CN1327877C - Compound Chinese medicinal formulation for treating chronic atrophic gastritis and its preparing method - Google Patents
Compound Chinese medicinal formulation for treating chronic atrophic gastritis and its preparing method Download PDFInfo
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Abstract
The present invention relates to a compound traditional Chinese medicine preparation used for treating chronic atrophic gastritis and a preparation method thereof. The compound traditional Chinese medicine preparation is prepared from heterophylly falsestarwort root, red peony root, Guangxi dragon's blood, largehead atractylodes rhizome, red sage root, bupleurum root, baical skullcap root, white peony root, liquorice, corymbose hedyotis herb, bittersweet, smilax, cynanchum paniculatum, ardisia japonica and indian trumpet flower seed. The compound traditional Chinese medicine preparation used for treating chronic atrophic gastritis of the present invention has the functions of adjusting the functions of human bodies, improving the environment inside the stomach, improving the power of the stomach, protecting the barrier of the stomach mucosa and improving the blood stream of the mucosa; thereby, a favorable environment is provided for the repair and regeneration of the atrophy of the stomach mucosa glandular organ, and the present invention has the advantages of simple dosage form and convenient administration.
Description
Technical field:
The present invention relates to compound Chinese medicinal preparation and preparation method, be specifically related to a kind of compound Chinese medicinal preparation and preparation method that is used for the treatment of chronic atrophic gastritis.
Background technology:
Chronic gastritis is a kind of commonly encountered diseases, frequently-occurring disease, especially chronic atrophic gastritis or with intestinal gland metaplasia, atypical hyperplasia person a kind of digestive tract disease of obstinate refractory especially, with the incidence rate of gastric cancer certain relation is arranged.Nineteen eighty-three WHO claims that atrophic gastritis is a state before the gastric cancer, so with intestinal gland metaplasia or atypical hyperplasia be gastric precancerous lesion.The domestic and international at present treatment to this disease still lacks than active drug, and doctor trained in Western medicine only stays in periodic review, close observation stage.
Though the record of no chronic atrophic gastritis name of disease in motherland's medical science is attributable to categories such as " stomach network pain ", " stomach painful abdominal mass ", " flatulence ", " noisy ", belch " according to its clinical symptoms.Say as " element ask the most pure virginity will be greatly discuss a piece of writing ": " strongly fragrant the sending out of wood, take care and pain in the sick stomach of people Anhui." treatise on Febrile Diseases says: " the feeling fullness but no pain person, this is a painful abdominal mass." " Jing Yue's complete work. noisy " in describe noisy incidence in detail, " noisy a card, or do or end, its be disease also, then absolutely empty in the abdomen, if none, like hungry non-famine, like peppery non-peppery, like the non-pain of pain, and the regretful farming of chest and diaphragm, cannot be described, maybe must eat and temporary ending, or food is answered noise then, or hold concurrently to feel sick, or see that gradually stomach Anhui has a pain." above quoted passage all described the various clinical symptoms of chronic atrophic gastritis definitely.
Also respectively there is research in modern doctor family to primary disease, lets a hundred schools contend, and what have controls with the differentiation of symptoms and signs for classification of syndrome opinion, and Chen Yu is divided into five types with primary disease, is permitted to have of one's own then to be divided into six types and to carry out diagnosis and treatment based on an overall analysis of the illness and the patient's condition.CAIM (Chinese Association Of Integrative Medicine) digestive system disease Professional Committee had formulated chronic gastritis Chinese and Western in conjunction with differentiation of symptoms and signs for classification of syndrome diagnostic criteria and criterion of therapeutical effect in 1989, and primary disease is divided into incoordination between the liver and stomach, weakness of the spleen and stomach, damp-heat in the spleen and stomach, deficiency of stomach-Yin, stomach network blood stasis five types.What have finds out effective side's medicine in long-term clinical practice, formed basic side (medicine) plus-minus opinion and controlled and the side's of fixing treatment trend, subtracts treatment as the YangBing Chu different Tonga that disappears to wither; Wang Wenzhong is with hard masses softening and resolving side, and Liu Xuanran is with the powder for curing gastritis that disappears fixing side treatment.Many Chinese patent medicines based on the treatment chronic superficial gastritis appear in recent years, but very few at the Chinese patent medicine of atrophic gastritis treatment.
Summary of the invention:
The objective of the invention is to use tcm theory, a kind of regulating qi and activating blood, clearing heat to ease the stomach are provided, can reverse gastric mucosa body of gland atrophy treatment chronic atrophic gastritis compound Chinese medicinal preparation evident in efficacy.
