CN105381256A - Traditional Chinese medicine composition for treating gastritis and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating gastritis and preparation method thereof Download PDF

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Publication number
CN105381256A
CN105381256A CN201510939567.XA CN201510939567A CN105381256A CN 105381256 A CN105381256 A CN 105381256A CN 201510939567 A CN201510939567 A CN 201510939567A CN 105381256 A CN105381256 A CN 105381256A
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preparation
chinese medicine
medicine composition
ethanol
clear paste
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陈致慜
马靖喧
李春雷
霍志金
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HANDAN PHARMACEUTICAL CO Ltd
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HANDAN PHARMACEUTICAL CO Ltd
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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)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8967—Lilium, e.g. tiger lily or Easter lily
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    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/57—Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
    • A—HUMAN NECESSITIES
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
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    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236—Ligusticum (licorice-root)
    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/80—Scrophulariaceae (Figwort family)
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    • A61K36/88—Liliopsida (monocotyledons)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/884—Alismataceae (Water-plantain family)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968—Ophiopogon (Lilyturf)
    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/898—Orchidaceae (Orchid family)
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    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
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Abstract

The invention relates to a preparation method of a traditional Chinese medicine composition and especially relates to a traditional Chinese medicine composition for treating gastritis and a preparation method thereof. The preparation method comprises crushing medicinal materials, immersing the materials in ethanol with a concentration of 50-90% for 1-3 days, carrying out slow percolation, collecting the percolate until the percolate is colorless, recovering ethanol from the percolate, carrying out condensation to obtain clear paste with relative density of 1.10-1.30, acquiring active medical substances, and preparing the traditional Chinese medicine composition by a pharmaceutical method. The traditional Chinese medicine composition obtained by the preparation method has the characteristics of good stability and substantial treatment effects.

