CN106474251A - A kind of pharmaceutical preparation treating anticardiolipin antibody positive early stage threatened abortion - Google Patents
A kind of pharmaceutical preparation treating anticardiolipin antibody positive early stage threatened abortion Download PDFInfo
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Abstract
The invention belongs to tcm field, it is related to a kind of pharmaceutical preparation treating anticardiolipin antibody positive early stage threatened abortion and preparation method thereof, this pharmaceutical preparation is made up of medicinal raw material of Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Cortex seu Radix Euonymi oxyphyllae, Radix Scutellariae, Semen Ziziphi Spinosae.Entirely square eliminating evil and just do not hinder, promoting blood circulation and not damaging fetus, play tonifying kidney and nourishing yin, Shugan Qingre, blood circulation promoting and blood stasis dispelling altogether, the effect of pacify sub- Herba Leonuri, caused by the treatment ACA positive, early stage threatened abortion patient syndrome of yin deficiency and blood heat curative effect is safe and reliable, finds no obvious toxic-side effects to mother and baby.Chinese medicine wide material sources of the present invention, price is relatively low, and the dosage form made is suitable for patient and carries and use.
Description
Technical field
The invention belongs to tcm field, it is related to a kind of medicine system treating anticardiolipin antibody positive early stage threatened abortion
Agent and preparation method thereof.
Background technology
Early stage threatened abortion is, before pregnant 12 weeks, vagina and to bleed on a small quantity, with paroxysmal lower abdominal pain or lumbago and backache
For cardinal symptom, gynecologial examination opening of the cervix is not opened, and fetal membrane is not broken and is consistent with menolipsis week number, and gestation is still hopeful continuator.Belong to
The categories such as the traditional Chinese medical science " vaginal bleeding during pregnancy, frequent fetal movement ".As correctly treated not in time, induced abortion, abortion or concurrent diapause often can be developed into,
Directly affect the normal development of fetus and the physical and mental health of anemia of pregnant woman.
In recent years, substantial amounts of active immunity and passive immunity animal model prove both at home and abroad, anticardiolipin antibody
(Anticardiolipin antibody, ACA) has direct pathogenic effects to early stage threatened abortion patient, and anticardiolipin resists
Body is the autoantibody using negatively charged cuorin in platelet and endothelial cell membrane as target antigen.At present it is generally believed that
ACA mono- aspect energy interference body phospholipid dependency coagulation function, thus injured blood vessel endothelium and trigger intrinsic coagulation system, change
Become thromboxane/prostaglandin level, promote platelet aggregation, thrombosiss, cause Placental ischemia, lead to Fetus Intrauterine Growth slow
Slow, stillborn fetuses are so that miscarriage.On the other hand, pregnant early stage ACA may interfere with the fusion of cytotrophoblast and syncytiotrophoblast and amniotic membrane
Growth promoter, thus lead to miscarry.
The treatment of the threatened abortion that ACA causes at present, adopts immunosuppressant (prednisone or prednisone etc.) both at home and abroad
United anticoagulation medicine (aspirin or heparin etc.) is treated, but prolonged application can cause blood glucose rise, osteoporosises, infection, blood
The side reactions such as platelet minimizing, bleeding.Safe and effective medicine therefore how is applied so that its anticardiolipin antibody extremely increasing is turned
The moon, so that it is the major subjects of Chinese scholars research that gestation can smoothly complete.The traditional Chinese medical science thinks kidney governing reproduction, and how the traditional Chinese medical science is to mend
Kidney, blood-nourishing, heat clearing away are the rule for the treatment of.Modern medicine study proves, " kidney " in Chinese medicine is had with the body reproduction immunity of modern medicine
Substantial connection, kidney-reinforcing drug scalable body reproductive endocrine-immunological network.The traditional Chinese medical science " unpregnancy is first prevented, its damage of pre- training ", " both simultaneously
Pregnant diseases prevention, disease are early to be controlled " Therapeutic Principle, the untoward reaction that simple application Western medicine is likely to occur can be overcome, and reduce
Relapse rate, determined curative effect.It is thus desirable to proposing a kind of pharmaceutical preparation treating early stage threatened abortion.
Content of the invention
For overcoming the deficiencies in the prior art, inventor on the basis of recipe handed down from ancestors, the body constitution in conjunction with modern and modern times
Theory of medicine, dialectical combine it is believed that deficiency of kidney yin with differential diagnosis of diseases, heat formation from yin deficiency causes stasis descending, and obstruction of collaterals by blood stasis loses the fetus,
For mark, card genus kidney deficiency heat in blood.Accordingly, there is provided a kind of curative effect determines, the treatment anticardiolipin antibody of Small side effects positive early stage
The pharmaceutical preparation of threatened abortion, is particularly suited for anticardiolipin antibody positive threatened abortion patient's YinXuXueRe pattern of syndrome.
Technical scheme is as follows：
A kind of pharmaceutical preparation treating anticardiolipin antibody positive early stage threatened abortion is it is characterised in that by Radix Rehmanniae Preparata, life
Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Cortex seu Radix Euonymi oxyphyllae, Radix Scutellariae, Semen Ziziphi Spinosae are made up of medicinal raw material.
It is further preferred that a kind of pharmaceutical preparation treating anticardiolipin antibody positive early stage threatened abortion, its feature exists
Make in the medicinal raw material by following weight：Radix Rehmanniae Preparata 15-20 part, Radix Rehmanniae 10-15 part, Radix Stellariae Yunnanensis 20-26
Part, Rhizoma panacis majoriss 7-12 part, Semen Cuscutae 8-13 part, Fructus Ligustri Lucidi 10-15 part, Rhizoma Atractylodis Macrocephalae 8-13 part, Cortex seu Radix Euonymi oxyphyllae 15-20 part, Radix Scutellariae 4-7
Part, Semen Ziziphi Spinosae 11-16 part.