The compound Chinese medicinal preparation of treatment chronic atrophic gastritis disclosed by the invention is the oral formulations of being made by active ingredient extractum and pharmaceutic adjuvant; Wherein active ingredient extractum is by Radix Pseudostellariae (Radix Pseudostellariae) 1.2～12%, Radix Paeoniae Rubra (Radix Paeoniae Rubra) 1.2～12%, Guangxi Sanguis Draxonis (Resina Draconis) 0.3～2.5%, the Rhizoma Atractylodis Macrocephalae (RhizomaAtractylodis Macrocephalae) 1.2～12%, Radix Salviae Miltiorrhizae (Radix SalviaeMiltiorrhizae) 1.2～12%, Radix Bupleuri (Radix Bupleuri) 0.8～8%, Radix Scutellariae (RadixScutellariae) 1.2～12%, the Radix Paeoniae Alba (Radix Paeoniae Alba) 1.2～12%, Radix Glycyrrhizae (Radix Glycyrrhizae) 0.8～8%, Herba Hedyotidis Corymbosae (Herbba HedyotidisCorymbosae) 4.1～40.5%, Herba Solani Lyrati (Radix Cynanchi Paniculati) 2.4～24%, Rhizoma Smilacis Chinensis (Rhizoma Smilacis Chinensis) 4.1～40.5%, Radix Cynanchi Paniculati (Radix Cynanchi Paniculati) 2.0～20.5%, Herba Ardisiae Japonicae (Herba ArdisiaeJaponicae) 2.0～20.5%, the prescription that Semen Oroxyli (Seen Oroxyli) 1.2～12% is formed extracts and makes.
Pharmaceutic adjuvant of the present invention is pharmaceutic adjuvant commonly used.
Oral formulations of the present invention is medically acceptable granule, tablet, capsule, pill, oral liquid etc.
Another object of the present invention is the preparation method that will disclose the compound Chinese medicinal preparation of above-mentioned treatment chronic atrophic gastritis.
The method of the compound Chinese medicinal preparation of preparation treatment chronic atrophic gastritis disclosed by the invention comprises the following steps:
The preparation of 1 active ingredient extractum
Get recipe quantity Radix Bupleuri, Radix Cynanchi Paniculati vapor distillation, collect the distillate of 1～10 times of amount of crude drug, device is preserved in addition, adds all the other medical materials except that Guangxi Sanguis Draxonis, adds up the water extraction secondary of 3～30 times of crude drug amounts, merge extractive liquid,, filter, vacuum concentration to density is 1.03～1.30 extractum, adds 5～40% pharmaceutic adjuvant of distillate such as Radix Bupleuri and extractum amount, spray drying gets dry powder, Guangxi Sanguis Draxonis is ground into the following powder of 100 orders and the dry powder mixing promptly makes the active ingredient extract dry powder.Every gram extract dry powder is equivalent to crude drug 3～6g, contains paeoniflorin 〉=0.4%.
The preparation of 2 oral formulations
Get 20～70% active ingredient extract dry powder and 80～30% pharmaceutic adjuvants, make granule, tablet, capsule, pill and oral liquid according to a conventional method.
Still a further object of the present invention is to disclose the application of above-mentioned prescription in the treatment chronic atrophic gastritis.
It is to take every day to be equivalent to extract dry powder 20～50g that the present invention treats chronic atrophic gastritis formula for treating dosage, and 3～6 months is a course of treatment.
The spleen is the source of growth and development for lid, and stomach is a reservoir of food and drink, and the two is with placed in the middle burnt, and main altogether digesting and assimilating is " the foundation of acquired constitution " by honor often.Temper should rise, and gastric qi a surname falls, rising-falling tone and then in burnt balance, so saying of " middle Jiao being as weighing non-flat uneasiness " arranged; Right taste physiological activity still relies in the hepatobiliary catharsis, and the chronic gastritis initial stage often rushes down not normal because of liver and gall are thin, hot and suffocating criminal's stomach, thus there is gastric abscess to expand, diseases such as belch, bitter taste.The victory of few sun, heat is objective in stomach, so bitter taste, yellow, greasy and thin fur, with the passing of time must cause the venation damage, kill damaging the spleen and stomach gas, QI and blood is all tired, warmly moisten inconsiderately, gradually cause deficiency of spleen-QI and stomach-QI and have stagnant heat concurrently, so tool is noisy, there are indentation, dimly red tongue, sublingual vein stasis of blood purple in loose stool, enlarged tongue, increase diseases such as thick.So the treatment chronic atrophic gastritis, when with regulating qi and activating blood, clearing heat to ease the stomach, regulating QI person summarizes QI invigorating and regulates the flow of vital energy also, and the mechanism of qi of suitable balance taste lifting, takes into account the mixed feature of cold and heat and asthenia and sthenia.
