CN100349595C - Medicinal composition for catharsis - Google Patents
Medicinal composition for catharsis Download PDFInfo
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- CN100349595C CN100349595C CNB2006100289445A CN200610028944A CN100349595C CN 100349595 C CN100349595 C CN 100349595C CN B2006100289445 A CNB2006100289445 A CN B2006100289445A CN 200610028944 A CN200610028944 A CN 200610028944A CN 100349595 C CN100349595 C CN 100349595C
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Abstract
The purgative medicine composition is a kind of Chinese medicine preparation prepared with aloe, natural indigo and amber as material, and may be prepared as tablet, capsule, granule or bolus. It has the functions of clearing away liver heat and loosening the bowels to relieve constipation and obvious purgative effect.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of relieving constipation, specifically, relating to Chinese medicine is the pharmaceutical composition of the raw material relieving constipation of making.
Background technology
Constipation is a kind of more common disease, especially the gerontal patient is in the majority, the serious disease though be nothing, but the patient often has bigger misery, cause conscience fire Sheng, constipation, abdominal distention stomachache, irritated insomnia etc., influence quality of life, work is also brought certain difficulty, thereby the patient there is bigger misery.Usually adopting operation or medicine to live for the treatment of constipation treats.
Compound Aloe capsule prescription is made up of Aloe, Indigo Naturalis, succinum, Cinnabaris, has that liver heat removing is purged heat, an effect of loosening bowel to relieve constipation, mind tranquilizing and the heart calming, be used for the conscience fire and contain, constipation, abdominal distention stomachache, irritated have a sleepless night etc. evident in efficacy.
But, owing to contain Cinnabaris in the prescription of this compound Aloe capsule, and being recited as of relevant Cinnabaris in the Pharmacopoeia of the People's Republic of China (version was an one in 2005) " this product is poisonous, should not take in a large number, also unsuitable a small amount of clothes for a long time, the hepatic and kidney function obstacle person prohibits clothes ".As seen, taking the medicine that contains Cinnabaris for a long time may cause damage to body, has potential toxic and side effects.Therefore, not only have potential unsafe factor, simultaneously, because of Cinnabaris belongs to the mineral substance medical material, along with the development of time, its resource can more and more be restricted.
Summary of the invention
The technical issues that need to address of the present invention are to overcome above-mentioned weak point, disclose a kind of pharmaceutical composition with relieving constipation.
The pharmaceutical composition of relieving constipation of the present invention, be based on understanding and the Therapeutic Principle of motherland's medical science to constipation and complication thereof, achieve with reference to modern pharmacological research, improvement forms on the basis of compound Aloe capsule prescription, and this pharmaceutical composition is made by containing the following weight Chinese medicinal raw materials:
Aloe 1-2 part, 1 part of Indigo Naturalis, 1 part of succinum.
In the side: Aloe: hardship, cold.Removing heat from the liver.Get the merit of its bitter cold relieving constipation by purgation, be used for purging heat to relax the bowels, be monarch drug.Indigo Naturalis, salty-cold, heat-clearing and toxic substances removing, purging liver-fire is ministerial drug.The monarch and his subjects' phase 5 brings out the best in each other, and has strengthened liver heat removing and has let out fire, functions of loosening bowel relieving constipation.Succinum, sweet, flat, the relieving convulsion adjuvant drug that is of calming the nerves.Full side plays altogether that liver heat removing is purged heat, the merit of loosening bowel to relieve constipation, mind tranquilizing and the heart calming.
What the present invention also comprised the treatment effective dose is the Chinese medicine preparation that active component and pharmaceutically acceptable carrier are formed by above-mentioned pharmaceutical composition, said Chinese medicine preparation comprises any one pharmaceutically acceptable dosage form, as tablet, capsule, granule or pill;
In described Chinese medicine preparation tablet, capsule, granule or the pill, every 1g contains Aloe in barbaloin, must not be less than 20mg.
Said filler selects a kind of or its mixture in corn starch, tapioca, modified starch, powdered sugar, calcium hydrogen phosphate, micropowder silica gel, dextrin or the magnesium stearate;
Said carrier comprises binding agent, as a kind of or its mixture in microcrystalline Cellulose, gelatin, polyvinylpyrrolidone, HPMC or the sucrose; Disintegrating agent such as starch, carboxymethyl starch, super carboxymethylstach sodium, lubricant such as magnesium stearate, Pulvis Talci, polyethylene glycol 6000, micropowder silica gel.
Preparation of drug combination method of the present invention comprises the steps:
With Aloe, succinum and Indigo Naturalis,, pulverize then by weight ratio, obtain said pharmaceutical composition, add carrier then, adopt method well known in the art, make tablet, capsule, granule or pill through concocting, processing.
The process of preparing Chinese medicine of pharmaceutical composition component of the present invention, processing method are a kind of method of routine, and step and technological parameter thereof are as follows:
Aloe: choose and pick up removal impurity, be chopped to fritter, put 80-120 ℃ of drying in the drying baker, pulverize the 60-100 order.
Indigo Naturalis: sterilization cabinet 0.12Mpa pressure, 120 ℃ of steam discontinuous sterilizations are put in pack, and each 1-1.5 hour, 30 minutes at interval, cool, take out and put the inherent 80-120 ℃ of drying of drying baker.
Succinum: Ex-all impurity, the water purification branch is drenched in the drinking water flushing, puts the inherent 80-120 ℃ of drying of drying baker, is broken into fritter, pulverizes the 60-100 order.
