CN1272047C - Medicine for invigorating liver and kidney to treat dryness of large intestine and constipation - Google Patents
Medicine for invigorating liver and kidney to treat dryness of large intestine and constipation Download PDFInfo
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Abstract
The present invention discloses a medicine for invigorating the liver and kidney to treat intestinal dryness with constipation. The present invention comprises 38 to 42% of songaria cynomorium herb, 18 to 22% of barbary wolfberry fruit, 18 to 22% of Chinese magnolivine fruit and 18 to 22% of honey; the summation of traditional Chinese medicine raw materials is 100%; sodium benzoate of 0.05% of the total amount of the traditional Chinese medicine raw materials is additionally added as an additive. The present invention has the preparation method: the Chinese magnolivine fruit is distilled by steam; 500 ml of distillate is collected for standby; the songaria cynomorium herbs and the barbary wolfberry fruit are additionally taken and merged with decoction dregs of the Chinese magnolivine fruit, soaked for 12 hours by adding water, decocted twice and separately filtered; filter liquor is merged at 50 DEGC and concentrated to paste with the relative density of 1.10; ethanol is added to make the alcohol content of the paste reach 60% to 65%; the paste stands for 24 hours and is filtered; the ethanol of the filter liquor is recovered till the filter liquor does not have alcohol taste; 2 times of water is added into the filter liquor, and the filter liquor is uniformly mixed, stands for 24 hours and filtered to obtain physic liquor; the honey with formula amount is additionally taken, boiled for 30 minutes by adding water, filtered and mixed with thephysic liquor; the additive of the sodium benzoate is additionally added, water is added to specified amount, and the medicine is obtained by separate package and sterilization. The present invention is sour and sweet in taste and suitable for symptoms of reness and weakness of waist and knees and intestinal dryness with constipation.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of Chinese medicine, particularly a kind of medicine of invigorating liver and kidney to treat dryness of large intestine and constipation.
Background technology
Constipation is modal clinically digestive system disease.It is reported that the U.S. has 2,000,000～3,000,000 people constipation persons to take medicine to help just every year, its incidence rate is about 2%; One group of statistics shows that annual about 900 people die from and the constipation diseases associated.The main clinical manifestation of constipation is the infrequent defecation time lengthening, and constipation with dry stool is difficult to resolve, though or have a mind to and the discharge difficulty.Constipation comes down to a kind of digestive tract function disease, and its basic pathology is abdominal muscle, podex muscle or colonic smooth muscle and myenteric nerve plexus dysfunction, often can cause that defecation power weakens and constipation takes place.Catharsis agent, volume stimulation enterokinesia of increase intestinal or the softening feces of adopting in the treatment more.Chinese medical theory thinks that the reason that causes constipation is a lot, all relevant with liver,kidney,spleen, stomach, large intestine, lung, qi-blood-body fluid, cold and heat and asthenia and sthenia etc., for middle-aged and elderly people based on deficiency of the liver and kindey, its basic pathogenesis is a deficiency in origin and excess in superficiality, from the beginning of real to mark, for a long time then based on deficiency in origin, should be in treatment based on strengthening the body resistance.
Common medicine has irritant laxative, osmotic laxative treatments, emollient laxative at present.Wherein comparatively the common chemical medicine has anthraquinone class cathartic, saline cathartic, plant oil, but prolonged application produces bigger untoward reaction.As anthraquinone class life-time service can cause water, electrolyte is lost and the colon dysfunction, also can cause the dependency of patient to medicine.Magnesium ion in the saline cathartic about 20% can be by intestinal absorption, and toxic reaction may take place the patient that renal dysfunction patient or maincenter suppress.The plant oil prolonged application can cause the absorption of vitamin A, D, K and calcium, phosphorus, unsuitable life-time service.Chinese medicine commonly used then lacks generally acknowledges effective preparation, and general unsatisfactory curative effect lacks animal experiment study.And in treatment, ignore this basic pathogenesis of deficiency in origin and excess in superficiality, and eliminating evil merely (the rushing down down) that has, the simple tonify deficiency that has, effect is undesirable.Therefore soft at waist knee joint flaccidity, in the treatment of dryness of the intestine constipation, still lack good effect, the little ideal medicament of side effect.
Summary of the invention
The objective of the invention is to, a kind of medicine of invigorating liver and kidney to treat dryness of large intestine and constipation is provided, prove through animal experiment study and drug effect, pharmacology test, this medicine can have good therapeutical effect to the soft dryness of the intestine constipation of waist knee joint flaccidity.
The raw material of Chinese medicine that comprises following weight ratio in the medicine of invigorating liver and kidney to treat dryness of large intestine and constipation of the present invention: Herba Cynomorii 38～42%, Fructus Lycii 18～22%, Fructus Schisandrae Chinensis 18～22%, Mel 18～22%, the summation of raw material of Chinese medicine is 100%, and the sodium benzoate that adds above-mentioned raw material of Chinese medicine total amount 0.05% in addition is as additive.
