CN1277570C - Pharmaceutical for treating alimentary tract ulcer disease and preparing process thereof - Google Patents
Pharmaceutical for treating alimentary tract ulcer disease and preparing process thereof Download PDFInfo
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- CN1277570C CN1277570C CNB031172814A CN03117281A CN1277570C CN 1277570 C CN1277570 C CN 1277570C CN B031172814 A CNB031172814 A CN B031172814A CN 03117281 A CN03117281 A CN 03117281A CN 1277570 C CN1277570 C CN 1277570C
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Abstract
The present invention relates to medicine for curing digestive canal ulcer diseases and a preparation method thereof. The present invention is characterized in that the medicine for curing digestive canal ulcer diseases is prepared from the following raw materials of 80 to 120 of elephant hide, 80 to 120 of bletilla tuber, 80 to 120 of fritillaria thunbergii, 80 to 120 of patent swertia herb, 4 to 6 of orange peel, 4 to 6 of chicken gizzard-membrane, 80 to 120 of cuttlebone and 80 to 120 of liquorice which are finally prepared into superfines of 300 to 500 meshes. Besides unique medicine combination, the medicine for curing digestive canal ulcer diseases of the present invention has the effects of acid removal, pain alleviation, ulcer healing and hemostasis. The functions of symptom improvement of the medicine for curing digestive canal ulcer diseases of the present invention to ulcer healing, pain easement, tongue pulses, etc., are obviously better than those of other medicine. The medicine for curing digestive canal ulcer diseases of the present invention can effectively control or eliminate pathopoiesis attack factors, and enhance defensivenessfactors. The medicine for curing digestive canal ulcer diseases of the present invention can simultaneously cure principal and subordinate symptoms, enhance organism immunizing power, reduce relapse rate, and sufficiently incarnate the integral recuperative medical care superiority, such as multiple targets and multiple links, of traditional Chinese physician. The medicine for curing digestive canal ulcer diseases of the present invention has preferable clinical curative effects and is prepared through modern high-tech superfines technologies and advanced sterilization technologies, the raw materials are furthest used, and resources are saved. The medicine for curing digestive canal ulcer diseases of the present invention has strong surface absorbing capacity and avidity and can effectively attach to the gastrointestinal.
Description
Technical field
The present invention relates to the Chinese medicine composition medicine, the concrete body medicine of treatment digestive tract ulcer disease and preparation method thereof of saying so.
Background technology
Digestive tract ulcer is a kind of commonly encountered diseases frequently-occurring disease, and any age all can take place, and along with the quickening of work rhythm, this sick sickness rate is more and more higher, usually is chronic and outbreak repeatedly is very big to health and labour force influence.Its pathogeny is along with in recent years the basic research and the progress of clinical research, and the cause of disease that wherein has is comparatively clear and definite, and what have is not clear fully as yet so far.But think that this pathogeny is relevant with attack factor, gastric mucosa epidemic prevention factor dynamic unbalance in the human stomach, also relevant with the human immune system, inherited genetic factors, geogen, Nervous and Mental Factors, the medicine that causes ulcer and chemicals, even dietary habit, smoking etc. all can cause the generation of peptic ulcer.
At present the Chinese medicine of treatment digestive tract ulcer is more, mostly be decoction and ball, loose, cream, pellet form, and the Chinese patent medicine of determined curative effect is less.And on dosage form, for want of scientific, also have influence on the absorption and the curative effect of medicine.
Summary of the invention
The purpose of this invention is to provide a kind of safe, effective, stable, processing technology is advanced, the medicine of the treatment digestive tract ulcer disease of science and preparation method thereof.
