CN1899519A - Chinese medicine suppository for treating colitis and its preparing method - Google Patents
Chinese medicine suppository for treating colitis and its preparing method Download PDFInfo
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- CN1899519A CN1899519A CNA200610045288XA CN200610045288A CN1899519A CN 1899519 A CN1899519 A CN 1899519A CN A200610045288X A CNA200610045288X A CN A200610045288XA CN 200610045288 A CN200610045288 A CN 200610045288A CN 1899519 A CN1899519 A CN 1899519A
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Abstract
The present invention is a kind of Chinese medicine suppository for treating colitis and its preparation process, and belongs to the field of medicine technology. The Chinese medicine suppository is prepared with astragalus root, notoginseng, frankincense, gallnut, Japanese ampelopsis and bletilla tuber in certain weight proportion, and through grinding gallnut, frankincense, bletilla tuber and notoginseng into fine powder; twice decocting astragalus root and Japanese ampelopsis, filtering the decoction, drying and crushing; mixing with supplementary material and the fine powder; and forming suppository. The Chinese medicine suppository has high curative effect on colitis, no toxicity and taking convenience.
Description
Technical field
The present invention relates to a kind of Chinese medicine suppository for the treatment of colitis and preparation method thereof, belong to field of pharmaceutical technology.
Technical background
Chronic ulcerative colitis is a kind of agnogenic colon chronic inflammatory disease, is called chronic non-specific ulcerative colitis again, the special colitis of sending out.Its morbidity may be relevant with factors such as immunity, heredity, infection, Nervous and Mental Factors, lysozyme, allergy.The traditional Chinese medical science thinks that primary disease is many owing to experience summer-heat cold-damp or feelings will internal injury, and eating and drinking without temperance causes internal organs gas harmony and stagnates, the QI and blood addiction stagnates, cold and stagnate and insufficiency of the spleen leading to overabundance of dampness, deficiency of spleen-YANG and kidneyYANG etc., and then causing failure of the spleen to transport and transform, conversion of dampness into heat and falling ill belongs to categories such as traditional Chinese medical science dysentery, diarrhea, intestinal is out-of-the-way.
Primary disease is found in any age, but sees that with person between twenty and fifty (its pathological changes mainly betides the mucosa of colon, and based on hemorrhage, rotten to the corn, the ulcer of mucosa, involves rectum and far-end colon more more.Cardinal symptom has diarrhoea, slit liquid just, bloody purulent stool, stomachache, tenesmus, state of an illness delay, Chang Fanfu outbreak.
The treatment of primary disease does not still have effective radical cure method at present both at home and abroad.Doctor trained in Western medicine is mainly used salazosulfamide, aminosallcylic acid, metronidazole, corticosteroid, immunosuppressant etc., though some effects are arranged, untoward reaction is obvious.Tcm treatment according to syndrome differentiation adopts methods such as decoction oral, medicine retention enema, acupuncture.Though said method has certain curative effect, cure rate is still waiting further raising, and treatment means is very inconvenient, influences patient's compliance.
Summary of the invention
The objective of the invention is to propose a kind of Chinese medicine suppository for the treatment of colitis and preparation method thereof in order to overcome the deficiency of existing treatment colitis medicine.Rectally of the present invention, evident in efficacy, have no side effect, counterweight, in, slight ulcerative colitis all has positive effect, makes the treatment of ulcerative colitis both safe and effective, easy to use again, can improve the compliance of extensive patients.
The object of the present invention is achieved like this: a kind of Chinese medicine suppository for the treatment of colitis is characterized in that: it is made by following bulk drugs:
Radix Astragali 550-650 part Radix Notoginseng 75-90 part Olibanum 195-210 part
Galla Chinensis 195-210 part Radix Ampelopsis 550-700 part Pseudobulbus Bletillae (Rhizoma Bletillae) 195-215 part
Adjuvant 800-3000 part
Optimum formula of the present invention is made by following bulk drugs:
200 parts of 80 parts of Olibanums of 550 portions of Radix Notoginseng of the Radix Astragali
200 parts of 650 parts of Pseudobulbus Bletillae (Rhizoma Bletillae) of 200 portions of Radix Ampelopsis of Galla Chinensis
1000 parts of adjuvants
A kind of used adjuvant for the treatment of the Chinese medicine suppository of colitis of the present invention can be the various conventional adjuvant of preparation suppository.Comprise fatty glyceride, Polyethylene Glycol, cocoa butter, glycerin gelatine etc.
