CN105748718A - Pharmaceutic preparation for treating recurrent spontaneous abortion caused by blocking antibody deficiency - Google Patents
Pharmaceutic preparation for treating recurrent spontaneous abortion caused by blocking antibody deficiency Download PDFInfo
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Abstract
The invention belongs to the technical field of traditional Chinese medicine and relates to a pharmaceutic preparation for treating recurrent spontaneous abortion caused by blocking antibody deficiency and a preparing method thereof.The pharmaceutic preparation is elaborately prepared by embelia parviflora, Ficus erecta Thumb.var.beecheyana, loranthus parasiticus, radix acanthopanacis senticosi, radix codonopsis, Calystegia hederacea Wall., semen cuscutae, fructus lycii, rhizoma cimicifugae and herba lycopi.The pharmaceutic preparation has the advantages that the medicinal materials are combined to achieve effects of tonifying the kidney and the spleen, benefiting qi and nourishing blood and preventing miscarriage, elimination exists in tonifying, tonifying exists in promotion, and the kidney is tonified allow yin and yang to be tonified, kidney qi to be strong and essential qi to be strong; the spleen is tonified to achieve powerful qi and blood metaplasia and allow the chong and ren channels to be full, the fetus qi to be strong and robust, and the fetus to be supported and nourished.
Description
Technical field
The invention belongs to technical field of Chinese medicine, relate to a kind of asthenia of both the spleen and kidney card blocking antibody for the treatment of and lack the pharmaceutical preparation causing recurrent abortion, especially a kind of asthenia of both the spleen and kidney card blocking antibody for the treatment of lacks pharmaceutical preparation causing recurrent abortion and preparation method thereof.
Background technology
Recurrent abortion (recurrentspontaneousabortion, RSA) is a kind of common pregnancy complications, refers to the fetus spontaneous abortion before occurring 2 times or more than 2 times pregnant 28 weeks with same spouse.The primary disease cause of disease and pathogenesis are considerably complicated, are also the difficult and complicated illness of global common concern.About the RSV of half is relevant with immunity, immune indexes thinks blocking antibody (blockingantibody, BA) Maximum Value, the research of blocking antibody and recurrent abortion becomes one of focus of primary disease research, blocking antibody is not enough or feminine gender can cause that paternal antigen is killed by mother's immune system identification, makes embryo be subject to immune attack and miscarry.
BA is lacked the RSA caused and adopts paternal or unrelated third party's individuality lymphocyte to carry out active immunity treatment by modern medicine; the quantity that can make the regulatory T cells in peripheral blood increases; induction parent produces immunologic tolerance; reduce the parent immune attack to embryo half alloantigen; suppress the cellular immunity rejection between female tire; protection embryo, reduces the purpose of abortion ratio.But it has Hematogenous infection, transfusion reaction, graft versus host disease, excites or increase the weight of the Potential danger factors such as autoimmune disease, and passive immunotherapy is blood products and expensive due to medicine, and patient is not easily accepted by.
Recurrent abortion is called " habitual abortion " by Chinese medicine, it is believed that the debility of CHONG and REN meridians of suffering from a deficiency of the kidney, and tire is become homeless and is, or deficiency-weakness of spleen-QI, carries and taking the photograph admittedly, and blood deficiency then moistens foster weary source, and deficiency is appointed in punching, and so that feotus vitality can not be conserved one's health habitual abortion occurs, other are also relevant to feelings will, blood stasis, heat in blood etc..Low for blocking antibody, the many angles from positive QI-insufficiency of the traditional Chinese medical science are analyzed, and healthy energy refers to the abilities such as body disease-resistant, eliminating evil, adjustment, reparation, is the coordination of body each several part, to global advantage and the effect of function system, this is the core concept of traditional Chinese medical science immunity.The kidney being the origin of congenital constitution, kidney qi loss cause can not astringency inducing feotus vitality, as " female section through opinion " say: " woman's the kidney pulse lies in tire, is the vital qi of mother, being relied also of son, if kidney qi loss, just can not astringency inducing feotus vitality ".The spleen being the foundation of acquired constitution, insufficiency of the spleen then no resource of generating and transforming QI and blood, such as " General Treatise on the Cause and Symptoms of Diseases " institute cloud: " if the deficient person of QI and blood, son dirty is occupied by air-cooled, then insufficiency of vital energy and blood, thus can not fetus nourishing, institute is so that tire number is fallen ".Therefore, habitual abortion answers spleen kidney with mending, and positive so-called Fu Qing is main is sayed: the kidney invigorating and not spleen reinforcing, then the essence of kidney is how hurriedly raw is also the spleen mending the day after tomorrow, just so mending congenital kidney also.
