CN102274394A - Chinese medicinal composition for treating postnatal constipation - Google Patents
Chinese medicinal composition for treating postnatal constipation Download PDFInfo
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Abstract
The invention provides a Chinese medicinal composition for treating postnatal constipation, which is prepared from 490 to 600 parts of Chinese angelica, 215 to 325 parts of mulberry, 270 to 380 parts of fructus cannabis, 270 to 380 parts of polygonum multiflorum, 160 to 270 parts of dwarf lilyturf tuber, 210 to 330 parts of root of rehmannia, 160 to 270 parts of snakegourd seeds, 210 to 330 parts of peach kernel and 160 to 270 parts of large head atractylodes rhizome, wherein the components are derived from Chinese medicinal materials or Chinese medicinal extracts in amounts which are equivalent to the raw doses of the Chinese medicinal materials. The invention also provides the preparation method of the Chinese medicinal composition for treating postnatal constipation. The Chinese medicinal composition provided by the invention is pure Chinese medicinal preparation prepared by leaching nine Chinese medicines and refining the extracts, does not contain irritative purgating medicines, can greatly improve postnatal constipation, deficiency of qi and blood and other symptoms, has exact treatment effect, and is safe and effective.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, a kind of specifically Chinese medicine composition for the treatment of puerperal constipation.
Background technology
Puerperal constipation is a kind of common gynecological disease, and sickness rate is higher, and China has 5000～6,000 ten thousand trouble approximately.Puerperal constipation not only brings misery to the patient, and can not in time get rid of and cause enteral ecological deterioration, gastrointestinal function disorder owing to vivotoxin, causes endocrine disturbance, metabolic disturbance afterwards, also might cause various diseases.
The Chinese medicine of traditional treatment constipation contains cathartic drug mostly, though the effect of loosening bowel to relieve constipation is obvious, but there is not tangible QI invigorating nourishing blood function, 200410092757.4 the Chinese patent that is as application number discloses a kind of Chinese medicine for the treatment of constipation, and this kind Chinese medicine comprises: 40～60 parts of Radix Angelicae Sinensis, 50～70 parts of Herba Cynomoriis, 15～25 parts of Huang Shi, 80～100 parts of Fructus Cannabiss and 15～20 parts of Radix Et Rhizoma Rhei.Though this Chinese medicine has the short treating period fast characteristics of fruit that take effect for constipation, but it contains purgatives medicine composition excitatory such as Radix Et Rhizoma Rhei, postpartum women is insufficiency of vital energy and blood originally, taking this kind Chinese medicine easily feels frustrated, the situation of insufficiency of vital energy and blood is further deepened, and the Radix Et Rhizoma Rhei in this kind Chinese medicine is the medicine that has women breast-feeding their children to forbid, and is unsuitable for postpartum women and takes.
Summary of the invention
The inventor comes from theory of Chinese medical science, sums up experience in many ways, cuts out through the clinical practice empirical to form.The object of the present invention is to provide a kind of medicine for the treatment of the Chinese medicine of puerperal constipation and comprising said composition, this Chinese medicine composition and medicine do not contain irritant cathartic, and have the effect of enriching blood for moistening the intestine, are applicable to that the puerperal constipation women takes.
The present invention also aims to provide manufacturing method for above mentioned medicine, by this method, can obtain being used for the treatment of that puerperal constipation is evident in efficacy, sophisticated technologies, stay-in-grade pharmaceutical composition.
The present invention also aims to provide the application of above-mentioned Chinese medicine composition in the medicine of preparation puerperal constipation.
In order to reach above purpose, the invention provides a kind of Chinese medicine composition for the treatment of puerperal constipation, comprise: 490 parts～600 parts Radix Angelicae Sinensis, 215 parts～325 portions Fructus Moris, 270 parts～380 parts Fructus Cannabiss, 270 parts～380 parts Radix Polygoni Multiflori, 160 parts～270 parts Radix Ophiopogonis, 210 parts～330 parts Radix Rehmanniae, 160 parts～270 parts Semen Trichosanthis, 210 parts～330 parts Semen Persicaes and 160 parts～270 parts Rhizoma Atractylodis Macrocephalaes, the source of described component is Chinese medicine medical material or the Chinese medicine extract that is equivalent to above-mentioned Chinese crude drug crude drug amount.
Preferably, described Chinese medicine composition comprises: 495 parts～595 parts Radix Angelicae Sinensis, 220 parts～320 portions Fructus Moris, 275 parts～375 parts Fructus Cannabiss, 275 parts～375 parts Radix Polygoni Multiflori, 165 parts～265 parts Radix Ophiopogonis, 220 parts～320 parts Radix Rehmanniae, 165 parts～265 parts Semen Trichosanthis, 220 parts～320 parts Semen Persicaes and 165 parts～265 parts Rhizoma Atractylodis Macrocephalaes.
The cause of disease of puerperal constipation mainly is the thin fluid injury in puerperal, and intestinal loses profit, or the plain official report deficiency of vital energy, and because of the product yang-energy is more hindered, the unable propelling movement stool of the deficiency of vital energy in the constipation intestinal, is stopped up under the difficulty that stagnates.Can be divided into the blood deficiency dryness of the intestine according to its clinical manifestation, hyperactivity of fire caused by deficiency of YIN, three types of deficient qi and bloods.Chinese medicine composition prescription of the present invention at the main pathogenesis of puerperal constipation, is a monarch drug with Radix Angelicae Sinensis and Fructus Mori, in order to nourishing blood to promote the production of body fluid, loosening bowel to relieve constipation rationally; With Radix Polygoni Multiflori, Fructus Cannabis is ministerial drug, and nourishing YIN and benefiting blood is arranged, and strengthens the merit of loosening bowel to relieve constipation; With Radix Ophiopogonis, Radix Rehmanniae, Semen Trichosanthis, Semen Persicae and the Rhizoma Atractylodis Macrocephalae is adjuvant drug, sails a boat in order to increase liquid, and intestine moistening is logical deep and remote, the blood circulation promoting and blood stasis dispelling of holding concurrently, and spleen invigorating helps fortune.Monarch, minister, adjuvant drug are coordinated mutually, reach the effect that intestine moistening is enriched blood.
