CN106511881A - Traditional Chinese medicinal composition for kidney tonifying and miscarriage prevention and preparation method thereof - Google Patents

Traditional Chinese medicinal composition for kidney tonifying and miscarriage prevention and preparation method thereof Download PDF

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CN106511881A
CN106511881A CN201710050712.8A CN201710050712A CN106511881A CN 106511881 A CN106511881 A CN 106511881A CN 201710050712 A CN201710050712 A CN 201710050712A CN 106511881 A CN106511881 A CN 106511881A
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parts
radix
parched
chinese medicine
medicine composition
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CN106511881B (en
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刘瑞芬
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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Abstract

The invention discloses a traditional Chinese medicinal composition for kidney tonifying and miscarriage prevention, which is prepared from the following raw-material components: 16 to 20 parts of semen cuscutae, 16 to 20 parts of radix dipsaci stir-fried with salt water, 12 to 18 parts of herba taxilli, 10 to 14 parts of cortex eucommiae stir-fried with salt water, 10 to 14 parts of fructus lycii, 16 to 20 parts of stir-baked rhizoma dioscoreae, 25 to 35 parts of radix codonopsis, 25 to 35 parts of radix astragali preparata, 10 to 14 parts of stir-fried rhizoma atractylodis macrocephalae, 10 to 14 parts of poria cocos, 12 to 18 pars of stir-fried radix paeoniae alba, 10 to 14 parts of radix scutellariae, 10 to 14 parts of radix ophiopogonis, 6 to 12 parts of radix aucklandiae, 6 to 12 parts of fructus amomi, 10 to 14 parts of semen platycladi, 10 to 14 parts of bulbus lilii and 4 to 8 parts of radix glycyrrhizae preparata. Medicinal materials selected for the traditional Chinese medicinal composition provided by the invention are suitable in compatibility, are refined in formula, functionally supplement one another, aim at dampness removal and phlegm elimination, and restrict and assist one another in medicinal property; the kidney tonifying, the vital essence benefiting, the qi circulation promotion, the spleen strengthening, the heat clearing, the miscarriage prevention, the heart nourishing and the mind tranquillization are integrated; the curative effect is obvious; toxic and side reactions are few.

Description

A kind of Chinese medicine composition for tonifying kidney for preventing miscarriage and preparation method thereof
Technical field
The present invention relates to technical field of Chinese medicines, and in particular to a kind of Chinese medicine composition and its preparation side for tonifying kidney for preventing miscarriage Method.
Background technology
Threatened abortion, fetal intrauterine growth retardation and recurrent abortion are department of obstetrics and gynecology commonly encountered diseases and difficult disease, clinical table Now bled for trimester of pregnancy vagina on a small quantity, color is light dim, or the soreness of waist, stomachache, tenesmus, or fetal in utero shipping be slow, or once repeatly it is pregnant repeatly Fall, dizziness and tinnitus, frequent urination at night, complexion are dark dim；Light red tongue is dim, and deep-rolling pulse chi pulse is slow.In recent years, for various reasons, aura stream Produce, the sickness rate of fetal intrauterine growth retardation and recurrent abortion in gravid woman is in continuous ascendant trend, not only serious prestige Side of body fetus and the health and lives safety of parent, more bring great psychic pain to patient and household.
Chinese medicine thinks kidney governing reproduction, and vessels of the uterus lies in kidney, and parent kidney qi is the foundation of fetal development, and the growth of fetus QI and blood to be leaned on is supplemented nutrition, and QI and blood is taste institute metaplasia again, therefore deficiency of kidney-QI, weakness of the spleen and stomach are the Etiologicals for causing to miscarry. It is but kidney and spleen invigorating is only a basic rule for the treatment of of treatment by Chinese herbs miscarriage, due to the cause of disease and its complexity of miscarriage, existing with benefit The antiabortive medicine of kidney and strengthening spleen effect is due to lacking specific aim to the selection of each crude drug in medicine and the allotment of compatibility relationship, more It is that simply the medicine with the kidney invigorating, spleen invigorating effect is combined, therefore, the curative effect of most of antiabortive medicines can not still be made us It is satisfied, or even the side effect that some medicines are also serious to fetus.
