CN105232991B - A kind of pharmaceutical composition for treating mucosal lesion - Google Patents

A kind of pharmaceutical composition for treating mucosal lesion Download PDF

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CN105232991B
CN105232991B CN201510777276.5A CN201510777276A CN105232991B CN 105232991 B CN105232991 B CN 105232991B CN 201510777276 A CN201510777276 A CN 201510777276A CN 105232991 B CN105232991 B CN 105232991B
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李毅
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Li Yi
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Abstract

The invention provides the preparation that a kind of pharmaceutical composition for treating mucosal lesion, the raw material that it includes following weight proportioning are prepared:42 58 parts of bletilla, 22 38 parts of fritillaria thunbergii, 22 38 parts of pseudo-ginseng, 12 28 parts of calcined oyster shell, 2 18 parts of red ginseng.Pharmaceutical composition of the present invention provides a kind of novel drugs that are efficient, safe and free of toxic and side effects, being adapted to long-term use for clinical treatment mucosal lesion, has wide market prospects.

Description

A kind of pharmaceutical composition for treating mucosal lesion
Technical field
The present invention relates to a kind of pharmaceutical composition for treating mucosal lesion and its production and use, category medicine neck Domain.
Background technology
Mucosal lesion is to cause gastric ulcer and the dominant pathophysiology link of acute or chronic gastritis.It is now recognized that it is damaged Generation and stomach lining self-protection decrease or it is relative weaken, i.e., attack sexual factor and protection/defense with stomach lining It is closely related that factor is unbalance.Medical expert is by largely investigating discovery in recent years, the people between 20 to 40 years old, only 47% Stomach lining is more normal, but this period is exactly labour's most prosperous and powerful period, and it is well imagined to the influence that the mankind bring, institute With mucosal lesion by one of subject matter faced as 21 century human health.
The medicine of the treatment gastric mucosa damage occurred in the market has proton pump inhibitor (Omeprazole etc.), antiacid (sodium acid carbonate etc.), gastric mucosa protectant (Colloidal Bismuth Subcitrate etc.) and anti-helicobacter pylori medicine etc..Simple Western medicine is controlled Treatment is only centered around gastric acid secretion inhibiting, protection stomach lining etc., although healing rate is preferable in the recent period, late relapse rate is high, And most of chemicalses are in addition to playing the role of to treat disease, can also stimulating gastrointestinal road, make originally impaired gastrointestinal mucosa Further it is damaged, side effect is big, is easily used to destroy the balance of body for a long time, aggravates disease, it is also possible to cause it The growth of his disease.In recent years, Chinese herbal medicine is relaxed with its property of medicine, is not likely to produce drug resistance, is adapted to the advantages that long-term use of, wide It is general to be applied to treatment mucosal lesion.
To meet the needs of the needs of patient medication and treatment, the etiology and pathogenesis of mucosal lesion is illustrated from traditional Chinese medical science angle, A kind of medicine that is efficient, safe and free of toxic and side effects, being adapted to long-term use is found, tool is of great significance.
The content of the invention
The technical scheme is that provide a kind of pharmaceutical composition for treating mucosal lesion and preparation method thereof and Purposes.
The invention provides a kind of pharmaceutical composition for treating mucosal lesion, and it includes the raw material system of following weight proportioning The standby preparation formed:
Bletilla 42-58 parts, fritillaria thunbergii 22-38 parts, pseudo-ginseng 22-38 parts, calcined oyster shell 12-28 parts, red ginseng 2-18 parts.
Preferably, the preparation that the raw material that described pharmaceutical composition includes following weight proportioning is prepared:
50 parts of bletilla, 30 parts of fritillaria thunbergii, 30 parts of pseudo-ginseng, 20 parts of calcined oyster shell, 10 parts of red ginseng.
Wherein, described pharmaceutical composition be by bletilla, fritillaria thunbergii, pseudo-ginseng, calcined oyster shell, red ginseng primary medicinal powder or water or Extractive with organic solvent is active component, adds the preparation that pharmaceutically acceptable auxiliary material or complementary composition are prepared into.
