CN1500518A - Freeze drying powder containing red ginseng and accessory piece for injection - Google Patents

Freeze drying powder containing red ginseng and accessory piece for injection Download PDF

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Publication number
CN1500518A
CN1500518A CNA021493685A CN02149368A CN1500518A CN 1500518 A CN1500518 A CN 1500518A CN A021493685 A CNA021493685 A CN A021493685A CN 02149368 A CN02149368 A CN 02149368A CN 1500518 A CN1500518 A CN 1500518A
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Prior art keywords
ethanol
add
crude drug
time
cold preservation
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CNA021493685A
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CN1270739C (en
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曾晓春
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Sanju Medical & Pharmaceutical Co ltd
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Yaan Sanjiu Pharmaceutical Co Ltd
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Abstract

The present invention discloses the preparation of freeze dried Shengfu powder for injection. The preparation process includes separated alcohol extraction of red sage and aconite root piece, recovering alcohol, macroporous resin treatment of the filtrate, water washing to eliminate impurity, alcohol elution and freeze drying.

Description

The preparation method of the attached freeze-dried powder of one seed ginseng
Technical field
The present invention relates to a kind of preparation method of traditional medicine Injectio, particularly relate to the preparation method of joining attached freeze-dried powder.
Background technology
Shenfu decoction is the proved recipe in ancient times, especially the classics prescription in the tcm emergency treatment.Traditional decoction has been improved in the prior art and made SHENFU ZHUSHEYE, SHENFU ZHUSHEYE becomes the indispensable medicine of emergency department rapidly because of its determined curative effect, onset in the middle of treatment ischemic shock, cardiovascular and cerebrovascular disease.The ginseng aconite injection preparation that further development quality is stable, controlled, active constituent content is higher is not only the needs of medical practice, also is the needs of Chinese medicine pharmaceutical development.
Summary of the invention
The object of the invention is to provide the preparation method of the attached freeze-dried powder of a seed ginseng.
The present invention seeks to be achieved through the following technical solutions:
Radix Ginseng Rubra 500 weight portion Radix Aconiti Lateralis Preparatas 1000 weight portions
Get Radix Ginseng Rubra and add 50-70% alcohol reflux 2-5 time, each 1-3 hour, add 5-7 for the first time and doubly measure 50-70% ethanol, add 4-6 for the 2-5 time and doubly measure 50-70% ethanol, merge ethanol extract 2-5 time, reclaim ethanol to there not being the alcohol flavor, thin up cold preservation 12-48 hour, filters, filtrate is crossed macroporous resin, washes decontamination with water, reuse 60-80% ethanol elution, collect the 60-80% ethanol elution, reclaim ethanol to there not being the alcohol flavor, be equivalent to crude drug 1-3g/ml, cold preservation 12-48 hour;
Get Radix Aconiti Lateralis Preparata and add 50-70% alcohol reflux 2-5 time, each 1-3 hour, add 4-6 for the first time and doubly measure 50-70% ethanol, the 2-5 time 3-5 doubly measures 50-70% ethanol, merges ethanol extract 2-5 time, reclaims ethanol to there not being the alcohol flavor, thin up cold preservation 12-48 hour, filters, filtrate is crossed macroporous resin, washes decontamination with water, reuse 85-95% ethanol elution, collect the 85-95% ethanol elution, reclaim ethanol to there not being the alcohol flavor, be equivalent to crude drug 3-5g/ml, cold preservation 12-48 hour;
Mix said extracted liquid, stir evenly, add water,, stir evenly, add 0.1-1% active carbon heated and boiled 20-60 minute, put coldly, add water, transfer PH to 4.0-9.0 with mannitol 2-5%, fine straining, packing, lyophilization, promptly.
Macroporous resin model of the present invention is D101, D201, D601, HP-20.
The present invention joins the every ml of attached freeze-dried powder and contains Radix Ginseng total saponins with ginsenoside Re (C 48H 82O 18) meter, must not be less than 2.4mg; Contain aconite alkaloids with aconitine (C 24H 47NO 11) meter, should be 0.3~0.6mg.
It is as follows that the present invention joins the drug efficacy study of attached freeze-dried powder:
One, cardiotonic
1. to the influence of isolated frog heart: injection ginseng attached (lyophilizing) each dosage group (2.5,5.0,10.0,15.0,20.0mg) does not have the significance influence to frog heart heart rate; 2.5,5.0mg can promote myocardial contraction (P<0.05~0.01) significantly.
2. to the influence of rabbit: injection ginseng attached (lyophilizing) each dosage group (n=4 at systemic heart, 0.5,1.0,2.0g/kg), the result, 2.0 g/kg can significantly increase myocardial contraction, the amplitude amplitude obviously strengthens (P<0.05~0.01), and myocardial failure (P<0.01) due to the antagonism aconitine of energy significance.
