CN103494851B - A kind of preparation method of stomach Shu Xin preparation - Google Patents
A kind of preparation method of stomach Shu Xin preparation Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title claims abstract description 29
- 210000002784 stomach Anatomy 0.000 title claims abstract description 11
- 239000000203 mixture Substances 0.000 claims abstract description 15
- 241001453169 Asplenium Species 0.000 claims abstract description 12
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 claims description 67
- 238000000605 extraction Methods 0.000 claims description 28
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 27
- 239000000706 filtrate Substances 0.000 claims description 21
- 230000006837 decompression Effects 0.000 claims description 16
- 239000008187 granular material Substances 0.000 claims description 16
- 239000007788 liquid Substances 0.000 claims description 16
- 239000006071 cream Substances 0.000 claims description 15
- 238000011084 recovery Methods 0.000 claims description 13
- 239000002904 solvent Substances 0.000 claims description 13
- 238000001035 drying Methods 0.000 claims description 10
- 229920002472 Starch Polymers 0.000 claims description 6
- 239000002775 capsule Substances 0.000 claims description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 6
- 239000008107 starch Substances 0.000 claims description 6
- 235000019698 starch Nutrition 0.000 claims description 6
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 5
- 229930006000 Sucrose Natural products 0.000 claims description 5
- 239000005720 sucrose Substances 0.000 claims description 5
- 239000002671 adjuvant Substances 0.000 claims description 4
- 238000001914 filtration Methods 0.000 claims description 4
- 235000019359 magnesium stearate Nutrition 0.000 claims description 3
- 239000003826 tablet Substances 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 11
- 239000003814 drug Substances 0.000 abstract description 3
- 238000009472 formulation Methods 0.000 abstract description 3
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 239000002552 dosage form Substances 0.000 abstract 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 17
- 229930003944 flavone Natural products 0.000 description 15
- 235000011949 flavones Nutrition 0.000 description 15
- 150000002213 flavones Chemical class 0.000 description 14
- 238000000746 purification Methods 0.000 description 7
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 239000012567 medical material Substances 0.000 description 5
- 208000012895 Gastric disease Diseases 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 238000004064 recycling Methods 0.000 description 3
- 238000010992 reflux Methods 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- 241000699670 Mus sp. Species 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
- VSCWAEJMTAWNJL-UHFFFAOYSA-K aluminium trichloride Chemical compound Cl[Al](Cl)Cl VSCWAEJMTAWNJL-UHFFFAOYSA-K 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 description 2
- 229930182470 glycoside Natural products 0.000 description 2
- 150000002338 glycosides Chemical class 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 238000005457 optimization Methods 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 229940075582 sorbic acid Drugs 0.000 description 2
- 235000010199 sorbic acid Nutrition 0.000 description 2
- 239000004334 sorbic acid Substances 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 208000018556 stomach disease Diseases 0.000 description 2
- 239000006228 supernatant Substances 0.000 description 2
- 206010000087 Abdominal pain upper Diseases 0.000 description 1
- -1 Dichlorodiphenyl Acetate Chemical compound 0.000 description 1
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 1
- 241000699666 Mus <mouse, genus> Species 0.000 description 1
- 206010067171 Regurgitation Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- GAMYVSCDDLXAQW-AOIWZFSPSA-N Thermopsosid Natural products O(C)c1c(O)ccc(C=2Oc3c(c(O)cc(O[C@H]4[C@H](O)[C@@H](O)[C@H](O)[C@H](CO)O4)c3)C(=O)C=2)c1 GAMYVSCDDLXAQW-AOIWZFSPSA-N 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 238000003483 aging Methods 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 238000005352 clarification Methods 0.000 description 1
- 235000020965 cold beverage Nutrition 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 230000002183 duodenal effect Effects 0.000 description 1
- 238000005265 energy consumption Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 150000002212 flavone derivatives Chemical class 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 238000003304 gavage Methods 0.000 description 1
- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical group CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- VHBFFQKBGNRLFZ-UHFFFAOYSA-N vitamin p Natural products O1C2=CC=CC=C2C(=O)C=C1C1=CC=CC=C1 VHBFFQKBGNRLFZ-UHFFFAOYSA-N 0.000 description 1
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- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to a kind of preparation method of stomach Shu Xin preparation, belong to the technical field of Chinese medicine.This product is made up the dosage form that pharmaceutics allows of Asplenium trchomanes L. and Radix cynanchi wilfordii.Invention formulation good stability, bioavailability is high, taking convenience, and outward appearance U.S. is clean, easy to patients; The preparation method provided effectively can prepare the preparation of needs, ensures that the preparation production technique obtained is scientific and reasonable.