Wherein, the preparation is powder, oral fluid agent, granule, hard capsule, soft capsule, tablet, pill or drop Pill.
The invention provides the method for preparing described pharmaceutical composition, comprise the steps:
Each raw material is weighed, powder or water or organic solvent extraction is directly played, filters, concentration, add pharmaceutically acceptable auxiliary Material or complementary composition are prepared into pharmaceutically conventional preparation.
Specifically, comprise the steps:
A. the fritillaria thunbergii, pseudo-ginseng and red ginseng of prescription amount are taken, is crushed, sieving, adds ethanol to extract, merges extract solution, decompression is dense Medicinal extract is reduced to, and collects the dregs of a decoction, it is standby;
B. the bletilla and calcined oyster shell for taking prescription amount merge with the step a dregs of a decoction, extracting in water, merge extract solution, decompression Concentration, adds ethanol precipitation, takes supernatant to be concentrated under reduced pressure into medicinal extract, standby;
C. take step a and step b medicinal extract to mix, dry, obtain dry extract;
D. step c dry extract is taken, pharmaceutically acceptable auxiliary material is added or complementary composition is prepared into and pharmaceutically commonly used Preparation.
Present invention also offers purposes of the described pharmaceutical composition in the medicine for preparing treatment mucosal lesion.
Wherein, described medicine is the medicine for the treatment of stomachache and/or gastral cavilty turgor.
Pharmaceutical composition of the present invention is made up of bletilla, pseudo-ginseng, fritillaria thunbergii, calcined oyster shell, red ginseng according to specific proportioning, Fang Zhongbai And bitter sweet is puckery is slightly cold, can astringing to arrest bleeding, detumescence and promoting granulation, be monarch drug in a prescription;Pseudo-ginseng, sweetness and bitterness tepor, energy removing blood stasis and hemostasis, analgesic therapy of invigorating blood circulation, it is Ministerial drug;Pseudo-ginseng is walked without keeping, and bletilla is kept without walking, two medicine phases 5, and one, which walks one, keeps, and the row stasis of blood is stopped blooding, and the work(of myogenic pain relieving is strengthened; Pseudo-ginseng has good detumescence ding-tong in modern pharmacological research, relaxing smooth muscle, protects gastric mucosa, promotes the effect of growth, in vain And then there is significantly disappear carbuncle sore, putrefaction-removing granulation-promoting, antiulcer, antibacterial, two medicines are combined with blood stasis dispersing and fresh blood promoting, promoting blood circulation analgesic therapy Work(;Fritillaria thunbergii bitter it is cold in nature enter cardiopulmonary warp, can clearing heat and eliminating phlegm, dissipating bind disappear carbuncle, calcined oyster shell checking exuberance of yang tonifying yin, softening and resolving hard mass, two medicines The work(with relieving haperacidity analgesic is shared, is adjutant;The sweet temperature of red ginseng, can be reinforced vital energy, and tonifying spleen is promoted the production of body fluid, QI invigorating sore effect, and can Prevent that all medicines are cold, to make medicine.All medicines share, gathers the effect of holding back ulcer myogenic, blood stasis dispersing and fresh blood promoting, promoting blood circulation and stopping pain, astringing to arrest bleeding altogether.
Pharmaceutical composition of the present invention can effectively treat mucosal lesion, total effective rate 91.59%, and cure-remarkable-effectiveness rate is 71.96%.Pharmaceutical composition of the present invention improves significantly to the symptom such as stomachache, gasteremphraxis caused by mucosal lesion, right Peptic ulcer, gastric ulcer have obvious prevention effect, have certain bactericidal action to helicobacter pylori.Medicine of the present invention Adverse reaction is not found during composition clinical research, and a kind of efficient, safety, nothing are provided for clinical treatment mucosal lesion Toxic side effect, it is adapted to long-term use of novel drugs, there are wide market prospects.
