (see the following form 1-3).(0.5g/100ml) Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester of equivalent is used respectively in compound gastrodia elata element injection
with polyoxyethylene sorbitan monoleate (Tween 80), safety experiment comparative study result shows, uses (0.5g/100ml) Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester of equivalent
group is all obviously organized low than use polyoxyethylene sorbitan monoleate (Tween 80) in hemolytic, zest, anaphylaxis and the toxicity such as to reduce blood pressure, considerably reduce by the present invention probability and the risk that untoward reaction occurs compound gastrodia elata element injection in clinical practice, improve the safety of clinical application.
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
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
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), 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 (80 DEG C), adds 3 times of water gagings, fully stirs, cold preservation 48 hours, filter, filtrate reduced in volume to relative density is about 1.15 (80 DEG C), 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 (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 (Solutol
) 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
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), 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 (80 DEG C), adds 3 times of water gagings, fully stirs, cold preservation 48 hours, filter, filtrate reduced in volume to relative density is about 1.15 (80 DEG C), 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 (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
cosolvent is made and water for injection is mixed with 1000ml solution with tween 80.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
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), 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 (80 DEG C), adds 3 times of water gagings, fully stirs, cold preservation 48 hours, filter, filtrate reduced in volume to relative density is about 1.15 (80 DEG C), 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 (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
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
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
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), 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 (80 DEG C), adds 3 times of water gagings, fully stirs, cold preservation 48 hours, filter, filtrate reduced in volume to relative density is about 1.15 (80 DEG C), 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 (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
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.
The present invention adopts polyethyleneglycol-12-hydroxy stearin as after cosolvent, and its safety is better, solubilization-aid effect is more obviously better than polyoxyethylene sorbitan monoleate, and concrete data see table:
Table 1
with polyoxyethylene sorbitan monoleate (Tween 80) LD
50toxicity test data compare
Table 2 intravenous injection
haemolysis and serum histamine levels compare afterwards with polyoxyethylene sorbitan monoleate (Tween 80)
Table 3 intravenous injection
compare with polyoxyethylene sorbitan monoleate (Tween 80) blood pressure lowering level afterwards
Claims (6)
1. improve a pharmaceutical composition for compound gastrodia elata element injection safety, it is characterized in that, primarily of the injection pharmaceutical composition that gastrodin, Rhizoma Chuanxiong extract, Flos Carthami extract and polyethyleneglycol-12-hydroxy stearin are made.
2. the pharmaceutical composition of raising compound gastrodia elata element injection according to claim 1 safety, it is characterized in that, every 100ml solution is containing gastrodin, the Rhizoma Chuanxiong extract of 5-15g Ligusticum chuanxiong Hort, the Flos Carthami extract of 5-15g flos carthami of 5-15g gastrodine medical material, and the usage ratio of gastrodine, Rhizoma Chuanxiong, flos carthami is 1:1:1.
3. the pharmaceutical composition of raising compound gastrodia elata element injection according to claim 1 safety, it is characterized in that, the consumption of described polyethyleneglycol-12-hydroxy stearin is 0.005g ~ 5.0g/100ml.
4. the pharmaceutical composition of raising compound gastrodia elata element injection according to claim 3 safety, it is characterized in that, the consumption of described polyethyleneglycol-12-hydroxy stearin is 0.05g ~ 1.0g/100ml.
5. the pharmaceutical composition of raising compound gastrodia elata element injection according to claim 1 safety, it is characterized in that, also comprise polyoxyethylene sorbitan monoleate in described pharmaceutical composition, the usage ratio of polyethyleneglycol-12-hydroxy stearin and polyoxyethylene sorbitan monoleate is 0.005g ~ 5.0g/100ml:0.001g ~ 2.0g/100ml.
6. the pharmaceutical composition of the raising compound gastrodia elata element injection safety according to claim 1 to 5 any one, it is characterized in that, described medicine composition dosage form is injection, powder pin or lyophilizing.
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| CN104415321A (en) * | 2013-09-10 | 2015-03-18 | 成都力思特制药股份有限公司 | Cerebrolysin hydrolysate injection and preparation method thereof |
| CN106309569A (en) * | 2016-11-06 | 2017-01-11 | 成都先先先生物科技有限公司 | Medicine compound for increasing safety of compound codonopsis pilosula injection |
| CN106309923A (en) * | 2016-11-06 | 2017-01-11 | 成都先先先生物科技有限公司 | Medicine compound for increasing safety of compound sealwort injection |
| 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 |
| CN106361826A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Preparation method of pharmaceutical composition for improving safety of compound radix codonopsis injection solution |
| CN106361793A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Preparation method of pharmaceutical composition for improving safety of compound herba artemisiae scopariae injection solution |
| CN106361814A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Preparation method of pharmaceutical 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 |
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| CN106540082A (en) * | 2016-11-06 | 2017-03-29 | 成都先先先生物科技有限公司 | A kind of preparation method for improving compound Polygonatum parenteral solution security pharmaceutical composition |
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| CN104415321A (en) * | 2013-09-10 | 2015-03-18 | 成都力思特制药股份有限公司 | Cerebrolysin hydrolysate injection and preparation method thereof |
| CN106309569A (en) * | 2016-11-06 | 2017-01-11 | 成都先先先生物科技有限公司 | Medicine compound for increasing safety of compound codonopsis pilosula injection |
| CN106309923A (en) * | 2016-11-06 | 2017-01-11 | 成都先先先生物科技有限公司 | Medicine compound for increasing safety of compound sealwort injection |
| 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 |
| CN106361826A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Preparation method of pharmaceutical composition for improving safety of compound radix codonopsis injection solution |
| CN106361793A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Preparation method of pharmaceutical composition for improving safety of compound herba artemisiae scopariae injection solution |
| CN106361814A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Preparation method of pharmaceutical 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 |
| CN106389322A (en) * | 2016-11-06 | 2017-02-15 | 成都先先先生物科技有限公司 | Pharmaceutical composition for improving safety of compound Herba Artemisiae Scopariae 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 |
| CN106540082A (en) * | 2016-11-06 | 2017-03-29 | 成都先先先生物科技有限公司 | A kind of preparation method for improving compound Polygonatum parenteral solution security pharmaceutical composition |
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Application publication date: 20151125 |