Description
Technical field
The present invention is a kind of preparation method of stomach Shu Xin preparation, belongs to the technical field of Chinese medicine.
Technical background
Because living-pattern preservation, the sickness rate of gastropathy increases year by year, and in current general population, existing nearly seventy percent suffers from gastropathy.And drink cold drink due to learning pressure and happiness, patients with gastric disease is especially in the trend of becoming younger.Stomach Shu Xin granule is made up of Asplenium trchomanes L., Radix cynanchi wilfordii; Effect replenishing YIN and removing heat, and stomach and alleviating pain; For the gastralgia caused by gastric heat the moon wound, belch acid regurgitation; Stomach and duodenal bulbar ulcer.The technique that existing product adopts WS-11501 (ZD-1501)-2002 to record, method simple coarse, causes active constituent content on the low side, affects the treatment.Also there is researcher to improve the content of effective ingredient, adopt methanol solution as extractant, but the methanol used is larger to human injury.
So in view of such circumstances, a kind of preparation method of reasonable benefit/risk is provided to be the thing being badly in need of solving.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of preparation method.
Technical scheme of the present invention forms like this:
A kind of Chinese medicine preparation is prepared from as follows by Asplenium trchomanes L. 333.3g, Radix cynanchi wilfordii 333.3g and adjuvant: thing of getting it filled, add 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filtering, is the clear paste of 1.20 when filtrate is concentrated into relative density 80 DEG C, treat that cream is chilled to 40 DEG C, clarification, adds adjuvant, makes oral formulations.Described oral formulations refers to capsule, granule, tablet.
The preparation method of described granule: thing of getting it filled, adds 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filter, be the clear paste of 1.20 when filtrate is concentrated into relative density 80 DEG C, treat that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery is to clear paste during relative density 80 DEG C being 1.25, add 950g sucrose, mix homogeneously, granulate, drying, namely granulate obtains granule.
The preparation method of described capsule: thing of getting it filled, adds 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filter, be the clear paste of 1.20 when filtrate is concentrated into relative density 80 DEG C, treat that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery is to clear paste during relative density 80 DEG C being 1.25, drying under reduced pressure, pulverizes, adds the magnesium stearate of appropriate amount of starch and 0.2%, mix homogeneously, fill, obtains capsule.
The preparation method of described tablet, is characterized in that: thing of getting it filled, and adds 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filtering, is the clear paste of 1.20 when filtrate is concentrated into relative density 80 DEG C, treat that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery is to clear paste during relative density 80 DEG C being 1.25, and drying under reduced pressure, pulverizes, add and can press starch in right amount, mix homogeneously, namely tabletting obtains tablet.
The preparation method of described oral liquid, is characterized in that: add 8 times amount 70% alcohol reflux 3 times, each 1 hour, filter, decompression filtrate recycling ethanol is the clear paste of 1.20 to relative density 60 DEG C, adds 2 times of water gagings, abundant stirring 30 minutes, filter, filtrate reduced in volume is to 800ml, add 100g sucrose and 2g sorbic acid, add water to 1000ml, mix homogeneously, subpackage, sterilizing, obtains oral liquid.
Experimental example:
With Rhizoma Kaempferiae glycosides for reference substance, adopt aluminum chloride determination of color total flavones, and with the extraction ratio of total flavones for performance assessment criteria, optimal screening total flavones extraction purification condition, and carried out effect experiment.
1. optimization for extracting condition
(1) amount of water is investigated
Take Asplenium trchomanes L. 111.1g and Radix cynanchi wilfordii 111.1g respectively, totally 3 parts, add various dose soak by water respectively 3 times, each 2 hours, with the extraction ratio of total flavones for operation index amount of water is on the impact of total flavones stripping.
As can be seen from the above results, adopt 8 times amount and 10 times of water gagings all can obtain good result, but in conjunction with manufacturing cost and energy consumption, let us preferably add 8 times of water gagings.
