CN1839933A - Red sage root extract refining and edulcoration method - Google Patents

Red sage root extract refining and edulcoration method Download PDF

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Publication number
CN1839933A
CN1839933A CN 200610020201 CN200610020201A CN1839933A CN 1839933 A CN1839933 A CN 1839933A CN 200610020201 CN200610020201 CN 200610020201 CN 200610020201 A CN200610020201 A CN 200610020201A CN 1839933 A CN1839933 A CN 1839933A
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cold preservation
hours
contain
crude drug
concentrated
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耿福能
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Abstract

The invention discloses a process for refining radix salvia miltiorrhiza extract by employing water-alcohol method as the basic technique, wherein the refined radix salvia miltiorrhiza extract can be used for preparing radix salvia miltiorrhiza injection, Xiangdan injection, Danhong injection, injection for coronary disease and transfusion product containing radix salvia miltiorrhiza.

Description

The method of red sage root extract refining and edulcoration
Technical field
The present invention relates to pharmaceutical field, be specially the method for red sage root extract refining and edulcoration.
Technical background
Radix Salviae Miltiorrhizae has the effect of activating blood circulation to dissipate blood stasis, nourishing blood to tranquillize the mind and removing heat from blood eliminating carbuncle.Radix Salviae Miltiorrhizae Injection, XIANGDAN ZHUSHEYE, DANHONG ZHUSHEYE, GUANXINNING ZHUSHEYE that is made by Radix Salviae Miltiorrhizae extract and the various great transfusion preparations that contain Radix Salviae Miltiorrhizae are because of its definite curative effect has been widely used in clinical.Along with the widespread usage of above-mentioned preparation, the report of the untoward reaction of these kinds is also more and more.In causing numerous factors of adverse effect, " remove impurity is not to the greatest extent " is considered to one of maximum arch-criminal who causes untoward reaction.Therefore, this area presses for the safe and effective red sage root extract refining method of exploitation.
Summary of the invention
Purpose of the present invention promptly is to overcome the shortcoming of prior art, a kind of method of red sage root extract refining and edulcoration of the various untoward reaction that can reduce to greatest extent and avoid causing not to the utmost because of " remove impurity " is provided, and guarantee the effective ingredient that this prescription requires to greatest extent, make clinical application safer, effective.
Purpose of the present invention is achieved through the following technical solutions: a kind of method of red sage root extract refining and edulcoration, and it may further comprise the steps:
(1) red rooted salvia adds purified water and decocts three times through selection, clean system, cutting, adds 8 times of water gagings for the first time, decocts 2 hours, and second and third time adds 4-6 times of water gaging, decocts 1-1.5 hour at every turn, and collecting decoction filters, and is concentrated into every milliliter and contains crude drug 1.25 grams;
(2) add ethanol and make and contain alcohol amount and reach 75% percent by volume, stir evenly cold preservation 48 hours, filter, filtrate is concentrated into every milliliter and contains crude drug 4 grams, adds ethanol and makes and contain the alcohol amount and reach 80% percent by volume, stir evenly, cold preservation 48 hours filters, and reclaims ethanol, be concentrated into every milliliter and contain crude drug 6 grams, add the injection water and contain crude drug 2 gram to every milliliter, stir evenly cold preservation 48 hours;
(3) transfer pH value to 6.5-8.5 with alkaline matter, cold preservation 16-24 hour, filter;
(4) transfer pH value to 3.8-4.5 with hydrochloric acid, cold preservation 16-24 hour, filter;
(5) the 0.1%-0.5% active carbon boiled 15-30 minute, filtering decarbonization, and cold preservation, stand-by.
By top narration as can be seen, the present invention has the following advantages: this patent is based on traditional aqueous extraction-alcohol precipitation technology, Radix Salviae Miltiorrhizae extract is made with extra care, extracting solution after refining, after making the various injections that contain Radix Salviae Miltiorrhizae, the related request under meeting the corresponding quality standard item of each kind, other are as protein, oxalates, tannin, potassium ion, resins etc. all meet the version " related request of Chinese pharmacopoeia appendix " related substance inspection " in 2005, the various untoward reaction that reduce to greatest extent and avoided causing not to the utmost because of " remove impurity ", and guaranteed the effective ingredient that this prescription requires to greatest extent, make clinical application safer, effectively.Radix Salviae Miltiorrhizae extract after refining can be used to the infusion solutions product for preparing Radix Salviae Miltiorrhizae Injection, XIANGDAN ZHUSHEYE, DANHONG ZHUSHEYE, GUANXINNING ZHUSHEYE and contain Radix Salviae Miltiorrhizae.
