CN1947746B - Expectoranting medicine for clearing phlegm-heat and its preparation method - Google Patents
Expectoranting medicine for clearing phlegm-heat and its preparation method Download PDFInfo
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Abstract
A Chinese medicine Tanreqing in the form of infusion, capsule, powder, oral liquid, or injection for antipyresis, detoxication, resolving phlegm and settling fright is prepared from bear gall powder, goat horn, scutellaria root, honeysuckle flower and forsythia fruit through respectively extracting active components, dissolving in the water for injection, regulating pH value, mixing, adding propanol, filtering, and sterilizing.
Description
Technical field
The invention belongs to tcm field, refer in particular to a kind of Chinese patent medicine preparation and preparation method thereof, be particularly for clear medicament of a kind of expectorant heat and preparation method thereof.
Background technology
Granted publication number once disclosed a kind of Jiawei double coptis medicament and preparation method thereof for the Chinese invention patent of CN1060050C, mainly contain Fel Ursi powder, Cornu Naemorhedi, Radix Scutellariae, Flos Lonicerae and Fructus Forsythiae in its medicament, during preparation, what mainly adopt is methods such as saponification, hydrolysis, decoction, and deep processing to spice, the effective ingredient of spice can be fully used, made medicament is divided into liquid dosage form and fixed dosage form, be used for the treatment of the serious symptom wind-warm lung-heat disease, has heat-clearing and toxic substances removing, effect such as it is relieving convulsion to reduce phlegm.
Summary of the invention
Technical problem to be solved by this invention provides on the basis of existing technology a kind of on the one hand, and compatibility is the clear medicament of expectorant heat more reasonably, and interior syndrome's phase of holding concurrently its exterior and the interior card phase to acute calenture is all effective in cure.
Technical problem to be solved by this invention provides the clear medicaments preparation method of a kind of above-mentioned expectorant heat on the other hand, and this preparation method can further improve the purity of extract than prior art, simplifies process conditions, process, shortens process cycle.
Technical problem solved by the invention can be achieved through the following technical solutions:
Contains total urso cholic acid, total amino acids, baicalin, Flos Lonicerae extract and Fructus Forsythiae extract in the clear medicament composition of this expectorant heat, wherein the shared parts by weight of each composition are as follows:
Total urso cholic acid 20-60 part
Total amino acids 10-30 part
Baicalin 200-300 part
Flos Lonicerae extract 200-300 part
Fructus Forsythiae extract 450-550 part
Described total urso cholic acid hardship, cold, have spasmolytic, function of gallbladder promoting, heat clearing away, detoxifcation, antibacterial, eliminate the phlegm, effect such as blood pressure lowering.Described total amino acids have heat clearing away, relieving convulsion, make eye bright, function such as detoxifcation, cure mainly diseases such as headache due to pathogenic wind-heat, unhappiness, haematemesis, optic atrohic blindness, toxic swelling and pediatric epilepsy scared.It contains 18 seed amino acids and lipoid, phospholipid, cholesterol etc., and glucosamine and 12 kinds of trace element.
Can also contain propylene glycol in the clear medicament of described expectorant heat, make the medicament of liquid dosage form.
Effects such as the clear medicament of expectorant heat of the present invention is used for the treatment of the serious symptom wind-warm lung-heat disease, has heat-clearing and toxic substances removing, and it is relieving convulsion to reduce phlegm are a kind of efficient and quick-acting first aid Chinese patent medicines.
This medicament is preparation like this: Fel Ursi powder is obtained total urso cholic acid through saponification, purification; Cornu Naemorhedi is obtained total amino acids through hydrolysis, purification, hyperfiltration; Radix Scutellariae is carried acid precipitation, precipitate with ethanol, acid precipitation, hyperfiltration, purified and obtain baicalin again through water; With obtaining Forsythia volatile oil behind the Fructus Forsythiae decocting in water and boiling liquid by purification, obtain the Fructus Forsythiae extracting solution, hyperfiltration, low-temperature vacuum drying obtains the Fructus Forsythiae extract dry extract; With the Flos Lonicerae decocting in water, boil the liquid purification, drying obtains the Flos Lonicerae extract dry extract.With the extract drying of the above-mentioned medicine of respectively distinguishing the flavor of, mix after, can obtain electuary, hard capsule or the powder of the clear solid type of expectorant heat.Above-mentioned extract of respectively distinguishing the flavor of medicine is dissolved in water, adds propylene glycol, and preparation can obtain oral liquid, the injection (as aqueous injection, injectable powder, intravenous drip agent) of liquid dosage form.