(2) extraction time is investigated
Take Asplenium trchomanes L. 111.1g and Radix cynanchi wilfordii 111.1g respectively, totally 3 parts, add 8 times amount soak by water respectively, each 2 hours, with the extraction ratio of total flavones for operation index extraction time is on the impact of total flavones stripping.
As can be seen from the above results, the extraction ratio of total flavones raises along with the increase of extraction time, but extract 4 times with extract the effect of 3 times without marked difference, for saving, we adopt 3 extractions man-hour.
(3) extraction time is investigated
Take Asplenium trchomanes L. 111.1g and Radix cynanchi wilfordii 111.1g respectively, totally 3 parts, add 8 times of soak by water respectively 3 times, with the extraction ratio of total flavones for operation index extraction time is on the impact of total flavones stripping.
As can be seen from the above results, the extraction ratio of different ageings to total flavones has a certain impact, in conjunction with the extraction ratio of man-hour and total flavones, we determine the combination that No. 2, employing is tested, and namely extract 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time.
2. purification condition optimization
Prepared by extract: take each medical material, add 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.20 (80 DEG C), is divided into 2 parts, carry out purification in different ways respectively, investigate purification condition to the impact of the total flavones rate of transform.
Method one: clear paste is cooled to 40 DEG C, adds 2 times amount ethanol, and mixing, places 24 hours, get supernatant, filters, and reclaim ethanol, being concentrated into relative density is 1.25 (80 DEG C), drying under reduced pressure, measures content.
Method two: treat that cream is chilled to 40 DEG C, adds equivalent n-butanol extraction 3 times, and merge n-butyl alcohol liquid, decompression and solvent recovery to relative density is the clear paste of 1.25 (80 DEG C), drying under reduced pressure, measures content.
As can be seen from the total flavones rate of transform above, the purification effect of purification process two ratio method one is good, and it is good that effective ingredient retains comparatively first method, still selected purification process be: add equivalent n-butanol extraction 3 times.
3. preparation technology's checking
Take Asplenium trchomanes L. and each 222.2g of Radix cynanchi wilfordii, mixing, totally 3 parts.Add 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filters, filtrate is concentrated into the clear paste that relative density is 1.20 (80 DEG C), treat that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery to relative density is the clear paste of 1.25 (80 DEG C), drying under reduced pressure, pulverizes, and measures general flavone content and Rhizoma Kaempferiae glycosides content.
4. different process route is on the impact of product drug effect
Because the chemical composition of different process route enrichments is distinguished to some extent, still with other conventional preparation technology, pharmacologic effect carried out to the technique after screening compare, sample preparation and therapeutic evaluation result as follows:
Sample 1: thing of getting it filled, adds 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filter, be the clear paste of 1.20 when filtrate is concentrated into relative density 80 DEG C, treat that cream is chilled to 40 DEG C, add 2 times of ethanol, mixing, leave standstill 24 hours, get supernatant, filter, reclaim ethanol, be concentrated into the clear paste of relative density 1.25 (80 DEG C), make granule.
Sample 2: thing of getting it filled, adds 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filters, filtrate is concentrated into the clear paste that relative density is 1.20 (80 DEG C), treat that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery to relative density is the clear paste of 1.25 (80 DEG C), makes granule.
Sample 3: add 8 times amount 70% alcohol reflux 3 times, each 1 hour, filter, decompression filtrate recycling ethanol to relative density is the clear paste of 1.20 (60 DEG C), add 2 times of water gagings, fully stir 30 minutes, filter, filtrate is concentrated into the clear paste of relative density 1.25 (80 DEG C), makes granule.
Dichlorodiphenyl Acetate causes the impact of mouse writhing reaction: get healthy mice, male and female half and half, random packet, normal saline group (20.0ml/kg), indomethacin group (0.014g/kg), sample sets (high dose), often organize 10, each knob all gavages administration, qd, successive administration 4 days, after last administration 1h, 0.6% acetum 0.2ml/ of each group of fresh configuration of equal lumbar injection only, observes and records every mice writhing number of times carry out statistical analysis in writhing response and 30min first.
Result shows, the technique (2 groups, sample) of the application can effective rich active ingredient, improves the curative effect of product.
Concrete embodiment
Embodiment 1: Asplenium trchomanes L. 333.3g, Radix cynanchi wilfordii 333.3g
Above two taste medical materials, add 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filters, filtrate is concentrated into the clear paste that relative density is 1.20 (80 DEG C), treats that cream is chilled to 40 DEG C, adds equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery to relative density is the clear paste of 1.25 (80 DEG C), adds 950g sucrose, mix homogeneously, granulates, dry, namely granulate obtains granule, a 15g, 2-3 time on the one.