A kind of Chinese medicine suppository for the treatment of colitis of the present invention can prepare by the following method:
A) Galla Chinensis, Olibanum, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng four flavors of described weight proportion are made fine powder.
B) Radix Astragali of described weight proportion, Radix Ampelopsis two flavors are decocted with water twice, merge decocting liquid twice, filter, it is 1.15～1.20 clear paste that filtrate is concentrated into relative density.
C) gained fine powder, clear paste are mixed, drying is pulverized the cream powder of preparation cost invention Chinese medicine suppository.
D) the adjuvant heat fused is added the cream powder, fully mixing is made suppository of the present invention.
For suppository of the present invention, also can prepare by following method:
A) Galla Chinensis, Olibanum, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng four flavors of described weight proportion are made fine powder.
B) Radix Astragali, Radix Ampelopsis two flavors with described weight proportion decoct with water twice, merge decocting liquid twice, filter, and filtrate concentrates, spray drying, and powder gets dry extract.
C) the adjuvant heat fused is added fine powder, dried cream powder, fully mixing is made suppository of the present invention.
In the above each component, weight is calculated with crude drug, and in the present invention, if weight is unit with the gram, this composition can be made into 1000 of suppositorys, treatment colitis, each 1-2 grain, every day 1-2 time.
More than each form to be by weight as proportioning, when producing, can increase or reduce according to corresponding ratio, can be unit with kilogram or with the ton as large-scale production, weight can increase or reduce, but the crude drug weight proportion constant rate between the each component.
The present invention be at distinguished veteran doctors of TCM on the basis of proved recipe, after the screening, through a large amount of technical study and pharmacodynamics, the resulting suppository of toxicology test.The present invention has the function of QI invigorating, blood stasis dispelling, hemostasis, antidiarrheal.It is efficient to be used for the treatment of colitis, nontoxic, easy to use, brings great convenience to doctor and patient.
For a better understanding of the present invention, below by pharmacodynamics, toxicology test further set forth the present invention (hereinafter referred to as: the colitis bolt) treatment colitis beneficial effect.Experimental example comprises pharmacodynamics of the present invention, toxicology test.Test is intended to further specify effect of the present invention below, but not restriction of the present invention.
Pharmacodynamic test of active extract of the present invention
Test respectively at observation in vitro in the bacteriostasis of colitis bolt, the body for the therapeutical effect of two kinds of rat colitis models and to the anastalsis of docking mice.
A) external bacteriostasis of the present invention
Adopt the doubling dilution preparation to contain the agar plate culture medium that variable concentrations is subjected to the reagent thing, standby good bacterium liquid is inoculated into respectively on the surface of above-mentioned pastille agar plate culture medium with multiple spot inoculation instrument, cultivated 18 hours for 37 ℃, the least concentration of contained drug is the minimal inhibitory concentration (MIC) of this medicine in the plate of no bacterial growth, observe the MIC scope of each bacterium, adopt NDST statistical software calculation procedure to calculate MIC
50And MIC
90After measuring MIC, will not see that successively the culture of respectively managing of bacterial growth is drawn 0.1ml respectively and is poured on the plate, and cultivate 18 hours, and obtained the minimum bactericidal concentration (MBC) that is subjected to the reagent thing for 37 ℃.
The result shows that the colitis bolt has antibacterial preferably or bactericidal effect.To the MIC scope of most of strains all between 0.125-32mg/ml, MIC
50Mostly be 2-8mg/ml greatly, stronger to the effect of intestinal common pathogens such as colon bacillus, proteus vulgaris, enterococcus, citrobacter and shigella flexneri, MIC
50Be 2-4mg/ml; Gram-positive coccis such as staphylococcus aureus, staphylococcus epidermidis and pseudomonas aeruginosa effect are taken second place MIC
50Be 8-16mg/ml.MBC to 8 strain antibacterials measures as can be seen by the colitis bolt, and the colitis bolt has good killing effect to 8 strain antibacterials of test usefulness, and the prompting test sample is to the bactericidal action that act as of test organisms.
