CN109078115B - Traditional Chinese medicine preparation for treating gastrointestinal hemorrhage and preparation method thereof - Google Patents
Traditional Chinese medicine preparation for treating gastrointestinal hemorrhage and preparation method thereof Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title claims abstract description 34
- 239000003814 drug Substances 0.000 title claims abstract description 26
- 208000012671 Gastrointestinal haemorrhages Diseases 0.000 title claims abstract description 14
- 244000131316 Panax pseudoginseng Species 0.000 claims abstract description 67
- 235000003181 Panax pseudoginseng Nutrition 0.000 claims abstract description 67
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 137
- 235000019441 ethanol Nutrition 0.000 claims description 49
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 42
- 239000000843 powder Substances 0.000 claims description 40
- 239000000284 extract Substances 0.000 claims description 25
- 239000008367 deionised water Substances 0.000 claims description 23
- 229910021641 deionized water Inorganic materials 0.000 claims description 23
- 239000011347 resin Substances 0.000 claims description 22
- 229920005989 resin Polymers 0.000 claims description 22
- 239000008187 granular material Substances 0.000 claims description 20
- 241001313857 Bletilla striata Species 0.000 claims description 19
- 239000003480 eluent Substances 0.000 claims description 16
- 241000180649 Panax notoginseng Species 0.000 claims description 15
- 235000003143 Panax notoginseng Nutrition 0.000 claims description 15
- 238000001035 drying Methods 0.000 claims description 15
- 238000000034 method Methods 0.000 claims description 14
- 238000001179 sorption measurement Methods 0.000 claims description 14
- 238000002156 mixing Methods 0.000 claims description 12
- 238000007873 sieving Methods 0.000 claims description 12
- 239000000706 filtrate Substances 0.000 claims description 10
- 238000001914 filtration Methods 0.000 claims description 10
- 239000012530 fluid Substances 0.000 claims description 10
- 230000005484 gravity Effects 0.000 claims description 10
- 238000005406 washing Methods 0.000 claims description 8
- 239000000047 product Substances 0.000 claims description 7
- 239000002904 solvent Substances 0.000 claims description 7
- 239000007788 liquid Substances 0.000 claims description 6
- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 claims description 5
- VHUUQVKOLVNVRT-UHFFFAOYSA-N Ammonium hydroxide Chemical compound [NH4+].[OH-] VHUUQVKOLVNVRT-UHFFFAOYSA-N 0.000 claims description 5
- 239000004677 Nylon Substances 0.000 claims description 5
- 235000011114 ammonium hydroxide Nutrition 0.000 claims description 5
- 239000003729 cation exchange resin Substances 0.000 claims description 5
- 238000001816 cooling Methods 0.000 claims description 5
- 239000003085 diluting agent Substances 0.000 claims description 5
- 229920001778 nylon Polymers 0.000 claims description 5
- 238000010992 reflux Methods 0.000 claims description 5
- 238000003756 stirring Methods 0.000 claims description 5
- 241000233855 Orchidaceae Species 0.000 claims description 4
- 238000000605 extraction Methods 0.000 claims description 4
- 241000208340 Araliaceae Species 0.000 claims description 3
- 238000011068 loading method Methods 0.000 claims description 3
- 238000010298 pulverizing process Methods 0.000 claims description 3
- 238000011084 recovery Methods 0.000 claims description 3
- 239000007779 soft material Substances 0.000 claims 1
- 206010046274 Upper gastrointestinal haemorrhage Diseases 0.000 description 9
- 206010053567 Coagulopathies Diseases 0.000 description 8
- 230000035602 clotting Effects 0.000 description 8
- 238000005516 engineering process Methods 0.000 description 8
- 239000008280 blood Substances 0.000 description 6
- 210000004369 blood Anatomy 0.000 description 6
- 230000023555 blood coagulation Effects 0.000 description 6
- 241000283973 Oryctolagus cuniculus Species 0.000 description 5
- 239000000469 ethanolic extract Substances 0.000 description 4
- 208000032843 Hemorrhage Diseases 0.000 description 3
- 208000008469 Peptic Ulcer Diseases 0.000 description 3