The content of the invention
For above-mentioned prior art, it is an object of the invention to provide a kind of evident in efficacy, with low cost, toxic and side effects are little Chinese medicine composition for tonifying kidney for preventing miscarriage and preparation method thereof.
For achieving the above object, the present invention adopts following technical proposals：
First aspect present invention, there is provided a kind of Chinese medicine composition for tonifying kidney for preventing miscarriage, its raw material are consisted of：
Semen Cuscutae 16-20 parts, prepared RADIX DIPSACI with salt solution 16-20 parts, Herba Taxilli 12-18 parts, Cortex Eucommiae(processed with salt) 10-14 parts, Fructus Lycii 10-14 Part, Rhizoma dioscoreae (parched) 16-20 parts, Radix Codonopsis 25-35 parts, Radix Astragali Preparata 25-35 parts, Rhizoma Atractylodis Macrocephalae (parched) 10-14 parts, Poria 10-14 parts, Radix Paeoniae Alba (parched) 12-18 parts, Radix Scutellariae 10-14 parts, Radix Ophiopogonis 10-14 parts, Radix Aucklandiae 6-12 parts, Fructus Amomi 6-12 parts, Semen Platycladi 10-14 parts, Bulbus Lilii 10-14 Part, Radix Glycyrrhizae Preparata 4-8 parts.
The Chinese medicine composition for tonifying kidney for preventing miscarriage of the present invention, preferred prescription is：
18 parts of Semen Cuscutae, 18 parts of prepared RADIX DIPSACI with salt solution, 15 parts of Herba Taxilli, 12 parts of Cortex Eucommiae(processed with salt), 12 parts of Fructus Lycii, 18 parts of Rhizoma dioscoreae (parched), party 30 parts of ginseng, 30 parts of Radix Astragali Preparata, 12 parts of Rhizoma Atractylodis Macrocephalae (parched), 12 parts of Poria, 15 parts of Radix Paeoniae Alba (parched), 12 parts of Radix Scutellariae, 12 parts of Radix Ophiopogonis, 9 parts of the Radix Aucklandiae, sand 9 parts of core, 12 parts of Semen Platycladi, 12 parts of Bulbus Lilii, 6 parts of Radix Glycyrrhizae Preparata.
The compatibility mechanism of Chinese medicine composition of the present invention：With Semen Cuscutae, Radix Dipsaci as monarch drug, the kidney invigorating and essence nourishing, astringency inducing punching are appointed, and kidney is prosperous Self energy sprouts tire.Herba Taxilli, Cortex Eucommiae(processed with salt) invigorating the liver and kidney, Gu Chong appoint, and make nausea strong；Fructus Lycii, Rhizoma dioscoreae (parched) replenishing kidney-YIN；Radix Codonopsis, process The Radix Astragali, Rhizoma Atractylodis Macrocephalae (parched), Poria air making-up and spleen enlivening, are that, to support congenital the day after tomorrow, all medicines are minister.Radix Paeoniae Alba (parched) nourishing blood to suppress the hyperactive liver emergency, can prevent son Shrink in palace；Radix Scutellariae, Radix Ophiopogonis nourishing YIN and clearing away heat it is antiabortive；The Radix Aucklandiae, Fructus Amomi regulating qi-flowing for harmonizing stomach；Semen Platycladi, Bulbus Lilii tranquilizing by nourishing the heart, are all adjuvant drug； Radix Glycyrrhizae Preparata is to make, coordinating the actions of various ingredients in a prescription.
The present invention has played the kidney invigorating and essence nourishing, air making-up and spleen enlivening, heat clearing away jointly by kinds of traditional Chinese medicines is carried out compatibility between medicine Antiabortive effect, with obvious potentiation, has given full play to the compatibility relationship that mutual reinforcement between mutually makes.
In sum, selected by we, medical material compatibility is suitable, and refining formula functionally complements each other, and with tonifying kidney for preventing miscarriage is Purpose, integrates the kidney invigorating, beneficial essence, circulation of qi promoting, spleen invigorating, clearing heat and preventing abortion, tranquilizing by nourishing the heart, evident in efficacy；Mutually make in the property of medicine and mutually help, Toxicity is few, takes safety.