Description

A kind of Chinese medicine composition preparation method and preparation for the treatment of gastritis
Invention field
The present invention relates to a kind of preparation method of Chinese medicine composition, the preparation method being particularly used for the treatment of the Chinese medicine composition of gastritis and the pharmaceutical preparation prepared by the method.
Background technology
MOLUO DAN is a kind of regulating the stomach and sending down the abnormal ascending QI, spleen invigorating relieving distension, the medicine of dredging collateral to stop pain.For chronic atrophic gastritis and have a stomach-ache, distension, painful abdominal mass is vexed, indigestion and loss of appetite, belch, the heartburn disease that Dengs.Usage and dosage, oral, honeyed pill 9 ~ 18g, 3 times on the one, ante cibum rice water or warm water send down, or to follow the doctor's advice.It is formed by the 18 taste Chinese drug preparations such as Bulbus Lilii, Radix Ophiopogonis, Herba Dendrobii, Poria, the Rhizoma Atractylodis Macrocephalae (parched with bran), the Radix Linderae, the Radix Paeoniae Alba, Radix Notoginseng, Rhizoma Corydalis (processed with vinegar), Endothelium Corneum Gigeriae Galli (frying fragrant), Radix Scrophulariae, Radix Angelicae Sinensis, and pharmacological action is as follows
1 effect: Radix Angelicae Sinensis all has inhibitory action to dysentery bacterium, vibrio cholera, Bacillus proteus, escherichia coli, and Radix Notoginseng total arasaponins has comparatively high inhibition effect to some fungus.
2 gastric mucosas: we have repair to gastric mucosa injury.
The 3 reason research Radixs Linderae have dual regulation that is excited and that suppress to gastrointestinal smooth muscle, and facilitating digestion liquid is secreted; Endothelium Corneum Gigeriae Galli improves gastric secretion, acidity and digestion power.
4 immunologic functions: according to pharmacological experiment Poria, the Rhizoma Atractylodis Macrocephalae except spleen invigorating, effectively improve humoral immune function.
5 pharmacology find that in we, Radix Notoginseng, Radix Angelicae Sinensis, Poria etc. all have hepatoprotective, relieving alcohol liver poisoning, promote the function of seroconversion in liver.
Chinese patent discloses the following formula of MOLUO DAN preparation
Described Rhizoma Atractylodis Macrocephalae parched with bran, Rhizoma Corydalis processed with vinegar, Endothelium Corneum Gigeriae Galli (parched) selected by Endothelium Corneum Gigeriae Galli.
And preparation method:
Above 18 tastes, decoct with water 1-3 time, each 1.5-3 hour, collecting decoction, filter, filtrate is concentrated in right amount, add ethanol, make alcohol content reach 60-80%, leave standstill, filter, reclaim ethanol, filtrate concentrates, and add water cold preservation, filter, eventually pass normal process steps directly or add pharmaceutically acceptable excipient and make clinical acceptable dosage form.
Chinese patent 200710120838.4 discloses the following content assaying method of MOLUO DAN,
Assay is as follows:
According to high effective liquid chromatography for measuring;
Chromatographic condition and system suitability test: be filler with octadecylsilane chemically bonded silica; With the acetonitrile-water of 15-60:40-85 for mobile phase; Determined wavelength is 230nm, and number of theoretical plate calculates should be not less than 1000 ~ 5000 by peoniflorin peak;
The preparation of reference substance solution: it is appropriate that precision takes peoniflorin reference substance, solubilizer methanol, ethanol, n-butyl alcohol, water, chloroform or ethyl acetate make the solution of every 1ml containing 30-50 μ g, to obtain final product;
The preparation of need testing solution: get the big honeyed pills under MOLUO DAN small honey pill or weight differential item, shred, precision takes 1 ~ 10g, add kieselguhr 1 ~ 10g, grind well, put in tool plug conical flask, precision adds solvent methanol, ethanol, n-butyl alcohol, water, chloroform or ethyl acetate 15-25ml, close plug, weigh, supersound process or hot reflux or merceration extract 30 minutes, taking-up is put and is weighed to room temperature, with solvent methanol, ethanol, n-butyl alcohol, water, chloroform or ethyl acetate complement to 15-25ml and shake up, filter, accurate absorption subsequent filtrate 4-6ml, put in 10ml measuring bottle, solubilizer methanol, ethanol, n-butyl alcohol, water, chloroform or diluted ethyl acetate are to scale, shake up, obtain,
Algoscopy: accurate absorption reference substance solution and each 20 μ l of need testing solution respectively, injection liquid chromatography, measures, to obtain final product; The every 1g of MOLUO DAN contains the Radix Paeoniae Alba with peoniflorin C 23h 28o 11meter, must not be less than 0.8mg.
The present inventor finds in clinical and production practices, prior art is in curative effect, stability, the aspects such as the saving of raw material need to improve, and to improve the effect of medicine, extend shelf life, reduce the use amount of medicine, improve the adaptability of medicine, the present inventor improves prior art for this reason, thus completes the present invention.
Summary of the invention:
For improving the defect of prior art, the invention provides a kind of new preparation method of MOLUO DAN, the method for the invention, its formula is as follows:
Its preparation method is as follows:
Pulverizing medicinal materials, with the ethanol as solvent of 50-90%, floods after 1-3 days, slowly percolation, collects percolate to colourless, and percolate reclaims ethanol, is concentrated into the clear paste of relative density 1.10-1.30; Obtain pharmaceutically active substance, through formulation method, be prepared into pharmaceutical preparations composition.Preferably, preparation method of the present invention is as follows:
Pulverizing medicinal materials, with the ethanol as solvent of 70%, floods after 2 days, slowly percolation, collects percolate to colourless, and percolate reclaims ethanol, is concentrated into the clear paste of relative density 1.10-1.30; Obtain pharmaceutically active substance, through formulation method, be prepared into pharmaceutical preparations composition.
The present invention's preferred preparation its preparation method is as follows, and clear paste adds equivalent water-cooled and hides, and filter, filtrate adds correctives, and add water mixing, is configured to the volume of regulation, embedding, sterilizing, makes mixture, oral liquid; Or clear paste adds auxiliary materials and mixing, granulation, drying, make granule, capsule or tablet; Or adding soybean oil, Cera Flava, polyoxyethylene sorbitan monoleate and potassium sorbate after clear paste drying and crushing, mixing, makes soft capsule.
