CN106511881B - A Chinese medicinal composition for invigorating kidney and preventing miscarriage, and its preparation method - Google Patents

A Chinese medicinal composition for invigorating kidney and preventing miscarriage, and its preparation method Download PDF

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CN106511881B
CN106511881B CN201710050712.8A CN201710050712A CN106511881B CN 106511881 B CN106511881 B CN 106511881B CN 201710050712 A CN201710050712 A CN 201710050712A CN 106511881 B CN106511881 B CN 106511881B
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刘瑞芬
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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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    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps

Abstract

The invention discloses a traditional Chinese medicine composition for tonifying kidney and preventing miscarriage, which comprises the following raw materials: 16-20 parts of semen cuscutae, 16-20 parts of salted teasel root, 12-18 parts of parasitic loranthus, 10-14 parts of salted eucommia bark, 10-14 parts of wolfberry fruit, 16-20 parts of fried Chinese yam, 25-35 parts of codonopsis pilosula, 25-35 parts of roasted astragalus membranaceus, 10-14 parts of fried bighead atractylodes rhizome, 10-14 parts of poria cocos, 12-18 parts of fried white paeony root, 10-14 parts of scutellaria baicalensis, 10-14 parts of radix ophiopogonis, 6-12 parts of elecampane, 6-12 parts of fructus amomi, 10-14 parts of platycladi seed, 10-14 parts of lily and 4-8 parts of honey-fried licorice root. The traditional Chinese medicine composition disclosed by the invention has the advantages that the selected medicinal materials are compatible, the formula is refined, the functions complement each other, the purposes of removing dampness and eliminating phlegm are achieved, the functions of tonifying kidney, replenishing vital essence, promoting qi circulation, tonifying spleen, clearing heat and preventing miscarriage and nourishing heart and soothing nerves are integrated, and the curative effect is obvious; the medicine is prepared with the assistant effect on the medicine property, and has little toxic and side effect.

Description

A Chinese medicinal composition for invigorating kidney and preventing miscarriage, and its preparation method
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for tonifying kidney and preventing miscarriage and a preparation method thereof.
Background
Threatened abortion, late intrauterine fetal development and recurrent abortion are common and difficult diseases of obstetrics and gynecology, and are clinically manifested as a small amount of bleeding in the vagina during gestation, pale dark color, waist soreness, abdominal pain, tenesmus, delayed intrauterine fetal delivery, frequent pregnancy, dizziness, tinnitus, frequent nocturia and dark complexion; dark tongue, deep and slippery pulse, and slow pulse. In recent years, the incidence of threatened abortion, delayed intrauterine fetal development and recurrent abortion in pregnant women is on the rise due to various reasons, which not only seriously threatens the health and life safety of fetus and mother, but also brings great mental pain to patients and family members.
According to the traditional Chinese medicine, the kidney governs reproduction, the cell is tied to the kidney, the maternal kidney qi is the root of fetal development, the growth of the fetus depends on the nourishment of qi and blood, and qi and blood are generated by the spleen and the stomach, so that the deficiency of the kidney qi and the weakness of the spleen and the stomach are the main causes of abortion. However, the kidney and spleen tonifying is only a basic treatment rule for treating abortion by using traditional Chinese medicines, and due to the cause and complexity of abortion, most of the traditional miscarriage prevention medicines with the effects of tonifying the kidney and spleen are simply combined because the selection of raw materials in the medicines and the allocation of compatibility relation lack pertinence, so that the curative effect of most of the miscarriage prevention medicines is still unsatisfactory, and even some medicines have serious side effects on fetuses.
Disclosure of Invention
Aiming at the prior art, the invention aims to provide a traditional Chinese medicine composition for tonifying kidney and preventing miscarriage and a preparation method thereof, wherein the traditional Chinese medicine composition has the advantages of obvious curative effect, low cost and small toxic and side effects.