Below by way of embodiment, the present invention is described in further detail, but is not intended to limit the present invention, ability The various changes and replacement that field technique personnel make according to the present invention, without departing from the spirit of the present invention, all should belong to this hair Bright scope of the following claims.
Embodiment
The preparation of 1 pharmaceutical composition of the present invention of embodiment
Raw material is weighed by following weight proportions:
Bletilla 50g, fritillaria thunbergii 30g, pseudo-ginseng 30g, calcined oyster shell 20g, red ginseng 10g
Preparation method is as follows:
A. fritillaria thunbergii, pseudo-ginseng and red ginseng are taken, is crushed, crosses 60 mesh sieves, adds the 70%-95%v/v ethanol extraction two of 8 times of amounts It is secondary, each 1h, merge extract solution, be concentrated under reduced pressure into medicinal extract, and the dregs of a decoction are collected, it is standby.
B. take bletilla and calcined oyster shell and the step a dregs of a decoction to merge, add the water of 10 times of amounts to extract twice, each 1h, merging carries Liquid is taken, is concentrated under reduced pressure, adds 50%v/v ethanol precipitations, takes supernatant to be concentrated under reduced pressure into medicinal extract, it is standby;
C. take step a and step b medicinal extract to mix, dry, obtain dry extract.
D. step c dry extract is taken, pharmaceutically acceptable auxiliary material is added or complementary composition is prepared into and pharmaceutically commonly used Preparation.
The preparation of 2 pharmaceutical composition of the present invention of embodiment
Raw material is weighed by following weight proportions:
Bletilla 42g, fritillaria thunbergii 22g, pseudo-ginseng 22g, calcined oyster shell 12g, red ginseng 2g
Preparation method is as follows:
A. fritillaria thunbergii, pseudo-ginseng and red ginseng are taken, is crushed, crosses 60 mesh sieves, adds the 70%-95%v/v ethanol extraction two of 8 times of amounts It is secondary, each 1h, merge extract solution, be concentrated under reduced pressure into medicinal extract, and the dregs of a decoction are collected, it is standby.
B. take bletilla and calcined oyster shell and the step a dregs of a decoction to merge, add the water of 10 times of amounts to extract twice, each 1h, merging carries Liquid is taken, is concentrated under reduced pressure, adds 50%v/v ethanol precipitations, takes supernatant to be concentrated under reduced pressure into medicinal extract, it is standby;
C. take step a and step b medicinal extract to mix, dry, obtain dry extract.
D. step c dry extract is taken, pharmaceutically acceptable auxiliary material is added or complementary composition is prepared into and pharmaceutically commonly used Preparation.
The preparation of 3 pharmaceutical composition of the present invention of embodiment
Raw material is weighed by following weight proportions:
Bletilla 58g, fritillaria thunbergii 38g, pseudo-ginseng 38g, calcined oyster shell 28g, red ginseng 18g
Preparation method is as follows:
A. fritillaria thunbergii, pseudo-ginseng and red ginseng are taken, is crushed, crosses 60 mesh sieves, adds the 70%-95%v/v ethanol extraction two of 8 times of amounts It is secondary, each 1h, merge extract solution, be concentrated under reduced pressure into medicinal extract, and the dregs of a decoction are collected, it is standby.
B. take bletilla and calcined oyster shell and the step a dregs of a decoction to merge, add the water of 10 times of amounts to extract twice, each 1h, merging carries Liquid is taken, is concentrated under reduced pressure, adds 50%v/v ethanol precipitations, takes supernatant to be concentrated under reduced pressure into medicinal extract, it is standby;
C. take step a and step b medicinal extract to mix, dry, obtain dry extract.
D. step c dry extract is taken, pharmaceutically acceptable auxiliary material is added or complementary composition is prepared into and pharmaceutically commonly used Preparation.
Beneficial effects of the present invention are proved below by way of specific experiment.
