CN105726970A - Medicine composition for treating early threatened abortion caused by deficiency of kidney yang - Google Patents
Medicine composition for treating early threatened abortion caused by deficiency of kidney yang Download PDFInfo
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- CN105726970A CN105726970A CN201610183867.4A CN201610183867A CN105726970A CN 105726970 A CN105726970 A CN 105726970A CN 201610183867 A CN201610183867 A CN 201610183867A CN 105726970 A CN105726970 A CN 105726970A
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Abstract
The invention belongs to the field of traditional Chinese medicines and relates to a medicine composition for treating early threatened abortion caused by deficiency of kidney yang and a preparation method thereof. The medicine composition is elaborately prepared by using Chinese dodder seed, prepared rhizome of adhesive rehmannia, morinda root, root of woods greenstar, Chinese taxillus twig, Chinese magnoliavine fruit, rhizome of conic gymnadenia and fragrant solomonseal rhizome as medicinal raw materials. The medicine composition has the advantages that the medicines are combined, interact, are indispensable and have the functions of warming and invigorating kidney yang, tonifying the spleen and nourishing the liver, supplementing qi and nourishing blood and preventing abortion by astringency; and the medicine composition can achieve the effects of tonifying kidney yang, tonifying the spleen and regulating the liver when being used for treating patients suffering early threatened abortion caused by deficiency of kidney yang, has obviously better treatment effects than western medicine therapy, shows enormous advantages of traditional Chinese medicines in early threatened abortion and is worthy of being further studied and applied.
Description
Technical field
The invention belongs to tcm field, relate to pharmaceutical composition of a kind of kidney yang deficiency syndrome early stage threatened abortion and preparation method thereof.
Background technology
Early stage threatened abortion is the commonly encountered diseases of department of obstetrics and gynecology, account for the 15% of gestation, refer to that gestation occurred before 12 weeks hemorrhage on a small quantity with vagina, companion's lower abdomen pendant pain or soreness of waist pain etc. are the disease of main clinical manifestation, early stage threatened abortion wishes to continue to gestation through having a rest and still having after treatment, if but do not give attention, then it would be likely to develop into inevitable abortion.In recent years, the sickness rate of threatened abortion raises year by year, and primary disease has the tendency repeatedly occurred, not only cause the injury of patient's body and mind, have an effect on family, social stablizing, therefore how effectively to prevent and treat early stage threatened abortion, and be effectively extended to clinic, apply to patient easily, be always up the direction that medical circle is made great efforts.
Generally believe clinically and cause a lot of because have of threatened abortion; such as operating pressure is excessive, emotion excessively anxiety and anxiety, and living environment is polluted, and sucks or contact too much toxic chemical substance; anemia of pregnant woman occurs that microorganism is infected, and the reason such as exception or endocrine regulation occurs in immunologic function.Western medical treatment early stage threatened abortion approach is single, and routine gives supplementary progesterone, vitamin E, chorionic-gonadotropin hormone (HCG), and it is only effective to luteal phase defect person to supplement progesterone, and person caused by immune factor adopts active immunization to treat.
Primary disease is early on the books in motherland's medical science.Threatened abortion belongs to the category of motherland's medical science " vaginal bleeding during pregnancy ", " frequent fetal movement ".For a long time in the understanding to primary disease, motherland's medical science have accumulated the experience of many preciousnesses.Zhang Zhongjing it " Medical Treasures of the Golden Chamber married woman's gestation abnormal pulse is demonstrate,proved and controlled " in Han dynasty proposes to dissipate antiabortive fetus nourishing with Chinese angelica powder and the Rhizoma Atractylodis Macrocephalae, controls the record of abdominal pain during pregnancy in addition with Ass-hide Glue and Argyi Leaf Decoction, opens the beginning that the in love product of flesh and blood are antiabortive, is the source of antiabortive principle-method-recipe-medicines later age.Song dynasty " female section hundred is asked " proposes Cortex Eucommiae ball and treats the hardship of frequent fetal movement.Yuan Dynasty's ZHU Dan-xi proposes saying of " Radix Scutellariae, the Rhizoma Atractylodis Macrocephalae being antiabortive panacea ", affects later age so far.Ming Dynasty's Zhang Jingyue " Jing Yue's complete work married woman rule " emphasizes that determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs is antiabortive, and first propose dynamically to observe the weight change of the big symptom (stomachache, hematochezia, the soreness of waist, tenesmus) of frequent fetal movement four, whether prediction embryo survival, to determine antiabortive or lower tire, perfect pregnancy disease " cure the disease and develop simultaneously with antiabortive " and the big rule for the treatment of of " lower tire " two, propose the prevention thought of " its damage of pre-training " simultaneously, instruct clinic so far.Qing Dynasty's "Fu Qingzhu works on obstetric" extensively discusses antiabortive seven methods, and Wang Qingren proposes the antiabortive method of blood stasis dispelling in " correction of the errors of medical works SHAOFU ZHUYN DECOCTION ".Lid nausea is uneasy, must to some extent because of, or empty or real or cold or heat, can be all the disease of nausea.Go to its institute sick, be antiabortive method." later age under the guide of determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, in conjunction with the continuous summing up experience of clinical practice, gradually formed the multiple method of multiple treatment primary disease.Chinese medicine primary disease determined curative effect, non-evident effect, easily accept for patient and his family.
