CN106620131A

CN106620131A - Formula of traditional Chinese medicine kidney-tonifying and pregnancy-promoting paste and preparation method thereof

Info

Publication number: CN106620131A
Application number: CN201610923818.XA
Authority: CN
Inventors: 黄梅花
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-10-29
Filing date: 2016-10-29
Publication date: 2017-05-10
Anticipated expiration: 2036-10-29
Also published as: CN106620131B

Abstract

The invention relates to a formula of traditional Chinese medicine kidney-tonifying and pregnancy-promoting paste and a preparation method thereof. The paste includes the following raw materials, by weight: 2-12 parts of herba epimedii, 2-12 parts of semen cuscutae, 2-10 parts of morinda officinalis, 2-10 parts of human placenta, 2-15 parts of herba cistanche, 3-15 parts of radix rehmanniae preparata, 1-6 parts of dipsacus asperoides, 2-12 parts of radix bupleuri, 2-8 parts of angelica sinensis, 2-6 parts of white paeony roots, 1-10 parts of astragalus complanatus, 4-20 parts of cornu cervi degelatinatum, 4-16 parts of Chinese wolfberries, 2-10 parts of glossy privet fruits, 8-30 parts of raw astragalus membranaceus, 4-12 parts of codonopsis pilosula, 4-16 parts of poria cocos, 8-20 parts of Chinese yam, 2-8 parts of rhizoma cyperi, 2-12 parts of herba leonuri, 2-6 parts of salviae miltiorrhizae, 1-6 parts of peach kernels, 2-6 parts of caulis spatholobi, 1-4 parts of notopterygium roots, 2-8 parts of pangolin, 4-12 parts of donkey-hide gelatin, 4-14 parts of turtle plastron glue, and 20-60 parts of honey. The raw material medicines are combined reasonably, and are boiled and concentrated for a long time for combining the active components in the traditional Chinese medicines to prepare the natural, safe and healthy traditional Chinese medicine kidney-tonifying and pregnancy-promoting paste. The paste has good curative effects and is prepared completely from natural plants, so that the paste is free of heavy metals or toxicity and can be continuously taken for a long time. The paste is convenient to take and carry.

Description

A kind of Kidney-supplementing gravidity assisting cream side and preparation method thereof

Technical field

The invention belongs to pharmaceutical technology field, is related to a kind of Kidney-supplementing gravidity assisting cream side and preparation method thereof.

Background technology

Infertility refer to do not practise contraception after marriage, there is normal sexuality, living together 1 year and not gestation person (it is happy outstanding. obstetrics and gynecology [M]. 7th edition. Beijing：People's Health Publisher, 2008：351.).Never pregnant person, the traditional Chinese medical science claims " not producing entirely ", and doctor trained in Western medicine claims " constitutional It is infertile "；There is the then infertile person of gestation, the traditional Chinese medical science claims " breaks ", and doctor trained in Western medicine claims " secondary infertility ".With the development of society, life The quickening of rhythm, the increase of life stress, environmental pollution is on the rise, shifting to an earlier date for sexual behaviour, marries and have children late and national two tire The sickness rate of the relieving of policy, fertility and infertility constantly rises, the Physiological Psychology health of severe jamming women, no Pregnant disease more and more obtains global concern as mankind itself's healthy reproduction problem.

The reason for infertility, is a lot, wherein by ovulation failure cause account for 25%-30% (Luo Lilan. it is infertile with it is sterile [M]. second edition. Beijing：People's Health Publisher, 2009：253,262-263.).Normal ovulation process is in hypothalamuses-hang down Complete under body-hypothalamic pituitary ovarium axises and neuroendocrine regulation, any one link can cause ovulation failure and cause infertile extremely. It is mainly shown as follicle aplasia or little follicle ovulation (diameter is less than 18mm) or the abnormal three kinds of situations of follicular development.Doctor trained in Western medicine for The treatment of primary disease is mainly drug ovulation, although its ovulation rate is very high, pregnancy rate is not high, and complication is also more, Such as multiple pregnancy, ovarian hyperstimulation syndrome, at the same long-term taking promoting ovulation drug ovarian function will also result in can not Inverse harmful effect.

In recent years, increasing scholar constantly studies Chinese medicine ovulation failure infertility, and achieve compared with Good curative effect, Chinese medicine increasingly has advantage in terms of the disease is treated.At present Research Literature report is as follows：Li Shuling etc. (Li Shuling, Wang Jiuling, Li Yuzhu. Yishen Huoxue Decoction ovulation failure infertility 60 [J], journal of shanghai Chinese medicine, 2008,42 (4)：60 ovulatory dysfunction infertility 41-43.) are treated, side is used from plan Yishen Huoxue Decoction, consisting of：Tu Silk give, Herba Epimedii, Fructus Ligustri Lucidi, Radix Angelicae Sinensis, Fructus Lycii, Fructus Rubi, Herba Lycopi, Caulis Spatholobi, Radix Bupleuri, Radix Cyathulae, Fluoritum, Herba Leonuri, Radix Paeoniae Rubra, Radix Paeoniae Alba, Radix Glycyrrhizae.3 menstrual cycle are treated altogether, are taken within the 14th day and the 12nd, 15 days in each menstrual cycle, daily 1 dose, it is decocted in water for oral dose, point 2 clothes take altogether 8 doses.During this period gestation person is discontinued.Pregnancy rate is up to 61.7% after treatment.Xu Huiqun, Hu Contend in beauty (Xu Huiqun, contend in beauty recklessly. the kidney invigorating gravidity assisting side treatment ovulation failure infertility observation of curative effect [J], journal of shanghai Chinese medicine, 2005,39 (5) .) think that the basic cause of disease of primary disease is " kidney deficiency ", therefore treatment is based on kidney-replenishing blood-nourishing.Using substantially square：Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Morindae Officinaliss, Fluoritum, Fructus Corni, Semen Persicae, SEMEN COICIS, Cornu Cervi tablet, Rhizoma Curculiginises, Semen Cuscutae.Simultaneously menstrual cycle according to not Same time：Follicular phase, the onset of ovulation, luteal phase add and subtract to basic side.As a result in 56 patients for treating, pregnancy rate reaches 55.35%.Zhao bird (Zhao bird. ovulation failure infertility [J] is treated in invigorating kidney, promoting blood circulation ruling by law. the Henan traditional Chinese medical science, 2004,24 (1)： 51.) think that invigorating kidney, promoting blood circulation is the principle for the treatment of of ovulation failure infertility, it takes Bushen Huoxue Fang to menolipsiss cycle person： The red Radix Paeoniae Alba, Herba Lycopi, Herba Leonuri, Radix Bupleuri, Radix Achyranthis Bidentatae, Caulis Spatholobi, Fructus Ligustri Lucidi, Herba Artemisiae Anomalae, Pollen Tyjphae, Rhizoma Curculiginises, Herba Epimedii, Fructus Rubi, Semen Cuscutae, Fructus Lycii.To the person that has menstrual cycle, prescription is taken within the 6th day in the cycle：Radix Rehmanniae Preparata, Herba Cistanches, Rhizoma Curculiginises, Herba Epimedii, Rhizoma Dioscoreae, Fructus Rubi, Fructus Ligustri Lucidi, the Radix Polygoni Multiflori, Semen Cuscutae, Herba Ecliptae, Fructus Lycii, Radix Dipsaci, Radix Angelicae Sinensis.In the 13-17 days cycles, change clothes Prescription：Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Bupleuri, Rhizoma Curculiginises, Herba Epimedii, Fructus Rubi, Fructus Ligustri Lucidi, Semen Cuscutae, Herba Ecliptae, Fructus Lycii, Radix Dipsaci, Radix Angelicae Sinensis, Herba Lycopi, Cornu Cervi Pantotrichum.56 ovulation failure infertility patients are treated altogether, and 265 cycle therapy of Jing, wherein nonresponder accounts for 25%, pregnant person accounts for 71.4%, recovers ovulation function person and accounts for 75%.Chen Yan (Chen Yan. Shugan Bushen soup induced ovulation clinical observation [J]. Inner Mongol Chinese medicine, 2013,5：6-7.) from Shugan Bushen soup treatment ovulation failure infertility patient is intended, square medicine is as follows： Chinese yam and angelica, Fructus Corni, Fructus Akebiae, Cornu Cervi tablet, Radix Rehmanniae Preparata, Rhizoma Polygonati Odorati, Fructus Ligustri Lucidi, Radix Bupleuri, Fructus Toosendan, Semen Cuscutae, Herba Epimedii.Altogether Choose 80 patients to be observed, be randomly divided into treatment group 40 and matched group 40, matched group is treated using clomiphene, two After 3 menstrual cycle treatments, treatment group's pregnancy rate (55%) has statistics to group higher than matched group (25%), two groups of comparing differences Meaning (P<0.01).Zhao Shuming, Wang Ru etc. (Zhao Shuming, Wang Ru etc. kidney tonifying, essence replenishing invigorating the spleen and relieving depression of liver-QI Chinese medicine cycle therapy infertility is treated Effect observation [J]. the Sichuan traditional Chinese medical science, 2007,25 (6)：92-93.) think that primary disease is relevant with spleen kidney deficiency damage, therefore treatment is with kidney tonifying, essence replenishing Spleen invigorating is rule for the treatment of, according to the different times medication of menstrual cycle, ovulation failure infertility 100 is treated altogether.Follicular phase is medicinal： Fructus Lycii, Fructus Rubi, the Radix Astragali, Radix Pseudostellariae, the Rhizoma Atractylodis Macrocephalae, Fructus Corni, Herba Epimedii, Radix Rehmanniae Preparata, Semen Cuscutae, Chinese yam and angelica etc.；The onset of ovulation medicine With：Radix Angelicae Sinensis, Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Fructus Leonuri, Fructus Lycii, Semen Cuscutae, Herba Epimedii, Radix Bupleuri, Radix Curcumae, Flos Carthami, Semen Persicae etc.；Luteal phase medicine With：Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Semen Caesalpiniae Minaciss, the Radix Astragali, Radix Angelicae Sinensis, the Cortex Eucommiae, Radix Pseudostellariae, Herba Epimedii, Semen Cuscutae etc.；Premenstruum is medicinal：Radix Angelicae Sinensis, river Rhizome of chuanxiong, Radix Bupleuri, Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Folium Artemisiae Argyi, Radix Cyathulae, Radix Curcumae, Herba Lycopi, Fructus Leonuri etc..Jing after treatment, pregnancy rate is up to 66%.Cai Qinhua (Cai Qinhua. Method of adjusting and reinforcing liver and kidney treatment anovulatory infertility 52 [J], the Jiangsu traditional Chinese medical science, 1998,19 (2)：24.) think primary disease with Kidney deficiency stagnation of liver-QI is relevant, therefore treatment is based on Method of adjusting and reinforcing liver and kidney, substantially just：Fructus Lycii, the Radix Paeoniae Alba, Rhizoma dioscoreae, Semen Cuscutae, Fructus Corni, Radix Angelicae Sinensis, Radix Rehmanniae Preparata, Herba Cistanches, Radix Morindae Officinaliss, Radix Bupleuri, Rhizoma Curculiginises, Herba Epimedii, Cortex Moutan, treat 6 menstrual cycle, altogether by daily 1 dose 52 ovulation failure infertility patients for the treatment of, total effective rate 84.6%.