- 206010034344 Peptic ulcer haemorrhage Diseases 0.000 description 3
- 208000007107 Stomach Ulcer Diseases 0.000 description 3
- 230000000740 bleeding effect Effects 0.000 description 3
- 230000017531 blood circulation Effects 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 201000005917 gastric ulcer Diseases 0.000 description 3
- 238000005469 granulation Methods 0.000 description 3
- 230000003179 granulation Effects 0.000 description 3
- 208000011906 peptic ulcer disease Diseases 0.000 description 3
- 230000001737 promoting effect Effects 0.000 description 3
- 208000034507 Haematemesis Diseases 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 238000002481 ethanol extraction Methods 0.000 description 2
- 238000009776 industrial production Methods 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 238000000746 purification Methods 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 239000006228 supernatant Substances 0.000 description 2
- 230000008961 swelling Effects 0.000 description 2
- 208000004998 Abdominal Pain Diseases 0.000 description 1
- 206010013839 Duodenal ulcer haemorrhage Diseases 0.000 description 1
- 208000007882 Gastritis Diseases 0.000 description 1
- 208000000616 Hemoptysis Diseases 0.000 description 1
- 206010027514 Metrorrhagia Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 206010053476 Traumatic haemorrhage Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000003255 drug test Methods 0.000 description 1
- 208000000718 duodenal ulcer Diseases 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 208000035861 hematochezia Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 230000008736 traumatic injury Effects 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
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Abstract
The invention relates to a traditional Chinese medicine preparation for gastrointestinal hemorrhage and a preparation method thereof, in particular to a traditional Chinese medicine preparation which is prepared by respectively extracting and purifying rhizoma bletillae and pseudo-ginseng to obtain a medicinal composition and matching the medicinal composition according to a certain proportion.
Description
Technical Field
The invention relates to a medical technology, in particular to a traditional Chinese medicine preparation for treating gastrointestinal hemorrhage and a preparation method thereof.
Background
The upper gastrointestinal hemorrhage has many causes, such as peptic ulcer, drug injury, gastritis, tumor, etc. In terms of peptic ulcer alone, it is a large susceptible population, and according to statistics, about 10% of people have gastric ulcer and duodenal ulcer in a certain period of their lives, while about 15% to 25% of peptic ulcer patients have upper gastrointestinal hemorrhage in combination, and men are more common than women, and elderly patients have a tendency to increase in peptic ulcer and upper gastrointestinal hemorrhage, wherein duodenal ulcer hemorrhage is more common than gastric ulcer and about 3 to 4 times as much as gastric ulcer, according to statistics of 25000 inpatients of our country, the mortality rate of peptic ulcer and upper gastrointestinal hemorrhage is 0.5% to 3%, while many foreign scholars consider that the mortality rate of peptic ulcer hemorrhage is still 5% to 10%, therefore, the drug for treating upper gastrointestinal hemorrhage has a large market demand, on the other hand, the traditional Chinese medicine has a large advantage in treating upper gastrointestinal hemorrhage, the traditional Chinese medicine has the medicinal parts from dried tubers of orchid plant bletilla striata (Thunb.) Reichb.f. which are bitter, sweet, astringent and slightly cold in nature, has the effects of astringing to stop bleeding, relieving swelling and promoting granulation, and is named as pseudo-ginseng, which is produced in Yunnan Wenshan, so that the pseudo-ginseng is named as Panax notoginseng (Burk.) F.H. metrorrhagia, is used for hemoptysis, hematemesis, hematochezia and hematemesis, traumatic hemorrhage, thoracico-abdominal pain, traumatic injury with swelling and pain.