In order to achieve the purpose, the invention adopts the following technical scheme:
the invention provides a traditional Chinese medicine composition for tonifying kidney and preventing miscarriage, which comprises the following raw materials:
16-20 parts of semen cuscutae, 16-20 parts of salted teasel root, 12-18 parts of parasitic loranthus, 10-14 parts of salted eucommia bark, 10-14 parts of wolfberry fruit, 16-20 parts of fried Chinese yam, 25-35 parts of codonopsis pilosula, 25-35 parts of roasted astragalus membranaceus, 10-14 parts of fried bighead atractylodes rhizome, 10-14 parts of poria cocos, 12-18 parts of fried white paeony root, 10-14 parts of scutellaria baicalensis, 10-14 parts of radix ophiopogonis, 6-12 parts of elecampane, 6-12 parts of fructus amomi, 10-14 parts of platycladi seed, 10-14 parts of lily and 4-8 parts of honey-fried licorice root.
The invention relates to a traditional Chinese medicine composition for tonifying kidney and preventing miscarriage, which preferably comprises the following components:
18 parts of semen cuscutae, 18 parts of salted teasel root, 15 parts of parasitic loranthus, 12 parts of salted eucommia bark, 12 parts of wolfberry fruit, 18 parts of fried Chinese yam, 30 parts of codonopsis pilosula, 30 parts of roasted astragalus membranaceus, 12 parts of fried bighead atractylodes rhizome, 12 parts of poria cocos, 15 parts of fried white peony root, 12 parts of scutellaria baicalensis, 12 parts of radix ophiopogonis, 9 parts of elecampane, 9 parts of fructus amomi, 12 parts of platycladi seed, 12 parts of lily and 6 parts of honey-fried licorice root.
The compatibility mechanism of the traditional Chinese medicine composition is as follows: dodder seed and teasel root are used as monarch drugs to tonify kidney and replenish essence, consolidate thoroughfare and conception vessels and make kidney exuberant and self-sprouting. Herba Taxilli and cortex Eucommiae with salt have effects of nourishing liver and kidney, and strengthening Chong and ren meridians; fructus Lycii and parched rhizoma Dioscoreae have effects of invigorating kidney and nourishing yin; the codonopsis pilosula, the roasted astragalus, the fried bighead atractylodes rhizome and the poria cocos tonify qi and invigorate spleen, and are acquired by nourishing the innate body and taking various medicines as ministers. Parched radix Paeoniae alba has effects of nourishing blood, softening liver, and relieving spasm, and can be used for preventing uterine contraction; scutellariae radix and radix Ophiopogonis have effects in nourishing yin, clearing away heat, and preventing miscarriage; aucklandia root and amomum fruit for regulating qi and harmonizing stomach; the arborvitae seed and the lily root are used as adjuvant drugs for nourishing the heart and soothing the nerves; prepared licorice root, radix Glycyrrhizae Praeparata, is used to regulate the effects of the drugs in the recipe.
The invention combines a plurality of traditional Chinese medicines, and the medicines play roles of tonifying kidney and replenishing essence, tonifying qi and strengthening spleen, and clearing heat and preventing miscarriage together, thereby having obvious synergistic effect and fully playing a compatibility relationship of mutual reinforcement and mutual assistance.
In conclusion, the medicinal materials selected by the formula are compatible, the formula is refined, the functions complement each other, the purposes of tonifying kidney and preventing miscarriage are achieved, the traditional Chinese medicine composition integrates the functions of tonifying kidney, replenishing vital essence, promoting qi circulation, strengthening spleen, clearing heat and preventing miscarriage and nourishing heart and tranquilization, and has a remarkable curative effect; the medicine is prepared in an adjuvant mode on the medicine property, has little toxic and side effect and is safe to take.
In the traditional Chinese medicine composition for tonifying the kidney and preventing miscarriage, all raw material components are organic whole, and the deficiency is not essential. In the research and development process, the inventor finds that the overall action effect of the traditional Chinese medicine composition is obviously reduced by reducing any one raw material component in the composition or replacing the raw material components of the traditional Chinese medicine composition by the raw material medicines with similar medicine properties; other raw material components are added on the basis of the traditional Chinese medicine composition, so that the overall effect of the traditional Chinese medicine composition is not obviously improved, and even the overall effect of the traditional Chinese medicine composition is reduced.