In the Chinese medicine composition for tonifying kidney for preventing miscarriage of the present invention, each raw material components are organic wholes, lack one not Can.Inventor had found in R＆D process, reduces any one of above-mentioned composition raw material components, or with the similar property of medicine Crude drug the raw material components of Chinese medicine composition of the present invention are replaced, then the overall action effect of Chinese medicine composition significantly drops It is low；Other raw material components are further added by the basis of the Chinese medicine composition of the present invention, the whole structure of Chinese medicine composition is not Improve significantly, or even the situation that the whole structure for having Chinese medicine composition is reduced occurs.
Each raw material directly can be added water to cook by the above-mentioned Chinese medicine composition for tonifying kidney for preventing miscarriage, it is also possible to according to additive method Prepare.
In a specific embodiment of the present invention, the preparation method of the above-mentioned Chinese medicine composition for tonifying kidney for preventing miscarriage For：
By Semen Cuscutae, prepared RADIX DIPSACI with salt solution, Herba Taxilli, Cortex Eucommiae(processed with salt), Fructus Lycii, Rhizoma dioscoreae (parched), Radix Codonopsis, Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Poria, The mixing of Radix Paeoniae Alba (parched), Radix Scutellariae, Radix Ophiopogonis, the Radix Aucklandiae, Semen Platycladi, Bulbus Lilii and Radix Glycyrrhizae Preparata, adds water to cook twice, before second decoction terminates 5-10 minutes add Fructus Amomi；Filtration (adds 8-10 times for the first time and measures water, decoct 30-60 minutes；Add 6-8 times second and measure water, decoct Boil 20-40 minutes), merging filtrate is obtained final product.
Chinese medicine ingredients are complicated, existing water soluble ingredient in a kind of medical material, have oil-soluble or Alcohol soluble composition, and some work again Property composition easily inactivate at high temperature, therefore Effective Component of Chinese Medicine is carried out by selecting suitable extracting method and extraction process Extract and separate, effective ingredient can be extracted to greatest extent and ensure the activity of effective ingredient, so as to ensure the clinic of product Effect.
Experiment proves that, using above-mentioned preparation method, can extract to greatest extent in Chinese medicine composition it is effective into Divide and ensure the activity of effective ingredient, so as to ensure the clinical effectiveness of product；For example, for the Fructus Amomi in raw material, using " after Under " mode, the volatilizing loss of effective ingredient in Fructus Amomi can be reduced so as to which effective ingredient is retained in soup to greatest extent In.
Application of the above-mentioned Chinese medicine composition in the pharmaceutical preparation for tonifying kidney for preventing miscarriage is prepared is also the model of present invention protection Enclose.
A kind of second aspect present invention, there is provided pharmaceutical preparation for tonifying kidney for preventing miscarriage, by above-mentioned Chinese medicine composition and pharmacy Upper acceptable adjuvant is prepared from.
Said medicine preparation can make various pharmaceutical dosage forms, such as pill, capsule, tablet, powder, granule or oral Liquid etc..
The pharmaceutically acceptable adjuvant is the customary adjuvant in pharmaceutical preparation, such as：Disintegrating agent, lubricant, adhesive Deng；One or more preferably in glycerol, butanediol, trehalose, glycine betaine, starch, sodium carboxymethyl cellulose.
The Chinese medicine composition of the present invention or effect of pharmaceutical preparation：It is the kidney invigorating, spleen invigorating, antiabortive.Cure mainly vaginal bleeding during pregnancy and frequent fetal movement The disease such as (threatened abortion), diapause (fetal intrauterine growth retardation), habitual abortion (recurrent abortion).
Beneficial effects of the present invention：
Medical material compatibility selected by the Chinese medicine composition of the present invention is suitable, and refining formula functionally complements each other, strong with the kidney invigorating For the purpose of spleen is antiabortive, integrate the kidney invigorating, beneficial essence, circulation of qi promoting, spleen invigorating, clearing heat and preventing abortion, tranquilizing by nourishing the heart, it is evident in efficacy；In the property of medicine Mutually make and mutually help, toxicity is few.
