CN105311223A - Pharmaceutical composition for treating climacteric syndrome and preparation method thereof - Google Patents

Abstract

The invention belongs to the field of traditional Chinese medicines and relates to a pharmaceutical composition for treating climacteric syndrome and a preparation method thereof. The pharmaceutical composition is prepared from the following raw materials in parts by weight: 8-20 parts of ginkgo leaf, 6-15 parts of motherwort, 6-15 parts of angelica, 5-12 parts of prepared rehmannia root, 5-12 parts of radix adenophorae, 5-12 parts of oyster, 5-12 parts of jujubes, 3-12 parts of hawthorn, 3-12 parts of schisandra, 3-12 parts of ginseng, 3-6 parts of lonicerae flos and 1-10 parts of licorice. The pharmaceutical composition has the effects of invigorating qi and promoting blood circulation, regulating menstruation and alleviating pain, nourishing yin and moistening the lung, clearing the heart and soothing the nerves, strengthening the spleen and tonifying the kidneys as well as improving the physique, and has the advantages of good curative effect, low side effect and convenience in taking when being used for treating female climacteric syndrome.

Description

A kind of pharmaceutical composition for the treatment of climacteric syndrome and preparation method thereof

Technical field

The invention belongs to the field of Chinese medicines, particularly relate to a kind of pharmaceutical composition for the treatment of climacteric syndrome and preparation method thereof.

Background technology

Female climacteric syndrome is that women's ovarian function fails to the transition period disappeared completely gradually, due to a series of clinical symptoms that physiology and psychology change and occurs, commonly warms sweating, irritable, palpitation and insomnia or melancholy forgetful etc.According to clinical manifestation, primary disease belongs to the category of " menopausal syndrome " of Chinese medicine.Primary disease be that women is before and after menopause, kidney qi is exhaustion gradually, virtual loss is appointed in punching, asthenia of essence and blood, menses is gradually exhausted, the menstruation physiological change that the menopause that arrives occurs by breaking, but some women is due to the impact of body constitution or Nervous and Mental Factors and other factors, for the moment can not adapt to these physiological changies, make negative and positive disequilibrium, internal organs QI and blood functional disorder and the syndrome of a series of function disorders that occurs.

Symptoms: 1, menoxenia: be climacteric women the most generally, the most outstanding performance.Menstruation often postpones, and even some months is just risen once, also reduces gradually through amount.When estrogen is fewer and feweri, when endometrium can not have been caused to change, menstruation just stopped, and is called menopause.2, battle array hot flush: be climacteric one of principal character, some women is because estrogenic level declines within climacteric, and in blood, calcium level also declines to some extent, has a burst of position and generates heat, blushes, perspires, with dizzy, nervous, the persistent period be one or two minute or 12 minutes-15 minutes not etc.3, cardiovascular and lipoidosis: coronary heart disease, diabetes may be occurred.4, neural, mental disorder: the women had, blood pressure fluctuates comparatively obvious up and down, and instability of may being in a bad mood is emotional, personality change, hypomnesis, whole body discomfort etc.5, motor system is degenerated: occur waist, back of the body limbs pain, scapulohumeral periarthritis, cervical spondylosis appear in some women.

Chinese patent application 201210326875.1 discloses a kind of Chinese medicine for the treatment of female dimacteric syndrome, this Chinese medicine composition is prepared from by the raw material of following weight: each 13-17 gram of the Radix Rehmanniae, the Rhizoma Atractylodis Macrocephalae, Fructus Lycii, Fructus Ligustri Lucidi, Fructus Corni, each 10-14 gram of the Radix Paeoniae Alba, Cortex Moutan, Poria, each 8-12 gram of Rhizoma Alismatis, Radix Salviae Miltiorrhizae 13-17 gram, