CN1157163A

CN1157163A - Ginseng and Aconite Injection and its preparing method

Info

Publication number: CN1157163A
Application number: CN 96117458
Authority: CN
Inventors: 刘鸿祥
Original assignee: Yaan Sanjiu Pharmaceutical Co Ltd
Current assignee: Yaan Sanjiu Pharmaceutical Co Ltd
Priority date: 1996-02-14
Filing date: 1996-02-14
Publication date: 1997-08-20
Anticipated expiration: 2016-02-14
Also published as: CN1051014C

Abstract

The present invention relates to an injection preparation-Shenfu Injection and its preparation method. Said invented injection can be used for curing faint diseases due to fulminant desertion of yang qi, such as various shocks and various diseases resulted from yang vacuity by using intravenous drip or venous push-injection or intramuscular injection. Said injection per 1 ml contains 0.1g of ginseng extract and 0.2g of aconite extract. Its preparation method includes: using ethyl alcohol reflux extraction process to obtain ginseng extract; using water precipitation extraction process to obtain aconite extract; then mixing the two extracts so as to obtain the invented product.

Description

A kind of SHENFU ZHUSHEYE and preparation method thereof

The present invention is a kind of SHENFU ZHUSHEYE and preparation method thereof, belongs to drug-preparing technology field

The present invention is that the transformation of the way forms according to ancient proved recipe " shenfu decoction ".The conventional dosage forms of " shenfu decoction " adopts decoct oral more, and not only body is slow to drug absorption, and uses also inconvenient.

The objective of the invention is to provide that a kind of body is fast to drug absorption for fear of above-mentioned the deficiencies in the prior art part, good effect, SHENFU ZHUSHEYE esy to use, safe and reliable and preparation method thereof.

Purpose of the present invention can reach by following measure:

Contain among every 1ml of SHENFU ZHUSHEYE and be equivalent to primary dose: Radix Ginseng 0.1g, Radix Aconiti Lateralis Preparata 0.2g.

The preparation method of SHENFU ZHUSHEYE is to get the extraction that Radix Ginseng, Radix Aconiti Lateralis Preparata carry out active ingredient respectively: the Radix Ginseng alcohol reflux; Radix Aconiti Lateralis Preparata extracts with water precipitation, merges Radix Ginseng, the formulated injection of Radix Aconiti Lateralis Preparata extracting solution then, and its processing step is as follows:

A, preparation Radix Ginseng extractive solution

(1), get Radix Ginseng, add soak with ethanol 36-60 hour, soak 1.;

(2), medicinal residues add alcohol reflux three times, each 1.5-3 hour, reflux extracting liquid 2.;

(3), get soak and 1. 2. merge with reflux extracting liquid, amalgamation liquid 3.;

(4), medicinal residues ethanol drip washing, will drench liquid and 3. amalgamation liquid merges, extracting solution 4.;

(5), get extracting solution and 4. filter, add the activated carbon of 0.02-0.1% by its volume, stirred 0.5-1.5 hour, placed 1-2 hour, filtration, must filtrate 5.;

(6), get filtrate 5. decompression recycling ethanol add an amount of water for injection to there not being the alcohol flavor, put coldly, transfer pH value to 6-8 with NaOH solution, cold preservation, standby, the Radix Ginseng reserve liquid 6.;

B, preparation Radix Aconiti Lateralis Preparata extracting solution

(7), electric osmose water is put in the container, add concentrated hydrochloric acid again, make pH value reach 3-4, sour water 7.;

(8), get Radix Aconiti Lateralis Preparata, with ordinary water wash by rubbing with the hands, electric osmose water cleans, 7. the sour water that adds the octuple amount decocts three times continuously, each 1.5-2.5 hour, merges three times decoction liquor, filter, and concentrating under reduced pressure, put cold, must concentrated solution 8.;

