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CN101574361A - Medical prescription and preparation method of catalpol-puerarin freeze-dried powder injection - Google Patents

Medical prescription and preparation method of catalpol-puerarin freeze-dried powder injection Download PDF

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Publication number
CN101574361A
CN101574361A CNA2009101040698A CN200910104069A CN101574361A CN 101574361 A CN101574361 A CN 101574361A CN A2009101040698 A CNA2009101040698 A CN A2009101040698A CN 200910104069 A CN200910104069 A CN 200910104069A CN 101574361 A CN101574361 A CN 101574361A
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CN
China
Prior art keywords
catalpol
puerarin
freeze
dried powder
preparation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CNA2009101040698A
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Chinese (zh)
Inventor
徐晓玉
祝慧凤
何瑶
何正光
李万玉
陈怡�
马强
刘家兰
原欢欢
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Southwest University
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Southwest University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Southwest University filed Critical Southwest University
Priority to CNA2009101040698A priority Critical patent/CN101574361A/en
Publication of CN101574361A publication Critical patent/CN101574361A/en
Priority to CN201010205703XA priority patent/CN101966196A/en
Pending legal-status Critical Current

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Abstract

本发明涉及梓醇与葛根素组合制成冻干粉针剂的处方及其制备方法,其特征在于梓葛冻干粉针的处方组成含梓醇1~1000mg,葛根素1~3000mg,甘露醇100~8000mg,海藻糖50~4000mg,50%丙二醇适量。本发明含有梓醇与葛根素合制成的冻干粉针剂的医药用途,即用于治疗临床脑缺血性脑疾病。本发明还包括处方中所用辅料,用于制备梓醇及葛根素与其它药物以不同配比治疗脑缺血性脑疾病的组合物的冻干粉针剂。本发明目的在于提供一种治疗脑缺血性疾病的中药有效成分复方药物制剂。该制剂能透过血脑屏障,减轻脑缺血的损伤程度,提高脑组织缺血缺氧的耐受能力,促进脑微血管新生与成熟,保护神经血管单元,促进神经元轴突和树突生长,增强突触重构,改善脑缺血后神经行为,提高神经功能评分,促进脑缺血后受累肢体运动功能恢复。The present invention relates to a prescription of freeze-dried powder injection prepared by combining catalpol and puerarin and a preparation method thereof, which is characterized in that the prescription of catalpol freeze-dried powder injection contains 1-1000 mg of catalpol, 1-3000 mg of puerarin, and 100 mg of mannitol. ~8000mg, trehalose 50~4000mg, 50% propylene glycol in appropriate amount. The medical application of the freeze-dried powder injection prepared by combining catalpol and puerarin is to treat clinical cerebral ischemic brain diseases. The invention also includes auxiliary materials used in the prescription, which are used to prepare the freeze-dried powder injection of catalpol, puerarin and other medicines in different proportions for treating cerebral ischemic brain diseases. The object of the present invention is to provide a compound pharmaceutical preparation of active ingredients of traditional Chinese medicine for treating cerebral ischemic diseases. The preparation can pass through the blood-brain barrier, reduce the damage degree of cerebral ischemia, improve the tolerance of brain tissue ischemia and hypoxia, promote the neogenesis and maturation of cerebral microvessels, protect neurovascular units, and promote the growth of neuronal axons and dendrites. , enhance synaptic remodeling, improve neurological behavior after cerebral ischemia, improve neurological function scores, and promote motor function recovery of affected limbs after cerebral ischemia.