Manufacturing method for above mentioned medicine is, with Herba Cynomorii, Fructus Lycii, the Fructus Schisandrae Chinensis three flavor medical materials of prescription, gets the Fructus Schisandrae Chinensis vapor distillation earlier, and collection distillate 500ml is standby; Other gets Herba Cynomorii, Fructus Lycii and the merging of Fructus Schisandrae Chinensis medicinal residues, soaks 12 hours, decocts secondary, 1.5 hours for the first time, 1 hour for the second time, gradation filtered, merging filtrate and to be concentrated into relative density at 50 ℃ be 1.10 clear paste adds ethanol and makes and contain the alcohol amount and reach 60%-65%, leaves standstill 24 hours, filter, filtrate recycling ethanol adds 2 times of water gagings to there not being the alcohol flavor, mixing, left standstill 24 hours, and filtered, get medicinal liquid; Other gets the Mel of formula ratio, adds water boil 30 minutes, filter, and filtrate and above-mentioned medicinal liquid mixing, other adds the additive sodium benzoate, adds water to ormal weight, packing, sterilization is promptly.
The medicine of the invigorating liver and kidney to treat dryness of large intestine and constipation of the present invention's preparation is the liquid of yellowish-brown; Sour in the mouth, sweet.Have invigorating the liver and kidney, benefiting essence-blood, bone and muscle strengthening function, it is soft to be specially adapted to waist knee joint flaccidity, dryness of the intestine constipation symptom.
The specific embodiment
Below in conjunction with embodiment and drug effect, the present invention is described in further detail for pharmacological testing.
Embodiment 1:
Prescription: Herba Cynomorii 240g, Fructus Lycii 120g, Fructus Schisandrae Chinensis 120g, Mel 120g, sodium benzoate 0.3g, make 1000ml.
Method for making: above three flavor medical materials, get the Fructus Schisandrae Chinensis vapor distillation, collect distillate 500ml, standby; Other gets Herba Cynomorii, Fructus Lycii and the merging of Fructus Schisandrae Chinensis medicinal residues, soaks 12 hours, decocts secondary, 1.5 hours for the first time, 1 hour for the second time, gradation filtered, merging filtrate also is concentrated into the clear paste that relative density is 1.10 (50 ℃), adds ethanol and makes and contain alcohol amount and reach 60%-65%, leaves standstill 24 hours, filter, filtrate recycling ethanol adds 2 times of water gagings to there not being the alcohol flavor, mixing, left standstill 24 hours, and filtered, get medicinal liquid.Other gets Mel, adds water boil 30 minutes, filters, and filtrate and above-mentioned medicinal liquid mixing add sodium benzoate, add water to ormal weight, packing, and sterilization, promptly.
Character: the liquid of yellowish-brown; Sour in the mouth, sweet.
Discrimination method:
(1) get this product 50ml, add active carbon 2g, placed 10 minutes, filter, filtrate evaporate to dryness, residue add Diluted Alcohol 5ml makes dissolving, as need testing solution.Other gets Herba Cynomorii control medicinal material 1g, adds water 30ml, boils 15 minutes, shines medical material solution in pairs with legal system.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B) test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose.With glacial acetic acid-alcohol-water (4: 1: 2) is developing solvent, launches, and takes out, and dries, and spray is with ninhydrin solution, and it is clear to be heated to the speckle colour developing at 100 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
(2) get this product 50ml, add ethyl acetate 30ml, jolting is extracted, and ethyl acetate liquid is concentrated into 1ml, as need testing solution.Other gets Fructus Lycii control medicinal material 2g, adds water 35ml, and heated and boiled 15 minutes is put coldly, filters, and filtrate adds ethyl acetate 20ml jolting extracts, and ethyl acetate liquid is concentrated into 1ml, in contrast medical material solution.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B) test, draw each 5 μ l of above-mentioned two kinds of solution, respectively on the same silica gel g thin-layer plate of idea, with chloroform-ethyl acetate-formic acid (3: 2: 1) is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
(3) get this product 60ml, add chloroform 30ml, jolting is extracted, and chloroform solution is concentrated into 1ml, as need testing solution.Other gets Fructus Schisandrae Chinensis control medicinal material 1g, adds water 30ml, boils 15 minutes, puts coldly, filters, and filtrate adds chloroform 20ml, and jolting is extracted, and chloroform solution is concentrated into 1ml, in contrast medical material solution.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B) test, draw each 5 μ l of above-mentioned two kinds of solution, put in same silica gel G F respectively
254On the lamellae, be developing solvent, launch, take out, dry, put under the ultra-violet lamp (254nm) and inspect with the upper solution of petroleum ether (30～60 ℃)-Ethyl formate-formic acid (15: 5: 1).In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
Inspection item:
Relative density should be not less than 1.04 (an appendix VII of Chinese Pharmacopoeia version in 2000 A).
The PH value should be 4.0～5.5 (an appendix VII of Chinese Pharmacopoeia version in 2000 G).