1 pharmaceutical composition of the present invention of experimental example treats the clinical trial of mucosal lesion
1 data and method
1.1 general information
220 peptic ulcer patients of active patients are collected, it is some sequentially to extract random digit from table of random number, respectively It is encapsulated in envelope, patient randomly selects, and all random digits are that odd number person is included in control group, and even number person is included in treatment group.Wherein control Treatment group 110, man 59, female 51,18~65 years old age (average 41.6 years old), course of disease January~1 year, gastric ulcer 41,12 Duodenalulcer 59, combined Peptic Ulcer 10;Control group 110, man 60, female 50,19~64 years old age (average 40.5 Year), course of disease January~1 year, gastric ulcer 41, duodenal ulcer 61, combined Peptic Ulcer 8.The sex of two groups of patients, year Age, the course of disease, ulcer area, position, number, smoking and the no significant difference such as drink.
The case selection standard of 1.2 peptic ulcers
1.2.1 diagnostic criteria
(1) periodicity of prolonged and repeated generation, the chronic upper abdomen pain of rhythmicity, can alleviate using alkaline drug;(2) Upper abdomen has limitation deep in tenderness;(3) x-ray canel barium meal contrast examination is shown in Ulcer niche;(4) endoscopy visible active stage, bursts Ulcer.
1.2.2 inclusive criteria
(1) patient has periodicity epigastric pain, pantothenic acid, repeatedly belch, the clinical symptoms such as anti-work;(2) electronic gastroscopy is Active peptic ulcer;(3) ulcer diameter is between 3~20mm;(4) age, M-F was similar at 18~65 years old;(5) The medicine for influenceing therapeutic scheme is not taken before treatment and during treatment.
1.2.3 exclusion standard
(1) endoscope turns out to be giving a farfetched interpretation property ulcer, stomach bottom ulcer, gastric ulcer merging severe dysplasia person;(2) trying Test in first 30 days and complication occurs and carries out operator;(3) have the gastric and duodenal ulcer of cause specific, as gastrinoma, Hepatic sclerosis;(4) women of gestation or preparation gestation, women breast-feeding their children;(5) allergic constitution or to multi-medicament allergy sufferers;(6) have Other complication can affect the treatment and observation or have the disease of taboo to trial drug;(7) angiocarpy, liver, kidney and hematopoiesis are associated with The severe primary such as system disease, mental patient.
1.3 curative effect determinate standards were published with reference to China Medical Science Press in 2002《New Chinese medicine clinical research is instructed Principle》.
1.3.1 gastroscopy effect criterion
Recovery from illness:Ulcer and surrounding inflammation all disappear, cicatrization;It is effective:Ulcer disappears, but still has inflammation;Effectively:Burst Ulcer size reduction >=50%, or ulcer quantity are reduced, wherein 1 healing of such as 2 ulcer;It is invalid:Ulcer size reduction ﹤ 50% or It is unchanged.
Helicobacter pylori (Helicobacter pylori, Hp) is removed:Rapid urease test and the breathing examination of 13C urea It is feminine gender to test, and such as only a kind of method is feminine gender, then is still considered as the positive.
1.3.2 therapeutic effect of syndrome criterion
Clinical recovery:Symptom, sign disappear or it is basic disappear, syndrome is scored reduction >=95%;It is effective:Symptom, sign are bright Aobvious to improve, syndrome is scored reduction >=70%;Effectively:Symptom, sign are taken a favorable turn, and syndrome is scored reduction >=30%;It is invalid:Disease Shape, sign are not improved, even aggravating, syndrome scores reduction less than 30%.
1.3.3 the effect of cardinal symptom, is evaluated
Clinic control:After the course for the treatment of terminates, symptom disappears;It is effective:After the course for the treatment of terminates, Syndrome Scale reduces 2 grades;Effectively:Treat After journey terminates, Syndrome Scale reduces 1 grade;It is invalid:Above standard person is not reached.1.3.4 safety evaluation standard
1 grade:Safety, has no adverse reaction;2 grades:Compare safety, if any adverse reaction, be not required to do any processing can continue to Medicine;3 grades:There is safety issue, there is moderate adverse reaction, can continue to be administered after processing;4 grades:Because in adverse reaction Only test.