Radix Angelicae Sinensis sweet in the mouth, suffering, sweet in the mouth can be mended, and Xin Wen can loose, and is the key medicine of invigorating blood circulation of enriching blood; Warm in nature and the matter of Radix Angelicae Sinensis profit is moisturized laxation.The merit of selecting its blood enriching and dryness moistening relieving constipation for use of Radix Angelicae Sinensis, and become silted up puerperal, Radix Angelicae Sinensis has the energy of blood circulation promoting and blood stasis dispelling concurrently. more" Compendium of Materia Medica is equipped with medicine " claims Radix Angelicae Sinensis " stasis can be led to, and blood deficiency can be mended, and blood depletion can be moistened, and blood disorderly can be held up ".Described as " book on Chinese herbal medicine is through hundred kinds of records ": " Radix Angelicae Sinensis is hot fragrant gentle, and this number of holding concurrently is long, real medicine for nourishing blood." the cold in nature and matter of Fructus Mori sweet in the mouth profit, be longer than nourishing YIN and supplementing blood, the intestine moistening of promoting the production of body fluid.Two medicines have share the merit of nourishing blood to promote the production of body fluid, loosening bowel to relieve constipation, have the energy of blood circulation promoting and blood stasis dispelling concurrently, are applicable to the disease of blood deficiency difficulty in defecation in puerperal.
The Radix Polygoni Multiflori sweet in the mouth is cool in nature, slow the letting out of enriching blood, " herbal classic is met the source " record: " Radix Polygoni Multiflori give birth to then property is double disperses ", " moderns control the dry and large intestine constipation due to pathogenic wind of Tianjin blood depletion, and are promptly logical with the bright person decoction that counts out money, with the property steepest of its taste water ".The Fructus Cannabis sweet in the mouth is flat, and matter oiliness profit is longer than loosening bowel to relieve constipation and is had the tonify deficiency effect concurrently, and all blood deficiency Tianjin lacks constipation, should use it.Two medicines have share the energy that promotes the production of body fluid and enrich blood, and with Radix Angelicae Sinensis mutually 5, the power of enriching blood wins, and the prosperous row of QI and blood is with the power of principal drug assistance.
Body fluid can carry QI, qi promoting blood production, QI can promote blood circulation.The monarch and his subjects are furnished with promote the production of body fluid and nourish blood wonderful mutually, promote the production of body fluid to have more the merit of intestine moistening.
Radix Ophiopogonis, Radix Rehmanniae are the product of promoting production of body fluid with drugs sweet in flavor and cold in nature, have to promote the production of body fluid with it and moisturize, and increase the merit that liquid is sailed a boat; The sweet Han Run of Semen Trichosanthis falls, but last removing heat from the lung and dissipating phlegm, but following loosening bowel to relieve constipation; The bitter sweet property of Semen Persicae is flat, hardship is then fallen and is rushed down with blood stasis expelling, sweet can with smooth QI and blood with tissue regeneration promoting, its body heavy wool fat merit again is apt to moisturize laxation, is applicable to the blood deficiency and depleted fluid constipation, and Shennong's Herbal is said: " main congestion; blood closes addiction ", " medicine origin " meaning " can benefiting blood and regulating blood circulation " is with Radix Angelicae Sinensis and Fructus Cannabis mutually 5, the power victory of intestine moistening; Rhizoma Atractylodis Macrocephalae sweetness and bitterness and temperature, sweet spleen reinforcing, in the gentleness, bitter dampness is the key medicine of vigorate qi and replenish the blood, and replenishing QI to invigorate the spleen can help fortuneization, makes the large intestine conduction multiple normal, and the prosperous stomach Xingqi body fluid that can be of spleen is to remove dryness of the stomach, loosening bowel to relieve constipation.
Medicine has the speciality of individual character, there is sociable magical effect the side, Chinese medicine composition of the present invention place is at the main pathogenesis of puerperal constipation, with Radix Angelicae Sinensis and Fructus Mori is monarch drug, with Radix Polygoni Multiflori, Fructus Cannabis is that ministerial drug is in order to nourishing blood to promote the production of body fluid, loosening bowel to relieve constipation, with Radix Ophiopogonis, Radix Rehmanniae, Semen Trichosanthis, the Semen Persicae and the Rhizoma Atractylodis Macrocephalae are adjuvant drug, avoid Radix Et Rhizoma Rhei, bitter colds such as Folium Sennae are cut down the removing the pathogens intensely product, and all medicines share, enriching blood and promoting secretion of body fluid, relieving constipation and not feeling frustrated, promote the production of body fluid and nourish blood, special from the blood enriching and dryness moistening angle of effecting a permanent cure, main diving with the flavor of enriching blood for moistening the intestine laxation, hold concurrently simultaneously to consider and become silted up puerperal more, feelings such as the deficiency of vital energy are suitable for treating women's puerperal constipation.
Chinese medicine composition of the present invention is through extracting refining pure Chinese medicinal preparation by nine flavor Chinese medicines, and do not contain irritating purgatives medicine, can improve puerperal constipation greatly, symptoms such as insufficiency of vital energy and blood, and determined curative effect, safe and effective, this medicine also can be used for the senile weakness constipation of treatment operation back blood deficiency and constipation simultaneously.