Other should meet every regulation relevant under the mixture item (appendix IJ of Chinese Pharmacopoeia version in 2000)
Assay: measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D).
Chromatographic condition and system suitability test octadecylsilane chemically bonded silica are filler; Acetonitrile-water-phosphoric acid (2: 98: 0.2) is mobile phase; Detect the long 220nm of being of wave-wave.Number of theoretical plate calculates by the gallic acid peak should be not less than 2600.
It is an amount of that the preparation precision of reference substance solution takes by weighing the gallic acid reference substance, adds mobile phase and make the solution that every 1ml contains 2mg, promptly.
The accurate this product 1ml that draws of the preparation of need testing solution puts in the 50ml measuring bottle, adds mobile phase and is diluted to scale, shakes up, and filters, and gets subsequent filtrate, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Specification: every dress 10ml, every contains Herba Cynomorii with gallic acid (C
7H
6O
5) meter, must not be less than 0.40mg.
Function cures mainly: invigorating the liver and kidney, benefiting essence-blood, bone and muscle strengthening.It is soft to be used for waist knee joint flaccidity, the dryness of the intestine constipation.
Usage and dosage: oral, a 10ml, 2-3 time on the one.
Embodiment 2:
Prescription: Herba Cynomorii 300g, Fructus Lycii 150g, Fructus Schisandrae Chinensis 150g, Mel 150g, sodium benzoate 0.375g, make certain solution.All the other are with embodiment 1.
Embodiment 3:
Prescription: Herba Cynomorii 200g, Fructus Lycii 100g, Fructus Schisandrae Chinensis 100g, Mel 100g, sodium benzoate 0.25g, make certain solution.All the other are with embodiment 1.
The foregoing description can also exemplify many, needs only all scalable production of scope that provides in the present invention, can obtain the medicine of the object of the invention equally.
Prescription is analyzed:
Prescription of the present invention is to form in conjunction with the theory of Chinese medical science foundation development on the clinical research basis for many years.Be monarch drug with the Herba Cynomorii in the side, merit is with kidney-replenishing, benefiting essence-blood, and loosening bowel to relieve constipation, it is soft to cure mainly waist knee joint flaccidity, the dryness of the intestine constipation.The invigorating the liver and kidney of Fructus Lycii function makes eye bright, and cures mainly the soreness of waist seminal emission of deficiency of the liver and kindey etc., and matching with Herba Cynomorii to strengthen the effect of its invigorating the liver and kidney, is to be ministerial drug.The Fructus Schisandrae Chinensis nourishing kidney of can astringing the lung, its sour in the mouth can be restrained, and is warm in nature and moisten, on the gas of astringing the lung, following can nourishing kidney-yin, be adjuvant drug; Take a broad view of the brief refine of full side, but the merit invigorating the liver and kidney, benefiting essence-blood, bone and muscle strengthening in order to strengthen the function that we moisturize, makes with Mel, and Gan Pingrun supports, and makes we milder, harmony.This side's reasonable recipe, all medicines share the effect that reaches invigorating the liver and kidney, benefiting essence-blood, bone and muscle strengthening, and soft to waist knee joint flaccidity, the dryness of the intestine constipation has significant curative effect.
Herba Cynomorii: be the chylocaulous of the parasitic herbaceous plant Herba Cynomorii of Cynomoriaceae meat.The property of medicine is sweet, temperature.Return liver, kidney, large intestine channel.Its effect is a reinforcing the kidney and supporting YANG, loosening bowel to relieve constipation.Main product in the Inner Mongol, ground such as Gansu, Qinghai, Xinjiang.Gather spring.Remove inflorescence, put and partly bury half dew in the sandy soil, connect to shine to be with and scald, make it dry, mildew-resistant.Section is given birth to and is used.
Kidney yang lose empty, asthenia of essence and blood, sexual impotence, infertile, flaccidity and weakness of the lower limbs, muscles and bones unable normal and Herba Cistanches, Cornu Cervi Pantotrichum, Semen Cuscutae are equal to usefulness, as " danxi's experiential therapy " Huqian Wan; The bone that is used to suffer from a deficiency of the kidney is thin, and a little less than the muscles and bones flaccidity, walking hardship can be equal to usefulness with Radix Rehmanniae Preparata, Radix Achyranthis Bidentatae.
2. the constipation of blood deficiency and depleted fluid dryness of the intestine can singly be obeyed with enduring cream, or is equal to usefulness with Herba Cistanches, Fructus Cannabis, Radix Rehmanniae.Control positive azoospermia void as " book on Chinese herbal medicine is highly necessary ", the moon Sanguis Draxonis that declines, big dryness of the intestine dries up, and constipation is obstructed, promptly singly fries in shallow oil extract with this product and adds honey and receive the cream clothes.