Radix Pseudostellariae, Radix Paeoniae Rubra two flavors are monarch in the side." Bencao Congxin " meaning Radix Pseudostellariae " its power not descend Radix Ginseng " is the product of light benefit in the Qi-tonifying drug, and spleen invigorating is transported and not scorching, nourishing stomach-YIN and do not grow greasy; The Radix Paeoniae Rubra removing heat from blood and promoting blood circulation.Two medicines are monarch, the merit of playing benefiting QI for activating blood circulation altogether.
The Rhizoma Atractylodis Macrocephalae, Radix Salviae Miltiorrhizae, Guangxi Sanguis Draxonis, Radix Bupleuri, Radix Scutellariae are minister in the side.The auxiliary Radix Pseudostellariae spleen invigorating of the Rhizoma Atractylodis Macrocephalae helps fortune, and Radix Salviae Miltiorrhizae cooperates the Radix Paeoniae Rubra cooling blood and dissolving stasis; Guangxi Sanguis Draxonis has the effect of blood activating and promoting tissue regeneration; Radix Bupleuri depressed liver-energy dispersing and QI regulating, liter are sent out a few positive clearing heat in QI system; The Radix Scutellariae hardship is fallen row and is loose, and removes damp-heat in the spleen and stomach.One rise and one drop, burnt mechanism of qi in the Heibei provincial opera.
The Radix Paeoniae Alba, Radix Glycyrrhizae sour and sweet drugs can transforme into YIN in the side, relieving spasm to stop pain, and because of stagnant heat friendship resistance, so add Herba Hedyotidis Corymbosae, Rhizoma Smilacis Chinensis, the clear stagnant heat of Herba Solani Lyrati, subduing inflammation.Be assistant but consider one the cold and cool hot temperature detoxifcation of gastric qi analgesic Radix Cynanchi Paniculati that hinders, more than be adjuvant drug altogether.Again with Herba Ardisiae Japonicae, the relieving distension of Semen Oroxyli soothing liver-QI stomach function regulating for making.
In a word, we's compatibility focuses on the deficiency of vital energy of stomach reinforcing, and the stasis of blood of row stomach network stagnates, take into account gastric heat, increase fall, soothing the liver gallbladder, taste, suitable moisturizing.
According to reported in literature, the main paeonol that contains in the Radix Cynanchi Paniculati volatile ingredient, paeonol pharmacodynamics proof has analgesic effect, experimental rat hind leg foot sole of the foot edema is had antiinflammatory and antibacterial action the experimental pain of mice.The Radix Bupleuri volatile ingredient has antiinflammatory action to the mice ear inflammation that Oleum Tiglii causes.Because of the drug action of Radix Cynanchi Paniculati, Radix Bupleuri volatile ingredient relevant with compound preparation effect of the present invention, so should keep the volatile effective component in Radix Cynanchi Paniculati, the Radix Bupleuri, the present invention adopts vapor distillation with this two flavors medicine when preparation active ingredient extractum for this reason, extracts volatile component wherein.And the effect of Rhizoma Atractylodis Macrocephalae volatile oil is a rising gastric juice pH value, reduces gastric acidity, and this effect with compound preparation of the present invention is opposite, so do not extract volatile oil when extracting active ingredient extractum.Though Herba Ardisiae Japonicae contains volatile oil, after measured the sample in Shanghai, Jiangsu, Jiangxi, Zhejiang etc., its amount is few, big production is difficult to collect, and do not give collection too.
It is as follows to carry out the toxicity test result with active ingredient extractum of the present invention.
Can't measure LD because of toxicity is low
50So, carry out mtd test, its mouse oral is irritated stomach LD
50＞30g extractum/kg/24 hour, animal activity was normal after the administration, did not see overt toxicity reaction and dead.
1. test objective:
Observe per os in the animal 24 hours and irritate toxic reaction and the death condition that stomach heal and produced behind the clever extractum of stomach.
2. materials and methods:
2.1 test sample:
2.1.1 title: active ingredient extractum of the present invention
2.1.2 the unit of providing: Shanghai herbal pharmaceutical one factory
2.1.3 content: every gram extractum contains 5.37 gram crude drugs
2.1.4 compound method: with distilled water sample ligand being made concentration is 40% suspension.