Description

The prescription and the preparation method of Chinese catalpa Pueraria lobota lyophilized injectable powder
Technical field
The present invention relates to herbal pharmacology and field of traditional Chinese.Be specifically related to the prescription and the preparation method of the lyophilized injectable powder of Chinese medicine Radix Rehmanniae effective ingredient catalpol and kudzu vine root puerarin, clinically can be used for treating cerebral ischemic brain diseases.
Background technology
Cerebrovascular disease is one of three big causes of death of present serious harm human health.Dying from the cerebrovascular patient more than heart disease and cancer in China, occupy three big cause of the death first places, have sickness rate height, disability rate height, characteristics that mortality rate is high, is to threaten the mankind especially commonly encountered diseases, the frequently-occurring diseases of middle-aged and elderly people health.Wherein, ischemic cerebrovascular accounts for 60%~80% in the cerebrovascular disease.Therefore, how to have caused relevant scholar's extensive attention both at home and abroad by the medical treatment cerebral ischemia.
At present, Drug therapy is the Therapeutic Method of main employing clinically.The medicine of treatment cerebral ischemia both at home and abroad can be divided into five classes: antiplatelet drug, anticoagulant, thrombolytic medicine, vasodilation and cerebral protective agent.But the treatment target spot of these medicines is single, and toxic and side effects is bigger, is difficult to the effect that reaches satisfied.Chinese medicine and compound preparation mainly are to play a role by multi-level, the many target spot of methods such as benefiting QI for activating blood circulation, dredge the meridian passage, too many levels, and toxic and side effects is less relatively.Therefore it is remarkable to seek a kind of effect, and the little new drug of toxic and side effects becomes the focus of domestic and international research.
Catalpol (catalpol) is one of main effective ingredient of Chinese medicine Radix Rehmanniae Rehmannia glutinosa Libsch., it is the effective active composition of its " YIN nourishing " effect, be a kind of iridoid glycoside compounds of less stable, multiple pharmacologically active such as have diuresis, cathartic, blood sugar lowering, protect the liver.Up-to-date pharmacological research shows; catalpol has significant neural blood vessel defencive function to ischemic encephalopathy; can pass through blood brain barrier; improve the tolerance of cerebral tissue to hypoxic-ischemic; promote the growth of neuron axon and dendron; strengthen synapse reconstruct, the limbs neurological functional recovery of getting involved after the promotion cerebral ischemia improves significantly to the ischemic stroke tool.
Puerarin (kakkone) is a kind of pyrite glycosides that extracts from Chinese medicine Herba Gelsemii Elegantis Pueraria lobata (Willd) Ohwi root, belongs to isoflavonoid.Be usually used in treating cardiovascular and cerebrovascular disease, and kidney is had certain protective role.Many pharmacological researches show that puerarin has obvious protective effect to cerebral ischemic brain diseases, can pass through blood brain barrier, and expansion of cerebral vascular reduces blood viscosity and improves the cerebral tissue blood supply, and acute cerebrovascular ischemia sexually transmitted disease (STD) is become curative effect certainly.
Summary of the invention
The object of the invention is to provide a kind of middle pharmaceutically active ingredient compound medicinal formulation for the treatment of cerebral ischemia diseases.Said preparation can see through blood brain barrier; alleviate the degree of injury of cerebral ischemia; improve the tolerance of cerebral tissue hypoxic-ischemic; promote cerebral microvascular newborn and ripe, neuroprotective blood vessel unit promotes the growth of neuron axon and dendron; strengthen synapse reconstruct; improve neurobehavioral after the cerebral ischemia, improve function of nervous system's scoring, the extremity motor function that promotes to get involved after the cerebral ischemia recovers.The present invention be directed to the cerebral ischemia pathological change, adopt pharmaceutically active ingredient catalpol and puerarin composition compound recipe in the reliable pharmacological, make that lyophilized injectable powder achieves the above object.
The present invention relates to the medical usage that catalpol and puerarin make up the lyophilized injectable powder of making, promptly be used for the treatment of clinical cerebral ischemic brain diseases; Prescription of lyophilized injectable powder and preparation method thereof is made in catalpol and puerarin combination.
The present invention is used for the treatment of the Chinese catalpa Pueraria lobota injection prescription of freeze-drying powder of cerebral ischemic brain diseases and forms, and comprises catalpol, puerarin, mannitol, trehalose, propylene glycol
Each component is every part of catalpol 1~1000mg in the drug prescription, puerarin 1~3000mg, and mannitol 100~8000mg, trehalose 50~4000mg, 50% propylene glycol is an amount of.
The present invention realizes the object of the invention by implementing following technical scheme.
The specific embodiment
Chinese catalpa Pueraria lobota lyophilized injectable powder prescription:
Embodiment 1 (1000 preparation unit)
Catalpol 1g
Puerarin 1g
Mannitol 100g
Trehalose 50g
50% propylene glycol adds to 2000ml.
Embodiment 2 (1000 preparation unit)
Catalpol 10g
Puerarin 20g
Mannitol 100g
Trehalose 50g
50% propylene glycol adds to 2000ml.
Embodiment 3 (1000 preparation unit)
Catalpol 500g
Puerarin 300g
Mannitol 5000g
Trehalose 2500g
50% propylene glycol adds to 2000ml.
Embodiment 3 (1000 preparation unit)
Catalpol 1000g
Puerarin 3000g
Mannitol 8000g
Trehalose 4000g
50% propylene glycol adds to 2000ml.
Preparation method:
1. recipe quantity catalpol, puerarin and adjuvant decided in accurate title, adds an amount of 50% propylene glycol, fully stirs and make its dissolving, adds 50% propylene glycol again to full dose.
2. aseptic filtration: the microporous filter membrane fine straining of 0.22 μ m.
3. with the medicinal liquid packing, loading amount is every bottle of 3ml, and half tamponade is put into freeze dryer by the lyophilisation condition lyophilization.
4. lyophilization condition
This product eutectic point is-20 ℃;
Pre-freeze: quick freezing ,-45 ℃ of pre-freeze 3h;
Sublimation drying: evacuation with extremely-24 ℃ of plate temperature rises, is incubated 10h with 4h;
Parsing-desiccation: with 3h with plate temperature rise to 40 ℃, insulation 8h, lyophilizing finishes.
The total head plug, roll lid, packing, full inspection, warehouse-in.

