CN100340261C - Chinese medicinal compsns. for treating postpartum disease - Google Patents
Chinese medicinal compsns. for treating postpartum disease Download PDFInfo
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- CN100340261C CN100340261C CNB2006100000740A CN200610000074A CN100340261C CN 100340261 C CN100340261 C CN 100340261C CN B2006100000740 A CNB2006100000740 A CN B2006100000740A CN 200610000074 A CN200610000074 A CN 200610000074A CN 100340261 C CN100340261 C CN 100340261C
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Abstract
The present invention relates to a Chinese medicine composition, a medicine containing the composition, a preparation method for the medicine and an application of the medicine. The composition comprises 10 to 50% of astragalus root, 1 to 10% of donkey-hide gelatin, 10 to 50% of motherwort, 1 to 15% of peach seed, 10 to 30% of angelica and 1 to 10% of argy wormwood leaf. The components can be Chinese medicinal materials or Chinese medicine water extract of which the quantity is equivalent to the raw Chinese medicinal materials. The Chinese medicine composition of the present invention can be used for treating postpartum diseases, such as puerpera blood depletion, puerpera blood stasis, etc.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, specifically, is a kind of Chinese medicine composition that is used for the treatment of diseases such as anemia in puerperal, blood stasis, and the component of said composition can be directly to be ground into Chinese crude drug that powder is used as medicine and/or the Chinese medicine extract that obtains through extraction.
Background technology
Puerpera's puerperal disease is the commonly encountered diseases and the frequently-occurring disease of gynecological, mainly show as diseases such as prolonged lochia, subinvolution of uterus, puerperal anemia, blood stasis, the traditional Chinese medical science belongs to the deficiency of qi and blood syndrome of blood stasis of holding concurrently, doctor trained in Western medicine belongs to the bad category of the involution of uterus in puerperal, disease sees that lochia exceeds the time limit incessantly, when dripping urine endlessly, not smooth not well, amount for a long time less, the color dimness has piece, no foul smell, empty and bearing-down sensation of the lower abdomen, pain, refreshing tired weak, pale complexion, tongue is dim or have petechia, deficient and weak pulse or string puckery or heavy etc., card genus deficiency of qi and blood, uterus silt resistance.Investigation according to world's rights and interests of women protection association shows; because pre-marital or antenatal artificial abortion, medicine stream, induced labor rate constantly increase; patient's quantity of diseases such as prolonged lochia increases rapidly; be not only the common disease in puerpera puerperal at reproduction age, miscarrying improperly or irregular easilier causes the generation of prolonged lochia and increases the weight of.
The medicine that is used for the treatment of diseases such as anemia in puerperal, blood stasis now is a lot, as: CHANFUKANG KELI, Cortex Eucommiae electuary etc., in the clinical practice, these medicines mostly cause it not dominate the market for a long time because of reasons such as curative effect are not remarkable, preparation is coarse, quality is wayward, stability of drug products is relatively poor, this shows Chinese patent medicine the puerperal of subinvolution of uterus treat market be still comparatively speaking blank, so market in urgent need develop a kind of determined curative effect and significantly, the Chinese medicine medicine of sophisticated technologies, treatment puerperal disease that drug quality is stable.
Summary of the invention
The inventor comes from theory of Chinese medical science, sums up experience in many ways, is closed by " Medical Treasures of the Golden Chamber " Ass-hide Glue and Argyi Leaf Decoction, " interior wound is debated puzzled opinion " Radix Angelicae Sinensis decoction for tonifying blood two reef knots, carries through the clinical practice empirical to form.The present invention is a Chinese medicine composition, is to extract the pure Chinese medicinal preparation that makes by Six-element Chinese medicine process, can improve symptoms such as anemia in puerperal, blood stasis greatly, and determined curative effect, and is safe and effective.
The object of the present invention is to provide a kind of Chinese medicine composition and comprise the medicine of said composition, this medicine can be treated diseases such as anemia in puerperal, blood stasis.
The present invention also aims to provide manufacturing method for above mentioned medicine,, can obtain being used for the treatment of evident in efficacy, the sophisticated technologies of puerperal disease, stay-in-grade pharmaceutical composition by this method.
The present invention also aims to provide aforementioned pharmaceutical compositions to be used for the treatment of the purposes of puerperal diseases such as anemia in puerperal, blood stasis.
In order to achieve the above object, the invention provides a kind of Chinese medicine composition, component comprises Radix Astragali 10-50%, Colla Corii Asini 1-10%, Herba Leonuri 10-50%, Semen Persicae (stir-fry) 1-15%, Radix Angelicae Sinensis 10-30%, Folium Artemisiae Argyi 1-10% in the said composition, and the source of described component can be Chinese crude drug fecula or the Chinese crude drug extract that is equivalent to above-mentioned Chinese crude drug crude drug amount.
Above-mentioned composition of the present invention is the systematic treating side's medicine at puerperal, disease such as anemia, blood stasis was set up, it is formed for Chinese medicine compound, pay attention to the raising of autoimmune system, blood circulation promoting and blood stasis dispelling, QI invigorating and blood producing, compensate qi and blood is accelerated the body rehabilitation in puerperal in treatment subinvolution of uterus, and the medicine source of crude drug is extensive, has no side effect, reasonable recipe, curative effect is good.
Composition prescription of the present invention is reasonable, side according to traditional medicine separates, Radix Astragali sweet in the mouth is warm in nature in the side, go into spleen, lung meridian, " Mingyi Bielu " carries its " by the five internal organs stagnant blood; it is deficient to mend the husband ", " medicine origin " meaning: " the kind weakness of the spleen and stomach of controlling ", Materia Medica of Decoction also claims: " the deficient deficiency of tonifying five ZANG-organs ".The deficient QI failing to control person, the energy hemostasis by invigorating QI of using; The Qi and blood deficiency person, the then qi-supplementing, blood-engendering of using; Blood stasis due to qi deficiency person, but the benefiting QI for activating blood circulation of using are the good merchantable brand of invigorating the spleen and replenishing QI.So we reuse the gas of the big tonifying the spleen and stomach of the Radix Astragali, with abundant source of generating QI and blood, both can answer the power that it is had under one's command, the prosperous blood of gas is given birth to, the congested row of gas, blood stasis dispelling is not just being hindered, and is monarch drug in the side.
The flat matter of Colla Corii Asini sweet in the mouth profit is gone into liver, kidney channel, and the Shennong's Herbal meaning is controlled " woman's hematochezia ", and this medicine was both kind enriches blood, can stop blooding again, till the more than good merchantable brand commonly used of hematochezia in puerperal.
Herba Leonuri acrid in the mouth, bitterness are slightly cold, and go into the heart, Liver Channel." Amplification on Materia Medica addendum " meaning: " all diseases in preceding puerperal of managing property, promoting the circulation of blood is nourished blood ", " book on Chinese herbal medicine covers sheng, a reed pipe wind instrument " cloud: " clots absorbing blood, tissue regeneration promoting blood ".This medicine master goes into blood system, the special blood circulation promoting and blood stasis dispelling of merit and regulating menstruation is married woman's multiparity key medicine.Be harmonious with above-mentioned Colla Corii Asini two medicines, tonifying blood and arresting bleeding does not stay the stasis of blood, and blood circulation promoting and blood stasis dispelling is not just being hindered, and is ministerial drug in the side altogether.
The monarch and his subjects are furnished with the wonderful of QI and blood interpromoting relation in five elements mutually, with the principal drug assistance hemostasis by invigorating QI, and the merit of benefiting QI for activating blood circulation.
Semen Persicae bitter in the mouth, Gan Xingping go into the heart, liver, large intestine channel, and Shennong's Herbal is said " main blood stasis, blood closes " addiction, " medicine origin " meaning " energy benefiting blood and regulating blood circulation ", and it can be enriched blood, and can invigorate blood circulation again, and the energy menstruction regulating and pain relieving of holding concurrently is a good medicine of controlling all diseases of women's blood deficiency stasis.With Colla Corii Asini mutually 5, the power of enriching blood wins, and the prosperous gas of blood is given birth to, and the prosperous blood of gas is capable, with the power of principal drug assistance; Semen Persicae of the present invention (stir-fry) is meant the Semen Persicae after the process of preparing Chinese medicine.