The specific embodiment
The present invention will be further described below in conjunction with embodiment:
Embodiment 1: a kind of method of red sage root extract refining and edulcoration, and it may further comprise the steps:
(1) through the 1000g Radix Salviae Miltiorrhizae crude drug of selection, clean system, cutting, add purified water and decoct three times, add 8 times of water gagings for the first time, decocted 2 hours, second and third time adds 4 times of water gagings, decocts 1 hour at every turn, and collecting decoction filters, and is concentrated into about 600ml;
(2) add ethanol and make and contain alcohol amount and reach 75% percent by volume, stir evenly cold preservation 48 hours, filter, filtrate is concentrated into 250ml, adds ethanol and makes and contain the alcohol amount and reach 80% percent by volume, stir evenly, cold preservation 48 hours filters, and reclaims ethanol, filtrate is concentrated into about 160ml, add the injection water to 500ml, stir evenly cold preservation 48 hours;
(3) transfer pH value to 6.5 with 10% sodium hydroxide solution, cold preservation 16 hours is filtered;
(4) transfer pH value to 3.8 with dilute hydrochloric acid, cold preservation 16 hours is filtered;
(5) 0.5% active carbons boiled 15 minutes, filtering decarbonization, and cold preservation, stand-by.
(281 ± 3nm) is 0.59 to the trap of the Radix Salviae Miltiorrhizae extract that makes, and every index such as pH value, aseptic, pyrogen testing, resin, protein, oxalates, tannin, heavy metal, arsenic salt, potassium ion all meets " the pertinent regulations of Chinese pharmacopoeia version in 2005.
Embodiment 2: a kind of method of red sage root extract refining and edulcoration,
It may further comprise the steps:
(1) through the 1000g Radix Salviae Miltiorrhizae crude drug of selection, clean system, cutting, add purified water and decoct three times, add 8 times of water gagings for the first time, decocted 2 hours, second and third time adds 6 times of water gagings, decocts 1.2 hours at every turn, and collecting decoction filters, and is concentrated into about 600ml;
(2) add ethanol and make and contain alcohol amount and reach 75% percent by volume, stir evenly cold preservation 48 hours, filter, filtrate is concentrated into 250ml, adds ethanol and makes and contain the alcohol amount and reach 80% percent by volume, stir evenly, cold preservation 48 hours filters, and reclaims ethanol, filtrate is concentrated into about 160ml, add the injection water to 500ml, stir evenly cold preservation 48 hours;
(3) transfer pH value to 7.5 with alkaline matter, cold preservation 24 hours is filtered;
(4) transfer pH value to 4.2 with hydrochloric acid, cold preservation 24 hours is filtered;
(5) 0.3% active carbons boiled 15-30 minute, filtering decarbonization, and cold preservation, stand-by.
(281 ± 3nm) is 0.73 to the trap of the Radix Salviae Miltiorrhizae extract that makes, and every index such as pH value, aseptic, pyrogen testing, resin, protein, oxalates, tannin, heavy metal, arsenic salt, potassium ion all meets " the pertinent regulations of Chinese pharmacopoeia version in 2005.
Embodiment 3: a kind of method of red sage root extract refining and edulcoration,
It may further comprise the steps:
(1) through the 1000g Radix Salviae Miltiorrhizae crude drug of selection, clean system, cutting, add purified water and decoct three times, add 8 times of water gagings for the first time, decocted 2 hours, second and third time adds 5 times of water gagings, decocts 1.5 hours at every turn, and collecting decoction filters, and is concentrated into about 600ml;
(2) add ethanol and make and contain alcohol amount and reach 75% percent by volume, stir evenly cold preservation 48 hours, filter, filtrate is concentrated into 250ml, adds ethanol and makes and contain the alcohol amount and reach 80% percent by volume, stir evenly, cold preservation 48 hours filters, and reclaims ethanol, filtrate is concentrated into about 160ml, add the injection water to 500ml, stir evenly cold preservation 48 hours;
(3) transfer pH value to 8.5 with 10% sodium hydroxide solution, cold preservation 20 hours is filtered;
(4) transfer pH value to 4.5 with dilute hydrochloric acid, cold preservation 20 hours is filtered;
(5) 0.1% active carbons boiled 20 minutes, filtering decarbonization, and cold preservation, stand-by.
(281 ± 3nm) is 0.93 to the trap of the Radix Salviae Miltiorrhizae extract that makes, and every index such as pH value, aseptic, pyrogen testing, resin, protein, oxalates, tannin, heavy metal, arsenic salt, potassium ion all meets " the pertinent regulations of Chinese pharmacopoeia version in 2005.

