CN102641406A - Pharmaceutical composition with laxative function and application thereof - Google Patents

Pharmaceutical composition with laxative function and application thereof Download PDF

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Publication number
CN102641406A
CN102641406A CN2012101517656A CN201210151765A CN102641406A CN 102641406 A CN102641406 A CN 102641406A CN 2012101517656 A CN2012101517656 A CN 2012101517656A CN 201210151765 A CN201210151765 A CN 201210151765A CN 102641406 A CN102641406 A CN 102641406A
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pharmaceutical composition
extract
constipation
oligofructose
semen pruni
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CN2012101517656A
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邱俊生
曹正洪
吴九妹
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Flying Man (chinese) Pharmaceutical Co Ltd
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Flying Man (chinese) Pharmaceutical Co Ltd
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Abstract

The invention relates to a pharmaceutical composition with a laxative function, which is an oral preparation mainly comprising the following active ingredients in percentage by weight: 10-50% of fructooligosaccharide, 5-30% of aloe vera whole leaf powder, 10-50% of Semen pruni extract and 5-30% of American ginseng extract. Supplemented by the fructooligosaccharide capable of promoting intestinal peristalsis to strengthen the laxative effect, various drugs are compatible with each other, complement each other, and play a role in toning liver and kidney, clearing heat and moistening intestines, nourishing heart and tranquilizing mind together, so that the purpose of improving constipation is achieved, and the pharmaceutical composition is safe and non-toxic.