Folium Artemisiae Argyi bitter in the mouth, hot warm in nature is returned the liver,spleen,kidney warp." property of medicine opinion " carries: " only collapse blood, antiabortive, end stomachache ", " Newly Revised Canon of Materia Medica " meaning: " main hematochezia " for controlling woman uterine bleeding, gestation hemorrhage is used good merchantable brand always, and with Colla Corii Asini mutually 5, the merit benefit of hemostasis increases.Itself and Semen Persicae are adjuvant drug altogether.
" medical science main story " cloud: " the Radix Angelicae Sinensis person makes each merit of returning to some extent of QI and blood number also ", so have the blood of drawing return through merit, holding concurrently is messenger drug.
All medicines share, and QI and blood is ruled together, reinforcing and reducing concurrently, benefiting QI and nourishing blood, hemostasis and do not stay the stasis of blood, blood circulation promoting and blood stasis dispelling tissue regeneration promoting and just not hindering; QI and blood must be mended, and has under one's command and has the right, and blood stasis must be dispelled, and fresh blood is spontaneous, then blood follow into through and go, all diseases can be separated, and are bad for the treatment involution of uterus in puerperal, card belongs to QI and blood deficiency, uterus silt resistance person's good recipe.
In the compositions of the present invention; can select the whole starch of flavour of a drug; also can extract the back is used as medicine with the form of extract; also can select extracting section volatile oil, part to be used as medicine jointly for extract; as long as comprised said components; said composition can reach the drug effect of treatment Blood stasis in puerperal, promptly within the category that the present invention protected.In a preferred embodiment of the invention, the Radix Astragali, Herba Leonuri are used as medicine with the form of water extract; Radix Angelicae Sinensis, Semen Persicae, Folium Artemisiae Argyi are extracted volatile oil earlier, volatile oil is preferably made clathrate (being also referred to as inclusion complex), the medicinal residues water extraction, extracting solution is merged into medicinal liquid with the lower layer of water liquid of carrying behind the volatile oil, carry with ethanol is counter, the effective ingredient of getting alcohol extract and two kinds of forms of above-mentioned volatile oil clathrate compound is used as medicine jointly; The Colla Corii Asini molten.
In a preferred embodiment of the invention, the component of aforementioned pharmaceutical compositions and proportioning (weight) are preferred: the Radix Astragali 32%, Colla Corii Asini 6%, Herba Leonuri 32%, Semen Persicae (stir-fry) 10%, Radix Angelicae Sinensis 13% and Folium Artemisiae Argyi 7%.
The present invention also provides a kind of medicine for the treatment of puerperal disease, it comprises above-mentioned Chinese medicine composition and pharmacy acceptable auxiliary, and according to the difference of pharmaceutical dosage form, selected adjuvant is also different, in this pharmaceutical preparation, be at least 0.4mg/g with the content of Radix Astragali effective ingredient astragaloside.
Above-mentioned pharmaceutical preparation can be any dosage form, is preferably peroral dosage form, and it is that on the pharmacy meaning all can supply oral dosage form, preferred particulates agent, capsule, tablet, oral liquid and syrup; Because Colla Corii Asini is the animal colloid, adopt its molten is used as medicine in order to protect the effective ingredient the present invention that is not destroyed, and in order to make medicine keep preferable mouthfeel; characteristics according to the puerpera; and preparation should act on considerations such as mitigation, in an embodiment of the present invention, and more preferably granule and capsule.Experimental results show that, the curative effect of medicine of the present invention obviously is better than the Chinese patent medicine (as: CHANFUKANG KELI) of existing treatment puerperal disease, and by comparison, the present composition has reduced the flavour of a drug of existing Chinese patent medicine and formed, farthest reduce dosage, and improved drug effect.
The present invention also provides manufacturing method for above mentioned medicine, comprising:
(1) getting Colla Corii Asini in the prescription ratio is ground into and obtains Colla Corii Asini (melted) cream after fritter adds the water molten;
(2) Radix Astragali, Herba Leonuri extracting in water are concentrated into relative density 1.00-1.45 (50-75 ℃) one-tenth herbal decoction;
(3) take by weighing Radix Angelicae Sinensis, Semen Persicae, Folium Artemisiae Argyi elder generation extracting in water volatile oil in the prescription ratio, it is standby to collect volatile oil; Leach the water liquid that extracts behind the volatile oil, the medicinal residues water extraction, merge with water liquid behind the extraction volatile oil, be concentrated into relative density 1.0～1.6 (50-75 ℃), add alcoholic solution (preferred alcohol, ethanol as 70～95%) counter carrying stirred, left standstill, and gets alcohol extract and is concentrated into relative density 1.10-1.50 and makes into precipitate with ethanol extractum (thick paste).
(4) above-mentioned Colla Corii Asini (melted) cream, herbal decoction, volatile oil and precipitate with ethanol extractum are mixed.
In order to obtain the pharmaceutical composition that active component is more stable, active constituent content is higher, the preferred available ethanol of the volatile oil that obtains in the above-mentioned steps (3) is as solvent, with beta-schardinger dextrin-inclusion composite volatile oil inclusion complex.
The technology that the present composition is prepared into various peroral dosage forms is as follows:
A. granule dosage form: the herbal decoction that the Colla Corii Asini (melted) cream that (1) method is made and (2) method are made, the precipitate with ethanol cream that (3) method is made mix, and each recipe quantity compound adds dextrin or other binding agent, and fully mixing is put 60-80 ℃ of drying, pulverizes; The volatile oil that makes with said method or its inclusion complex, correctives (for example steviosin), fully mixing is granulated, drying, promptly.
B. tablet: the herbal decoction that the Colla Corii Asini (melted) cream that (1) method is made and (2) method are made, the precipitate with ethanol cream that (3) method is made mix, and compound adds dextrin or other binding agent, and fully mixing is put 60-80 ℃ of drying and crushing; The volatile oil or its inclusion complex that make with above-mentioned steps (3), fully mix (also can add correctives as required), add suitable amount of adhesive (for example starch) and disintegrating agent (for example carboxymethyl starch sodium) mixing, granulation, drying, add moderate lubrication agent (for example magnesium stearate), disintegrating agent (carboxymethyl starch sodium) mixing again, tabletting also can carry out film coating, promptly as required.
C. capsule: the herbal decoction that the Colla Corii Asini (melted) cream that (1) method is made and (2) method are made, the precipitate with ethanol cream that (3) method is made mix, and each recipe quantity compound adds dextrin or other binding agent, abundant mixing, and drying is pulverized; The volatile oil that makes with said method or its inclusion complex and correctives (for example steviosin), an amount of filler (for example starch) mixing, drying incapsulates, promptly.
D. syrup: get Chinese crude drug in the prescription ratio, Colla Corii Asini is ground into fritter and adds after the water molten standby; The Radix Astragali, Herba Leonuri decoct with water, and merge decocting liquid, are concentrated into relative density and are 1.00-1.45 (50-75 ℃ of survey), and be standby; Radix Angelicae Sinensis, Folium Artemisiae Argyi, Semen Persicae extract volatile oil, medicinal residues decoct with water, water liquid behind aqueous extract and the extraction volatile oil merges, and being concentrated into relative density is the medicinal liquid of 1.0-1.6 (50-75 ℃), preferably under fully stirring, (preferred 1-3 doubly measures to add ethanol precipitation, the ethanol of 80-95%), leave standstill, get supernatant, add volatile oil (or volatile oil inclusion complex), mix with standby Colla Corii Asini (melted) cream and herbal decoction, dissolving adds simple syrup, put cold, add sodium citrate or other antiseptic and stir evenly, leave standstill, draw supernatant, fill, promptly.