Animal experiment proves that pharmaceutical composition of the present invention and said Chinese medicine preparation have the function of removing heat from the liver, loosening bowel to relieve constipation, can be used for the treatment of astriction.General dosage is 0.35～1.85 gram/sky/60kg body weight, specifically can be determined by the doctor according to patient's concrete conditions such as the state of an illness.
The invention provides the method for quality control of pharmaceutical composition.The present invention by control pharmaceutical composition in Aloe (with barbaloin C
21H
22O
9Meter) content carries out the quality control of pharmaceutical composition.Its detection method is a high performance liquid chromatography.Detection method and condition are:
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water (20-30: 70-80) be mobile phase; The detection wavelength is 355nm.Number of theoretical plate should be not less than 5000 by the barbaloin peak.
It is an amount of that the preparation precision of reference substance solution takes by weighing the barbaloin reference substance, puts in the measuring bottle, adds methanol and make the solution that every 1ml contains 0.1mg, promptly.
Pharmaceutical composition of the present invention (the weight portion proportioning is 2 parts of Aloes, 1 part of Indigo Naturalis, 1 part of succinum) is got in the preparation of need testing solution, and porphyrize is got about 0.1-0.2g, the accurate title, decide, put in the 50ml measuring bottle, it is an amount of to add methanol, supersound process 10-30 minute, put cold, add methanol to scale, shake up, filter, get subsequent filtrate, promptly.
Accurate respectively each the 10 μ l of above-mentioned two kinds of solution that draw of algoscopy inject chromatograph of liquid, measure, promptly.
Detection index explanation: " Aloe recorded of Chinese pharmacopoeia version in 2005 has two kinds of Aloe vulgaris and Aloe ferox Millers, and when the pharmaceutical composition that this detection method detects was used Aloe vulgaris, every 1g pharmaceutical composition contained Aloe with barbaloin (C
21H
22O
9) meter is not less than 20mg, every 1g contained Aloe and is not less than 10mg in barbaloin when Aloe was used Aloe ferox Miller in the pharmaceutical composition.
The raw material of pharmaceutical composition of the present invention all derives from natural Chinese medicine, meets the regulation of national standard, and drug effect is remarkable, few side effects, and safety improves greatly, and therapeutic effect there was no significant difference compared with prior art.But, owing to contain Cinnabaris in the prescription of compound Aloe capsule, and being recited as of relevant Cinnabaris in the Pharmacopoeia of the People's Republic of China (version was an one in 2005) " this product is poisonous, should not take in a large number, also unsuitable a small amount of clothes for a long time, the hepatic and kidney function obstacle person prohibits clothes ".As seen, taking the medicine that contains Cinnabaris for a long time may cause damage to body, has potential toxic and side effects.Simultaneously, because of Cinnabaris belongs to the mineral substance medical material, along with the development of time, its resource can more and more be restricted.Therefore, not only there is potential unsafe factor, and is subjected to the restriction of resource.And pharmaceutical composition of the present invention has been owing to deducted the Cinnabaris with potential toxic and side effects, and protected the mineral resources of Cinnabaris, its therapeutic effect also with the prior art there was no significant difference.Therefore, has stronger positive effect.
The specific embodiment
Embodiment 1
Tablet:
Take by weighing Aloe 15g, succinum 10g and Indigo Naturalis 10g by weight ratio, Aloe, succinum, Indigo Naturalis clean, concoct (Aloe: choose and pick up removal impurity, be chopped to fritter, put 100 ℃ of dryings in the drying baker, pulverize 80 orders respectively.Indigo Naturalis: sterilization cabinet 0.12Mpa pressure, 120 ℃ of steam discontinuous sterilizations are put in pack, and each 1.5 hours, 30 minutes at interval, cool, take out and put the inherent 100 ℃ of dryings of drying baker.Succinum: Ex-all impurity, the water purification branch is drenched in the drinking water flushing, puts the inherent 100 ℃ of dryings of drying baker, is broken into fritter, pulverizes 80 orders.), pulverize the back and cross 60 mesh sieves, use 70% alcohol granulation, in 70 ℃ of oven dry, add lubricant 0.5% (in the weight of raw material), the super carboxymethylstach sodium of micropowder silica gel 5% (in the weight of raw material) adopts method tabletting well known in the art, obtains tablet.Every 1g contains Aloe in barbaloin, 〉=20mg.
Embodiment 2
Capsule:
Take by weighing Aloe 15g, succinum 10g, Indigo Naturalis 10g by weight ratio, Aloe, succinum, Indigo Naturalis clean, concoct (Aloe: choose and pick up removal impurity, be chopped to fritter, put 120 ℃ of dryings in the drying baker, pulverize 100 orders respectively.Indigo Naturalis: sterilization cabinet 0.12Mpa pressure, 120 ℃ of steam discontinuous sterilizations are put in pack, and each 1.5 hours, 30 minutes at interval, cool, take out and put the inherent 120 ℃ of dryings of drying baker.Succinum: Ex-all impurity, the water purification branch is drenched in the drinking water flushing, puts the inherent 80 ℃ of dryings of drying baker, is broken into fritter, pulverizes 60 orders), pulverize the back and cross 60 mesh sieves, add 0.5% magnesium stearate (in the weight of raw material), filling (hard capsule).Perhaps adopt embodiment 1 same procedure, obtain active component, after the granulation, add 0.5% micropowder silica gel, filling (hard capsule).Every 1g contains Aloe in barbaloin, for 〉=20mg.