The history that Chinese medicine is prevented miscarriage existing several thousand, its curative effect is affirmative, has broad prospects.It is, therefore, desirable to provide the Chinese medicine composition of a kind of preventing and treating recurrent abortion with better curative effect.
Summary of the invention
Inventor is good at combining modern medical theory with traditional medical theory, dialectical combine with differential diagnosis of diseases, for the etiology and pathogenesis that recurrent abortion blocking antibody is low, based on clinical treatment experience for many years, learn wildly from other's strong points, hammer away, in order to overcome the deficiencies in the prior art, it is provided that a kind of asthenia of both the spleen and kidney card blocking antibody for the treatment of lacks the pharmaceutical preparation causing recurrent abortion.
For achieving the above object, the present invention adopts the following technical scheme that
A kind of asthenia of both the spleen and kidney card blocking antibody for the treatment of lacks the pharmaceutical preparation causing recurrent abortion, and it is medicinal raw material elaborate by Radix seu Caulis Embeliae Parviflorae, Radix Fici beecheyanae, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, Radix Codonopsis, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae), Semen Cuscutae, Fructus Lycii, Rhizoma Cimicifugae, Herba Lycopi.
In order to increase the synergism of effective active composition in medicine, make all medicines with the use of to reach the one-plus-one technique effect more than two, inventor is through long-term, substantial amounts of screening prescription is tested, it is preferred that following technical scheme: a kind of asthenia of both the spleen and kidney card blocking antibody for the treatment of lacks the pharmaceutical preparation causing recurrent abortion, it is characterized in that being made up of the medicinal raw material of following weight: Semen Cuscutae 15-20 part, Fructus Lycii 20-30 part, Radix Et Caulis Acanthopanacis Senticosi 10-15 part, Radix Fici beecheyanae 20-30 part, Herba Taxilli 6-9 part, Radix seu Caulis Embeliae Parviflorae 8-13 part, Radix Codonopsis 10-15 part, Rhizoma Cimicifugae 5-8 part, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 10-15 part, Herba Lycopi's 7-12 part.
Further preferably, a kind of asthenia of both the spleen and kidney card blocking antibody for the treatment of lacks the pharmaceutical preparation causing recurrent abortion, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 18 parts, Fructus Lycii 25 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Fici beecheyanae 24 parts, Herba Taxilli 8 parts, Radix seu Caulis Embeliae Parviflorae 12 parts, Radix Codonopsis 10 parts, Rhizoma Cimicifugae 5 parts, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 15 parts, Herba Lycopi 8 parts.
Fang Zhong: the sweet temperature of Semen Cuscutae, tonifying kidney and nourishing liver, warming the spleen helps stomach, and controlling nocturnal emission with astringent drugs is antiabortive；Fructus Lycii profit and nourish, double can bring down a fever, invigorating the liver and kidney kidney-YIN being deficient, two medicine 5 tonifying kidney and nourishing livers, nourishing YIN Yiyang is monarch drug.Radix Et Caulis Acanthopanacis Senticosi replenishing QI to invigorate the spleen, kidney-replenishing tranquilizing mind, promoting blood circulation to remove obstruction in the collateral；Radix Fici beecheyanae invigorating the spleen and replenishing QI, invigorating the spleen for eliminating dampness, bone and muscle strengthening, promoting blood circulation to remove obstruction in the collateral, two medicine 5 spleen invigorating invigorating middle warmer, benefiting qi and raising yang, dredge the meridian passage is ministerial drug.Herba Taxilli invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit；Radix seu Caulis Embeliae Parviflorae replenishing and activating blood, strong waist knee joint；Radix Codonopsis invigorating the spleen and replenishing QI, spleen invigorating lung benefiting, spleen invigorating fortune and not dry, grow stomach-Yin and do not wet, lung moistening and do not violate cold and cool, nourish blood and partially do not grow greasy, inspire clear sun；The kind liter of Rhizoma Cimicifugae lifts yang-energy；Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) invigorating spleen to remove dampness, the easypro spleen of Herba Lycopi and blood, line water detumescence, have for adjuvant.All medicines close 5 has kidney and spleen invigorating, benefiting QI and nourishing blood, admittedly appoint antiabortive merit, invigorating middle warmer has and disappears, and has benefit, the kidney invigorating to make negative and positive to mend in row, and kidney qi is prosperous, and vital essence is strong；Spleen invigorating makes QI and bloodization raw strong, and Sheng is filled in punching times, and feotus vitality is strong, and tire has direct bearing, makes tire foster to some extent, and self energy feotus vitality is healthy and strong.