Fructus Lycii: be the mature fruit of plant of Solanaceae lycium barbarum.The property of medicine is sweet, flat.Return liver, kidney channel.Effect is a nourishing the liver and kidney, replenishing vital essence to improve eyesight.Main product in Ningxia, ground such as Gansu, Xinjiang.Two season of autumn in summer gathers when fruit is orange red, dries in the air to rhicnosis, shines to crust stiffly again, and the sarcocarp softness give birth to be used.
The hepatic and renal YIN deficiency and senilism card: the moon of this product energy nourish liver and kidney is the product of the smart liver blood of flat the kidney invigorating.Visual deterioration, the cataract blurred vision of treatment due to the asthenia of essence and blood, have a dizzy spell, soreness of the waist and knees, seminal emission lingering diarrhea, deafness, odontoseisis, early whitening of beard and hair, insomnia and dreamful sleep and the hepatic and renal YIN deficiency, in the side of hectic fever night sweat, card such as quench one's thirst, all rather commonly used.Can singly use, or the product compatibility of enriching blood with invigorating the liver and kidney, beneficial essence.Endure the cream clothes as " Longevity and Life Preservation " Fructus Lycii cream list with this product; Qibao Meiran Dan (" the hall side of accumulating virtue ") with product such as Radix Achyranthis Bidentatae, Semen Cuscutae, Radix Polygoni Multiflori with using.Because of it can also make eye bright, thus especially be used for two dryness and uneasy feeling of the eye of the hepatic and renal YIN deficiency or damage of essence blood deficiency more, the cataract blurred vision, often and the same usefulness of product such as Radix Rehmanniae Preparata, Fructus Corni, Rhizoma Dioscoreae, Flos Chrysanthemi, as QIJU DIHUANG WAN.
Fructus Schisandrae Chinensis: be the mature fruit of magnoliaceae schisandra or schisandra chinensis.The former practises title " Radix Schisandrae Bicoloris ", and main product is in northeast; The latter practises title " Fructus Schisandrae Sphenantherae ", property of medicine acid, sweet, warm.Return lung, heart kidney channel.Effect is astringent or styptic treatment for spontaneous sweating for convergence, supplementing QI for promoting the production of body fluid, kidney calming.Main product is the each province in southwest and on the south the Yangtze river basin.Take during fruit maturation autumn.Dry.Give birth to or through vinegar, closely mix steaming and dry usefulness.
1, chronic cough dyspnea due to deficiency this product sour in the mouth convergence, Gan Wen and moistening, can on the gas of astringing the lung, following nourishing kidney-yin is the key medicine of treatment chronic cough dyspnea due to deficiency.Control chronic cough of deficiency lung, can with the same usefulness of Pericarpium Papaveris, as Schisandrae Pill (" health man treasured side "); Control deficiency of both the lung and kidney and breath with cough, normal and Fructus Corni, Radix Rehmanniae Preparata, Rhizoma Dioscoreae are equal to usefulness, as Duqi Wan (" the doctor ancestor has appointed volume "); This product is longer than astringing lung-QI and relieving cough, and compatibility Herba Ephedrae, Herba Asari, Rhizoma Zingiberis etc. can be used for cold fluid-retention cough with asthma card, as XIAOQINGLONG TANG (treatise on Febrile Diseases).
2, spontaneous perspiration, night sweat this product is bittersweet, based on acid, the kind hidroschesis of astringing the lung.Control spontaneous perspiration, night sweat person, can be equal to usefulness with Radix Ephedrae, Concha Ostreae.
3, seminal emission, spermatorrhea: and the sweet temperature of this product is puckery, goes into kidney, and energy the kidney invigorating arresting seminal emission is for controlling the smart medicine commonly used of seminal emission, spermatorrhea admittedly that closes of suffering from a deficiency of the kidney.Control spermatorrhea person, can be equal to usefulness, as Ootheca Mantidis ball (Effective Formulas Tested by Physicians for Generations) with Ootheca Mantidis, Radix Aconiti Lateralis Preparata, Os Draconis; The person that controls the nocturnal emission, normal and Radix Ophiopogonis, Fructus Corni, Radix Rehmanniae Preparata, Rhizoma Dioscoreae are equal to usefulness, as MAIWEIDIHUANGWAN (Golden Mirror of Medicine).
4, incessant chronic diarrhea: the convergence of this product sour in the mouth adstringency, can relieving diarrhea with astringents.Control the spleen-kidney vacuity cold incessant chronic diarrhea, can grind into powder with frying perfume (or spice) with Fructus Evodiae, rice water takes, as Fructus Schisandrae Chinensis diffusing (" general Ji ability side "); Or with Fructus Psoraleae, Semen Myristicae, the same usefulness of Fructus Evodiae, as SISHEN WAN (" internal medicine summary ").
5, Tianjin wound is thirsty, and this product of quenching one's thirst is sweet with QI invigorating, and acid can be promoted the production of body fluid, and has the merit that supplementing QI for promoting the production of body fluid quenches the thirst.Control heat impairing vital QI the moon, the hyperhidrosis thirster, normal and Radix Ginseng, Radix Ophiopogonis same usefulness, as SHENGMAI SAN (" differentiation on endogenous "); Control interior-heat caused by deficiency of YIN, the diabete of thirsty many Yus, many and Rhizoma Dioscoreae, the Rhizoma Anemarrhenae, day medicated powder, the Radix Astragali are equal to usefulness, as good wine soup (" Records of Tradition Chinese and Western Medicine in Combination ").