E. oral liquid: get Six-element medical material in the prescription in the prescription ratio, the extraction of medical material and D with, add correctives (for example sucrose), sodium citrate and/or antiseptic, leave standstill, draw supernatant, fill, promptly.
F. pill: the herbal decoction that the Colla Corii Asini (melted) cream that (1) method is made and (2) method are made, the precipitate with ethanol extractum that (3) method is made mix, and each recipe quantity compound adds dextrin or other binding agent, abundant mixing, and drying is pulverized; The volatile oil or the abundant mixing of its inclusion complex that make with said method add that Mel or water or Cera Flava or 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 that relates in the various drug forms of the present composition---volatile oil inclusion complex (or claiming clathrate), it also can be the volatile oil without enclose (knot), its mechanism of action is identical with drug effect, because the physico-chemical property of volatile oil itself, characteristics in conjunction with preparation process, the present invention preferably adopts the volatile oil inclusion complex, more preferably the inclusion complex that obtains behind beta-cyclodextrin inclusion compound of volatile oil.
According to this area routine techniques, compositions of the present invention also can be made into honeyed pill, water-honeyed pill, the watered pill, paste pill, wax pill, concentrated pill, 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.For example, when needs prepared the condensed water honeyed pill, this step also can comprise with the hydromel of 5%-25% carried out (comprising crude drug powder and extract dry extract etc.) process of general system contraction to dried medicated powder, to make condensed water honeyed pill product; Again for example: the condensed water honeyed pill contracts through general ball and generally also will polish behind the ball, and drying can obtain final product.
In above-mentioned preferred embodiment, the design of the concrete parameter of preparation were established is according to the character of different Chinese crude drugs and pharmacological action difference, definite with screening by analysis optimization technology.
For example, contain a large amount of protein and several amino acids and trace element in the Colla Corii Asini, if its drug effect is descended, so select molten to be used as medicine through heating extraction; Contain multiple volatile oil and pure dissolubility effective ingredient in Radix Angelicae Sinensis, Semen Persicae, the Folium Artemisiae Argyi, so adopting earlier, extraction volatile oil boils with decocting again, alcohol is counter to be carried, in order more effectively to extract active component, carry out again with the water extract merging of medicinal residues with extracting lower aqueous solution behind the volatile oil that ethanol is counter to be carried in the practical operation; The volatile oil highly volatile will improve the stability of volatile oil component greatly behind its enclose, it is more complete that it is absorbed.Experiment showed, that through pharmacology pharmacodynamic it is rational selection process scheme.The technical conditions of water extraction (optimum technology parameter of extraction) are to be index with paste-forming rate and Astragaloside content, adopt three factors, three water-glasses to carry out that orthogonal test determines.
The Chinese crude drug that is adopted in the compositions of the present invention is the medical material that version pharmacopeia in 2000 is recorded, and through identifying, every index all meets the pharmacopeia regulation.
The physical and chemical identification of compositions of the present invention and medicine: wherein the assay of astragaloside is measured according to dual-wavelength scanning, evidence, and this method sensitivity, favorable reproducibility, in medicine of the present invention, every gram contains astragaloside should be at least 0.4mg.
The inspection of arsenic salt and heavy metal in the medicine of the present invention: press one one of Chinese Pharmacopoeia version in 2000, the regulation under appendix IXE, the IXF item checks that to the arsenic salt and the heavy metal of this product 3 batch samples the result is in prescribed limit.
Health examination in the medicine of the present invention:, meet pharmacopeia hygiology standard through health examination.
The present invention also provides the application of above-mentioned composition in the medicine of preparation treatment puerperal disease.
The clinical dosage of medicine granule of the present invention is recommended as 10g/ time, 3 times/day.
The pharmacology pharmacodynamic experimental study
Experimental drug: the granules medicine of the embodiment of the invention 1 (hereinafter referred to as the happy granule of Colla Corii Asini puerpera);
Contrast medicine: CHANFUKANG KELI (manufacturer is Shenzhen LangShengYiYao company limited, and main component is Herba Leonuri, Radix Angelicae Sinensis, Radix Ginseng, the Radix Astragali, Radix Polygoni Multiflori, Semen Persicae, Pollen Typhae, Radix Rehmanniae Preparata, Rhizoma Cyperi, Thallus Laminariae (Thallus Eckloniae), the Rhizoma Atractylodis Macrocephalae, Auricularia).
Normal control and model control group: irritate the stomach feedwater.
One. the research of vigorate qi and replenish the blood effect
1. to the influence of mice hemorrhagic anemia:
60 of mices, the male and female dual-purpose, body weight 20 ± 2g, 10 of matched groups, all the other ip in mice heparin sodium injection 640u/kg, at once by the blood-letting of eyeball of mouse rear vein beard, each 0.18ml/10g, blood-letting is 2 times in the 8h, makes the hemorrhagic anemia model.Cut the blood sampling of Mus tail behind the 24h and measure RBC (erythrocyte) in the blood, Hb (hemoglobin), the hemorrhagic anemia mice is divided into 5 groups at random, the anemia model control group, chanfukang groups of grains 12g/kg, the happy granule 4g/kg of Colla Corii Asini puerpera, 8g/kg and 16g/kg group, gastric infusion, the stomach feedwater is irritated in normal control and model contrast, and continuous once a day 5d cuts the blood sampling of Mus tail and measures RBC, Hb in the blood behind the last administration 24h.By shown in the table 1, the happy granule of Colla Corii Asini puerpera can make the RBC of hemorrhagic anemia mice, Hb return to level.
The happy granule of table 1. Colla Corii Asini puerpera is to the influence of hemorrhagic anemia mice RBC, Hb (n=10, x ± s)
| Group | Dosage (g/kg) | RBC10 12/L | Hb(g/L) | ||
| Before the medicine | Behind the medicine | Before the medicine | Behind the medicine | ||
| The happy granule of normal control anemia model contrast chanfukang granule Colla Corii Asini puerpera happy granule Colla Corii Asini puerpera happy granule Colla Corii Asini puerpera | - - 12 4 8 15 | 9.14±1.08 5.16±0.71 △△△ 4.87±0.50 5.02±0.61 4.89±0.42 5.06±0.53 | 9.32±0.75 7.88±1.19 △△ 8.63±1.28 9.95±2.18 * 10.2±1.08 *** 10.5±1.24 *** | 183.5±14.8 86.7±13.7 △△△ 89.4±7.1 88.6±8.8 84.1±11.3 89.9±7.0 | 191.2±9.7 166.8±8.2 △△△ 181.2±19.3 * 187.4±15.2 *** 197.9±20.4 *** 199.5±12.0 *** |
△ △P＜0.01
△ △ △＜0.001 with the normal control group relatively
*P＜0.05,
* *Compare with model control group P＜0.001
2. to the influence of mouse monokaryon macrophage phagocytic function: 50 of mices, the male and female dual-purpose, body weight 20 ± 2g is divided into 5 groups at random, normal control is irritated the stomach feedwater, chanfukang granule 12g/kg group, Ah produce'ing FULE KELI 4g/kg, 8g/kg and 16g/kg group, gastric infusion, once a day, continuous 5d.Behind the last administration 24h, mouse tail vein injection 20% india ink normal saline 0.1ml/10g gets blood 10ul from the mouse orbit venous plexus when 2min, 17min respectively after injection, be dissolved in 0.1%Na
2CO
3Among the solution 2ml, measure optical density OD value at 722 type spectrophotometer wavelength 680nm places, and calculate phagocytic index K value.Shown in table 2 result, the happy granule of Colla Corii Asini puerpera can obviously strengthen the huge ability of biting of mouse monokaryon.