Summary of the invention
"Fu Qingzhu works on obstetric" says " one-tenth of husband's tire becomes the essence of kidney ".Kidney yin, kidney yang combined effect under, just make uterus have consolidating semen to become pregnant, educate viviparous long physiological function.Kidney storing essence, essence is the material base of fetus nourishing;Kidney essense is abundant, and born of the same parents must nourish, and needs fetus nourishing unit to give a birth to phase maturation;And kidney the yang aspect of yang, then uterus being played warm biochemical action, born of the same parents get Qi Wen only just can be made under the evaporation of kidney yang not tremble with fear, menses are smooth and not stagnant, and it is warm and can grow up that tire obtains it;Suffer from a deficiency of the kidney the then debility of CHONG and REN meridians, frequent fetal movement, send out as primary disease.
Inventor is on the basis of recipe handed down from ancestors, in conjunction with body constitution and the modern medical theory of modern, dialectical combines with differential diagnosis of diseases, it is provided that the pharmaceutical composition of the treatment kidney yang deficiency syndrome early stage threatened abortion that a kind of curative effect is determined, side effect is little.
The technical solution used in the present invention is as follows:
A kind of pharmaceutical composition treating kidney yang deficiency syndrome early stage threatened abortion, it is characterised in that be that medicinal raw material is made by Semen Cuscutae, Radix Rehmanniae Preparata, Radix Morindae Officinalis, Polyalthia nemoralis A. D C., Herba Taxilli, Fructus Schisandrae Chinensis, Rhizoma Gymnadeniae, Rhizoma Polygonati Odorati.
Indivedual medicinal raw materials in the present invention have the kidney invigorating, antiabortive, spleen invigorating, effect of nourishing blood, but all not there is good curative effect, the artificial synergism increasing effective active composition of invention, by lot of experiments research persistent exploration, is finally obtained following technical scheme:
A kind of pharmaceutical composition treating kidney yang deficiency syndrome early stage threatened abortion, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 13-18 part, Radix Rehmanniae Preparata 8-13 part, Radix Morindae Officinalis 7-12 part, Polyalthia nemoralis A. D C. 10-15 part, Herba Taxilli 5-8 part, Fructus Schisandrae Chinensis 2.5-4.5 part, Rhizoma Gymnadeniae 20-25 part, Rhizoma Polygonati Odorati 7-12 part.
Further, a kind of pharmaceutical composition treating kidney yang deficiency syndrome early stage threatened abortion, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 15 parts, Radix Rehmanniae Preparata 10 parts, Radix Morindae Officinalis 10 parts, Polyalthia nemoralis A. D C. 15 parts, Herba Taxilli 7 parts, Fructus Schisandrae Chinensis 4 parts, Rhizoma Gymnadeniae 25 parts, Rhizoma Polygonati Odorati 10 parts.
Fang Zhong: the sweet temperature of Semen Cuscutae, tonifying kidney and nourishing liver, warming the spleen helps stomach, and nourishing YIN is YANG invigorating again, and astringency inducing punching is appointed, for monarch drug.Radix Morindae Officinalis Xin Ganwen, reinforcing the kidney and supporting YANG is held concurrently and is dissipated evil and expelling wind and removing dampness, bone and muscle strengthening, the sweet temperature of Radix Rehmanniae Preparata, nourishing YIN and supplementing blood, and benefit essence fills out marrow, two medicine 5 kidney-replenishing blood-nourishings, negative and positive alternate, helps kidney qi to grow, Yuanyang benefit Sheng, for ministerial drug.Polyalthia nemoralis A. D C. is sweet flat, invigorating spleen and reinforcing stomach, tonifying the kidney to consolidate the essence;Herba Taxilli invigorating the liver and kidney, bone and muscle strengthening, the meridian dredging, replenishing QI and blood, antiabortive;Rhizoma Gymnadeniae is sweet flat, and Yishen Jianpi is regulated the flow of vital energy and blood, hemostasis and pain-relieving, calms the nerves relieving convulsion;Trimethyl gallic acid is held back and is promoted the production of body fluid, protect reinforcing premodial qi, above enter lung, under enter kidney, entering lung has the benefit of Jiyuan of promoting the production of body fluid, enter kidney have controlling nocturnal emission with astringent drugs support marrow merit;Sweet cold the alcohol of Rhizoma Polygonati Odorati is good, and abnormal smells from the patient eases up, therefore can grow tonifying YIN essence, increases yang-energy, with and poor, five medicines are adjuvant drug.All medicine 5 use, interacts, indispensable, has warming and recuperating the kidney-YANG, spleen invigorating nourishing the liver, benefiting QI and nourishing blood, effect that astringency inducing is antiabortive.
The medicinal part that medicinal raw material of the present invention is all recorded in the ancient books and records such as " Chinese Pharmacopoeia ", " China's book on Chinese herbal medicine " is for standard, and pharmacological activity present Research is as described below.