B) the present invention causes the influence of rat acute colitis to acetic acid:
Get body weight and be 60 of the male rats of 180-210g, be divided into 6 groups at random: normal control group, model control group, GUCHANG ZHIXIE WAN positive control (3.00g/kg) group, colitis bolt heavy dose (0.47g/kg crude drug) group, middle dosage (0.24g/kg crude drug) group, low dose of (0.12g/kg crude drug) group.Each is organized the rat fasting and can't help water after 48 hours, with the pentobarbital sodium anesthetized animal, rat is fixed on a low buttocks high position, use round end silica gel catheter per anum to insert 8cm in the enteric cavity, inject 1ml 10% acetic acid (the normal control group is then injected the 1ml normal saline), keep this position after 20 seconds, the 2ml normal saline flushing reinjects.After the modeling next day rectally, successive administration 7 days.After the last administration 24 hours, each treated animal was put to death in dislocation, take out from the make progress intestinal segment of 10cm of anal canal, and longitudinal incision, perusal is local to be changed, and is placed in 10% formalin solution fixingly, carries out histopathologic examination, the comparable group differences.
The result shows the colitis bolt in the 0.12-0.47g/kg dosage range, can obviously alleviate the rat symptom of diarrhea, promotes the reparation of colonic pathological change, and the rat acute colitis that acetic acid is caused has the obvious treatment effect.
C) the present invention is to the influence of the inductive rat ulcer colitis of trinitro-benzene-sulfonic acid:
Get body weight and be 60 of the male rats of 180-200g, grouping is with 1.2.Each is organized the rat fasting and can't help water after 48 hours, with the pentobarbital sodium anesthetized animal, rat is fixed on a low buttocks high position, use round end silica gel catheter per anum to insert 8cm in the enteric cavity, inject 5% (W/V) TNBS 0.6ml and 50% ethanol 0.25ml (the normal control group is then injected the 0.85ml normal saline), this position kept 60 seconds, and the modeling agent is fully contacted with intestinal wall.Continue per rectum every day later on and give 50% ethanol 0.5ml, consolidate the modeling damage, begin the rectally treatment simultaneously, successive administration 15 days.After the last administration 24 hours, each treated animal was put to death in dislocation, take out from the make progress intestinal segment of 10cm of anal canal, and longitudinal incision, perusal is local to be changed, and is placed in 10% formalin solution fixingly, carries out histopathologic examination, the comparable group differences.
The result shows that administration respectively organizes the colonic pathological change degree and obviously be lighter than model control group, especially colitis bolt 0.47g/kg dosage group rat, its colonic pathological change degree obviously alleviates, and illustrates that the colitis bolt has the obvious treatment effect to the inductive rat ulcer colitis of trinitro-benzene-sulfonic acid.
D) the present invention is to the influence in mice docking bleeding time:
Get 50 of the female mices of body weight 18-22g, be divided into 5 groups at random: normal control group, GUCHANG ZHIXIE WAN positive control (4.00g/kg) group, colitis bolt heavy dose (1.00g/kg crude drug) group, middle dosage (0.50g/kg crude drug) group, low dose of (0.25g/kg crude drug) group, successive administration 5 days.After the last administration, mice put into special holder in 1 hour, cut off the Mus tail at distance tail point 0.5cm place and pick up counting, inhaled to dehematize with filter paper every 30 seconds and drip 1 time, till blood seepage flow stops (depletion of blood during the filter paper suction) naturally, be the bleeding time.
The result shows that under the colitis bolt 1.00g/kg-0.50g/kg dosage, rectally is 5 days continuously, can obviously shorten the mice bleeding time, illustrates that the colitis bolt has tangible anastalsis.
Acute toxicity test
A). the rectally approach:
Select 20 of healthy mices, body weight 20.0 ± 1.0g, male and female half and half.Every 20g body weight mice gives diameter 2mm, long 5mm enteritis bolt from anus (be equivalent to 1.01g crude drug/kg), administration reaches at once and there is no animal the overt toxicity reaction occurs in 14 days observation period, and weight of mice is good, no animal dead behind the fasting 6h.Be subjected to the restriction of enteritis bolt pharmaceutical dosage form and medicine-feeding part, can't measure the LD of this medicine rectally
50, its rectally LD
50Greater than 1.01g crude drug/kg.
B) gastric infusion approach:
Select 20 of healthy mices, body weight 20.0 ± 2.0g, male and female half and half.Once irritating stomach behind the fasting 6h gives 41.7% colitis bolt extract 0.8ml/20g body weight and (is equivalent to 31.4g crude drug/kg), at once reach in administration and in 14 days observation period, there is no animal and overt toxicity reaction occurs, weight of mice is good, does not also have animal dead.Be subjected to the restriction of drug level and administration volume, can't measure the LD of this medicine oral administration
50, its gastric infusion LD
50Greater than 31.4g crude drug/kg.