6, cardiopalmus, insomnia, dreaminess this product can invigorating heart and kidney, again can mind tranquilizing and the heart calming.Control cloudy anemia and decrease, lack of preservation of spirit, or fidgets due to deficiency cardiopalmus, the insomnia and dreamful sleep of disarmony between the heart and kidney, normal and Radix Ophiopogonis, Radix Salviae Miltiorrhizae, the Radix Rehmanniae, Semen Ziziphi Spinosae are equal to usefulness, as Tianwang Buxin Dan (" health preserving is secret to be cutd open ")
Mel: be Apidae insecticide apis cerana or honey that apis mellifera led to.The property of medicine is sweet, and is flat.Return lung, spleen, large intestine channel.Function is invigorating middle warmer, moisturizes pain relieving, detoxifcation.All produce in most of area, the whole nation.Gather spring to autumn, filters the back for using.
1, deficiency-weakness of spleen-QI, the anxious pain of gastral cavity abdomen contraction: this product also for being rich in the invigorating the spleen and replenishing QI medicine of nutritional labeling, should be used for deficiency-weakness of spleen-QI, the dietetic patient.Can take as food.Much more outstanding excipient as invigorating the spleen and replenishing QI pill, unguentum, or process the adjuvant of invigorating the spleen and replenishing QI medicine as big gun.The empty epigastric pain of centering, abdominal pain alleviated by pressure, pain of empty stomach very, peace person slightly after the food, but both invigorating middle warmer of this product, but relieving spasm to stop pain again, giving consideration to both the incidental and fundamental.Single with effective.The product compatibility of invigorating middle warmer relieving spasm to stop pain such as more normal and the Radix Paeoniae Alba, Radix Glycyrrhizae.
2, dryness of the intestine constipation this product has the effect of loosening bowel to relieve constipation, treatment dryness of the intestine constipation person, can be singly with taking after mixing it with water, or with YIN nourishing such as card and Radix Rehmanniae, Radix Angelicae Sinensis, Fructus Cannabiss, promote the production of body fluid, nourish blood, the product compatibility of loosening bowel to relieve constipation.Also this product can be made suppository, include in the anus, with the admittance stool, as honey suppository (treatise on Febrile Diseases).
Pharmacodynamic test of active extract
Specify:, all refer to the medicine of invigorating liver and kidney to treat dryness of large intestine and constipation of the present invention with the compound cynomorium oral liquid that hereinafter occurs.
1. to the defecation of mice with constipation
1.1 defecation test to dryness accumulated in the stomach and intestine dehydration constipation model mice
Get the Kunming kind healthy mice of body weight 24～26g, male and female half and half are divided into 6 groups at random by body weight, i.e. blank group, model control group, basic, normal, high dosage group of compound cynomorium oral liquid and CONGRONG TONGBIAN KOUFUYE group.Except that the blank group, other are respectively organized mice and prohibit water non-fasting 72h, cause dryness accumulated in the stomach and intestine dehydration constipation model.The blank group is irritated stomach and is given the 2% india ink suspension that is configured to distilled water, the administration group is then irritated the 2% india ink suspension that stomach gives to replace with medicinal liquid distilled water, administration volume 1ml/20g body weight, after the administration mice put into the mice box, 1 in every box, the dried filter paper of earning of underlay white, every mice of observed and recorded are discharged the time (min) of melena and the melena sum that the interior mice of 4h is discharged first.T checks the significance of each group difference, the results are shown in Table 1.
The influence of table 1 pair dryness accumulated in the stomach and intestine dehydration constipation model mice defecation (X ± S, n=10)
| Group | Dosage (g/kg) | Arrange the melena time (min) first | Row's melena is counted in the 4h |
| Dosage group high dose group CONGRONG TONGBIAN KOUFUYE group in the blank group model matched group low dose group | 1.93 3.86 7.71 0.51 | 191.1±77.7 356.1±16.9 △△ 336.0±78.9 267.1±111.1 * 230.3±83.2 ** 324.6±67.9 | 2.4±1.7 0.3±0.7 △△ 0.5±1.2 1.9±2.1 * 2.8±1.9 ** 0.9±1.6 |
Annotate: compare △ △ P＜0.01 with the blank group; With the model control group ratio,
*P＜0.05,
*P＜0.01
1.2 defecation test to compound diphenoxylate (DC) model mice
Get body weight 22～24g Kunming kind healthy mice, male and female half and half are divided into 6 groups at random by body weight, the blank group, and model control group, the compound cynomorium oral liquid is low. middle and high dosage group and CONGRONG TONGBIAN KOUFUYE group.Each is organized mice and prohibits water non-fasting 12h. except that the blank group is given the equivalent distilled water, and all the other each groups are irritated stomach and given compound diphenoxylate (DC) suspension 50mg/kg.Behind the 30min, each treated animal is irritated stomach and is subjected to the reagent thing, administration volume 1mL/20g body weight, and blank group and model control group are given the equivalent distilled water.The argol that every group of mice of observed and recorded discharged is counted, loose stool is counted and the number of animals of defecation not, observes 12h continuously, respectively organizes index, and t checks the significance of each group difference, referring to table 2.