2.1.5 solvent: distilled water
2.2 animal
2.2.1 source, strain: Kunming mouse, provide by animal housing of Shanghai Institute of Pharmaceutical Industry, the quality certification number closes for Shanghai is moving and demonstrate,proves No. 107, word.
2.2.2 body weight: 18-22g
2.2.3 sex: male and female half and half
2.2.4 number of animals: 20
2.3 dosage: 30g extractum/kg
2.4 every animals received capacity: 0.5ml/20g body weight
2.5 route of administration: per os is irritated stomach
2.6 test method:
Get 20 of healthy mices (male and female half and half), animal is hungry 6 hours before the administration, and each per os is irritated stomach 0.5ml/20g body weight, irritates stomach in 24 hours altogether 3 times, observed 7 days after the administration, and animal general toxicity symptom and death toll after the record administration, dead animal is dissected huge inspection.Observation period is put to death whole surviving animals when stopping, and dissects huge inspection.
2.7 observation index:
2.7.1 death condition
2.7.2 toxic reaction
3. result of the test:
3.1 general observation of symptoms after the administration
Activity was not normally seen overt toxicity reaction and dead after the animal per os was irritated stomach.
Observation period is put to death whole surviving animals when stopping, and dissects huge inspection, and main organs is not seen obvious pathological changes.
4. conclusion
Its mouse oral is irritated stomach LD
50＞30g extractum/kg/24/ hour (being equivalent to 105 times of clinical dosages).
It is as follows to carry out pharmacodynamics test with granule of the present invention.
One, the influence of granule xylol induced mice auricle inflammation of the present invention
1. test objective
Observe the antiinflammatory action of granule of the present invention, understand its antiinflammatory characteristics and dose-effect relationship.
2. be subjected to the reagent product
2.1 granule of the present invention: every restraint agent is equivalent to 3.85 gram crude drugs, and herbal pharmaceutical one factory in Shanghai provides.
2.2 Western medicine positive control: aspirin, SIGMA Co.
2.3 Chinese medicine positive control: stomach nourishing granule, Zhengda Qingchunbao Pharmaceutical Co., Ltd provides.
2.4 negative control: normal saline
3. animal
3.1 the source: Kunming kind white mice is provided by the The 2nd Army Medical College Experimental Animal Center.
3.2 body weight: 18.0～25.0
3.3 sex: male and female half and half
3.4 each treated animal number: 20
4. test method is selected
In the test of the antiinflammatory of routine,, selected granule of the present invention the inhibiting method of swelling due to the proinflammatory agent (dimethylbenzene) to be observed the acute antiinflammatory action of this medicine according to the pertinent regulations of " study of tcm new drug guide ".
5. test key step
5.1 animal grouping
This experimental animal is pressed the method for single dose administration and two doses administration every day, respectively be grouped as follows: the single dose administration group comprises the heavy dose of group of granule of the present invention (3.11/kg), middle dosage group (1.55g/kg) and small dose group (0.78g/kg), Western medicine positive control " aspirin " (0.1g/kg) is organized, Chinese medicine contrast " stomach nourishing granule " group (6.0g/kg) and blank normal saline matched group; Two doses administration group comprises granule of the present invention heavy dose of group (3.11g/kg * 2), middle dosage group (1,55g/kg * 2) and small dose group (0.78g/kg * 2).
5.2 administration finishes back 45min, evenly smears dimethylbenzene 0.1ml in the wide positive and negative two sides of auris dextra, makes this wide swelling of picking up the ears.
6. animals administer afterreaction
15min puts to death animal after smearing dimethylbenzene, cut two ears along each auricle baseline, sweep away auricle (diameter 9mm) in same position with card punch, weigh respectively, is the swelling degree with the difference of the left two auricle weight in the right side divided by the percentage ratio of left side ear weight, compare with the blank group, and carry out statistical procedures.
7. dosage setting
By trial test, the large, medium and small dosage group of granule of the present invention has been selected 19.4,9.8 and 4.9 times of clinical recommended dose, i.e. 3.11/kg, 1.55g/kg and 0.78g/kg respectively; " stomach nourishing granule " group is 6.0g/kg (be equivalent to clinical recommended dose 20 times).
8. the medication and the course of treatment
Administration group and matched group are oral administration, and be consistent with approach with clinical plan, adopts single and twice dose regimen.
9. statistical method
The Total Test data are all represented with mean ± standard deviation.
To result of the test, respectively statistical computation swelling degree separately, and compare with t-check (software Statistica) and negative control group and positive controls.