It is further preferred that a kind of pharmaceutical preparation treating anticardiolipin antibody positive early stage threatened abortion, its feature exists
Make in the medicinal raw material by following weight：18 parts of Radix Rehmanniae Preparata, 12 parts of Radix Rehmanniae, 25 parts of Radix Stellariae Yunnanensis, Rhizoma panacis majoriss
10 parts, 12 parts of Semen Cuscutae, 15 parts of Fructus Ligustri Lucidi, 12 parts of the Rhizoma Atractylodis Macrocephalae, 15 parts of Cortex seu Radix Euonymi oxyphyllae, 6 parts of Radix Scutellariae, 15 parts of Semen Ziziphi Spinosae.
It is further preferred that a kind of pharmaceutical preparation treating anticardiolipin antibody positive early stage threatened abortion, its feature exists
Make in the medicinal raw material by following weight：15 parts of Radix Rehmanniae Preparata, 15 parts of Radix Rehmanniae, 20 parts of Radix Stellariae Yunnanensis, Rhizoma panacis majoriss
12 parts, 10 parts of Semen Cuscutae, 15 parts of Fructus Ligustri Lucidi, 10 parts of the Rhizoma Atractylodis Macrocephalae, 20 parts of Cortex seu Radix Euonymi oxyphyllae, 6 parts of Radix Scutellariae, 12 parts of Semen Ziziphi Spinosae.
Inventor thinks kidney governing reproduction, and the kidney deficiency debility of CHONG and REN meridians is it is impossible to take the photograph blood fetus nourishing；Married woman has pregnant, hinders spleen, transporting late and
Life is wet, humidogene heat, simultaneously because pregnant rear blood gathers sprouts tire, liver is become homeless uses, edema with the liver involved suppression and do not reach, liver is no hidden, if there being temperament and interest not relax,
Or such as flare up, then mutually fiery movability, kidney deficiency fire is dynamic, and the vaginal bleeding during pregnancy hematochezia that arrives, or to having an abortion.Therefore, we adopt yin nourishing in the treatment
The method of heat clearing away, meanwhile, in conjunction with the pathomechanism of primary disease：Based on thrombosiss, Gu Zuo was invigorated blood circulation with the product of blood circulation promoting and blood stasis dispelling, trimester of pregnancy
Blood stasis dispelling medicine is originally disabling, herein with it, also takes the meaning of its " having therefore lossless ".Using tonifying kidney and nourishing yin, Shugan Qingre, Blood-Activating-and-Stasis-Removing
Treatment ACA positive threatened abortion obtains ideal effect.The sweet temperature of Radix Rehmanniae Preparata in side, nourishing YIN and supplementing blood, beneficial essence fills out marrow；Radix Rehmanniae is sweet cold clear
Hot removing heat from blood, YIN nourishing and the production of body fluid promoting, two medicine 5 both tonifying kidney-yins, and tonifying liver cool place liver blood dispersing liver-energy, are monarch drug.The sweet temperature of Semen Cuscutae, nourishing
Liver and kidney, warming the spleen helps stomach, antiabortive；Fructus Ligustri Lucidi replenishing YIN to strengthen the kidney, QI invigorating soothing liver-QI, stimulates the menstrual flow and blood；Radix Stellariae Yunnanensis strengthening spleen and nourishing blood, tonifying liver benefit
Kidney, kidney and spleen invigorating used by three medicines 5, and the first day after tomorrow simultaneously mends, and is appointed with Gu Chong, pacifies sub- Herba Leonuri.Rhizoma panacis majoriss bitter sweet is trembled with fear, clearing away heat and nourishing YIN, and dissipating blood stasis stop
Blood；Cortex seu Radix Euonymi oxyphyllae toil is put down, expelling wind and removing dampness, promoting blood circulation to restore menstrual flow, promoting diuresis to remove toxic substance；Radix Scutellariae bitter cold, heat clearing and damp drying, eliminating fire and detoxication, hemostasis
Antiabortive；Two medicines 5 are used, heat clearing and damp drying, promoting blood circulation and hemostasis, dampness removing dissipating blood stasis, and yin nourishing is antiabortive；Rhizoma Atractylodis Macrocephalae invigorating the spleen and benefiting QI, eliminate dampness and have diuretic effect；Ziziphi Spinosae
Core suppressing the hyperactive liver qi-regulating, nourishing lung-YIN, warming middle-JIAO dampness removing, tranquilizing the mind, five medicines are adjuvant drug.
Further, the pharmacological activity present Research of each medicine used by the present invention is as follows：
Radix Rehmanniae Preparata：【Nature and flavor】Sweet, tepor.【Return through】Return liver and kidney channel.【Indication】Nourishing YIN and supplementing blood, beneficial 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, Heat Diabetes, blood deficiency and yellow complexion, severe palpitation, menoxenia, metrorrhagia
Hematochezia, dizziness, tinnitus, early whitening of beard and hair.【Usage and dosage】9～15g.
Radix Rehmanniae：【Nature and flavor】Sweet, tremble with fear.【Return through】GUIXIN, liver and kidney channel.【Indication】Clearing away heat and cooling blood, yin nourishing, promote the production of body fluid.With
In calentura crimson tongue excessive thirst, yin asthenia generating intrinsic heat, hectic fever due to YIN-deficiency consumptive fever, Heat Diabetes, spit blood, epistaxis, spot dermexanthesis.【Usage and dosage】9～
15g.