The happy granule of table 2 Colla Corii Asini puerpera is to the influence of mouse monokaryon macrophage function (n=10, x ± s)
| Group | Dosage (g/kg) | Phagocytic index (K value) |
| The happy granule of normal control group chanfukang granule Colla Corii Asini puerpera happy granule Colla Corii Asini puerpera happy granule Colla Corii Asini puerpera | - 12 4 8 16 | 0.03053±0.00843 0.03743±0.00469 * 0.03690±0.00659 0.03976±0.00710 * 0.04287±0.00985 ** |
*P＜0.05
*Compare with the normal control group P＜0.01
3. the influence that mice load swimming endurance is moved: 50 of mices, male and female dual-purpose, body weight 20 ± 2g, be divided into 5 groups at random, every group 10, the normal control group is irritated stomach feedwater, chanfukang granule 12g/kg, the happy granule 4g/kg of Colla Corii Asini puerpera, 8g/kg and 16g/kg group, gastric infusion, once a day, continuous 5d, carry out mice load swimming exercise behind the last administration 30min, the mouse tail load weight is 10% of a body weight.The load mice is put into depth of water 22cm, and 13 ℃ of water temperatures in 50 * 35 * 25cm (length * wide * height) container, are extremely drowned mice the dead time from putting into water with the stopwatch imprinting.Shown in table 3 result, the happy granule energy of Colla Corii Asini puerpera significant prolongation mice swimming time has the obvious anti-fatigue effect.
The happy granule of table 3 Colla Corii Asini puerpera is to the influence of mice load swimming endurance time (n=10, x ± s)
| Group | Dosage (g/kg) | Be drowned the time (sec) |
| The happy granule of normal control group chanfukang granule Colla Corii Asini puerpera happy granule Colla Corii Asini puerpera happy granule Colla Corii Asini puerpera | - 12 4 8 16 | 171.5±43.7 207.2±40.2 233.0±45.5 ** 279.9±65.5 *** 355.4±73.7 *** |
*P＜0.01
* *Compare with normal group P＜0.001
Conclusion: medicine of the present invention can make the RBC of hemorrhagic anemia mice, Hb return to normal level, can obviously strengthen the phagocytic function of mouse monokaryon macrophage, and significant prolongation load mice is swum the fatigue proof time.
Two, the research of involution of uterus effect
1. to the influence of rabbit isolated uterine smooth muscle contraction
Rabbit, female unpregnancy, body weight 2.5～3.0kg, 24-48h subcutaneous injection diethylstilbestrol 4mg/kg before the experiment manually impels animal to be in proestrus or rutting period, to improve the sensitivity of uterus to medicine.Shoot rabbit during experiment dead, cut off the abdominal cavity rapidly, isolate complete uterus gently, put into the plate that fills Smith solution immediately, carefully remove residual fat and connective tissue.The ligation of vagina end threading is fixed on the L type ventilation hook, the long uterus of the about 2cm of clip, put into the Maxwell melting bath pipe that fills 30ml Smith liquid, the ligation of other end threading is on the muscular strength transducer, the water bath with thermostatic control of isolated organ analyzer remains on 37 ± 0.5 ℃, and continuous bubbling air (60-90 bubble/min) in working solution.After writing down one section normalized curve, inject different pharmaceutical, observe the variation of uterine smooth muscle shrinks before and after the administration amplitude, frequency and uterine motility (frequency * amplitude), and before carrying out administration, self relatively reach after the administration between group relatively.
The happy granule of table 4 Colla Corii Asini puerpera is to the influence of rabbit isolated uterine smooth muscle contraction amplitude (n=5, x ± s)
| Medicine | Dosage g/L | Before the medicine (mm) | Medicine after-contraction amplitude (mm) | ||
| 10 minutes | 20 minutes | 30 minutes | |||
| The happy granule of normal saline chanfukang granule Colla Corii Asini puerpera happy granule Colla Corii Asini puerpera happy granule Colla Corii Asini puerpera | - 6.7 2 4 8 | 24.88±3.96 25.67±7.53 24.00±6.72 27.75±6.18 22.58±5.63 | 25.60±3.85 51.33±17.83 *△ 40.67±4.76 ***△△ 47.67±8.98 ***△△ 56.75±2.79 ***△△ | 25.00±3.54 54.67±15.67 **△△ 37.00±5.90 **△ 45.75±3.66 ***△△ 53.83±4.07 ***△△△ | 25.80±3.96 42.50±9.83 **△ 28.83±6.27 42.50±4.55 ***△△ 47.50±4.64 ***△△△ |
*P＜0.05,
*P＜0.01,
* *Compare with normal saline P＜0.001
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001 self administration relatively
The happy granule of table 5 Colla Corii Asini puerpera is to the influence of rabbit isolated uterine smooth muscle contraction frequency (n=5, x ± s)
| Medicine | Dosage g/L | Before the medicine (inferior min) | Medicine after-contraction frequency (inferior/min) | ||
| 10 minutes | 20 minutes | 30 minutes | |||
| The happy granule of normal saline chanfukang granule Colla Corii Asini puerpera happy granule Colla Corii Asini puerpera happy granule Colla Corii Asini puerpera | - 6.7 2 4 8 | 2.88±0.11 2.90±0.10 2.72±0.26 2.68±0.26 2.96±0.38 | 3.16±0.48 1.86±0.31 ***△△ 3.72±0.24 *△△△ 3.47±0.21 △△ 3.14±0.33 | 2.92±0.11 1.68±0.18 ***△△ 3.33±0.21 **△△ 3.25±0.46 2.66±0.41 | 2.96±0.09 1.34±0.30 ***△△ 3.03±0.16 3.43±0.23 ***△△ 3.26±0.34 |
*P＜0.05,
*P＜0.01,
* *Compare with normal saline P＜0.001
△ △P＜0.05,
△ △ △Compare before and after P＜0.001 self administration
The happy granule of table 6 Colla Corii Asini puerpera is to the influence of rabbit isolated smooth muscle energy (n=5, x ± s)
| Medicine | Dosage g/L | Before the medicine (mm time/minute) | Medicine after-contraction energy (mm time/minute) | ||
| 10 minutes | 20 minutes | 30 minutes | |||
| The happy Colla Corii Asini puerpera of the happy Colla Corii Asini puerpera of normal saline chanfukang granule Colla Corii Asini puerpera is happy | - 6.7 2 4 8 | 71.58±11.51 69.72±20.85 64.85±18.12 75.35±22.77 68.28±17.31 | 82.00±21.84 103.88±54.72 150.98±19.16 ***△△ 165.07±30.82 ***△△ 176.86±18.12 ***△△△ | 72.80±8.76 85.88±26.40 122.80±17.81 ***△△ 149.26±28.47 ***△△ 144.40±26.51 ***△△ | 76.60±13.39 59.00±19.99 88.07±22.29 146.43±22.69 ***△ 154.32±17.39 ***△△ |
*P＜0.01,
* *Compare with normal saline P＜0.001
△ △P＜0.01,
△ △ △Compare before and after P＜0.001 self administration
Show that by table 4,5,6 results normal saline there is no obvious influence to rabbit isolated uterine smooth muscle contraction frequency, amplitude and uterine smooth muscle activity; Behind one section normal contraction curve of record, add the happy granule of Colla Corii Asini puerpera, observe after the administration 10,20,30min is to the influence of rabbit isolated uterine smooth muscle contraction.By table 4,5, the happy granule of 6 presentation of results Colla Corii Asini puerperas (2g/L, 4g/L, 8g/L) the rabbit isolated smooth muscle there is tangible excitation, shows as the enhancing of uterus muscle tension force, shrinkage amplitude increasing, rhythm and pace of moving things quickening and drug influence and dosage and be the dependency positive correlation.
2. the influence that rabbit is shunk at the body uterine smooth muscle:
Rabbit, female unpregnancy, body weight 2.5～3.0kg, the intravenous anesthesia of pentobarbital sodium 40mg/kg rabbit ear edge, facing upward the position is fixed on the operating-table, in the hypogastric region unhairing, cut the abdominal cavity along the center hunter's line and find out duodenum and uterus, the ligation pylorus is put into catheter in ten duodenum 12 and is used with perfusion fully, choose one section that is about 3cm at a side cornua uteri, mid point stitches a surgical thread in order to being connected with the muscular tension transducer, and vagina end and fallopian tube ovary end sutured are respectively placed Smith solution (38.5 ± 0.3 ℃) with stomach wall around glass infuser on the fulcrum of special glass tube bottom both sides, and note insulation, treat that tracing one section normal contraction curve after uterine smooth muscle is stablized experimentizes.