Specific embodiment
Below by instantiation, the present invention will be further elaborated, it should explanation, the description below be only for The present invention is explained, its content is not defined.
Embodiment 1：
Formula：18 grams of Semen Cuscutae, 18 grams of prepared RADIX DIPSACI with salt solution, 15 grams of Herba Taxilli, 12 grams of Cortex Eucommiae(processed with salt), 12 grams of Fructus Lycii, Rhizoma dioscoreae (parched) 18 Gram, 30 grams of Radix Codonopsis, 30 grams of Radix Astragali Preparata, 12 grams of Rhizoma Atractylodis Macrocephalae (parched), 12 grams of Poria, 15 grams of Radix Paeoniae Alba (parched), 12 grams of Radix Scutellariae, 12 grams of Radix Ophiopogonis, the Radix Aucklandiae 9 Gram, 9 grams of Fructus Amomi, 12 grams of Semen Platycladi, 12 grams of Bulbus Lilii, 6 grams of Radix Glycyrrhizae Preparata.
Preparation method：
By Semen Cuscutae, prepared RADIX DIPSACI with salt solution, Herba Taxilli, Cortex Eucommiae(processed with salt), Fructus Lycii, Rhizoma dioscoreae (parched), Radix Codonopsis, Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Poria, The mixing of Radix Paeoniae Alba (parched), Radix Scutellariae, Radix Ophiopogonis, the Radix Aucklandiae, Semen Platycladi, Bulbus Lilii and Radix Glycyrrhizae Preparata, adds water to cook and (adds 8 times of amount water for the first time, decoct twice Boil 30 minutes；Add 8 times of amount water for the second time, decoct 20 minutes), Fructus Amomi is added within 5 minutes before second decoction terminates, after decoction Filtration, merging filtrate are obtained final product.
Filtrate after decoction is orally taken, and the daily morning and evening is twice.
Embodiment 2：
Formula：16 grams of Semen Cuscutae, 20 grams of prepared RADIX DIPSACI with salt solution, 12 grams of Herba Taxilli, 14 grams of Cortex Eucommiae(processed with salt), 10 grams of Fructus Lycii, Rhizoma dioscoreae (parched) 20 Gram, 25 grams of Radix Codonopsis, 35 grams of Radix Astragali Preparata, 10 grams of Rhizoma Atractylodis Macrocephalae (parched), 14 grams of Poria, 12 grams of Radix Paeoniae Alba (parched), 14 grams of Radix Scutellariae, 10 grams of Radix Ophiopogonis, the Radix Aucklandiae 12 grams, 6 grams of Fructus Amomi, 14 grams of Semen Platycladi, 10 grams of Bulbus Lilii, 8 grams of Radix Glycyrrhizae Preparata.
Preparation method：
By Semen Cuscutae, prepared RADIX DIPSACI with salt solution, Herba Taxilli, Cortex Eucommiae(processed with salt), Fructus Lycii, Rhizoma dioscoreae (parched), Radix Codonopsis, Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Poria, The mixing of Radix Paeoniae Alba (parched), Radix Scutellariae, Radix Ophiopogonis, the Radix Aucklandiae, Semen Platycladi, Bulbus Lilii and Radix Glycyrrhizae Preparata, adds water to cook twice, (add 10 times of amount water for the first time, Decoct 30 minutes；Add 6 times of amount water for the second time, decoct 20 minutes), Fructus Amomi is added within 5 minutes before second decoction terminates, decoction After filter, merging filtrate is obtained final product.
Filtrate after decoction is orally taken, and the daily morning and evening is twice.
Embodiment 3：
Formula：20 grams of Semen Cuscutae, 16 grams of prepared RADIX DIPSACI with salt solution, 18 grams of Herba Taxilli, 10 grams of Cortex Eucommiae(processed with salt), 14 grams of Fructus Lycii, Rhizoma dioscoreae (parched) 16 Gram, 35 grams of Radix Codonopsis, 25 grams of Radix Astragali Preparata, 14 grams of Rhizoma Atractylodis Macrocephalae (parched), 10 grams of Poria, 18 grams of Radix Paeoniae Alba (parched), 10 grams of Radix Scutellariae, 14 grams of Radix Ophiopogonis, the Radix Aucklandiae 6 Gram, 12 grams of Fructus Amomi, 10 grams of Semen Platycladi, 14 grams of Bulbus Lilii, 4 grams of Radix Glycyrrhizae Preparata.