Radix Stellariae Yunnanensis：Root for pinkwort Yunnan Herba stellariae mediae.【Nature and flavor】Sweet；Mild-natured.【Return through】Liver；Spleen；Kidney channel.
【Indication】Strengthening spleen and nourishing blood；The liver and the kidney tonifying；Detumescence.Main anemia；Spirit is deficient；Dizzy nervous；Tinnitus dim eyesight；Hectic fever；Seminal emission；
Menoxenia；Leukorrhagia；Fracture；Mastitis.【Usage and dosage】For oral administration：Decoct soup, 15-30g；Or fricassee clothes.External：In right amount, fresh goods
Smash deposited.
Rhizoma panacis majoriss：【Nature and flavor】Bitter in the mouth；Sweet；Cold in nature.【Indication】Clearing away heat and nourishing YIN；Dissipate stasis of blood hemostasis；Reducing swelling and alleviating pain.Main calentura
Excessive thirst；Deficiency of YIN cough due to lung-heat；Hemoptysis；Spit blood；Epistaxis；Have blood in stool；Hematuria；Metrorrhagia；Traumatic hemorrhage；Traumatic injury wound is swollen；Rheumatic arthralgia；Stomach
Bitterly；Menoxenia；Acute toothache；Laryngopharynx swelling and pain；Sore and toxic.【Usage and dosage】For oral administration：Decoct, 3-15g；Or enter ball, dissipate；Or bubble
Wine.External：In right amount, grind into powder and dry mix or adjust painting；Or wiping of steeping in wine；Or fresh goods smash deposited.
Cortex seu Radix Euonymi oxyphyllae：【Nature and flavor】Bitter；Pungent；Flat.【Return through】The heart；Large intestine；Liver Channel.【Indication】Expelling wind and removing dampness；Promoting blood circulation is logical
Warp；Promoting diuresis to remove toxic substance.Main air pain of dampness syndrome；Dysentery；Have loose bowels；Dysmenorrhea；Amenorrhea；Injury and bone fracture；Tinea pedis；Edema；Scrotum pruritus due to damp pathogen；Skin infection swells
Poison.【Usage and dosage】For oral administration：Decoct soup, 15-30g.External：In right amount, pan-fried water smoking is washed, or smashes deposited, or grinds into powder and dress.
Semen Cuscutae：【Nature and flavor】Sweet, temperature.【Return through】Return liver, kidney, spleen channel.【Indication】Nourishing the liver and kidney, astringent sperm contracting urine, peace
Tire, 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, fetal movement is not
Peace, spleen kidney deficiency is rushed down；Externally treating leucoderma.【Usage and dosage】6～12g；Suitable amount used externally.
Fructus Ligustri Lucidi：【Nature and flavor】Sweet, bitter, cold.【Return through】Return liver and kidney channel.【Indication】Nourishing the liver and kidney, improving eyesight black hair.With
In vertigo and tinnitus, soreness of the waist and knees, early whitening of beard and hair, poor vision.
The Rhizoma Atractylodis Macrocephalae：【Nature and flavor】Bitter, sweet, temperature.【Return through】Returns spleen, stomach.【Indication】Invigorating the spleen and benefiting QI, eliminate dampness and have diuretic effect, hidroschesis,
Antiabortive.For spleen eating less, abdominal distention diarrhea, phlegm retention anti-dazzle nervous, edema, spontaneous perspiration, frequent fetal movement.Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.
For spleen eating less, loose stool of having loose bowels, frequent fetal movement.
Radix Scutellariae：【Nature and flavor】Hardship, trembles with fear.【Return through】Return lung, gallbladder, spleen, large intestine, small intestine meridian.【Indication】Heat clearing and damp drying, pathogenic fire purging
Removing toxic substances, hemostasis, antiabortive.For hygropyrexia, fever disease in summer vomiting and nausea uncomfortable in chest, damp and hot feeling of fullness, dysentery, jaundice, cough due to lung-heat, hyperpyrexia excessive thirst, blood
Heat tells nosebleed, carbuncle sore tumefacting virus, frequent fetal movement.【Usage and dosage】3～9g.
Semen Ziziphi Spinosae：【Nature and flavor】Sweet, sour, put down.【Return through】Return liver, gallbladder, heart channel.【Indication】Tonifying liver, mind calming, arresting sweating, raw
Tianjin.For restlessness of asrhenia type and insomnia, horrified to much dream, body void hidrosis, injury thirst.【Usage and dosage】9～15g.
Pharmaceutical preparation of the present invention can be by Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi
Son, the Rhizoma Atractylodis Macrocephalae, Cortex seu Radix Euonymi oxyphyllae, Radix Scutellariae, Semen Ziziphi Spinosae or its water or its extractive with organic solvent are active component, add medicine to be subjected to
Carrier be prepared from.
Further, pharmaceutical preparation of the present invention, its preparation method mainly comprises following step：By Radix Rehmanniae Preparata, life
Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Cortex seu Radix Euonymi oxyphyllae, Radix Scutellariae, Semen Ziziphi Spinosae add water to cook secondary,
3-8 times once adding water as medical material weight portion, decocts 1.0-1.5 hour, adds water for the second time 3-6 times for medical material weight portion and decoct
1.5-2.0 hour, collecting decoction, filtration, filtrate reduced in volume obtains thick paste, and relative density is 1.05-1.10 (recording when 65 DEG C),
Add ethanol to make alcohol content reach 35%, stand 8-12 hour, filtration, filtrate recycling ethanol, be concentrated to give active constituents of medicine；With
This active component is mixed individually or with pharmaceutically acceptable carrier, makes according to galenic pharmacy routine techniquess.