Medicine of the present invention is the medicament that is formed by following feedstock production:
Corium elephatis 80~120 Pseudobulbus Bletillae (Rhizoma Bletillae)s 80~120 Bulbus Fritillariae Thunbergii 80~120 XIAOERFUTONGCAO 80~120
Pericarpium Citri Reticulatae 4~6 Endothelium Corneum Gigeriae Galli 4~6 Os Sepiae 80~120 Radix Glycyrrhizaes 80~120
The said medicine raw material prepares according to the following steps:
1) after Corium elephatis was cut into small pieces after moistening, drying was inserted and is fried bubble in the hot sand and cause yellow, and sieve is abandoned sand grains, and the cooling back is pulverized standby;
2) Endothelium Corneum Gigeriae Galli is removed foreign material parching to brown in hot sand, and sieve is abandoned sand grains, and the cooling back is pulverized standby;
3) all the other six kinds of spices are removed impurity, pulverize standby;
4) the standby raw material of above-mentioned 1 to 3 step gained in proportion behind the mixing, is ground into 300~500 purpose superfine powder and gets final product.
5) adopt cobalt 60 sterilizations behind the drug packages.
Sterilization back quality standard meets the " pertinent regulations that Chinese pharmacopoeia version in 2000 is an one.
The present invention removes the drug regimen uniqueness, has relieving gastric hyperacidity to alleviate stomachache, infections hemostatic effect heals, obviously being better than other medicines aspect the doing well,improvings such as ulcer healing, pain relief, tongue arteries and veins, can control or eliminate pathogenic attack factor effectively, strengthen defense factor, treating both the principal and the secondary aspects of a disease at the same time, human body immunity improving power reduces relapse rate, has demonstrated fully the integral body medical treatment advantage of the many target spots of traditional Chinese medical science too many levels.The present invention adopts preparation of modern high technology superfine powder technology and advanced sterilization technology in the course of processing except that clinical efficacy is arranged preferably, can maximally utilise raw material, economizes on resources.The ultra micro efflorescence, plant cell wall is broken, and very strong surface adsorption and affinity are arranged, therefore have better dispersibility and dissolubility, can effectively be attached to gastrointestinal mucosa, and be digested and assimilated, make ulcer surface can be repaired as early as possible, heal, the medication target spot is clear and definite, thereby improves the bioavailability of human body, can better bring into play curative effect of medication, reached that consumption is few, curative effect is high, taking convenience, price is low, and the medicine material steady sources.
Below be medicine acute toxicity of the present invention and long term toxicity test:
This experiment adopts the ICR mice that this medicine is carried out the acute toxicity test of its mouse oral maximum dosage-feeding.
Purpose: observe to be subjected to that the reagent thing is once heavy dose of to give acute toxicity and the death condition that animal produces.
Material: medicine of the present invention, clinical recommendation consumption: each 3 grams, every day 3 times.(the Kunming IMS provides, lot number 20020612)
Animal: healthy ICR mice, body weight 20 ± 2g, male and female half and half, Yunnan Province natural drug pharmacology key lab provides.Laboratory animal rank: II level, the quality certification number: No. 9806, Yun Weidong pipe.
Method: select 20 of the healthy IRC mices of body weight 20 ± 2g, male and female half and half take by weighing medicated powder 3.8 grams, add water to 20 milliliters and become pasty states, and every milliliter contains crude drug 0.19 gram, press the 0.5ml/10g body weight to the mouse stomach administration, every day secondary.Observe animal behavior symptom in 1 hour after the administration, and behind medicine 1 hour weighing the weight of animals, animal behavior and body weight change situation before and after the observed and recorded administration.
The result: after 20 mouse stomach administrations, animal does not see any unusually in 1 hour, and body weight does not have significant change yet before and after the administration.Observed 7 days continuously, any untoward reaction does not appear in animal, the healthy survival of all animals, ordinary circumstance is good, activity freely, diet is normal.Administration was put to death all animals after 7 days, carry out the cardinal principle obduction, it is any unusual that important devices such as the heart, liver, spleen, lung, kidney, stomach organize perusal all not find, recording its mouse oral maximum, to give dose be 19g/kg, is equivalent to 148.4 times (calculating by 70 kg body weight) of clinical recommended dose.