Semen Cuscutae: [nature and flavor] are sweet, temperature.[return through] returns liver,kidney,spleen warp.[function cures mainly] nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.For impotence and seminal emission, dripping urination, enuresis frequent micturition, soreness of the waist and knees, blurred vision tinnitus, vaginal bleeding due to deficiency of the kidney during pregnancy, frequent fetal movement, spleen is suffered from a deficiency of the kidney and is rushed down;Externally treating leucoderma.
Radix Rehmanniae Preparata: [nature and flavor] are sweet, tepor.[return through] returns liver, kidney channel.[function cures mainly] nourishing YIN and supplementing blood, benefit essence fills out marrow.For the hepatic and renal YIN deficiency, soreness of the waist and knees, osteopyrexia and fever, night sweat is passed out semen, and interior-heat is quenched one's thirst, blood deficiency and yellow complexion, severe palpitation, menoxenia, metrostaxis, dizziness, tinnitus, early whitening of beard and hair.[usage and dosage] 9~15g.
Radix Morindae Officinalis: [nature and flavor] Xin Gan;Temperature.[return through] liver;Kidney channel.[function cures mainly] reinforcing the kidney and supporting YANG;Bone and muscle strengthening;Expelling wind and removing dampness.Main impotence due to deficiency of the kidney;Seminal emission premature ejaculation;Few abdomen cold type of pain;Incontinence of urine;Cold womb is infertile;Anemofrigid-damp arthralgia;Soreness of the waist and knees;Rheumatism limb gas.
Polyalthia nemoralis A. D C.: [nature and flavor] are sweet is flat.[function cures mainly] invigorating spleen and reinforcing stomach, tonifying the kidney to consolidate the essence.Controlling chronic gastritis, taste lose, inappetence, myasthenia of limbs, seminal emission.
Herba Taxilli: [nature and flavor] bitter, sweet, flat.[return through] returns liver, kidney channel.[function cures mainly] invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit.For rheumatic arthralgia, soreness of the waist and knees, muscles and bones is unable, metrorrhagia through many, blood leaking in gestation, frequent fetal movement;Hypertension.
Fructus Schisandrae Chinensis: [nature and flavor] are sour, sweet, temperature.[return through] returns lung, the heart, kidney channel.[function cures mainly] restrains astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.For chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Tianjin wound is thirsty, and deficient pulse of losing heart, interior-heat is quenched one's thirst, palpitation and insomnia.[usage and dosage] 1.5~6g.
Rhizoma Gymnadeniae: [nature and flavor] are sweet;Flat.[return through] lung;Spleen;Stomach warp.[function cures mainly] relieving cough and asthma;Yishen Jianpi;Regulate the flow of vital energy and blood;Pain relieving.Main cough and asthma due to lung deficiency;Asthenia is become thin;Neurasthenia;Suffer from a deficiency of the kidney lassitude loin and legs;Sexual impotence;Spermatorrhea;Frequent micturition;Chronic hepatitis;Chronic diarrhea;Lose blood;Leukorrhagia;Breast is few;Traumatic injury.
Rhizoma Polygonati Odorati: [nature and flavor] are sweet, are slightly cold.[return through] attaches to the lung and stomach meridians.[function cures mainly] nourishing YIN to relieve dryness, promoting the production of body fluid to quench thirst.Hindering for lung stomach-Yin, cough caused by dryness-heat, dry throat and mouth, interior-heat is quenched one's thirst.
A kind of method that present invention also offers pharmaceutical composition preparing treatment kidney yang deficiency syndrome early stage threatened abortion.
The method of a kind of pharmaceutical composition preparing treatment kidney yang deficiency syndrome early stage threatened abortion provided by the invention, mainly comprises the steps that
(1) take Radix Morindae Officinalis, Polyalthia nemoralis A. D C. add medical material amount 5-8 times 50% ethanol water, extract secondary, each 1.5 hours, filtered while hot, be concentrated into and obtain ethanol extraction concentrated solution without alcohol taste;
(2) take Semen Cuscutae, Radix Rehmanniae Preparata, Herba Taxilli, Fructus Schisandrae Chinensis, Rhizoma Gymnadeniae, Rhizoma Polygonati Odorati together with filtering residue after Radix Morindae Officinalis, Polyalthia nemoralis A. D C. ethanol extraction, add 5-8 times of water soaking 3-4 hour, decoct extraction twice, each 1.0-2.0 hour;Filtered while hot, it is concentrated into relative density 1.05-1.10 (60 DEG C record), adding ethanol makes alcohol content be 30% (volume ratio), after standing 24 hours, discard lower sediment thing, obtain supernatant, be concentrated into relative density 1.05-1.10 (60 DEG C record) and mix with above-mentioned ethanol extraction concentrated solution afterwards, under inlet temperature 140~150 DEG C, 75~80 DEG C of conditions of leaving air temp, carry out spray drying obtain active constituents of medicine;This composition individually or mixes with pharmaceutically acceptable carrier, makes according to galenic pharmacy routine techniques.