Find that the traditional Chinese medical science has remarkable result in terms of gynecological's Ovulation barrier sterile from the studies above, while Chinese medicine has expense The advantages of being acted on low, curative effect affirmative, Small side effects, strong and lasting overall section, but the sick treatment course is long, at least 3-6 Individual month, at most 2 years even longer, and many patients fail to adhere to the diagnosis and treatment of system that cure rate clinically is for many years because of a variety of causes Carry out never new breakthrough.Chinese herbal ointment formula application in recent years is more and more extensive, and the dosage form takes easy to carry.One cream side, The amount of blue or green taste is made in extracted concentration, is generally available for patient to take 30 days or so.The soft extract for making only needs cold preservation, takes out when taking 10-15ml, it is simple and convenient with warm boiled water, not by meeting of going on business, amusement and travel or outgoing work is equal is affected.Cause This, Chinese herbal ointment formula treats infertility also by the recognition and acceptance of increasing patient institute.

The content of the invention

In order to overcome the deficiencies in the prior art, the present invention to provide a kind of Kidney-supplementing gravidity assisting cream side and preparation method thereof, should Kidney-supplementing gravidity assisting cream side treatment ovulation failure is barrenness caused, while to the menstruation caused by ovarian hypofunction and ovulation failure Amount less, the later stage, amenorrhea etc., it is with good curative effect and without any side effects.

The invention provides following technical scheme：

A kind of Kidney-supplementing gravidity assisting cream side, raw material includes the following each component of weight portion：Herba Epimedii 2-12 parts, Semen Cuscutae 2- 12 parts, Radix Morindae Officinaliss 2-10 parts, Placenta Hominiss 2-10 parts, Herba Cistanches 2-15 parts, Radix Rehmanniae Preparata 3-15 parts, Radix Dipsaci 1-6 parts, Radix Bupleuri 2-12 parts, Radix Angelicae Sinensis 2-8 parts, Radix Paeoniae Alba 2-6 parts, Semen Astragali Complanati 1-10 parts, Cornu Cervi Degelatinatum 4-20 parts, Fructus Lycii 4-16 parts, Fructus Ligustri Lucidi 2-10 parts, SHENGHUANG Stilbene 8-30 parts, Radix Codonopsis 4-12 parts, Poria 4-16 parts, Rhizoma Dioscoreae 8-20 parts, Rhizoma Cyperi 2-8 parts, Herba Leonuri 2-12 parts, Radix Salviae Miltiorrhizae 2-6 parts, Fructus Persicae Core 1-6 part, Caulis Spatholobi 2-6 parts, Rhizoma Et Radix Notopterygii 1-4 parts, Squama Maniss 2-8 parts, Colla Corii Asini 4-12 parts, Colla Plastri Testudiniss 4-14 parts, Mel 20-60 Part.

In such scheme preferably, raw material includes the following each component of weight portion：Herba Epimedii 4-10 parts, Semen Cuscutae 4- 8 parts, Radix Morindae Officinaliss 2-6 parts, Placenta Hominiss 4-8 parts, Herba Cistanches 4-10 parts, Radix Rehmanniae Preparata 4-10 parts, Radix Dipsaci 2-4 parts, Radix Bupleuri 2-8 parts, Radix Angelicae Sinensis 2-6 parts, Radix Paeoniae Alba 2-4 parts, Semen Astragali Complanati 2-8 parts, Cornu Cervi Degelatinatum 4-12 parts, Fructus Lycii 4-12 parts, Fructus Ligustri Lucidi 4-8 parts, Radix Astragali 8-20 Part, Radix Codonopsis 4-8 parts, Poria 4-12 parts, Rhizoma Dioscoreae 8-12 parts, Rhizoma Cyperi 2-4 parts, Herba Leonuri 2-8 parts, Radix Salviae Miltiorrhizae 2-4 parts, Semen Persicae 1-2 parts, Caulis Spatholobi 2-4 parts, Rhizoma Et Radix Notopterygii 1-2 parts, Squama Maniss 2-4 parts, Colla Corii Asini 4-8 parts, Colla Plastri Testudiniss 4-8 parts, Mel 20-40 parts.

In any of the above-described scheme preferably, raw material includes the following each component of weight portion：

4 parts of Herba Epimedii, 6 parts of Semen Cuscutae, 4 parts of Radix Morindae Officinaliss, 4 parts of Placenta Hominiss, 6 parts of Herba Cistanches, 8 parts of Radix Rehmanniae Preparata, 2 parts of Radix Dipsaci, bavin 4 parts recklessly, 2 parts of Radix Angelicae Sinensis, 2 parts of the Radix Paeoniae Alba, 4 parts of Semen Astragali Complanati, 6 parts of Cornu Cervi Degelatinatum, 6 parts of Fructus Lycii, 6 parts of Fructus Ligustri Lucidi, 12 parts of Radix Astragali, Radix Codonopsis 6 parts, 6 parts of Poria, 8 parts of Rhizoma Dioscoreae, 2 parts of Rhizoma Cyperi, 4 parts of Herba Leonuri, 2 parts of Radix Salviae Miltiorrhizae, 1 part of Semen Persicae, 2 parts of Caulis Spatholobi, 1 part of Rhizoma Et Radix Notopterygii, wear mountain 2 parts of first, 6 parts of Colla Corii Asini, 4 parts of Colla Plastri Testudiniss, 30 parts of Mel.