Long term toxicity test: give rat oral gavage with medicine of the present invention, on every Saturdays day, 14 weeks of administration (for more than 3 times of clinical verification medication cycle).If high, in low three dosage groups, 40 of every treated animals.High, medium and low three dosage are equivalent to 3.84g/kg, 2.56g/kg, the 1.28g/kg (this dosage is equivalent to 30,20,10 times of clinical recommended drug dosage) of original pharmaceutical content respectively.The healthy survival of all animals as a result, growth promoter and behavioral activity show no obvious abnormalities reaction, and every indexs such as hematology, blood biochemical are not all had obvious influence.14 weeks of medication, the heart of each medication group, liver, lung, stomach, duodenum, adrenal gland, thyroid, testis, epididymis, prostate, uterus and ovary, the perusal no abnormality seen, histopathologic examination does not find toxicity damage yet; Medication 14 all 2 week of drug withdrawal back reversibility observations are learned every index to hematology, blood biochemical and are not had obvious influence.Each medication group organ coefficient and matched group comparing difference do not have significance meaning (P>0.05).The perusal and the histopathologic examination of institute's taking internal organ all do not find toxicity damage.Do not see that the slowness poisoning changes.
Experimental data such as following table:
The influence that table 1 administration was learned rat blood in 97 days (X ± SD, n=20)
Project | Matched group | High dose group | Middle dosage group | Low dose group |
RBC(10 12/L) HB(g/L) WBC(10 9/L) W-G(%) W-L(%) PLT(10 9/ L) clotting time (S) | 8.32±0.62 139.3±10.3 7.78±1.70 22.6±4.73 77.4±4.73 168.8±15.0 68.6±17.2 | 8.65±0.55 143.8±9.1 8.35±2.41 22.6±5.78 77.8±6.07 137.0±21.0 ** 72.3±28.8 | 8.56±0.56 142.6±9.4 7.85±2.47 24.8±5.50 75.2±5.50 124.9±11.9 ** 72.7±28.8 | 8.96±1.06 ** 148.2±12.5 ** 6.57±1.88 24.6±6.15 75.4±6.15 117.1±9.96 ** 51.9±21.9 |
Annotate: compare with matched group:
*Other P of P<0.01>0.05
Table 2 administration 97 days to the biochemical influence of rat blood (X ± SD, n=20)
Project | Matched group | High dose group | Middle dosage group | Low dose group |
ALT(u/L) AST(u/L) ALP(u/L) TP(g/L) ALB(g/L) UREA(mmol/L) CRE(μmol/L) TB(μmol/L) CHO(mmol/L) GLU(mmol/L) | 92.6±20.1 345.4±113.7 78.7±20.2 70.4±2.02 33.7±1.06 9.37±2.34 48.2±16.8 4.08±0.69 1.74±0.26 5.11±0.39 | 86.3±26.0 386.5±111.4 71.7±17.2 71.4±3.28 33.8±1.12 9.96±1.09 44.5±5.59 4.94±1.26 * 1.56±0.31 5.05±0.52 | 79.9±14.6 * 315.7±99.8 68.2±18.4 67.9±3.40 * 33.5±0.77 9.52±1.29 44.3±4.63 4.12±1.12 1.70±0.31 4.70±0.58 * | 84.0±17.3 343.4±71.3 69.8±19.7 69.8±3.90 33.7±1.47 9.96±1.84 47.2±8.98 4.22±0.96 1.62±0.37 5.14±0.52 |
Annotate: compare with matched group
*Other P of P<0.05>0.05
The table 3 administration influence to the Rats Organs and Tissues coefficient in 97 days (X ± SD, g/100g, n=20)
Internal organs | Matched group | High dose group | Middle dosage group | Low dose group |
Conscience spleen lung kidney | 0.29±0.03 2.36±0.23 0.23±0.04 0.54±0.09 0.30±0.04 | 0.34±0.03 ** 2.77±0.36 ** 0.25±0.03 * 0.64±0.11 ** 0.35±0.05 ** | 0.32±0.03 ** 2.59±0.25 * 0.25±0.04 * 0.60±0.08 * 0.34±0.03 ** | 0.36±0.03 ** 2.79±0.17 ** 0.27±0.03 ** 0.64±0.08 ** 0.35±0.03 ** |