1.4 treatment method
Pharmaceutical composition (being prepared according to embodiment 1, TCM Preparation Room develop by ShanXi Chinese Medicine Academy) of the present invention, every time 3 Gram, 2 times a day, 30-60 minutes are oral before meals.Control group:(trade name dissolves vertical Soviet Union to Pantoprazole, and the East China pharmacy of Hangzhou Sino-U.S. has Limit company produces, Chinese medicines quasi-word:Chinese medicines quasi-word H20010032) each 40mg, one time a day, 30-60 minutes are oral before meals.Two groups Administration time is 8 weeks.If two groups of patients merge Helicobacter pylori infection, (Amoxicillin 1000mg+ CLAs are added 500mg, 2 times a day, oral meal) 1 week.
1.5 observation index
Clinical symptoms improvement rate:The related symptoms pretherapy and post-treatment to two groups improve situation and analyzed, and therapeutic effect of syndrome judges By four grade evaluations such as clinical recovery, effective, effective, invalid;Treat preceding and be discontinued interior progress gastrocopy in 4 weeks and pylorus spiral shell Bacillus detects (rapid urease test and 13C urea breath tests).
1.6 statistical procedures
Pretherapy and post-treatment mean compares using paired-sample t test in each group, between two groups the comparison of mean use independent sample t Examine.
2 results
2.1 two groups of Clinical efficacy comparisons:It is shown in Table 1, table 2.
1 two groups of Clinical efficacy comparisons (ITT) of table
Clinical curative effect analysis:PP is analyzed:Treatment group's cure-remarkable-effectiveness rate is 71.96%, and total effective rate is 91.59% (n=107); Control group cure-remarkable-effectiveness rate is 62.62%, and total effective rate is 89.72% (n=107);Two groups of statistically significant (P of difference<0.05); ITT is analyzed:Treatment group's cure-remarkable-effectiveness rate is 70.00%, and total effective rate is 90.00% (n=110);Control group cure-remarkable-effectiveness rate is 60.91%, total effective rate is 88.18% (n=110);Two groups of statistically significant (P of difference<0.05).As a result show:Treatment The effect of group, is better than control group.
2.1 two groups of gastroscopy effects compare:It is shown in Table 3
3 two groups of gastroscopy effects of table compare
Gastroscopy effect is evaluated:Treatment group's cure-remarkable-effectiveness rate is 71.03%, and total effective rate is 92.52% (n=107);Control group is cured Aobvious rate is 61.68%, and total effective rate is 87.85% (n=107);Two groups of no significant difference (P<0.05).As a result table It is bright:The effect for the treatment of group, is better than control group.
HP eradication rates compare after 2.3 two groups of treatments
Treatment group is with HP positives 78, HP positives 5 after treatment, and HP eradication rates are 93.59%;Control group with HP positives 75, HP positives 6 after treatment, HP eradication rates are 92.00%;Two groups of HP eradication rate comparing differences are without conspicuousness Meaning (P > are O.05).
2.4 cardinal symptom efficacy analysis:It is shown in Table 4
The comparison (example) that cardinal symptom scores after 4 two groups of patient's medications of table
In the front and rear group of two groups of cardinal symptom curative treatments relatively, significant difference (P has been statistically analyzed it<0.05), two Primary symptom has clear improvement.It is poor to be statistically analyzed conspicuousness compared with more each symptom curative effect of control group for Liao Hou treatment groups Different (P<0.05).As a result show:The effect for the treatment of group, is better than control group.
2.5 Chinese medicine syndrome integrals compare:It is shown in Table 5
Chinese medicine syndrome integral compares after 5 two groups of patients of table treat
Two groups of Chinese medicine syndrome integrals compare before and after treatment, are statistically analyzed, P<0.001, there is significant difference, illustrate two Before the effect of after group treatment, is substantially better than treatment;, through statistical analysis, there are significant difference in Liao Hou treatment groups compared with control group (P<0.05), as a result show:Treatment group is better than control group.