In order to express the pharmaceutical composition of the present invention better, the pharmaceutical composition of the present invention can be prepared as dosage form conventional clinically.Being preferably, pharmaceutical composition described above prepares into oral formulations, i.e. powderous preparations, powder, pill, sublimed preparation, unguentum, granule, oral liquid, tablet, capsule etc..It is highly preferred that pharmaceutical composition of the present invention conventionally preparation technology prepares into granule, tablet or capsule;Most preferably, pharmaceutical composition described above prepares into capsule.
The present invention is also claimed aforementioned pharmaceutical compositions purposes in preparation treatment kidney yang deficiency syndrome early stage threatened abortion medicine.Pharmaceutical composition of the present invention is when treatment early stage threatened abortion, particularly during kidney yang deficiency syndrome early stage threatened abortion, it is shown that activity significantly.Clinical observation experiment embodiment 9 of the present invention shows, compare with western medicine group: in clinical total effects: treatment group and matched group total effective rate respectively 92.5% and 72.5%, two groups of total effective rate comparing differences statistically significant (P < 0.05), the curative effect for the treatment of group is substantially better than matched group;In TCM symptom score compares: after the treatment for the treatment of group, TCM symptom score is all substantially more less than before treatment, with comparing difference statistically significant (P < 0.01) before treatment, matched group compares with before treatment, difference statistically significant (P < 0.05);Comparing between two groups after treatment, treatment group is better than matched group in improving tcm symptom, and the minimizing for the treatment of group symptom integral becomes apparent from, difference statistically significant (P < 0.01).
The present invention relatively and prior art, has following clear superiority:
Chinese medicine preparation prescription of the present invention mainly develops according to the pathogenic characteristic of kidney yang deficiency syndrome early stage threatened abortion, and full side closes 5 warming and recuperating the kidney-YANG, spleen invigorating nourishing the liver, benefiting QI and nourishing blood, effect that astringency inducing is antiabortive.
The component of the present composition all adopts natural raw material of Chinese medicine, and preparation is easy, medicine source is wide, cost is low for it.It follows the prescriptions principle of the traditional Chinese medical science, reliable effect, mild in medicine property and, toxic and side effects does not occur.
Chinese medicine preparation of the present invention adopts advanced extraction equipment and technique, abundant effective component extracting, can be made into Chinese medicine preparation that is convenient oral or that carry, such as tablet, capsule or granule.
Detailed description of the invention
Further describing the present invention below by way of specific embodiment, the present invention is not limited only to following example.Within the scope of the invention or without departing from present disclosure, spirit and scope, change, combination or the replacement that the present invention is carried out, will be apparent to the person skilled in the art, and be included within the scope of the present invention.
Embodiment 1 capsule
Prescription: Semen Cuscutae 15 parts, Radix Rehmanniae Preparata 10 parts, Radix Morindae Officinalis 10 parts, Polyalthia nemoralis A. D C. 15 parts, Herba Taxilli 7 parts, Fructus Schisandrae Chinensis 4 parts, Rhizoma Gymnadeniae 25 parts, Rhizoma Polygonati Odorati 10 parts.
Preparation method: (1) takes Radix Morindae Officinalis, Polyalthia nemoralis A. D C. add medical material amount 5-8 times 50% ethanol water, extract secondary, each 1.5 hours, filtered while hot, be concentrated into and obtain ethanol extraction concentrated solution without alcohol taste;
(2) take Semen Cuscutae, Radix Rehmanniae Preparata, Herba Taxilli, Fructus Schisandrae Chinensis, Rhizoma Gymnadeniae, Rhizoma Polygonati Odorati together with filtering residue after Radix Morindae Officinalis, Polyalthia nemoralis A. D C. ethanol extraction, add 5-8 times of water soaking 3-4 hour, decoct extraction twice, each 1.0-2.0 hour;Filtered while hot, it is concentrated into relative density 1.05-1.10 (60 DEG C record), adding ethanol makes alcohol content be 30% (volume ratio), after standing 24 hours, discard lower sediment thing, obtain supernatant, it is concentrated into relative density 1.05-1.10 (60 DEG C record) to mix with the ethanol extraction concentrated solution of step (1) afterwards, inlet temperature 140~150 DEG C, carry out spray drying under 75~80 DEG C of conditions of leaving air temp and obtain active constituents of medicine, making capsule according to galenic pharmacy routine techniques, every 0.35g, containing crude drug 1.2g.