Long term toxicity test
Test selects 1.88,0.94 for use, three dosage groups of 0.47g/kg, and every day, rectally was 2 times, the toxic action that successive administration produced the Wistar rat in 90 days.Duration of test is observed the general situation of rat, regularly weighs in and food-intake, carries out hematology and blood biochemical detection in 14 days respectively in administration 90 days and drug withdrawal.Putting to death 1/2 zootomy main organs for every group administration 90 days weighs, calculates organ coefficient and carry out histopathologic examination.Put to death each treated animal in 14 days in drug withdrawal and carry out the same cardinal principle and pathologic finding, organ coefficient calculates.
Result of the test shows, rat successive administration 90 days, and in entire test, each organizes rat generally in order, and fur is glossy, and each administration treated animal body weight all has increase, compares no significant difference with matched group.Every index and organ coefficient and the relatively more equal no significant differences of matched group such as hematology, blood biochemical.Each dosage treated animal heart of histopathologic examination, liver, spleen, lung, kidney, stomach, put main organs such as medicine position rectum and matched group and relatively there is no obvious pathomorphology and change.Therefore, test thinks that colitis bolt rectally very is a safety.
The specific embodiment
Embodiment 1:
Take by weighing following bulk drugs by weight:
Radix Astragali 550g Radix Notoginseng 80g Olibanum 200g
Galla Chinensis 200g Radix Ampelopsis 650g Pseudobulbus Bletillae (Rhizoma Bletillae) 200g
Adjuvant 1000g
The above-mentioned raw materials medicine is prepared by following method:
A) Galla Chinensis, Olibanum, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng are made fine powder.
B) Radix Astragali, Radix Ampelopsis two flavors are decocted with water twice, add 11 times of water gagings for the first time, decocted 1.5 hours; For the second time add 8 times of water gagings, decocted 1.5 hours; Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.15～1.20 (80 ℃).
C) gained fine powder, clear paste are mixed, dry below 80 ℃, pulverize, be prepared into the cream powder.
D) with the mixed fatty glycerides heat fused, add active component, fully mixing is made suppository.
Through clinical trial, treatment colitis, each 1 of rectally, every day 2 times, 10 days is a course of treatment, observes 1-4 the course of treatment, total effective rate is 98%.
Embodiment 2:
Radix Astragali 600g Radix Notoginseng 85g Olibanum 190g
Galla Chinensis 220g Radix Ampelopsis 650g Pseudobulbus Bletillae (Rhizoma Bletillae) 195g
Adjuvant 900g
The above-mentioned raw materials medicine is prepared by following method:
A) Galla Chinensis, Olibanum, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng four flavors are made fine powder.
B) Radix Astragali, Radix Ampelopsis two flavors are decocted with water twice, merge decocting liquid twice, filter, filtrate concentrates, spray drying, and powder gets dry extract.
C) the cocoa butter heat fused is added fine powder, dried cream powder, fully mixing is made suppository of the present invention.
Through clinical trial, each 1 of rectally, every day 2 times, treatment colitis, 10 days is a course of treatment, observes 1-4 the course of treatment, total effective rate is 96%.
Embodiment 3:
Take by weighing following bulk drugs by weight:
Radix Astragali 650g Radix Notoginseng 75g Olibanum 210g
Galla Chinensis 200g Radix Ampelopsis 700g Pseudobulbus Bletillae (Rhizoma Bletillae) 200g
Adjuvant 2000g
The above-mentioned raw materials medicine is prepared by following method:
A) Galla Chinensis, Olibanum, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng are made fine powder.
B) Radix Astragali, Radix Ampelopsis two flavors are decocted with water twice, add 11 times of water gagings for the first time, decocted 1.5 hours; For the second time add 8 times of water gagings, decocted 1.5 hours; Collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.15～1.20 (80 ℃).
C) gained fine powder, clear paste are mixed, dry below 80 ℃, pulverize, be prepared into the cream powder.
D) with the Macrogol 4000 heat fused, add active component, fully mixing is made suppository.
Through clinical trial, treatment colitis, each 1 of rectally, every day 2 times, 10 days is a course of treatment, observes 1-4 the course of treatment, total effective rate is 92%.
Embodiment 4:
Radix Astragali 600g Radix Notoginseng 90g Olibanum 190g
Galla Chinensis 190g Radix Ampelopsis 500g Pseudobulbus Bletillae (Rhizoma Bletillae) 215g
Adjuvant 900g
The above-mentioned raw materials medicine is prepared by following method:
A) Galla Chinensis, Olibanum, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng four flavors are made fine powder.