The rabbit duodenum gives chanfukang granule 6.67g/kg, the happy granule 1.95g/kg of Colla Corii Asini puerpera has 3.90g/kg, before the observed and recorded administration and after the administration 10,20,30min and 1,2,3,5 hour happy granule of Colla Corii Asini puerpera be to the influence of rabbit at body uterine smooth muscle contraction movement.By table 7,8, that 9 presentation of results rabbit duodenums give the happy granule of Colla Corii Asini puerpera is the strongest in the excitation of body uterine smooth muscle to rabbit after 1～2 hour.
The happy granule of table 7 Colla Corii Asini puerpera to rabbit at the influence of body uterine smooth muscle shrinkage amplitude (n=5, x ± s)
| Medicine | Dosage g/kg | Before the medicine (mm) | Medicine after-contraction amplitude (mm) | ||||||
| 10 minutes | 20 minutes | 30 minutes | 1 hour | 2 hours | 3 hours | 5 hours | |||
| The happy donkey-hide gelatin puerpera of physiological saline chanfukang particle donkey-hide gelatin puerpera is happy | - 6.67 1.95 3.90 | 22.05± 4.86 26.93± 3.49 23.42± 4.01 23.89± 4.86 | 24.15± 5.99 28.88± 4.46 30.21± 4.66 # 33.45± 4.97 *# | 21.24± 5.65 27.50± 5.96 30.12± 4.41 *# 29.52± 5.31 * | 24.16± 4.35 28.00± 5.36 29.46± 4.88 30.79± 4.93 | 25.10± 5.76 34.73± 4.75 *# 34.40± 6.10 *## 38.67± 4.81 **## | 22.50± 6.35 41.76± 8.79 **## 40.67± 9.79 **## 47.94± 8.39 ***### | 24.38± 7.13 44.85± 7.40 **## 29.21± 7.61 31.09± 7.92 | 22.40± 6.93 42.55± 6.20 **## 20.67± 6.07 23.12± 5.74 |
#P＜0.05, compare before and after ###P＜0.001 self administration ##p＜0.01
*P＜0.05,
*P＜0.01,
* *Compare with normal saline P＜0.001
The happy granule of table 8 Colla Corii Asini puerpera to rabbit at the influence of body uterine smooth muscle contraction frequency (n=5 x ± s)
| Medicine | Dosage g/kg | Medicine last time/min | Medicine after-contraction frequency (inferior/min) | ||||||
| 10 minutes | 20 minutes | 30 minutes | 1 hour | 2 hours | 3 hours | 5 hours | |||
| The happy donkey-hide gelatin puerpera of physiological saline chanfukang particle donkey-hide gelatin puerpera is happy | - 6.67 1.95 3.90 | 5.92± 0.56 5.78± 0.46 5.60± 0.44 5.88± 0.40 | 5.94± 0.49 5.94± 0.43 5.80± 0.37 5.92± 0.44 | 5.84± 0.38 5.92± 0.65 5.82± 0.38 5.960± 0.48 | 5.90± 0.37 5.96± 0.44 5.98± 0.45 5.84± 0.38 | 5.80± 0.44 5.86± 0.34 5.68± 0.58 6.00± 0.59 | 5.96± 0.52 5.82± 0.51 5.60± 0.56 5.88± 0.61 | 5.92± 0.39 5.92± 0.59 5.80± 0.60 6.00± 0.64 | 5.76± 0.30 6.04± 0.48 5.88± 0.62 5.90± 0.57 |
All compare with matched group p＞0.05
The happy granule of table 9 Colla Corii Asini puerpera to rabbit at the influence of body uterine smooth muscle energy (n=5 x ± s)
| Medicine | Dosage g/kg | Preceding mm time/minute of medicine | Medicine after-contraction energy (mm time/minute) | ||||||
| 10 minutes | 20 minutes | 30 minutes | 1 hour | 2 hours | 3 hours | 5 hours | |||
| The happy donkey-hide gelatin puerpera of physiological saline chanfukang particle donkey-hide gelatin puerpera is happy | - 6.67 1.95 3.90 | 130.63± 31.31 154.74± 13.59 132.03± 31.11 141.71± 36.26 | 143.26± 36.65 172.44± 36.41 174.90± 27.11 198.01± 31.12 *# | 122.64± 27.64 165.35± 55.50 174.41± 19.90 **# 176.88± 42.50 * | 143.05± 30.98 166.44± 30.84 174.80± 20.54 # 178.69± 21.54 | 147.14± 43.42 204.30± 37.67 # 194.90± 39.66 # 233.43± 45.31 *## | 133.79± 38.38 244.26± 62.28 **# 231.45± 79.35 # 282.83± 65.28 **## | 144.09± 42.03 268.40± 71.73 *## 172.55± 60.93 185.10± 46.70 | 127.78± 34.74 257.58± 48.18 **## 121.25± 34.67 136.94± 41.35 |
#P＜0.05,
##P＜0.01,
###Compare before and after P＜0.001, self administration;
*P＜0.05,
*P＜0.01,
* *Compare with the normal saline group P＜0.001
Conclusion (of pressure testing): the happy granule of Colla Corii Asini puerpera have excited exsomatize, at body rabbit uterine smooth muscle, promote uterine contraction, discharge surplus blood, the turbid liquid in utero left over, satisfy and to go by stagnant blood, fresh blood must be living, make the long-pending postpartum uterine contraction of the stasis of blood in the uterine cavity weak due to bad treatment of the involution of uterus in puerperal.
Three, effect of dissolving stasis and relieving pain research
Influence to syndrome of blood stasis Mouse Uterus microcirculation disturbance blood flow:
50 of mices, female, body weight 26-30g is divided into 5 groups at random, the happy granule 4g/kg of Colla Corii Asini puerpera, 8g/kg, 16g/kg group, chanfukang granule 12g/kg and normal control group.The matched group feedwater, gastric infusion, once a day, continuous 3d, 1h after the last administration, pentobarbital sodium 45mg/kg ip anesthetized mice, cut open the belly, use JI-200 type laser-Doppler microcirculation blood flow analyser, time constant is 0.3 second, amplification is 10 times, and the microcirculation blood flow of imprinting is the magnitude of voltage in the unit interval.Probe is fixed in apart from mesometrium place, cornua uteri 5mm left side, keep probe and in whole experiment, do not have rotation and displacement, imprinting should zone microcirculatory blood flow 10min as modeling before the mesometrium blood flow, every then caudal vein is injected 10% high molecular dextran 0.1ml/10g, causes blood stasis type uterus model of microcirculation obstacle.Record modeling 0,1,5,10min microcirculation blood flow with comparison before the modeling, calculate uterus microcirculation blood flow rate of change (%).