Preparation method is with embodiment 1.
Embodiment 4：
Filtrate after embodiment 1 is decocted is prepared into capsule in conventional manner, and specification is 0.25g/ grains.
Embodiment 5：
Filtrate after embodiment 1 is decocted is prepared into pill in conventional manner.
Comparative example 1：
The present inventor the multi-flavor crude drug with the close property of medicine has been carried out in R＆D process compatibility relationship investigation and The research of drug effect, as a result finds, even if similar but different from other the crude drug compatibility of the property of medicine between a few taste crude drug makes With rear, its effect significant difference.For example：By Poria, Radix Ophiopogonis, the Radix Aucklandiae, Semen Platycladi and Bulbus Lilii in the medicament composing prescription of embodiment 1 Replace with Radix Rehmanniae Preparata, Colla Corii Asini, Herba Visci, Radix Morindae Officinaliss and Caulis Akebiae；Consumption and preparation method are with embodiment 1.
Diethylstilbestrol induced abortion model is set up in conventional manner, investigates the Chinese medicine group of the embodiment of the present invention 1 and comparative example 1 Effect of fetus care in middle of the compound to abortion model, animal experiment show that the effect of fetus care in middle of the Chinese medicine composition of the embodiment of the present invention 1 will show Write better than comparative example 1.Illustrate that the compositionss of the present invention meet the compatibility relationship of Chinese medicine, there is between each component collaboration to promote to make With being not the simple replacement or combination of the crude drug with the similar property of medicine.
Comparative example 2：
In Chinese medicine composition, the dose of each crude drug is the mark efficacy of a drug, even if the medicine composition of prescription is identical, if but medicine The consumption of thing is different, and its efficacy of a drug then has dividing for size, and compatibility relationship then has the change of monarch, so as to its effect then It is each different.The present inventor has carried out investigation and drug effect in R＆D process to the content of each raw material in Chinese medicine composition Research, as a result finds, the difference of inappropriate proportioning raw materials relation, especially monarch drug and deal shared by ministerial drug, its effect Significant difference.For example：The consumption of Semen Cuscutae in embodiment 1 is adjusted to into 25 grams, the consumption of prepared RADIX DIPSACI with salt solution is adjusted to 12 grams, Herba Taxilli Consumption be adjusted to 20 grams, the consumption of Cortex Eucommiae(processed with salt) is adjusted to 5 grams, and the consumption of Fructus Lycii is adjusted to 18 grams, and the consumption of Rhizoma dioscoreae (parched) is adjusted Whole is 12 grams, and the consumption of Radix Codonopsis is adjusted to 40 grams, and the consumption of other raw materials is with embodiment 1, and prepares as described in Example 1.
Diethylstilbestrol induced abortion model is set up in conventional manner, investigates the Chinese medicine group of the embodiment of the present invention 1 and comparative example 2 Effect of fetus care in middle of the compound to abortion model, animal experiment show that the Chinese medicine composition effect of fetus care in middle of the embodiment of the present invention 1 is notable Better than comparative example 2.The consumption for illustrating each crude drug in the compositionss of the present invention is not that conventional adjustment institute is getable, this In bright Chinese prescription, the consumption proportion of each raw medicinal material be according to the various considerations such as its character of medicinal material, monarch compatibility because What element was determined, for the overall drug effect of Chinese medicine composition plays very important effect.
Animal experiment：
1. the impact pair normal Wistar pregnant rat isolated uterine smooth muscle
(1) test method：
Wistar adult female rats 30 are taken, body weight 250-350 gram is divided into test group, positive controls and blank right According to group, 10 are per group, the body weight and health status of each group rat is without significant difference.