Disclosure of Invention
The invention provides a new medicine for treating upper gastrointestinal hemorrhage, which is prepared by extracting and purifying effective parts from rhizoma bletillae and pseudo-ginseng by adopting modern technology
The technical scheme for solving the technical problems is as follows: a preparation method of a traditional Chinese medicine preparation for treating gastrointestinal hemorrhage comprises the following steps:
s1: the bletilla striata is smashed into coarse powder, and the weight ratio of the bletilla striata coarse powder to deionized water is 1: 10-20, adding deionized water into the coarse powder of the bletilla striata, decocting and extracting for 2-3 times, wherein each time lasts for 0.5-2 hours, concentrating the filtrate under reduced pressure at 80 ℃ until the specific gravity is 1.1-1.15, and mixing the concentrated solution with absolute ethyl alcohol according to the weight ratio of 1: 5-10, slowly adding absolute ethyl alcohol into the concentrated solution, uniformly stirring, settling for 5-10 hours, filtering, and concentrating under reduced pressure at 80 ℃ until the specific gravity is 1.16-1.20 to obtain effective components of the rhizoma bletillae;
s2: pulverizing pseudo-ginseng into coarse powder, wherein the weight ratio of the pseudo-ginseng coarse powder to ethanol is 1: 9-20, adding ethanol into the pseudo-ginseng coarse powder, carrying out reflux extraction for 2-3 times, wherein each time lasts for 1-3 hours, and carrying out reduced pressure recovery on the ethanol from the filtrate to obtain pseudo-ginseng ethanol extract and pseudo-ginseng medicinal residues;
s3: and (4) adding water to dilute the pseudo-ginseng alcohol extract obtained in the step (S2), wherein the weight ratio of the pseudo-ginseng alcohol extract to the water is 1: 4-10, after enriching the diluent by using a macroporous adsorption resin column, eluting by using 3-8 BV of deionized water to collect water washing liquid, eluting by using 5-10 BV of ethanol, collecting ethanol eluent, recovering an ethanol solvent under reduced pressure to obtain a fluid extract, and drying the fluid extract to obtain a first pseudo-ginseng effective part;
s4: and (5) adding deionized water into the pseudo-ginseng dregs obtained in the step (S2), wherein the weight ratio of the added deionized water to the pseudo-ginseng coarse powder is 1: 10-20, decocting for 0.5-1.5 hours, filtering, cooling, taking supernate and the water washing liquid obtained in the step S3, adding cation exchange resin, eluting with 0.2mol/L ammonia water, concentrating the eluent under reduced pressure, and drying in vacuum to obtain a second pseudo-ginseng effective part;
s5: mixing the effective part of the bletilla striata obtained in the step S1, the effective part of the first pseudo-ginseng obtained in the step S3 and the effective part of the second pseudo-ginseng obtained in the step S4, adding sugar and ethanol with the mass concentration of 70% to prepare soft granules, granulating the soft granules through a 14-mesh nylon sieve, drying the obtained wet granules at 60 ℃, sieving the obtained dry granules through a 14-mesh sieve to complete granules, and sieving through a No. 4 sieve to remove fine powder to obtain a finished product.
On the basis of the technical scheme, the invention can be further improved as follows.
Further, the bletilla striata is a dried tuber of the orchid plant bletilla striata bletillarstriata (Thunb.) reichb.f.
Further, the Panax notoginseng is dried root and rhizome of Panax notoginseng (Burk.) F.H.Chen) belonging to Araliaceae.
Further, the macroporous adsorption resin is nonpolar or weak polar macroporous adsorption resin.
Further, the conditions for enriching the macroporous adsorption resin column in the step S3 are that the ratio of the pseudo-ginseng coarse powder to the resin in parts by weight is 1: 1-5, wherein the height ratio of the resin chromatographic column diameter is 1: 3-9, the sample loading flow rate is 1-3 mL/min/g, the eluent is ethanol with the mass concentration of 60% -80%, and the dosage of the eluent is 5-7 BV.
Further, the mass concentration of ethanol in step S2 is 50% to 90%.
Further, the weight ratio of the rhizoma bletillae to the panax notoginseng is 1: 1-3, and the finished product obtained in the step S5 is a granular preparation.
A Chinese medicinal preparation is prepared by the above preparation method.
Compared with the prior art, the method of the invention has the following beneficial effects:
(1) the invention adopts modern separation and purification technology, extracts and purifies effective parts for stopping bleeding and promoting blood circulation to remove blood stasis from traditional Chinese medicine rhizoma bletillae and pseudo-ginseng, and combines the effective parts according to a certain proportion to form a new generation of pharmaceutical composition for treating upper gastrointestinal hemorrhage.
(2) The product of the invention is prepared by modern technology, has the characteristics of high technology content, high purity of active ingredients of the medicine, small dosage, convenient taking and the like, has strong operability and is suitable for industrial production.