The pharmaceutical research present situation of each medical material used by the present invention is as described below.
Radix seu Caulis Embeliae Parviflorae: [nature and flavor] are bitter；Puckery；Warm in nature.[return through] liver；Kidney channel.[function cures mainly] enriches blood；Invigorate blood circulation；Strong waist knee joint.The all cards of main blood deficiency；Menoxenia；Amenorrhea；Puerperal asthenia；Waist and leg ache；Injury and bone fracture.[usage and dosage] takes orally: decoct soup, 15～30g.External: appropriate, fresh goods is smash deposited.
Radix Fici beecheyanae: [nature and flavor] are sweet；Pungent；Warm in nature.[return through] lung；Spleen；Kidney channel.[function cures mainly] replenishing QI to invigorate the spleen；Promoting blood circulation to remove obstruction in the collateral；Expelling wind and removing dampness.Main overstrain is weak；Lack of appetite；Agalactia；Insufficiency of the spleen leucorrhea；Proctoptosis；Menoxenia；Wind syndrome of head pain；Traumatic injury；Rheumatic arthralgia.[usage and dosage] takes orally: decoct soup, 30-60g.External: appropriate, smashes deposited.
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.
Radix Et Caulis Acanthopanacis Senticosi: [nature and flavor] hardship pungent, micro-, temperature.[return through] returns spleen, kidney, heart channel.[function cures mainly] replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization.For deficiency of spleen-YANG and kidneyYANG, body void is weak, inappetence, soreness of waist and knee joint, insomnia and dreamful sleep.[usage and dosage] 9～27g.[function cures mainly] replenishing kidney, strengthening waist；Benefiting vital QI for tranquillizing；Promoting blood circulation to remove obstruction in the collateral.
Radix Codonopsis: [nature and flavor] are sweet is flat.[return through] returns spleen, lung meridian.[function cures mainly] invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency is coughed, and interior-heat is quenched one's thirst.
Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae): [nature and flavor] sweet micro-hardship；Flat.[return through] liver；Kidney channel.[function cures mainly] spleen invigorating；Dampness removing；Regulating menstruation.Main weakness of the spleen and stomach；Dyspepsia；Infantile milk regurgitation；Infantile malnutrition；Five types of stranguria；Leukorrhagia；Menoxenia.
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.[usage and dosage] 6～12g；Suitable amount used externally.
Fructus Lycii: [nature and flavor] are sweet is flat.[return through] returns liver, kidney channel.[function cures mainly] nourishing the liver and kidney, replenishing vital essence to improve eyesight.For asthenia damage of essence, soreness of waist and knee joint, vertigo and tinnitus, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, and blurred vision is failed to understand.
Rhizoma Cimicifugae: [nature and flavor] are pungent, micro-sweet, are slightly cold.[return through] returns lung, spleen, stomach, large intestine channel.[function cures mainly] delivers rash, heat-clearing and toxic substances removing, rises and lifts yang-energy.For headache due to pathogenic wind-heat, toothache, aphtha, laryngopharynx swelling and pain, measles without adequate eruption, YANG toxin syndrome sends out speckle；Proctoptosis, uterine prolapse.
Herba Lycopi: [nature and flavor] are bitter, pungent, tepor.[return through] returns liver, spleen channel.[function cures mainly] blood circulation promoting and blood stasis dispelling, line water detumescence.For menoxenia, amenorrhea, dysmenorrhea, postnatal blood stasis is suffered from abdominal pain, edema.
Pharmaceutical preparation of the present invention is that the Radix seu Caulis Embeliae Parviflorae in prescription, Radix Fici beecheyanae, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, Radix Codonopsis, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae), Semen Cuscutae, Fructus Lycii, Rhizoma Cimicifugae, Herba Lycopi are extracted effective ingredient as active ingredient according to certain weight using proper method, this composition individually or mixes with pharmaceutically acceptable carrier, makes the pharmaceutical preparation of the present invention according to galenic pharmacy routine techniques.
The present inventor finds under study for action, by optimized fabrication method, can when keeping active drug, remove impurity or the part without drug effect, reduce the impurity interference to therapeutic effect, make that this pharmaceutical preparation is more efficient, effect faster, and thus reduces the consumption of medicine, further reduce the misery of patient.