The pharmaceutical preparation of the present invention can make any pharmaceutically useful dosage form, and these dosage forms include：Tablet, sugar coated tablet,
Film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, mouth containing agent, granule, electuary, ball
Agent, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drip
Agent, patch.
Further, pharmaceutical preparation described above is preferably made peroral dosage form, such as：Soft capsule, capsule, tablet, mouth
Take liquid, granule, pill, powder, sublimed preparation, unguentum.
Further, pharmaceutical preparation described above is preferably made tablet, capsule or granule, is most preferably made for capsule
Agent.
The present invention be inventor through repeatedly studying, progressively improve, finally a kind of successful preferable medicine of curative effect,
When using, usage and dosage is determined according to the situation of patient, can take 1-3 time daily, each 1-20 agent, such as：1-20 bag or grain or
Piece.
The present invention is also claimed said medicine preparation in preparation treatment anticardiolipin antibody positive early stage threatened abortion
Purposes in medicine, especially in the medicine of preparation treatment anticardiolipin antibody positive early stage threatened abortion blood stasis due to renal deficiency card
Purposes.By clinical observation test example 9：The comparison of (1) two group of clinical total effects：Treatment group is always effective with matched group
Rate is respectively 89.6% and 68.8%, and two groups of total effective rate comparing differences are statistically significant (P ＜ 0.05), the curative effect for the treatment of group
It is substantially better than matched group；(2) two groups of ACA turn out cloudy comparitive study：Treatment group and matched group total effective rate be respectively 91.7% and
62.5%, two groups of total effective rate comparing differences are statistically significant (P ＜ 0.05), and the curative effect for the treatment of group is substantially better than matched group；
Before and after (3) two groups of treatments, TCM symptom score compares：After treatment group's treatment, TCM symptom score is all substantially less than before treatment, with
Comparing difference statistically significant (P ＜ 0.01) before treatment, matched group compares with before treatment, statistically significant (the P ＜ of difference
0.05)；Compare between two groups after treatment, treatment group is better than matched group in terms of improving tcm symptom, treatment group's symptom integral reduces
Become apparent from, difference statistically significant (P ＜ 0.01).
The present invention relatively and prior art, has following clear superiority：First, pharmaceutical preparation prescription of the present invention is mainly foundation
The positive pathogenic characteristic of early stage threatened abortion patient anticardiolipin antibody develops, entirely square eliminating evil and just do not hinder, promoting blood circulation and not
Damaging fetus, play the effect of tonifying kidney and nourishing yin, Shugan Qingre, blood circulation promoting and blood stasis dispelling, peace sub- Herba Leonuri altogether, early stage elder generation's megastream caused by treatment ACA is positive
Produce patient's syndrome of yin deficiency and blood heat curative effect safe and reliable, obvious toxic-side effects are found no to mother and baby.Chinese medicine wide material sources of the present invention, valency
Lattice are relatively low, and the dosage form made is suitable for patient and carries and use.Show huge advantage in terms for the treatment of threatened abortion for the Chinese medicine.
Specific embodiment
Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.At this
In bright scope or without departing from the change in present disclosure, spirit and scope, the present invention being carried out, combination or replace
Change, will be apparent to the person skilled in the art, and be included within the scope of the present invention.
Embodiment 1 capsule
Prescription：18 parts of Radix Rehmanniae Preparata, 12 parts of Radix Rehmanniae, 25 parts of Radix Stellariae Yunnanensis, 10 parts of Rhizoma panacis majoriss, 12 parts of Semen Cuscutae, Fructus Ligustri Lucidi
15 parts of son, 12 parts of the Rhizoma Atractylodis Macrocephalae, 15 parts of Cortex seu Radix Euonymi oxyphyllae, 6 parts of Radix Scutellariae, 15 parts of Semen Ziziphi Spinosae.
Preparation method：By Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Chui Siwei
Lance, Radix Scutellariae, Semen Ziziphi Spinosae add water to cook secondary, adding water for the first time as medical material weight portion 5 times, decoct 1.5 hours, add water for the second time
Decoct 1.5 hours for 5 times of medical material weight portion, collecting decoction, filtration, filtrate reduced in volume obtains thick paste, relative density is 1.07
(recording when 65 DEG C), adds ethanol to make alcohol content reach 35%, stands 8-12 hour, filtration, filtrate recycling ethanol, be concentrated to give medicine
Thing active component, makes capsule according to galenic pharmacy routine techniquess, and every contains crude drug 1.0g.
Embodiment 2 capsule
Prescription：15 parts of Radix Rehmanniae Preparata, 15 parts of Radix Rehmanniae, 20 parts of Radix Stellariae Yunnanensis, 12 parts of Rhizoma panacis majoriss, 10 parts of Semen Cuscutae, Fructus Ligustri Lucidi
15 parts of son, 10 parts of the Rhizoma Atractylodis Macrocephalae, 20 parts of Cortex seu Radix Euonymi oxyphyllae, 6 parts of Radix Scutellariae, 12 parts of Semen Ziziphi Spinosae.