Detailed Description
The invention is described in further detail below:
a preparation method of a traditional Chinese medicine preparation for treating gastrointestinal hemorrhage comprises the following steps:
s1: the bletilla striata is smashed into coarse powder, and the weight ratio of the bletilla striata coarse powder to deionized water is 1: 10-20, adding deionized water into the coarse powder of the bletilla striata, decocting and extracting for 2-3 times, wherein each time lasts for 0.5-2 hours, concentrating the filtrate under reduced pressure at 80 ℃ until the specific gravity is 1.1-1.15, and mixing the concentrated solution with absolute ethyl alcohol according to the weight ratio of 1: 5-10, slowly adding absolute ethyl alcohol into the concentrated solution, uniformly stirring, settling for 5-10 hours, filtering, and concentrating under reduced pressure at 80 ℃ until the specific gravity is 1.16-1.20 to obtain effective components of the rhizoma bletillae;
s2: pulverizing pseudo-ginseng into coarse powder, wherein the weight ratio of the pseudo-ginseng coarse powder to ethanol is 1: 9-20, adding ethanol into the pseudo-ginseng coarse powder, carrying out reflux extraction for 2-3 times, wherein each time lasts for 1-3 hours, and carrying out reduced pressure recovery on the ethanol from the filtrate to obtain pseudo-ginseng ethanol extract and pseudo-ginseng medicinal residues;
s3: and (4) adding water to dilute the pseudo-ginseng alcohol extract obtained in the step (S2), wherein the weight ratio of the pseudo-ginseng alcohol extract to the water is 1: 4-10, after enriching the diluent by using a macroporous adsorption resin column, eluting by using 3-8 BV of deionized water to collect water washing liquid, eluting by using 5-10 BV of ethanol, collecting ethanol eluent, recovering an ethanol solvent under reduced pressure to obtain a fluid extract, and drying the fluid extract to obtain a first pseudo-ginseng effective part;
s4: and (5) adding deionized water into the pseudo-ginseng dregs obtained in the step (S2), wherein the weight ratio of the added deionized water to the pseudo-ginseng coarse powder is 1: 10-20, decocting for 0.5-1.5 hours, filtering, cooling, taking supernatant, adding the water washing liquid obtained in the step S3 into cation exchange resin, eluting with 0.2mol/L ammonia water, concentrating the eluent under reduced pressure, and drying in vacuum to obtain a second pseudo-ginseng effective part;
s5: mixing the effective part of the bletilla striata obtained in the step S1, the effective part of the first pseudo-ginseng obtained in the step S3 and the effective part of the second pseudo-ginseng obtained in the step S4, adding sugar and ethanol with the mass concentration of 70% to prepare soft granules, granulating the soft granules through a 14-mesh nylon sieve, drying the obtained wet granules at 60 ℃, sieving the obtained dry granules through a 14-mesh sieve to complete granules, and sieving through a No. 4 sieve to remove fine powder to obtain a finished product.
The bletilla striata is a dried tuber of the orchid plant bletilla striata (Thunb.) Reichb.f.
The Notoginseng radix is dried root and rhizome of Panax notoginseng (Burk.) F.H.Chen of Araliaceae.
The macroporous adsorption resin is nonpolar or weak polar macroporous adsorption resin.
The conditions for enriching by using the macroporous adsorption resin column in the step S3 are that the ratio of the pseudo-ginseng coarse powder to the resin in parts by weight is 1: 1-5, wherein the height ratio of the resin chromatographic column diameter is 1: 3-9, the sample loading flow rate is 1-3 mL/min/g, the eluent is ethanol with the mass concentration of 60% -80%, and the dosage of the eluent is 5-7 BV.
The mass concentration of the ethanol in the step S2 is 50-90%, and the mass concentration of the ethanol in the step S3 is 50-90%.
The weight ratio of the rhizoma bletillae to the pseudo-ginseng is 1: 1-3, and the finished product obtained in the step S5 is a granular preparation.
A Chinese medicinal preparation is prepared by the above preparation method.