In any of the above-described scheme preferably, raw material includes the following each component of weight portion：6 parts of Herba Epimedii, Semen Cuscutae 8 Part, 6 parts of Radix Morindae Officinaliss, 4 parts of Placenta Hominiss, 4 parts of Herba Cistanches, 6 parts of Radix Rehmanniae Preparata, 4 parts of Radix Dipsaci, 4 parts of Radix Bupleuri, 4 parts of Radix Angelicae Sinensis, 4 parts of the Radix Paeoniae Alba, Sha Yuan 4 parts of son, 6 parts of Cornu Cervi Degelatinatum, 4 parts of Fructus Lycii, 4 parts of Fructus Ligustri Lucidi, 8 parts of Radix Astragali, 6 parts of Radix Codonopsis, 6 parts of Poria, 10 parts of Rhizoma Dioscoreae, Rhizoma Cyperi 2 Part, 8 parts of Herba Leonuri, 4 parts of Radix Salviae Miltiorrhizae, 2 parts of Semen Persicae, 4 parts of Caulis Spatholobi, 2 parts of Rhizoma Et Radix Notopterygii, 4 parts of Squama Maniss, 4 parts of Colla Corii Asini, 6 parts of Colla Plastri Testudiniss, honey 30 parts of sugar.

The present invention also provides the preparation method of above-mentioned Kidney-supplementing gravidity assisting cream side, including following steps：

1) medicine is soaked：By Herba Epimedii, Semen Cuscutae, Radix Morindae Officinaliss, Placenta Hominiss, Herba Cistanches, Radix Rehmanniae Preparata, Radix Dipsaci, Radix Bupleuri, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Semen Astragali Complanati, Cornu Cervi Degelatinatum, Fructus Lycii, Fructus Ligustri Lucidi, Radix Astragali, Radix Codonopsis, Poria, Rhizoma Dioscoreae, Rhizoma Cyperi, Herba Leonuri, Radix Salviae Miltiorrhizae, Semen Persicae, Sanguis Gallus domesticus Rattan and Rhizoma Et Radix Notopterygii are soaked, and add the 8-10 times of water measured, and soak 1-3 hours；

2) extract：Using pressurization decocting method, by step 1) in immersion medical material decoct twice, decoctions pressure be 1- 1.5kg, it is 100-150 DEG C to decoct temperature, and decocting time is each 50-80min, and the medicinal liquid that decoction squeezing twice is taken out is placed Cooling precipitation, takes supernatant and crosses 80-100 eye mesh screens to obtain filtrate standby after precipitation；

3) Squama Maniss are decocted：Using pressurization decocting method, add the 8-10 times of decocting measured to boil twice Squama Maniss, decoct pressure Power is 1-1.5kg, and it is 100-150 DEG C to decoct temperature, and decocting time is each 50-80min, will twice decoct the medicine that squeezing is taken out Liquid places cooling precipitation, supernatant is taken after precipitation and is crossed 120-180 eye mesh screens to obtain Squama Maniss filtrate standby；

4) concentrate：Step 2) filtrate that obtains in operating pressure 0.2-0.3Mpa, temperature 115-124 DEG C with vapour pressure heating Boil, drag for surface offscum and constantly stir medicinal liquid (i.e. step 2) filtrate), while by step 3) the Squama Maniss filtrate that obtains converts Enter, concentration of liquid medicine forms the clear paste of paste, now take concentration drop in dry kraft paper with rod, to drip cream indiffusion, knot It is degree for pearl；

5) cream is received：In step 4) concentration clear paste in add Mel, Colla Corii Asini and Colla Plastri Testudiniss while hot, in operating pressure 0.2- 0.35Mpa, temperature 118-125 DEG C, are stirred continuously receipts cream, obtain the Kidney-supplementing gravidity assisting cream side that relative density is 1.3-1.40.

When Kidney-supplementing gravidity assisting cream side is prepared, step 1) through immersion, decoct out beneficial to the effective ingredient in medicine； Step 2) and 3) in, to ensure that water is totally submerged medical material during decoction；Step 4) concentration when constantly agitation medicinal liquid be to prevent coking, and Prevent from overflowing；Step 5) in be stirred continuously in case sticky end rise Jiao, while open exhaust fan, accelerate it to evaporate, with moisture not Disconnected evaporation, firepower keeps minimum.

In such scheme preferably, step 1) 9 times of water measured of middle addition, soak 2 hours.

In any of the above-described scheme preferably, step 2) decoctions pressure is 1.2kg, it is 120 DEG C to decoct temperature, during decoction Between be each 60min.

In any of the above-described scheme preferably, step 2) the medicinal liquid placement cooling precipitation that squeezing is taken out will be twice decocted, Take supernatant after precipitation to cross 100 eye mesh screens to obtain filtrate standby.

In any of the above-described scheme preferably, step 3) decoctions pressure is 1.2kg, it is 120 DEG C to decoct temperature, during decoction Between be each 60min.The water of rapid 3) middle 9 times of amounts of addition.

In any of the above-described scheme preferably, step 3) the medicinal liquid placement cooling precipitation that squeezing is taken out will be twice decocted, Take supernatant after precipitation to cross 150 eye mesh screens to obtain filtrate standby.

In any of the above-described scheme preferably, step 4) operating pressure 0.3Mpa, 120 DEG C of temperature.

In any of the above-described scheme preferably, step 5) operating pressure 0.3Mpa, 125 DEG C of temperature.

In any of the above-described scheme preferably, step 5) relative density that control Kidney-supplementing gravidity assisting cream side is 1.40.

In any of the above-described scheme preferably, also including step 6) subpackage and cool cream：Select clean rank to be 100,000 grades, Temperature<20 DEG C of toilets, by step 5) soft extract that obtains takes advantage of hot subpackage, and room temperature 24 hours after subpackage are put after lid cover seal Put in refrigerator-freezer and store, standing time is less than 3 months.

In any of the above-described scheme preferably, step 5) Colla Plastri Testudiniss in advance through heating refining or molten.

Crude drug used in the present invention and pharmaceutic adjuvant, indices meet 2015 editions《The People's Republic of China (PRC) Pharmacopeia》Record, present invention also offers principle active component and pharmacology of the said medicine in treatment ovulation failure infertility Activity：

Medicine of the present invention be by Herba Epimedii, Semen Cuscutae, Radix Morindae Officinaliss, Placenta Hominiss, Herba Cistanches, Radix Rehmanniae Preparata, Radix Dipsaci, Radix Bupleuri, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Semen Astragali Complanati, Cornu Cervi Degelatinatum, Fructus Lycii, Fructus Ligustri Lucidi, Radix Astragali, Radix Codonopsis, Poria, Rhizoma Dioscoreae, Rhizoma Cyperi, Herba Leonuri, Radix Salviae Miltiorrhizae, Semen Persicae, Caulis Spatholobi, Rhizoma Et Radix Notopterygii, Squama Maniss, Colla Corii Asini, Colla Plastri Testudiniss are constituted.Herba Epimedii, Semen Cuscutae, Placenta Hominiss, Radix Morindae Officinaliss, Cornu Cervi Degelatinatum, The medicine nourishing the liver and kidney such as Fructus Ligustri Lucidi, Fructus Lycii, Semen Astragali Complanati, fill up essence and blood, warming YANG transfer, with parahormone sample effect, ovary can be made HCG/LH receptor-specifics adhesion and HCG/LH acceptor numbers increase, and have excitation to hypothalamus-hypophysis-gonad axis function, together When do not affect the incretion balance in natural reproduction cycle again.Liver is adjusted in Radix Rehmanniae Preparata, Radix Dipsaci, Radix Bupleuri, Radix Angelicae Sinensis, Radix Paeoniae Alba the kidney invigorating, strengthens monarch drug Adjusting and reinforcing liver and kidney is acted on, and has liver-smoothing, qi-regulating effect.The sweet temperature spleen invigorating of the Radix Astragali；Radix Codonopsis replenishing QI to invigorate the spleen, the sweet light spleen invigorating eliminating dampness by diuresis of Poria, Rhizomadioscoreae Medicine kidney tonifying gas, strengthening the spleen and stomach, reinforce the kidney beneficial essence, three has shared replenishing QI to invigorate the spleen, the work(of stomach function regulating eliminating dampness by diuresis, the meaning for having SHENLING BAISHU SAN.Chicken Caulis seu Radix Schisandrae Henryi, Herba Leonuri, Semen Persicae, Squama Maniss, Rhizoma Et Radix Notopterygii, Rhizoma Cyperi nourshing blood and promoting blood circulation, eight extra-channel of taking good care of oneself, promoting blood circulation to remove blood stasis dysmenorrhea, depressed liver-energy dispersing and QI regulating can increase The contractility of Enlarged uteri, intensity, frequency and uterine motility, excited uterine smooth muscle increases the blood flow of uterus and ovary tissue Amount, promotes the growth of inner membrance and the formation of follicle, and promotes the rupture of dominant follicle to discharge.Colla Corii Asini, Colla Plastri Testudiniss as glue class medicine, Not only cream can have been received but can nourishing YIN and benefiting blood, and have excitation to isolated uterine.

