CN1259960C - Medication for curing stomach trouble and disease of bills and preparation method - Google Patents

Abstract

The present invention relates to a medicament for treating cholic disease and gastropathy and a preparation method thereof. The medicament is prepared from the following raw materials of 100 to 200 proportions by weight of mile swertia herb, 100 to 200 proportions by weight of scutellaria amoena, 100 to 200 proportions by weight of orange fruit, 100 to 200 proportions by weight of herba bupleuri, 100 to 200 proportions by weight of white peony root, 50 to 150 proportions by weight of water plantain, 50 to 150 proportions by weight of tuckahoe, 40 to 120 proportions by weight of virgate wormwood herb, 25 to 75 proportions by weight of common lophatherum herb and 25 to 75 proportions by weight of rush. The medicament has definite therapeutic effect on gastritis and remnant gastritis with biliary regurgitation, and cholecystitis, and has the advantages of no adverse side effect, low price and fine compliance for patients; the medicament is an ideal new medicament prepared from traditional Chinese medicine, and is clinically and generally used. The medicament has significant curative effect on the gastritis and the remnant gastritis with biliary regurgitation, and has a total effective rate of 90.68% for clinical treatment and a total effective rate of 93% for the treatment of the cholecystitis. The medicament adopts the form of capsules so as to overcome the inconvenience for taking the traditional Chinese medicine, and the capsules overcome the defects, particularly for a patient frequently on a business trip for enhancing the stability and the bioavailability of the medicament.

Description

Medicine of treatment gallbladder gastropathy and preparation method thereof

Technical field

The present invention relates to a kind of medicine for the treatment of gallbladder gastropathy.Be the Chinese patent medicine of feedstock production specifically, the invention still further relates to the preparation method of this medicine with the Chinese herbal medicine.

Background technology

Bile reflux is the major reason that chronic gastritis forms.The effect of bile reflux in causing gastric mucosa precancerous lesion and gastric cancer in recent years comes into one's own.(1) Thomas finds that with BIDA scintillation measuring duodenum regurgitation volume itself and the preceding intensity of variation of gastric mucosa cancer have tangible parallel relation.(2) clinical observation also shows after subtotal gastrectomy, because gastroduodenal backflows and causes gastric mucosa and have than severe disease and become, the danger that remnant gastric cancer takes place in the postoperative 15-20 increases.

Treatment to bile reflux gastritis does not have special effective method at present.Think that in the past the turn of tidal stream operation is unique effective Therapeutic Method, but symptom was not seen change after the discovery in old age had the patient of 30-50% to perform the operation approximately.At present medical treatment mainly be use absorption bile and in and the medicine of cholic acid and anti-reflux.But the former two such as sucralfate, the solid amide weak curative effect of cholestyramine and gallbladder; The latter can increase lower esophageal sphincter tension force, improves gastric antrum contraction frequency and intensity, promotes gastric emptying, reduces bile reflux.But gastric emptying quickens to only occur in the patient of delayed gastric emptying, and normal person does not then have an effect to gastric emptying, and metoclopramide might cause the side effect of the outer assemblage simulator sickness of vertebral body, and a little less than the motilium effect, cisapride can cause diarrhoea etc.Therefore actively seek the treatment bile reflux gastritis not only effectively but also the medicine of non-evident effect.

Summary of the invention

The purpose of this invention is to provide a kind of costalgia, jaundice and the bile reflux gastritis due to the dampness-heat in the liver and gallbladder, medicine of cholecystitis and preparation method thereof of being used for.

The present invention is based on understanding and the Therapeutic Principle of motherland's medical science to gastropathy mechanism, achieve with reference to modern pharmacological research, from motherland's medicine treasure-house, filter out the natural edible-plant medicine of 'Shugan Lidan ', eliminating damp-heat, by the theory of Chinese medical science prescription, skim the cream off milk, costalgia, jaundice and bile reflux gastritis and bile reflux partial gastritis, cholecystitis due to the dampness-heat in the liver and gallbladder are had significant curative effect.