Preferably, a kind of asthenia of both the spleen and kidney for the treatment of demonstrate,proves the preparation method that blocking antibody lacks the pharmaceutical preparation causing recurrent abortion, and it comprises the following steps:
(1) Radix seu Caulis Embeliae Parviflorae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi are pulverized, with 65-70% alcohol reflux 1-3 time, united extraction liquid, concentrating under reduced pressure obtains rare extractum, upper polyamide column, first with pure water be eluted to effluent colourless after use 90% ethanol elution again, collecting ethanol elution, decompression recycling ethanol is to without alcohol taste, continuing to be concentrated into extractum, lyophilization, obtains the dry cream of Chinese medicine；
(2) by Radix Fici beecheyanae, Herba Taxilli, Radix Codonopsis, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae), Semen Cuscutae, Fructus Lycii, Rhizoma Cimicifugae boiling secondary, add water into medical material weight portion 4-10 times for the first time, decoct 1.0-1.5 hour, add water as medical material weight portion 3-8 times of second time decocts 1.0-1.5 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.03-1.08 (60 DEG C record), adding ethanol makes alcohol content reach 35%, stands 12 hours in 0-5 DEG C, filters, filtrate recycling ethanol, it is concentrated into extractum, lyophilization, obtains the dry cream of Chinese medicine；
Mixing homogeneously after broken with the Chinese medicine dried cream powder of (2) gained to (1), this composition individually or mixes with pharmaceutically acceptable carrier, makes the pharmaceutical preparation of the present invention according to galenic pharmacy routine techniques.
The pharmaceutical preparation of the present invention can be 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, sucks agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.
It is further preferred that the pharmaceutical preparation of the present invention is peroral dosage form, as: soft capsule, capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum.
Further preferably.The pharmaceutical preparation of the present invention is tablet, capsule or granule, it is most preferred that capsule.
The pharmaceutical preparation of present invention situation according to patient in use determines usage and dosage.The pharmaceutical preparation of present invention situation according to patient in use determines usage and dosage, can take 1-3 time every day, each 1-20 agent, such as: 1-20 bag or grain or sheet.
The present invention be inventor through repeatedly studying, progressively improve, last successfully a kind of good pharmaceutical preparation of curative effect, and demonstrated the curative effect of pharmaceutical preparation of the present invention by clinical case further.By 9: two groups of pregnancy rates of the embodiment of the present invention, exceed the pregnant frequency comparing difference not statistically significant of former miscarriage, experimental group pregnant Zhou Dachao 12 frequency and term labor rate are above matched group (P < 0.05), difference is statistically significant, and the therapeutic effect for the treatment of group is with the obvious advantage；After treatment, two groups are all significantly improved (P < 0.01) containing AntiCD3 McAb-BE, anti-CD4-BE, anti-CD8-BE total positives number, treatment group containing AntiCD3 McAb-BE, anti-CD4-BE, anti-CD8-BE total positives number be better than matched group (P < 0.05)；Treatment group and matched group total effective rate respectively 89.6% and 68.8%, 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.Therefore, the present invention is also claimed said medicine preparation and causes the purposes in the medicine of recurrent abortion in preparation treatment blocking antibody shortage.
In a word: compared with prior art, the present invention both have followed Chinese medical discrimination medicine law, has incorporated again modern pharmacology, and legislation is comprehensively, prescription is rigorous rationally, full side closes 5, has kidney and spleen invigorating, benefiting QI and nourishing blood, admittedly appoint antiabortive merit, there are Mutiple Targets, too many levels, multi-level comprehensive regulation effect, regulate immunity, promote that blocking antibody improves, improve the effect of all diseases of asthenia of both the spleen and kidney.
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.
The present invention can not only change the symptom of habitual abortion patient, and can improve the blocking antibody level of habitual abortion patient, promotes that blocking antibody turns sun；On the other hand, treatment by Chinese herbs habitual abortion, the potential risks such as the transfer overcome the propagation passing the infectious disease that active immunity treatment primary disease exists, promoting tumor and anti-graft disease, part infectious disease is carried patient and can also implement treatment, eliminate the fear that Hematogenic infectious disease is propagated by patient.
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 18 parts, Fructus Lycii 25 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Fici beecheyanae 24 parts, Herba Taxilli 8 parts, Radix seu Caulis Embeliae Parviflorae 12 parts, Radix Codonopsis 10 parts, Rhizoma Cimicifugae 5 parts, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 15 parts, Herba Lycopi 8 parts.