Claims (5)

1. pharmaceutical preparation that is used for the treatment of cerebral ischemic brain diseases, promptly Chinese catalpa Pueraria lobota lyophilized injectable powder is characterized in that catalpol and puerarin make up the prescription composition of making lyophilized injectable powder and contain following composition: catalpol, puerarin, mannitol, trehalose, propylene glycol.
2. Chinese catalpa as claimed in claim 1 Pueraria lobota lyophilized injectable powder is characterized in that each amounts of components is catalpol 1~1000mg in the described prescription, puerarin 1~3000mg, and mannitol 100~8000mg, trehalose 50~4000mg, 50% propylene glycol is an amount of.
3. the preparation method of Chinese catalpa as claimed in claim 1 Pueraria lobota freeze-dried powder.
4. catalpol, puerarin and be applied to treat cerebral ischemic brain diseases with the lyophilized injectable powder dosage form with pharmaceutical composition of other treatment cerebral ischemia disease.
5. Chinese catalpa as claimed in claim 1 Pueraria lobota freeze-dried powder, in its prescription used each adjuvant preparation catalpol, puerarin and with other drug with the application in the composite freeze-dried powder agent of different proportionings treatment cerebral ischemic brain diseases.
CNA2009101040698A 2009-06-12 2009-06-12 Medical prescription and preparation method of catalpol-puerarin freeze-dried powder injection Pending CN101574361A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CNA2009101040698A CN101574361A (en) 2009-06-12 2009-06-12 Medical prescription and preparation method of catalpol-puerarin freeze-dried powder injection
CN201010205703XA CN101966196A (en) 2009-06-12 2010-06-10 Formula of catalpol-puerarin injection and powder and preparation method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CNA2009101040698A CN101574361A (en) 2009-06-12 2009-06-12 Medical prescription and preparation method of catalpol-puerarin freeze-dried powder injection

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101966196A (en) * 2009-06-12 2011-02-09 西南大学 Formula of catalpol-puerarin injection and powder and preparation method

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090239942A1 (en) 2006-09-15 2009-09-24 Cloyd James C Topiramate Compositions and Methods of Making and Using the Same
CN105816422B (en) * 2015-01-05 2020-08-14 天士力医药集团股份有限公司 Silibinin injection and preparation method thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101288677B (en) * 2007-04-17 2011-01-12 普尔药物科技开发(深圳)有限公司 Puerarin derivatives powder injection and its production method
CN101455648B (en) * 2009-01-05 2011-09-28 浙江康恩贝制药股份有限公司 Puerarin freeze-drying preparation
CN101574361A (en) * 2009-06-12 2009-11-11 西南大学 Medical prescription and preparation method of catalpol-puerarin freeze-dried powder injection

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101966196A (en) * 2009-06-12 2011-02-09 西南大学 Formula of catalpol-puerarin injection and powder and preparation method

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Open date: 20091111