CN1113785A - Acanthopanax root injection freeze-dried powder injection and producing technology for acanthopanax root extract - Google Patents

Acanthopanax root injection freeze-dried powder injection and producing technology for acanthopanax root extract Download PDF

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Publication number
CN1113785A
CN1113785A CN 94107718 CN94107718A CN1113785A CN 1113785 A CN1113785 A CN 1113785A CN 94107718 CN94107718 CN 94107718 CN 94107718 A CN94107718 A CN 94107718A CN 1113785 A CN1113785 A CN 1113785A
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China
Prior art keywords
acanthopanacis senticosi
radix
caulis acanthopanacis
injection
water
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CN 94107718
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CN1053817C (en
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宋士岳
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Heilongjiang WanDaShan Pharmaceutical Factory
Heilongjiang Wusu Jiang Pharmaceutical Co., Ltd.
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宋士岳
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Priority to CN94107718A priority Critical patent/CN1053817C/en
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Abstract

The present invention relates to a freeze-dried powdered injection for acanthopanax root injection and its extract production process. The invented acanthopanax root injection includes the extract of acanthopanax root, and rest is water. Its extract production process is as follows: the acanthopanax root is decocted in water, and then its decoction is passed through such procedures of concentration, precipitation by using ethyl alcohol, precipitation by water, thermal treatment, refrigeration and adsorption decotoring by using macroporous adsorption resin, and then the invented product can be made up. Said invention can be used for curing the cardiovascular diseases of cerebral infraction and coronary heart disease, etc..