Annotate: compare with matched group
*P<0.05
*P<0.01
(reversibility is observed X ± SD, n=10) in the influence that table 4 pair rat blood is learned
Project | Matched group | High dose group | Middle dosage group | Low dose group |
RBC(10 12/L) HB(g/L) WBC(10 9/L) W-G(%) W-L(%) PLT(10 9/ L) clotting time (S) | 8.71±0.57 146.0±8.69 6.35±1.30 24.9±3.07 75.1±3.07 128.0±12.8 66.0±23.7 | 8.46±0.57 140.7±9.71 7.15±1.38 24.4±3.89 75.6±3.89 119.4±7.31 76.8±20.5 | 9.35±0.41 ** 155.9±6.81 * 5.54±0.70 22.8±5.03 77.2±5.03 125.4±16.6 62.7±15.9 | 8.64±0.51 144.0±8.43 6.54±0.92 22.5±4.09 76.5±3.17 122.6±4.81 65.2±20.1 |
Annotate: compare with matched group
*P<0.05
*Other P of P<0.01>0.05
(reversibility is observed X ± SD to the biochemical influence of table 5 pair rat blood, n=10)
Project | Matched group | High dose group | Middle dosage group | Low dose group |
ALT(u/L) AST(u/L) ALP(u/L) TP(g/L) ALB(g/L) UREA(mmol/L) CRE(μmol/L) TB(μmol/L) CHO(mmol/L) GLU(mmol/L) | 89.9±15.9 388.4±116.9 82.7±19.7 69.8±13.7 32.2±0.84 8.85±1.71 43.4±7.43 6.60±1.86 2.87±0.38 5.52±0.37 | 90.7±16.2 366.9±119.9 79.6±19.7 71.5±3.66 32.9±0.96 8.93±0.99 42.9±7.12 7.04±2.07 3.01±0.65 5.66±0.62 | 101.6±15.9 441.9±99.9 82.2±26.5 70.4±4.19 33.4±1.06 * 8.72±1.33 44.2±4.00 7.77±2.68 2.92±0.42 6.02±0.78 | 108.0±13.1 * 484.1±152.1 77.9±13.1 70.8±4.94 32.9±1.25 8.92±0.44 46.4±5.06 7.06±1.53 3.18±0.58 5.76±0.79 |
Annotate: compare with matched group
*Other P of P<0.05>0.05
The influence of table 6 pair Rats Organs and Tissues coefficient (reversibility is observed X ± SD, g/100g, n=10)
Internal organs | Matched group | High dose group | Middle dosage group | Low dose group |
Conscience spleen lung kidney | 0.35±0.04 3.02±0.28 0.22±0.07 0.70±0.20 0.34±0.03 | 0.34±0.06 3.13±0.32 0.26±0.07 0.67±0.16 0.33±0.03 | 0.34±0.04 3.32±0.16 0.26±0.05 0.69±0.14 0.35±0.02 | 0.34±0.02 3.17±0.24 0.25±0.03 0.649±0.09 0.35±0.03 |
Annotate: respectively organize P>0.05 with matched group
The specific embodiment
Embodiment 1:
Take by weighing following raw material (weight is kilogram) according to quantity:
Corium elephatis 80 Pseudobulbus Bletillae (Rhizoma Bletillae)s 80 Bulbus Fritillariae Thunbergii 80 XIAOERFUTONGCAO 80
Pericarpium Citri Reticulatae 4 Endothelium Corneum Gigeriae Galli 4 Os Sepiae 80 Radix Glycyrrhizaes 80
Carry out according to the following steps:
1) after Corium elephatis was cut into 2 * 6 centimetres of fritters after moistening, drying was inserted and is fried bubble in the hot sand and cause yellow, and sieve is abandoned sand grains, and the cooling back is pulverized standby;
2) Endothelium Corneum Gigeriae Galli is removed foreign material parching to brown in hot sand, and sieve is abandoned sand grains, and the cooling back is pulverized standby;
3) all the other six kinds of spice Pseudobulbus Bletillae (Rhizoma Bletillae)s, Bulbus Fritillariae Thunbergii, XIAOERFUTONGCAO, Pericarpium Citri Reticulatae, Os Sepiae, Radix Glycyrrhizae is removed impurity, pulverizes standby;
4) the standby raw material of above-mentioned 1 to 3 step gained in proportion behind the mixing, is ground into 300~500 purpose superfine powder, by the specification packing;
5) adopt cobalt 60 sterilizations behind the drug packages.