Embodiment 3
Make pill (comprising the watered pill, water-honeyed pill and honeyed pill) dosage form
1. make the watered pill or water-honeyed pill
Take by weighing Aloe 15g, succinum 10g, Indigo Naturalis 10g by weight ratio, adopt embodiment 1 same procedure, obtain active component, add 40g water or mulse, system soft material pill or general ball.Every 1g contains Aloe in barbaloin 〉=20mg.
2. make honeyed pill
Take by weighing Aloe 15g, succinum 10g, Indigo Naturalis 10g by weight ratio, adopt embodiment 1 same procedure, obtain active component, add the honey after 30g refines, system soft material pill.Every 1g contains Aloe in barbaloin, 〉=20mg.
Embodiment 4
Aloe content is (with barbaloin C in the pharmaceutical composition of the present invention
21H
22O
9Meter) quality control and detection method.
Pharmaceutical composition is made by following raw materials in weight portion: 2 parts of Aloes, 1 part of Indigo Naturalis, 1 part of succinum.
Concrete detection method and condition:
This detection method is a high performance liquid chromatography.
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water (25: 75) is a mobile phase; The detection wavelength is 355nm.Number of theoretical plate should be not less than 5000 by the barbaloin peak.
It is an amount of that the preparation precision of reference substance solution takes by weighing the barbaloin reference substance, puts in the brown measuring bottle, adds methanol and make the solution that every 1ml contains 0.1mg, promptly.
Pharmaceutical composition of the present invention (the weight portion proportioning is 2 parts of Aloes, 1 part of Indigo Naturalis, 1 part of succinum) is got in the preparation of need testing solution, and porphyrize is got about 0.1g, the accurate title, decide, put in the 50ml measuring bottle, it is an amount of to add methanol, supersound process 30 minutes, put cold, add methanol to scale, shake up, filter, get subsequent filtrate, promptly.
Accurate respectively each the 10 μ l of above-mentioned two kinds of solution that draw of algoscopy inject chromatograph of liquid, measure, promptly.
The result: the every 1g of pharmaceutical composition of the present invention contains Aloe with barbaloin (C
21H
22O
9) meter, be 53.34mg.
Embodiment 5
First: to the experimentation of constipation animal defecation influence
One, dehydration is caused the influence of mice with constipation defecation
Experiment material
1. animal: ICR mice, body weight 18～22g, male and female dual-purpose.Beijing Vital River Experimental Animals Technology Co., Ltd. provides, animal licence numbering: SCXK (capital) 2002-0003.
2. medicine and reagent
2.1 be subjected to the reagent thing
Compound Aloe capsule: Shanghai Fuxing Linxi Medicine Industry Co., Ltd provides.
Compound method: take by weighing an amount of compound Aloe capsule, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Middle dosage group: 0.35g/Kg;
Heavy dose of group: 0.70g/Kg.
Pharmaceutical composition of the present invention.
Compound method: take by weighing an amount of pharmaceutical composition of the present invention, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Small dose group: 0.15g/Kg;
Middle dosage group: 0.30g/Kg;
Heavy dose of group: 0.60g/Kg.
* annotate: middle dosage is the clinical equivalent amount, is equivalent to 10 times of people's consumptions.
2.2 positive drug
Phenolphthalein tablets (phenolphthalein): Beijing Taiyang Pharmaceutical Co., Ltd., lot number: 051034.
Compound method: get an amount of phenolphthalein tablets, be dissolved in and make suspension, gastric infusion in the distilled water.Dosage is 10mg/Kg.
2.3 other
Carbon element prepared Chinese ink: Shanghai Ink Factory.
Method
Animal marrow machine is divided into: the normal control group; The constipation model group; Large, medium and small 3 the dosage groups of pharmaceutical composition of the present invention; Big or middle 2 the dosage groups of compound Aloe capsule; The phenolphthalein tablets group.
Except that the normal control group, all the other animal feed rice were also prohibited water 54 hours, all animals fasting subsequently 18 hours (water is can't help in the fasting of normal control group).
Each administration treated animal on the 4th is irritated stomach and is given relative medicine (containing 30% carbon element prepared Chinese ink), 30% carbon element prepared Chinese ink of capacity such as matched group and model group animal filling stomach.Subsequently the animal list is only placed under the 800ml glass beaker, observe its defecation situation, count the grain number of melena that every animal is arranged, observed continuously 8 hours.
Carry out the check and the non parametric tests of mean with the SPSS11.0 statistical software, compare between organizing.
The result:
Result's demonstration is prohibited water food rice and can be caused the constipation of mice hydropenia, compares with matched group, and the model group animal arranges the melena number of animals in 8 hours and melena grain number average obviously reduces (P＜0.01).Compound Aloe capsule, each dosage of pharmaceutical composition of the present invention all can promote the animal defecation, show as all obviously increases of defecation animal number of elements, defecation grain number and defecation rate in 8 hours.Each dosage group effect of pharmaceutical composition wherein of the present invention all has notable difference (P＜0.05～P＜0.01) with model group, shows to have obvious defecating feces excretion.Compound Aloe capsule dosage group row melena number of animals, melena grain number and defecation rate are all than the obvious increase of model group (P＜0.01).Though and heavy dose of group row's melena number of animals and melena grain number have increase, do not have significant difference with model group, may with its drug level height, the rare pass of water content.
Positive control drug phenolphthalein can obviously increase the quantity of animal row melena, but the defecation rate is not had obvious influence.The results are shown in
Table 1.