The present invention also provides a kind of medicine for the treatment of puerperal constipation, and it comprises above-mentioned Chinese medicine composition and pharmacy acceptable auxiliary, and the content of this medicament ferulic acid is at least 0.12mg/g.
Above-mentioned pharmaceutical preparation can be any dosage form, is preferably granular pattern, capsule formulation, tablet form, oral liquid, injection, pill or powder.
Preferably, described tablet form is dispersible tablet, effervescent tablet, chewable tablet or slow releasing tablet.
Preferably, described capsule formulation is soft wafer, hard wafer or microcapsule.
Experiment showed, existing Chinese patent medicine (as MARENJIAONANG) for existing treatment constipation, the medicine relieving constipation curative effect of treatment puerperal constipation provided by the invention is obvious, and by comparison, medicine of the present invention more has the curative effect of enriching blood concurrently, is applicable to that puerperal, the blood deficiency women took.
The present invention also provides a kind of manufacturing method for above mentioned medicine, comprising:
A, Fructus Cannabis powder, Peach Seed, Semen Trichosanthis powder and Radix Polygoni Multiflori powder will be obtained behind Fructus Cannabis, Semen Persicae, Semen Trichosanthis and the Radix Polygoni Multiflori pulverize separately;
B, Fructus Cannabis powder, Peach Seed and Semen Trichosanthis powder are mixed the back alcohol extraction with Radix Angelicae Sinensis, it is 1.16～1.22 extractum that alcohol extract is concentrated into relative density, collects the alcohol extraction medicinal residues;
C, will the Radix Polygoni Multiflori powder, Fructus Mori, Radix Rehmanniae, the Rhizoma Atractylodis Macrocephalae and mix the back Radix Ophiopogonis and obtain volatile oil through water distillation and extraction earlier, getting the water liquid that extracts behind the volatile oil and medicinal residues carries out first time water and carries, collect water extract and water and carry medicinal residues, carry out second time water after water carried medicinal residues and the alcohol extraction medicinal residues mix and carry, merging twice water extract and being concentrated into relative density is 1.25～1.30 herbal decoction;
D, described extractum, volatile oil and herbal decoction are mixed.
Preferably, also comprise: use ethanol as solvent the volatile oil that step c obtains, make volatile oil clathrate compound with the beta-schardinger dextrin-inclusion.
Preferably, also comprise: described extractum and herbal decoction are mixed, add adjuvant after drying, pulverizing; Wrap oily conjugate with described volatilization again and correctives mixing, granulation, drying obtain described medicine.
The present invention also provides the application of above-mentioned Chinese medicine composition in the medicine of preparation puerperal constipation.
The clinical dosage of medicine granule of the present invention is recommended as 18g/ people/day.
Experiment showed, that Chinese medicine composition of the present invention has positive effect to improve to puerperal constipation, and have the effect of enriching blood concurrently, the result of II clinical trial phase shows determined curative effect, and is safe and effective, and long-time stability are investigated and also shown, Chinese medicine composition steady quality of the present invention, reliable.
The specific embodiment
In order further to understand the present invention, below in conjunction with embodiment the preferred embodiment of the invention is described, but should be appreciated that these describe just to further specifying the features and advantages of the present invention, rather than to the restriction of claim of the present invention.The Chinese medicine of the described employing of Chinese medicine composition that following examples are used is the medical material that version pharmacopeia in 2005 is recorded, and through identifying, every index all meets the pharmacopeia regulation.
Embodiment 1
The Chinese medicine composition prescription that present embodiment provides:
Radix Angelicae Sinensis 4.54kg Fructus Mori 2.25kg Fructus Cannabis 2.71kg
Radix Polygoni Multiflori 2.71kg 1.79kg Radix Ophiopogonis Radix Rehmanniae 2.25kg
Semen Trichosanthis 1.79kg Semen Persicae 2.25kg Rhizoma Atractylodis Macrocephalae 1.79kg
Preparation method comprises the steps:
1, Fructus Cannabis powder, Peach Seed, Semen Trichosanthis powder and Radix Polygoni Multiflori powder will be obtained behind Fructus Cannabis, Semen Persicae, Semen Trichosanthis and the Radix Polygoni Multiflori pulverize separately.
2, with Fructus Cannabis powder, Peach Seed and Semen Trichosanthis powder and the volumetric concentration that adds 3.5 times of amounts after Radix Angelicae Sinensis mixes be 95% alcoholic solution reflux, extract, 2 hours, filter, the volumetric concentration that medicinal residues add 2.5 times of amounts is 95% alcoholic solution reflux, extract, 1 hour, it is standby to filter collection alcohol extraction medicinal residues, the alcohol extract of twice alcohol extraction is merged the back decompression recycling ethanol, under 55 ℃～65 ℃, the condition of vacuum 0.07Mpa～0.08MPa, concentrate again, obtain relative density and be 1.19 extractum 3.49kg.
3, Radix Polygoni Multiflori powder, Fructus Mori, Radix Rehmanniae, the Rhizoma Atractylodis Macrocephalae and Radix Ophiopogonis are mixed the back and obtain volatile oil through water distillation and extraction earlier, and be encapsulated with for use with the 0.6kg beta-schardinger dextrin-, the inclusion temperature is 40 ℃, the amount of water of every milliliter of volatile oil is 200 milliliters, cold preservation 12 hours, filter collection solid, baking temperature is 50 ℃; Getting the water liquid that extracts behind the volatile oil and medicinal residues adds 6 times of water gagings and carries out first time water and carry, the time that the first time, water was carried is 2 hours, collect water extract and water and carry medicinal residues, adding 5 times of water gagings after water carried medicinal residues and the alcohol extraction medicinal residues mix carries out second time water and carries, the time that the second time, water was carried is 1 hour, merge twice water extract and under 55 ℃～65 ℃, the condition of vacuum 0.07Mpa～0.08MPa, concentrate, obtain relative density and be 1.27 herbal decoction 7.85kg.