Above-mentioned raw materials medicine and adjuvant through rational proportion, are boiled, concentrated in fusion Chinese medicine by the present invention through long-time Effective ingredient develop the Chinese herbal ointment formula of natural, safe and healthy the kidney invigorating gravidity assisting, clinically using for many years, with very Good curative effect, and raw material is natural plant source, without heavy metal (such as lead, hydrargyrum, arsenic) or toxic component (such as fluotitanic acid Potassium), long lasting for taking, and can take easy to carry, by the recognition and acceptance of increasing patient institute.

The cream side of the present invention using twenties tastes tunnel Chinese medicine, without being simply toxic herb, can long lasting for taking, Clinically use for many years, the generation of none adverse events.Cream side combines traditional medicine, evidence-based medicine EBM, clinical practice, both Traditional Chinese medical science traditional characteristicses are maintained, " lacking evidence-based foundation " is avoided again, can more objectively count curative effect.The cream side of the present invention is main Effect be kidney tonifying, essence replenishing and yang invigorating, depressed liver-energy dispersing and QI regulating invigorate blood circulation, excited hypothalamic pituitary gonadal axises, recover ovulation, and improve uterus and The blood supply of ovary, promotes endometrium, the growth of follicle and the discharge of dominant follicle, long-term clinical practice to find effectively to control Treat ovulation failure infertility.

Beneficial effects of the present invention are embodied in：The present invention have the kidney invigorating adjust liver, assistant to invigorate blood circulation, our mild in medicine property and, negative and positive Giving young employees remedial-courses in general knowledge and vocational skills, qi and blood tonifying can long-term taking.Now clinically there is treatment well to the infertility caused by ovulation failure using for many years Effect.And the crude drug in the present invention is natural plant source, without heavy metal (such as lead, hydrargyrum, arsenic) or toxic component (such as fluorine Potassium titanate), any side effect will not be brought to human body；This research is also applied to ovarian hypofunction, the moon caused by ovulation failure The diseases such as hypomenorrhea, later stage, amenorrhea have good curative effect, have wide range of applications；Chinese medicinal material used is in the present invention Common medical material, abundant raw material, cream side of our hospital makes many decades, and manufacturing technology is ripe, easily production.With national two tires policy Decontrol, the crowd of the required cream side is more and more, there is actual economic worth and clinical value, with very strong practicality, its Economic and social benefit is notable.

Specific embodiment

In order to further appreciate that the technical characteristic of the present invention, the present invention is explained in detail with reference to specific embodiment State.Embodiment only has exemplary effect to the present invention, not with any restricted effect, those skilled in the art The modification of any unsubstantiality made on the basis of the present invention, should all belong to protection scope of the present invention.

Embodiment 1：A kind of Kidney-supplementing gravidity assisting cream side

Prescription：4 parts of Herba Epimedii, 6 parts of Semen Cuscutae, 4 parts of Radix Morindae Officinaliss, 4 parts of Placenta Hominiss, 6 parts of Herba Cistanches, 8 parts of Radix Rehmanniae Preparata, Radix Dipsaci 2 Part, 4 parts of Radix Bupleuri, 2 parts of Radix Angelicae Sinensis, 2 parts of the Radix Paeoniae Alba, 4 parts of Semen Astragali Complanati, 6 parts of Cornu Cervi Degelatinatum, 6 parts of Fructus Lycii, 6 parts of Fructus Ligustri Lucidi, Radix Astragali 12 Part, 6 parts of Radix Codonopsis, 6 parts of Poria, 8 parts of Rhizoma Dioscoreae, 2 parts of Rhizoma Cyperi, 4 parts of Herba Leonuri, 2 parts of Radix Salviae Miltiorrhizae, 1 part of Semen Persicae, 2 parts of Caulis Spatholobi, Rhizoma Et Radix Notopterygii 1 Part, 2 parts of Squama Maniss, 6 parts of Colla Corii Asini, 4 parts of Colla Plastri Testudiniss, 30 parts of Mel.

The preparation method of the Kidney-supplementing gravidity assisting cream side of the present embodiment, including following steps：

1) medicine is soaked：By Herba Epimedii, Semen Cuscutae, Radix Morindae Officinaliss, Placenta Hominiss, Herba Cistanches, Radix Rehmanniae Preparata, Radix Dipsaci, Radix Bupleuri, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Semen Astragali Complanati, Cornu Cervi Degelatinatum, Fructus Lycii, Fructus Ligustri Lucidi, Radix Astragali, Radix Codonopsis, Poria, Rhizoma Dioscoreae, Rhizoma Cyperi, Herba Leonuri, Radix Salviae Miltiorrhizae, Semen Persicae, Sanguis Gallus domesticus Rattan and Rhizoma Et Radix Notopterygii are soaked, and add the water of 9 times of amounts, soak 2 hours；

Can be with drinking water logging medicine, drinking water its quality meets the world《Drinking water sanitary standard》；

2) extract：Using pressurization decocting method, by step 1) in immersion medical material decoct twice, decoct pressure be 1.2kg, it is 120 DEG C to decoct temperature, and decocting time is each 60min, the medicinal liquid that decoction squeezing twice is taken out is placed into cooling and is sunk Form sediment, supernatant is taken after precipitation and is crossed 80 eye mesh screens to obtain filtrate standby；

Can be using materials decoction device monomer electricity boiling machine (minute-pressure circulation), specification has 40,000 ml, by Beijing east China original armarium Company limited produces YJ20B-G closed medicine decocting machines.

3) Squama Maniss are decocted：Using pressurization decocting method, add the decocting of 9 times of amounts to boil twice Squama Maniss, decoct pressure For 1.2kg, it is 120 DEG C to decoct temperature, and decocting time is each 60min, and the medicinal liquid that decoction squeezing twice is taken out is placed into cooling Precipitation, takes supernatant and crosses 150 eye mesh screens to obtain Squama Maniss filtrate standby after precipitation；

4) concentrate：Step 2) filtrate that obtains, with vapour pressure heated and boiled, drags in operating pressure 0.3Mpa, 120 DEG C of temperature Go surface offscum and constantly stir medicinal liquid, while by step 3) the Squama Maniss filtrate that obtains is blended into, and concentration of liquid medicine forms paste Clear paste, now with rod take concentration drop in dry kraft paper, to drip cream indiffusion, become pearl for degree；

Can be by the steam-jacked kettle (model of the powerful Machinery Co., Ltd.'s production in city of Zhucheng using concentrator： GT6J1C), capacity 100L；

5) cream is received：In step 4) concentration clear paste in add Mel, Colla Corii Asini and Colla Plastri Testudiniss while hot, in operating pressure 125 DEG C of 0.3Mpa, temperature, is stirred continuously receipts cream, obtains the Kidney-supplementing gravidity assisting cream side that relative density is 1.40；

It is by the steam-jacked kettle (model of the powerful Machinery Co., Ltd.'s production in city of Zhucheng that can adopt and receive cream equipment： GT6J0.5C), capacity 50L；

6) subpackage and cool cream：Cool cream, make-up room are toilet, and clean rank is 100,000 grades, temperature<20 DEG C, soft extract takes advantage of heat Pour in automatic packer, be quickly dispensed into clean in advance, in the porcelain jar sterilized (volume 500ml).Room temperature after subpackage 24 hours, place in refrigerator-freezer after lid cover seal and store, up to 3 months standing time.