10. result of the test
10.1 test data
Result of the test sees Table 1 and table 2:
Table 1 granule single dose administration of the present invention xylol causes scorching antiinflammatory action (n=20)
| Group | The swelling degree (X ± SD%) | Compare the P value with normal saline |
| Dosage granule heavy dose of the present invention in the low dose of granule of the present invention of normal saline aspirin stomach nourishing granule granule of the present invention | 152.87±29.52 98.29±32.39 133.81±39.53 146.09±37.13 135.48±33.98 129.19±34.41 | 0.00009 0.07163 0.4328 0.0575 0.0172 |
Table 2 granule multiple dose administration of the present invention xylol causes scorching antiinflammatory action (n=20)
| Group | The swelling degree (X ± SD%) | Compare the P value with normal saline |
| Dosage granule heavy dose of the present invention in the low dose of granule of the present invention of normal saline aspirin stomach nourishing granule granule of the present invention | 152.97±29.52 98.29±29.39 133.81±39.53 121.93±23.52 120.43±43.07 109.68±32.41 | 0.00009 0.07163 0.000 0.0051 0.0006 |
10.2 result treatment
Statistical result sees Table 1 and table 2
The single dose administration group is the result represent: the heavy dose of group of granule of the present invention (3.11g/kg) antiinflammatory action is (P＜0.05) significantly, is dose-effect relationship between each dosage group; Do not show significant difference Deng dosage " stomach nourishing granule " group (being equivalent to granule heavy dose of the present invention).
Multiple dose group administration group result shows: the heavy dose of group of granule of the present invention (3.11g/kg * 2), middle dosage group (1.55g/kg * 2) and small dose group (0.78g/kg * 2) antiinflammatory action all have the difference (P＜0.01) of highly significant, are dose-effect relationship between each dosage group.
The result shows: compare with normal saline group group, granule of the present invention has significant antiphlogistic effects (P＜0.05) when 3.11/kg (preparation) single dose administration (be equivalent to clinical recommended dose 19.4 times), when integral dose reaches 3.11g/kg～6.22g/kg (be equivalent to clinical recommended dose 19.4 times and 39 times) every day twice administration, have the antiphlogistic effects (P＜0.01) of highly significant, and be dose-effect relationship.With " stomach nourishing granule " (be equivalent to clinical recommendation once used amount 20 times) relatively, the antiinflammatory action of Chinese medicine granule of the present invention is stronger.
Two, the analgesic effect of granule of the present invention
1. test objective
Observe the analgesic effect of granule of the present invention, understand its pain relieving characteristics and dose-effect relationship.
2. be subjected to the reagent product: the same.
3. animal: the same.
4. test method is selected
This test has adopted classical mouse writhing method to observe the analgesic effect of granule of the present invention.
5. test key step
5.1 animal grouping
This experimental animal is divided into six groups: the heavy dose of group of granule of the present invention (3.11g/kg), middle dosage group (1.55g/kg) and small dose group (0.78g/kg), Chinese medicine positive control " stomach nourishing granule " are organized (6.0g/kg) Western medicine positive control " aspirin " and (0.1g/kg) are organized and blank normal saline matched group.Every group of 20 mices, male and female half and half.
5.2 test procedure
Mice is weighed, according to dosage administration.Behind the 1h, lumbar injection acetic acid (0.7%, 0.2ml/ only) causes pain.That observes mice in the 10min turns round the body number of times.
6. animals administer afterreaction
Mice after the administration, lumbar injection acetic acid is again turned round the body number of times with it and the blank group compares, and carries out statistical procedures.
7. dosage setting
By trial test, the large, medium and small dosage group of granule of the present invention has been selected 19.4,9.7 and 4.9 times of clinical recommended dose, i.e. 3.11g/kg, 1.55/kg and 0.78/kg respectively; " stomach nourishing granule " group is 6.0g/kg (be equivalent to clinical recommended dose 20 times).
8. the medication and the course of treatment
Administration group and matched group are oral administration, and be consistent with approach with clinical plan; Single administration.
9. statistical method
The Total Test data are all represented with mean ± standard deviation.
To result of the test, respectively statistical computation separately turn round the body number of times, and compare with t-check (software Statistica) and negative control group and positive controls.
10. result of the test
10.1 test data
Result of the test sees Table 3:
Table 3 granule Dichlorodiphenyl Acetate of the present invention causes the analgesic effect (n=20) of pain
| Group | Turn round body number of times (X ± SD) | Compare the P value with normal saline |
| Dose particles agent heavy dose in the low dose of granule of normal saline aspirin stomach nourishing granule granule | 19.6±9.84 5.70±4.62 13.25±9.32 19.50±6.27 12.10±7.36 12.92±3.44 | ------- 0.000005 0.0667 0.962 0.00722 0.00256 |
10.2 result treatment
Statistical result sees Table 3.