Blood flow rate after the modeling=(the preceding blood flow of the preceding blood flow/modeling of blood flow-modeling after the modeling) * 100%
The happy granule of table 10 Colla Corii Asini puerpera is to syndrome of blood stasis Mouse Uterus due to the high molecular dextran
The influence of microcirculation disturbance blood flow (x ± s, n=10)
| Group | Dosage g/kg | △ blood flow before the modeling | Blood flow rate after the modeling #(％) | |||
| 0 minute | 1 minute | 5 minutes | 10 minutes | |||
| The happy donkey-hide gelatin puerpera of the happy donkey-hide gelatin puerpera of normal control chanfukang particle donkey-hide gelatin puerpera is happy | - 12 4 8 16 | 60.81±13.29 61.38±15.81 66.13±13.69 63.14±14.25 63.99±10.73 | -44.54±14.43 -16.45± 24.75 ** -6.39± 23.24 *** -3.93± 28.33 *** -0.87± 12.54 *** | -47.70±19.04 0.09± 25.36 *** 7.47± 17.38 *** 4.86± 25.43 *** 23.17± 19.22 *** | -48.18±13.21 12.65± 27.24 *** 7.58± 20.81 *** 12.50± 19.72 *** 25.39± 15.46U | -42.23±11.62 6.56± 25.43 *** 14.66± 16.84 *** 25.97± 19.81 *** 29.30± 12.72 *** |
*P＜0.01,
* *Compare with the normal control group P＜0.001
By table 10 presentation of results: the happy granule of Colla Corii Asini puerpera is the syndrome of blood stasis Mouse Uterus microcirculation disturbance (P＜0.001) that caused of antagonism high molecular dextran effectively, increases uterus microcirculation blood flow.
To luring the influence of pain agent acetic acid induced mice pain reaction:
50 of mices, male and female half and half, body weight 20 ± 2g, be divided into 5 groups at random, the normal control group is irritated the stomach feedwater, chanfukang granule 12g/kg group, the happy granule 4g/kg of Colla Corii Asini puerpera, 8g/kg, 16g/kg group, gastric infusion, once a day, 3d, every Mus ip% glacial acetic acid 0.1mg/10g behind the last administration 30min, at once manual time-keeping, behind the observed and recorded injection acetic acid in the 15min mice pain turn round the body number of times, show that the happy granule of Colla Corii Asini puerpera has significant analgesia role.
The influence of the happy granule Dichlorodiphenyl Acetate of table 11 Colla Corii Asini puerpera induced mice pain (n=10, x ± s)
| Group | Dosage (g/kg) | Pain is turned round body number of times/15min |
| The happy Colla Corii Asini puerpera of the happy Colla Corii Asini puerpera of normal control group chanfukang granule Colla Corii Asini puerpera is happy | - 12 4 8 16 | 27.6±8.81 21.5±8.29 21.3±6.34 19.3±7.53 * 14.0±3.92 *** |
*P＜0.05,
* *Compare with the normal control group P＜0.001
Experimental result shows: the happy granule of Colla Corii Asini puerpera can obviously alleviate the mice pain reaction due to the H+, and the obvious Blood stasis Mouse Uterus microcirculation disturbance that caused of antagonism high molecular dextran, illustrate that the happy granule of Colla Corii Asini puerpera has the effect of promoting blood circulation, removing blood stasis and relieving pain, the stasis of blood go then blood return through, general rule is not bitterly, QI-blood circulation, what the stasis of blood stagnation of the blood stagnated obtains to alleviate.
Four, the research of enriching blood for moistening the intestine effect:
50 of mices, male and female half and half, body weight 20 ± 2g is divided into 5 groups at random, and 10 every group, the normal control group is irritated the stomach feedwater, chanfukang granule 12g/kg group, the happy granule 4g/kg of Colla Corii Asini puerpera, 8g/kg and 16g/kg group, gastric infusion, once a day, continuous 3d.Mice fasting 6h before carrying out carbon ink propelling experiment, the medicine that will contain 10% carbon ink is given mouse stomach, animal is put to death in the 15min dislocation after the administration, change mouse peritoneal and separate mesentery, the clip upper end is to pylorus, and the lower end is to the small intestinal of ileocecus, place on the pallet and gently small intestinal is pulled into straight line, measure small intestinal length as " small intestinal total length ", the distance from pylorus to the prepared Chinese ink forward position is as " prepared Chinese ink is at the enteral advance distance ", and calculates prepared Chinese ink with formula and advance percentage rate.
The happy influence to the mouse small intestine wriggling of table 12 Colla Corii Asini puerpera (n=10 x ± s)
| Group | Dosage g/kg | Small intestinal total length (cm) | Carbon ink advance distance cm | Prepared Chinese ink propelling rate % |
| The happy Colla Corii Asini puerpera of the happy Colla Corii Asini puerpera of normal control group chanfukang granule Colla Corii Asini puerpera is happy | - 12 4 8 16 | 41.9±4.3 43.7±2.6 42.3±4.1 43.7±3.7 43.8±3.2 | 25.2±6.6 35.6±3.4 38.3±4.2 39.2±2.5 41.8±3.8 | 60.68±16.11 81.37±6.29 *** 90.72±7.37 *** 90.01±6.15 *** 95.58±7.13 *** |
* *Compare with the normal control group P＜0.001
The result represents by table 12, and the happy granule of Colla Corii Asini puerpera prepared Chinese ink advance distance and prepared Chinese ink propelling rate in mouse small intestine obviously increase, and show that the happy granule of Colla Corii Asini puerpera has the effect of enriching blood for moistening the intestine, and the symptom of blood deficiency dryness of the intestine constipation in puerperal is alleviated.
Conclusion: the present composition (the happy granule of Colla Corii Asini puerpera) is a compound Chinese medicinal preparation, and the clinical puerperal involution of uterus of being used for the treatment of badly has a definite curative effect.Above-mentioned experiment show composition grain of the present invention can obviously increase in the mice enterokinesia, have the effect of enriching blood for moistening the intestine, puerperal blood deficiency dryness of the intestine symptom is alleviated, effect is better than similar medicine chanfukang granule.
The happy granule of Colla Corii Asini puerpera has vigorate qi and replenish the blood, enhancing body nonspecific immunity function, and resisting fatigue makes the hemorrhagic anemia syndrome of deficiency of blood be adjusted to normal level; The energy enriching blood for moistening the intestine makes thin fluid injury in puerperal, intestinal lose the profit symptom and is improved; Promote to alleviate the palace pain that contracts by uterine contraction, improve Blood stasis uterus microcirculation disturbance, in the palace tissue regeneration promoting that contracts, have blood stasis dispelling, an effect of the two-ways regulation of invigorating blood circulation.
Toxicology test
Acute toxicity testing:
According to the acute toxicity test requirement, carry out trial test, because of this poison of drug is very little, can't measure LD50, so carry out maximum dosage-feeding mensuration in one day.
Get 40 of the mices of body weight 19-20g, male and female half and half, be divided into two groups at random, matched group is irritated the stomach feedwater, the administration group is irritated stomach and is given pharmaceutical composition of the present invention, and the administration volume is pressed 0.4ml/10g/ time, and gastric infusion is three times in the 24h, mice consumption 120kg/kg (being equivalent to crude drug 369.6g/kg) observed 7 then continuously as calculated.Press the maximum gastric capacity (0.4ml/10g that irritates of maximum concentration (the suitable crude drug 3.08g of the every ml of every gram) and mice, be administered three times in the 24h), calculate giving mice dosage is 120g/kg (369.6 crude drugs/kg), be equivalent to 70kg people's usual amounts every day 0.4286g/kg by kg body weight conversion and (be equivalent to 280 times of 92.4g crude drug/70kg), observed the variations such as body weight, feed, behavioral activity, hair color and feces of 7d before the administration of observed and recorded mice and after the administration then continuously 7 days.
The happy granule acute toxicity test of table 13 Colla Corii Asini puerpera to the influence of mice body weight change (g, x ± s, n=20)
| Group | Dosage (g/kg) | Body weight | The body weight gain rate | |
| Before the medication | After the medication 7 days | |||
| The happy granule of matched group Colla Corii Asini puerpera | - 120 | 19.03±0.65 18.93±0.61 | 24.11±0.78 23.90±0.83 | 26.69 26.25 * |
*Compare with matched group p＞0.05
By table 13 presentation of results, administration group and matched group body weight are not seen notable difference (P＞0.05), and feces is soft stool in administration next day only, administration after 48 hours feces promptly be shaped, 7 days mice hair color lights after administration, feed, behavioral activity etc. there is no abnormal change.Cut open internal organs such as inspection naked-eye observation mice thoracic cavity, abdominal cavity and do not see hydrops and abnormal change, observing none only poisoning and phenomena of mortality generation in 7 days.