The present invention is made by the following weight proportion raw material:

Herba Swertiae Mileensis 100～200, Radix Scutellariae 100～200, Fructus Aurantii 100～200, HERBA BUPLEURI 100～200, the Radix Paeoniae Alba 100～200, Rhizoma Alismatis 50～150, Poria 50～150, Herba Artemisiae Scopariae 40～120, Herba Lophatheri 25～75, Medulla Junci 25～75.

The preparation method that above-mentioned each component is made medicine of the present invention is:

1) pre-treatment of Chinese crude drug: with Chinese crude drug selection, clean, cutting, drying, pulverizing, sterilization, oven dry, the into middle database of pulverizing, sieve;

2) Chinese medicine extraction: clean medicine Herba Swertiae Mileensis is ground into fine powder; Fructus Aurantii, Radix Bupleuri distillating extracting oil, the aqueous solution after the distillation device are in addition collected; Seven flavors such as medicinal residues and all the other Radix Scutellariae were soaked 12 hours, decoct three times, and each 2～3 hours, filter, merging filtrate, filtrate and above-mentioned aqueous solution merge, and merging filtrate is concentrated into the extractum of relative density 1.20 (50 ℃);

3) extractum and above-mentioned fine powder are mixed, make granule, drying, spray and add above-mentioned volatile oil, incapsulate, promptly.

Also can make tablet, powder, electuary (granule), pill by existing method.

Medicine of the present invention is the new prescription of the treatment bile reflux gastritis that the summary refine comes out on the basis of long-term clinical practice.Effect with anti-inflammation, the motion of enhancing intestinal propulsion and gastric emptying motion, analgesia and promotion bile secretion.Be applicable to 'Shugan Lidan ', eliminating damp-heat, hypochondriac pain, jaundice and bile reflux gastritis, bile reflux partial gastritis, cholecystitis due to the dampness-heat in the liver and gallbladder.

Because medicine of the present invention does not have bad side reaction to the determined curative effect of bile reflux gastritis and bile reflux partial gastritis, cholecystitis, low price, patient compliance is good, is a comparatively ideal new Chinese medicine, can generally use clinically.

Medicine of the present invention adopts capsule, and change Chinese medicine and taken inconvenience, patient especially to often going on business, capsule has overcome these drawbacks, has improved stability of drug and bioavailability;

Through clinical verification, this product is evident in efficacy to bile reflux gastritis and bile reflux partial gastritis, and totall effective rate in clinical treatment is 90.68%; To treatment cholecystitis total effective rate is 93%.

For showing the therapeutic effect of medicine of the present invention, illustrated with the clinical observation of following system to gallbladder gastropathy.

One, treatment bile reflux gastritis and bile reflux partial gastritis 266 routine observation of curative effect

With Drug therapy bile reflux gastritis of the present invention and bile reflux partial gastritis 266 examples, satisfactory effect is reported as follows:

1. object and method

1.1 case is selected: this group case all through the outpatient of gastroscope and biopsy pathology inspection confirmation, is divided into 2 groups at random.(1) treatment group; 204 examples, male 142 examples, women 62 examples, age 18-62 year, 44.5 years old mean age.Bile reflux gastritis 96 examples wherein, bile reflux partial gastritis 108 examples behind the gastrectomy (operation Bi Shi II formula 86 examples, Bi Shi I type 22 examples).(2) matched group: 62 examples, male 44 examples, women 18 examples, age 19-64 year, 42.8 years old mean age.Bile reflux gastritis 30 examples wherein, stomach excision back bile reflux partial gastritis 32 examples (Bi Shi II formula 22 examples, Bi Shi I formula 10 examples).Following situation is not listed the object of observation in; 1. have a stomachache and the patient of hemorrhage complication is arranged.2. the age is at under-18s or over-65s; Gestation or women breast-feeding their children; To this medicine allergy sufferers.3. be associated with serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, psychotic.4. do not meet the standard of including in, not medication in accordance with regulations can't be judged that curative effect or data are few etc. to affect the treatment or safety judgement person.

The sick kind of treatment group and matched group distributes

	The treatment group	Matched group
			Bile reflux gastritis	96 examples	30 examples
The bile reflux partial gastritis	108 examples	32 examples

1.2 diagnostic criteria: burning pain behind (1) upper abdomen and the breastbone, and increase the weight of bilious vomiting after the meal.(2) see under the gastroscope that gastric or residual gastric bile exist, and are the yellow fluid sample, the obvious xanthochromia of gastric mucosa.(3) endoscopic biopsy pathology has the inflammation of varying degree.