Two groups of traditional Chinese medicine preparations are prepared according to two embodiments of different proportions:
example 1:
s1, crushing 10Kg of traditional Chinese medicine rhizoma bletillae into coarse powder, wherein the weight ratio of the rhizoma bletillae coarse powder is as follows: deionized water 1: 20 (by weight), decocting and extracting for 2 times, each time for 1 hour, concentrating the filtrate under reduced pressure until the specific gravity is 1.12 (measured at 80 ℃), slowly adding absolute ethyl alcohol into the concentrated solution, and mixing the concentrated solution: anhydrous ethanol ═ 1: 8, stirring, settling for 10 hours, filtering, and concentrating under reduced pressure until the specific gravity is 1.16-1.20 (measured at 80 ℃), so as to obtain 9.3Kg of effective components of rhizoma bletillae;
s2, crushing 10Kg of traditional Chinese medicine pseudo-ginseng into coarse powder according to the weight ratio of pseudo-ginseng coarse powder: 75% ethanol ═ 1: 15 (by weight), extracting under reflux for 2 times, each for 1 hr, and recovering solvent from the filtrate under reduced pressure to obtain Notoginseng radix ethanol extract;
s3, adding water to dilute the pseudo-ginseng alcohol extract obtained in the step S2, wherein the pseudo-ginseng alcohol extract: water 1: 8, enriching the diluent by an AB-8 type macroporous adsorption resin column, eluting with 5BV (resin volume) of deionized water, eluting with 75% ethanol of 8BV, collecting ethanol eluent, recovering ethanol solvent under reduced pressure to obtain fluid extract, drying the fluid extract under reduced pressure, and crushing to obtain about 1.8kg of the first pseudo-ginseng effective part;
s4, mixing the pseudo-ginseng dregs obtained after the ethanol extraction in the step S2 according to the ratio of pseudo-ginseng coarse powder: deionized water 1: 10, adding deionized water, decocting for 0.5 hour, filtering, cooling, taking supernate and washing water in the step S3, adding the treated DKSZ-1 type cation exchange resin, eluting with 0.2mol/L ammonia water, concentrating the eluent under reduced pressure, drying in vacuum, and crushing to obtain about 0.8Kg of the second pseudo-ginseng effective part extract;
s5, mixing the effective parts of rhizoma bletillae, the effective part of the first pseudo-ginseng and the effective part of the second pseudo-ginseng, adding 30Kg of powdered sugar, adding a proper amount of 70% ethanol, preparing into soft granules, sieving with a 14-mesh nylon sieve for granulation, drying the wet granules at 60 ℃, sieving the dry granules with a 14-mesh sieve for granulation, and sieving with a No. 4 sieve for removing fine powder to obtain the first group of traditional Chinese medicine preparation.
Example 2:
s1, crushing 10Kg of traditional Chinese medicine rhizoma bletillae into coarse powder, wherein the weight ratio of the rhizoma bletillae coarse powder is as follows: deionized water 1: 15 (by weight), decocting and extracting for 2 times, each time for 1.5 hours, concentrating the filtrate under reduced pressure until the specific gravity is 1.14 (measured at 80 ℃), slowly adding absolute ethyl alcohol into the concentrated solution, and mixing the concentrated solution: anhydrous ethanol ═ 1: stirring at a ratio of 6, settling for 8 hours, filtering, and concentrating under reduced pressure until the specific gravity is 1.16-1.20 (measured at 80 ℃), so as to obtain 8.9Kg of effective components of rhizoma bletillae;
s2, crushing 10Kg of traditional Chinese medicine pseudo-ginseng into coarse powder according to the weight ratio of pseudo-ginseng coarse powder: 75% ethanol ═ 1: 15 (by weight), extracting under reflux for 2 times, each for 2 hr, and recovering solvent from the filtrate under reduced pressure to obtain Notoginseng radix ethanol extract;
s3, adding water to dilute the pseudo-ginseng alcohol extract obtained in the step S2, wherein the pseudo-ginseng alcohol extract: water 1: and 6, enriching the diluent by an AB-8 type macroporous adsorption resin column, eluting by 5BV (resin volume) of deionized water and then 70 percent ethanol of 8BV, collecting ethanol eluent, recovering an ethanol solvent under reduced pressure to obtain a fluid extract, drying the fluid extract under reduced pressure, and crushing to obtain about 1.5kg of the first pseudo-ginseng effective part.