The traditional Chinese medicine composition for tonifying the kidney and preventing miscarriage can be prepared by directly decocting the raw materials in water or preparing the traditional Chinese medicine composition according to other methods.
In a specific embodiment of the present invention, the preparation method of the traditional Chinese medicine composition for tonifying kidney and preventing miscarriage comprises:
mixing semen Cuscutae, salted radix Dipsaci, herba Taxilli, salted Eucommiae cortex, fructus Lycii, parched rhizoma Dioscoreae, radix Codonopsis, radix astragali Preparata, parched Atractylodis rhizoma, Poria, parched radix Paeoniae alba, Scutellariae radix, radix Ophiopogonis, radix aucklandiae, semen Platycladi, Bulbus Lilii and radix Glycyrrhizae Preparata, decocting with water twice, and adding fructus Amomi 5-10 min before the second decoction; filtering (adding 8-10 times of water for decocting for 30-60 min for the first time, adding 6-8 times of water for decocting for 20-40 min for the second time), and mixing filtrates.
The traditional Chinese medicine components are complex, one medicinal material contains water-soluble components and oil-soluble or alcohol-soluble components, and some active components are easy to inactivate at high temperature, so that the effective components of the traditional Chinese medicine can be extracted and separated to the maximum extent by selecting a proper extraction method and an appropriate extraction process, and the activity of the effective components is ensured, thereby ensuring the clinical effect of the product.
Tests prove that by adopting the preparation method, the effective components in the traditional Chinese medicine composition can be extracted to the maximum extent and the activity of the effective components is ensured, so that the clinical effect of the product is ensured; for example, the mode of 'back-down' is adopted for the fructus amomi in the raw materials, so that the volatilization loss of the effective components in the fructus amomi can be reduced, and the effective components can be retained in the soup to the maximum extent.
The application of the traditional Chinese medicine composition in preparing the medicinal preparation for tonifying the kidney and preventing miscarriage also belongs to the protection scope of the invention.
In a second aspect of the invention, the invention provides a pharmaceutical preparation for tonifying kidney and preventing miscarriage, which is prepared from the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.
The above medicinal preparation can be made into various dosage forms, such as pill, capsule, tablet, powder, granule or oral liquid.
The pharmaceutically acceptable auxiliary materials are conventional auxiliary materials in medicinal preparations, such as: disintegrants, lubricants, binders, and the like; preferably one or more of glycerol, butanediol, trehalose, betaine, starch, and sodium carboxymethylcellulose.
The traditional Chinese medicine composition or the pharmaceutical preparation has the following effects: tonifying kidney, invigorating spleen, and preventing miscarriage. It can be used for treating threatened abortion, fetal atrophy (intrauterine growth retardation), and habitual abortion (recurrent abortion).
The invention has the beneficial effects that:
the traditional Chinese medicine composition disclosed by the invention has the advantages that the selected medicinal materials are compatible, the formula is refined, the functions complement each other, the purposes of tonifying kidney, strengthening spleen and preventing miscarriage are achieved, the traditional Chinese medicine composition integrates the functions of tonifying kidney, replenishing essence, promoting qi circulation, strengthening spleen, clearing heat and preventing miscarriage and nourishing heart and soothing nerves, and the curative effect is obvious; the medicine is prepared with the assistant effect on the medicine property, and has little toxic and side effect.
Detailed Description
The present invention is further illustrated by the following specific examples, which should be construed as merely illustrative, and not limitative of the remainder of the disclosure.
Example 1:
the formula is as follows: 18 g of dodder, 18 g of salted teasel root, 15 g of loranthus parasiticus, 12 g of salted eucommia bark, 12 g of medlar, 18 g of fried Chinese yam, 30 g of codonopsis pilosula, 30 g of roasted astragalus, 12 g of fried bighead atractylodes rhizome, 12 g of tuckahoe, 15 g of fried white peony root, 12 g of scutellaria baicalensis, 12 g of dwarf lilyturf tuber, 9 g of costustoot, 9 g of fructus amomi, 12 g of platycladi seed, 12 g of lily and 6 g of honey-fried licorice root.