1.3 method: treatment group: medicine of the present invention, each 2, every day three times, boiled water is swallowed.Matched group; QIZHIWEITONG CHONGJI (Changbaishan Pharmaceutic Co., Ltd., Dalian's production), each 5 grams, every day 3 times, boiled water is taken after mixing it with water.Took medicine continuously 1 month, and finished the check gastroscope course of treatment.Also survey patient's blood, urine, stool routine examination before and after the treatment respectively; Liver function, kidney merit and Electrocardioscopy.

2. result

2.1 curative effect is judged: produce effects: transference cure, anacholia backflows and does not have the mucosa xanthochromia under the gastroscope, and the biopsy pathology mucosal inflammation is clearly better; Effectively; Symptom obviously alleviates, rarely seen bile reflux show bubble under the scope, and the slight xanthochromia of mucosa, the biopsy pathology mucosal inflammation takes a turn for the better; Invalid; Symptom does not have obvious improvement, and bile reflux is the yellow fluid sample under the scope, the obvious xanthochromia of mucosa, and the biopsy pathology mucosal inflammation changes not obvious.

2.2 treatment group and treatment of control group result see Table 2 and table 3 respectively

Bile reflux gastritis and bile reflux partial gastritis curative effect of disease table 2 (treatment group)

	Clinical cure	Produce effects	Take a turn for the better	Invalid	Add up to
							Example (%)	Example (%)	Example (%)	Example (%)	Example (%)
Bile reflux gastritis	29	38	20	9	96
						The bile reflux partial gastritis	40	29	29	10	108
Add up to	69	67	49	19	204

Bile reflux gastritis and bile reflux partial gastritis curative effect of disease table 3 (matched group)

	Clinical cure	Produce effects	Take a turn for the better	Invalid	Add up to
							Example (%)	Example (%)	Example (%)	Example (%)	Example (%)
Bile reflux gastritis	5	8	10	8	30
						The bile reflux partial gastritis	2	9	10	11	32
Add up to	7	17	20	18	62

* two groups are compared P＜0.05

This shows treatment group clinical drug of the present invention healing person 69Example, produce effects 67Example takes a turn for the better 49Example, total responder 185Example accounts for 90.68%The matched group QIZHIWEITONG CHONGJI, the clinical cure person 7Example, produce effects 17Example takes a turn for the better 20Example, total responder 44Example accounts for 70.97%Two groups of comparing differences have significance (P＜0.05).

All there is not drug reaction in two groups of treatments.Blood, urine, stool routine examination regulating liver-QI, renal function, Electrocardioscopy etc. have no significant change before and after two groups of treatments.

Model case

Examine on October 28th, 2000 Lee * women 37 the beginning of the year.Vexed 2 years of patient's burning epigastric pain, belch, bitter taste, nearly March is vomiting yellow fluid sample often.Red tongue coating nature Huang, stringy pulse.Gastroscope is seen and is seen a large amount of bile in antrum hyperemia, edema, the gastral cavity, the obvious xanthochromia of gastric mucosa, and 3 of antrums, symptom report chronic superficial gastritis are got in biopsy.Tcm symptom is analyzed; Gastric abscess, the heat stagnation type.Have urine examined before the treatment, stool routine examination is normal; Hepatic and renal function and electrocardiogram are normal.Give medicine of the present invention (capsule) treatment, each 2, every day 3 times, after the patient took medicine 3 days, burning epigastric pain, bitter taste in the mouth and dry throat and vomiting bile sample thing begin to alleviate; Clothes to 15 a day above-mentioned symptom obviously alleviates; Took the above-mentioned symptom complete obiteration continuously 30 days.The check gastroscope sees that gastric mucosa recovers normal salmon pink and do not have xanthochromia, does not see bile reflux; Biopsy pathology shows that stomach lining inflammation obviously alleviates.