S4, mixing the pseudo-ginseng dregs obtained after the ethanol extraction in the step S2 according to the ratio of pseudo-ginseng coarse powder: deionized water 1: 10, adding deionized water, decocting for 1 hour, filtering, cooling, taking supernatant and washing water in the step S3, adding the treated DKSZ-1 type cation exchange resin, eluting with 0.2mol/L ammonia water, concentrating the eluent under reduced pressure, drying in vacuum, and crushing to obtain about 0.7Kg of the second pseudo-ginseng effective part extract.
S5, mixing the effective parts of rhizoma Bletillae, the effective part of the first Notoginseng radix, and the effective part of the second Notoginseng radix, adding 30Kg of sugar powder, adding appropriate amount of 70% ethanol, making into soft granules, sieving with 14 mesh nylon sieve, granulating, drying the wet granules at 60 deg.C, sieving with 14 mesh sieve, grading, sieving with No. 4 sieve, and removing fine powder to obtain the second group of Chinese medicinal preparation.
According to the two groups of examples, different raw material proportions and different extraction effects are known, and the example 1 is superior to the example 2, so that the proportion is very important for preparing, and the traditional Chinese medicine preparation can be an oral preparation or granules, preferably granules.
To test the effectiveness of the drug, the first group of traditional Chinese medicine preparations prepared in example 1 was used to perform drug tests on rabbits according to the following experimental procedures:
1ml of blood is taken from the ear vein of the rabbit, the needle is removed, the blood is gently placed into the test tube along the wall of the test tube, and the time is recorded by a stopwatch when the blood is sucked into the syringe. And slightly tilting the test tube once every half minute at an angle of about 30 degrees, observing whether the blood flows or not until the test tube is tilted to 90 degrees and the blood does not flow any more and is completely coagulated, and stopping timing, wherein the blood coagulation time is the blood coagulation time.
The effective parts of rhizoma bletillae and radix notoginseng are irrigated to the stomach of the rabbit by 2g/Kg (mixed by warm saline water of 5-20 ml/Kg), after 30min, the blood coagulation time after administration is measured according to the method, and the percentage of shortening of the blood coagulation time is calculated.
The formula E% ([ (B-a)/B ] × 100) and the percentage of clotting time reduction ═ average clotting time before dosing-average clotting time after dosing)/average clotting time before dosing × 100%
Wherein E% is the percentage of clotting time reduction; b is the mean clotting time before dosing; a is the mean clotting time after administration.
The experimental results are shown in table 1, and the experimental results show that compared with the control group before administration, the administration groups obviously shorten the rabbit blood coagulation time, which indicates that effective parts of rhizoma bletillae and pseudo-ginseng have better blood coagulation effect.
TABLE 1 influence of effective fractions of rhizoma Bletillae and radix Notoginseng on rabbit clotting time
Therefore, compared with the prior art, the method has the following beneficial effects:
(1) the invention adopts modern separation and purification technology, extracts and purifies effective parts for stopping bleeding and promoting blood circulation to remove blood stasis from traditional Chinese medicine rhizoma bletillae and pseudo-ginseng, and combines the effective parts according to a certain proportion to form a new generation of pharmaceutical composition for treating upper gastrointestinal hemorrhage.
(2) The product of the invention is prepared by modern technology, has the characteristics of high technology content, high purity of active ingredients of the medicine, small dosage, convenient taking and the like, has strong operability and is suitable for industrial production.
The above description is only a preferred embodiment of the present invention, and therefore should not be taken as limiting the scope of the invention, which is defined by the appended claims and their equivalents and modifications within the scope of the description.