The influence of table 2 pair DC constipation model mice defecation (X ± S, n=10)
| Group | Dosage (g/kg) | Argol is counted | Loose stool is counted | Defecation number of animals not |
| Dosage group high dose group CONGRONG TONGBIAN KOUFUYE group in the blank group model matched group low dose group | 1.93 3.86 7.71 0.51 | 8.1±4.01 2.5±2.43 △△ 3.9±3.35 4.7±2.37 * 9.5±3.16 ** 3.6±1.67 | 0 0 0.3±0.53 0.4±0.59 2.0±1.86 ** 0 | 0 2 0 0 0 0 |
Annotate: compare △ △ P (0.01 with the blank group; With the model control group ratio,
*P＜0.05,
*P＜0.01
Table 1,2 results show that compound cynomorium oral liquid height, middle dosage group can obviously shorten the constipation animal and arrange the melena time first, significantly increase defecation count (P＜0.05 or 0.01).
2, the mouse small intestine ahead running is tested
Get the healthy Kunming mouse of body weight 23～25g, male and female half and half are divided into 5 groups at random by body weight, i.e. blank group, basic, normal, high dosage group of compound cynomorium oral liquid and CONGRONG TONGBIAN KOUFUYE group.With the charcoal end is mark, and the blank group is irritated stomach and given the 7% carbon ink suspension that is mixed with normal saline, and the administration group is then irritated stomach and given the 7% carbon ink suspension that replaces distilled water to be configured to medicinal liquid, and the administration volume is the 0.4mL/20g body weight, irritates 30min behind the stomach; Mice is put to death in cervical vertebra dislocation, and the taking-up gastrointestinal of cutting open the belly immediately is tiled on the glass plate, and displacement and the small intestinal total length (from pylorus to ileum) of side amount carbon ink head end in intestinal tube calculated and advanced percentage rate.T checks the significance of each group difference, the results are shown in Table 3.
Table 3 compound cynomorium oral liquid to the propulsive influence of small intestine movement of mice (X ± S, n=10)
| Group | Dosage (g/kg) | Small intestinal length (cm) | Carbon ink advance distance (cm) | Advance percentage rate (%) |
| Dosage group high dose group CONGRONG TONGBIAN KOUFUYE group in the blank group low dose group | 1.93 3.86 7.71 0.51 | 51.8±3.38 48.6±6.38 49.5±3.70 49.1±5.33 48.3±4.49 | 39.4±3.55 37.5±6.85 42.9±6.35 46.2±5.27 ** 43.1±6.35 | 76.24±6.48 77.43±9.01 86.57±9.83 * 95.02±6.47 ** 91.03±10.31 ** |
With blank group ratio,
*P＜0.05,
*P＜0.01
Table 3 result shows that compound cynomorium oral liquid high dose group can significantly strengthen intact animal's intestinal propulsion motion (P＜0.01).
3, anti-stress
3.1 the cold-resistant experiment of mice: get 40 of ICR mices, male and female half and half are divided into 4 groups at random, 10 every group.The A group waits capacity as the normal saline blank; The B group is the ginseng aqueous extract positive control, and dosage is 3g/kg; The C group is compound cynomorium oral liquid low dose group, dosage 3.86g/kg; The D group is compound cynomorium oral liquid high dose group, dosage 7.71g/kg.Irritate behind the stomach and mice to be put in 30 minutes-5 ± 1 ℃ cold house, clock, keep ventilation state simultaneously, it is stable to keep in the environment oxygen and gas concentration lwevel.After 2 hours mice is taken out, statistics is respectively organized mice survival number, calculates and respectively organizes the mice percentage survival.
The table 4 mice experimental result that resists cold
| Group | n | Dosage (g/k g) | The survival number | Survival rate (%) |
| A B C D | 10 10 10 10 | / 3 3.86 7.71 | 1 9 5 8 | 10 90 ** 50 * 80 ** |
Compare with the blank group,
*P＜0.05,
*P＜0.01.
3.2 the high temperature resistant experiment of mice: get 40 of ICR mices, male and female half and half, random packet, 10 every group, grouping and medication are the same.Irritate behind the stomach and mice to be put into 45 ± 1 ℃ calorstat in 30 minutes, clock immediately, and close observation, keep ventilation state, it is stable to keep in the environment oxygen and gas concentration lwevel.Take out whole mices in the calorstat after 30 minutes, calculate administration group and control group mice survival number, its result is referring to table 5.