Embodiment 2 capsule
Prescription: Semen Cuscutae 13 parts, Radix Rehmanniae Preparata 10 parts, Radix Morindae Officinalis 8 parts, Polyalthia nemoralis A. D C. 10 parts, Herba Taxilli 5 parts, Fructus Schisandrae Chinensis 3 parts, Rhizoma Gymnadeniae 20 parts, Rhizoma Polygonati Odorati 8 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 3 capsule
Prescription: Semen Cuscutae 18 parts, Radix Rehmanniae Preparata 12 parts, Radix Morindae Officinalis 10 parts, Polyalthia nemoralis A. D C. 12 parts, Herba Taxilli 7 parts, Fructus Schisandrae Chinensis 3 parts, Rhizoma Gymnadeniae 20 parts, Rhizoma Polygonati Odorati 8 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 4 capsule
Prescription: Semen Cuscutae 15 parts, Radix Rehmanniae Preparata 12 parts, Radix Morindae Officinalis 7 parts, Polyalthia nemoralis A. D C. 10 parts, Herba Taxilli 8 parts, Fructus Schisandrae Chinensis 2.5 parts, Rhizoma Gymnadeniae 20 parts, Rhizoma Polygonati Odorati 8 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 5 capsule
Prescription: Semen Cuscutae 16 parts, Radix Rehmanniae Preparata 12 parts, Radix Morindae Officinalis 8 parts, Polyalthia nemoralis A. D C. 12 parts, Herba Taxilli 6 parts, Fructus Schisandrae Chinensis 3.5 parts, Rhizoma Gymnadeniae 22 parts, Rhizoma Polygonati Odorati 8 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 6 capsule
Prescription: Semen Cuscutae 18 parts, Radix Rehmanniae Preparata 13 parts, Radix Morindae Officinalis 10 parts, Polyalthia nemoralis A. D C. 12 parts, Herba Taxilli 8 parts, Fructus Schisandrae Chinensis 4 parts, Rhizoma Gymnadeniae 29 parts, Rhizoma Polygonati Odorati 12 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 7 tablet
Prescription: Semen Cuscutae 15 parts, Radix Rehmanniae Preparata 12 parts, Radix Morindae Officinalis 10 parts, Polyalthia nemoralis A. D C. 15 parts, Herba Taxilli 6 parts, Fructus Schisandrae Chinensis 3 parts, Rhizoma Gymnadeniae 25 parts, Rhizoma Polygonati Odorati 8 parts.
Preparation method: (1) takes Radix Morindae Officinalis, Polyalthia nemoralis A. D C. add medical material amount 5-8 times 50% ethanol water, extract secondary, each 1.5 hours, filtered while hot, be concentrated into and obtain ethanol extraction concentrated solution without alcohol taste;
(2) take Semen Cuscutae, Radix Rehmanniae Preparata, Herba Taxilli, Fructus Schisandrae Chinensis, Rhizoma Gymnadeniae, Rhizoma Polygonati Odorati together with filtering residue after Radix Morindae Officinalis, Polyalthia nemoralis A. D C. ethanol extraction, add 5-8 times of water soaking 3-4 hour, decoct extraction twice, each 1.0-2.0 hour;Filtered while hot, it is concentrated into relative density 1.05-1.10 (60 DEG C record), adding ethanol makes alcohol content be 30% (volume ratio), after standing 24 hours, discard lower sediment thing, obtain supernatant, it is concentrated into relative density 1.05-1.10 (60 DEG C record) to mix with the ethanol extraction concentrated solution of step (1) afterwards, inlet temperature 140~150 DEG C, carry out spray drying under 75~80 DEG C of conditions of leaving air temp and obtain active constituents of medicine, making tablet according to galenic pharmacy routine techniques, every 0.4g, containing crude drug 1.0g.
Embodiment 8 granule
Prescription: Semen Cuscutae 15 parts, Radix Rehmanniae Preparata 10 parts, Radix Morindae Officinalis 10 parts, Polyalthia nemoralis A. D C. 15 parts, Herba Taxilli 7 parts, Fructus Schisandrae Chinensis 4 parts, Rhizoma Gymnadeniae 25 parts, Rhizoma Polygonati Odorati 10 parts.
Preparation method: (1) takes Radix Morindae Officinalis, Polyalthia nemoralis A. D C. add medical material amount 5-8 times 50% ethanol water, extract secondary, each 1.5 hours, filtered while hot, be concentrated into and obtain ethanol extraction concentrated solution without alcohol taste;
(2) take Semen Cuscutae, Radix Rehmanniae Preparata, Herba Taxilli, Fructus Schisandrae Chinensis, Rhizoma Gymnadeniae, Rhizoma Polygonati Odorati together with filtering residue after Radix Morindae Officinalis, Polyalthia nemoralis A. D C. ethanol extraction, add 5-8 times of water soaking 3-4 hour, decoct extraction twice, each 1.0-2.0 hour;Filtered while hot, it is concentrated into relative density 1.05-1.10 (60 DEG C record), adding ethanol makes alcohol content be 30% (volume ratio), after standing 24 hours, discard lower sediment thing, obtain supernatant, it is concentrated into relative density 1.05-1.10 (60 DEG C record) to mix with the ethanol extraction concentrated solution of step (1) afterwards, inlet temperature 140~150 DEG C, carry out spray drying under 75~80 DEG C of conditions of leaving air temp and obtain active constituents of medicine, making granule according to galenic pharmacy routine techniques, every bag of 3.0g, containing crude drug 5.0g.