The result shows: compare with negative control group, the effect of heavy dose of group of granule of the present invention (3.11g/kg) and middle dosage group (1.55g/kg) has the difference of highly significant (P＜0.01); The effect of Western medicine positive control " aspirin " also has the difference of highly significant (P＜0.01); And Chinese medicine positive control " stomach nourishing granule " group result does not show significant difference.
11. conclusion (of pressure testing)
The result shows: compare with normal saline, granule of the present invention is when 1.55g/kg～3.11g/kg (be equivalent to clinical recommended dose 9.7 times and 19.4 times), analgesic effect (P＜0.01) with highly significant, and be certain dose-effect relationship: with Chinese medicine positive control " stomach nourishing granule " (6.0g/kg, be equivalent to 20 times of clinical recommended dose) to compare, its analgesic effect is stronger.
Three, granule of the present invention is to the influence of mice gastric emptying
1. test objective
Observe the influence of granule of the present invention, understand its effect characteristics and dose-effect relationship the mice gastric emptying.
2. be subjected to the reagent product
2.1 title: granule of the present invention
2.2 the unit of providing: Shanghai herbal pharmaceutical one factory
2.3 content, tire, preparation labelled amount, solvent, compound method
Granule of the present invention: the same
Positive control drug: the same
Negative control: dextrin
3. animal
3.1 the source: Kunming kind white mice is provided by the The 2nd Army Medical College Experimental Animal Center.
3.2 body weight: 18.0～25.0
3.3 sex: male and female half and half
3.4 each treated animal number: 10
4. test method is selected
This test has adopted the mice barium meal to irritate the method for stomach, observes the influence of granule of the present invention to gastric emptying.
5. test key step
5.1 animal grouping
This experimental animal is divided into five groups: the heavy dose of group of granule of the present invention (3.11g/kg), middle dosage group (1.55g/kg) and small dose group (0.78g/kg), " stomach nourishing granule " group (3.0g/kg) and blank dextrin (3.1g/kg) matched group.Every group of 10 mices, male and female half and half.
5.2 test procedure
The test mice non-fasting is freely drunk water.Granule of the present invention is made into 2.6%, 5.2% and 10.4% barium meal with barium sulfate glue; Positive control drug " stomach nourishing granule " also is made into 10.0% barium meal with barium sulfate glue; Be made into negative control with dextrin and barium sulfate glue.More than each group irritate that barium sulfate provides by Shanghai Changhai Hospital in stomach medicine.Each group is all irritated stomach by the 0.3ml/kg body weight.Put to death animal behind the administration 1h,, observe the gastric emptying situation with TOSHIBA KXO-30R type-ray machine film making (film making Index A EC is-2).
6. dosage setting
The large, medium and small dosage group of granule of the present invention has been selected 19.4,9.7 and 4.9 times of clinical recommended dose, i.e. 3.11g/kg, 1.55g/kg and 0.78/kg respectively; " stomach nourishing granule " group is 3.0g/kg (be equivalent to clinical recommended dose 10 times).
7. the medication and the course of treatment
Administration group and matched group are oral administration, and be consistent with approach with clinical plan.
8. statistical method
Because of the final result of test is graphic materials (a molybdenum target X-mating plate),, carried out the sxemiquantitative comparison with negative control and positive control so the result has been adopted double blinding range estimation method relatively.
9. result of the test:
Result of the test is seen the X-mating plate (the large, medium and small dosage group of granule of the present invention, " stomach nourishing granule " group and dextrin matched group) of each treated animal.
The degree of gastric emptying can be from the X-mating plate size of stomach push away, promptly gastric surface is long-pending more little, gastric barium sulfate is residual few more, gastric emptying is complete more; Gastric surface is long-pending big more, and gastric barium sulfate is residual many more, and gastric emptying is incomplete more.
The result shows: compare with negative control group, the large and small dosage group of granule of the present invention there is no tangible gastric emptying, and the gastric emptying of middle dosage group is (the long-pending difference in size of gastric surface is obvious) obviously; Positive control " stomach nourishing granule " group is not seen the effect that tangible gastric emptying is arranged yet.
The result shows: granule of the present invention had than remarkable influence the mice gastric emptying when 1.55g/kg (be equivalent to clinical recommended dose 9.7 times); Positive control " stomach nourishing granule " 3.0g/kg (be equivalent to clinical recommended dose 10 times) does not see gastric emptying influentially, illustrates that granule of the present invention is stronger slightly than " stomach nourishing granule " to the influence of gastric emptying.