Preparation method：By Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Chui Siwei
Lance, Radix Scutellariae, Semen Ziziphi Spinosae add water to cook secondary, adding water for the first time as medical material weight portion 6 times, decoct 1.0 hours, add water for the second time
Decoct 2.0 hours for 5 times of medical material weight portion, collecting decoction, filtration, filtrate reduced in volume obtains thick paste, relative density is 1.08
(recording when 65 DEG C), adds ethanol to make alcohol content reach 35%, stands 8-12 hour, filtration, filtrate recycling ethanol, be concentrated to give medicine
Thing active component, makes capsule according to galenic pharmacy routine techniquess, and every contains crude drug 1.1g.
Embodiment 3 capsule
Prescription：18 parts of Radix Rehmanniae Preparata, 10 parts of Radix Rehmanniae, 20 parts of Radix Stellariae Yunnanensis, 12 parts of Rhizoma panacis majoriss, 10 parts of Semen Cuscutae, Fructus Ligustri Lucidi
15 parts of son, 10 parts of the Rhizoma Atractylodis Macrocephalae, 18 parts of Cortex seu Radix Euonymi oxyphyllae, 5 parts of Radix Scutellariae, 12 parts of Semen Ziziphi Spinosae.
Preparation method：By Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Chui Siwei
Lance, Radix Scutellariae, Semen Ziziphi Spinosae add water to cook secondary, adding water for the first time as medical material weight portion 8 times, decoct 1.0 hours, add water for the second time
Decoct 1.5 hours for 3 times of medical material weight portion, collecting decoction, filtration, filtrate reduced in volume obtains thick paste, relative density is 1.05
(recording when 65 DEG C), adds ethanol to make alcohol content reach 35%, stands 8-12 hour, filtration, filtrate recycling ethanol, be concentrated to give medicine
Thing active component, makes according to galenic pharmacy routine techniquess.
Embodiment 4 capsule
Prescription：15 parts of Radix Rehmanniae Preparata, 15 parts of Radix Rehmanniae, 20 parts of Radix Stellariae Yunnanensis, 12 parts of Rhizoma panacis majoriss, 8 parts of Semen Cuscutae, Fructus Ligustri Lucidi
10 parts, 10 parts of the Rhizoma Atractylodis Macrocephalae, 20 parts of Cortex seu Radix Euonymi oxyphyllae, 4 parts of Radix Scutellariae, 11 parts of Semen Ziziphi Spinosae.
Preparation method：By Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Chui Siwei
Lance, Radix Scutellariae, Semen Ziziphi Spinosae add water to cook secondary, adding water for the first time as medical material weight portion 5 times, decoct 1.5 hours, add water for the second time
Decoct 1.5 hours for 5 times of medical material weight portion, collecting decoction, filtration, filtrate reduced in volume obtains thick paste, relative density is 1.10
(recording when 65 DEG C), adds ethanol to make alcohol content reach 35%, stands 8-12 hour, filtration, filtrate recycling ethanol, be concentrated to give medicine
Thing active component, makes according to galenic pharmacy routine techniquess.
Embodiment 5 capsule
Prescription：20 parts of Radix Rehmanniae Preparata, 12 parts of Radix Rehmanniae, 26 parts of Radix Stellariae Yunnanensis, 10 parts of Rhizoma panacis majoriss, 13 parts of Semen Cuscutae, Fructus Ligustri Lucidi
12 parts of son, 13 parts of the Rhizoma Atractylodis Macrocephalae, 18 parts of Cortex seu Radix Euonymi oxyphyllae, 7 parts of Radix Scutellariae, 12 parts of Semen Ziziphi Spinosae.
Preparation method：By Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Chui Siwei
Lance, Radix Scutellariae, Semen Ziziphi Spinosae add water to cook secondary, adding water for the first time as medical material weight portion 8 times, decoct 1.5 hours, add water for the second time
Decoct 1.5 hours for 6 times of medical material weight portion, collecting decoction, filtration, filtrate reduced in volume obtains thick paste, relative density is 1.10
(recording when 65 DEG C), adds ethanol to make alcohol content reach 35%, stands 8-12 hour, filtration, filtrate recycling ethanol, be concentrated to give medicine
Thing active component, makes according to galenic pharmacy routine techniquess.
Embodiment 6 capsule
Prescription：15 parts of Radix Rehmanniae Preparata, 12 parts of Radix Rehmanniae, 25 parts of Radix Stellariae Yunnanensis, 10 parts of Rhizoma panacis majoriss, 10 parts of Semen Cuscutae, Fructus Ligustri Lucidi
10 parts of son, 10 parts of the Rhizoma Atractylodis Macrocephalae, 20 parts of Cortex seu Radix Euonymi oxyphyllae, Radix Scutellariae 5,16 parts of Semen Ziziphi Spinosae.
Preparation method：By Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Chui Siwei
Lance, Radix Scutellariae, Semen Ziziphi Spinosae add water to cook secondary, adding water for the first time as medical material weight portion 6 times, decoct 1.0 hours, add water for the second time
Decoct 2.0 hours for 6 times of medical material weight portion, collecting decoction, filtration, filtrate reduced in volume obtains thick paste, relative density is 1.08
(recording when 65 DEG C), adds ethanol to make alcohol content reach 35%, stands 8-12 hour, filtration, filtrate recycling ethanol, be concentrated to give medicine
Thing active component, makes according to galenic pharmacy routine techniquess.