With Drug therapy bile reflux gastritis of the present invention, bile reflux partial gastritis 204 examples.Treatment group gallbladder stomach health clinical cure person 69 examples, produce effects 67 examples, 49 examples that take a turn for the better, total responder's 185 examples account for 90.68%.The matched group QIZHIWEITONG CHONGJI, clinical cure person 7 examples, produce effects 17 examples, 20 examples that take a turn for the better, total responder's 44 examples account for 70.97%.In the clinical symptoms, once did relative comparison, therapeutic outcome is as follows: 168 examples are organized in the burning epigastric pain treatment before (1) treatment, matched group 52 examples, and two groups are compared P＞0.05; 52 examples are organized in the bilious vomiting treatment, matched group 16 examples, and two groups are compared P＞0.05, and symptom of digestive tract incidence rate difference does not have significance before treatment group and the matched group medication.Burning epigastric pain treatment group doing well,improving 136 examples are not improved 32 examples after the medication, and matched group doing well,improving 12 examples are not improved 40 examples and compared P＜0.05 for two groups; Bilious vomiting treatment group doing well,improving 40 examples are not improved 40 examples.Two groups are compared P＜0.05; Bilious vomiting treatment group doing well,improving 40 examples are not improved 12 examples, and matched group doing well,improving 0 example is not improved 16 examples, and two groups are compared P＜0.05.This shows that relatively, the treatment group is alleviated burning epigastric pain and alleviated bilious vomiting and all obviously is better than matched group (P＜0.05) after two groups of symptom of digestive tract medications.(2) epigastrium is burnt sample pain remission rate 80.95%, and bilious vomiting remission rate 76.96% obviously is better than matched group.This prescription alleviates bile reflux because above-mentioned pharmacological action so can increase gastrointestinal motility, promotes gastric emptying.Therefore the effect that the protection gastric mucosa is still arranged in addition is particularly useful for the treatment of bile reflux gastritis.

Two, Drug therapy cholecystitis 130 routine observation of curative effect of the present invention

With medicine of the present invention the gallbladder Weikang capsule for curing gastric disease is carried out clinical verification work, short term effect is remarkable, now is reported as follows:

1. case is selected

Select cholecystitis patient 130 examples of inside and outside section of my institute of in January, 1998-March outpatient service, wherein male 67 examples, woman's 63 examples, age 18-65 year, course of disease two weeks-20 year, be diagnosed as chronic cholecystitis 80 examples through B ultrasonic, acute cholecystitis 50 examples, 100 examples are organized in treatment in 130 examples, control tissue 30 examples, two groups of sexes, the age course of disease distribute close, and two groups sick plants to distribute and see Table 1

The sick kind of table 1 treatment group and matched group distributes

	The treatment group	Matched group
			Chronic cholecystitis	62 examples	18 examples
Acute cholecystitis	38 examples	12 examples

2, method

1). the treatment group: oral medicine of the present invention (capsule), each 2, every day three times, took continuously 15.

2). matched group: oral XIAOYAN LIDAN PIAN (Yunnan Jin Ke pharmaceutical Co. Ltd), each 6, every day three times, took continuously 15.

3). write down two groups clinical symptoms before and after taking medicine respectively, sign, defecation routine test, the routine blood test chemical examination, and do ultrasound diagnosis.

4). statistical procedures adopts X four fold table and the prompt X check of tube.

3. criterion of therapeutical effect

A., chronic cholecystitis

1). clinical cure: dyspepsia (the upper abdomen born of the same parents are expanded, belch, nausea and vomiting. and return acid) wait gastrointestinal symptom disappearance, better to the fat meal toleration.The normal rest pain of evening or upper right after the meal abdomen or middle epigastrium disappears, and the B ultrasonic check shows that gallbladder size, gallbladder, gallbladder tube structure, interior entrant sound are good.

2). produce effects: dyspepsia (the upper abdomen born of the same parents are expanded, belch, nausea and vomiting. and return acid) wait gastrointestinal symptom disappearance, better to the fat meal toleration.The check of evening or upper right after the meal abdomen or the normal rest pain disappearance of middle epigastrium B ultrasonic shows that gallbladder size, gallbladder, gallbladder tube structure, interior entrant sound are good.