Correctives as sucrose, Mel, stevioside etc., adjuvant as dextrin, starch, mannitol, lactose, microcrystalline Cellulose, soybean oil, Cera Flava, polyoxyethylene sorbitan monoleate and potassium sorbate etc.
Compared to the prior art, main active obviously increases method of the present invention, and drug effect significantly improves, and preparation stability significantly improves,
Below by way of experimental data, beneficial effect of the present invention is described:
Experiment content:
The present invention and prior art carry out contrast experiment
Test 1, acidic ethanol caused to the impact of rat acute mucosal lesion
Animal grouping administration, in administration the 7th day each treated animal respectively fasting can't help water 48h, each treated animal gastric infusion (water) 1 time again before test, every rat oral gavage acidic ethanol 2ml (150mmol/L hydrochloric acid mixes in 1: 1 ratio with 60% ethanol) after 2h, use excess diethyl ether anesthetized rat lethal after 1h respectively, open abdomen and get stomach, use clamp cardia, 1% formalin 5ml is injected by pylorus, clamping pylorus, full stomach is placed in 1% formalin and fixes 10min, cut off along greater gastric curvature, stomach is turned up, content is washed away gently with clear water, stomach is laid on glass plate, mucosal lesion length is measured with precimeter, using damaged length (damage width is greater than 1mm person to be doubled to calculate) summation as gastric mucosal damage index, and calculate suppression ratio.
Experimental result is as follows:
From result, each group gastric mucosa all has and damages in various degree, and all comparatively model control group is light for of the present invention group and prior art group, and damage index obviously reduces (P<0.05).
The comparison of rat regenerated mucosa thickness
Group Number of animals (only) Regenerated mucosa thickness (μm)
Matched group 10 423
Model group 10 105
Of the present invention group 10 346
Prior art group 10 301
The comparison of ulcer stove granulation cicatrix layer thickness
Experiment 2, impact on rat gastric secretion
Animal grouping administration, often organize 10 rats, each treated animal fasting taboo water 24h respectively after last administration, with etherization, osculum is cut off along ventrimeson, pull out stomach gently, ligation pylorus, again by duodenal administration 1 time, suturing them otch, fu jie of taking out stitches out after 6h pricks cardia, extract full stomach, bloodstain is cleaned with filter paper, coat of the stomach is cut off along greater gastric curvature, incline and gastric content, be collected in graduated centrifuge tube, with 1500r/min centrifugation 10min, accurate record gastric juice amount, be that indicator measures total acidity gastric juice with phenol red, the special capillary tube method of wheat is adopted to measure pepsin activity.
Experimental result is as follows:
From result, of the present invention group and prior art group all can reduce total acidity gastric juice and pepsin activity.
Antibacterial tests in experiment 3, body:
Of the present invention group and prior art group all can reduce infection of staphylococcus aureus dead mouse number, extend the survival natural law of infecting mouse;
Experimental result is as follows:
Test 4. anti-inflammation test results:
Of the present invention group and prior art group all can reduce dimethylbenzene induced mice auricle swelling degree.
On mice delayed allergy (the sufficient sole of the foot thickens method) impact (sufficient sole of the foot thickness difference mm)
Experiment 5, accelerated stability experiment
Sample is placed on 40 DEG C ± 2 DEG C, is positioned in climatic chamber under the condition of relative humidity 75% ± 5%, with setting-up time sampling, carry out assay to related component, the primary stability result of the test after test is as follows
Primary stability result of the test after inventive samples test
Primary stability result of the test after prior art sampling test
Advantage of the present invention is mainly manifested in:
By improving preparation method, achieve following technique effect: the dose reducing medicine, the content of active component increases, and preparation stability increases, and the curative effect of medicine increases.
Detailed description of the invention:
Further illustrate the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1
Its preparation method is as follows:
Pulverizing medicinal materials, with the ethanol as solvent of 70%, floods after 2 days, slowly percolation, collects percolate to colourless, and percolate reclaims ethanol, is concentrated into the clear paste of relative density 1.10-1.30; Clear paste adds water cold preservation, and filter, filtrate adds correctives, and add water mixing, is configured to the volume of regulation, embedding, sterilizing, makes mixture, oral liquid; Or clear paste adds auxiliary materials and mixing, granulation, drying, make granule, capsule or tablet; Or adding soybean oil, Cera Flava, polyoxyethylene sorbitan monoleate and potassium sorbate after clear paste drying and crushing, mixing, makes soft capsule.
Embodiment 2
Its preparation method is as follows:
Pulverizing medicinal materials, with the ethanol as solvent of 50%, floods after 1 day, slowly percolation, collects percolate to colourless, and percolate reclaims ethanol, is concentrated into the clear paste of relative density 1.10-1.30; Obtain pharmaceutically active substance, clear paste adds water cold preservation, and filter, filtrate adds correctives, and add water mixing, is configured to the volume of regulation, embedding, sterilizing, makes mixture, oral liquid; Or clear paste adds auxiliary materials and mixing, granulation, drying, make granule, capsule or tablet; Or adding soybean oil, Cera Flava, polyoxyethylene sorbitan monoleate and potassium sorbate after clear paste drying and crushing, mixing, makes soft capsule.
Embodiment 3
Its preparation method is as follows:
Pulverizing medicinal materials, with the ethanol as solvent of 90%, floods after 3 days, slowly percolation, collects percolate to colourless, and percolate reclaims ethanol, is concentrated into the clear paste of relative density 1.10-1.30; Clear paste adds water cold preservation, and filter, filtrate adds correctives, and add water mixing, is configured to the volume of regulation, embedding, sterilizing, makes mixture, oral liquid; Or clear paste adds auxiliary materials and mixing, granulation, drying, make granule, capsule or tablet; Or adding soybean oil, Cera Flava, polyoxyethylene sorbitan monoleate and potassium sorbate after clear paste drying and crushing, mixing, makes soft capsule.
Sample prepared by above embodiment method, measures through determination: every 1g contains the Radix Paeoniae Alba with peoniflorin C 23h 28o 11meter, is no less than 1.4mg.