By the curative effect Mechanism Study: carried out tests such as trace element, plasma C AMP, CGMP level, clectrogastrogram to 30 routine patient treatments are forward and backward, confirmed granule treatment atrophic gastritis of the present invention, prevent canceration, regulated many-side such as body neuro humor and have obvious effect.Experimental results show that: after " synthetic method " duplicates the atrophic gastritis model, after taking granule of the present invention, by gastric content weight, gastric acidity, mucosa pH value, stride stomach potential difference, optical microscope undertissue and learn tests such as inspection, the every index of administration group rat all has obvious recovery, illustrates that granule of the present invention has the obvious treatment effect to atrophic gastritis.Through contrast clinical trial, the pathology efficacy result is: 51 examples are organized in treatment, and total effective rate is 82.35%.Matched group (stomach nourishing granule) 30 examples, aggregate efficiency is 60%; The symptom efficacy result is that treatment group total effective rate is 92.16%.Matched group is 73.33%.Result of the test proves: granule curative effect of the present invention obviously is better than " stomach nourishing granule ".
The present invention treats the Chinese traditional compound medicine scalable body function of chronic atrophic gastritis, improves the gastric environment, improves gastric motility, and the protection gastric mucosal barrier improves mucosal blood flow, thereby is reparation, the regeneration of the atrophy of gastric mucosa body of gland, and good environment is provided.And dosage form is simple, and taking convenience brings glad tidings to the patient, can adapt to fast pace, high efficiency social life, and this medical instrument has bright prospects, and the important social benefit is arranged.
The specific embodiment:
Embodiment 1,
Prescription: Radix Pseudostellariae 1500g, Radix Paeoniae Rubra 1500g, Guangxi Sanguis Draxonis powder 333g, Rhizoma Atractylodis Macrocephalae 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Bupleuri 1000g, Radix Scutellariae 1500g, Radix Paeoniae Alba 1500g, Radix Glycyrrhizae 1000g, Herba Hedyotidis Corymbosae 5000g, Herba Solani Lyrati 3000g, Rhizoma Smilacis Chinensis 5000g, Radix Cynanchi Paniculati 2500g, Herba Ardisiae Japonicae 2500g, Semen Oroxyli 1500g.
More than ten five tastes, Radix Cynanchi Paniculati, Radix Bupleuri vapor distillation are collected distillate 17.5L, device is preserved in addition, adds all the other medical materials except that Guangxi Sanguis Draxonis, adds water 320L, extract secondary, merge extractive liquid, filters, and vacuum concentration to relative density is the extractum of 1.14 (60～65 ℃), add distillate and dextrin 3.2kg spray dryinges such as Radix Cynanchi Paniculati, Radix Bupleuri, dry powder and Guangxi Sanguis Draxonis powder mixing are made granule promptly, content of paeoniflorin 0.41%.
Embodiment 2,
Press embodiment 1 prescription, more than ten five tastes, Radix Cynanchi Paniculati, Radix Bupleuri vapor distillation, collect distillate 16L, device is preserved in addition, adds all the other medical materials except that Guangxi Sanguis Draxonis, add water 300L, extract secondary, merge extractive liquid,, filter, vacuum concentration to relative density is the extractum of 1.14 (60～65 ℃), adds distillate and dextrin 3.2kg spray dryinges such as Radix Cynanchi Paniculati, Radix Bupleuri, dry powder and Guangxi Sanguis Draxonis powder mixing, the general ball of making, promptly.Content of paeoniflorin 0.41%.
Embodiment 3,
Press embodiment 1 prescription, more than ten five tastes, Radix Cynanchi Paniculati, Radix Bupleuri vapor distillation are collected distillate 18L, device is preserved in addition, adds all the other medical materials except that Guangxi Sanguis Draxonis, adds water 350L, extracts secondary, merge extractive liquid, filters, and vacuum concentration to relative density is the extractum of 1.25 (60～65 ℃), adds 35L ethanol, stir, filter, reclaim ethanol, add distillate and dextrin 1kg spray dryinges such as Radix Cynanchi Paniculati, Radix Bupleuri, dry powder and Guangxi Sanguis Draxonis powder mixing are granulated, tabletting, coating, promptly.Content of paeoniflorin 0.67%.
