CN105477365A - Preparation method of traditional Chinese medicinal composition for treating gastritis and preparation prepared by adopting preparation method - Google Patents

Preparation method of traditional Chinese medicinal composition for treating gastritis and preparation prepared by adopting preparation method Download PDF

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Publication number
CN105477365A
CN105477365A CN201510940201.4A CN201510940201A CN105477365A CN 105477365 A CN105477365 A CN 105477365A CN 201510940201 A CN201510940201 A CN 201510940201A CN 105477365 A CN105477365 A CN 105477365A
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preparation
chinese medicine
relative density
prepared
extractum
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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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    • A61K36/18—Magnoliophyta (angiosperms)
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Abstract

The invention relates to a preparation method of a traditional Chinese medicinal composition, and in particular relates to a preparation method of a traditional Chinese medicinal composition for treating gastritis and a medicinal preparation prepared by adopting the preparation method. The product prepared by adopting the method provided by the invention has the characteristics of good stability and obvious treatment effects. The preparation method provided by the invention comprises the following steps: adding water into the medicinal materials and extracting, mixing the obtained medicine liquid, filtering, concentrating the filtrate to extract with the relative density being 1.05-1.20; carrying out high-speed centrifugation, microfiltration or ultrafiltration on the extract to obtain medicine liquid, concentrating the medicine liquid into clear paste with the relative density being 1.05-1.30; and carrying out treatment to obtain medicinal active substance, and preparing the medicinal preparation composition through a preparation method.

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:
Medical material extracting in water 2-3 time, each 0.5-3 hour, merges medicinal liquid, and filter, filtrate is concentrated into the extractum of relative density 1.05-1.20; Extractum is through high speed centrifugation (separation factor: 10000-20000), microfiltration (aperture: 0.01-10 μm), ultrafiltration (molecular cut off: 1-10 ten thousand); Concentration of liquid medicine after ultrafiltration to relative density is the clear paste of 1.05-1.30; Obtain pharmaceutically active substance, through formulation method, be prepared into pharmaceutical preparations composition.
Preferably, preparation method of the present invention is as follows:
Medical material extracting in water 2 times, each 2 hours, merge medicinal liquid, filter, filtrate is concentrated into the extractum of relative density 1.05-1.20; Extractum through high speed centrifugation (separation factor: 15000) or microfiltration (aperture: 0.1 μm) or ultrafiltration (molecular cut off: 50,000) obtain medicinal liquid, concentration of liquid medicine to relative density is the clear paste of 1.05-1.30; 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 10 424
Model group 10 104
Of the present invention group 10 338
Prior art group 10 310
The comparison of ulcer stove granulation cicatrix layer thickness
Group Number of animals (only) Granulation cicatrix layer thickness (μm)
Matched group 10 0
Model group 10 0.614
Of the present invention group 10 0.151
Prior art group 10 0.236
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:
Group Number of animals (only) Death toll (only) Survival rate %
Normal group 20 0 100
Model group 20 12 40
Of the present invention group 20 6 70
Prior art group 20 8 60
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)
Dosage group Number of animals (only) 24h swelling degree of the paw (mm) after injection
Negative control group 10 0.217
Of the present invention group 10 0.467
Prior art group 10 0.347
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:
Medical material extracting in water 2 times, each 2 hours, merge medicinal liquid, filter, filtrate is concentrated into the extractum of relative density 1.05-1.20; Extractum through high speed centrifugation (separation factor: 15000) or microfiltration (aperture: 0.1 μm) or ultrafiltration (molecular cut off: 50,000) obtain medicinal liquid, concentration of liquid medicine to relative density is the clear paste of 1.05-1.30; 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.
Embodiment 2
Its preparation method is as follows:
Medical material extracting in water 2 times, each 0.5 hour, merge medicinal liquid, filter, filtrate is concentrated into the extractum of relative density 1.05-1.20; 10000), microfiltration (aperture: 0.01 μm), ultrafiltration (molecular cut off: 10,000) extractum is through high speed centrifugation (separation factor:; Concentration of liquid medicine after ultrafiltration to relative density is the clear paste of 1.05-1.30; Obtain pharmaceutically active substance, 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.
Embodiment 3
Its preparation method is as follows:
Medical material extracting in water 3 times, each 3 hours, merge medicinal liquid, filter, filtrate is concentrated into the extractum of relative density 1.05-1.20; 20000), microfiltration (aperture: 10 μm), ultrafiltration (molecular cut off: 100,000) extractum is through high speed centrifugation (separation factor:; Concentration of liquid medicine after ultrafiltration to relative density is the clear paste of 1.05-1.30; 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.
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:
Medical material extracting in water 2-3 time, each 0.5-3 hour, merges medicinal liquid, and filter, filtrate is concentrated into the extractum of relative density 1.05-1.20; Extractum obtains medicinal liquid through high speed centrifugation (separation factor: 10000-20000) or microfiltration (aperture: 0.01-10 μm) or ultrafiltration (molecular cut off: 1-10 ten thousand), and concentration of liquid medicine to relative density is the clear paste of 1.05-1.30; 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:
Medical material extracting in water 2-3 time, each 0.5-3 hour, merges medicinal liquid, and filter, filtrate is concentrated into the extractum of relative density 1.05-1.20; Extractum obtains medicinal liquid through high speed centrifugation (separation factor: 10000-20000) or microfiltration (aperture: 0.01-10 μm) or ultrafiltration (molecular cut off: 1-10 ten thousand), and concentration of liquid medicine to relative density is the clear paste of 1.05-1.30; 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:
Medical material extracting in water 2 times, each 2 hours, merge medicinal liquid, filter, filtrate is concentrated into the extractum of relative density 1.05-1.20; Extractum through high speed centrifugation (separation factor: 15000) or microfiltration (aperture: 0.1 μm) or ultrafiltration (molecular cut off: 50,000) obtain medicinal liquid, concentration of liquid medicine to relative density is the clear paste of 1.05-1.30; 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:
Medical material extracting in water 2 times, each 2 hours, merge medicinal liquid, filter, filtrate is concentrated into the extractum of relative density 1.05-1.20; Extractum through high speed centrifugation (separation factor: 15000) or microfiltration (aperture: 0.1 μm) or ultrafiltration (molecular cut off: 50,000) obtain medicinal liquid, concentration of liquid medicine to relative density is the clear paste of 1.05-1.30; 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.
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.
CN201510940201.4A 2015-12-16 2015-12-16 Preparation method of traditional Chinese medicinal composition for treating gastritis and preparation prepared by adopting preparation method Pending CN105477365A (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 (1)

* Cited by examiner, † Cited by third party
Title
国家药典委员会: "《中华人民共和国药典 2010年版 1部》", 31 January 2010, 中国医药科技出版社 *

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