4, with above-mentioned extractum with after herbal decoction is mixed, add the dextrin mix homogeneously, pulverize after placing 70 ℃ of vacuum dryings, with the Benexate Hydrochloride mixing, add 1.2kg sucrose, 0.82kg lactose mixing, be 2% PVP and 91% alcoholic solution granulation with volumetric concentration, dry, be packaged into bag with aluminum-plastic composite membrane, every bag of 6g promptly gets granule dosage form finished product.
As required, the present invention also can be prepared into the oral type medicament of other types, and preparation technology is as follows:
(1) tablet
The extractum that step 2 is made makes herbal decoction with step 3 to be mixed, and each recipe quantity compound adds dextrin or other binding agents, and fully mixing places 60 ℃～80 ℃, and vacuum is dry under the condition of 0.07Mpa～0.09Mpa, pulverizes; Mixed with volatile oil or its clathrate that said method makes, also can add correctives as required as required, add suitable amount of adhesive and disintegrating agent mixing, granulate, drying adds moderate lubrication agent, disintegrating agent mixing again, tabletting also can carry out film coating, promptly as required.
(2) capsule
The extractum that step 2 is made makes herbal decoction with step 3 to be mixed, and each recipe quantity compound adds dextrin or other binding agents, abundant mixing, and drying is pulverized; Granulate behind the volatile oil that makes with said method or its clathrate, correctives such as steviosin and an amount of filler mixing, drying, incapsulate, promptly.
(3) oral liquid
The extractum c that b is made makes herbal decoction and volatile oil mixing, adds correctives such as sucrose, sodium citrate and/or antiseptic, and is static, draws supernatant, fill, promptly.
(4) pill
The extractum that step 2 is made makes herbal decoction with step 3 to be mixed, and each recipe quantity compound adds dextrin or other binding agents, abundant mixing, and drying is pulverized; The volatile oil or the abundant mixing of its clathrate that make with said method add that Mel, water, Cera Flava, rice flour or rice are stuck with paste and make according to the preparation method of other conventional pills, get final product.
Need to prove, contain the effective ingredient volatile oil clathrate compound that relates in the various drug forms of Chinese medicine composition of the present invention, it also can be the volatile oil without inclusion, its mechanism of action is identical with drug effect, because the physico-chemical property of volatile oil itself, in conjunction with the process characteristic of preparation, the present invention preferably adopts volatile oil clathrate compound, more preferably the clathrate that obtains after the beta-schardinger dextrin-inclusion of volatile oil.
According to this area routine techniques, compositions of the present invention also can be made into injection, powder etc., and its processing step is routine operation, and visual medical material situation difference takes the circumstances into consideration to change process conditions, and it is conventionally known to one of skill in the art.At the difference of needed product, the preparation process of medicine of the present invention also can be different, but are the common practise preparation process, describe no longer one by one.
Embodiment 2
Prescription:
Radix Angelicae Sinensis 4.14kg Fructus Mori 2.15kg Fructus Cannabis 2.71kg
Radix Polygoni Multiflori 2.75kg 1.80kg Radix Ophiopogonis Radix Rehmanniae 2.30kg
Semen Trichosanthis 1.82kg Semen Persicae 2.25kg Rhizoma Atractylodis Macrocephalae 1.89kg
Preparation method: with embodiment 1.
Embodiment 3
Prescription:
Radix Angelicae Sinensis 4.74kg Fructus Mori 2.55kg Fructus Cannabis 2.51kg
Radix Polygoni Multiflori 2.65kg 1.65kg Radix Ophiopogonis Radix Rehmanniae 2.10kg
Semen Trichosanthis 1.65kg Semen Persicae 2.20kg Rhizoma Atractylodis Macrocephalae 1.89kg
Preparation method: with embodiment 1.
In the above-mentioned preferred embodiment, the design of the concrete parameter of preparation technology's circuit is according to different Chinese medicine character and pharmacological action difference, definite with screening by analysis optimization technology.The optimum technology parameter of alcohol-extracting technology is to be index with paste-forming rate, petroleum ether extractum rate and the ferulic acid rate of transform, adopts three factors, three water-glasses to carry out that orthogonal test determines.The optimum technology parameter of water extraction technical conditions is to be index with herbal decoction yield and stilbene glucoside, adopts three factors, three water-glasses to carry out that orthogonal test determines.
The inspection of arsenic salt and heavy metal in the medicine of the present invention: according to one one of Chinese Pharmacopoeia version in 2005, the regulation under appendix IXE, the IXF item checks that to arsenic salt and heavy metal in the pharmaceutical composition of embodiment 1 to 3 preparation the result is in prescribed limit.
The thin layer chromatography that provides with reference to an appendix V of Chinese Pharmacopoeia version in 2005 I B detects the medicine that embodiment 1 to 3 prepares, wherein Radix Angelicae Sinensis effective ingredient content of ferulic acid detects according to high-efficient liquid phase technique, in medicine of the present invention, every gram medicament contg should be at least 0.12mg/g; The microbial limit test that provides with reference to Chinese Pharmacopoeia appendix X III C detects the medicine that embodiment 1 to 3 prepares; The medicine that the method that provides with reference to an appendix I of Chinese Pharmacopoeia version in 2005 C prepares embodiment 1 to 3 carries out melting and detects; Detect with reference to the medicine of an appendix IX of Chinese Pharmacopoeia version in 2005 H aquametry to embodiment 1 to 3 preparation, above-mentioned testing result is all listed in table 1.
The drug quality testing result of table 1 embodiment 1 to 3 preparation
Above result shows: composition granule provided by the invention meets the pertinent regulations under the granule item among appendix IC of Chinese Pharmacopoeia version in 2005.