Water described in the preparation process can be purified water or water for injection.
The specific embodiment
Below further set forth the present invention in the improvement of being done aspect component and the preparation technology by the specific embodiment, it should be noted that the following examples only as illustrating, content of the present invention is not limited thereto.
A kind of tanreqin injection, its composition contains total urso cholic acid, total amino acids, baicalin, Flos Lonicerae extract and Fructus Forsythiae extract, and wherein the shared parts by weight of each composition are as follows:
40 parts of total urso cholic acids
20 parts of total amino acidss
250 parts of baicalins
250 parts of Flos Lonicerae extracts
500 parts of Fructus Forsythiae extracts;
Its preparation process is: get Fel Ursi powder, add 8-12 doubly, suspend as 10 times of amount deionized waters, add dose 8-12% again, the solid sodium hydroxide as 10%, heated and boiled is carried out saponification, saponification 16-20 hour, after 20 hours, stop heating, put cold, transfer pH value to 1.0～2.0 with dilute hydrochloric acid, filter taking precipitate, wash with water to neutrality, cold drying obtains thick total urso cholic acid, adds 8-12% again, as 10% active carbon, add 4-5 doubly, refluxed 1 hour as the ethyl acetate of 5 times of amounts, filter, the ethyl acetate extraction that insoluble matter adds 2 times of amounts more once, merge extractive liquid,, add anhydrous sodium sulfate and make it reach 2%, stir, placement is spent the night, filter, filtrate is reclaimed ethyl acetate, is concentrated into about 2 times of amounts that are about crude product, placed 3～5 days for 5～10 ℃, filter, wash with water, drain to neutrality, vacuum drying below 60 ℃ gets total urso cholic acid;
Cornu Naemorhedi is added 8-12 doubly measure, about 16 hours, filter as 8 times of sulphuric acid reflux of measuring 4mol/L, precipitate is with the water washing secondary of 4 times of amounts, merging filtrate, washing liquid, the lime cream with 16% transfer pH value to 3.5-5.0, as 4.0, filter, it is 1.04～1.06 (60 ℃) that filtrate is concentrated into relative density, add 1% activated carbon decolorizing, filter, filtrate is stirred and is slowly added ethanol down, make and contain alcohol amount and reach 70%, cold preservation 12 hours, hyperfiltration, reclaim ethanol, cool, stir and to add ethanol down and make and contain alcohol and measure and reach 80%, cold preservation 12 hours, coarse filtration, hyperfiltration is reclaimed ethanol, and is concentrated into thick paste, vacuum drying below 60 ℃ gets total amino acids;
The Radix Scutellariae pulverizing is decocted with water secondary, add 8-10 for the first time doubly, as 8 times of water gagings, decocted 1 hour, and added 6-8 for the second time doubly, as 6 times of water gagings, decocted 30 minutes, collecting decoction is transferred pH value to 1.0～2.0 with hydrochloric acid, 30 ℃ are incubated 30 minutes, leave standstill 1 hour, filter, precipitation adds 6-8 times of water gaging suspendible, transfers pH value to 7.0 with 10% sodium hydroxide, adds the stirring of equivalent ethanol again and makes dissolving, filter, filtrate transfers pH value to 1-3, as 2.0 with dilute hydrochloric acid, 80 ℃ are incubated 30 minutes, placement is spent the night, coarse filtration, hyperfiltration, precipitation is washed with purified water, drain, vacuum drying below 50 ℃ gets baicalin;