Table 1 pair dehydration causes the influence (x ± s) of mice with constipation defecation
| Group | Dosage (g/kg) | Number of animals (only) | Row's melena number of animals (only) | Defecation rate (%) | Melena grain number (grain/8 hours) |
| The little phenolphthalein of the big compound aloe capsule Chinese traditional medicine of control group model group compound aloe capsule composition big pharmaceutical composition Chinese traditional medicine composition | - - 0.7 0.35 0.6 0.3 0.15 0.010 | 13 13 13 13 13 13 13 13 | 13 5 9 12 11 8 11 7 | 100 ** 38 69 92 ** 84 * 62 84 * 54 | 1.85±1.29 * 0.62±0.84 1.38±1.27 3.38±2.76 ** 4.85 ±4.52 ** 2.69±2.78 * 2.54±2.17 ** 2.38±2.68 * |
Annotate: compare with model group,
*P＜0.05,
*P＜0.01.
Two, compound diphenoxylate is caused the influence of mice with constipation defecation
Experiment material
1. animal: ICR mice, body weight 18～22g, male and female dual-purpose.Beijing Vital River Experimental Animals Technology Co., Ltd. provides, animal licence numbering: SCXK (capital) 2002-0003.
2. medicine and reagent
2.1 be subjected to the reagent thing
Compound Aloe capsule: Shanghai Fuxing Linxi Medicine Industry Co., Ltd provides.Lot number: 051102
Compound method: take by weighing an amount of compound Aloe capsule, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Middle dosage group: 0.35g/Kg;
Heavy dose of group: 0.70g/Kg.
Pharmaceutical composition of the present invention.
Compound method: take by weighing an amount of pharmaceutical composition of the present invention, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Small dose group: 0.15g/Kg;
Middle dosage group: 0.30g/kg;
Heavy dose of group: 0.60g/Kg.
* annotate: middle dosage is the clinical equivalent amount, is equivalent to 10 times of people's consumptions.
2.2 positive drug
Metoclopramide: Beijing Taiyang Pharmaceutical Co., Ltd., lot number: 050104, gastric infusion.Dosage is 10mg/Kg.
Compound method: get an amount of metoclopramide sheet, be dissolved in and make suspension in the distilled water, gastric infusion, dosage are 10mg/Kg.
2.4 modeling medicine
R-1132: Changzhou Kang Pu pharmaceutcal corporation, Ltd, lot number: 0508010.
Compound method: get an amount of R-1132, be dissolved in and make suspension, gastric infusion in the distilled water.Dosage is 40mg/Kg.
2.4 other
Carbon element prepared Chinese ink: Shanghai Ink Factory.
Method
Animal is divided at random: the normal control group; The constipation model group; Large, medium and small 3 the dosage groups of pharmaceutical composition of the present invention; Big or middle 2 the dosage groups of compound Aloe capsule; The metoclopramide group.
The all continuous gastric infusion 2 days (0.2ml/10g) of each administration treated animal, every day 1 time, normal control group and constipation model group animal are waited the capacity water purification.The equal fasting of all animals be can't help water 18 hours after the administration on the 2nd.
Each treated animal gavaged diphenoxylate (the normal control group waits the capacity water purification) on 1, and each administration treated animal is all irritated stomach and given relative medicine (containing 30% carbon element prepared Chinese ink) after 30 minutes, 30% carbon element prepared Chinese ink of capacity such as matched group and model group animal filling stomach.Only place under the 800ml glass beaker animal is single subsequently, observe its defecation situation, count a number of melena that every animal is arranged, and irritate stomach once more in the 6th hour end and give tested medicine, observed continuously 12 hours.
The result
The result shows, can cause the animal constipation after gavaging diphenoxylate, with matched group relatively, row's melena grain number obviously reduces (P＜0.01) in the model group animal 12 hours.Compound Aloe capsule, each dosage of pharmaceutical composition of the present invention all can promote the animal defecation, show as defecation grain number and the increase of defecation rate in 12 hours, and wherein heavy dose of effect obviously with model group comparing difference remarkable (P＜0.01), has obvious defecating feces excretion.And the effect of compound Aloe capsule and pharmaceutical composition of the present invention does not have significant difference.
The positive control drug metoclopramide can obviously increase the quantity of animal row melena.The results are shown in Table 2.
Table 2 pair compound diphenoxylate causes the influence (x ± s) of mice with constipation defecation
| Group | Dosage (g/kg) | Number of animals (only) | The defecation number of animals (only/12 hours) | Defecation rate (%) | Defecation grain number (grain/12 hours) |
| The little metoclopramide of the big compound aloe capsule Chinese traditional medicine of control group model group compound aloe capsule composition big pharmaceutical composition Chinese traditional medicine composition | 0.7 0.35 0.6 0.3 0.15 0.01 | 12 10 10 9 10 10 10 11 | 12 0 8 3 7 4 6 5 | 100 ** 0 80 ** 33 70 ** 40 * 60 ** 45 * | 9.92±5.36 ** 0.00±0.00 2.40±1.96 ** 0.89±1.45 2.40±2.06 ** 1.70±3.03 1.80±1.60 ** 0.91±1.16 * |
Annotate: compare with model group,
*P＜0.05,
*P＜0.01.
Second portion: to the experimentation of gastrointestinal motility influence
One, to the influence of intact animal's gastric emptying and intestinal propulsion motion
Experiment material
1. animal: ICR mice, body weight 18～22g, male and female dual-purpose.Beijing Vital River Experimental Animals Technology Co., Ltd. provides, animal licence numbering: SCXK (capital) 2002-0003.