Description

A kind of pharmaceutical composition and application thereof with bowel relaxing functions
Technical field
The present invention relates to a kind of Chinese medicine preparation and method for preparing of bowel relaxing functions, belong to the Chinese medicine health care product field.
Background technology
Constipation is a common clinical symptoms, and clinical manifestation is the obvious minimizing of defecation frequency.Along with the quickening of rapid economy development and work and rhythm of life makes people's stress increase day by day, and the level of material life improves and also makes dietary structure become meticulous, thereby makes the sickness rate of constipation further improve.Accumulate and but the constipation primosome is endotoxic, thereby influence the body normal physiological function.
Large intestine is accepted through the small intestinal remaining food debris in back of separating the useful from the waste, and absorbing redundant moisture forms feces, per anum and get rid of external." element asks LINGLAN secret allusion quotation opinion " said: " large intestine person, the palace of conduction change here ".This function of large intestine is the extension of the turbid descending function of stomach, simultaneously falls relevant with lung respectful.Not normal like large intestine conduction, the ANOMALOUS VARIATIONS of can occur defecating matter, amount and number of times is like constipation etc.Chinese medicine is thought: large intestine loses in conduction and causes constipation etc., can be by the bright excess-heat dryness accumulated in the stomach and intestine of sun, and gastric qi descends, and the lung qi heap soil or fertilizer over and around the roots is contained in losing clear respectful causing down; Also can not transported by yang deficiency, a little less than the middle deficiency of vital energy, intestinal juice factor such as dry up causes.If it is not smooth unfavorable that large intestine conducts, the QI-blood circulation of retardance large intestine passages through which vital energy circulates, the then long-pending for a long time stasis of blood becomes hemorrhoid.If damp and hot the knot in large intestine, ying-qi is not all right, and is contrary in meat, defends gas and return and must not return, and then can make meromyarian natural fibre line of meat generation swelling pain, so that meat corruption pus, and acute appendicitis takes place.
And, often adopt cathartic such as emodin, thereby zest is arranged and have side effects at present to the Chinese medicine of constipation; Child old man is difficult to tolerance; And take the easy dependency that forms for a long time, serious constipation can occur after the drug withdrawal, make the state of an illness characteristics of refractory occur reaching repeatedly.Therefore seek action temperature and treatment constipation medicine have the important clinical meaning.And the present invention treat constipation have action temperature with lasting, side effect is little, and the mechanism of action is many target spots, manifold effect, multi-functional comprehensive function often.
Summary of the invention
The objective of the invention is in order to overcome the deficiency in the background technology, and a kind of good effect of development, gentle lasting, the little pharmaceutical composition with bowel relaxing functions of side effect.
To achieve these goals; The technical scheme that the present invention adopts is: a kind of pharmaceutical composition with bowel relaxing functions is characterized in that said preparation is is the oral formulations that active ingredient is processed with oligofructose, aloe full leaf dried powder, Semen Pruni extract Radix Panacis Quinquefolii extract; Wherein the active ingredient percentage by weight consists of: oligofructose 10-50%, aloe full leaf dried powder 5-30%, Semen Pruni extract 10-50%, Radix Panacis Quinquefolii extract 5-30%.
Optimized technical scheme of the present invention is that a kind of pharmaceutical composition with bowel relaxing functions is characterized in that primary raw material consists of: oligofructose 20-35%, aloe full leaf dried powder 5-10%, Semen Pruni extract 10-20%, Radix Panacis Quinquefolii extract 10-15%.
The present invention is characterized in that wherein said oral formulations is that medically acceptable various dosage forms comprise tablet, capsule, granule or oral liquid.Chinese medicine active ingredient extract mixes, and processes tablet, capsule, granule, drop pill or oral liquid by routine operation method and pharmaceutic adjuvant.
Described pharmaceutical composition is used in the health food of the auxiliary bowel relaxing functions of preparation.
The present invention is according to the dialectical Cheng Fang of Traditional Chinese medical theory, and Aloe heat clearing away in the side, relieving constipation, parasite killing are returned liver, the heart, spleen channel.Traditional medicine thinks that Aloe has catharsis action temperature and, advantage such as easy to use and acceptant.Aloe is main hydroxyl anthraquinone derivatives, it is reported that Aloe can discharge aloe-emodin at intestinal, performance zest discharge function; Possible mechanism is to promote enterokinesia and increase enteric cavity moisture; And main site of action stimulates the mucus secretion at large intestine, performance catharsis effect.Semen Pruni acrid in the mouth, sweet, bitter, property is flat.Main spleen, large intestine, the small intestine meridian of returning.These article are hot can manage it diffusingly, and the family of the victim in a murder case will let out, and sweet lubricated profit is longer than the stagnation of QI of leading large intestine, lubricates the dry puckery of large intestine and relieving constipation, can manage it the aqueous vapor of whole body again, so have the effect of loosening bowel to relieve constipation, inducing diuresis to remove edema.Clinically with its treatment stagnation of QI dryness of the intestine constipation.Radix Panacis Quinquefolii: cloudy, the clear asthenic fire of lung benefiting, promoting the production of body fluid to quench thirst, GUIXIN, lung, kidney channel.Can participate in serum, bone marrow, internal organs, the synthetic lipid metabolism that reaches of brain internal protein.The present invention is aided with the oligofructose that promotes intestinal peristalsis promoting to strengthen defecating feces excretion, and all medicine compatibilities bring out the best in each other, and play liver-regulating and kidney-nourishing, clearing away heat and moistening the bowels, mind tranquilizing and the heart calming effect altogether, thereby reach the purpose of improving constipation.
The specific embodiment