Embodiment 9 clinical observation is tested
1 clinical data and method
1.1 physical data: choose the court's kidney yang deficiency syndrome in March ,-2014 in April, 2013 early stage threatened abortion patient, totally 80 example, wherein, first pregnant person 54 example, there are 1 person 20 example of history of spontaneous abortion, 2 person 7 examples, 3 times and above person 3 example;There is history of artificial abortion person 28 example;It is randomly divided into 2 groups, often organizes 42 examples.The treatment group mean age (29.57 ± 5.05) year, pregnant week (8.43 ± 1.88) week;The matched group mean age (30.08 ± 5.78) year, pregnant week (8.37 ± 1.69) week.2 groups of physical data compare, the equal not statistically significant of difference (P > 0.05), have comparability.
1.2 diagnosis marks
1.2.1 Western medicine diagnose standard: " new Chinese medicine guideline of clinical investigations " and happy outstanding 6th edition " obstetrics and gynecology " the early stage threatened abortion diagnostic criteria with reference to the revision in 2002 of national drug food surveillance authority is as follows: 1. have menolipsis history and morning sickness;2. vagina is hemorrhage on a small quantity, or with lower abdomen pendant pain or soreness of waist pain;3. urine pregnancy test is positive;4. cervical orifice is not opened, and body of uterus is soft, size and pregnant Zhou Xiangfu;5. Type B sound wave checks that uterus size, pregnant capsule or embryo (fetus) grow and pregnant Zhou Xiangfu.
1.2.2 Syndrome Differentiation of Traditional Chinese Medicine standard: " new Chinese medicine guideline of clinical investigations " and Ou Yanghui minister in ancient times the 1st edition " Gynecology of Chinese Medicine " with reference to the revision in 2002 of national drug food surveillance authority are formulated: main symptom: vagina is hemorrhage on a small quantity, matter is clear, color is light, lower abdomen pendant pain, soreness of waist pain;Two knees soreness;Secondary card: with dizziness and tinnitus, nocturia, or once had induced abortion repeatly, eye socket is pitch-dark or has facial dim speckle;Tongue arteries and veins: pale tongue, tongue is white, and deep-thready pulse is slightly sliding.Note: above syndrome main symptom is indispensable, one of adds item or two cards and namely tongue fur pulse condition is made a definite diagnosis.
1.3 case inclusive criterias: with reference to " the new Chinese medicine guideline of clinical investigations " of the revision in 2002 of national drug food surveillance authority: during (1) meets, Western medicine diagnose standard;(2) this researcher is accepted voluntarily;(3) age is between 22~40 years old.
1.4 case exclusion standards: " new Chinese medicine guideline of clinical investigations " (1) age > 40 years old or < of reference national drug food surveillance authority revision in 2002 22 years old;(2) primary disease Western medicine diagnose standard and TCM syndrome diagnostic criteria are not met;(3) merge intentionally, brain, liver, the serious disease patient such as kidney and hemopoietic system;(4) cannot partner, as being associated with nerve, mental disease, or be reluctant partner;(5) eliminating and chromosomal abnormality, genitals anatomical factors, endocrine factors, genital infection, blocking antibody exception, extraneous undesirable element etc. cause the patient of early stage threatened abortion.
1.5 Therapeutic Method:
Treatment group: the capsule of the oral embodiment of the present invention 1 preparation, every day 2 times, each 2-4 grain, takes after meal half an hour.
Matched group: chorionic-gonadotropin hormone 1000U, the next day intramuscular injection, Progesterone soft gelatin capsule 200mg, 1 time every night.
Advise patient to note lying up, it is to avoid tired, prohibit sexual life, have the balanced diet, nutritious food, supplements the various nutrient substance that gestation is required;Emotion regulation, keeps happy, it is to avoid direct stimulation, positive partner treatment.It is 1 course for the treatment of that two groups of patients treat 7 days all continuously, altogether 2 courses for the treatment of of treatment.
1.6 observation index:
1.6.1 the index symptom before and after patient treatment, sign change are observed;Symptom score standard carries out according to " new Chinese medicine guideline of clinical investigations (tries) ": vaginal hemorrhage: bleeding time >=within 7 days, it is 3 points;4-6 days bleeding time was 2 points, within≤3 days, was 1 point;Hemorrhage continue unclean, it is necessary to packing paper is 3 points, and hemorrhage dripping difficulty is clean, and amount is 2 points less, hemorrhage cuts in and out, drop and under be 1 point;All the other symptoms according to degree without, light, in, heavily classification, its corresponding score value respectively 0,1,2,3 points, every symptom score sum is total score, and total score has 24 points, and score is more high, then symptom is more heavy.
1.6.2B super monitoring fetal development situation, detects serum endocrine: Serum HCG, progesterone, estradiol, immune indexes etc..