Embodiment 2:
Take by weighing following raw material (weight is kilogram) according to quantity:
Corium elephatis 100 Pseudobulbus Bletillae (Rhizoma Bletillae)s 100 Bulbus Fritillariae Thunbergii 100 XIAOERFUTONGCAO 100
Pericarpium Citri Reticulatae 5 Endothelium Corneum Gigeriae Galli 5 Os Sepiae 100 Radix Glycyrrhizaes 100
Press the method preparation of embodiment 1.
Embodiment 3:
Take by weighing following raw material (weight is kilogram) according to quantity:
Corium elephatis 120 Pseudobulbus Bletillae (Rhizoma Bletillae)s 120 Bulbus Fritillariae Thunbergii 120 XIAOERFUTONGCAO 120
Pericarpium Citri Reticulatae 6 Endothelium Corneum Gigeriae Galli 6 Os Sepiae 120 Radix Glycyrrhizaes 120
Press the method preparation of embodiment 1.
Claims (2)
1 one kinds of medicines for the treatment of the digestive tract ulcer disease is characterized in that it being the medicament that is formed by following feedstock production: Corium elephatis 80~120, the Pseudobulbus Bletillae (Rhizoma Bletillae) 80~120, Bulbus Fritillariae Thunbergii 80~120, XIAOERFUTONGCAO 80~120, Pericarpium Citri Reticulatae 4~6, Endothelium Corneum Gigeriae Galli 4~6, Os Sepiae 80~120, Radix Glycyrrhizae 80~120; And preparation by the following method:
1) after Corium elephatis was cut into small pieces after moistening, drying was inserted and is fried bubble in the hot sand and cause yellow, and sieve is abandoned sand grains, and the cooling back is pulverized standby;
2) Endothelium Corneum Gigeriae Galli is removed foreign material parching to brown in hot sand, and sieve is abandoned sand grains, and the cooling back is pulverized standby;
3) all the other six kinds of spices are removed impurity, pulverize standby;
4) the standby raw material of above-mentioned 1 to 3 step gained in proportion behind the mixing, is ground into 300~500 purpose superfine powder, makes medicine.
2, the preparation method of the medicine of treatment digestive tract ulcer disease according to claim 1 is characterized in that carrying out according to the following steps:
1) after Corium elephatis was cut into small pieces after moistening, drying was inserted and is fried bubble in the hot sand and cause yellow, and sieve is abandoned sand grains, and the cooling back is pulverized standby;
2) Endothelium Corneum Gigeriae Galli is removed foreign material parching to brown in hot sand, and sieve is abandoned sand grains, and the cooling back is pulverized standby;
3) all the other six kinds of spices are removed impurity, pulverize standby;
4) the standby raw material of above-mentioned 1 to 3 step gained in proportion behind the mixing, is ground into 300~500 purpose superfine powder;
5) adopt cobalt 60 sterilizations behind the drug packages.
Priority Applications (1)
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CNB031172814A CN1277570C (en) | 2003-01-30 | 2003-01-30 | Pharmaceutical for treating alimentary tract ulcer disease and preparing process thereof |
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CNB031172814A CN1277570C (en) | 2003-01-30 | 2003-01-30 | Pharmaceutical for treating alimentary tract ulcer disease and preparing process thereof |
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CN1520869A CN1520869A (en) | 2004-08-18 |
CN1277570C true CN1277570C (en) | 2006-10-04 |
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CN104352939A (en) * | 2014-11-19 | 2015-02-18 | 利川市民族中医院 | Capsule for treating peptic ulcer and helicobacter pyloridis |
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Granted publication date: 20061004 Termination date: 20100130 |