Embodiment 7 tablet
Prescription：18 parts of Radix Rehmanniae Preparata, 12 parts of Radix Rehmanniae, 25 parts of Radix Stellariae Yunnanensis, 10 parts of Rhizoma panacis majoriss, 12 parts of Semen Cuscutae, Fructus Ligustri Lucidi
15 parts of son, 12 parts of the Rhizoma Atractylodis Macrocephalae, 15 parts of Cortex seu Radix Euonymi oxyphyllae, 6 parts of Radix Scutellariae, 15 parts of Semen Ziziphi Spinosae.
15 parts of Radix Rehmanniae Preparata, 15 parts of Radix Rehmanniae, 20 parts of Radix Stellariae Yunnanensis, 12 parts of Rhizoma panacis majoriss, 10 parts of Semen Cuscutae, Fructus Ligustri Lucidi 15
Part, 10 parts of the Rhizoma Atractylodis Macrocephalae, 20 parts of Cortex seu Radix Euonymi oxyphyllae, 6 parts of Radix Scutellariae, 12 parts of Semen Ziziphi Spinosae.
Preparation method：By Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Chui Siwei
Lance, Radix Scutellariae, Semen Ziziphi Spinosae add water to cook secondary, adding water for the first time as medical material weight portion 7 times, decoct 1.0 hours, add water for the second time
Decoct 1.5 hours for 5 times of medical material weight portion, collecting decoction, filtration, filtrate reduced in volume obtains thick paste, relative density is 1.07
(recording when 65 DEG C), adds ethanol to make alcohol content reach 35%, stands 8-12 hour, filtration, filtrate recycling ethanol, be concentrated to give medicine
Thing active component, makes tablet according to galenic pharmacy routine techniquess, and every contains crude drug 0.8g.
Embodiment 8 granule
Prescription：15 parts of Radix Rehmanniae Preparata, 15 parts of Radix Rehmanniae, 20 parts of Radix Stellariae Yunnanensis, 12 parts of Rhizoma panacis majoriss, 10 parts of Semen Cuscutae, Fructus Ligustri Lucidi
15 parts of son, 10 parts of the Rhizoma Atractylodis Macrocephalae, 20 parts of Cortex seu Radix Euonymi oxyphyllae, 6 parts of Radix Scutellariae, 12 parts of Semen Ziziphi Spinosae.
Preparation method：By Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Chui Siwei
Lance, Radix Scutellariae, Semen Ziziphi Spinosae add water to cook secondary, adding water for the first time as medical material weight portion 5 times, decoct 1.5 hours, add water for the second time
Decoct 2.0 hours for 5 times of medical material weight portion, collecting decoction, filtration, filtrate reduced in volume obtains thick paste, relative density is 1.09
(recording when 65 DEG C), adds ethanol to make alcohol content reach 35%, stands 8-12 hour, filtration, filtrate recycling ethanol, be concentrated to give medicine
Thing active component, makes granule according to galenic pharmacy routine techniquess, and every bag contains crude drug 3.5g.
Embodiment 9 clinical observation is tested
1 clinical data and method
1.1 physical data：In October, 2012～2014 year May is in hospital in the court and patient diagnosis are threatened abortion and look into anti-
Cardiolipin antibody positive patient 96,23～39 years old age, 30.5 years old mean age；Wherein 55 have history of spontaneous abortion, natural
Miscarriage 1 time 33, spontaneous abortion 2 times 16, more than 3 times persons of spontaneous abortion 6.Adopt random by digits table with 1：1 is divided into
Treatment group and matched group, wherein treatment group 48,24～39 years old age, year mean age (30.7 ± 3.7)；Menopause is
35-48 days, average (43.5 ± 5.7) sky.Matched group 48,23～39 years old age, year mean age (29.8 ± 3.4)；Menolipsis
Time is 33-49 days, average (44.7 ± 6.3) sky.Two groups of patient ages, menopause, abortion times compare, and difference no counts
Learn meaning (P ＞ 0.05), there is comparability.
1.2 diagnosis marks
1.2.1 the diagnostic criteria reference of threatened abortion：Zhang Yuzhen the 7th edition《Gynecology of Chinese Medicine》Early stage threatened abortion diagnosis mark
Accurate as follows：1. medical history：There are menolipsis history and morning sickness；2. symptom：The a small amount of bleeding of vagina, or fall pain or soreness of waist pain with lower abdomen；
3. pregnancy tests：Urine pregnancy test is positive；4. gynecologial examination：Cervical orifice is not opened, and body of uterus is soft, and size is consistent with pregnant week；⑤
Ultrasound investigation：Type B sound wave is checked that uterus size, pregnant bursa or embryo (fetus) develop and is consistent with pregnant week；6. examination of basal body temperature：
Keep level luteal phase (maintaining high temperature curve)；7. Serum HCG (β-HCG), progesterone (P) level and pregnant week
Substantially it is consistent with B ultrasonic result (pregnant bursa size, fetal development)；8. serum ACA detection is positive.
1.2.2 the TCM Syndrome Type parting standard of threatened abortion：With reference to the revision in 2002 of national drug food surveillance authority《In
Medicine Clinical Researches of New Drugs guideline》Formulate YinXuXueRe pattern of syndrome, main symptom：Ferritic is weak or once has habitual abortion medical history；Pregnant just a small amount of
Colporrhagia, color is red；Abdomen pendant pain；Secondary disease：Mesh is puckery, dry pharynx, dizziness and tinnitus, chest side of body dull pain, dysphoria with feverish sensation in the chest palms and soles, insomnia, constipation,
Oliguria with reddish urine；Red tongue, few tongue, thready and rolling pulse are powerless.Meet in above main symptom, wantonly three persons in secondary card, are diagnosable in conjunction with tongue arteries and veins
For YinXuXueRe disease.