Claims (1)

1. the method for a red sage root extract refining and edulcoration is characterized in that:
It may further comprise the steps:
(1) red rooted salvia adds purified water and decocts three times through selection, clean system, cutting, adds 8 times of water gagings for the first time, decocts 2 hours, and second and third time adds 4-6 times of water gaging, decocts 1-1.5 hour at every turn, and collecting decoction filters, and is concentrated into every milliliter and contains crude drug 1.25 grams;
(2) add ethanol and make and contain alcohol amount and reach 75% percent by volume, stir evenly cold preservation 48 hours, filter, filtrate is concentrated into every milliliter and contains crude drug 4 grams, adds ethanol and makes and contain the alcohol amount and reach 80% percent by volume, stir evenly, cold preservation 48 hours filters, and reclaims ethanol, be concentrated into every milliliter and contain crude drug 6 grams, add the injection water and contain crude drug 2 gram to every milliliter, stir evenly cold preservation 48 hours;
(3) transfer pH value to 6.5-8.5 with alkaline matter, cold preservation 16-24 hour, filter;
(4) transfer pH value to 3.8-4.5 with hydrochloric acid, cold preservation 16-24 hour, filter;
(5) the 0.1%-0.5% active carbon boiled 15-30 minute, filtering decarbonization, and cold preservation, stand-by.
CN 200610020201 2006-01-23 2006-01-23 Red sage root extract refining and edulcoration method Pending CN1839933A (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101985417A (en) * 2010-11-02 2011-03-16 贵州景峰注射剂有限公司 Process for extracting salvianic acid A
CN101278972B (en) * 2008-05-29 2011-05-04 山东华信制药集团股份有限公司 Technique for preparing Salvia miltiorrhiza injection with pH gradient sedimentation method combined with hyperfiltration technique
CN102885888A (en) * 2012-10-30 2013-01-23 湖北天圣康迪制药有限公司 Method for preparing salvia miltiorrhiza injection
CN107441162A (en) * 2017-06-19 2017-12-08 上海华源安徽锦辉制药有限公司 The minimizing technology of allergic dopants in a kind of red sage roo drip liquid
CN111721884A (en) * 2020-06-30 2020-09-29 南京中医药大学 Method for detecting trace plant protein components in thermite injection and intermediate thereof

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101278972B (en) * 2008-05-29 2011-05-04 山东华信制药集团股份有限公司 Technique for preparing Salvia miltiorrhiza injection with pH gradient sedimentation method combined with hyperfiltration technique
CN101985417A (en) * 2010-11-02 2011-03-16 贵州景峰注射剂有限公司 Process for extracting salvianic acid A
CN101985417B (en) * 2010-11-02 2013-06-05 贵州景峰注射剂有限公司 Process for extracting salvianic acid A
CN102885888A (en) * 2012-10-30 2013-01-23 湖北天圣康迪制药有限公司 Method for preparing salvia miltiorrhiza injection
CN107441162A (en) * 2017-06-19 2017-12-08 上海华源安徽锦辉制药有限公司 The minimizing technology of allergic dopants in a kind of red sage roo drip liquid
CN111721884A (en) * 2020-06-30 2020-09-29 南京中医药大学 Method for detecting trace plant protein components in thermite injection and intermediate thereof

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