Two, to the therapeutical effect of hemorrhagic shock animal
1. to the influence of hemorrhagic shock rats: in administration 10min, injection ginseng attached (lyophilizing) each dosage group is consistent with matched group to the influence of rat blood pressure, do not see obvious influence, behind the 20min, injection ginseng attached (lyophilizing) big or middle dosage group shows significant boosting, show that boosting relatively relaxes, low dose of also have certain boosting, but do not have significance; The reduction of middle dosage energy significance antagonism heart rate when 60min, all the other dosage group there was no significant differences show that the recovery to heart rate there is no obvious influence.
2. to the influence of hemorrhagic shock cat blood pressure: after injection ginseng attached (lyophilizing) (0.25,0.5,1.0, the 2.0g/kg) input slight hypotensive effect is arranged, different boostings all appears when reinjecting 0.5g/kg, 1.0g/kg or 2.0g/kg, can obviously raise systolic pressure (1.0g/kg), mean pressure (0.5g/kg and 1.0g/kg), diastolic pressure (0.5g/kg and 2.0g/kg) have significantly Antishock function.
Three, to the influence of traumatic shock mice survival rate
The result shows, the traumatic shock mice that injection ginseng attached (lyophilizing) (n=20,1.25,2.5,5.0g/kg) causes extremity Ischemic Reperfusion has the preventive and therapeutic effect (P<0.05~0.01) of significance.。
Four, anti-arrhythmia effect
1. to the ARR influence of chloroform induced mice: injection ginseng attached (lyophilizing) (n=20,1.25,2.5,5.0g/kg), chloroform is brought out the antagonism (P<0.05~0.001) that the mice arrhythmia has highly significant.
2. to the influence of rat ventricular due to the aconitine: injection ginseng attached (lyophilizing) (n=10,0.25,0.5,1.0g/kg), big or middle dosage can the postponement aconitine of significance due to the time of occurrence (min) (P<0.05~0.01) of rat ventricular.
3. to the ARR influence of Cavia porcellus due to the ouabain: injection ginseng attached (lyophilizing) (0.5,1.0,2.0g/kg), Cavia porcellus arrhythmia due to the ouabain there is in various degree antagonism, the time retardation that VP (chamber early), VT (chamber speed) appear in large, medium and small dosage compares there was no significant difference (P>0.05) with matched group; Dosage big or middle is significantly postponed (P<0.05~0.01) to VF (quivering in the chamber), CA (cardiac muscle stops fighting) time of occurrence.
Five, to the influence of animal anoxia enduring and acute myocardial ischemia
1. to the influence of mice normal pressure anoxia enduring: injection ginseng attached (lyophilizing) (1.25,2.5,5.0g/kg) can obviously improve the ability of mice anoxia enduring, makes life span significant prolongation (P<0.05~0.01).
2. to the influence of isoproterenol load mice anoxia enduring life span: injection ginseng attached (lyophilizing) (n=12,1.25,2.5,5.0g/kg) the equal significance of each dosage group prolongs mice life span (P<0.05~0.01).
3. to the influence of rat heart muscle ischemia: the result shows, injection ginseng attached (lyophilizing) (0.5,1.0,2.0g/kg) has certain improvement effect to rat heart muscle ischemia due to the pituitrin.
Embodiment 1:
Get Radix Ginseng Rubra 500g and add alcohol reflux 3 times, each 2 hours, add 6 times of amount 60% ethanol for the first time, 2nd, add 5,7 times of amount 65%, 70% ethanol for 3 times, merge 3 times ethanol extract, reclaim ethanol to there not being the alcohol flavor, thin up is to 1000-3000ml, and cold preservation 24 hours is filtered, filtrate is crossed the D101 macroporous resin, water 4000ml flush away impurity, reuse 75% ethanol 3000ml eluting, collect 75% ethanol elution, reclaim ethanol to there not being the alcohol flavor, be equivalent to crude drug 2g/ml, cold preservation 24 hours.
Get Radix Aconiti Lateralis Preparata 1000g and add alcohol reflux 3 times, each 2 hours, add for the first time 6 times of amount 60% ethanol, 2nd, add 5,7 times of amount 65%, 70% ethanol for 3 times, merge 3 times ethanol extract, reclaim ethanol to there not being the alcohol flavor, thin up to thin up to 3000-5000ml, cold preservation 24 hours, filter, filtrate is crossed the D101 macroporous resin, water 8000ml flush away impurity, reuse 90% ethanol 6000ml eluting, collect the 85-95% ethanol elution, reclaim ethanol to there not being the alcohol flavor, be equivalent to crude drug 4g/ml, cold preservation 24 hours.
Mix said extracted liquid, stir evenly, add water to about 5000ml,, stir evenly, add 0.5% active carbon heated and boiled 20-60 minute, put coldly, add water to 5000ml with mannitol 3%, accent PH to 5-7, fine straining, 1000 bottles of packing, lyophilization, promptly.Every ml contains Radix Ginseng total saponins in the ginsenoside Re, must not be less than 2.4mg; Contain aconite alkaloids in aconitine, should be 0.3~0.6mg.