Rat copulation is become pregnant after 7d, hits unconsciously, cuts open the belly and takes out a cross-talk palace of 2.0cm length, is placed in Rockwell liquid, constant temperature (35 ± 0.5 DEG C), it is passed through O2, tonotransducer is connected with XWT-164 balance recorders, rest tension 1g, after balance 10min Administration, the Chinese medicine composition of the administration embodiment 1 of test group, the ultimate density for making medicine in bath are 16mg/ml；Positive control The commercially available BAOTAILING PIAN of group administration, the ultimate density for making medicine in bath are 16mg/ml；Blank control group adds the physiology of equivalent Saline.After record administration 10min, the change of uterine smooth muscle, the results are shown in Table 1.
(2) result of the test：
Impact of the Chinese medicine composition of the present invention to normal Wistar pregnant rat isolated uterine smooth muscle the results are shown in Table 1.
Impact of the table 1 to normal Wistar pregnant rat isolated uterine smooth muscle
As a result show：Test group and positive controls can reduce the contractility of pregnant Uterine Smooth Muscle, slow down its contraction Frequency, compared with blank control group, has significant difference；Test group is compared with positive controls, with significant difference, is said The Chinese medicine composition of the bright present invention is compared compared with positive control medicine (BAOTAILING PIAN), and its antiabortive anti-abortional effect is higher.
2. the impact of pair Mouse Uterus and the development of ovary
(1) test method：
Kunming kind female mice (young Mus) 30 is taken, body weight 10-15 gram is divided into test group, positive controls and blank right According to group, 10 are per group, the body weight and health status of each group mice is without significant difference.
Capsule prepared by the test group gastric infusion embodiment of the present invention 4, dosage are 4.8g crude drugs/kg, once a day, Successive administration 14 days；
The commercially available BAOTAILING PIAN of positive controls gastric infusion, dosage are 4.8g crude drugs/kg, once a day, successive administration 14 days；
The normal saline of blank control group gavage same volume.
Animal, separating uterus and ovary were put to death in the 15th day, is weighed, calculate uterus and ovarian index (mg/10g body weight).
(2) result of the test：
Result of the test is shown in Table 2.
Table 2：To Mouse Uterus and the impact of ovarian growth development
As a result show：Test group and positive controls can promote the growth promoter of Mouse Uterus and ovary, right with blank Compare according to group, have significant difference；Test group is compared with positive controls, with significant difference, in illustrating the present invention Drug composition is compared compared with positive control medicine (BAOTAILING PIAN), and the ability of its promotion Mouse Uterus and the development of ovary is higher.
3. the anti-abortional effect of pair diethylstilbestrol induced abortion model
(1) test method：
Kunming mouse, 2 monthly ages, body weight are female 28-32g, male 36-40g.Mice is by female：Male (2：1) ratio is closed Cage copulation.The day of the cloudy bolt of detection is pregnant 1st day, and 80 cloudy bolt Mus are divided into 4 groups by the pregnancy period at random, 20 per group.
The normal saline of matched group and model group gavage same volume；
Capsule prepared by the test group gastric infusion embodiment of the present invention 4, dosage are 4.8g crude drugs/kg；
Positive controls are administered commercially available BAOTAILING PIAN, and dosage is 4.8g crude drugs/kg；
Above-mentioned each group, daily gavage 1 time, successive administration 10d.In addition to matched group, in gestation continuous subcutaneous injection on the 7th oneself The female phenol 2d of alkene, the isopyknic normal saline 2d of matched group subcutaneous injection, each group put to death in gestation on the 18th, dissect, and observe each group Live births.
(2) result of the test：
Result of the test is shown in Table 3.
Table 3：Anti-abortional effect to diethylstilbestrol induced abortion model
As a result show：The anti-abortional effect of test group and positive controls all to diethylstilbestrol induced abortion model；Test group Compare with positive controls, with significant difference, illustrate the Chinese medicine composition of the present invention compared with positive control medicine (spirit of preventing miscarriage Piece) to compare, the ability of its anti-abortional effect to diethylstilbestrol induced abortion model is higher.