2. medicine and reagent
2.1 be subjected to the reagent thing
Compound Aloe capsule: Shanghai Fuxing Linxi Medicine Industry Co., Ltd provides.Lot number: 051102
Compound method: take by weighing an amount of compound Aloe capsule, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Middle dosage group: 0.35g/Kg;
Heavy dose of group: 0.70g/Kg.
Pharmaceutical composition of the present invention.
Compound method: take by weighing an amount of pharmaceutical composition of the present invention, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Small dose group: 0.15g/Kg;
Middle dosage group: 0.30g/Kg;
Heavy dose of group: 0.60g/Kg.
*Annotate: middle dosage is the clinical equivalent amount, is equivalent to 10 times of people's consumptions.
2.2 positive drug
Metoclopramide: Beijing Taiyang Pharmaceutical Co., Ltd., lot number: 050104.
Compound method: get an amount of metoclopramide sheet, be dissolved in and make suspension in the distilled water, gastric infusion, dosage are 10mg/Kg.
2.3 other medicines and reagent
Sodium carboxymethyl cellulose (CMC): chemical pure, Shantou Xilong Chemical Factory, Guangdong, lot number: 0411232.
Azovan blue: Fluka import packing, Shanghai chemical reagent purchasing and supply station provides.
2.4 semi-solid nutrition is stuck with paste
16g milk powder, 8g sugar, 10g mouse feed powder (crossing 75 mesh sieves) and 0.5g azovan blue are added among the 250mlCMC (5%), abundant stirring and evenly mixing, to the blue semi-solid pastel that becomes 1g/ml, 4 ℃ of refrigerators are preserved.Be placed to room temperature during experiment.
3. instrument
Electronic balance: OHAUS TP200S, the U.S..
Method
Animal is divided at random: normal control group, large, medium and small 3 the dosage groups of pharmaceutical composition of the present invention; Big or middle 2 the dosage groups of compound Aloe capsule; Metoclopramide 10mg/kg group.Gastric infusion, continuous 2 days, control animals gave the equivalent water purification simultaneously.After the administration on the 2nd the animal fasting be can't help water 18 hours, only gave the semi-solid 0.8ml/ of paste of mouse stomach in 1 hour after the administration on the 3rd.Take off cervical vertebra after 15 minutes and put to death mice, open abdomen, ligation stomach cardia and pylorus are got stomach, dry the back with filter paper and claim full weight, cut off body of stomach along greater gastric curvature then, dry behind the flush away gastric content, claim net weight.Take out small intestinal simultaneously rapidly, directly be laid on the blank sheet of paper after peeling off gently, measure small intestinal total length (pylorus is to the distance of ileocecus) and advance distance (pylorus is to blue semi-solid distance of sticking with paste the forward position).Be calculated as follows gastric emptying rate and intestinal propulsion rate respectively.
Gastric emptying rate=(0.8-gastric residual quantity)/0.8.Gastric residual quantity=stomach full weight-stomach net weight wherein.
Intestinal propulsion rate=advance distance/small intestinal total length
The result:
The result shows that compound Aloe capsule, pharmaceutical composition of the present invention all can improve the ahead running of small intestine movement of mice, but gastric emptying is not had obvious influence.The positive control drug metoclopramide all has obvious facilitation to gastric emptying and intestinal propulsion motion.The results are shown in Table 3.
The influence of table 3 pair normal mouse gastric emptying and intestinal propulsion motion (x ± s)
| Group | Dosage (g/Kg) | Number of animals (only) | Gastric emptying rate (%) | Advance percentage rate (%) |
| The little metoclopramide of the big compound aloe capsule Chinese traditional medicine of control group compound aloe capsule composition big pharmaceutical composition Chinese traditional medicine composition | 0.7 0.35 0.6 0.3 0.15 0.010 | 12 14 13 13 12 12 14 | 34.91±13.48 42.55±13.35 39.73±11.41 36.67±8.36 37.26±9.44 43.31±12.02 60.32±13.12 ** | 59.76±6.13 65.72±7.25 *65.53±7.94 64.44±4.23 *70.17±5.33 **65.08±5.21 *72.05±6.59 ** |
Annotate: compare with matched group,
*P＜0.05,
*P＜0.01.
Two, atropine is caused the influence of gastrointestinal motility obstacle animal pattern intestinal propulsion motion
Experiment material
1. animal: ICR mice, body weight 18～22g, male and female dual-purpose.Beijing Vital River Experimental Animals Technology Co., Ltd. provides, animal licence numbering: SCXK (capital) 2002-0003.
2. medicine and reagent
2.1 be subjected to the reagent thing
Compound Aloe capsule: Shanghai Fuxing Linxi Medicine Industry Co., Ltd provides.Lot number: 051102
Compound method: take by weighing an amount of compound Aloe capsule, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Middle dosage group: 0.35g/kg;
Heavy dose of group: 0.70g/kg.
Pharmaceutical composition of the present invention.
Compound method: take by weighing an amount of pharmaceutical composition of the present invention, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Small dose group: 0.15g/Kg;
Middle dosage group: 0.30g/Kg;
Heavy dose of group: 0.60g/Kg.
*Annotate: middle dosage is the clinical equivalent amount, is equivalent to 10 times of people's consumptions.
2.2 positive drug
Metoclopramide: Beijing Taiyang Pharmaceutical Co., Ltd., lot number: 050104.
Compound method: get an amount of metoclopramide sheet, be dissolved in and make suspension, gastric infusion in the distilled water.Dosage is 10mg/Kg.
2.3 modeling medicine
Atropine sulfate injection: Tianjin gold credit aminoacid company limited, lot number: 0511221.Dosage is 2mg/Kg.