The preparation method comprises the following steps:
mixing semen Cuscutae, salted radix Dipsaci, herba Taxilli, salted Eucommiae cortex, fructus Lycii, parched rhizoma Dioscoreae, radix Codonopsis, radix astragali Preparata, parched Atractylodis rhizoma, Poria, parched radix Paeoniae alba, Scutellariae radix, radix Ophiopogonis, radix aucklandiae, semen Platycladi, Bulbus Lilii and radix Glycyrrhizae Preparata, decocting with water twice (first time adding 8 times of water, decocting for 30 min, second time adding 8 times of water, decocting for 20 min), adding fructus Amomi 5 min before the second time of decoction, decocting, filtering, and mixing filtrates.
The decoction is orally administered twice a day in the morning and at night.
Example 2:
the formula is as follows: 16 g of dodder, 20 g of salted teasel root, 12 g of loranthus parasiticus, 14 g of salted eucommia bark, 10g of medlar, 20 g of fried Chinese yam, 25g of codonopsis pilosula, 35 g of roasted astragalus, 10g of fried bighead atractylodes rhizome, 14 g of poria cocos, 12 g of fried white peony root, 14 g of scutellaria baicalensis, 10g of ophiopogon root, 12 g of costustoot, 6 g of fructus amomi, 14 g of platycladi seed, 10g of lily and 8g of honey-fried licorice root.
The preparation method comprises the following steps:
mixing semen Cuscutae, salted radix Dipsaci, herba Taxilli, salted Eucommiae cortex, fructus Lycii, parched rhizoma Dioscoreae, radix Codonopsis, radix astragali Preparata, parched Atractylodis rhizoma, Poria, parched radix Paeoniae alba, Scutellariae radix, radix Ophiopogonis, radix aucklandiae, semen Platycladi, Bulbus Lilii and radix Glycyrrhizae Preparata, decocting with water twice (10 times of water for 30 min for the first time and 6 times of water for 20 min for the second time), adding fructus Amomi 5 min before the second time, decocting, filtering, and mixing filtrates.
The decoction is orally administered twice a day in the morning and at night.
Example 3:
the formula is as follows: 20 g of dodder, 16 g of salted teasel root, 18 g of loranthus parasiticus, 10g of salted eucommia bark, 14 g of medlar, 16 g of fried Chinese yam, 35 g of codonopsis pilosula, 25g of roasted astragalus root, 14 g of fried bighead atractylodes rhizome, 10g of tuckahoe, 18 g of fried white peony root, 10g of scutellaria root, 14 g of dwarf lilyturf tuber, 6 g of costustoot, 12 g of fructus amomi, 10g of platycladi seed, 14 g of lily and 4 g of honey-fried licorice root.
The preparation method is the same as example 1.
Example 4:
the filtrate obtained after the decoction in example 1 is prepared into capsules by a conventional method, and the specification is 0.25 g/capsule.
Example 5:
the decocted filtrate of example 1 is prepared into pills by a conventional method.
Comparative example 1:
the inventor conducts investigation of compatibility and research of drug effects on multiple raw material medicines with similar drug properties in the research and development process, and finds that even if the drug properties of a certain raw material medicine are similar, the difference of the drug effects is obvious after the raw material medicine is compatible with other different raw material medicines. For example: the tuckahoe, the dwarf lilyturf tuber, the costus root, the platycladi seed and the lily in the medicine formula of the embodiment 1 are replaced by prepared rehmannia root, donkey-hide gelatin, mistletoe, morinda officinalis and akebia stem; the amount and preparation were the same as in example 1.
An abortion model caused by diethylstilbestrol is established by a conventional method, and the miscarriage prevention effect of the traditional Chinese medicine composition of the embodiment 1 and the comparative example 1 on the abortion model is considered, and animal experiments show that the miscarriage prevention effect of the traditional Chinese medicine composition of the embodiment 1 is obviously better than that of the comparative example 1. The composition conforms to the compatibility of the traditional Chinese medicines, has a synergistic effect among the components, and is not simple replacement or combination of the raw material medicines with similar medicinal properties.