1.3 case inclusive criterias：With reference to the revision in 2002 of national drug food surveillance authority《New Chinese medicine clinical research refers to
Lead principle》：(1) in meeting, Western medicine diagnostic criteria.(2) voluntarily accept this researcher.(3) age is between 20～40 years old.
1.4 case exclusion standards：With reference to the revision in 2002 of national drug food surveillance authority《New Chinese medicine clinical research refers to
Lead principle》(1) age ＞ 40 years old or ＜ 20 years old；(2) primary disease Western medicine diagnostic criteria 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, be such as associated with nerve, spiritual disease
Suffer from, or be reluctant partner；(5) exclusion and chromosomal abnormality, genitals anatomical factors, endocrine factors, genital infection, closing
Antibody exception, extraneous undesirable element etc. lead to the patient of early stage threatened abortion.
1.5 Therapeutic Method：Two groups of patients all advise absolute bed rest, forbid that sexual life and various ass work move or work,
Keep happy.
Treatment group：On the basis of secondary, the capsule of the oral embodiment of the present invention 1 preparation, 2 times a day, each 2-4 grain, after meal
Half an hour takes.
Matched group：On the basis of Primary Care, matched group oral aspirin, 75mg/d.
It is 1 course for the treatment of that two groups of patients all continuously treat 7 days, 7 days check ACA 1 time；Treat 2 courses for the treatment of altogether.
1.6 observation index：TCM syndrome observes (symptom, picture of the tongue, pulse condition etc.)；The observation of vaginal hemorrhage dwell time；
Detection blood ACA turns out cloudy situation；B ultrasonic monitors fetal development situation, if there being in utero hematocele person, monitors hematocele absorbing state.
1.7 efficacy assessment standard：
1.7.1 total effectses criterion：Foundation《Chinese medical disease Standardization of diagnosis and curative effect》And《New Chinese medicine clinical research is instructed
Principle》Threatened abortion criterion of therapeutical effect：Clinical cure：After treatment vaginal hemorrhage stop, stomachache soreness of waist symptom disappear, uterus size with
Pregnant week is consistent, and ultrasound diagnosis fetal development is normal.Effective：After treatment, vaginal hemorrhage stops, and stomachache soreness of waist symptom is obviously improved, card
Wait integration and reduce >=70%, uterus size is consistent with pregnant week, and ultrasound diagnosis fetal development is normal.Effectively：After treatment, vaginal hemorrhage stops
Only, stomachache soreness of waist symptom makes moderate progress, and syndrome integral reduces >=30%, and uterus size is consistent with pregnant week, ultrasound diagnosis fetal development
Normally.Invalid：After treatment, colporrhagia, stomachache soreness of waist symptom ditto or increase, final inevitable abortion.
1.7.2 blood ACA turns out cloudy curative effect determinate standard：Cure：After treatment, the various antibody of blood ACA is all turned out cloudy.Effectively：Treatment
The equal positive of blood ACA-IgG and ACA-IgM afterwards, any of which item is turned out cloudy.Invalid：After treatment, blood ACA is still the positive.
2 results
The comparison of 2.1 liang of group clinic total effectses：Treatment group cures 24, effective 13, effective 6, invalid 5, comparison
Group cures 11, effective 9, effective 13, invalid 15, treatment group and matched group total effective rate be respectively 89.6% and
68.8%, two groups of total effective rate comparing differences are statistically significant (P ＜ 0.05), and the curative effect for the treatment of group is substantially better than matched group.
It is shown in Table 1.
The comparison of the clinical total effectses of 1 liang of group of table
Note：Compare with matched group, * P ＜ 0.05.
2.2 liang of group ACA turn out cloudy comparitive study：Treatment group cures 31, effective 13, invalid 4, and matched group group cures 15
Example, effective 15, invalid 18, treatment group is respectively 91.7% and 62.5% with matched group total effective rate, two groups of total effective rates
Comparing difference statistically significant (P ＜ 0.05), the curative effect for the treatment of group is substantially better than matched group.It is shown in Table 2.
2 liang of table group ACA turn out cloudy comparitive study
Note：Compare with matched group, * P ＜ 0.05.
Before and after 2.3 liang of group treatments, TCM symptom score compares：After treatment group's treatment, TCM symptom score is all bright than before treatment
Aobvious less, with treatment before comparing difference statistically significant (P ＜ 0.01), matched group with treat before compare, difference has statistics
Meaning (P ＜ 0.05)；Compare between two groups after treatment, treatment group is better than matched group, treatment group's symptom in terms of improving tcm symptom
Integration minimizing becomes apparent from, difference statistically significant (P ＜ 0.01).It is shown in Table 3.
Before and after 3 liang of group treatments of table, TCM symptom score compares
Note：Compare with before treatment, * P ＜ 0.05, * * P ＜ 0.01；Compare with the matched group same period,#P ＜ 0.01.
2.4 safety conditions：Routine blood test, routine urinalysis, electrocardiogram change without exception before and after treatment group patient treatment, treated
In journey, vital sign steadily and the no untoward reaction such as nausea and vomiting, allergy, illustrate that our clinical application is safe and reliable.
Caused by the Drug therapy ACA positive of the present invention, threatened abortion curative effect is safe and reliable in a word, and mother and baby is found no substantially
Toxic and side effects it is shown that Chinese medicine treatment early stage threatened abortion in terms of huge advantage.In current clinical treatment primary disease list
Pure application Western medicine side effect is excessive, in the case of simple application Chinese Herbs are imprecise, there is provided the thinking of etiology and pathogenesis and cutting
Real effectively square medicine data, is worth research application further.