Embodiment 2：A kind of Kidney-supplementing gravidity assisting cream side

Prescription：6 parts of Herba Epimedii, 8 parts of Semen Cuscutae, 6 parts of Radix Morindae Officinaliss, 4 parts of Placenta Hominiss, 4 parts of Herba Cistanches, 6 parts of Radix Rehmanniae Preparata, Radix Dipsaci 4 Part, 4 parts of Radix Bupleuri, 4 parts of Radix Angelicae Sinensis, 4 parts of the Radix Paeoniae Alba, 4 parts of Semen Astragali Complanati, 6 parts of Cornu Cervi Degelatinatum, 4 parts of Fructus Lycii, 4 parts of Fructus Ligustri Lucidi, 8 parts of Radix Astragali, 6 parts of Radix Codonopsis, 6 parts of Poria, 10 parts of Rhizoma Dioscoreae, 2 parts of Rhizoma Cyperi, 8 parts of Herba Leonuri, 4 parts of Radix Salviae Miltiorrhizae, 2 parts of Semen Persicae, 4 parts of Caulis Spatholobi, 2 parts of Rhizoma Et Radix Notopterygii, 4 parts of Squama Maniss, 4 parts of Colla Corii Asini, 6 parts of Colla Plastri Testudiniss, 30 parts of Mel.

The preparation method of the Kidney-supplementing gravidity assisting cream side of the present embodiment is with embodiment 1.

Embodiment 3：A kind of Kidney-supplementing gravidity assisting cream side

Prescription：4 parts of Herba Epimedii, 4 parts of Semen Cuscutae, 2 parts of Radix Morindae Officinaliss, 4 parts of Placenta Hominiss, 4 parts of Herba Cistanches, 4 parts of Radix Rehmanniae Preparata, Radix Dipsaci 2 Part, 2 parts of Radix Bupleuri, 2 parts of Radix Angelicae Sinensis, 2 parts of the Radix Paeoniae Alba, 2 parts of Semen Astragali Complanati, 4 parts of Cornu Cervi Degelatinatum, 4 parts of Fructus Lycii, 4 parts of Fructus Ligustri Lucidi, 8 parts of Radix Astragali, 4 parts of Radix Codonopsis, 4 parts of Poria, 8 parts of Rhizoma Dioscoreae, 2 parts of Rhizoma Cyperi, 2 parts of Herba Leonuri, 2 parts of Radix Salviae Miltiorrhizae, 1 part of Semen Persicae, 2 parts of Caulis Spatholobi, 1 part of Rhizoma Et Radix Notopterygii, 2 parts of Squama Maniss, 4 parts of Colla Corii Asini, 4 parts of Colla Plastri Testudiniss, 20 parts of Mel.

Embodiment 4：A kind of Kidney-supplementing gravidity assisting cream side

Prescription：10 parts of Herba Epimedii, 8 parts of Semen Cuscutae, 6 parts of Radix Morindae Officinaliss, 8 parts of Placenta Hominiss, 10 parts of Herba Cistanches, 10 parts of Radix Rehmanniae Preparata, river Disconnected 4 parts, 8 parts of Radix Bupleuri, 4 parts of Radix Angelicae Sinensis, 4 parts of the Radix Paeoniae Alba, 8 parts of Semen Astragali Complanati, 12 parts of Cornu Cervi Degelatinatum, 12 parts of Fructus Lycii, 8 parts of Fructus Ligustri Lucidi, SHENGHUANG 20 parts of stilbene, 8 parts of Radix Codonopsis, 12 parts of Poria, 12 parts of Rhizoma Dioscoreae, 4 parts of Rhizoma Cyperi, 8 parts of Herba Leonuri, 4 parts of Radix Salviae Miltiorrhizae, 2 parts of Semen Persicae, 4 parts of Caulis Spatholobi, 2 parts of Rhizoma Et Radix Notopterygii, 4 parts of Squama Maniss, 8 parts of Colla Corii Asini, 8 parts of Colla Plastri Testudiniss, 40 parts of Mel.

Embodiment 5：A kind of Kidney-supplementing gravidity assisting cream side

Prescription：2 parts of Herba Epimedii, 2 parts of Semen Cuscutae, 2 parts of Radix Morindae Officinaliss, 2 parts of Placenta Hominiss, 2 parts of Herba Cistanches, 3 parts of Radix Rehmanniae Preparata, Radix Dipsaci 1 Part, 2 parts of Radix Bupleuri, 2 parts of Radix Angelicae Sinensis, 2 parts of the Radix Paeoniae Alba, 1 part of Semen Astragali Complanati, 4 parts of Cornu Cervi Degelatinatum, 4 parts of Fructus Lycii, 2 parts of Fructus Ligustri Lucidi, 8 parts of Radix Astragali, 4 parts of Radix Codonopsis, 4 parts of Poria, 8 parts of Rhizoma Dioscoreae, 2 parts of Rhizoma Cyperi, 2 parts of Herba Leonuri, 2 parts of Radix Salviae Miltiorrhizae, 1 part of Semen Persicae, 2 parts of Caulis Spatholobi, 1 part of Rhizoma Et Radix Notopterygii, 2 parts of Squama Maniss, 4 parts of Colla Corii Asini, 4 parts of Colla Plastri Testudiniss, 20 parts of Mel.

Embodiment 6：A kind of Kidney-supplementing gravidity assisting cream side

Prescription：12 parts of Herba Epimedii, 12 parts of Semen Cuscutae, 10 parts of Radix Morindae Officinaliss, 10 parts of Placenta Hominiss, 15 parts of Herba Cistanches, 15 parts of Radix Rehmanniae Preparata, 6 parts of Radix Dipsaci, 12 parts of Radix Bupleuri, 8 parts of Radix Angelicae Sinensis, 6 parts of the Radix Paeoniae Alba, 10 parts of Semen Astragali Complanati, 20 parts of Cornu Cervi Degelatinatum, 16 parts of Fructus Lycii, 10 parts of Fructus Ligustri Lucidi, 30 parts of Radix Astragali, 12 parts of Radix Codonopsis, 16 parts of Poria, 20 parts of Rhizoma Dioscoreae, 8 parts of Rhizoma Cyperi, 12 parts of Herba Leonuri, 6 parts of Radix Salviae Miltiorrhizae, 6 parts of Semen Persicae, Sanguis Gallus domesticus 6 parts of rattan, 4 parts of Rhizoma Et Radix Notopterygii, 8 parts of Squama Maniss, 12 parts of Colla Corii Asini, 14 parts of Colla Plastri Testudiniss, 60 parts of Mel.

Embodiment 7：A kind of Kidney-supplementing gravidity assisting cream side

The formula of the present embodiment is same as Example 5, and difference is preparation method.

1) medicine is soaked：By Herba Epimedii, Semen Cuscutae, Radix Morindae Officinaliss, Placenta Hominiss, Herba Cistanches, Radix Rehmanniae Preparata, Radix Dipsaci, Radix Bupleuri, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Semen Astragali Complanati, Cornu Cervi Degelatinatum, Fructus Lycii, Fructus Ligustri Lucidi, Radix Astragali, Radix Codonopsis, Poria, Rhizoma Dioscoreae, Rhizoma Cyperi, Herba Leonuri, Radix Salviae Miltiorrhizae, Semen Persicae, Sanguis Gallus domesticus Rattan and Rhizoma Et Radix Notopterygii are soaked, and add the water of 8 times of amounts, soak 1 hour；

2) extract：Using pressurization decocting method, by step 1) in immersion medical material decoct twice, decoctions pressure be 1kg, It is 100 DEG C to decoct temperature, and decocting time is each 50min, the medicinal liquid that decoction squeezing twice is taken out is placed into cooling and is precipitated, precipitation After take supernatant and cross 80 eye mesh screens to obtain filtrate standby；

3) Squama Maniss are decocted：Using pressurization decocting method, by Squama Maniss add 8 times amount decoctings boil twice, decoct pressure Power is 1kg, and it is 100 DEG C to decoct temperature, and decocting time is each 50min, and the medicinal liquid that decoction squeezing twice is taken out is placed into cooling Precipitation, takes supernatant and crosses 120 eye mesh screens to obtain Squama Maniss filtrate standby after precipitation；

4) concentrate：Step 2) filtrate that obtains, with vapour pressure heated and boiled, drags in operating pressure 0.2Mpa, 115 DEG C of temperature Go surface offscum and constantly stir medicinal liquid, while by step 3) the Squama Maniss filtrate that obtains is blended into, and concentration of liquid medicine forms paste Clear paste, now with rod take concentration drop in dry kraft paper, to drip cream indiffusion, become pearl for degree；

5) cream is received：In step 4) concentration clear paste in add Mel, Colla Corii Asini and Colla Plastri Testudiniss while hot, in operating pressure 118 DEG C of 0.2Mpa, temperature, is stirred continuously receipts cream, obtains the Kidney-supplementing gravidity assisting cream side that relative density is 1.30；

6) subpackage and cool cream：Clean rank is selected to be 100,000 grades, temperature<20 DEG C of toilets, by step 5) soft extract that obtains Hot subpackage is taken advantage of, room temperature 24 hours after subpackage are placed in refrigerator-freezer after lid cover seal and stored, up to 3 months standing time.