Extracting honeysuckle decocts with water secondary, adds 10-15 for the first time and doubly measures, decocted 1 hour as 15 times of water gagings, add 10 times of water gagings for the second time, decocted 30 minutes, collecting decoction filters, and it is 1.20～1.25 (70 ℃) that filtrate is concentrated into relative density, add 20% lime cream and transfer pH value to 12, stir, filter, after precipitation added 5 times of amount ethanol stirring suspendibles, the sulphuric acid with 50% was transferred pH value to 3.0～4.0, filters, the sodium hydroxide of filtrate reuse 40% is transferred pH value to 6.5～7.0, filter, filtrate recycling ethanol is concentrated into 100ml, with 4 (60ml of n-butanol extraction, 60ml, 40ml, 40ml), divide and get n-butanol extracting liquid, reclaim n-butyl alcohol, be dissolved in water, 5～10 ℃ left standstill 48 hours, coarse filtration, hyperfiltration is got filtrate and is concentrated into thick paste, 60 ℃ of vacuum dryings get the Flos Lonicerae extract dry extract;
Fructus Forsythiae adds water, decocts secondary, extracts volatile oil when decocting in volatile oil extractor at every turn, obtains Forsythia volatile oil; Add for the first time 10 times of water gagings and decocted 1 hour, add 8 times of water gagings for the second time, decocted 30 minutes, collecting decoction filters, and it is 1.02～1.04 (60 ℃) that filtrate is concentrated into relative density, adding ethanol makes and contains alcohol amount and reach 70%, left standstill 24 hours, and filtered filtrate recycling ethanol, be concentrated into 80ml, add 1% activated carbon decolorizing, filter, filtrate is used n-butanol extraction 4 times (48ml, 48ml, 32ml, 32ml), divide and get n-butanol extracting liquid, reclaim n-butyl alcohol, be dissolved in water, placed 3～5 days for 5～10 ℃, coarse filtration, hyperfiltration is got filtrate and is concentrated into thick paste, 60 ℃ of vacuum dryings.
Above-mentioned each extract is added the dissolving of injection water respectively, transfer pH value to 7.0～8.0, together with the Forsythia volatile oil mixing, add propylene glycol and make and reach 10% of total amount, add 2% active carbon and boiled coarse filtration 30 minutes, three-stage filtration, filtrate add the injection water, adjust total amount to 1000ml, transferring pH value is 7.0～8.0, hyperfiltration is with 0.2 μ filtering with microporous membrane, embedding, sterilized 20 minutes, and promptly got tanreqin injection for 121 ℃.
Said method is compared with existing processes: its difference is when extracting the Radix Scutellariae glycosides, in the acid precipitation process after water is carried, time of repose shortens to 1 hour by standing over night, deduct precipitate with ethanol filter process before, add ethanol Direct Filtration after stirring and dissolving, holding temperature during the raising acid precipitation second time, the precipitation behind the acid precipitation is washed with purified water, and drying condition changes vacuum drying below 50 ℃ into.
When extracting total urso cholic acid, reduce the consumption of solid sodium hydroxide in the saponification process, increase an ethyl acetate extraction process during purification, 3～5 days thereafter placement condition is 5～10 ℃, filtrate washes with water to neutrality, and drying condition changes vacuum drying below 60 ℃ into.
When extracting total amino acids, Cornu Naemorhedi is directly used the acidolysis of sulphuric acid reflux, deducts hydrolytic process, the cold preservation time when shortening alcoholization, and increase the process of once refining, and after ethanol reclaims, vacuum drying below 60 ℃.
When extracting Fructus Forsythiae extract, deduct the extraction of Forsythia volatile oil, when boiling the liquid purification, after the filtrate recycling ethanol, use n-butanol extraction respectively 4 times, divide and get n-butanol extracting liquid, reclaim n-butyl alcohol, and increase water-washing process one time.
When extracting Flos Lonicerae extract, Flos Lonicerae is decocted twice, boil in the liquid purge process, increase alkali deposited and acid precipitation before the precipitate with ethanol.