Preparation method: Radix seu Caulis Embeliae Parviflorae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi are pulverized by (1), with 65-70% alcohol reflux 1-3 time, united extraction liquid, concentrating under reduced pressure obtains rare extractum, upper polyamide column, first with pure water be eluted to effluent colourless after use 90% ethanol elution again, collecting ethanol elution, decompression recycling ethanol is to without alcohol taste, continuing to be concentrated into extractum, lyophilization, obtains the dry cream of Chinese medicine；
(2) by Radix Fici beecheyanae, Herba Taxilli, Radix Codonopsis, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae), Semen Cuscutae, Fructus Lycii, Rhizoma Cimicifugae boiling secondary, add water into medical material weight portion 4-10 times for the first time, decoct 1.0-1.5 hour, add water as medical material weight portion 3-8 times of second time decocts 1.0-1.5 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.03-1.08 (60 DEG C record), adding ethanol makes alcohol content reach 35%, stands 12 hours in 0-5 DEG C, filters, filtrate recycling ethanol, it is concentrated into extractum, lyophilization, obtains the dry cream of Chinese medicine；
Mix homogeneously after broken with the Chinese medicine dried cream powder of (2) gained to (1), make the pharmaceutical preparation of the present invention according to galenic pharmacy routine techniques.The present embodiment capsule every contains crude drug 0.65g.
Embodiment 2 capsule
Prescription: Semen Cuscutae 18 parts, Fructus Lycii 20 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, Radix Fici beecheyanae 20 parts, Herba Taxilli 8 parts, Radix seu Caulis Embeliae Parviflorae 10 parts, Radix Codonopsis 15 parts, Rhizoma Cimicifugae 8 parts, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 15 parts, Herba Lycopi 12 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 3 capsule
Prescription: Semen Cuscutae 15 parts, Fructus Lycii 20 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Fici beecheyanae 25 parts, Herba Taxilli 6 parts, Radix seu Caulis Embeliae Parviflorae 10 parts, Radix Codonopsis 12 parts, Rhizoma Cimicifugae 5 parts, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 10 parts, Herba Lycopi 10 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 4 capsule
Prescription: Semen Cuscutae 20 parts, Fructus Lycii 28 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Fici beecheyanae 28 parts, Herba Taxilli 6 parts, Radix seu Caulis Embeliae Parviflorae 13 parts, Radix Codonopsis 10 parts, Rhizoma Cimicifugae 5 parts, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 12 parts, Herba Lycopi 10 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 5 capsule
Prescription: Semen Cuscutae 17 parts, Fructus Lycii 24 parts, Radix Et Caulis Acanthopanacis Senticosi 14 parts, Radix Fici beecheyanae 25 parts, Herba Taxilli 9 parts, Radix seu Caulis Embeliae Parviflorae 10 parts, Radix Codonopsis 12 parts, Rhizoma Cimicifugae 7 parts, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 10 parts, Herba Lycopi 10 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 6 capsule
Prescription: Semen Cuscutae 1 part, Fructus Lycii 30 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, Radix Fici beecheyanae 25 parts, Herba Taxilli 7 parts, Radix seu Caulis Embeliae Parviflorae 12 parts, Radix Codonopsis 12 parts, Rhizoma Cimicifugae 6 parts, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 10 parts, Herba Lycopi 7 parts.
Preparation method: the operation with reference to embodiment 1 carries out.
Embodiment 7 granule
Prescription: Semen Cuscutae 18 parts, Fructus Lycii 25 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Fici beecheyanae 25 parts, Herba Taxilli 8 parts, Radix seu Caulis Embeliae Parviflorae 12 parts, Radix Codonopsis 10 parts, Rhizoma Cimicifugae 5 parts, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 10 parts, Herba Lycopi 10 parts.