Embodiment 4,
Press embodiment 1 prescription, more than ten five tastes, Radix Cynanchi Paniculati, Radix Bupleuri vapor distillation, collect distillate 20L, device is preserved in addition, adds all the other medical materials except that Guangxi Sanguis Draxonis, add water 330L, extract secondary, merge extractive liquid,, filter, vacuum concentration to relative density is the extractum of 1.25 (60～65 ℃), adds 37L ethanol, stir, filter, reclaim ethanol, add distillate and dextrin 1kg spray dryinges such as Radix Cynanchi Paniculati, Radix Bupleuri, dry powder and Guangxi Sanguis Draxonis powder mixing incapsulate promptly.Content of paeoniflorin 0.67%.
Embodiment 5,
Press embodiment 1 prescription, more than ten five tastes, Radix Cynanchi Paniculati, Radix Bupleuri vapor distillation are collected distillate 15L, device is preserved in addition, adds all the other medical materials, adds water 300L, extracts secondary, merge extractive liquid, filters, and vacuum concentration to relative density is the extractum of 1.25 (60～65 ℃), add 35L ethanol, stir, filter, reclaim ethanol, add distillates such as Radix Cynanchi Paniculati, Radix Bupleuri and add water to volume 20L again, filter, oral liquid is made in embedding, promptly.Content of paeoniflorin 0.16%.
Claims (3)
1, a kind of compound Chinese medicinal preparation, it is characterized in that this compound preparation be by percentage by weight consist of Radix Pseudostellariae 1.2～12%, Radix Paeoniae Rubra 1.2～12%, Guangxi Sanguis Draxonis 0.3～2.5%, the Rhizoma Atractylodis Macrocephalae 1.2～12%, Radix Salviae Miltiorrhizae 1.2～12%, Radix Bupleuri 0.8～8%, Radix Scutellariae 1.2～12%, the Radix Paeoniae Alba 1.2～12%, Radix Glycyrrhizae 0.8～8%, Herba Hedyotidis Corymbosae 4.1～40.5%, Herba Solani Lyrati 2.4～24%, Rhizoma Smilacis Chinensis 4.1～40.5%, Radix Cynanchi Paniculati 2.0～20.5%,
Herba Ardisiae Japonicae2.0～20.5%, the prescription of Semen Oroxyli 1.2～12% compositions extracts the active ingredient extractum of acquisition and the oral formulations that pharmaceutic adjuvant is made.
2, a kind of preparation method of compound Chinese medicinal preparation as claimed in claim 1 is characterized in that this method comprises the following steps:
(1) preparation of active ingredient extractum
Formula ratio by claim 1, get Radix Bupleuri, Radix Cynanchi Paniculati vapor distillation, collect the distillate of 1～10 times of amount of crude drug, device is preserved in addition, adding is all the other medical materials except that Guangxi Sanguis Draxonis, add up the water extraction secondary of 3～30 times of crude drug amounts, merge extractive liquid,, filter, vacuum concentration is 1.03～1.30 extractum to density, add 5～40% pharmaceutic adjuvant of distillates such as Radix Bupleuri and extractum amount, spray drying gets dry powder, Guangxi Sanguis Draxonis is ground into the following powder of 100 orders and the dry powder mixing promptly makes the active ingredient extract dry powder; Every gram extract dry powder is equivalent to crude drug 3～6g;
(2) preparation of oral formulations
Get above-mentioned extract dry powder and pharmaceutic adjuvant, make granule, tablet, capsule, pill and oral liquid according to a conventional method.
3, the application of a kind of compound Chinese medicinal preparation as claimed in claim 1 in preparation treatment chronic atrophic gastritis medicine.
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| CNB2004100538608A CN1327877C (en) | 2004-08-19 | 2004-08-19 | Compound Chinese medicinal formulation for treating chronic atrophic gastritis and its preparing method |
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| CNB2004100538608A CN1327877C (en) | 2004-08-19 | 2004-08-19 | Compound Chinese medicinal formulation for treating chronic atrophic gastritis and its preparing method |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1045351A (en) * | 1989-03-10 | 1990-09-19 | 兰州医学院第一附属医院 | A kind of manufacture method for the treatment of the chronic atrophic gastritis medicine |
| CN1357336A (en) * | 2000-12-14 | 2002-07-10 | 上海市药材有限公司中药制药一厂 | Mixed Chinese medicine prepn for treating chronic atrophied gastritis and its preparing method |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1045351A (en) * | 1989-03-10 | 1990-09-19 | 兰州医学院第一附属医院 | A kind of manufacture method for the treatment of the chronic atrophic gastritis medicine |
| CN1357336A (en) * | 2000-12-14 | 2002-07-10 | 上海市药材有限公司中药制药一厂 | Mixed Chinese medicine prepn for treating chronic atrophied gastritis and its preparing method |
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