Embodiment 8：A kind of Kidney-supplementing gravidity assisting cream side

The formula of the present embodiment is same as Example 6, and difference is preparation method.

1) medicine is soaked：By Herba Epimedii, Semen Cuscutae, Radix Morindae Officinaliss, Placenta Hominiss, Herba Cistanches, Radix Rehmanniae Preparata, Radix Dipsaci, Radix Bupleuri, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Semen Astragali Complanati, Cornu Cervi Degelatinatum, Fructus Lycii, Fructus Ligustri Lucidi, Radix Astragali, Radix Codonopsis, Poria, Rhizoma Dioscoreae, Rhizoma Cyperi, Herba Leonuri, Radix Salviae Miltiorrhizae, Semen Persicae, Sanguis Gallus domesticus Rattan and Rhizoma Et Radix Notopterygii are soaked, and add the water of 10 times of amounts, soak 3 hours；

2) extract：Using pressurization decocting method, by step 1) in immersion medical material decoct twice, decoct pressure be 1.5kg, it is 150 DEG C to decoct temperature, and decocting time is each 80min, the medicinal liquid that decoction squeezing twice is taken out is placed into cooling and is sunk Form sediment, supernatant is taken after precipitation and is crossed 100 eye mesh screens to obtain filtrate standby；

3) Squama Maniss are decocted：Using pressurization decocting method, by Squama Maniss add 10 times amount decoctings boil twice, decoct pressure Power is 1.5kg, and it is 150 DEG C to decoct temperature, and decocting time is each 80min, and the medicinal liquid that decoction squeezing twice is taken out is placed into cold But precipitate, supernatant is taken after precipitation and is crossed 180 eye mesh screens to obtain Squama Maniss filtrate standby；

4) concentrate：Step 2) filtrate that obtains, with vapour pressure heated and boiled, drags in operating pressure 0.3Mpa, 124 DEG C of temperature Go surface offscum and constantly stir medicinal liquid, while by step 3) the Squama Maniss filtrate that obtains is blended into, and concentration of liquid medicine forms paste Clear paste, now with rod take concentration drop in dry kraft paper, to drip cream indiffusion, become pearl for degree；

5) cream is received：In step 4) concentration clear paste in add Mel, Colla Corii Asini and Colla Plastri Testudiniss while hot, in operating pressure 125 DEG C of 0.35Mpa, temperature, is stirred continuously receipts cream, obtains the Kidney-supplementing gravidity assisting cream side that relative density is 1.30；

Clinical drug experimental example of the present invention

First, data and method

1st, all cases in case source are all from January, 2014 in January, 2016 People's Hospital, Shiyan City of Hubei Province traditional Chinese medical science Section, gynecological and Reproductive Medicine Center outpatient service, totally 210.Its randomized, double-blind is divided into into 7 groups, embodiment 1 group 30,2 groups of embodiment 30, embodiment 3 group 30, embodiment 4 group 30, embodiment 5 group 30, embodiment 6 group 30, clomiphene group 30.

2nd, diagnostic criteria

With reference to national higher medical institution teaching material《Obstetrics and gynecology》、《New Chinese medicine guideline of clinical investigations》In《Chinese medicine The infertile guideline of clinical investigations for the treatment of》Infertile diagnostic criteria caused by anovulation, so as to formulate Western medicine diagnostic criteria.

1) Western medicine diagnostic criteria：

1. woman matrimonial cohabitation more than 1 year after marriage, sexual life is normal, and bridegroom's or husband's side reproductive function is normal, does not practise contraception and does not become pregnant： Or once gestation is not then practised contraception continuous 1 year infertile person, referred to as infertility.

2. basal body temperature continuously records single-phase more than 3 months

9. vaginal exfoliated cell smear checks aperiodicity change

4. cervical mucus crystalization inspection occurs without ellipsoid

5. the moon premenstrual endometrium inspection in 6 days changes without the typical secretory phase

6. serial B ultrasonic monitors anovulation sign

7. blood, urine progesterone level are less than luteal phase

Possess in the above 7 1. and 2.～7. in any 2, ovulation failure infertility can be diagnosed.

3rd, case standard is included

3.1st, Western medicine diagnostic criteria is met

3.2nd, the age is in 21-35 year married femle

3.3rd, systematic observation can on request be received

4th, Excluded cases standard

4.1st, primary disease diagnostic criteria is not met；

4.2nd, bridegroom's or husband's side factor is barrenness caused；

4.3rd, the Hypergonadotropic amenorrhea such as insensitive syndrome of premature ovarian failure, ovary；

4.4th, ovary infringement caused by operation or inflammation, other endocrine functions caused by abnormal person such as thyroid, adrenal gland；

4.5th, the infertility caused by other organic diseases；

4.6th, it is associated with the serious condition person such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system；

4.7th, cannot partner, be such as associated with nerve, mental disease, or be reluctant partner；

4.8th, not by regulation medication, it is impossible to judge the not congruent judgement person that affects the treatment of curative effect or data.

5th, Therapeutic Method and the course for the treatment of

5.1st, to be practiced a 1-6 and preparation technology respectively made by Pharmacy department of People's Hospital, Shiyan City for embodiment 1-6 group The cream side being made, can take after clean period, and B ultrasonic monitoring has been ovulated or LUFS or next menstruations extremely can be disabled, and 2 times a day, Each 10ml, warm water is taken after mixing with liquid.Clomiphene group：Start to take clomiphene within the 5th day from menstrual onset the 5th day or withdrawal bleeding 50mg, one time a day, serve on 5 days.

5.2 courses for the treatment of enter group patient with continuously 3 menstrual cycle for the treatment of as a course for the treatment of.

6th, observation index

6.1 examination of basal body temperature (BBT)：By WHO standard judgment curves

BBT measuring methods and time：Clinical thermometer mercury column is waved to degrees Celsius less than 35 degrees Celsius before advising patient to sleep daily, It is put in the at arm's length place of the head of a bed, measures body temperature (placing 5 minutes in Sublingual) after waking up every morning at once, avoids getting up before measurement, greatly Amplitude is stood up, talks, taking food and the activity such as defecation.Body temperature is marked on basal body temperature form, and in thermometer after measurement On record other special circumstances (such as catch a cold, drink, travelling or night shift).If when per set time in morning or so measurement body temperature Most preferably；Optimal Nighttime sleep reaches 6-8 hours；Such as participate in day night shift or class Three person to determine after sleeping six hours.

6.2nd, follicular development monitoring method and time

Lithotomy position is taken after patient's emptying wing moon bright, with condom transvaginal probe is covered, in set sterilization coupling agent is coated with, visited Head is placed in vagina palintrope Long Chu.Patient uterine, bilateral ovaries are detected, record follicle growth situation is (such as：Whether there is follicular development, send out Follicle quantity is educated, dominant follicle is whether there is and is formed), the quantity of dominant follicle, size and form, endometrium thickness.B ultrasonic monitor in Menstrual cycle the starts for 8-10 days, and each B ultrasonic detects follicular development within 1-2 days, and as follicle maximum gauge 14mm daily one is changed to It is secondary, until ovulation or there is sign.

6.3rd, the change of hormonal readiness before and after seven groups of patient's treatments is observed：

The measure of hormonal readiness：It is high in menstrual cycle the 21st day～22 days or BBT before seven groups of patients treatment and after treatment The the 6th or 7 day (the empty stomach morning 9 of phase：00-10：00), amenorrhea person is in medical (the empty stomach morning 09 on the same day：-10：00) elbow is extracted respectively Venous blood, determines E2, P.