Comparative example 2:
the dosage of each raw material medicine in the traditional Chinese medicine composition is marked, even if the medicine composition of the prescription is the same, if the dosage of the medicine is different, the efficacy of the medicine is divided into the magnitude, and the compatibility relationship is changed by monarch, minister, assistant and guide, so that the main treatment principle of the effect is different. The inventor researches the content of each raw material in the traditional Chinese medicine composition and the drug effect in the research and development process, and finds that the difference of the drug effect is obvious when the ratio of the unsuitable raw materials is different, especially when the monarch drug and the ministerial drug are different in the occupied parts. For example: the dosage of the dodder seed in the example 1 is adjusted to 25g, the dosage of the salted himalayan teasel root is adjusted to 12 g, the dosage of the mistletoe is adjusted to 20 g, the dosage of the salted eucommia bark is adjusted to 5g, the dosage of the medlar is adjusted to 18 g, the dosage of the fried yam is adjusted to 12 g, the dosage of the codonopsis pilosula is adjusted to 40g, and the dosages of other raw materials are the same as the dosage in the example 1, and the preparation method is carried out according to the method in the example 1.
An abortion model caused by diethylstilbestrol is established by a conventional method, and the abortion prevention effect of the traditional Chinese medicine composition of the embodiment 1 and the comparative example 2 on the abortion model is considered, and animal experiments show that the abortion prevention effect of the traditional Chinese medicine composition of the embodiment 1 is obviously better than that of the comparative example 2. The dosage of each raw material medicine in the composition is not obtained by conventional adjustment, and in the traditional Chinese medicine formula, the dosage and the proportion of each raw material medicine are determined according to various consideration factors such as the characteristics of the raw materials, monarch, minister, assistant and guide compatibility and the like, so that the composition plays an important role in the overall efficacy of the traditional Chinese medicine composition.
Animal experiments:
1. effect on Ex vivo uterine smooth muscle of Normal Wistar pregnant rat
(1) The test method comprises the following steps:
30 Wistar adult female rats with the weight of 250-350 g are taken and divided into a test group, a positive control group and a blank control group, each group is 10, and the weight and the health condition of the rats in each group have no obvious difference.
Mating and conception of rat for 7d, stunning, laparotomy, taking out 2.0cm long uterus, placing in Luo's solution, maintaining the temperature (35 + -0.5 deg.C), and introducing O2Connecting a tension transducer with an XWT-164 balance recorder, keeping the tension at 1g, balancing for 10min, and administering the Chinese medicinal composition of example 1 to make the final concentration of the medicine in the bath be 16 mg/ml; the positive control group is administered with commercially available BAOTIANLING tablet to make the final concentration of the medicine in the bath tank be 16 mg/ml; the blank control group was added with an equal amount of physiological saline. Changes in uterine smooth muscle after 10min of administration were recorded and the results are shown in table 1.
(2) And (3) test results:
the results of the effects of the traditional Chinese medicine composition on the isolated uterine smooth muscle of a normal Wistar pregnant rat are shown in Table 1.
TABLE 1 Effect on Ex vivo uterine smooth muscle of Normal Wistar pregnant rats
Figure BDA0001217664130000051
Figure BDA0001217664130000052
The results show that: the test group and the positive control group can reduce the contractility of uterine smooth muscle of pregnant mice and slow down the contraction frequency thereof, and compared with a blank control group, the test group and the positive control group have significant difference; compared with a positive control medicament (a tocolytic tablet), the traditional Chinese medicine composition has stronger miscarriage prevention and fetus protection effects.
2. Effect on mouse uterine and ovarian development
(1) The test method comprises the following steps:
30 Kunming female mice (young mice) with the weight of 10-15 g are taken and divided into a test group, a positive control group and a blank control group, each group is 10, and the weight and the health condition of the mice in each group have no obvious difference.
Test groups administered the capsule prepared in example 4 of the present invention by gavage administration, with an administration amount of 4.8g crude drug/kg, 1 time per day, for 14 days;
the positive control group is administered with commercial BAOTIANLING tablet by intragastric administration, with dosage of 4.8g crude drug/kg, 1 time per day, and continuous administration for 14 days;
the blank control group was gavaged with the same volume of saline.