4. safety testing：
(1) acute toxicity test：
Respectively with body weight be 18～22 grams, the kunming mice 40 of male and female half and half only as experimental animal, gavage mode is divided respectively Two groups be administered for single administration and three times, the Chinese medicine composition that respectively prepared by the gavage embodiment of the present invention 1；Mice single administration The dosage of group is 12.0g (crude drug)/kg, and the dosage that three administrations (interval 4～6 hours) are organized is 26.0g (crude drug)/kg, gavage To observation post administration one week, animal dead is not found；Therefore the Chinese medicine composition acute toxicity of the present invention is low, clinical application peace Entirely.
(2) long term toxicity test：
Kunming mice 81 is only divided into into 4.0g (crude drug)/kg/ days, 8.0g (crude drug)/kg/ days and 16.0g (crude drug)/kg/ Its three dosage groups, the Chinese medicine composition that respectively prepared by gavage embodiment 1, successive administration 2 months.After administration 1 month, high dose Group and matched group put to death 1/3 animal respectively, determine indices；After administration 2 months, each dosage group is removed and stays 1/3 animal to make respectively Convalescent period observation is outer, and remaining is all put to death, and determines indices.Observation and measure project include that such as outward appearance Signs and behavior are lived Dynamic, secretions, fecal character；The conventional index and biochemical indicator of blood；System postmortem and organ coefficient and histological examination etc. Content.
As a result show：Mice continuous oral is given with various dose, on the food-intake and body weight increase of mice without impact.It is right Hepatic and renal function does not find that overt toxicity is acted on；Illustrate the Chinese medicine composition safety non-toxic of the present invention.
(3) special toxicity test：
Sensitive period of teratogenesis toxicity test to embry ogenesis, the growth promoter of tire Mus, tire Mus outward appearance and internal organs, skeleton development, Difference that there are no significant compared with matched group.
General Reproductiv e Toxicity Assessment is sent out to pregnancy rate, embry ogenesis, tire Mus growth promoter, tire Mus outward appearance and internal organs, skeleton Educate without impact.The Chinese medicine composition non-toxic reaction of the present invention is illustrated, without teratogenesis, long-term prescription is safe and reliable.
Clinical trial：
1. object of study
December 2014 January in 2013 patients with recurrent spontaneous abortion 120 to hospital is chosen, equal Jing inquires disease in detail History and conventional cause of disease examination, 23～38 years old age, continuous spontaneous abortion for several times >=2 times, most 5 times, be early stage (<12 weeks) stream Produce.Selected patient is randomly divided into into treatment group and matched group, 60 per group.The nothings such as the age for the treatment of group and matched group, the course of disease Significant (p ＞ 0.05), with comparability.
2. diagnose and criterion of therapeutical effect：Publish with reference to State Administration of Traditional Chinese Medicine《The diagnosis of recurrent spontaneous abortion and curative effect Evaluation criteria》.
3. Therapeutic Method：
Chinese medicine composition (decoction) prepared by the oral embodiment of the present invention 1 for the treatment of group, twice daily, continuously takes to gestation 3 months；
Matched group intramuscular injection progesterone injection (Zhejiang Province XianJu Pharmacy stock Co., Ltd, Chinese medicines quasi-word H33020829), 20mg/ time, day 1 time, continuously it is injected to gestation 3 months.2 groups of Pregnancies are observed, and carries out statistical analysis.
4. result：
Therapeutic outcome is shown in Table 4.
Table 4：Each group Pregnancy synopsis
Jing X2Inspection, is compared with matched group, and treatment group's Pregnancy Success number of cases significantly raises (P<0.05), Pregnancy failure number of cases Significantly reduce (P<0.05), Pregnancy Success rate is significantly raised.Illustrate that the Chinese medicine preparation of the present invention has very well to recurrent abortion Clinical therapeutic efficacy.
The above, the only present invention preferably specific embodiment, but protection scope of the present invention is not limited thereto, It is any to be familiar with those skilled in the art in the technical scope of present disclosure, technology according to the present invention scheme and its invention Design in addition equivalent or change, should all be included within the scope of the present invention.