Claims (10)
1. a kind of pharmaceutical preparation treating anticardiolipin antibody positive early stage threatened abortion is it is characterised in that by Radix Rehmanniae Preparata, the Radix Rehmanniae
Huang, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Cortex seu Radix Euonymi oxyphyllae, Radix Scutellariae, Semen Ziziphi Spinosae are made up of medicinal raw material.
2. as claimed in claim 1 treatment anticardiolipin antibody the positive early stage threatened abortion pharmaceutical preparation it is characterised in that
It is made up of the medicinal raw material of following weight：Radix Rehmanniae Preparata 15-20 part, Radix Rehmanniae 10-15 part, Radix Stellariae Yunnanensis 20-26 part,
Rhizoma panacis majoriss 7-12 part, Semen Cuscutae 8-13 part, Fructus Ligustri Lucidi 10-15 part, Rhizoma Atractylodis Macrocephalae 8-13 part, Cortex seu Radix Euonymi oxyphyllae 15-20 part, Radix Scutellariae 4-7 part,
Semen Ziziphi Spinosae 11-16 part.
3. as claimed in claim 2 treatment anticardiolipin antibody the positive early stage threatened abortion pharmaceutical preparation it is characterised in that
It is made up of the medicinal raw material of following weight：18 parts of Radix Rehmanniae Preparata, 12 parts of Radix Rehmanniae, 25 parts of Radix Stellariae Yunnanensis, Rhizoma panacis majoriss 10
Part, 12 parts of Semen Cuscutae, 15 parts of Fructus Ligustri Lucidi, 12 parts of the Rhizoma Atractylodis Macrocephalae, 15 parts of Cortex seu Radix Euonymi oxyphyllae, 6 parts of Radix Scutellariae, 15 parts of Semen Ziziphi Spinosae.
4. as claimed in claim 2 treatment anticardiolipin antibody the positive early stage threatened abortion pharmaceutical preparation it is characterised in that
It is made up of the medicinal raw material of following weight：15 parts of Radix Rehmanniae Preparata, 15 parts of Radix Rehmanniae, 20 parts of Radix Stellariae Yunnanensis, Rhizoma panacis majoriss 12
Part, 10 parts of Semen Cuscutae, 15 parts of Fructus Ligustri Lucidi, 10 parts of the Rhizoma Atractylodis Macrocephalae, 20 parts of Cortex seu Radix Euonymi oxyphyllae, 6 parts of Radix Scutellariae, 12 parts of Semen Ziziphi Spinosae.
5. the pharmaceutical preparation of described treatment anticardiolipin antibody positive early stage threatened abortion as arbitrary in claim 1-4, it is special
Levy and be that preparation method comprises following step：By Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Stellariae Yunnanensis, Rhizoma panacis majoriss, Semen Cuscutae, Fructus Ligustri Lucidi, white
Art, Cortex seu Radix Euonymi oxyphyllae, Radix Scutellariae, Semen Ziziphi Spinosae add water to cook secondary, adding water for the first time as medical material weight portion 3-8 times, decoct 1.0-1.5
Hour, add water for the second time 3-6 times for medical material weight portion and decoct 1.5-2.0 hour, collecting decoction, filtration, filtrate reduced in volume
Obtain thick paste, relative density is 1.05-1.10 (recording when 65 DEG C), add ethanol to make alcohol content reach 35%, stand 8-12 hour, filter
Cross, filtrate recycling ethanol, be concentrated to give active constituents of medicine；Individually or with pharmaceutically acceptable carrier mixed with this active component
Close, make according to galenic pharmacy routine techniquess.
6. the pharmaceutical preparation of described treatment anticardiolipin antibody positive early stage threatened abortion as arbitrary in claim 1-5, it is special
Levy and be that described pharmaceutical preparation is preferably made peroral dosage form.
7. as claimed in claim 6 treatment anticardiolipin antibody the positive early stage threatened abortion pharmaceutical preparation it is characterised in that
Described peroral dosage form is preferably soft capsule, capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum.
8. as claimed in claim 7 treatment anticardiolipin antibody the positive early stage threatened abortion pharmaceutical preparation it is characterised in that
Described peroral dosage form is preferably tablet, capsule or granule.
9. as claimed in claim 8 treatment anticardiolipin antibody the positive early stage threatened abortion pharmaceutical preparation it is characterised in that
Described peroral dosage form is preferably capsule.
10. the arbitrary described pharmaceutical preparation of claim 1-4 is in preparation treatment anticardiolipin antibody positive early stage threatened abortion
Purposes in medicine.
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|---|---|---|---|
| CN201610172987.4A CN105770157A (en) | 2016-03-24 | 2016-03-24 | Medicine preparation for treating ACA (anticardiolipin antibody) positive early threatened abortion |
| CN2016101729874 | 2016-03-24 |
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| Publication Number | Publication Date |
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| CN201611057544.7A Withdrawn CN106474251A (en) | 2016-03-24 | 2016-11-26 | A kind of pharmaceutical preparation treating anticardiolipin antibody positive early stage threatened abortion |
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|---|---|---|---|---|
| CN102552788A (en) * | 2012-01-06 | 2012-07-11 | 孙克勤 | Defend Chinese medicine composite capable of preventing abortion |
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- 2016-03-24 CN CN201610172987.4A patent/CN105770157A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552788A (en) * | 2012-01-06 | 2012-07-11 | 孙克勤 | Defend Chinese medicine composite capable of preventing abortion |
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