Description

Acanthopanax root injection freeze-dried powder injection and producing technology for acanthopanax root extract
The present invention relates to a kind of medicine of producing with Radix Et Caulis Acanthopanacis Senticosi, and the production technology of the Radix Et Caulis Acanthopanacis Senticosi extract that uses when producing this product.
As existing many years of oral, external, but that these usings method make that active substance enters cardiovascular diseases's ratio to Radix Et Caulis Acanthopanacis Senticosi was very few as a kind of Chinese medicine, thereby had weakened its effectiveness aspect cardiovascular treatment greatly.
The object of the present invention is to provide a kind of Radix Et Caulis Acanthopanacis Senticosi medicinal liquid that can directly enter blood is Radix Et Caulis Acanthopanacis Senticosi injection, strengthens the drug effect of Radix Et Caulis Acanthopanacis Senticosi, reduces thermal source, ensures the quality of products.
The present invention includes three aspect applications:
1, Radix Et Caulis Acanthopanacis Senticosi injection:
Its composition comprises (weight or capacity are in the corresponding ratio that outpours): Radix Et Caulis Acanthopanacis Senticosi extract 80-120ml, all the other are no heat source water, make the 1000ml transfusion altogether.
2, Radix Et Caulis Acanthopanacis Senticosi lyophilized injectable powder:
Its composition comprises (weight or capacity are in the corresponding ratio that outpours): Radix Et Caulis Acanthopanacis Senticosi extract 60-99%, all the other are water.
3, the production technology of above-mentioned Radix Et Caulis Acanthopanacis Senticosi extract (described ratio is a weight ratio):
A adds Caulis Et Caulis Acanthopanacis Senticosi, leaf, root 3-6 times of water gaging and decocts each 2 hours 2-5 time;
B is evaporated to 1: 1.5-3;
C adds 95% ethanol to be made and contains alcohol amount and reach more than 75%;
D to there not being the alcohol flavor, gets crude drug in whole with the liquid distilling under reduced pressure;
E adds fresh no thermal source injection water, to crude drug in whole 1: 1;
F is at 110-120 ℃, pressure sterilizing 30-50 minute;
G was at 0-4 ℃ of cold preservation 20-30 hour;
H decolours with absorption with macroporous adsorbent resin;
I boils off ethanol again with the adsorbate ethanol elution;
J will steam excess and be dissolved in water;
The k ethyl acetate extraction, evaporate to dryness;
L will steam excess and be dissolved in water, and incorporate destaining solution into, get Radix Et Caulis Acanthopanacis Senticosi extract.
Effect of the present invention is:
1, Harms Radix Et Caulis Acanthopanacis Senticosi Acanthopanx senticosus(Rupr et maxim), it is a kind of machaka of Araliaceae Acanthopanax (Acanthopanx), domestic application for many years, be written into Chinese pharmacy 1977 editions, wherein said main medicinal part is that rhizome and root are under ground portion, can strengthening the body resistance, tranquillizing and allaying excitement, can be made into various oral liquids, be mainly used in calmness, calm the nerves, Gu just holding up this.
The present invention has broken through the classical content that forms for a long time, proves through relevant pharmacodynamics test, and making the Radix Et Caulis Acanthopanacis Senticosi patent medicine that injection directly enters cardiovascular system has following effect:
A can improve the anti-adaptability to changes of animal body.Can improve the mice hypoxia-bearing capability through test, prolong the mice swimming time.Can remove superoxide anion and hydroxyl radical free radical, improve human body SOD level and reduce malonaldehyde.
B is to the cardiovascular and cerebrovascular vessel effect.Animal isolated coronary flow is had remarkable increase effect, and showing can coronary artery dilating, to the acute myocardial infarction that caused by posthypophysis with to the experimental acute cerebral infarction of cat the good protective action of dwindling infarction size is arranged all.
C is to the influence of blood.Can reduce platelet aggregation, reduce the viscosity of blood, can prevent that the murine interleukin that cyclophosphamide causes from reducing.
D is used as infusion treatment, and the ischemic cardio cerebrovascular diseases effective percentage is reached more than 94%, shows significant technological progress.
2, injection formulation can reduce the trouble of interim preparation, ensures drug quality.Before the present invention, because Radix Et Caulis Acanthopanacis Senticosi injection requires pH value higher, and glucose injection requires pH value lower, when pressing usual way preparation mixed liquor, if when preparing by the pH value of glucose requirement, mixed liquor produces precipitation, if when preparing by the pH value of Radix Et Caulis Acanthopanacis Senticosi requirement, glucose decomposes toxigenicity behind sterilization process.This technology is produced injection products from crude drug in whole and is adopted peculiar process, fundamentally solved this problem, and mixed liquor keeps the PH4.2 stable performance, product is deposited and was not produced precipitation in 2 years, this product is through the mouse tolerance dose test, long term toxicity test and stability test (being finished by pharmacology teaching and research room of Harbin Medical University) have also passed through every medicine inspection, have proved that this technology has reached the ripe level of carrying out society generalization.
3, with this product of this explained hereafter, through the 194 routine clinical uses of Jilin Province's electric industry worker's hospital, the 30 routine clinical uses of No.1 Hospital Attached to Harbin Medical Univ.'s acute cerebral infarction, the 35 routine clinical uses of the hospital of traditional Chinese hospital, county, Chuansha, Shanghai City, and join matched group clinical observation in 1: 1, its cure rate is with being almost recovered of the whole nation revision of cerebrovascular academic conference for the second time " clinical efficacy evaluation criteria " regulation in 1986, produce effects, effective, invalid branch, and the result is as follows:
The Jilin group is breathed out medical university Shanghai
Cure produce effects 146 examples 17 examples 22 examples
Effective 43 examples, 7 examples, 10 examples
Invalid 5 examples, 6 examples, 3 examples
Total significant figure 189 examples 24 examples 32 examples
Total effective rate 97% 80% 91.4%
By to 224 examples in various degree, different phase cerebral infarction case and patients with coronary heart disease clinical treatment and the observation in various degree of 35 examples, confirm Radix Et Caulis Acanthopanacis Senticosi injection for recovering function of nervous system behind the cerebral infarction, allevating angina pectoris improves electrocardiogram, and obvious effect is all arranged.For cardiovascular and cerebrovascular vessel ischemic diseasess such as cerebral infarction, coronary heart disease, angina pectoriss, obvious clinical efficacy is arranged, find no allergy and Liver and kidney toxic and side effects, be the ideal medicament that reaches the popularization degree.
3, break through traditional custom that only makes the following part of land used, can utilize the above stem and leaf in ground to make crude drug in whole, effectively protected precious medicine source.
4, the extract that adopts distinctive decoloration process to manufacture, fixed substance is few, color is shallow, can work as with No. 2 form and aspect of Chinese Pharmacopoeia, and the extension blood vessel wall that has overcome in the former use makes it hardened problem, and tangible technological progress is arranged.
5, adopt the extract of peculiar explained hereafter to dewater according to a conventional method and make lyophilized injectable powder, be suitable for long preservation and outlet.
Embodiment 1:
The big injection of Radix Et Caulis Acanthopanacis Senticosi contains glucose 30 grams or 60 grams, Radix Et Caulis Acanthopanacis Senticosi extract 80ml or 120ml, and all the other are no thermal source water for injection, make the 1000ml transfusion altogether.
Embodiment 2:
Radix Et Caulis Acanthopanacis Senticosi injection contains glucose 50 grams, Radix Et Caulis Acanthopanacis Senticosi extract 100ml, and remaining injection water (no heat source water) is made 1000ml altogether.
Embodiment 3:
Radix Et Caulis Acanthopanacis Senticosi injection contains Radix Et Caulis Acanthopanacis Senticosi extract 80ml or 120ml, and all the other are no thermal source water for injection, makes the 1000ml transfusion altogether, available 50ml or the packing of 100ml peace bottle.
Embodiment 4:
Radix Et Caulis Acanthopanacis Senticosi injection, sodium chloride-containing 5 grams or 15 grams, Radix Et Caulis Acanthopanacis Senticosi extract 80ml or 120ml, all the other are no thermal source water for injection, make the 1000ml transfusion altogether.
Embodiment 5:
Radix Et Caulis Acanthopanacis Senticosi injection, sodium chloride-containing 9 grams or 10 grams, Radix Et Caulis Acanthopanacis Senticosi extract 100ml, all the other are no thermal source water for injection, make the 1000ml transfusion altogether.
Embodiment 6:
The production technology of used Radix Et Caulis Acanthopanacis Senticosi extract among the embodiment 1,2,3,4,5: with Caulis Et Caulis Acanthopanacis Senticosi, leaf, root, add 3-6 times of water (with 5 times for well), boil 2-5 time, (as 3 times) each 2 hours, be evaporated to 1 then: 1.5-3(was as 1: 2), adding 95% ethanol makes and contains alcohol amount and reach more than 75%, distilling under reduced pressure afterwards to do not have alcohol distinguish the flavor of crude drug in whole, add no thermal source water for injection again, reach and crude drug in whole 1: 1, and then at 110-120 ℃, pressure sterilizing 30-50 minute; At 0-4 ℃ of cold preservation 20-30 hour; With macroporous adsorbent resin (as D-101) adsorption bleaching, destaining solution is preserved, this destaining solution can for further utilizing drug effect with dryness adsorbate 95% ethanol elution, boil off ethanol again as Radix Et Caulis Acanthopanacis Senticosi extract, to steam excess is dissolved in water, with ethyl acetate extraction, evaporate to dryness, will steam excess and be dissolved in water, after being dissolved in water, incorporate in the destaining solution, get Radix Et Caulis Acanthopanacis Senticosi extract.
Embodiment 7:
Embodiment 1,2 described Radix Et Caulis Acanthopanacis Senticosi injection and production technologies comprise: get Radix Et Caulis Acanthopanacis Senticosi extract 80ml, 100ml or 120ml and add fresh no thermal source water for injection dilution, add glucose 30-60 gram (as 50 grams), and agitating solution, this moment, volume was 1000ml.
Embodiment 8:
Embodiment 4,5 described Radix Et Caulis Acanthopanacis Senticosi injections and production technology comprise: get Radix Et Caulis Acanthopanacis Senticosi extract 80 or 100 or 120ml, add fresh no thermal source water for injection dilution, add sodium chloride 5-15 gram (as 9 grams or 10 grams), agitating solution, this moment volume 1000ml.
Embodiment 9:
Radix Et Caulis Acanthopanacis Senticosi extract among the embodiment 6 is done injectable powder method evaporate to dryness, freezing with existing, make the lyophilized injectable powder of peace bottle packing.