Chinese medicine generally is divided into two big types of constipation of excess type and constipation due to insufficiency with constipation, and wherein constipation of excess type can be subdivided into functional constipation and constipation due to disorder of QI again, and constipation due to insufficiency can be subdivided into that the deficiency of vital energy is secret, hematasthenic constipation, the deficiency of YIN is secret, yang deficiency is secret etc.Chinese medicine thinks that its generation is relevant with factors such as age, diet, heredity, body constitution, and is all in close relations with the heart, liver, spleen, lung, kidney the five internal organs.
The inventor is in tcm clinical practice and drug research decades, and the treatment patient has invented this combination of oral medication up on ten thousand person-times of bases surplus 20.
Through concrete embodiment technical scheme of the present invention is further described below, the embodiment that wherein gives an example only is to explanation of the present invention, and can not limit protection scope of the present invention by any way.
Embodiment 1
Prescription: oligofructose 180g, aloe full leaf dried powder 150g, Semen Pruni extract 85g (quite Semen Pruni 500g), Radix Panacis Quinquefolii extract 20g (quite Radix Panacis Quinquefolii 300g), dextrin 12.5g, magnesium stearate 2.5g.Raw materials mix is even, sieves, and pours into capsule, makes 1000 of capsules.Specification usage and dosage: 450mg/ grain, every day twice, each three, 2800mg/ days, 60/bottle.
Embodiment 2
Prescription: oligofructose 200g, aloe full leaf dried powder 100g, Semen Pruni extract 75g, Radix Panacis Quinquefolii extract 30g, dextrin 12g, magnesium stearate 2g.Raw materials mix is even, adds suitable adjuvant dextrin, magnesium stearate, sieves, and tabletting makes tablet.
Embodiment 3
Prescription: oligofructose 150g, aloe full leaf dried powder 100g, Semen Pruni extract 75g, Radix Panacis Quinquefolii extract 10g.Add suitable adjuvant dextrin, magnesium stearate, sieve, granulate, make granule.
Embodiment 4
Semen Pruni extract obtains through following manner: Radix Salviae Miltiorrhizae adds 8-10 times of weight water decocting and boils 2-3 time, and during each 1-2, density is 1.16 extractum when being concentrated into 65 ℃, obtains Semen Pruni extract.
Radix Panacis Quinquefolii extract obtains through following manner: Radix Salviae Miltiorrhizae adds 8-10 times of weight water decocting and boils 2-3 time, and during each 1-2, density is 1.16 extractum when being concentrated into 65 ℃, obtains Radix Panacis Quinquefolii extract.
Each raw material is prepared by following percentage by weight: oligofructose 10%, aloe full leaf dried powder 15%, Semen Pruni extract 45%, Radix Panacis Quinquefolii extract 25%.An amount of dextrin, magnesium stearate, raw materials mix is even, adds suitable adjuvant dextrin, magnesium stearate, sieves, and pours into capsule, makes capsule.
For ease of contrast, below embodiment is represented with form, each raw materials by weight meter, and all be equipped with an amount of adjuvant and make corresponding dosage form
Embodiment 5 6 7 8 9 10 11 12 13 14
Oligofructose 10 50 30 40 25 35 45 15 20 28
Aloe full leaf dried powder 30 15 10 5 20 25 16 22 32 28
Semen Pruni extract 15 30 50 10 35 20 25 40 15 45
Radix Panacis Quinquefolii extract 20 30 5 10 8 15 35 25 9 18
Dosage form Capsule Tablet Granule Granule Tablet Oral liquid Tablet Capsule Capsule Oral liquid
Preparation active ingredient quantitative criterion total saponins of the present invention is measured 2.0g/100g according to the method for " mensuration of total saponins in the health food " in " health food check and assessment technique standard " (version in 2003); Oligofructose carries out oligofructose 10-20g/100g according to the related request of " QB 2154-1995 food additive oligofructoses ".
The present invention to the oral dose of bowel relaxing functions Chinese medicine preparation is: 2-3g/ day.30 days courses of treatment.
Pharmacological evaluation proves:
Preparation of the present invention (round trip flight people board relieving constipation capsule) is tested observation through pharmacodynamics test and is found the influence and the negative control group of mice with constipation defecation character and enterokinesia are compared; Low concentration medication group can increase just quantity of mice with constipation dehumidifying (P < 0.05); And compare between the middle low concentration group, both difference between the effects do not have significance (P>0.05).With the blank group relatively, high, in or low concentration medication group all can improve the propelling percentage rate (P < 0.05) of mice with constipation enterokinesia, and the effect of high concentration medication group more obvious (P < 0.05).See table 1.
Table 1: the present invention is to the influence (
Figure 993359DEST_PATH_IMAGE001
± s) of mice defecation and enterokinesia
Figure 2012101517656100002DEST_PATH_IMAGE001
Annotate: * and all the other groups be P < 0.05 relatively; ▲ compare P < 0.05 with blank control group; △ and low concentration
Compare P < 0.05
Above result shows: this tried thing can reduce intestinal wall absorb moisture and action temperature with, have effect of relaxing bowel.
Acute toxicity test
Carry out acute toxicity test, bone marrow cell micronucleus test, sperm malformation test, Salmonella reversion test and 30d feeding trial according to toxicological evaluation program and method.Result: its mouse oral MTD>20.0g/kg.BW (recommended amounts is 0.05g/kg.bw), belong to non-poisonous material; Bone marrow cell micronucleus test, sperm malformation test and Salmonella reversion test result are all negative; The equal no abnormality seen of each item index in 30 feeding trials.Following table explanation the present invention does not have obvious influence to organ weights and the organ coefficient of animal.Acute toxicity test proves that pharmaceutical composition of the present invention is not observed toxicity.
Table 2: the present invention to the influence of Rats Organs and Tissues weight (x ± s, n=10)
Figure 2012101517656100002DEST_PATH_IMAGE002
Visible by table 3, the liver,kidney,spleen of each dose groups animal, the weight of gonad and matched group comparing difference not statistically significant explain that the present invention's organ weights and organ coefficient to animal under this experimental condition all do not have obvious influence.
Pharmaceutical composition of the present invention is constipation relieving effectively, and does not observe toxic reaction through the acute toxic reaction test, explains that pharmaceutical composition of the present invention is safely and effectively.
The present invention compares with existing preparation, has following advantage, and pharmaceutical composition of the present invention is not for containing the pure Chinese medicinal preparation of toxicity medical material, and it is obvious to have curative effect, action temperature and the characteristics that continue, have no side effect.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.Below, foregoing of the present invention is remake further detailed description through the specific embodiment of embodiment form.But should this be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following instance.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.