1.7 efficacy assessment standards: according to " Chinese medical disease Standardization of diagnosis and curative effect " and " new Chinese medicine guideline of clinical investigations " threatened abortion criterion of therapeutical effect: clinical cure: after treatment, vaginal hemorrhage stops, stomachache soreness of waist transference cure, uterus size and pregnant Zhou Xiangfu, ultrasound diagnosis fetal development is normal.Effective: after treatment, vaginal hemorrhage stops, stomachache soreness of waist symptom is obviously improved, and syndrome integral reduces >=70%, uterus size and pregnant Zhou Xiangfu, and ultrasound diagnosis fetal development is normal.Effective: after treatment, vaginal hemorrhage stops, stomachache soreness of waist symptom makes moderate progress, and syndrome integral reduces >=30%, uterus size and pregnant Zhou Xiangfu, and ultrasound diagnosis fetal development is normal.Invalid: colporrhagia after treatment, stomachache soreness of waist symptom ditto or increase the weight of, final inevitable abortion.Therapeutic index (N) computing formula (nimodipine method): N=[before (before treatment integration after integration-treatment)/treatment integration] X100%
2 results
The comparison of 2.1 liang of clinical total effectses of group: treatment group cures 21 examples, effective 11 examples, effective 5 examples, invalid 3 examples, matched group cures 8 examples, effective 8 examples, effective 13 examples, invalid 11 examples, treatment group and matched group total effective rate respectively 92.5% and 72.5%, two groups of total effective rate comparing differences statistically significant (P < 0.05), the curative effect for the treatment of group is substantially better than matched group.In Table 1.
The comparison of the clinical total effects of 1 liang of table group
Note: compare with matched group, * P < 0.05.
Before and after 2.2 liang of group treatments, TCM symptom score compares: after the treatment for the treatment of group, TCM symptom score is all substantially more less than before treatment, with comparing difference statistically significant (P < 0.01) before treatment, matched group compares with before treatment, difference statistically significant (P < 0.05);Comparing between two groups after treatment, treatment group is better than matched group in improving tcm symptom, and the minimizing for the treatment of group symptom integral becomes apparent from, difference statistically significant (P < 0.01).In Table 2.
Before and after the group treatment of 2 liang of table, TCM symptom score compares
Note: compare with before treatment, * P < 0.05, * * P < 0.01;Compare the same period with matched group,#P < 0.01.
2.3 safety conditions: routine blood test, routine urinalysis, electrocardiogram change without exception before and after treatment group patient treatment, in therapeutic process, vital sign is steadily and without the untoward reaction such as nausea and vomiting, allergy, illustrates that our clinical application is safe and reliable.
In a word, compatibility of drugs of the present invention is precise and appropriate rationally, and treatment kidney yang deficiency syndrome early stage threatened abortion patient kidney-replenishing spleen invigorating again can adjust liver, and therapeutic effect is substantially better than Western medicine therapy, show Chinese medicine huge advantage in treatment early stage threatened abortion, be worth studying application further.
Model case:
Wang, female, 27 years old, professional is married.The first visit date: on May 9th, 2013;Patient's companion's stomachache vomiting in pregnant 47 days is gone to a doctor for 3 days, and it is frequent that patient states nausea and vomiting within the next few days, eats and namely tells, and with lower abdomen pain, vagina hemorrhage 3 days on a small quantity, color is light red, and early pregnancy is shown in ultrasound diagnosis, in utero sees a small amount of embryonic tissue, has no heart pipe and beats.Stool is few, nocturia;Light red tongue white and thin fur, deep pulse is fine and smooth, and Western medicine diagnose is early stage threatened abortion, and differential diagnosis in tcm diagnosis is insufficiency of kidney-YANG;Taking the capsule of embodiments of the invention 1, every day 2 times, each 4, after patient takes medicine one week, colporrhagia stops, and not bitterly, nocturia number of times reduces lower abdomen.Following the service is checked B ultrasonic and is shown and in utero see pregnant capsule after one week, see that heart pipe is beaten.Follow up a case by regular visits to patient's term birth one girl baby's body to be good for.
Wu, female, 35 years old, civil servant is married.The first visit date: on October 21st, 2013;Pregnant 52 days companion's vaginas of patient are gone to a doctor on a small quantity for hemorrhage 5 days, and patient tells habitual abortion 3 times, arises that vaginal hemorrhage about each pregnant February, ultrasound diagnosis embryo stasi after January.Early pregnancy is shown in this time ultrasound diagnosis, in utero sees that pregnant capsule and heart pipe are beaten.Vaginal hemorrhage color, amount is few, accompanies lower abdomen dull pain, the soreness of waist, Na Gu still can, frequent urination at night.Pale tongue with thin fur, thready and rolling pulse.Western medicine diagnose is early stage threatened abortion, and differential diagnosis in tcm diagnosis is insufficiency of kidney-YANG;Taking the capsule of the embodiment of the present invention 2, every day 2 times, each 4, after patient takes medicine 5 days, blood is only;Advise absolute bed rest, following the service one week, check B ultrasonic after January and show that fetal growth retardation is survived.Follow up a case by regular visits to patient's term birth one girl baby's body to be good for.
Claims (10)
1. the pharmaceutical composition treating kidney yang deficiency syndrome early stage threatened abortion, it is characterised in that be that medicinal raw material is made by Semen Cuscutae, Radix Rehmanniae Preparata, Radix Morindae Officinalis, Polyalthia nemoralis A. D C., Herba Taxilli, Fructus Schisandrae Chinensis, Rhizoma Gymnadeniae, Rhizoma Polygonati Odorati.