Animals were sacrificed on day 15, uterus and ovaries were isolated, weighed, and uterus and ovary indices (mg/10g body weight) were calculated.
(2) And (3) test results:
the test results are shown in Table 2.
Table 2: effect on growth and development of uterus and ovary of mouse
Figure BDA0001217664130000061
Figure BDA0001217664130000062
The results show that: the test group and the positive control group can promote the growth and development of the uterus and the ovary of the mouse, and have significant difference compared with a blank control group; compared with a positive control medicament (a tocolytic tablet), the traditional Chinese medicine composition has stronger capacity of promoting the development of the uterus and the ovary of the mouse.
3. Fetus protection effect on abortion model caused by diethylstilbestrol
(1) The test method comprises the following steps:
the Kunming mouse, 2 months old, has the body weight of 28-32g female and 36-40g male. Mice were female: the male (2: 1) proportion was mated in cages. The day of vaginal suppository detection was day 1 of pregnancy, and 80 vaginal suppository mice were randomly divided into 4 groups of 20 mice per group according to pregnancy.
The normal saline with the same volume is perfused into the control group and the model group;
test groups administered the capsule prepared in example 4 of the present invention by gavage, with the dosage of 4.8g crude drug/kg;
the positive control group was administered with commercially available BAOTIANLING tablet at a dose of 4.8g crude drug/kg;
the above groups were administered by gavage 1 time a day for 10 days. Except for the control group, diethylstilbestrol was continuously injected subcutaneously on the 7 th day of pregnancy, and the control group was injected subcutaneously with an equal volume of physiological saline 2d, and each group was sacrificed on the 18 th day of pregnancy, dissected, and observed for the number of live births of each group.
(2) And (3) test results:
the test results are shown in Table 3.
Table 3: fetus protection effect on abortion model caused by diethylstilbestrol
Figure BDA0001217664130000063
Figure BDA0001217664130000064
The results show that: the test group and the positive control group have fetus protection effect on the abortion model caused by diethylstilbestrol; compared with a positive control medicament (tocolytic tablet), the traditional Chinese medicine composition has stronger tocolytic effect on a abortion model caused by diethylstilbestrol.
4. And (3) safety test:
(1) acute toxicity test:
respectively taking 40 Kunming mice with the body weight of 18-22 g and half of the male and female as test animals, respectively carrying out intragastric administration on the test animals, and respectively carrying out intragastric administration on the test animals in two groups of once administration and three times administration; the dose of the mice in the first administration group is 12.0g (crude drug)/kg, the dose of the mice in the third administration group (4-6 hours apart) is 26.0g (crude drug)/kg, and no death of the animals is found after one week of observation after the gavage administration; therefore, the traditional Chinese medicine composition has low acute toxicity and safe clinical medication.
(2) Long-term toxicity test:
the Kunming mouse 81 was divided into three dose groups of 4.0g (crude drug)/kg/day, 8.0g (crude drug)/kg/day and 16.0g (crude drug)/kg/day, and the composition prepared in example 1 was separately gavaged for continuous administration for 2 months. After 1 month of administration, 1/3 animals were sacrificed in the high dose group and the control group, respectively, and each index was measured; after 2 months of administration, all dose groups were sacrificed except 1/3 animals were individually kept for recovery observation and the indices were determined. Observation and measurement items include, for example, physical signs and behavioral activities, secretions, stool characteristics; conventional and biochemical indices of blood; the contents of the system autopsy, organ coefficients, and histological examination.
The results show that: the continuous oral administration of the composition to mice at different doses had no effect on the food intake and weight gain of the mice. No obvious toxic effect on the functions of the liver and the kidney is found; the safety and the non-toxicity of the traditional Chinese medicine composition are proved.
(3) Special toxicity test:
the teratogenesis sensitive period toxicity test has no significant difference on embryo formation, growth and development of fetal rats, appearance of fetal rats, viscera and skeleton development compared with a control group.
The general reproductive toxicity test has no influence on conception rate, embryo formation, growth and development of fetal mice, appearance of fetal mice, and development of viscera and skeleton. The traditional Chinese medicine composition has no toxic reaction, no teratogenesis effect and safe and reliable long-term use.