7th, the standard of curative effect evaluation according to《New Chinese medicine guideline of clinical investigations is drafted》：

7.1st, fully recover：Menstrual cycle recovers normal after treatment, and B ultrasonic monitoring has mature follicle and has ovulation or gestation.

7.2nd, it is effective：After treatment menstrual cycle it is normal (<40 days), B ultrasonic monitoring has mature follicle and has ovulation, BBT Occur one or more two-phases in 3 menstrual cycle or the two-phase that is not true to type occur 3 middle of the month.

7.3 effectively：Menstruation makes moderate progress after treatment, rises in 3 months once, the maximum follicular diameter of B ultrasonic monitoring compared with Increase more than 5mm or B ultrasonic monitoring discovery before treatment has follicular development.

7.4th, it is invalid：Menstrual cycle is without improvement after treatment, B ultrasonic monitoring have no follicular development phenomenon or maximum follicular diameter compared with Increase before treatment<5mm, BBT are single-phase.

8th, statistical analysis

Counted using statistic software SPSS 19.0.Measurement data withRepresent, mean compares to be checked using t, Enumeration data is expressed as a percentage, using x²Inspection, ranked data are using rank test and Rank correlation.

2nd, result

1st, physical data analytical table 1- tables 3 to show and carry out analysis of comparable to the enrolled physical data of seven groups of cases before treatment, Seven groups of cases are in the not statistically significant (P of aspect comparing difference such as age, the infertility course of disease, infertility type>0.05), have Comparability.

1 seven groups of case ages of table compare

2 seven groups of infertility courses of disease of table compare

3 seven groups of infertile types of table compare (example)

2nd, total effectses compare after seven groups of treatments

Jing after treatment, the total effective rate of embodiment 1-6 group is respectively 90%, 93.33%, 83.33%, 80%, 73.33%th, 76.67%, clomiphene group total effective rate 76.67%.Prompting：Embodiment group is evident in efficacy, wherein embodiment 1-4 Group total effective rate is above clomiphene group, and 2 groups of curative effects of embodiment are optimum.

Total effective rate compares after 4 seven groups of treatments of table

3rd, after seven groups of treatments ovulation rate comparison

Ovulation rate compares after seven groups of treatments, the ovulation rate of embodiment 1-6 group is respectively 77.11%, 80.48%, 75.00%th, 69.04%, 59.52%, 65.06%, clomiphene group ovulation rate 60.46%.Prompting：Embodiment 1-4 group is ovulated Rate is apparently higher than clomiphene group, and 2 groups of effects of embodiment are more notable.

The comparison of ovulation rate after 5 seven groups of treatments of table

Group	Treatment cycle	Ovulation number of times	Do not ovulate number of times	Ovulation rate (%)
					1 group of embodiment	83	64	19	77.11%
2 groups of embodiment	82	66	16	80.48%
					3 groups of embodiment	84	63	21	75.00%
4 groups of embodiment	84	58	26	69.04%
					5 groups of embodiment	84	50	34	59.52%
6 groups of embodiment	83	54	29	65.06%
					Clomiphene group	86	52	34	60.46%

3rd, there is two-phase rate and compares in BBT after seven groups of treatments

BBT two-phase rates compare after seven groups of treatments, Jing after statistics the BBT two-phase rates of embodiment 1-6 group be respectively 77.11%, 80.48%th, 75.00%, 69.04%, 59.52%, 65.06%, clomiphene group BBT two-phase rate 60.46%.Prompting：Implement Example 1-4 group BBT two-phase rates are apparently higher than clomiphene group, and 2 groups of effects of embodiment are more notable.

The comparison of BBT two-phase rates after 6 seven groups of treatments of table

Group	Treatment cycle	Two-phase	It is single-phase	Two-phase rate (%)
					1 group of embodiment	83	64	19	77.11%
2 groups of embodiment	82	66	16	80.48%
					3 groups of embodiment	84	63	21	75.00%
4 groups of embodiment	84	58	26	69.04%
					5 groups of embodiment	84	50	34	59.52%
6 groups of embodiment	83	54	29	65.06%
					Clomiphene group	86	52	34	60.46%

5th, before and after seven groups of treatments hormone comparison

E2, P value of patient there was no significant difference (P before seven groups of treatments>0.05), with comparability；After treatment, each embodiment Group E2, P value has significant difference (P with comparing before treatment<0.05)；Clomiphene group E2, P value has statistics with comparing before treatment Difference (P<0.05).E2, P value of patient has significant difference (P after seven groups of treatments<0.05).Before the treatment of embodiment 1-4 group E2, P Afterwards obvious better than clomiphene group, 2 groups of embodiment is more notable.

The comparison of hormone before and after 7 seven groups of treatments of table

6th, after seven groups of treatments pregnancy rate comparison

The comparison of seven groups of pregnancy rate after 3 months course of therapy, the pregnancy rate of embodiment 1-6 group is respectively 60%, 73.33%th, 53.33%, 50%, 36.67%, 40%, clomiphene group pregnancy rate 40%.Prompting：Embodiment 1-4 group pregnancy rate Apparently higher than clomiphene group, 2 groups of effects of embodiment are more notable.

The comparison of pregnancy rate after 8 seven groups of treatments of table

Group	Number of cases	Gestation	It is not pregnant	Pregnancy rate (%)
					1 group of embodiment	30	18	12	60%
2 groups of embodiment	30	22	8	73.33%
					3 groups of embodiment	30	16	14	53.33%
4 groups of embodiment	30	15	15	50%
					5 groups of embodiment	30	11	19	36.67%
6 groups of embodiment	30	12	18	40%
					Clomiphene group	30	12	18	40%

3rd, conclusion

In this clinical research, seven groups of physical data point not statistically significant (P of comparing difference>0.05), with comparability. Jing after treatment, embodiment group total effective rate is respectively 90%, 93.33%, 83.33%, 80%, 76.67%, 73.33%, Crow The fragrant group total effective rate 76.67% of rice.Prompting：Embodiment group is evident in efficacy, and embodiment 1-4 group total effective rate is above clomiphene Group, 2 groups of curative effects of embodiment are optimum.Embodiment group ovulation rate is respectively 77.11%, 80.48%, 75.00%, 69.04%, 59.52%th, 65.06%, clomiphene group ovulation rate 60.46%.Prompting：Embodiment 1-4 group ovulation rate is apparently higher than chromium Fragrant group, 2 groups of effects of embodiment are more notable.Embodiment group BBT two-phase rate is respectively 77.11%, 80.48%, 75.00%, 69.04%th, 59.52%, 65.06%, clomiphene group BBT two-phase rate 60.46%.Prompting：Embodiment 1-4 group BBT two-phase rate Apparently higher than clomiphene group, 2 groups of effects of embodiment are more notable.After treatment, each embodiment group E2, P value has with comparing before treatment Significant difference (P<0.05)；Clomiphene group E2, P value has significant difference (P with comparing before treatment<0.05).Embodiment 1-4 Obvious better than clomiphene group before and after group E2, P treatment, 2 groups of embodiment is more notable.Embodiment group pregnancy rate is respectively 60%th, 73.33%, 53.33%, 50%, 36.67%, 40%, clomiphene group pregnancy rate 40%.Prompting：Embodiment 1-4 group Pregnancy rate is apparently higher than clomiphene group, and 2 groups of effects of embodiment are more notable.

In sum, the cream in the present invention can improve sex hormone level and BBT biphasic or bipolar types, improve ovulation rate and gestation Rate, embodiment 1-4 group total effective rate is apparently higher than clomiphene group, and 2 groups of embodiment is more notable, it can be seen that, the cream side is The active drug for the treatment of ovulation failure infertility.