Claims (8)

1. a kind of Chinese medicine composition for tonifying kidney for preventing miscarriage, it is characterised in that its raw material is consisted of：
Semen Cuscutae 16-20 parts, prepared RADIX DIPSACI with salt solution 16-20 parts, Herba Taxilli 12-18 parts, Cortex Eucommiae(processed with salt) 10-14 parts, Fructus Lycii 10-14 parts are fried Rhizoma Dioscoreae 16-20 parts, Radix Codonopsis 25-35 parts, Radix Astragali Preparata 25-35 parts, Rhizoma Atractylodis Macrocephalae (parched) 10-14 parts, Poria 10-14 parts, Radix Paeoniae Alba (parched) 12-18 Part, Radix Scutellariae 10-14 parts, Radix Ophiopogonis 10-14 parts, Radix Aucklandiae 6-12 parts, Fructus Amomi 6-12 parts, Semen Platycladi 10-14 parts, Bulbus Lilii 10-14 parts are processed Radix Glycyrrhizae 4-8 parts.
2. Chinese medicine composition as claimed in claim 1, it is characterised in that its raw material is consisted of：
18 parts of Semen Cuscutae, 18 parts of prepared RADIX DIPSACI with salt solution, 15 parts of Herba Taxilli, 12 parts of Cortex Eucommiae(processed with salt), 12 parts of Fructus Lycii, 18 parts of Rhizoma dioscoreae (parched), Radix Codonopsis 30 Part, 30 parts of Radix Astragali Preparata, 12 parts of Rhizoma Atractylodis Macrocephalae (parched), 12 parts of Poria, 15 parts of Radix Paeoniae Alba (parched), 12 parts of Radix Scutellariae, 12 parts of Radix Ophiopogonis, 9 parts of the Radix Aucklandiae, Fructus Amomi 9 Part, 12 parts of Semen Platycladi, 12 parts of Bulbus Lilii, 6 parts of Radix Glycyrrhizae Preparata.
3. the preparation method of the Chinese medicine composition described in claim 1 or 2, it is characterised in that step is as follows：
Will be Semen Cuscutae, prepared RADIX DIPSACI with salt solution, Herba Taxilli, Cortex Eucommiae(processed with salt), Fructus Lycii, Rhizoma dioscoreae (parched), Radix Codonopsis, Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Poria, stir-fry white The mixing of Chinese herbaceous peony, Radix Scutellariae, Radix Ophiopogonis, the Radix Aucklandiae, Semen Platycladi, Bulbus Lilii and Radix Glycyrrhizae Preparata, adds water to cook twice, the 5-10 before second decoction terminates Minute adds Fructus Amomi, filters after decoction, and merging filtrate is obtained final product.
4. preparation method as claimed in claim 3, it is characterised in that the concrete operations that decocting is boiled are：Add 8-10 times for the first time Amount water, decocts 30-60 minutes；Add 6-8 times for second and measure water, decoct 20-40 minutes.
5. the purposes that the Chinese medicine composition described in claim 1 or 2 is used in the pharmaceutical preparation of tonifying kidney for preventing miscarriage in preparation.
6. a kind of pharmaceutical preparation for tonifying kidney for preventing miscarriage, Chinese medicine composition by described in claim 1 or 2 and pharmaceutically acceptable Adjuvant be prepared from.
7. pharmaceutical preparation as claimed in claim 6, it is characterised in that the pharmaceutically acceptable adjuvant is disintegrating agent, profit Lubrication prescription or adhesive.
8. pharmaceutical preparation as claimed in claim 6, it is characterised in that the dosage form of the pharmaceutical preparation is pill, capsule, piece Agent, powder, granule or oral liquid.
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Publication number Priority date Publication date Assignee Title
CN101406664A (en) * 2008-12-09 2009-04-15 陕西东泰制药有限公司 Chinese medicament preparation for tocolysis and preparation method thereof
CN103007178A (en) * 2013-01-17 2013-04-03 山东省医学科学院基础医学研究所 Chinese medicament for preventing and treating unexplained recurrent spontaneous abortion and preparation method thereof

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Publication number Priority date Publication date Assignee Title
CN101406664A (en) * 2008-12-09 2009-04-15 陕西东泰制药有限公司 Chinese medicament preparation for tocolysis and preparation method thereof
CN103007178A (en) * 2013-01-17 2013-04-03 山东省医学科学院基础医学研究所 Chinese medicament for preventing and treating unexplained recurrent spontaneous abortion and preparation method thereof

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