(9), get concentrated solution 8., add ethanol, stir, make to contain the alcohol amount and reach 75%, cold preservation is filtered, decompression recycling ethanol is put coldly, adds ethanol, stirs, and makes to contain the alcohol amount and reach 85%, transfers pH value 6-8 with NaOH solution, cold preservation is spent the night, alcohol extract 9.;

(10), get ethanol extract and 9. be filtered to clear and brightly, decompression recycling ethanol adds an amount of water for injection to there not being the alcohol flavor, puts coldly, transfers pH value to 6-8 with NaOH solution, cold preservation is standby, the Radix Aconiti Lateralis Preparata reserve liquid 10.;

C, preparation SHENFU ZHUSHEYE

(11), get the Radix Ginseng reserve liquid 6. with the Radix Aconiti Lateralis Preparata reserve liquid 10., merged after filtering respectively, the activated carbon (by the dosing volume calculation) that adds 0.02-0.1% boils, put cold, be filtered to clear and brightly, add the tween 80 (by the dosing volume calculation) of 0.1-0.5%, add an amount of water for injection, transfer pH value to 6-8 with NaOH solution, coarse filtration, fine straining, embedding, sterilization promptly gets SHENFU ZHUSHEYE.

The prescription of d, above-mentioned SHENFU ZHUSHEYE is: Radix Ginseng 100g, Radix Aconiti Lateralis Preparata 200g, and an amount of water for injection, an amount of tween 80 is made the 1000ml SHENFU ZHUSHEYE.

In preparation technology, preferably select following technological parameter for use: the ratio that adds activated carbon in the Radix Ginseng extractive solution is 0.5% (by the dosing volume calculation); The Radix Aconiti Lateralis Preparata decoction liquor was evaporated to 1: 1, contained among promptly every 1ml to be equivalent to primary dose 1g; The amount that adds tween 80 in Radix Ginseng, Radix Aconiti Lateralis Preparata extracting solution is 0.2% (by the dosing volume calculation); Transfer pH value to 7-7.5 with NaOH solution.

The present invention compared with prior art mainly has the following advantages:

1, safe in utilization effective.According to detection, the SHENFU ZHUSHEYE with method for preparing among every 1ml, contains Radix Ginseng total saponins and is not less than 0.8mg, contains aconite alkaloids and is not higher than 0.1mg in aconitine.This product shows that through pharmacology, effect experiment SHENFU ZHUSHEYE has the effect of animals survived time under the obvious prolongation low temperature, and the body of activation reticuloendothelial system function is arranged, and anti-interior toxic action is arranged, and important function such as antiinflammatory, anoxia enduring, resisting fatigue and antiallergic are arranged.To the rabbit of hemorrhagic shock, has stable reliable boosting.In the toxic shock dog model, can promote that left ventricular pressure recovers gradually.To cultivating myocardial cell significant protective effect is arranged.The energy microcirculation improvement reduces lactic acid content and blood plasma histone enzyme activity level.Effects such as the metabolic function of promotion liver and detoxification ability.Be mainly used in fainting of treatment yang-energy sudden collapse and take off disease, as infectivity, losing blood property, hypovolemic shock etc., also can be used for due to the yang deficiency palpitation with fear, palpitation with a distress feeling, cough with asthma, have a stomachache, have loose bowels, arthromyodynia etc., fainting of positive two void of gas taken off disease also certain therapeutic effect.The combined therapy effect of clinical practice, total effective rate reaches 89.74%, and obvious effective rate reaches 72.82%, does not see untoward reaction.

2, drug effect is quick, and is easy to use.This product can adopt intravenous drip or intravenous injection or intramuscular injection.During intravenous drip, use each 20-100ml with 5-10% glucose injection or normal saline dilution back; During intravenous injection, use each 5-20ml with the glucose injection dilution back of 5-50%; The each 2-4ml of intramuscular injection, 1-2 time on the one.The injection back can produce tangible curative effect in 10-30 minute, was one of first-aid medicine of the rescue critical patient of medical institutions indispensability.