Claims

1. a kind of Kidney-supplementing gravidity assisting cream side, raw material includes the following each component of weight portion：Herba Epimedii 2-12 parts, Semen Cuscutae 2-12 Part, Radix Morindae Officinaliss 2-10 parts, Placenta Hominiss 2-10 parts, Herba Cistanches 2-15 parts, Radix Rehmanniae Preparata 3-15 parts, Radix Dipsaci 1-6 parts, Radix Bupleuri 2-12 parts, when Return 2-8 parts, Radix Paeoniae Alba 2-6 parts, Semen Astragali Complanati 1-10 parts, Cornu Cervi Degelatinatum 4-20 parts, Fructus Lycii 4-16 parts, Fructus Ligustri Lucidi 2-10 parts, Radix Astragali 8-30 parts, Radix Codonopsis 4-12 parts, Poria 4-16 parts, Rhizoma Dioscoreae 8-20 parts, Rhizoma Cyperi 2-8 parts, Herba Leonuri 2-12 parts, Radix Salviae Miltiorrhizae 2-6 parts, Semen Persicae 1-6 parts, Caulis Spatholobi 2-6 parts, Rhizoma Et Radix Notopterygii 1-4 parts, Squama Maniss 2-8 parts, Colla Corii Asini 4-12 parts, Colla Plastri Testudiniss 4-14 parts, Mel 20-60 parts.

2. Kidney-supplementing gravidity assisting cream side according to claim 1, it is characterised in that：Raw material includes the following each group of weight portion Point：Herba Epimedii 4-10 parts, Semen Cuscutae 4-8 parts, Radix Morindae Officinaliss 2-6 parts, Placenta Hominiss 4-8 parts, Herba Cistanches 4-10 parts, Radix Rehmanniae Preparata 4-10 parts, Radix Dipsaci 2-4 parts, Radix Bupleuri 2-8 parts, Radix Angelicae Sinensis 2-4 parts, Radix Paeoniae Alba 2-4 parts, Semen Astragali Complanati 2-8 parts, Cornu Cervi Degelatinatum 4-12 parts, Fructus Lycii 4-12 Part, Fructus Ligustri Lucidi 4-8 parts, Radix Astragali 8-20 parts, Radix Codonopsis 4-8 parts, Poria 4-12 parts, Rhizoma Dioscoreae 8-12 parts, Rhizoma Cyperi 2-4 parts, Herba Leonuri 2-8 parts, Radix Salviae Miltiorrhizae 2-4 parts, Semen Persicae 1-2 parts, Caulis Spatholobi 2-4 parts, Rhizoma Et Radix Notopterygii 1-2 parts, Squama Maniss 2-4 parts, Colla Corii Asini 4-8 parts, Colla Plastri Testudiniss 4-8 parts, Mel 20-40 parts.

3. Kidney-supplementing gravidity assisting cream side according to claim 2, it is characterised in that：Raw material includes the following each group of weight portion Point：

4 parts of Herba Epimedii, 6 parts of Semen Cuscutae, 4 parts of Radix Morindae Officinaliss, 4 parts of Placenta Hominiss, 6 parts of Herba Cistanches, 8 parts of Radix Rehmanniae Preparata, 2 parts of Radix Dipsaci, Radix Bupleuri 4 Part, 2 parts of Radix Angelicae Sinensis, 2 parts of the Radix Paeoniae Alba, 4 parts of Semen Astragali Complanati, 6 parts of Cornu Cervi Degelatinatum, 6 parts of Fructus Lycii, 6 parts of Fructus Ligustri Lucidi, 12 parts of Radix Astragali, Radix Codonopsis 6 Part, 6 parts of Poria, 8 parts of Rhizoma Dioscoreae, 2 parts of Rhizoma Cyperi, 4 parts of Herba Leonuri, 2 parts of Radix Salviae Miltiorrhizae, 1 part of Semen Persicae, 2 parts of Caulis Spatholobi, 1 part of Rhizoma Et Radix Notopterygii, Squama Maniss 2 parts, 6 parts of Colla Corii Asini, 4 parts of Colla Plastri Testudiniss, 30 parts of Mel.

4. Kidney-supplementing gravidity assisting cream side according to claim 2, it is characterised in that：Raw material includes the following each group of weight portion Point：6 parts of Herba Epimedii, 8 parts of Semen Cuscutae, 6 parts of Radix Morindae Officinaliss, 4 parts of Placenta Hominiss, 4 parts of Herba Cistanches, 6 parts of Radix Rehmanniae Preparata, 4 parts of Radix Dipsaci, 4 parts of Radix Bupleuri, 4 parts of Radix Angelicae Sinensis, 4 parts of the Radix Paeoniae Alba, 4 parts of Semen Astragali Complanati, 6 parts of Cornu Cervi Degelatinatum, 4 parts of Fructus Lycii, 4 parts of Fructus Ligustri Lucidi, 8 parts of Radix Astragali, 6 parts of Radix Codonopsis, Fu 6 parts of Siberian cocklebur, 10 parts of Rhizoma Dioscoreae, 2 parts of Rhizoma Cyperi, 8 parts of Herba Leonuri, 4 parts of Radix Salviae Miltiorrhizae, 2 parts of Semen Persicae, 4 parts of Caulis Spatholobi, 2 parts of Rhizoma Et Radix Notopterygii, 4 parts of Squama Maniss, 4 parts of Colla Corii Asini, 6 parts of Colla Plastri Testudiniss, 30 parts of Mel.

5. the preparation method of Kidney-supplementing gravidity assisting cream side according to any one of claim 1 to 4, including following step Suddenly：

1）Leaching medicine：By Herba Epimedii, Semen Cuscutae, Radix Morindae Officinaliss, Placenta Hominiss, Herba Cistanches, Radix Rehmanniae Preparata, Radix Dipsaci, Radix Bupleuri, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Sha Yuan Son, Cornu Cervi Degelatinatum, Fructus Lycii, Fructus Ligustri Lucidi, Radix Astragali, Radix Codonopsis, Poria, Rhizoma Dioscoreae, Rhizoma Cyperi, Herba Leonuri, Radix Salviae Miltiorrhizae, Semen Persicae, Caulis Spatholobi and Rhizoma Et Radix Notopterygii is soaked, and adds the 8-10 times of water measured, and soaks 1-3 hours；

2）Extract：Using pressurization decocting method, by step 1）The medical material of middle immersion is decocted twice, and decoction pressure is 1-1.5kg, is decocted Temperature is boiled for 100-150 DEG C, decocting time is each 50-80min, the medicinal liquid that squeezing taking-up is decocted twice is placed into cooling heavy Form sediment, supernatant is taken after precipitation and is crossed 80-100 eye mesh screens to obtain filtrate standby；

3）Squama Maniss are decocted：Using pressurization decocting method, the 8-10 times of decocting measured is added to boil twice Squama Maniss, decocting pressure is 1-1.5kg, it is 100-150 DEG C to decoct temperature, and decocting time is each 50-80min, and the medicinal liquid that decoction squeezing twice is taken out is put Cooling precipitation is put, supernatant is taken after precipitation and is crossed 120-180 eye mesh screens to obtain Squama Maniss filtrate standby；

4）Concentration：Step 2）The filtrate for obtaining is boiled in operating pressure 0.2-0.3Mpa, temperature 115-124 DEG C with vapour pressure heating Boiling, drags for surface offscum and constantly stirs medicinal liquid, while by step 3）The Squama Maniss filtrate for obtaining is blended into, and concentration of liquid medicine forms thick The clear paste of paste, now takes concentration drop in dry kraft paper, to drip cream indiffusion, becomes pearl for degree；

5）Receive cream：In step 4）Mel, Colla Corii Asini and Colla Plastri Testudiniss are added in the clear paste of concentration while hot, in operating pressure 0.2- 0.35Mpa, temperature 118-125 DEG C, are stirred continuously receipts cream, obtain the Kidney-supplementing gravidity assisting cream side that relative density is 1.3-1.40.

6. the preparation method of Kidney-supplementing gravidity assisting cream side according to claim 5, it is characterised in that：Step 1）It is middle to add 9 times The water of amount, soaks 2 hours.

7. the preparation method of Kidney-supplementing gravidity assisting cream side according to claim 5, it is characterised in that：Step 2）Decocting pressure is 1.2kg, it is 120 DEG C to decoct temperature, and decocting time is each 60min.

8. the preparation method of Kidney-supplementing gravidity assisting cream side according to claim 5, it is characterised in that：Step 3）Decocting pressure is 1.2kg, it is 120 DEG C to decoct temperature, and decocting time is each 60min.

9. the preparation method of Kidney-supplementing gravidity assisting cream side according to claim 5, it is characterised in that：Step 4）Operating pressure 120 DEG C of 0.3Mpa, temperature.

10. the preparation method of Kidney-supplementing gravidity assisting cream side according to claim 5, it is characterised in that：Step 5）Operating pressure 125 DEG C of 0.3Mpa, temperature.