Conclusion: the happy particulate maximum dosage-feeding of the oral Colla Corii Asini puerpera of mice is a 120g/kg (369.6g crude drug/kg).When in more than 280 times of 70kg people's clinical every day of consumption, illustrate that this medicine peace coefficient is bigger.
Long term toxicity test:
Divide 4 groups at random with 80 of rats, begin to irritate stomach then and give pharmaceutical composition of the present invention, low dose group 4.5g/kg (crude drug 13.86g/kg), middle dosage group 11.25g/kg (crude drug 34.65g/kg, high dose group 22.5g/kg (crude drug 69.3g/kg), the matched group feedwater, twice on the one, successive administration 90d, general situation to rat, outward appearance, body weight gain, hematology RBC, Hb, HCT, WBC and classification, BPC, the blood biochemical liver, 10 index AST such as renal function, ALP, BUN, TP, ALB, GLU, T-BIL, Crea, T-CHO detects, the heart, liver, spleen, lung, kidney, the adrenal gland, the uterus, ovary, stomach, 10 kinds of organs and tissues forms such as intestinal are checked.
Influence to the general situation of rat: the happy granule high dose group of Colla Corii Asini puerpera, middle dosage group, low dose group reach with control rats none death during administration in 90 days, each organizes all no abnormal changes such as rats eating, activity, fur, stool, and body weight gain changes between administration group and matched group does not see notable difference.
Conclusion: the happy granule 4.5g/kg of Colla Corii Asini puerpera, 11.25g/kg, 22.5g/kg (be equivalent to 10 times of the clinical consumption of 70kg people approximately, 25 times, 50 times, by the conversion of kg body weight dosage), rat successive administration 90 days, general situation to rat, outward appearance, body weight gain, hematology RBC, HB, HCT, WBC and classification BPC, the blood biochemical liver, 10 index AST such as renal function, ALT, ALP, BUN, TP, ALB, GLU, T-BIL, Crea, T-CHO detects, the heart, liver, spleen, lung, kidney, the adrenal gland, the uterus, ovary, stomach, the inspection of 10 kinds of organs and tissues forms such as intestinal does not see that tangible toxicity changes.
In sum, the present composition is better than medicine commonly used at present to the treatment improvement effect of puerperal disease, to puerperal disease such as anemia, blood stasis after treatment, have positive effect to improve, the result of II clinical trial phase shows determined curative effect, safe and effective, long-time stability are investigated and are also shown, present composition steady quality, reliable.
The specific embodiment
For more clear explanation goal of the invention and technical scheme, be described in further detail by following embodiment.
Embodiment 1:
The prescription of compositions of the present invention:
Radix Astragali 1000g Colla Corii Asini 180g Herba Leonuri 1000g
Semen Persicae (stir-fry) 300g Radix Angelicae Sinensis 400g Folium Artemisiae Argyi 200g
Preparation method:
It is standby that above Six-element, Colla Corii Asini add the water molten;
The Radix Astragali, Herba Leonuri add the decocting that 10-16 doubly measures and boil more than 2 times or 2 times, and at least 0.5 hour at every turn, merge decocting liquid, filter, the thick paste that is evaporated to relative density and is 1.30～1.35 (60 ℃) is standby;
Radix Angelicae Sinensis, Semen Persicae, Folium Artemisiae Argyi distillating extracting oil (1-6 hour), and be encapsulated with for use with cycloheptaamylose; Concrete inclusion method is: volatile oil dilutes with 1-3 times of volume of ethanol, takes by weighing to be equivalent to the beta-schardinger dextrin-that volatile oil 6-10 doubly measures again, and adds entry in the ratio of beta-schardinger dextrin-: water=1-10g: 20-50ml, slight fever makes dissolving, and to keep the solution temperature be 20-40 ℃, under electronic stirring, slowly splash into the ethanol liquid of volatile oil, add the back and continue to stir 1-3 hour, put 0～20 ℃, left standstill 10-48 hour, sucking filtration, filter cake is put 40～60 ℃ of dryings, and porphyrize gets final product;
Water liquid behind extraction volatile oil device is in addition collected, medicinal residues add at least 2 times water (being generally 2-16 doubly) at least 0.5 hour (0.5-3 hour) of decoction, filter, merge with the water liquid behind the extraction volatile oil, be evaporated to relative density 1.08～1.10 (60 ℃ of surveys), the ethanol that adds at least 1 times of amount (preferred 1.5 times of amounts), stirred evenly 10-40 minute, 0-30 ℃ leaves standstill (preferred 48 hours) more than 6 hours, leach supernatant, decompression recycling ethanol also is concentrated into the thick paste that relative density is 1.30～1.35 (60 ℃);
Thick paste behind the above-mentioned ethanol extraction mixes with herbal decoction, donkey-hide gelatin mate and cycloheptaamylose inclusion complex, promptly gets the present composition.
Granule: after above-mentioned herbal decoction and donkey-hide gelatin mate are mixed, add dextrin, stevioside, fully mixing is put 70～75 ℃ of vacuum dryings, pulverizes, and with cycloheptaamylose inclusion complex mixing, makes the 1000g granule, and packing promptly gets brown granular.
Differentiate:
(1) get this product 10g, porphyrize adds kieselguhr 5g, mixes thoroughly, add ethanol 50ml, reflux, extract, 2 times each 0.5 hour, filters, merging filtrate reclaims ethanol, and residue divides 4 dissolvings with 25ml 0.1M hydrochloric acid solution, filter, merging filtrate drips saturated ammonium tetrathiocyanodiaminochromate solution 10ml under fully stirring, refrigerator was placed 1 hour, filtered, and residue and filter paper are with time washing of 15ml moisture, discard filtrate and washing liquid, precipitation drips 1% AgNO with acetone 15ml dissolving in acetone solution
3Solution produces to no longer including precipitation, filters, and precipitation is washed with small amount of acetone, merging filtrate and washing liquid, water bath method, residue is with anhydrous alcohol solution, last neutral alumina post (neutral alumina 5g, column internal diameter 0.9cm), earlier with dehydrated alcohol 15ml towards post, eluent discards, again with 70% ethanol 50ml eluting, the eluent evaporate to dryness, residue is with the 2ml dissolve with methanol, as need testing solution.Other gets the stachydrine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 1mg/ml, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned two kinds of solution, putting respectively on same silica gel g thin-layer plate, is developing solvent with n-butyl alcohol-hydrochloric acid-water (8: 2: 1), launches, take out, dry, spray is dried with rare iodine bismuth test solution, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on show the speckle of same color.
(2) get this product 10g, porphyrize, the 50ml that adds diethyl ether, reflux 1 hour filters, and filtrate volatilizes, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Radix Angelicae Sinensis control medicinal material 0.5g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution 10 μ l, control medicinal material solution 2 μ l, put respectively on same silica gel g thin-layer plate, with petroleum ether (60～90 ℃)-ethyl acetate (17: 3) 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 fluorescence speckle of same color.
(3) get this product 10g, porphyrize adds methanol 50ml, water-bath reflux, extract, 1 hour, filter, filtrate water bath method, residue add water 20ml, slight fever makes dissolving, with ethyl acetate extraction 3 times (15,10,10ml), combining extraction liquid, with 2% sodium carbonate liquor extraction 3 times (10,10,10ml), merge the sodium carbonate extract, regulate PH to 2 with the hydrochloric acid of the 2M degree of depth, with extracted with diethyl ether 3 times (15,10,10ml), merge ether solution, volatilize, residue adds dehydrated alcohol 1ml, makes dissolving, as need testing solution.Other gets Folium Artemisiae Argyi control medicinal material 2g, gets control medicinal material solution 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 respectively, point is developing solvent with benzene-chloroform-glacial acetic acid (6: 5: 1) on same silica gel g thin-layer plate, launches, take 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 principal spot of same color.
The result shows: present composition granule meets the relevant every regulation (an appendix I of Chinese Pharmacopoeia version in 2000 C) under the granule item.