2. the pharmaceutical composition for the treatment of kidney yang deficiency syndrome early stage threatened abortion as claimed in claim 1, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 13-18 part, Radix Rehmanniae Preparata 8-13 part, Radix Morindae Officinalis 7-12 part, Polyalthia nemoralis A. D C. 10-15 part, Herba Taxilli 5-8 part, Fructus Schisandrae Chinensis 2.5-4.5 part, Rhizoma Gymnadeniae 20-25 part, Rhizoma Polygonati Odorati 7-12 part.
3. the pharmaceutical composition for the treatment of kidney yang deficiency syndrome early stage threatened abortion as claimed in claim 2, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 15 parts, Radix Rehmanniae Preparata 10 parts, Radix Morindae Officinalis 10 parts, Polyalthia nemoralis A. D C. 15 parts, Herba Taxilli 7 parts, Fructus Schisandrae Chinensis 4 parts, Rhizoma Gymnadeniae 25 parts, Rhizoma Polygonati Odorati 10 parts.
4. the pharmaceutical composition of the treatment kidney yang deficiency syndrome early stage threatened abortion as described in as arbitrary in claim 1-3, it is characterised in that preparation method comprises the following steps:
(1) take Radix Morindae Officinalis, Polyalthia nemoralis A. D C. add medical material amount 5-8 times 50% ethanol water, extract secondary, each 1.5 hours, filtered while hot, be concentrated into and obtain ethanol extraction concentrated solution without alcohol taste;
(2) take Semen Cuscutae, Radix Rehmanniae Preparata, Herba Taxilli, Fructus Schisandrae Chinensis, Rhizoma Gymnadeniae, Rhizoma Polygonati Odorati together with filtering residue after Radix Morindae Officinalis, Polyalthia nemoralis A. D C. ethanol extraction, add 5-8 times of water soaking 3-4 hour, decoct extraction twice, each 1.0-2.0 hour;Filtered while hot, it is concentrated into relative density 1.05-1.10 (60 DEG C record), adding ethanol makes alcohol content be 30% (volume ratio), after standing 24 hours, discard lower sediment thing, obtain supernatant, be concentrated into relative density 1.05-1.10 (60 DEG C record) and mix with the ethanol extraction concentrated solution of step (1) afterwards, under inlet temperature 140~150 DEG C, 75~80 DEG C of conditions of leaving air temp, carry out spray drying obtain active constituents of medicine;This composition individually or mixes with pharmaceutically acceptable carrier, makes according to galenic pharmacy routine techniques.
5. the pharmaceutical composition for the treatment of kidney yang deficiency syndrome early stage threatened abortion as claimed in claim 4, it is characterised in that described pharmaceutical composition can be prepared as dosage form conventional clinically.
6. the pharmaceutical composition for the treatment of kidney yang deficiency syndrome early stage threatened abortion as claimed in claim 5, it is characterised in that the dosage form of described pharmaceutical composition is preferably peroral dosage form.
7. the pharmaceutical composition for the treatment of kidney yang deficiency syndrome early stage threatened abortion as claimed in claim 6, it is characterised in that described peroral dosage form is preferably powderous preparations, powder, pill, sublimed preparation, unguentum, granule, oral liquid, tablet, capsule etc..
8. the pharmaceutical composition for the treatment of kidney yang deficiency syndrome early stage threatened abortion as claimed in claim 7, it is characterised in that described peroral dosage form is preferably granule, tablet or capsule.
9. the pharmaceutical composition for the treatment of kidney yang deficiency syndrome early stage threatened abortion as claimed in claim 8, it is characterised in that described peroral dosage form is preferably capsule.
10. the purposes in preparation treatment kidney yang deficiency syndrome early stage threatened abortion medicine of the pharmaceutical composition as described in as arbitrary in claim 1-3.
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Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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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 |
CN103071105A (en) * | 2013-02-06 | 2013-05-01 | 孙迎春 | External traditional Chinese medicinal preparation for treating threatened abortion and preparation method thereof |
CN103751480A (en) * | 2014-01-21 | 2014-04-30 | 于信香 | Traditional Chinese medicine for treating habitual abortion |
CN105288056A (en) * | 2015-12-03 | 2016-02-03 | 广东伊茗药业有限公司 | Pharmaceutical composition for treating threatened abortion and preparation method of pharmaceutical composition |
-
2016
- 2016-03-28 CN CN201610183867.4A patent/CN105726970A/en not_active Withdrawn
Patent Citations (4)
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 |
CN103071105A (en) * | 2013-02-06 | 2013-05-01 | 孙迎春 | External traditional Chinese medicinal preparation for treating threatened abortion and preparation method thereof |
CN103751480A (en) * | 2014-01-21 | 2014-04-30 | 于信香 | Traditional Chinese medicine for treating habitual abortion |
CN105288056A (en) * | 2015-12-03 | 2016-02-03 | 广东伊茗药业有限公司 | Pharmaceutical composition for treating threatened abortion and preparation method of pharmaceutical composition |
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