3). take a turn for the better: dyspepsia (the upper abdomen born of the same parents are expanded, belch, nausea and vomiting. and return acid) wait gastrointestinal symptom disappearance, better to the fat meal toleration.The normal rest pain of evening or upper right after the meal abdomen or middle epigastrium disappears.

4). invalid: gastrointestinal reaction symptoms such as dyspepsia still exist, and are relatively poor to the fat meal toleration, and abdomen painful (evening or after the meal) still exists.

B, acute cholecystitis

1). clinical cure: pain disappears, and (the upper abdomen xiphoid-process is down to right upper quadrant of the abdomen, by light and heavy rest pain disappear, feel sick, vomiting, fear of cold, shiver with cold transference cure, blood test be normal, B ultrasonic is checked demonstration gallbladder size, wall thickness is normal, is it possible that levy feminine gender.

2). produce effects: pain disappear (the upper abdomen xiphoid-process is down to right upper quadrant of the abdomen, by light and heavy rest pain disappear, feel sick, vomiting, fear of cold, shiver with cold transference cure, blood test be normal, the B ultrasonic check shows that gallbladder size, wall thickness are normal, is it possible that levy feminine gender.The B ultrasonic check shows better

3). well: pain disappear (the upper abdomen xiphoid-process is down to right upper quadrant of the abdomen, by light and heavy rest pain disappear, feel sick, vomiting, fear of cold, shiver with cold transference cure, blood test be normal, the B ultrasonic check shows that gallbladder size, wall thickness are normal, is it possible that levy feminine gender.

4). invalid: pain, feel sick, vomiting, fear of cold, shiver with cold, hyperpyrexia, abdominal distention, tenderness, flesh are defended etc., and symptom exists, mwphy (is it possible that levying the positive) blood, ultrasound diagnosis is all undesired.

Four. the result

Treatment group and treatment of control group result see Table 2 and table 3 respectively.

Treatment acute and chronic cholecystitis curative effect of disease table 2

	Clinical cure	Produce effects	Take a turn for the better	Invalid	Add up to
							Example (%)	Example (%)	Example (%)	Example (%)	Example (%)
Chronic cholecystitis	29(59、 141)	20(63、152)	9(63、 128)	4(56、 115)	62
						Acute cholecystitis	19(39、58)	11(35、 48)	5(35、 71)	3(42、86)	38
Add up to	48(100)	31(100)	14(100)	7(100)	100

Treat acute and chronic cholecystitis curative effect table 3

	Clinical cure	Produce effects	Take a turn for the better	Invalid	Add up to
							Example (%)	Example (%)	Example (%)	Example (%)	Example (%)
Chronic cholecystitis	6(66、67)	6(66、 66)	3(44、100)	3(49、100)	18
						Acute cholecystitis	3(33、33)	3(33、 33)	3(501)	3(50)	12
Add up to	9(100)	9(100)	6(100)	6(100)	30

Five. efficacy evaluation

1. treatment group (medicine of the present invention) clinical cure person 48 examples, produce effects 31 examples, 14 examples that take a turn for the better, total responder's 93 examples account for 93%.Matched group (XIAOYAN LIDAN PIAN) clinical cure person 9 examples, produce effects 9 examples, 6 examples that take a turn for the better, total responder's 24 examples account for 80%.Learn by statistics and handle, have significant difference (P value＜0.05=between treatment group and the matched group.Illustrate that medication effect of the present invention is remarkable, therapeutic effect is good than XIAOYAN LIDAN PIAN.

2. the acute and chronic cholecystitis effect of Drug therapy of the present invention is remarkable.

3. this organizes 100 examples, does not all have conscious untoward reaction after taking medicine of the present invention (capsule).

4. invalid case may be heavier with the local pathological lesion of patient, and the course of disease is long, and administration time is short relevant.

5. medicine characteristics of the present invention are that effect is remarkable, and relief of symptoms is obvious, and produce effects is fast, short treating period, antiinflammatory, function of gallbladder promoting, good anti-bacterial effect, firmly get patient praise.

Description of drawings

Fig. 1 is a Chinese crude drug pre-treating technology flow chart of the present invention.

Fig. 2 is an extracting technique of Chinese medicine flow chart of the present invention.