Claims (4)

1. pharmaceutical composition with bowel relaxing functions is characterized in that said preparation is is the oral formulations that active ingredient is processed with oligofructose, aloe full leaf dried powder, Semen Pruni extract, Radix Panacis Quinquefolii extract; Wherein the active ingredient percentage by weight consists of: oligofructose 10-50%, aloe full leaf dried powder 5-30%, Semen Pruni extract 10-50%, Radix Panacis Quinquefolii extract 5-30%.
2. the pharmaceutical composition with bowel relaxing functions according to claim 1 is characterized in that primary raw material consists of: oligofructose 20-35%, aloe full leaf dried powder 5-10%, Semen Pruni extract 10-20%, Radix Panacis Quinquefolii extract 10-15%.
3. pharmaceutical composition according to claim 2 is characterized in that wherein said oral formulations is that medically acceptable various dosage forms comprise tablet, capsule, granule or oral liquid.
4. according to of medicine and the application in health food of each described pharmaceutical composition of claim 1~3 at the preparation bowel relaxing functions.
CN2012101517656A 2012-05-17 2012-05-17 Pharmaceutical composition with laxative function and application thereof Pending CN102641406A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103719669A (en) * 2014-01-02 2014-04-16 广东仙乐制药有限公司 Soft capsule for relieving constipation
CN103960710A (en) * 2014-03-19 2014-08-06 景颖 Health care soup for relieving gastrointestinal reactionafterchemotherapy of tumor patient as well as preparation method
CN105012575A (en) * 2014-04-28 2015-11-04 浙江金诺康生物制药有限公司 Composition for treating constipation and application thereof
CN105853672A (en) * 2016-03-15 2016-08-17 双飞人制药股份有限公司 Composition with bowel-relaxing function and preparation method thereof
CN105920180A (en) * 2016-04-21 2016-09-07 哈药集团中药二厂 Health food with efficacy of relaxing bowel and preparation method of health food
CN109125565A (en) * 2018-09-28 2019-01-04 福建省中科生物股份有限公司 A kind of composition with function of relaxing bowel

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101103811A (en) * 2007-08-09 2008-01-16 修正药业集团股份有限公司 Health food capable of relaxing the bowels

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101103811A (en) * 2007-08-09 2008-01-16 修正药业集团股份有限公司 Health food capable of relaxing the bowels

Non-Patent Citations (2)

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Title
侯士良: "《中药八百种详解》", 30 April 1999, article "郁李仁", pages: 286-287 *
宋明侠: "高效液相色谱-蒸发光散射检测器测定芦荟西洋参软胶囊中的芦荟苷和人参皂苷Rb1、Rg1和Re含量", 《按摩与康复医学》, vol. 2, no. 1, 31 January 2011 (2011-01-31), pages 3 - 1 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103719669A (en) * 2014-01-02 2014-04-16 广东仙乐制药有限公司 Soft capsule for relieving constipation
CN103960710A (en) * 2014-03-19 2014-08-06 景颖 Health care soup for relieving gastrointestinal reactionafterchemotherapy of tumor patient as well as preparation method
CN105012575A (en) * 2014-04-28 2015-11-04 浙江金诺康生物制药有限公司 Composition for treating constipation and application thereof
CN105853672A (en) * 2016-03-15 2016-08-17 双飞人制药股份有限公司 Composition with bowel-relaxing function and preparation method thereof
CN105920180A (en) * 2016-04-21 2016-09-07 哈药集团中药二厂 Health food with efficacy of relaxing bowel and preparation method of health food
CN109125565A (en) * 2018-09-28 2019-01-04 福建省中科生物股份有限公司 A kind of composition with function of relaxing bowel

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Application publication date: 20120822