Preparation method: Radix seu Caulis Embeliae Parviflorae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi are pulverized by (1), with 65-70% alcohol reflux 1-3 time, united extraction liquid, concentrating under reduced pressure obtains rare extractum, upper polyamide column, first with pure water be eluted to effluent colourless after use 90% ethanol elution again, collecting ethanol elution, decompression recycling ethanol is to without alcohol taste, continuing to be concentrated into extractum, lyophilization, obtains the dry cream of Chinese medicine；
(2) by Radix Fici beecheyanae, Herba Taxilli, Radix Codonopsis, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae), Semen Cuscutae, Fructus Lycii, Rhizoma Cimicifugae boiling secondary, add water into medical material weight portion 4-10 times for the first time, decoct 1.0-1.5 hour, add water as medical material weight portion 3-8 times of second time decocts 1.0-1.5 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.03-1.08 (60 DEG C record), adding ethanol makes alcohol content reach 35%, stands 12 hours in 0-5 DEG C, filters, filtrate recycling ethanol, it is concentrated into extractum, lyophilization, obtains the dry cream of Chinese medicine；
Mix homogeneously after broken with the Chinese medicine dried cream powder of (2) gained to (1), make the pharmaceutical preparation of the present invention according to galenic pharmacy routine techniques.The present embodiment granule every bag contains crude drug 2.5g.
Embodiment 8 tablet
Prescription: Semen Cuscutae 8 parts, Fructus Lycii 25 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Fici beecheyanae 24 parts, Herba Taxilli 8 parts, Radix seu Caulis Embeliae Parviflorae 12 parts, Radix Codonopsis 10 parts, Rhizoma Cimicifugae 5 parts, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 15 parts, Herba Lycopi 8 parts.
Preparation method: Radix seu Caulis Embeliae Parviflorae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi are pulverized by (1), with 65-70% alcohol reflux 1-3 time, united extraction liquid, concentrating under reduced pressure obtains rare extractum, upper polyamide column, first with pure water be eluted to effluent colourless after use 90% ethanol elution again, collecting ethanol elution, decompression recycling ethanol is to without alcohol taste, continuing to be concentrated into extractum, lyophilization, obtains the dry cream of Chinese medicine；
(2) by Radix Fici beecheyanae, Herba Taxilli, Radix Codonopsis, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae), Semen Cuscutae, Fructus Lycii, Rhizoma Cimicifugae boiling secondary, add water into medical material weight portion 4-10 times for the first time, decoct 1.0-1.5 hour, add water as medical material weight portion 3-8 times of second time decocts 1.0-1.5 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.03-1.08 (60 DEG C record), adding ethanol makes alcohol content reach 35%, stands 12 hours in 0-5 DEG C, filters, filtrate recycling ethanol, it is concentrated into extractum, lyophilization, obtains the dry cream of Chinese medicine；
Mix homogeneously after broken with the Chinese medicine dried cream powder of (2) gained to (1), make the pharmaceutical preparation of the present invention according to galenic pharmacy routine techniques.Every, the present embodiment tablet contains crude drug 0.5g.
The observation of curative effect of the low mo(u)ld bottom half recurrent abortion of blocking antibody is tested by embodiment 9 pharmaceutical preparation of the present invention
1 data and method
1.1 physical data: include institute of traditional Chinese medicine of Shandong Province in December, 2013 in December ,-2014 diagnosis and treatment 96 example patient altogether in as object of study, employing is random is divided into treatment group and matched group by digits table with 1:1, wherein treatment group 48 example, 24～37 years old age, year mean age (27.8 ± 4.8)；Abortion times 3～7 times, average (3.0 ± 2.0) are secondary；Matched group 48 example, 23～38 years old age, year mean age (28.2 ± 4.9)；Abortion times 3～6 times, average (2.9 ± 1.8) are secondary, and two groups of patient ages, abortion times compare, no significant difference (P > 0.05), have comparability.
1.2 diagnostic criterias:
1.2.1 the diagnostic criteria of recurrent abortion: with reference to " Gynecology of Chinese Medicine " (Zhang Yuzhen) relevant criterion: suffer fetal loss person before the gestation 28 weeks of 2 times or more than 2 times with homogeneity companion continuously；At least 1 low person of flow cytomery blocking antibody level (AntiCD3 McAb-BE, anti-CD4-BE, anti-CD8-BE)；
1.2.2 TCM Syndrome Type standard: draft " asthenia of both the spleen and kidney " pattern of syndrome standard with reference to " new Chinese medicine guideline of clinical investigations ", " Gynecology of Chinese Medicine " (Zhang Yuzhen) and " disease of tcm Standardization of diagnosis and curative effect ".Main syndromes: dizziness and tinnitus, soreness of waist and knee, breathe hard lazy speech, anorexia loose stool, nocturia, eye socket darkness or dull and sallow complexion, or the dim speckle of buccal.Tongue arteries and veins: the fat color of light red tongue is dim, deep-thready pulse, CHI-pulse being weak.