2.4 other medicines and reagent
Sodium carboxymethyl cellulose (CMC): chemical pure, Shantou Xilong Chemical Factory, Guangdong, lot number: 0411232.
Azovan blue: Fluka import packing, Shanghai chemical reagent purchasing and supply station provides.
2.5 semi-solid nutrition is stuck with paste
16g milk powder, 8g sugar, 10g mouse feed powder (crossing 75 mesh sieves) and 0.5g azovan blue are added among the 250mlCMC (5%), abundant stirring and evenly mixing, to the blue semi-solid pastel that becomes 1g/ml, 4 ℃ of refrigerators are preserved.Be placed to room temperature during experiment.
Method
Animal is divided at random: the normal control group; Model control group; Large, medium and small 3 the dosage groups of pharmaceutical composition of the present invention; Big or middle 2 the dosage groups of compound Aloe capsule; Metoclopramide 10mg/kg group.
Gastric infusion, continuous 3 days, matched group and model group animal gave the equivalent water purification simultaneously.After the administration on the 3rd the animal fasting be can't help water 18 hours, administration on the 4th is after 30 minutes, and except that the normal control group, each organizes mouse subcutaneous injection atropine sulfate (2mg/Kg).Every animal is irritated the semi-solid 0.5ml of paste of stomach after 20 minutes, puts to death zoometry intestinal propulsion rate (method is the same) after 25 minutes.
The result
The result shows that atropine can cause the mouse small intestine dyskinesia, makes mouse small intestine propelling rate significantly reduce (P＜0.001).Compound Aloe capsule, pharmaceutical composition of the present invention all can improve the intestinal propulsion rate that atropine causes gastrointestinal motility obstacle mice, and compound Aloe capsule and pharmaceutical composition effect no significant difference of the present invention.
The positive control drug metoclopramide causes the no obvious facilitation of intestinal propulsion motion of gastrointestinal motility obstacle mice to atropine.The results are shown in Table 4.
Table 4 pair atropine causes the influence (x ± s) of gastrointestinal motility obstacle animal pattern intestinal propulsion motion
| Group | Dosage (g/kg) | Number of animals (only) | Advance percentage rate (%) |
| The little metoclopramide of the big compound aloe capsule Chinese traditional medicine of control group model group compound aloe capsule composition big pharmaceutical composition Chinese traditional medicine composition | 0.7 0.35 0.6 0.3 0.15 0.01 | 18 14 10 11 10 13 10 14 | 72.08±22.54 ** 53.35±10.70 66.44±16.95 * 69.69±18.14 * 72.90±19.75 ** 63.13±11.74 * 70.55±15.99 ** 55.97±18.28 |
Annotate: compare with model group,
*P＜0.05,
*P＜0.01.
Third part: analgesic activity experimentation
Experiment material
1. animal: ICR mice, body weight 18～22g, male and female dual-purpose.Beijing Vital River Experimental Animals Technology Co., Ltd. provides, animal licence numbering: SCXK (capital) 2002-0003.
2. medicine and reagent
2.1 be subjected to the reagent thing
Compound Aloe capsule: Shanghai Fuxing Linxi Medicine Industry Co., Ltd provides.Lot number: 051102
Compound method: take by weighing an amount of compound Aloe capsule, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Middle dosage group: 0.35g/Kg;
Heavy dose of group: 0.70g/Kg.
Pharmaceutical composition of the present invention.
Compound method: take by weighing an amount of pharmaceutical composition of the present invention, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Small dose group: 0.15g/Kg;
Middle dosage group: 0.30g/Kg;
Heavy dose of group: 0.60g/Kg.
*Annotate: middle dosage is the clinical equivalent amount, is equivalent to 10 times of people's consumptions.
2.2 positive drug
Aspirin Enteric-coated Tablets: Bayer Vital GmbH, lot number: h20030542, gastric infusion.Dosage is 10mg/kg.
2.3 other reagent
Acetic acid (glacial acetic acid): analytical pure, Beijing Chemical Plant, lot number: 20050913.
Method
Animal is divided at random: matched group; The big or middle dosage group of compound Aloe capsule; Large, medium and small three the dosage groups of pharmaceutical composition of the present invention; The aspirin positive controls.
The equal gastric infusion of each treated animal, 0.2ml/10g, matched group give equal capacity water purification, once a day, and continuous 3 days.The acetum of the fresh configuration of 1 hour lumbar injection 0.6% after the administration on the 3rd, 0.3ml/ are only.Write down every mice and incubation period of writhing response occurs, and turn round the body number of times in 0～10 minute, 10～20 minutes.
The result
Behind mouse peritoneal injection acetic acid, cause pain because of stimulating peritoneum, writhing response appears in animal.The analgesic activity of compound Aloe capsule, the equal showed different of each dosage of pharmaceutical composition of the present invention, show as the writhing response prolongation of latency, turn round the body number of times in unit interval and reduce (P＜0.05～P＜0.01), and the effect of compound Aloe capsule and pharmaceutical composition of the present invention does not have significant difference.
Positive control drug metoclopramide and aspirin all can obviously suppress the writhing response due to the acetic acid, and analgesic activity is (P＜0.01) significantly.The results are shown in Table 5.