3, this Product transport, keeping, use etc. are all very convenient.

Below in conjunction with embodiment, provide preferred forms:

Embodiment

The processing step of preparation SHENFU ZHUSHEYE is as follows:

A, preparation Radix Ginseng extractive solution

(1), get Radix Ginseng 10kg, put and add ethanol 30,000 ml in the container, airtight, soaked 48 hours, soak 1.;

(2), medicinal residues reflux, extract, three times, add ethanol 30,000 ml at every turn, refluxed 2 hours, reflux extracting liquid 2.;

(3), get soak and 1. 2. merge with reflux, extract,, amalgamation liquid 3.;

(4), medicinal residues are used and the isopyknic ethanol drip washing of raw material, and 3. leacheate and amalgamation liquid are merged, and get extracting solution 4.;

(5), get extracting solution and 4. filter, add 0.5% activated carbon by its volume, stirred 1 hour, placed 1 hour, filtration, must filtrate 5.;

(6), get filtrate 5. decompression recycling ethanol add water for injection to 5 ten thousand ml to there not being the alcohol flavor, be chilled to room temperature, the NaOH solution with 40% transfers pH value to 7-7.5, cold preservation 24 hours is standby, gets the Radix Ginseng reserve liquid 6.;

B, preparation Radix Aconiti Lateralis Preparata extracting solution

(8), get Radix Aconiti Lateralis Preparata 20kg, wash by rubbing with the hands, after electric osmose water cleans, put in the container with ordinary water, the sour water that adds the octuple amount 7., decoct three times continuously, each 2 hours, merge three times decoction liquor, filter, be evaporated to 1: 1 (being to contain crude drug amount 1g among every 1ml), be chilled to room temperature, get concentrated solution 8.;

(9), get concentrated solution 8., add ethanol, stir, make to contain the alcohol amount and reach 75%, cold preservation 24 hours, filter, decompression recycling ethanol is chilled to room temperature to 2500ml, adds ethanol, stirring, make to contain alcohol amount and reach 85%, the NaOH solution with 40% is transferred pH value to 8, and cold preservation is spent the night, must alcohol extract 9.;

(10), get alcohol extract and 9. be filtered to clear and brightly, decompression recycling ethanol is added water for injection to 5 ten thousand ml to there not being the alcohol flavor, is chilled to room temperature, the NaOH solution with 40% transfers pH value to 7-7.5, cold preservation 24 hours is standby, gets the Radix Aconiti Lateralis Preparata reserve liquid 10.;

C, preparation SHENFU ZHUSHEYE

(11), get the Radix Ginseng reserve liquid 6. with the Radix Aconiti Lateralis Preparata reserve liquid 10., after filtering respectively, merge two liquid, the activated carbon of adding 0.05% (by the dosing volume calculation) boiled 30 minutes, was chilled to room temperature, be filtered to clear and bright, the tween 80 of adding 0.2% (by the dosing volume calculation), benefit adds to the full amount of water for injection, and transfers pH value to 7-7.5 with 40%NaOH solution, coarse filtration, fine straining, sterilization promptly gets 100,000 ml SHENFU ZHUSHEYE.

The prescription of d, above-mentioned SHENFU ZHUSHEYE is: Radix Ginseng 10kg, and Radix Aconiti Lateralis Preparata 20kg, an amount of water for injection, an amount of tween 80 is made 100,000 ml, contains among every 1ml and is equivalent to the crude drug in whole consumption: Radix Ginseng 0.1g, Radix Aconiti Lateralis Preparata 0.2g.

Claims

1, a kind of SHENFU ZHUSHEYE is characterized in that containing in every 1ml injection and is equivalent to primary dose: Radix Ginseng 0.1g, Radix Aconiti Lateralis Preparata 0.2g.