Claims (7)
1. the medicament of the heat clearing away of eliminating the phlegm is characterized in that being made up of the composition of following portions by weight:
Total urso cholic acid 20-60 part
Total amino acids 10-30 part
Baicalin 200-300 part
Flos Lonicerae extract 200-300 part
Fructus Forsythiae extract 450-550 part
Wherein total urso cholic acid is to be obtained through saponification, purification by Fel Ursi powder; Total amino acids is to be obtained through hydrolysis, purification, hyperfiltration by Cornu Naemorhedi; Baicalin is to be carried acid precipitation, precipitate with ethanol, acid precipitation, hyperfiltration, purify and obtain again through water by Radix Scutellariae; Fructus Forsythiae extract is to be obtained Forsythia volatile oil and boil liquid, hyperfiltration, low-temperature vacuum drying by purification obtaining behind decocting in water by Fructus Forsythiae; Flos Lonicerae extract be by Flos Lonicerae through decocting in water, boil the liquid purification, drying obtains.
2. according to the described medicament of claim 1, it is characterized in that the shared parts by weight of each composition are 40 parts of total urso cholic acids, 20 parts of total amino acidss, 250 parts of baicalins, 250 parts of Flos Lonicerae extracts, 500 parts of Fructus Forsythiae extracts.
3. medicament according to claim 1 and 2 is characterized in that can also containing propylene glycol in this medicament.
4. a method for preparing the described medicament of claim 1 is characterized in that getting Fel Ursi powder, adds 8-12 and doubly measures the deionized water suspension, the solid sodium hydroxide that adds dose 8-12% again, heated and boiled is carried out saponification, saponification 16-20 hour, as stopping heating after 20 hours, put coldly, transfer pH value to 1.0～2.0 with dilute hydrochloric acid, filter, taking precipitate washes with water to neutrality, cold drying obtains thick total urso cholic acid, adds the 8-12% active carbon again, adds 4-5 doubly, refluxed 1 hour as the ethyl acetate of 5 times of amounts, filter, the ethyl acetate extraction that insoluble matter adds 2 times of amounts more once, merge extractive liquid, adds anhydrous sodium sulfate and makes it reach 2%, stirs, placement is spent the night, filter, filtrate is reclaimed ethyl acetate, is concentrated into about 2 times of amounts that are about crude product, placed 3～5 days for 5～10 ℃, filter, wash with water, drain to neutrality, vacuum drying below 60 ℃ gets total urso cholic acid;
Cornu Naemorhedi is added 8-12 doubly measure, about 16 hours, filter as 8 times of sulphuric acid reflux of measuring 4mol/L, precipitate is with the water washing secondary of 4 times of amounts, merging filtrate, washing liquid, the lime cream with 16% transfer pH value to 3.5-5.0, filter, it is 1.04～1.06 that filtrate is concentrated into relative density, adds 1% activated carbon decolorizing, filter, filtrate is stirred down and is slowly added ethanol, makes to contain the alcohol amount and reach 70%, cold preservation 12 hours, ethanol is reclaimed in hyperfiltration, cools, stir and to add ethanol down and make and contain alcohol and measure and reach 80%, cold preservation 12 hours, coarse filtration, hyperfiltration, reclaim ethanol, and being concentrated into thick paste, vacuum drying below 60 ℃ gets total amino acids;
The Radix Scutellariae pulverizing is decocted with water secondary, add 8-10 times of water gaging for the first time, decocted 1 hour, for the second time add 6-8 times of water gaging, decocted collecting decoction 30 minutes, transfer pH value to 1.0～2.0,30 ℃ insulation 30 minutes with hydrochloric acid, left standstill 1 hour, filter, precipitation adds 6-8 times of water gaging suspendible, transfers pH value to 7.0 with 10% sodium hydroxide, adds the stirring of equivalent ethanol again and makes dissolving, filter, filtrate transfers pH value to 1-3 with dilute hydrochloric acid, and 80 ℃ are incubated 30 minutes, and placement is spent the night, coarse filtration, hyperfiltration, precipitation is drained with the purified water washing, vacuum drying below 50 ℃ gets baicalin;