The pharmacology pharmacodynamic test
Experimental drug and reagent:
1). the enriching blood for moistening the intestine granule: the enriching blood for moistening the intestine granule of the embodiment of the invention 1 preparation, the clinical recommendation consumption of people is 18g/ people/day.Press the body surface area conversion, 4 times of high doses with the human equivalent as laboratory animal, in, low dosage is that geometric ratio is successively decreased with 2, the high, medium and low dosage of mice is respectively 20.8g/kg, 10.4g/kg, 5.2g/kg, administration concentration is respectively 1.04g/ml, 0.52g/ml, 0.26g/ml, and the administration volume is 20ml/kg; The high, medium and low dosage of rat is respectively 14.4g/kg, 7.2g/kg, 3.6g/kg, and administration concentration is respectively 1.44g/ml, 0.72g/ml, 0.36g/ml, and the administration volume is 10ml/kg.Medicine is prepared with distilled water, puts refrigerator and cooled and hide to preserve, and faces the time spent to shake up.
2). MARENJIAONANG: provide lot number by Hunan Province Le Bang pharmaceutical Co. Ltd: 20030109.The mice dosage is 0.73g/kg in the experiment, and concentration is made into 0.0365g/ml; The rat dosage is 0.5g/kg, and concentration is made into 0.05g/ml.
3). LVJIAO BUXUE KELI: Jiuzhitang Co., Ltd. provides by the Hunan, lot number: 20030519.The mice dosage is 10.4g/kg, and concentration is made into 0.52g/ml.
4). R-1132: Fujian Xing'an Pharmaceutical Co., Ltd. provides, lot number 020412.
5). hemoglobin calibration solution: provide lot number by Maike Tech Co., Ltd., Sichuan Prov.: 030515.
6). hemoglobin conversional solution: provide lot number by Maike Tech Co., Ltd., Sichuan Prov.: 030319.
7). arabic gum: by the packing of Shanghai chemical reagent purchasing and supply station packing factory, lot number: 991130.
8). activated carbon powder: produce lot number: 980812 by Shenyang City's reagent two factories.
9). acetylphenylhydrazine: reagent three factories in Shanghai produce, lot number: 000224.
10). ether: the state-run air slaking chemical reagent work that prolongs of Changsha produces lot number: 010516.
Laboratory animal:
1) a .ICR cleaning level mice: female, the quality certification number must be provided by triumphant laboratory animal company limited by west, Shanghai pul: Shanghai is moving closes the card word No. 153.
3) a .SD cleaning level rat: female, the quality certification number must be provided by triumphant laboratory animal company limited by west, Shanghai pul: Shanghai is moving closes the card word No. 152.
Experimental apparatus:
1) .7230 type spectrophotometer: analytical tool factory in Shanghai produces.
2) .PB1502 type electronic balance: METTLER TOLEDO company product.
One, to the influence of mice intestinal progradation
Get 50 of cleaning level ICR female mices, body weight 18～22 grams, be divided into 5 groups at random: blank group, enriching blood for moistening the intestine granule low dosage 5.2g/kg, middle dosage 10.4g/kg, high dose 20.8g/kg group and MARENJIAONANG 0.73g/kg group, every group 10, water gastric infusion after 24 hours is can't help in fasting, 20ml/kg, matched group give the equal-volume distilled water, and all are irritated gastric juice and contain 5% charcoal end and 10% arabic gum.After each Mus administration 30 minutes, the cervical vertebra dislocation is put to death, open the abdominal cavity and separate mesentery, the intestinal tube of clip upper end to pylorus, lower end to ileocecus is tiled on the glass plate, gently small intestinal is pulled into straight line, measure intestinal tube length as the small intestinal total length, the distance in forward position, end is calculated the charcoal end and is advanced percentage rate as the advance distance of charcoal end at enteral from pylorus to charcoal, each administration group and matched group are organized a t check, the results are shown in and list in table 2.
Table 2 enriching blood for moistening the intestine granule is to the propulsive influence of mice intestinal
Compare with the blank group,
*P＞0.05,
*P＜0.05
By table 2 as seen, enriching blood for moistening the intestine granule 10.4g/kg, 20.8g/kg can obviously improve the propelling percentage rate (with matched group compare p＜0.05) of charcoal end in mouse small intestine, and mice enteral charcoal end is advanced obvious facilitation.
Two, to the influence of normal mouse defecation
Get 50 of cleaning level ICR female mices, body weight 18～22 grams, be divided into 5 groups at random: blank group, enriching blood for moistening the intestine granule low dosage 5.2g/kg, middle dosage 10.4g/kg, high dose 20.8g/kg group and MARENJIAONANG 0.73g/kg group, every group 10, water gastric infusion after 12 hours is can't help in fasting, 20ml/kg, matched group give the equal-volume distilled water, and all are irritated gastric juice and contain 5% charcoal end and 10% arabic gum.After the administration mice is placed in the glass bell jar, facet is lined with filter paper, observed continuously 6 hours, and time and 6 hours row's melena number of record mice the 1st row melena (containing powdered carbon feces), each administration group and matched group are organized a t check, the results are shown in Table 3.
Table 3 enriching blood for moistening the intestine granule is to the influence of normal mouse defecation
Compare with the blank group,
*P＞0.05,
*P＜0.05,
* *P＜0.01
By table 3 as seen, enriching blood for moistening the intestine granule 10.4g/kg, 20.8g/kg can obviously shorten the 1st row's melena time of mice, 20.8g/kg can obviously increase row's melena number in the mice 6 hours, with blank group comparing difference statistical significance (p＜0.05 is arranged, or p＜0.01), shows that the enriching blood for moistening the intestine granule has facilitation to the normal mouse defecation.