2, the preparation method of SHENFU ZHUSHEYE as claimed in claim 1 is characterized in that getting the extraction that Radix Ginseng, Radix Aconiti Lateralis Preparata carry out active ingredient respectively: the Radix Ginseng alcohol reflux; Radix Aconiti Lateralis Preparata extracts with water precipitation, merges Radix Ginseng, the formulated injection of Radix Aconiti Lateralis Preparata extracting solution then, and its processing step is as follows:

A, preparation Radix Ginseng extractive solution

(1), get the people and participated in soak with ethanol 36-60 hour, soak 1.;

(4), medicinal residues ethanol drip washing, 3. leacheate and amalgamation liquid are merged, extracting solution 4.;

(5), get extract and 4. filter, add the 0.02-0.1% activated carbon by its volume, stirred 0.5-1.5 hour, placed 1-2 hour, filtration, must filtrate 5.;

(6), get filtrate 5. decompression recycling ethanol add an amount of water for injection to there not being the alcohol flavor, put coldly, transfer PH to 6-8 with NaOH solution, cold preservation is standby, the Radix Ginseng reserve liquid 6.;

B, preparation Radix Aconiti Lateralis Preparata extracting solution

(8), get Radix Aconiti Lateralis Preparata, wash by rubbing with the hands with ordinary water, electric osmose water cleans, 7. the sour water that adds the octuple amount decocts three times continuously, each 1.5-2.5 hour, merges three times decoction liquor, filter, and concentrating under reduced pressure, put cold, must concentrated solution 8.;

(9), get concentrated solution 8., add ethanol, stir, make to contain the alcohol amount and reach 75%, cold preservation is filtered, decompression recycling ethanol is put coldly, adds ethanol, stirs, and makes to contain the alcohol amount and reach 85%, transfers pH value to 6-8 with NaOH solution, cold preservation is spent the night, alcohol extract 9.;

(10), get alcohol extract and 9. be filtered to clear and brightly, decompression recycling ethanol adds an amount of water for injection to there not being the alcohol flavor, puts coldly, transfers pH value 6-8 with NaOH solution, cold preservation is standby, the Radix Aconiti Lateralis Preparata reserve liquid 10.;

C, preparation SHENFU ZHUSHEYE

(11), get the Radix Ginseng reserve liquid 6. with the Radix Aconiti Lateralis Preparata reserve liquid 10., merged after filtering respectively, add the activated carbon (by the dosing volume calculation) of 0.02-0.1%, boil, put coldly, be filtered to clear and brightly, add the tween 80 (by the dosing volume calculation) of 0.1-0.5%, add an amount of water for injection, transfer pH value to 6-8 with NaOH solution, coarse filtration, fine straining, embedding, sterilization promptly gets SHENFU ZHUSHEYE.

The prescription of d, above-mentioned SHENFU ZHUSHEYE is: Radix Ginseng 100g, and Radix Aconiti Lateralis Preparata 200g, an amount of water for injection, an amount of tween 80 is made the 1000ml SHENFU ZHUSHEYE.

3, the preparation method of SHENFU ZHUSHEYE as claimed in claim 2, the ratio that it is characterized in that adding activated carbon in the Radix Ginseng extractive solution are 0.05% (by the dosing volume calculation).

4, the preparation method of SHENFU ZHUSHEYE as claimed in claim 2 is characterized in that the Radix Aconiti Lateralis Preparata decoction liquor was evaporated to 1: 1, contains among promptly every 1ml and is equivalent to primary dose 1g.

5, the preparation method of SHENFU ZHUSHEYE as claimed in claim 2, the amount that it is characterized in that adding tween 80 in Radix Ginseng, Radix Aconiti Lateralis Preparata extracting solution are 0.2% (by the dosing volume calculation).

6, the preparation method of SHENFU ZHUSHEYE as claimed in claim 2 is characterized in that transferring pH value to 7-7.5 with NaOH solution.