Extracting honeysuckle decocts with water secondary, adds 10-15 times of water gaging for the first time and decocts 1 hour, for the second time add 10 times of water gagings, decocted collecting decoction 30 minutes, filter, it is 1.20～1.25 that filtrate is concentrated into relative density, adds 20% lime cream and transfers pH value to 12, stir, filter, after precipitation adds 5 times of amount ethanol stirring suspendibles, sulphuric acid with 50% is transferred pH value to 3.0～4.0, filter, the sodium hydroxide of filtrate reuse 40% is transferred pH value to 6.5～7.0, filters, filtrate recycling ethanol, be concentrated into 100ml, use n-butanol extraction 4 times, divide and get n-butanol extracting liquid, reclaim n-butyl alcohol, be dissolved in water, 5～10 ℃ left standstill coarse filtration 48 hours, hyperfiltration, get filtrate and be concentrated into thick paste, 60 ℃ of vacuum dryings get the Flos Lonicerae extract dry extract;
Fructus Forsythiae adds water, decocts secondary, extracts volatile oil when decocting in volatile oil extractor at every turn, obtains Forsythia volatile oil; Add for the first time 10 times of water gagings and decocted 1 hour, add 8 times of water gagings for the second time, decocted 30 minutes, collecting decoction filters, and it is 1.02～1.04 that filtrate is concentrated into relative density, adding ethanol makes and contains alcohol amount and reach 70%, left standstill 24 hours, and filtered filtrate recycling ethanol, be concentrated into 80ml, add 1% activated carbon decolorizing, filter, filtrate is used n-butanol extraction 4 times, divide and get n-butanol extracting liquid, reclaim n-butyl alcohol, be dissolved in water, placed 3～5 days for 5～10 ℃, coarse filtration, hyperfiltration is got filtrate and is concentrated into thick paste, 60 ℃ of vacuum dryings;
Above-mentioned each extract is added the dissolving of injection water respectively, transfer pH value to 7.0～8.0, together with the Forsythia volatile oil mixing, add propylene glycol and make and reach 10% of total amount, add 2% active carbon and boiled coarse filtration 30 minutes, three-stage filtration, filtrate add the injection water, adjust total amount to 1000ml, transferring pH value is 7.0～8.0, hyperfiltration is with 0.2 μ filtering with microporous membrane, embedding, sterilization gets finished product.
5. method according to claim 4 is characterized in that: described finished product is made the solid type electuary, hard capsule or powder.
6. according to the preparation method of claim 4, it is characterized in that: described finished product is made as the oral liquid or the injection of liquid dosage form.
7. according to the preparation method of claim 4, it is characterized in that: described injection is aqueous injection, injectable powder or intravenous drip agent.
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101322749B (en) * | 2008-07-24 | 2010-09-15 | 广西源安堂药业有限公司 | Chinese medicine oral liquid for treating wind-heat cold and preparation thereof |
| CN101890054A (en) * | 2009-05-21 | 2010-11-24 | 上海凯宝药业股份有限公司 | Method for preparing Chinese medicinal injection |
| CN102784203A (en) * | 2011-05-20 | 2012-11-21 | 上海凯宝药业股份有限公司 | Tanreqing tablet and preparation method thereof |
| CN105326808B (en) * | 2013-12-02 | 2018-05-15 | 北京三泉医药技术有限公司 | Capsule for clearing heat and eliminating phlegm removing toxic substances |
| CN103610757B (en) * | 2013-12-02 | 2016-05-18 | 北京三泉医药技术有限公司 | For the parenteral solution of clearing heat and eliminating phlegm removing toxic substances |
| CN104814925A (en) * | 2015-05-20 | 2015-08-05 | 上海凯宝药业股份有限公司 | Heat-clearing and phlegm-eliminating oral liquid and preparation method thereof |
| CN105891353B (en) * | 2016-03-30 | 2018-01-05 | 上海凯宝药业股份有限公司 | A kind of method for building up and its finger-print of Tanreqing capsule fingerprint pattern |
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| CN1544033A (en) * | 2003-11-27 | 2004-11-10 | 贵州益佰制药股份有限公司 | Freeze-dried powder injection of Qingkailing and its preparation process |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1544033A (en) * | 2003-11-27 | 2004-11-10 | 贵州益佰制药股份有限公司 | Freeze-dried powder injection of Qingkailing and its preparation process |
Non-Patent Citations (1)
| Title |
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| 刘红敏等.痰热清注射液治疗中枢性发热38 例.《中医研究》.2005,第18卷(第9期),24-25. * |
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