The influence of table 5 pair mice acetic acid twisting reaction (x ± s)
| Group | Dosage (g/kg) | Number of animals (only) | Turn round body incubation period (second) | Turned round body number of times (inferior) in 0～10 minute | Turned round body number of times (inferior) in 10～20 minutes |
| The little metoclopramide aspirin of the big pharmaceutical composition Chinese traditional medicine of the big compound aloe capsule Chinese traditional medicine of control group compound aloe capsule composition composition | 0.7 0.35 0.6 0.3 0.15 0.01 0.01 | 14 14 14 14 14 14 14 12 | 146.93± 25.37 204.43± 49.24 *** 210.29± 90.63 * 223.86± 121.82 * 198.21± 48.83 ** 223.43± 114.64 * 298.36± 91.74 *** 263.17± 110.50 ** | 27.07±10.42 14.00 ±7.30 ** 17.00±9.81 * 13.29±8.38 *** 13.57±8.31 ** 15.14±8.47 ** 9.64±6.91 *** 5.75±5.31 *** | 17.50±9.51 15.07±7.86 14.21±6.98 10.79±7.92 10.14±7.58 * 13.07±8.46 10.57±9.39 4.50±4.15 *** |
Annotate: compare with matched group,
*P＜0.05,
*P＜0.01.
The 4th part: the experimentation of sedative-hypnotic effect
One, to the influence of normal mouse autonomic activities
Experiment material
1. animal: ICR mice, body weight 18～22g, male and female dual-purpose.Beijing Vital River Experimental Animals Technology Co., Ltd. provides, animal licence numbering: SCXK (capital) 2002-0003.
2. medicine and reagent
2.1 be subjected to the reagent thing
Compound Aloe capsule: Shanghai Fuxing Linxi Medicine Industry Co., Ltd provides.Lot number: 051102
Compound method: take by weighing an amount of compound Aloe capsule, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Middle dosage group: 0.35g/Kg;
Heavy dose of group: 0.70g/Kg.
Pharmaceutical composition of the present invention.
Compound method: take by weighing an amount of pharmaceutical composition of the present invention, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Small dose group: 0.15g/Kg;
Middle dosage group: 0.30g/kg;
Heavy dose of group: 0.60g/Kg.
*Annotate: middle dosage is the clinical equivalent amount, is equivalent to 10 times of people's consumptions.
2.2 positive drug
Metoclopramide: Beijing Taiyang Pharmaceutical Co., Ltd., lot number: 050104.
Compound method: get an amount of metoclopramide sheet, be dissolved in and make suspension in the distilled water, gastric infusion, dosage are 10mg/Kg.
3. instrument
Toy autonomic activities instrument: MK-ANIMEX, Japan.
Method
Animal is divided at random: the normal control group; Large, medium and small 3 the dosage groups of pharmaceutical composition of the present invention; Big or middle 2 the dosage groups of compound Aloe capsule.Gastric infusion 3 days, administration in the 3rd day placed the autonomic activities monitor with mice after 1 hour, write down animal activity number of times, stand number of times and defecation frequency in 5 minutes.
The result
The result shows that compare with matched group, compound Aloe capsule, pharmaceutical composition of the present invention all do not have significant difference to the mice autonomic activities.The results are shown in Table 6.
The influence of table 6 pair normal central nervous system of mice (x ± s)
| Group | Dosage (g/kg) | Animal (only) | The movable number of times of number (inferior/5 minute) | The number of times (inferior/5 minute) of standing |
| In the big compound Aloe capsule of matched group compound Aloe capsule | 0.7 0.35 | 14 14 14 | 755.93±34.67 757.79±17.87 755.64±30.36 | 39.57±14.03 53.50±15.11 * 44.93±13.24 |
| The little metoclopramide of the big pharmaceutical composition Chinese medicine of pharmaceutical composition compositions | 0.6 0.3 0.15 0.01 | 14 14 14 14 | 743.79±42.06 751.00±24.31 763.14±30.55 502.64±92.89 ** | 42.43±13.12 49.79±15.50 47.29±9.87 26.07±11.90 * |
Annotate: compare with matched group,
*P＜0.05,
*P＜0.01.
Two, the influence that the pentobarbital sodium inducing mouse is slept
Experiment material
1. animal: ICR mice, body weight 19～23g, male and female dual-purpose.Beijing Vital River Experimental Animals Technology Co., Ltd. provides, animal licence numbering: SCXK (capital) 2002-0003.
2. medicine and reagent
2.1 be subjected to the reagent thing
Compound Aloe capsule: Shanghai Fuxing Linxi Medicine Industry Co., Ltd provides.Lot number: 051102
Compound method: take by weighing an amount of compound Aloe capsule, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Middle dosage group: 0.35g/Kg;
Heavy dose of group: 0.70g/Kg.
Pharmaceutical composition of the present invention:
Compound method: take by weighing an amount of pharmaceutical composition of the present invention, be dissolved in and make suspension in the distilled water, gastric infusion, administration capacity 0.2ml/10g.
Small dose group: 0.15g/Kg;
Middle dosage group: 0.30g/Kg;
Heavy dose of group: 0.60g/Kg.
*Annotate: middle dosage is the clinical equivalent amount, is equivalent to 10 times of people's consumptions.
2.2 modeling medicine
Pentobarbital sodium: Beijing chemical reagents corporation, German import packing.
Method
Animal marrow machine is divided into: the normal control group; Large, medium and small 3 the dosage groups of pharmaceutical composition of the present invention; Big or middle 2 the dosage groups of compound Aloe capsule.Gastric infusion 3 days, administration in the 3rd day be after 1 hour, and lumbar injection 0.3% penta crust are than sodium solution, 0.1ml/10g, the record sleep percentage rate (sleeping number of animals/total number of animals) and the length of one's sleep (righting reflex loss is to reappearing).