B) Radix Astragali, Radix Ampelopsis two flavors are decocted with water twice, merge decocting liquid twice, filter, filtrate concentrates, spray drying, and powder gets dry extract.
C) glycerin gelatine is added the suitable quantity of water heat fused and add fine powder, dried cream powder, fully mixing is made suppository of the present invention.
Through clinical trial, each 1 of rectally, every day 2 times, treatment colitis, 10 days is a course of treatment, observes 1-4 the course of treatment, total effective rate is 91%.
Claims (5)
1, a kind of Chinese medicine suppository for the treatment of colitis, it is characterized in that: it is made by following bulk drugs:
Radix Astragali 550-650 part Radix Notoginseng 75-90 part Olibanum 195-210 part
Galla Chinensis 195-210 part Radix Ampelopsis 550-700 part Pseudobulbus Bletillae (Rhizoma Bletillae) 195-215 part
Adjuvant 800-3000 part.
2, the Chinese medicine suppository of treatment colitis according to claim 1 is characterized in that: optimum formula is made by following bulk drugs:
200 parts of 80 parts of Olibanums of 550 portions of Radix Notoginseng of the Radix Astragali
200 parts of 650 parts of Pseudobulbus Bletillae (Rhizoma Bletillae) of 200 portions of Radix Ampelopsis of Galla Chinensis
1000 parts of adjuvants.
3, the Chinese medicine suppository of treatment colitis according to claim 1 is characterized in that: used adjuvant can be the various conventional adjuvant of preparation suppository.Comprise fatty glyceride, Polyethylene Glycol, cocoa butter, glycerin gelatine etc.
4, the preparation method of the Chinese medicine suppository of treatment colitis according to claim 1.It is characterized in that:
A) Galla Chinensis, Olibanum, Pseudobulbus Bletillae (Rhizoma Bletillae), the Radix Notoginseng of described weight proportion are made fine powder.
B) Radix Astragali of described weight proportion, Radix Ampelopsis two flavors are decocted with water twice, merge decocting liquid twice, filter, it is 1.15～1.20 clear paste that filtrate is concentrated into relative density.
C) gained fine powder, clear paste are mixed, drying is ground into fine powder, the cream powder of preparation cost invention Chinese medicine suppository.
D) the adjuvant heat fused is added the cream powder, fully mixing is made suppository of the present invention.
5, the preparation method of the Chinese medicine suppository of treatment colitis according to claim 1.It is characterized in that:
A) Galla Chinensis, Olibanum, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng four flavors of described weight proportion are made fine powder.
B) Radix Astragali, Radix Ampelopsis two flavors with described weight proportion decoct with water twice, merge decocting liquid twice, filter, and filtrate concentrates, spray drying, and powder gets dry extract.
C) the adjuvant heat fused is added fine powder, dried cream powder, fully mixing is made suppository of the present invention.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200610045288XA CN100525814C (en) | 2006-07-05 | 2006-07-05 | Chinese medicine suppository for treating colitis and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200610045288XA CN100525814C (en) | 2006-07-05 | 2006-07-05 | Chinese medicine suppository for treating colitis and its preparing method |
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| Publication Number | Publication Date |
|---|---|
| CN1899519A true CN1899519A (en) | 2007-01-24 |
| CN100525814C CN100525814C (en) | 2009-08-12 |
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ID=37655630
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB200610045288XA Active CN100525814C (en) | 2006-07-05 | 2006-07-05 | Chinese medicine suppository for treating colitis and its preparing method |
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| CN (1) | CN100525814C (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872344A (en) * | 2012-11-01 | 2013-01-16 | 查迅 | Traditional Chinese medicine clysis granules for treating ulcerative colitis and preparation method thereof |
| CN104758763A (en) * | 2015-03-12 | 2015-07-08 | 刘亮 | Qi-regulating and intestine-soothing medicament for treating ulcerative colitis and preparation method thereof |
-
2006
- 2006-07-05 CN CNB200610045288XA patent/CN100525814C/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872344A (en) * | 2012-11-01 | 2013-01-16 | 查迅 | Traditional Chinese medicine clysis granules for treating ulcerative colitis and preparation method thereof |
| CN102872344B (en) * | 2012-11-01 | 2014-03-19 | 查迅 | Traditional Chinese medicine clysis granules for treating ulcerative colitis and preparation method thereof |
| CN104758763A (en) * | 2015-03-12 | 2015-07-08 | 刘亮 | Qi-regulating and intestine-soothing medicament for treating ulcerative colitis and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN100525814C (en) | 2009-08-12 |
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