1.3 include in, exclusion standard:
1.3.1 inclusive criteria: meeting above-mentioned diagnostic criteria, the women of child-bearing age at 22～40 years old age, signature Informed Consent Form also can adhere to therapist according to plan.
1.3.2 exclusion standard: couple or side's karyotype have exception；The positives such as antisperm antibody, anticardiolipin antibody or anti-endometrial antibodies；The anatomic abnormalities of reproductive tract infection or reproductive tract；Merge genital system tumor (optimum or pernicious)；Merge whole body serious systemic disease, tumor or psychotic.
1.4 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, and treatment 3 months is 1 course for the treatment of continuously, checks blocking antibody after 3 months.Find that patient's blocking antibody is increased to after normally, arrange to become pregnant；Hereafter continue to take medicine until drug withdrawal after pregnant 16 weeks.
Matched group: adopt spouse's lymphocyte active immunity treatment method: at interval of immunity in 4 weeks 1 time, be for 3 times 1 course for the treatment of.Check blocking antibody after terminating 1st course for the treatment of, as being increased to normal person not yet, continue booster immunization, until normally.Finding that patient's blocking antibody is increased to normal rear arrangement and becomes pregnant；Booster immunization 1 time after making a definite diagnosis uterine pregnancy 35 days；Hereafter at interval of immunity in 3 weeks 1 time；Until normally stopping immunity after pregnant 16 weeks.
Above two groups are all terminated rear enclosed antibody 2 courses for the treatment of and still can not be increased to normally or spontaneous abortion is Endodontic failure again.Patient's barrier contraception is required before not arranging pregnancy.
1.5 observation index: situation of becoming pregnant, record is become pregnant, and exceedes former miscarriage pregnant week, pregnant Zhou Dachao 12 weeks and term labor situation；Two groups for the treatment of rear enclosed antibody turn sun situation；Two groups of tcm symptoms scoring improvement situation (by degree without, light, in, heavily classification, its corresponding score value respectively 0,1,2,3 points).Adopt nimodipine method, i.e. integration × 100% before (before treatment integration after integration-treatment)/treatment.
1.6 criterions of therapeutical effect: cure: simultaneous phenomenon disappears or is obviously improved, blocking antibody 3 turns sun, pregnant 12 weeks B ultrasonic display fetal survivals.Taking a turn for the better: simultaneous phenomenon improves, blocking antibody 2 turns sun, pregnant 65dB super display embryo survival.Do not heal: simultaneous phenomenon, without improving or increasing the weight of, induced abortion miscarriage or B ultrasonic display embryo's stasi occurs.
1.7 statistical methods: adopt SPSS15.0 statistical software to be calculated.Each numerical value withRepresenting, measurement data adopts t inspection, and enumeration data adopts χ2Inspection, statistically significant for difference with P < 0.05.
2 results
After 2.1 liang of group treatments, Pregnancy compares: two groups of pregnancy rates, exceed the pregnant frequency comparing difference not statistically significant of former miscarriage, experimental group pregnant Zhou Dachao 12 frequency and term labor rate are above matched group (P < 0.05), difference is statistically significant, the therapeutic effect for the treatment of group is with the obvious advantage, in Table 1.
After the group treatment of 1 liang of table, Pregnancy compares
Note: compare with matched group,#P < 0.05.
2.2 liang of group lab index compare: treat front two groups of AntiCD3 McAb-BE, anti-CD4-BE, anti-CD8-BE total positives number through inspection, no significant difference (P > 0.05).After treatment, two groups are all significantly improved (P < 0.01) containing AntiCD3 McAb-BE, anti-CD4-BE, anti-CD8-BE total positives number.Treatment group containing AntiCD3 McAb-BE, anti-CD4-BE, anti-CD8-BE total positives number be better than matched group (P < 0.05), in Table 2.
Before and after the group treatment of 2 liang of table, blocking antibody number positive compares (example)
The comparisons of 2.3 liang of group Comprehensive Clinical curative effects: treatment group and matched group total effective rate respectively 89.6% and 68.8%, 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 3.
The comparison of 3 liang of table group Comprehensive Clinical curative effect
Note: compare with matched group, * P < 0.05.
2.4 safety conditions: after treating 3 months, 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.
Claims (10)
1. treat blocking antibody and lack and cause the pharmaceutical preparation of recurrent abortion for one kind, it is characterised in that be medicinal raw material elaborate by Radix seu Caulis Embeliae Parviflorae, Radix Fici beecheyanae, Herba Taxilli, Radix Et Caulis Acanthopanacis Senticosi, Radix Codonopsis, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae), Semen Cuscutae, Fructus Lycii, Rhizoma Cimicifugae, Herba Lycopi.