Three, to the influence of dryness accumulated in the stomach and intestine mice with constipation
Get 60 of cleaning level ICR female mices, body weight 18～22 grams, be divided into 6 groups at random: the normal control group, model control group, enriching blood for moistening the intestine granule low dosage 5.2g/kg, middle dosage 10.4g/kg, high dose 20.8g/kg group and MARENJIAONANG 0.73g/kg group, every group 10, raise (feed of freely drinking water) except that 10 mices of normal control group are conventional, all the other 50 mices are prohibited the water non-fasting, feed with rice, the equal fasting of each treated animal is 12 hours before the experiment, gastric infusion, 20ml/kg, normal control group and model control group give the equal-volume distilled water, and all are irritated gastric juice and contain 5% charcoal end and 10% arabic gum.After the administration mice is placed in the glass bell jar, facet is lined with filter paper, observed continuously 6 hours, and time and 6 hours row's melena number of record mice the 1st row melena (containing powdered carbon feces), each administration group and matched group are organized a t check, the results are shown in Table 4.
Table 4 enriching blood for moistening the intestine granule is to the influence of dryness accumulated in the stomach and intestine mice with constipation
Compare with the normal control group,
###P＜0.01; Compare with model control group,
*P＞0.05,
*P＜0.05,
* *P＜0.01
By table 4 as seen, compare with the normal control group, first grain row's melena time of model control group mice obviously prolongs, and row's melena number obviously reduced in 6 hours.Enriching blood for moistening the intestine granule 5.2g/kg, 10.4g/kg, 20.8g/kg all can obviously shorten first grain row's melena time of dryness accumulated in the stomach and intestine constipation mice, and the increase mice with constipation was arranged the melena number in 6 hours, showed that constipation has the obvious treatment effect to the enriching blood for moistening the intestine granule to the mice dryness accumulated in the stomach and intestine.
Four, to the influence of diphenoxylate mice with constipation
Get 60 of cleaning level ICR female mices, body weight 18～22 grams, be divided into 6 groups at random: normal control group, model control group, enriching blood for moistening the intestine granule low dosage 5.2g/kg, middle dosage 10.4g/kg, high dose 20.8g/kg group and MARENJIAONANG 0.73g/kg group, every group 10, the animal fasting be can't help water after 12 hours, except that the normal control group, other 5 treated animals are all irritated urogaster and are given compound diphenoxylate suspension 50mg/kg, each treated animal gastric infusion after 1 hour, 20ml/kg, normal control group and model control group give the equal-volume distilled water.After the administration mice is placed in the glass bell jar, facet is lined with filter paper, observes continuously 12 hours, writes down that the argol that each mice discharges is counted, loose stool is counted and the number of animals of defecation not, and each administration group and matched group are organized a t and checked, and the results are shown in Table 5.
Table 5 enriching blood for moistening the intestine granule is to the influence of diphenoxylate mice with constipation
Compare with the normal control group,
###P＜0.01; Compare with model control group,
*P＞0.05,
*P＜0.05,
* *P＜0.01
By table 5 as seen, compare with the normal control group, model control group mice argol is counted and is obviously reduced, and the defecation number of animals increases.Enriching blood for moistening the intestine granule 5.2g/kg, 10.4g/kg, 20.8g/kg can increase all that diphenoxylate mice with constipation argol is counted, loose stool is counted, and can reduce not defecation number of animals, show that constipation has therapeutical effect to the enriching blood for moistening the intestine granule to the mice diphenoxylate.
Five, to the influence of intestinal moisture absorption
Get 10 of SD female rats, body weight 180～200g, fasting be can't help water after 24 hours, and etherization also is fixed on the operation platen, does otch in the abdomen median line, find out ileocecus, begin 5 intestinal segments of ligation at the ileum near ileocecus, 3 centimetres every section, intestinal segment is not connected, inject normal saline, the basic, normal, high dose concentration 0.36g/ml of enriching blood for moistening the intestine granule, 0.72g/ml, 1.44g/ml medicinal liquid and MARENJIAONANG 0.05g/ml medicinal liquid respectively in each section intestinal, every section is all injected 0.2ml.Behind the injection medicinal liquid is computation time, sews up the animal otch and closes in the withdrawal of currency from circulation, puts to death animal after 2 hours, carefully extracts enteric cavity liquid and measures its volume, and each administration group and matched group are organized a t check, the results are shown in Table 6.
Table 6 enriching blood for moistening the intestine granule is to the influence of rat intestinal moisture absorption
Compare with the blank group,
*P＜0.05,
* *P＜0.01
By table 6 as seen, it is long-pending that enriching blood for moistening the intestine granule 3.6g/kg, 7.2g/kg, 14.4g/kg can obviously increase rat enteric cavity liquid, shows that the enriching blood for moistening the intestine granule can increase rat enteric cavity volume, and secretion has facilitation to intestinal moisture.
Six, to the blood tonification effect of losing blood property blood deficiency mice
Get 60 of cleaning level ICR female mices, body weight 19～22 grams are got 10 mices at random as the normal control group, after hemoglobin (Hb) is measured in all mice tail end blood samplings, with all the other 50 mouse orbit blood-letting, every about 0.5ml.Mice lost blood back 24 hours, the hemoglobin value is measured in each Mus tail end blood sampling, hemoglobin stratified random according to the mice that loses blood is divided into 5 groups: model control group, enriching blood for moistening the intestine granule low dosage 5.2g/kg, middle dosage 10.4g/kg, high dose 20.8g/kg group and LVJIAO BUXUE KELI 10.4g/kg group, normal control group are also taken a blood sample and are measured the hemoglobin value.Each treated animal gastric infusion of grouping back, 20ml/kg, every day 1 time, continuous 7 days, normal control group and model control group gave the equal-volume distilled water.After the last administration 1 hour, each was organized the mice blood sampling and measures the hemoglobin value, and calculated difference before and after the administration, organized a t check, the results are shown in Table 7.