The high temperature resistant experimental result of table 5 mice
| Group | n | Dosage (g/kg) | The survival number | Survival rate (%) |
| A B C D | 10 10 10 10 | / 3 3.86 7.71 | 1 6 4 8 | 10 60 * 40 * 80 ** |
Compare with the blank group,
*P＜0.05,
*P＜0.01.
From table 4,5 as can be known the compound cynomorium oral liquid high dose can significantly improve the anti-stress ability (P＜0.05 or 0.01) of animal.
4, to hydrogen can due to " insufficiency of kidney-YANG " card male mice influence
72 of the male mices of Kunming kind, body weight 18～22g divides 6 groups at random, gastric infusion or 0.5%CMCNa, every day 1 time, continuous 6 days, volume was 20ml/kg.In experiment beginning first day, except that matched group intramuscular injection normal saline, all the other 4 groups equal intramuscular injection hydrocortisone 20mg/kg, the next day 1 time, totally 3 times, after the last administration 1 hour, weigh, take temperature writes down (18 ℃ of autonomic activities number of times in 10 minutes (XZC4 type toy autonomic activities analyzer) and low temperature swimming, depth of water 35cm) time, the results are shown in Table 6.
The influence of table 6 pair mice " insufficiency of kidney-YANG " disease (x ± s, n=12)
| Group | Dosage (g/kg) | Body temperature (℃) | Autonomic activities number of times (inferior) | Swimming time (min) | Body weight gain (g) |
| Dosage group small dose group in the heavy dose of group of normal control model contrast | 7.71 3.86 1.93 | 38.2±0.43 ** 37.5±0.46 38.2±0.45 ** 38.1±0.57 * 38.1±0.50 | 553±93. 3** 327±71.7 493±82.2 ** 475±125 ** 425±101 * | 19.8±2.04 ** 16.1±1.4 19.7±2.6 ** 18.8±1.9 ** 18.0±2.6 * | 2.2±1.8 ** -1.2±2.2 -0.5±1.4 0.1±1.3 -0.4±1.7 |
Compare with model group
*P＜0.05,
*P＜0.01.
By table 6 result as seen, the compound cynomorium oral liquid can improve " insufficiency of kidney-YANG " disease mouse temperature, increases mice autonomic activities number of times, prolongs mice low temperature swimming time, shows that this medicine improves significantly to mice " insufficiency of kidney-YANG " disease.
Compound cynomorium oral liquid toxicology test
1. its mouse oral acute toxicity test
Get 50 of healthy Kunming mouses, ♀ ♂ half and half is divided into 5 groups at random, 10 every group.By 5 dosage groups of geometric progression design, maximal dose is 62.2g.kg
-1, the adjacent doses ratio is 1: 0.8.Behind the mice fasting 12h, once irritate the stomach contamination with the compound cynomorium oral liquid, capacity is 0.6ml (20g)
-1Body weight, 10d is observed in the contamination back, and record poisoning symptom, death time and death toll are calculated LD with the Bliss method
50
The animal poisoning manifestations is a weakness after the administration, creep and dyspnea until death.In the 48h, measure LD
50Be 43.34gkg
-1
2. long term toxicity test
Get body weight and be 80 of the SD rats of 100～120g, ♀ ♂ half and half is divided into 4 groups at random, and 20 every group, the conventional raising.With LD
500.2,0.1,0.05 establish 3 dosage groups 8.7,4.3,2.2gkg
-1D
-1With 1 matched group, the difference gastric infusion.The administration volume is 20mlkg
-1, matched group gives the distilled water with volume.Observed for 1 week before the administration, i.e. each treated animal activity, diet, feces has no abnormal, begins administration then.Be administered once every day on time, continuously 45d.The every 7d of experimental session measures a body weight, and changes the adjustment dosage according to rat body weight.Write down every observation index, each dosage group was got 2/3 and 1/3 animal at random after administration finished back and drug withdrawal 14d, carry out the inspections of four routine examinations such as hematological erythrocyte, hemoglobin, numeration of leukocyte and leukocyte differential count and hematology's biochemical indicator (5 indexs such as GPT, albumin, total protein, blood urea nitrogen, blood glucose), and cut open rapidly core, organ such as liver, spleen, lung, kidney, uterus, testis, brain, perusal has no abnormal.Measure above-mentioned organ weights, calculate organ coefficient, and internal organs such as the heart of high dose and matched group, liver, spleen, lung, kidney, rectum are carried out histopathologic examination.
Behind administration 3d, the rat of high, medium and low dosage group stool all begins thinning, and low dose group takes a turn for the better to some extent after the week.High behind the administration 30d, middle dosage group ♂ anus becomes unclean, and tail is dirty, and when the 28th day administration phase and the 30th day each dead 1, matched group is not seen above-mentioned phenomenon.In whole experiment, each body weight of organizing rat presents in various degree growth at different times, and high, medium and low dosage group body weight gain during administration is slow, with matched group significant difference (P＜0.05) is arranged relatively.But in convalescent period, the body weight gain of high, middle dosage group rat is accelerated, and it is good that body constitution is recovered.