Assay: the granule of getting under the content uniformity item is an amount of, gets about 3.0g, and accurate the title decides, add kieselguhr 3g, grind well, put in the apparatus,Soxhlet's, add methanol 100ml, reflux, extract, 6 hours is put cold, filter, extracting solution reclaims methanol, and water bath method, residue add water 40ml, slight fever makes dissolving, with water saturated n-butanol extraction 4 times (30,30,20,20ml) merge butanol extraction liquid, use 2%NaOH solution washing 2 times (50,50ml), discard alkali liquor, n-butyl alcohol liquid with the 50ml water washing once, water liquid discards, and n-butyl alcohol water bath method, residual liquid add dissolve with methanol and be settled to 2ml, shake up, as need testing solution.Other gets the astragaloside reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 3～5 μ l, reference substance 2 μ l, 4 μ l, the cross point is on same silica gel G plate respectively, with chloroform-methanol-water (30: 10: 1) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, about 5～7 minutes of 105 ℃ of bakings, clear to the speckle colour developing, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side, scan according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B).λ
S=530nm, λ
R=700nm measures test sample and reference substance trap integrated value, calculates, promptly.
This product is with astragaloside (C
41H
68O
14) meter, contain astragaloside 0.45mg/g.
Embodiment 2:
Prescription: Radix Astragali 1470g Colla Corii Asini 35g Herba Leonuri 1470g
Semen Persicae 35g Radix Angelicae Sinensis 35g Folium Artemisiae Argyi 35g
Preparation method: preparation of compositions is with embodiment 1;
Capsule: after above-mentioned herbal decoction and donkey-hide gelatin mate are mixed, add binding agents such as dextrin, fully mixing is put 60～80 ℃ of vacuum dryings, pulverizes, and with cycloheptaamylose inclusion complex mixing, filleies such as adding starch are granulated, and are encapsulated, promptly get capsule of the present invention.
The result shows: present composition capsule meets the relevant every regulation under the capsule item.
Qualitative and detection by quantitative is with embodiment 1.
This product contains astragaloside 0.48mg/g.
Embodiment 3:
Prescription: Radix Astragali 700g Colla Corii Asini 150g Herba Leonuri 500g
Semen Persicae 350g Radix Angelicae Sinensis 690g Folium Artemisiae Argyi 690g
Preparation method: preparation of compositions is with embodiment 1;
Tablet: after the extract of the invention described above compositions mixes, add binding agents such as dextrin, fully mixing, put 60～80 ℃ of vacuum dryings, pulverize, add disintegrating agent mixings such as lubricant such as filler, magnesium stearate such as starch and sodium carboxymethyl cellulose, granulate, tabletting promptly gets tablet of the present invention.
The result shows: present composition tablet meets the relevant every regulation under the tablet item.
Qualitative and detection by quantitative is with embodiment 1.
With astragaloside (C
41H
68O
14) meter, content is 0.41mg/g.
More than described the preferred embodiment for the present invention, so it is not in order to limit the present invention.Those skilled in the art can not depart from the improvement and the variation of category of the present invention and spirit to embodiment disclosed herein.
Claims (10)
1, a kind of Chinese medicine composition for the treatment of puerperal disease, its component by following weight proportion is formed: Radix Astragali 10-50%, Colla Corii Asini 1-10%, Herba Leonuri 10-50%, Semen Persicae 1-15%, Radix Angelicae Sinensis 10-30%, Folium Artemisiae Argyi 1-10%, the source of described component is Chinese crude drug or the Chinese medicine extract that is equivalent to above-mentioned Chinese crude drug crude drug amount.
2. the described Chinese medicine composition of claim 1, wherein said component consists of: Radix Astragali 25-40%, Colla Corii Asini 4-7%, Herba Leonuri 25-40%, Semen Persicae 5-13%, Radix Angelicae Sinensis 10-25%, Folium Artemisiae Argyi 4-8%.
3. the described Chinese medicine composition of claim 1, wherein said component consists of: the Radix Astragali 32%, Colla Corii Asini 6%, Herba Leonuri 32%, Semen Persicae 10%, Radix Angelicae Sinensis 13%, Folium Artemisiae Argyi 7%.
4. the described Chinese medicine composition of claim 1, wherein, the Radix Astragali and Herba Leonuri are water extract; Colla Corii Asini is the molten thing; Semen Persicae, Radix Angelicae Sinensis, Folium Artemisiae Argyi for the volatile oil of this three flavors medicine and water extract again through ethanol extract that alcohol is counter to be obtained after carrying; Described Semen Persicae is the Semen Persicae after concocting.
5. medicine for the treatment of puerperal disease, comprising each described Chinese medicine composition of claim 1-3 and pharmacy acceptable auxiliary, the content of astragaloside is at least 0.4mg/g in this medicine.
6. the described medicine of claim 5, wherein said medicine is a peroral dosage form, it is honeyed pill, condensed water honeyed pill, the watered pill, granule, capsule, tablet, powder, unguentum, oral liquid or syrup.
7. the preparation method of the described medicine of claim 5 may further comprise the steps:
(1) the Colla Corii Asini molten is made Colla Corii Asini (melted) cream;
(2) Radix Astragali, Herba Leonuri extracting in water are concentrated into relative density 1.00-1.45 and make herbal decoction;
(3) Radix Angelicae Sinensis, Semen Persicae, Folium Artemisiae Argyi are obtained volatile oil through water distillation and extraction earlier, the water liquid behind the volatile oil is carried in taking-up, medicinal residues are used earlier water extraction, extracting solution merges with the water liquid of carrying behind the volatile oil, be concentrated into relative density 1.0～1.6, add the alcoholic solution precipitate with ethanol, get the extractum of supernatant concentration to relative density 1.10-1.50;
(4) above-mentioned Colla Corii Asini (melted) cream, herbal decoction, volatile oil and precipitate with ethanol extractum are mixed.
8. the preparation method of the described medicine of claim 7, wherein also comprise the volatile oil that will obtain in the step (3) with ethanol as solvent, make the process of volatile oil inclusion complex with the beta-schardinger dextrin-inclusion.
9. the preparation method of medicine as claimed in claim 8, wherein, described preparation method also comprises mixes Colla Corii Asini (melted) cream, herbal decoction and precipitate with ethanol extractum, adds adjuvant, and drying is pulverized; With volatile oil inclusion complex and correctives mixing, granulate, drying obtains described medicine again.
10. the application of the described compositions of claim 1 in the medicine of preparation treatment puerperal disease.
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| CNB2006100000740A CN100340261C (en) | 2006-01-05 | 2006-01-05 | Chinese medicinal compsns. for treating postpartum disease |
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| CNB2006100000740A CN100340261C (en) | 2006-01-05 | 2006-01-05 | Chinese medicinal compsns. for treating postpartum disease |
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| CN104906519A (en) * | 2015-07-01 | 2015-09-16 | 陈旭东 | Medicine for treating female puerperal diseases |
| CN110548170A (en) * | 2018-06-01 | 2019-12-10 | 安徽舒源妇幼用品有限公司 | preparation method of antibacterial breathable postpartum care pad |
| CN109432246A (en) * | 2018-12-25 | 2019-03-08 | 佛山科学技术学院 | A kind of Chinese materia medica preparation and preparation method thereof of postpartum uterus rehabilitation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1513484A (en) * | 2002-12-31 | 2004-07-21 | 魏文利 | Traditional chinese medicine for treating postpartum diseases |
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| CN1513484A (en) * | 2002-12-31 | 2004-07-21 | 魏文利 | Traditional chinese medicine for treating postpartum diseases |
Non-Patent Citations (2)
| Title |
|---|
| 养血妇康颗粒剂对实验性气血虚证动物的影响 吴捷，陕西中医，第23卷第5期 2002 * |
| 固冲清宫汤治疗药物流产后出血过多48例 张翠萍，安徽中医学院学报，第13卷第1期 1994 * |
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