Claims (4)

1, a kind of ginseng aconite injection preparation is characterized in that every ml contains Radix Ginseng total saponins in the ginsenoside Re in the said preparation, must not be less than 2.4mg; Contain aconite alkaloids in aconitine, should be 0.3~0.6mg.
2, the preparation method of ginseng aconite injection preparation as claimed in claim 1 is characterized in that this method is:
Get Radix Ginseng Rubra and add 50-70% alcohol reflux 2-5 time, each 1-3 hour, add 5-7 for the first time and doubly measure 50-70% ethanol, add 4-6 for the 2-5 time and doubly measure 50-70% ethanol, merge ethanol extract 2-5 time, reclaim ethanol to there not being the alcohol flavor, thin up cold preservation 12-48 hour, filters, filtrate is crossed macroporous resin, washes decontamination with water, reuse 60-80% ethanol elution, collect the 60-80% ethanol elution, reclaim ethanol to there not being the alcohol flavor, be equivalent to crude drug 1-3g/ml, cold preservation 12-48 hour;
Get Radix Aconiti Lateralis Preparata and add 50-70% alcohol reflux 2-5 time, each 1-3 hour, add 4-6 for the first time and doubly measure 50-70% ethanol, the 2-5 time 3-5 doubly measures 50-70% ethanol, merges ethanol extract 2-5 time, reclaims ethanol to there not being the alcohol flavor, thin up cold preservation 12-48 hour, filters, filtrate is crossed macroporous resin, washes decontamination with water, reuse 85-95% ethanol elution, collect the 85-95% ethanol elution, reclaim ethanol to there not being the alcohol flavor, be equivalent to crude drug 3-5g/ml, cold preservation 12-48 hour;
Mix said extracted liquid, stir evenly, add water,, stir evenly, add 0.1-1% active carbon heated and boiled 20-60 minute, put coldly, add water, transfer PH to 4.0-9.0 with mannitol 2-5%, fine straining, packing, lyophilization, promptly.
3, preparation method as claimed in claim 2 is characterized in that the macroporous resin model is D101, D201, D601, HP-20 in this method.
4, profit requires 2 or 3 described preparation methoies, it is characterized in that this method is:
Get Radix Ginseng Rubra 500 weight portions and add alcohol reflux 3 times, each 2 hours, add for the first time 6 times of amount 60% ethanol, 2nd, add 5,7 times of amount 65%, 70% ethanol for 3 times, merge 3 times ethanol extract, reclaim ethanol to not having alcohol flavor, thin up, the 2-6 that is equivalent to the crude drug amount doubly, cold preservation 24 hours is filtered, and filtrate is crossed the D101 macroporous resin, washing decontamination with 8 times of crude drug amounts, 75% ethanol elution of 6 times of crude drug amounts of reuse is collected 75% ethanol elution, reclaims ethanol to there not being the alcohol flavor, be equivalent to crude drug 2g/ml, cold preservation 24 hours;
Get Radix Aconiti Lateralis Preparata 1000 weight portions and add alcohol reflux 3 times, each 2 hours, add for the first time 6 times of amount 60% ethanol, 2nd, add 5,7 times of amount 65%, 70% ethanol for 3 times, merge 3 times ethanol extract, reclaim ethanol to not having alcohol flavor, thin up, the 3-5 that is equivalent to the crude drug amount doubly, cold preservation 24 hours is filtered, and filtrate is crossed the D101 macroporous resin, washing decontamination with 8 times of crude drug amounts, 90% ethanol elution of 6 times of crude drug amounts of reuse is collected 90% ethanol elution, reclaims ethanol to there not being the alcohol flavor, be equivalent to crude drug 4g/ml, cold preservation 24 hours;
Mix said extracted liquid, stir evenly, add 5 times water of about Radix Aconiti Lateralis Preparata crude drug amount,, stir evenly, add 0.5% active carbon heated and boiled 20-60 minute, put coldly, add to 5 times water of Radix Aconiti Lateralis Preparata crude drug amount with mannitol 3%, accent PH to 5-7, fine straining, packing, lyophilization, promptly.
CN 02149368 2002-11-13 2002-11-13 Freeze drying powder containing red ginseng and accessory piece for injection Expired - Lifetime CN1270739C (en)

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CN1270739C CN1270739C (en) 2006-08-23

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101007074B (en) * 2006-01-25 2011-08-10 天津天士力之骄药业有限公司 Preparing method of Ginseng and Aconite preparation for injection
CN102920797A (en) * 2012-11-15 2013-02-13 沈阳药科大学 Extraction and purification process for active components of kusnezoff monkshood

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101007074B (en) * 2006-01-25 2011-08-10 天津天士力之骄药业有限公司 Preparing method of Ginseng and Aconite preparation for injection
CN102920797A (en) * 2012-11-15 2013-02-13 沈阳药科大学 Extraction and purification process for active components of kusnezoff monkshood

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Address after: 625000 No. 116 West South Street, Sichuan, Ya'an

Patentee after: SANJU MEDICAL & PHARMACEUTICAL CO.,LTD.

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