And (3) clinical trials:
1. study object
120 recurrent abortion patients who come to hospital in 12 months in 2013, 1 month and 2014 are selected, and after detailed inquiry of medical history and screening of conventional causes, the patients are aged 23-38 years old, and the number of continuous spontaneous abortion is more than or equal to 2 times and at most 5 times, and the patients are all early (<12 weeks) abortion. The patients to be enrolled were randomized into treatment and control groups of 60 patients each. The age, disease course and the like of the treatment group and the control group have no significant significance (p is more than 0.05), and the treatment group and the control group have comparability.
2. Diagnostic and therapeutic criteria: refer to the diagnosis and treatment effect evaluation Standard of recurrent spontaneous abortion published by the State administration of traditional Chinese medicine.
3. The treatment method comprises the following steps:
the treatment group orally takes the traditional Chinese medicine composition (decoction) prepared in the embodiment 1 of the invention twice a day until 3 months of pregnancy;
the control group was injected with progesterone injection (Zhejiang Xianju pharmaceutical Co., Ltd., national standard character H33020829) at a dose of 20 mg/time, 1 time a day, continuously until 3 months of gestation. The 2 groups were observed for pregnancy and statistically analyzed.
4. As a result:
the results are shown in Table 4.
Table 4: pregnancy condition comparison table for each group
Figure BDA0001217664130000081
Figure BDA0001217664130000082
Warp X2The success rate of pregnancy (P) was significantly higher in the treated group compared to the control group<0.05), the pregnancy failure rate is significantly reduced (P)<0.05), the success rate of pregnancy is obviously improved. The traditional Chinese medicine preparation has good clinical treatment effect on recurrent abortion.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be able to cover the technical solutions and the inventive concepts of the present invention within the technical scope of the present invention.

Claims (6)

1. A traditional Chinese medicine composition for tonifying kidney and preventing miscarriage is characterized by comprising the following raw materials: 18 parts of semen cuscutae, 18 parts of salted teasel root, 15 parts of parasitic loranthus, 12 parts of salted eucommia bark, 12 parts of wolfberry fruit, 18 parts of fried Chinese yam, 30 parts of codonopsis pilosula, 30 parts of roasted astragalus membranaceus, 12 parts of fried bighead atractylodes rhizome, 12 parts of poria cocos, 15 parts of fried white peony root, 12 parts of scutellaria baicalensis, 12 parts of radix ophiopogonis, 9 parts of elecampane, 9 parts of fructus amomi, 12 parts of platycladi seed, 12 parts of lily and 6 parts of honey-fried licorice root.
2. The preparation method of the traditional Chinese medicine composition of claim 1, which is characterized by comprising the following steps: mixing semen Cuscutae, salted radix Dipsaci, herba Taxilli, salted Eucommiae cortex, fructus Lycii, parched rhizoma Dioscoreae, radix Codonopsis, radix astragali Preparata, parched Atractylodis rhizoma, Poria, parched radix Paeoniae alba, Scutellariae radix, radix Ophiopogonis, radix aucklandiae, semen Platycladi, Bulbus Lilii and radix Glycyrrhizae Preparata, decocting with water twice, adding fructus Amomi 5-10 min before the second decoction, decocting, filtering, and mixing filtrates.
3. The preparation method according to claim 2, wherein the water decoction is carried out by the specific steps of: adding 8-10 times of water for the first time, and decocting for 30-60 minutes; adding 6-8 times of water for the second time, and decocting for 20-40 minutes.
4. A pharmaceutical preparation for tonifying kidney and preventing miscarriage, which is prepared from the traditional Chinese medicine composition of claim 1 and pharmaceutically acceptable auxiliary materials.
5. The pharmaceutical formulation of claim 4, wherein the pharmaceutically acceptable excipient is a disintegrant, a lubricant, or a binder.
6. The pharmaceutical preparation according to claim 4, wherein the pharmaceutical preparation is in the form of a pill, capsule, tablet, powder, granule or oral liquid.
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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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