Claims (3)

1, a kind of Radix Et Caulis Acanthopanacis Senticosi injection is characterized in that: contain Radix Et Caulis Acanthopanacis Senticosi extract 80-120ml therein, all the other are no thermal source water for injection, make the 1000ml transfusion altogether.
2, a kind of Radix Et Caulis Acanthopanacis Senticosi lyophilized injectable powder is characterized in that: contain Radix Et Caulis Acanthopanacis Senticosi extract 60-99% therein, all the other are water.
3, the Radix Et Caulis Acanthopanacis Senticosi extract production technology in a kind of claim 1 or 2 comprises:
A adds Caulis Et Caulis Acanthopanacis Senticosi, leaf, root 3-6 times of water gaging and decocts each 2 hours 2-5 time;
B is evaporated to 1: 1.5-3;
C adds 95% ethanol to be made and contains alcohol amount and reach more than 75%;
D with the liquid distilling under reduced pressure to do not have alcohol distinguish the flavor of crude drug in whole;
E added no thermal source injection water, to crude drug in whole 1: 1;
F is at 110-120 ℃, pressure sterilizing 30-50 minute;
G was at 0-4 ℃ of cold preservation 20-30 hour;
H decolours with macroporous adsorbent resin, again with eluate with the ethyl acetate extraction evaporate to dryness, will steam excess and be dissolved in water after, incorporate in the destaining solution Radix Et Caulis Acanthopanacis Senticosi extract.
CN94107718A 1994-07-04 1994-07-04 Acanthopanax root injection freeze-dried powder injection and producing technology for acanthopanax root extract Expired - Fee Related CN1053817C (en)

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CN94107718A CN1053817C (en) 1994-07-04 1994-07-04 Acanthopanax root injection freeze-dried powder injection and producing technology for acanthopanax root extract

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Application Number Priority Date Filing Date Title
CN94107718A CN1053817C (en) 1994-07-04 1994-07-04 Acanthopanax root injection freeze-dried powder injection and producing technology for acanthopanax root extract

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CN1113785A true CN1113785A (en) 1995-12-27
CN1053817C CN1053817C (en) 2000-06-28

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1058174C (en) * 1996-12-24 2000-11-08 郑袆 Medicine for coronary heart disease and production thereof
CN100446779C (en) * 2007-06-20 2008-12-31 黑龙江省珍宝岛制药有限公司 Method for preparing acanthopanax senticousus extracting liquid/extraction

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1058174C (en) * 1996-12-24 2000-11-08 郑袆 Medicine for coronary heart disease and production thereof
CN100446779C (en) * 2007-06-20 2008-12-31 黑龙江省珍宝岛制药有限公司 Method for preparing acanthopanax senticousus extracting liquid/extraction

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CN1053817C (en) 2000-06-28

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