Table 7 enriching blood for moistening the intestine granule is to the influence of losing blood property blood deficiency mice
Compare with the normal control group,
###P＜0.01; Compare with model control group,
*P＞0.05,
*P＜0.05,
* *P＜0.01
By table 7 as seen, compare with normal mouse, the hemoglobin value obviously reduced after mice lost blood, and enriching blood for moistening the intestine granule 5.2g/kg, 10.4g/kg, 20.8g/kg can obviously increase the hemoglobin value of the mice that loses blood, have blood tonification effect.
Seven, to the blood tonification effect of hemolytic blood deficiency mice
Get 60 of cleaning level ICR female mices, body weight 19～22 grams are divided into 6 groups at random: normal control group, model control group, enriching blood for moistening the intestine granule low dosage 5.2g/kg, middle dosage 10.4g/kg, high dose 20.8g/kg group and LVJIAO BUXUE KELI 10.4g/kg group.Each treated animal gastric infusion of grouping back, 20ml/kg, every day 1 time, continuous 7 days, normal control group and model control group gave the equal-volume distilled water.Respectively at the 1st, 4 day of administration, except that the normal control group, all the other 5 groups of mouse subcutaneous injections, 2% acetylphenylhydrazine 200mg/kg.After the last administration 1 hour, each was organized the mice blood sampling and measures hemoglobin (Hb), erythrocyte (RBC), organized a t check, the results are shown in Table 8.
Table 8 enriching blood for moistening the intestine granule is to the influence of hemolytic blood deficiency mice
Compare with the normal control group,
###P＜0.01; Compare with model control group,
*P＞0.05,
*P＜0.05
By table 8 as seen, compare with the normal control group, haemolysis mice hemoglobin value and erythrocyte number average obviously reduce due to the acetylphenylhydrazine, enriching blood for moistening the intestine granule 10.4g/kg, 20.8g/kg can obviously increase the hemoglobin value of haemolysis mice, 20.8g/kg can also obviously increase RBC number, show that the enriching blood for moistening the intestine granule has blood tonification effect to haemolysis mice due to the acetylphenylhydrazine.
Conclusion
Chinese medicine composition of the present invention is a compound Chinese medicinal preparation, and the clinical puerperal constipation that is used for the treatment of has definite curative effect.Above-mentioned experiment shows that Chinese medicine composition of the present invention can improve the propelling percentage rate of charcoal end in mouse small intestine, and mice enteral charcoal end is advanced obvious facilitation; Can shorten the 1st row's melena time of mice, the increase mice was arranged the melena number in 6 hours, and the normal mouse defecation is had facilitation; Can obviously shorten first grain row's melena time of dryness accumulated in the stomach and intestine constipation mice, the increase mice with constipation was arranged the melena number in 6 hours, and constipation has the obvious treatment effect to the mice dryness accumulated in the stomach and intestine; Can increase that diphenoxylate mice with constipation argol is counted, loose stool is counted, reduce not defecation number of animals, constipation has therapeutical effect to the mice diphenoxylate; Can increase rat enteric cavity volume, promote the secretion of intestinal moisture; Can increase losing blood property blood deficiency mice hemoglobin value, increase hemolytic blood deficiency mice hemoglobin value and RBC number, have blood tonification effect.
The intestine moistening granule enriching blood for moistening the intestine of enriching blood makes thin fluid injury in puerperal, intestinal lose the profit symptom and is improved, and does not contain the irritant cathartic composition, is applicable to that the women of puerperal constipation takes, and back blood deficiency and constipation senile weakness constipation simultaneously also can be used for performing the operation.
Toxicology test
Acute toxicity testing:
Enriching blood for moistening the intestine granule with Cmax, maximum volume is given mouse stomach, fails to obtain LD
50, its maximum tolerated dose can reach 149.6g/kg, and dose all refers to crude drug in the experiment, is equivalent to be grown up 262 times of clinical consumption of 70kg by kg body weight conversion, shows that the enriching blood for moistening the intestine granule is safe the referrer with the dosage range innerlich anwenden.The observation mice gave the enriching blood for moistening the intestine acute toxic reaction that granule is produced in one day.
Experimental drug
The enriching blood for moistening the intestine granule: present embodiment 1 preparation enriching blood for moistening the intestine granule, the clinical consumption per day of people is the 40g crude drug.Be made into maximum gastric infusion concentration 1.87g/ml with distilled water during experiment.
Laboratory animal
An ICR cleaning level white mice, body weight 19～21g, male and female half and half, available from west, Shanghai pul-Bi Kai laboratory animal company limited, the quality certification number: Shanghai is moving closes the card word No. 153, and animal places a cleaning level laboratory to raise 20～25 ℃ of room temperatures, relative humidity 55～70%.
Experimental technique
According to pre-test result, get 40 of ICR cleaning level mices, male and female half and half are divided into 2 groups, administration group and matched group immediately.Fasting be can't help water after 14 hours before the experiment, irritate stomach (ig) with the enriching blood for moistening the intestine granule of Cmax 1.87g/ml and give maximum volume 0.8ml/20g, matched group gives the equal-volume distilled water, 6 hours administration secondaries in interval in one day, enriching blood for moistening the intestine granule accumulative total dosage is 149.6g/kg, and observe animal behavior activity, hair color etc. and animals survived situation in 7 days every day after the administration.
Experimental result
After mice gave the enriching blood for moistening the intestine granule, activity slightly descended, and the stool number increases, and is just rare, recovered normal subsequently gradually, did not see other specific responses; Mice gives not see that Deviant Behavior is arranged behind the distilled water.Observed 7 days, 2 groups of mices all do not have death.After putting to death the dissection animal, the perusal heart, liver, spleen, lung, kidney etc. are all no abnormal, show that enriching blood for moistening the intestine granule maximum tolerated dose can reach 149.6g/kg, are equivalent to 262 times of the clinical consumption of people by the kg body weight conversion.The result sees table 9 for details.