The result
The result shows, compound Aloe capsule, pharmaceutical composition of the present invention are compared with matched group, the sedation of equal showed different, show as and prolong the length of one's sleep, the sleep rate increases, the effect of compound Aloe capsule and pharmaceutical composition of the present invention does not have significant difference, but except that pharmaceutical composition of the present invention can obviously increase sleeping number of animals, all the other all with the matched group no difference of science of statistics.The results are shown in Table 7.
The influence of table 7 pair pentobarbital sedation (x ± s)
| Group | Dosage (g/kg) | Number of animals (only) | Sleep number of animals (only) | Sleep rate (%) | The length of one's sleep (min) |
| The big pharmaceutical composition Chinese medicine of the big compound Aloe capsule Chinese medicine of matched group compound Aloe capsule compositions compositions is little | 0.7 0.35 0.6 0.3 0.15 | 12 10 10 10 10 10 | 7 8 6 7 9 10 | 58.3 80.0 60.0 70.0 90.0 100 * | 10.57±8.31 14.63±6.42 14.00±3.06 12.43±7.11 9.44±10.57 8.40±5.85 |
Annotate: compare with matched group,
*P＜0.05.
Comprehensive discussion
Pharmaceutical composition of the present invention is made up of Aloe, Indigo Naturalis and succinum 3 flavor Chinese crude drugs, and Aloe has the effect of heat clearing away, relieving constipation by purgation in the side, and the compatibility Indigo Naturalis is with heat-clearing and toxic substances removing, and succinum is with tranquilizing the mind.Full side's heat-clearing and toxic substances removing, relieving constipation by purgation are calmed the nerves, and are mainly used in the constipation that the treatment excess-heat causes, irritated irritability, diseases such as palpitation with fear insomnia.
Result of the test shows, pharmaceutical composition of the present invention all has the effect that promotes defecation to the mice of dryness accumulated in the stomach and intestine constipation due to the dehydration and compound diphenoxylate constipation induced; And can promote normally to reach that the intestinal of gastrointestinal motility obstacle mice advances due to the atropine, and gastric emptying is not had obvious influence.The modern pharmacology result of study shows that contained anthraquinone derivative, especially barbaloin in the Aloe can discharge emodin etc. in intestinal, have the zest discharge function, and its main site of action is at large intestine.Pharmaceutical composition relieving constipation of the present invention is relevant with contained Aloe with short intestinal progradation, and its effect does not have significant difference with compound Aloe capsule.
In writhing test due to the acetic acid, pharmaceutical composition of the present invention can obviously prolong writhing response incubation period, reduces and turns round the body number of times, show that the said preparation Dichlorodiphenyl Acetate stimulates the pain reaction that causes that inhibitory action is arranged, and effect has a certain amount of effect relationship.Modern pharmacological research shows that Indigo Naturalis has effects such as antiinflammatory, resisting pathogenic microbes, and is inhibited to acute inflammation, may be relevant with the analgesic activity of pharmaceutical composition of the present invention, and its effect does not have significant difference with compound Aloe capsule.
Theory of Chinese medical science is thought, excess-heat and stagnant knot mutually, FU QI being obstructed, so constipation, the Liver Channel hyperactivity of fire must not catharsis, so irritated irritability, colon stomach in excess-heat is stagnant, intenseness of heat is in interior, and the turbid heat disturding the heart and mind mind causes the insomnia palpitation with fear, i.e. " stomach does not conform to then unable to sleep soundly ", clinical symptoms such as agitation, insomnia can appear in the patient.Succinum, Cinnabaris are sedative in the compound Aloe capsule prescription.This result of the test shows that pharmaceutical composition of the present invention and compound Aloe capsule all do not have obvious influence to the autonomic activities of normal mouse, but can strengthen the central inhibitory action of pentobarbital sodium to a certain extent, shows as to prolong the animal sleep time, increases the sleep rate.The above-mentioned clinical symptoms of patient there is certain improvement effect, and the no significant difference of the two effect.
In sum, pharmaceutical composition of the present invention has relieving constipation, promotes enterokinesia, calmness and analgesic to act on, and is its relieving constipation by purgation, heat-clearing and toxic substances removing, tranquilizing the mind, pharmacology's foundation of the diseases such as gastrointestinal motility miopragia in the treatment the intestines and stomach excess-heat due to the knot.
Above-mentioned result of the test shows that pharmaceutical composition of the present invention has the function of removing heat from the liver, loosening bowel to relieve constipation, and it is remarkable to be used for conscience fire Sheng, constipation, abdominal distention stomachache, irritated insomnia effect.
Claims (5)
1. the pharmaceutical composition of a relieving constipation is characterized in that, is made by the following weight Chinese medicinal raw materials:
Aloe 1-2 part, 1 part of Indigo Naturalis, 1 part of succinum.
2. the Chinese medicine preparation of a relieving constipation is characterized in that, comprises described pharmaceutical composition of the claim 1 for the treatment of effective dose and pharmaceutically acceptable carrier.
3. preparation according to claim 2 is characterized in that, said Chinese medicine preparation comprises any one pharmaceutically acceptable dosage form.
4. preparation according to claim 3 is characterized in that, is tablet, capsule, granule or pill.
5. according to claim 2,3 or 4 described preparations, it is characterized in that in the described Chinese medicine preparation, every 1g contains Aloe in barbaloin, must not be less than 20mg.
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| 卫生部药品标准中药成方制剂第十八册 药典委员会，203，卫生部 1998 * |
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