2. pharmaceutical preparation as claimed in claim 1, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 15-20 part, Fructus Lycii 20-30 part, Radix Et Caulis Acanthopanacis Senticosi 10-15 part, Radix Fici beecheyanae 20-30 part, Herba Taxilli 6-9 part, Radix seu Caulis Embeliae Parviflorae 8-13 part, Radix Codonopsis 10-15 part, Rhizoma Cimicifugae 5-8 part, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 10-15 part, Herba Lycopi's 7-12 part.
3. pharmaceutical preparation as claimed in claim 2, it is characterised in that be made up of the medicinal raw material of following weight: Semen Cuscutae 18 parts, Fructus Lycii 25 parts, Radix Et Caulis Acanthopanacis Senticosi 12 parts, Radix Fici beecheyanae 24 parts, Herba Taxilli 8 parts, Radix seu Caulis Embeliae Parviflorae 12 parts, Radix Codonopsis 10 parts, Rhizoma Cimicifugae 5 parts, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae) 15 parts, Herba Lycopi 8 parts.
4. the pharmaceutical preparation as described in as arbitrary in claim 1-3, it is characterised in that preparation method comprises the following steps:
(1) Radix seu Caulis Embeliae Parviflorae, Radix Et Caulis Acanthopanacis Senticosi, Herba Lycopi are pulverized, with 65-70% alcohol reflux 1-3 time, united extraction liquid, concentrating under reduced pressure obtains rare extractum, upper polyamide column, first with pure water be eluted to effluent colourless after use 90% ethanol elution again, collecting ethanol elution, decompression recycling ethanol is to without alcohol taste, continuing to be concentrated into extractum, lyophilization, obtains the dry cream of Chinese medicine；
(2) by Radix Fici beecheyanae, Herba Taxilli, Radix Codonopsis, Rhizoma Calystegiae Hederaceae (Herba Calystegiae Hederaceae), Semen Cuscutae, Fructus Lycii, Rhizoma Cimicifugae boiling secondary, add water into medical material weight portion 4-10 times for the first time, decoct 1.0-1.5 hour, add water as medical material weight portion 3-8 times of second time decocts 1.0-1.5 hour, collecting decoction, filter, filtrate reduced in volume to relative density is 1.03-1.08 (60 DEG C record), adding ethanol makes alcohol content reach 35%, stands 12 hours in 0-5 DEG C, filters, filtrate recycling ethanol, it is concentrated into extractum, lyophilization, obtains the dry cream of Chinese medicine；
Mixing homogeneously after broken with the Chinese medicine dried cream powder of (2) gained to (1), this composition individually or mixes with pharmaceutically acceptable carrier, makes the pharmaceutical preparation of the present invention according to galenic pharmacy routine techniques.
5. the pharmaceutical preparation as described in as arbitrary in claim 1-4, it is characterized in that described pharmaceutical preparation is any pharmaceutically useful dosage form, including: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.
6. the pharmaceutical preparation as described in as arbitrary in claim 1-4, it is characterised in that described pharmaceutical preparation is peroral dosage form.
7. pharmaceutical preparation as claimed in claim 6, it is characterised in that described peroral dosage form is soft capsule, capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum.
8. pharmaceutical preparation as claimed in claim 7, it is characterised in that described peroral dosage form is preferably tablet, capsule or granule.
9. pharmaceutical preparation as claimed in claim 8, it is characterised in that described peroral dosage form is preferably capsule.
10. the arbitrary described pharmaceutical preparation of claim 1-3 lacks the purposes in the medicine causing recurrent abortion at preparation treatment blocking antibody.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106309579A (en) * | 2016-09-14 | 2017-01-11 | 中国中医科学院医学实验中心 | Traditional Chinese medicines formula for treating related diseases with low estrogen secretion level |
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2016
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Non-Patent Citations (2)
| Title |
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| 刘春香: "温肾补阳法治疗封闭抗体缺乏性复发性流产临床分析", 《当代医学》 * |
| 应翩 等: "张萍青治疗封闭抗体不足性复发性流产经验", 《浙江中西医结合杂志》 * |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106309579A (en) * | 2016-09-14 | 2017-01-11 | 中国中医科学院医学实验中心 | Traditional Chinese medicines formula for treating related diseases with low estrogen secretion level |
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Application publication date: 20160713 |