Claims (7)
1. A preparation method of a traditional Chinese medicine preparation for gastrointestinal hemorrhage is characterized by comprising the following steps: the method comprises the following steps:
s1: the bletilla striata is smashed into coarse powder, and the weight ratio of the bletilla striata coarse powder to deionized water is 1: 10-20, adding deionized water into the coarse powder of the bletilla striata, decocting and extracting for 2-3 times, wherein each time lasts for 0.5-2 hours, concentrating the filtrate under reduced pressure at 80 ℃ until the specific gravity is 1.1-1.15, and mixing the concentrated solution with absolute ethyl alcohol according to the weight ratio of 1: 5-10, slowly adding absolute ethyl alcohol into the concentrated solution, uniformly stirring, settling for 5-10 hours, filtering, and concentrating under reduced pressure at 80 ℃ until the specific gravity is 1.16-1.20 to obtain effective components of the rhizoma bletillae;
s2: pulverizing pseudo-ginseng into coarse powder, wherein the weight ratio of the pseudo-ginseng coarse powder to ethanol is 1: 9-20, adding ethanol into the pseudo-ginseng coarse powder, carrying out reflux extraction for 2-3 times, wherein each time lasts for 1-3 hours, and carrying out reduced pressure recovery on the filtrate to obtain ethanol
Extracting Notoginseng radix with ethanol to obtain extract and residue;
s3: and (4) adding water to dilute the pseudo-ginseng alcohol extract obtained in the step (S2), wherein the weight ratio of the pseudo-ginseng alcohol extract to the water is 1: 4-10, after enriching the diluent by using a macroporous adsorption resin column, eluting by using 3-8 BV of deionized water to collect water washing liquid, eluting by using 5-10 BV of ethanol, collecting ethanol eluent, recovering an ethanol solvent under reduced pressure to obtain a fluid extract, and drying the fluid extract to obtain a first pseudo-ginseng effective part;
s4: and (5) adding deionized water into the pseudo-ginseng dregs obtained in the step (S2), wherein the weight ratio of the added pseudo-ginseng coarse powder to the deionized water is 1: 10-20, decocting for 0.5-1.5 hours, filtering, cooling, taking supernate and the water washing liquid obtained in the step S3, adding cation exchange resin, eluting with 0.2mol/L ammonia water, concentrating the eluent under reduced pressure, and drying in vacuum to obtain a second pseudo-ginseng effective part;
s5: mixing the effective part of rhizoma bletillae obtained in the step S1 with the effective part of the first pseudo-ginseng obtained in the step S3 and the effective part of the second pseudo-ginseng obtained in the step S4, adding sugar and ethanol with the mass concentration of 70% to prepare a soft material, granulating by a 14-mesh nylon sieve, drying the obtained wet granules at 60 ℃, sieving the obtained dry granules by a 14-mesh sieve to complete granules, and sieving by a No. 4 sieve to remove fine powder to obtain a finished product;
the weight ratio of the bletilla striata to the pseudo-ginseng is 1: 1-3.
2. The method for preparing a Chinese medicinal preparation for treating gastrointestinal hemorrhage according to claim 1, wherein the method comprises the following steps: the bletilla striata is a dried tuber of the orchid plant bletilla striata (Thunb.) Reichb.f.
3. The method for preparing a Chinese medicinal preparation for treating gastrointestinal hemorrhage according to claim 1, wherein the method comprises the following steps: the Notoginseng radix is dried root and rhizome of Panax notoginseng (Burk.) F.H.Chen of Araliaceae.
4. The method for preparing a Chinese medicinal preparation for treating gastrointestinal hemorrhage according to claim 1, wherein the method comprises the following steps: the macroporous adsorption resin is nonpolar or weak polar macroporous adsorption resin.
5. The method for preparing a Chinese medicinal preparation for treating gastrointestinal hemorrhage according to claim 1, wherein the method comprises the following steps: the conditions for enriching by using the macroporous adsorption resin column in the step S3 are that the ratio of the pseudo-ginseng coarse powder to the resin in parts by weight is 1: 1-5, wherein the height ratio of the resin chromatographic column diameter is 1: 3-9, the sample loading flow rate is 1-3 mL/min/g, the eluent is ethanol with the mass concentration of 60% -80%, and the dosage of the eluent is 5-7 BV.
6. The method for preparing a Chinese medicinal preparation for treating gastrointestinal hemorrhage according to claim 1
Characterized in that: the mass concentration of the ethanol in the step S2 is 50% -90%.
7. A Chinese medicinal preparation prepared by the method for preparing the Chinese medicinal preparation for treating gastrointestinal hemorrhage according to any one of claims 1-6.
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