Embodiment 2: Asplenium trchomanes L. 333.3g, Radix cynanchi wilfordii 333.3g
Above two taste medical materials, add 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.20 (80 DEG C), treats that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery to relative density is the clear paste of 1.25 (80 DEG C), drying under reduced pressure, pulverizes, adds the magnesium stearate of appropriate amount of starch and 0.2%, mix homogeneously, fill, obtains capsule.
Embodiment 3: Asplenium trchomanes L. 333.3g, Radix cynanchi wilfordii 333.3g
Above two taste medical materials, add 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.20 (80 DEG C), treats that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery to relative density is the clear paste of 1.25 (80 DEG C), drying under reduced pressure, pulverizes, adds and can press starch in right amount, mix homogeneously, namely tabletting obtains tablet.
Embodiment 4: Asplenium trchomanes L. 333.3g, Radix cynanchi wilfordii 333.3g
Above two taste medical materials, add 8 times amount 70% alcohol reflux 3 times, each 1 hour, filter, decompression filtrate recycling ethanol to relative density is the clear paste of 1.20 (60 DEG C), adds 2 times of water gagings, abundant stirring 30 minutes, filter, filtrate reduced in volume is to 800ml, add 100g sucrose and 2g sorbic acid, add water to 1000ml, mix homogeneously, subpackage, sterilizing, obtains oral liquid.
Claims (4)
1. the preparation method of a stomach Shu Xin preparation, it is characterized in that: it is prepared from as follows by Asplenium trchomanes L. 333.3g, Radix cynanchi wilfordii 333.3g and adjuvant: thing of getting it filled, add 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filtering, is the clear paste of 1.20 when filtrate is concentrated into relative density 80 DEG C, treat that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery is to clear paste during relative density 80 DEG C being 1.25, add adjuvant, make capsule, granule, tablet.
2. according to the preparation method of stomach Shu Xin preparation according to claim 1, it is characterized in that: thing of getting it filled, add 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filter, be the clear paste of 1.20 when filtrate is concentrated into relative density 80 DEG C, treat that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery, to clear paste during relative density 80 DEG C being 1.25, adds 950g sucrose, mix homogeneously, granulate, dry, namely granulate obtains granule.
3. according to the preparation method of stomach Shu Xin preparation according to claim 1, it is characterized in that: thing of getting it filled, add 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filtering, is the clear paste of 1.20 when filtrate is concentrated into relative density 80 DEG C, treat that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery is to clear paste during relative density 80 DEG C being 1.25, drying under reduced pressure, pulverize, add the magnesium stearate of appropriate amount of starch and 0.2%, mix homogeneously, fill, obtains capsule.
4. according to the preparation method of stomach Shu Xin preparation according to claim 1, it is characterized in that: thing of getting it filled, add 8 times of soak by water 3 times, 2 hours first times, second time 1.5 hours, 1 hour third time, collecting decoction, filter, be the clear paste of 1.20 when filtrate is concentrated into relative density 80 DEG C, treat that cream is chilled to 40 DEG C, add equivalent n-butanol extraction 3 times, merge n-butyl alcohol liquid, decompression and solvent recovery to clear paste during relative density 80 DEG C being 1.25, drying under reduced pressure, pulverize, add and can press starch in right amount, mix homogeneously, namely tabletting obtains tablet.
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Effective date of registration: 20211029 Address after: 551400 high tech industry planning area, Qingzhen City, Guiyang City, Guizhou Province Patentee after: GUIZHOU SHUANGSHENG PHARMACEUTICAL Co.,Ltd. Address before: Room 315, No. 8, Hangfeng Road, Fengtai Science Park, Fengtai District, Beijing 100070 (Park) Patentee before: Wu Jianming |
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Address after: 551400 high tech industry planning area, Qingzhen City, Guiyang City, Guizhou Province Patentee after: Mingyuan Pharmaceutical Co.,Ltd. Address before: 551400 high tech industry planning area, Qingzhen City, Guiyang City, Guizhou Province Patentee before: GUIZHOU SHUANGSHENG PHARMACEUTICAL Co.,Ltd. |
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