2.6 two groups of adverse reaction situations
Treatment group's nausea 1 (2.2%), control group nausea 1 (2.5%), diarrhoea 1 (2.5%), is resistant to, not Influence the course for the treatment of, two groups of pretherapy and post-treatment blood, routine urinalysis and, hepatic and renal function is without significantly changing.
To sum up, pharmaceutical composition of the present invention can effectively treat mucosal lesion, total effective rate 91.59%, cure-remarkable-effectiveness rate For 71.96%.Pharmaceutical composition of the present invention improves significantly to the symptom such as stomachache, gasteremphraxis caused by mucosal lesion, There is obvious prevention effect to peptic ulcer, gastric ulcer, there is certain bactericidal action to helicobacter pylori.Medicine of the present invention Do not find adverse reaction during compositions clinical research, for clinical treatment mucosal lesion provide it is a kind of efficiently, safety, Have no toxic side effect, be adapted to long-term use of novel drugs, there are wide market prospects.

Claims (8)

  1. A kind of 1. pharmaceutical composition for treating mucosal lesion, it is characterised in that:It is prepared by the raw material of following weight proportioning The preparation formed:
    Bletilla 42-58 parts, fritillaria thunbergii 22-38 parts, pseudo-ginseng 22-38 parts, calcined oyster shell 12-28 parts, red ginseng 2-18 parts.
  2. 2. pharmaceutical composition according to claim 1, it is characterised in that:It is by following weight proportioning raw material prepare and Into preparation:
    50 parts of bletilla, 30 parts of fritillaria thunbergii, 30 parts of pseudo-ginseng, 20 parts of calcined oyster shell, 10 parts of red ginseng.
  3. 3. pharmaceutical composition according to claim 1 or 2, it is characterised in that:It is by bletilla, fritillaria thunbergii, pseudo-ginseng, forge it is male Oyster, the primary medicinal powder or water or extractive with organic solvent of red ginseng are active component, add pharmaceutically acceptable auxiliary material or auxiliary The preparation that property composition is prepared into.
  4. 4. pharmaceutical composition according to claim 3, it is characterised in that:The preparation is powder, oral fluid agent, particle Agent, hard capsule, soft capsule, tablet, pill or pill.
  5. 5. prepare the method for the pharmaceutical composition described in claim 1-4 any one, it is characterised in that:
    Weigh each raw material, directly beat powder or water or organic solvent extraction, filter, concentration, add pharmaceutically acceptable auxiliary material or Complementary composition is prepared into pharmaceutically conventional preparation.
  6. 6. according to the method for claim 5, it is characterised in that:Comprise the steps:
    A. the fritillaria thunbergii, pseudo-ginseng and red ginseng of prescription amount are taken, is crushed, sieving, adds ethanol to extract, merges extract solution, is concentrated under reduced pressure into Medicinal extract, and the dregs of a decoction are collected, it is standby;
    B. the bletilla and calcined oyster shell for taking prescription amount merge with the step a dregs of a decoction, extracting in water, merge extract solution, are concentrated under reduced pressure, Add ethanol precipitation, take supernatant to be concentrated under reduced pressure into medicinal extract, it is standby;
    C. take step a and step b medicinal extract to mix, dry, obtain dry extract;
    D. step c dry extract is taken, pharmaceutically acceptable auxiliary material is added or complementary composition is prepared into pharmaceutically conventional system Agent.
  7. 7. purposes of the pharmaceutical composition in the medicine for preparing treatment mucosal lesion described in claim 1-4 any one.
  8. 8. purposes according to claim 7, it is characterised in that:Described medicine is treatment stomachache and/or gastral cavilty turgor Medicine.
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Publication number Priority date Publication date Assignee Title
CN106361993B (en) * 2016-10-25 2019-12-06 陕西中医药大学 Pharmaceutical composition for preventing and treating gastric mucosal injury and preparation method thereof

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