Claims (7)

1. treat a preparation method for the Chinese medicine composition of gastritis, described Chinese medicine composition is prepared from by the raw material of Chinese medicine medicine of following weight proportion,
It is characterized in that, described preparation method step is as follows:
Pulverizing medicinal materials, with the ethanol as solvent of 50-90%, floods after 1-3 days, slowly percolation, collects percolate to colourless, and percolate reclaims ethanol, is concentrated into the clear paste of relative density 1.10-1.30; Obtain pharmaceutically active substance, through formulation method, be prepared into pharmaceutical preparations composition.
2. preparation method according to claim 1, is characterized in that, described Chinese medicine composition is prepared from by the raw material of Chinese medicine medicine of following weight proportion,
It is characterized in that, described preparation method step is as follows:
Pulverizing medicinal materials, with the ethanol as solvent of 50-90%, floods after 1-3 days, slowly percolation, collects percolate to colourless, and percolate reclaims ethanol, is concentrated into the clear paste of relative density 1.10-1.30; Obtain pharmaceutically active substance, through formulation method, be prepared into pharmaceutical preparations composition.
3. preparation method according to claim 1, is characterized in that, described Chinese medicine composition is prepared from by the raw material of Chinese medicine medicine of following weight proportion,
It is characterized in that, described preparation method step is as follows:
Pulverizing medicinal materials, with the ethanol as solvent of 70%, floods after 2 days, slowly percolation, collects percolate to colourless, and percolate reclaims ethanol, is concentrated into the clear paste of relative density 1.10-1.30; Obtain pharmaceutically active substance, through formulation method, be prepared into pharmaceutical preparations composition.
4. preparation method according to claim 1, is characterized in that, described Chinese medicine composition is prepared from by the raw material of Chinese medicine medicine of following weight proportion,
It is characterized in that, described preparation method step is as follows:
Pulverizing medicinal materials, with the ethanol as solvent of 70%, floods after 2 days, slowly percolation, collects percolate to colourless, and percolate reclaims ethanol, is concentrated into the clear paste of relative density 1.10-1.30; Clear paste adds water cold preservation, and filter, filtrate adds correctives, and add water mixing, is configured to the volume of regulation, embedding, sterilizing, makes mixture, oral liquid; Or clear paste adds auxiliary materials and mixing, granulation, drying, make granule, capsule or tablet; Or adding soybean oil, Cera Flava, polyoxyethylene sorbitan monoleate and potassium sorbate after clear paste drying and crushing, mixing, makes soft capsule.
5. preparation method according to claim 1, is characterized in that, described Chinese medicine composition is oral liquid.
6. preparation method according to claim 1, is characterized in that, described Chinese medicine composition is capsule.
7. preparation method according to claim 1, is characterized in that, described Chinese medicine composition is granule.
CN201510939567.XA 2015-12-16 2015-12-16 Traditional Chinese medicine composition for treating gastritis and preparation method thereof Pending CN105381256A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1457829A (en) * 2003-04-17 2003-11-26 邯郸制药有限公司 Chinese medicine composition for curing chronic atrophic sastritis and its preparing method and quality control method

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1457829A (en) * 2003-04-17 2003-11-26 邯郸制药有限公司 Chinese medicine composition for curing chronic atrophic sastritis and its preparing method and quality control method

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
凌沛学: "《中药学概论》", 31 August 2007, 中国轻工业出版社 *
高立霞等: "正交试验法优选摩罗片的提取工艺", 《泰山医学院学报》 *

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Application publication date: 20160309