Table 9 enriching blood for moistening the intestine granule animal acute toxicity test result
Compare with matched group,
*P＞0.05
Experiment conclusion
For observing enriching blood for moistening the intestine granule toxicity, give mouse stomach with Cmax, maximum volume, animal dead does not all appear, can not ask LD
50Twice of 6 hours successive administration at interval in 24 hours, enriching blood for moistening the intestine granule one day accumulative total dosage (maximum tolerated dose) reaches 149.6g/kg, be equivalent to be grown up 262 times of clinical consumption of 70kg by kg body weight conversion, observed 7 days continuously, no animal dead shows that the enriching blood for moistening the intestine granule is safe the referrer with the dosage range innerlich anwenden.
By The above results as can be known, Chinese medicine composition of the present invention has positive effect to improve to puerperal constipation, and has the effect of enriching blood concurrently, and the result of II clinical trial phase shows determined curative effect, and is safe and effective, Chinese medicine composition steady quality of the present invention, reliable.
The explanation of above embodiment just is used for helping to understand method of the present invention and core concept thereof.Should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention, can also carry out some improvement and modification to the present invention, these improvement and modification also fall in the protection domain of claim of the present invention.
To the above-mentioned explanation of the disclosed embodiments, make this area professional and technical personnel can realize or use the present invention.Multiple modification to these embodiment will be conspicuous concerning those skilled in the art, and defined herein General Principle can realize under the situation that does not break away from the spirit or scope of the present invention in other embodiments.Therefore, the present invention will can not be restricted to these embodiment shown in this article, but will meet and principle disclosed herein and features of novelty the wideest corresponding to scope.
Claims (10)
1. Chinese medicine composition for the treatment of puerperal constipation, comprise: 490 parts～600 parts Radix Angelicae Sinensis, 215 parts～325 portions Fructus Moris, 270 parts～380 parts Fructus Cannabiss, 270 parts～380 parts Radix Polygoni Multiflori, 160 parts～270 parts Radix Ophiopogonis, 210 parts～330 parts Radix Rehmanniae, 160 parts～270 parts Semen Trichosanthis, 210 parts～330 parts Semen Persicaes and 160 parts～270 parts Rhizoma Atractylodis Macrocephalaes, the source of described component is Chinese medicine medical material or the Chinese medicine extract that is equivalent to above-mentioned Chinese crude drug crude drug amount.
2. Chinese medicine composition according to claim 1, it is characterized in that, comprising: 495 parts～595 parts Radix Angelicae Sinensis, 220 parts～320 portions Fructus Moris, 275 parts～375 parts Fructus Cannabiss, 275 parts～375 parts Radix Polygoni Multiflori, 165 parts～265 parts Radix Ophiopogonis, 220 parts～320 parts Radix Rehmanniae, 165 parts～265 parts Semen Trichosanthis, 220 parts～320 parts Semen Persicaes and 165 parts～265 parts Rhizoma Atractylodis Macrocephalaes.
3. medicine for the treatment of puerperal constipation, comprising: each described Chinese medicine composition of claim 1 to 2 and pharmacy acceptable auxiliary, content of ferulic acid is at least 0.12mg/g in this medicine.
4. medicine according to claim 3 is characterized in that, described medicine is granular pattern, capsule formulation, tablet form, oral liquid, injection, pill or powder.
5. medicine according to claim 4 is characterized in that, described tablet form is dispersible tablet, effervescent tablet, chewable tablet or slow releasing tablet.
6. medicine according to claim 4 is characterized in that, described capsule formulation is soft wafer, hard wafer or microcapsule.
7. the preparation method of the described medicine of claim 3 comprises:
A, Fructus Cannabis powder, Peach Seed, Semen Trichosanthis powder and Radix Polygoni Multiflori powder will be obtained behind Fructus Cannabis, Semen Persicae, Semen Trichosanthis and the Radix Polygoni Multiflori pulverize separately;
B, Fructus Cannabis powder, Peach Seed and Semen Trichosanthis powder are mixed the back alcohol extraction with Radix Angelicae Sinensis, it is 1.16～1.22 extractum that alcohol extract is concentrated into relative density, collects the alcohol extraction medicinal residues;
C, will the Radix Polygoni Multiflori powder, Fructus Mori, Radix Rehmanniae, the Rhizoma Atractylodis Macrocephalae and mix the back Radix Ophiopogonis and obtain volatile oil through water distillation and extraction earlier, getting the water liquid that extracts behind the volatile oil and medicinal residues carries out first time water and carries, collect water extract and water and carry medicinal residues, carry out second time water after water carried medicinal residues and the alcohol extraction medicinal residues mix and carry, merging twice water extract and being concentrated into relative density is 1.25～1.30 herbal decoction;
D, described extractum, volatile oil and herbal decoction are mixed.
8. process for preparing medicine according to claim 7 is characterized in that, also comprises: use ethanol as solvent the volatile oil that step c obtains, make volatile oil clathrate compound with the beta-schardinger dextrin-inclusion.
9. process for preparing medicine according to claim 8 is characterized in that, also comprises: described extractum and herbal decoction are mixed, add adjuvant after drying, pulverizing; Obtain described medicine with described volatile oil clathrate compound and correctives mixing, granulation, drying again.
10. the application of the described Chinese medicine composition of claim 1 in the medicine of preparation puerperal constipation.
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| CN105148033A (en) * | 2015-08-24 | 2015-12-16 | 武春鸿 | Traditional Chinese medicine pills for treating blood and body fluid deficiency type puerperal constipation |
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