Fig. 3 is capsule technological process of production figure of the present invention.

The specific embodiment

Embodiment 1:

Take by weighing raw material (kilogram) by following proportioning:

Herba Swertiae Mileensis 100, Radix Scutellariae 100, Fructus Aurantii 100, HERBA BUPLEURI 100, the Radix Paeoniae Alba 100, Rhizoma Alismatis 50, Poria 50, Herba Artemisiae Scopariae 40, Herba Lophatheri 25, Medulla Junci 25.

Prepare according to the following steps with above-mentioned raw materials:

1) pre-treatment of Chinese crude drug: with Chinese crude drug selection, clean, cutting, drying, pulverizing, sterilization, oven dry, the into middle database of pulverizing, sieve;

2) Chinese medicine extraction: clean medicine Herba Swertiae Mileensis is ground into fine powder; Fructus Aurantii, Radix Bupleuri distillating extracting oil, the aqueous solution after the distillation device are in addition collected; Seven flavors such as medicinal residues and all the other Radix Scutellariae were soaked 12 hours, decoct three times, and each 2 hours, filter, merging filtrate, filtrate and above-mentioned aqueous solution merge, and merging filtrate is concentrated into the extractum of relative density 1.20 (50 ℃);

3) extractum and above-mentioned fine powder are mixed, make granule, drying, spray and add above-mentioned volatile oil, incapsulate, every 0.4 gram.

Embodiment 2:

Take by weighing raw material (kilogram) by following proportioning:

Herba Swertiae Mileensis 150, Radix Scutellariae 150, Fructus Aurantii 150, HERBA BUPLEURI 150, the Radix Paeoniae Alba 150, Rhizoma Alismatis 100, Poria 100, Herba Artemisiae Scopariae 80, Herba Lophatheri 50, Medulla Junci 50.

Prepare according to the following steps with above-mentioned raw materials:

1) and 2) with embodiment 1.

3) extractum and above-mentioned fine powder are mixed, make tablet by the method for prior art.

Embodiment 3:

Take by weighing raw material (kilogram) by following proportioning:

Herba Swertiae Mileensis 200, Radix Scutellariae 200, Fructus Aurantii 200, HERBA BUPLEURI 200, the Radix Paeoniae Alba 200, Rhizoma Alismatis 150, Poria 150, Herba Artemisiae Scopariae 120, Herba Lophatheri 75, Medulla Junci 75.

Prepare according to the following steps with above-mentioned raw materials:

1) and 2) with embodiment 1.

3) extractum and above-mentioned fine powder are mixed, make powder by the method for prior art.

Claims (3)

1, a kind of medicine for the treatment of gallbladder gastropathy is characterized in that it is the medicine of being made by the following weight proportion raw material:

Herba Swertiae Mileensis 100～200, Radix Scutellariae 100～200, Fructus Aurantii 100～200, HERBA BUPLEURI 100～200, the Radix Paeoniae Alba 100～200, Rhizoma Alismatis 50～150, Poria 50～150, Herba Artemisiae Scopariae 40～120, Herba Lophatheri 25～75, Medulla Junci 25～75.

2, the preparation method of the medicine of the described treatment gallbladder of claim 1 gastropathy is characterized in that preparing according to the following steps:

1) pre-treatment of Chinese crude drug: with Chinese crude drug selection, clean, cutting, drying, pulverizing, sterilization, oven dry, the into middle database of pulverizing, sieve;

2) Chinese medicine extraction: clean medicine Herba Swertiae Mileensis is ground into fine powder; Fructus Aurantii, Radix Bupleuri distillating extracting oil, the aqueous solution after the distillation device are in addition collected; Seven flavors such as medicinal residues and all the other Radix Scutellariae were soaked 12 hours, decoct three times, and each 2～3 hours, filter, merging filtrate, filtrate and above-mentioned aqueous solution merge, and merging filtrate is in 50 ℃ of extractum that are concentrated into relative density 1.20;

3) extractum and above-mentioned fine powder are mixed, make granule, drying, spray and add above-mentioned volatile oil, incapsulate, promptly.

3, the medicine of treatment gallbladder gastropathy according to claim 1 is characterized in that this medicine is tablet or powder or electuary or pill.

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