Administration finish and every detection index (except that GPT) of after convalescent period, respectively organizing rat all in range of normal value, each dosage group and matched group are not seen notable difference (P＞0.05, table 1,2).Dissect internal organs, naked eyes are not seen obvious pathological changes, and each dosage group and every internal organs index are all approaching with the contrast class value, and difference does not have significance meaning (P＞0.05).Slight water degeneration appears in pathological examination high dose group part animal liver tissue, but the slight water degeneration of drug withdrawal convalescent period hepatic tissue belongs to the reversibility pathological changes, the no any pathological change of other tissue also along with disappearance.
A large amount group dosage every day is 8.7gkg
-1(be equivalent to clinical consumption 80 times), continue about 30d, caused 10% animal dead.The rat of high dose group stool is rarer always, and this is due to the Herba Cynomorii loosening bowel to relieve constipation.When experiment finished, the content of high dose group GPT and matched group relatively had significant differences (P＜0.01), and the GPT value that drug withdrawal convalescent period records is starkly lower than and tests the GPT value that end records, referring to table 7,8.
Table 7 compound cynomorium oral liquid is learned the influence (x ± s) of index to 45 days blood biochemical of rat oral gavage
| Group | The GPT enzyme unit | Albumin/g.dl -1 | Blood urea nitrogen/d.dl -1 | Total protein/g.dl -1 | Blood glucose/mmol.l -1 |
| Dosage high dose in the matched group low dosage | 18.27±4.56 29.23±14.69 46.96±18.23 69.98±24.78 | 4.36±0.27 4.34±0.36 4.26±0.66 3.89±0.30 | 9.54±0.95 8.56±1.47 8.92±1.54 9.52±2.30 | 8.56±0.82 8.22±0.80 8.15±0.86 7.98±0.77 | 2.27±0.69 2.31±0.52 2.41±0.71 2.26±0.77 |
GPT item and matched group be P＜0.05 relatively all, all the other the every and relatively more equal P of matched group＞0.05.
Table 8 rat is learned the influence (x ± s) of index to blood biochemical after convalescent period through 14d
| Group | The GPT enzyme unit | Albumin/g.dl -1 | Blood urea nitrogen/g.dl -1 | Total protein/g.dl -1 | Blood glucose/mmol.l -1 |
| Dosage high dose in the matched group low dosage | 20.17±4.38 14.36±5.78 17.66±4.23 49.92±5.93 | 4.26±0.31 4.41±0.33 4.41±0.58 42.89±0.45 | 10.52±1.19 9.76±1.72 9.33±3.12 8.77±2.89 | 8.23±0.7 8.17±0.65 8.51±0.76 8.08±0.80 | 2.33±0.55 2.48±0.62 2.27±0.69 2.12±0.72 |
Except that high dose GPT, all the other the every and relatively more equal P of matched group＞0.05.
Claims (2)
1. the medicine of an invigorating liver and kidney to treat dryness of large intestine and constipation, raw material of Chinese medicine by following weight ratio is formed: Herba Cynomorii 38～42%, Fructus Lycii 18～22%, Fructus Schisandrae Chinensis 18～22%, Mel 18～22%, the summation of raw material of Chinese medicine is 100%, and the sodium benzoate that adds above-mentioned raw material of Chinese medicine total amount 0.05% in addition is as additive.
2. the preparation method of the medicine of invigorating liver and kidney to treat dryness of large intestine and constipation is characterized in that, follows these steps to preparation:
1) prescription is made up of the raw material of Chinese medicine of following weight ratio:
Herba Cynomorii 38～42%, Fructus Lycii 18～22%, Fructus Schisandrae Chinensis 18～22%, Mel 18～22%, the summation of raw material of Chinese medicine is 100%, and the sodium benzoate that adds above-mentioned raw material of Chinese medicine total amount 0.05% in addition is as additive;
2) with Herba Cynomorii, Fructus Lycii, the Fructus Schisandrae Chinensis three flavor medical materials of prescription, get the Fructus Schisandrae Chinensis steam distillation earlier, collect distillate 500ml, standby; Other gets Herba Cynomorii, Fructus Lycii and the merging of Fructus Schisandrae Chinensis medicinal residues, soaks 12 hours, decocts secondary, 1.5 hours for the first time, 1 hour for the second time, gradation filtered, merging filtrate, being concentrated under 50 ℃ of conditions and measuring its relative density is 1.10 clear paste, adds ethanol and makes and contain the alcohol amount and reach 60%-65%, left standstill 24 hours, and filtered, filtrate recycling ethanol is to there not being the alcohol flavor, add 2 times of water gagings, mixing left standstill 24 hours, filter, get medicinal liquid;
3) get the Mel of formula ratio in addition, added water boil 30 minutes, filter filtrate and above-mentioned medicinal liquid mixing;
4) add the additive sodium benzoate in addition, add water to ormal weight, packing, sterilization is promptly.
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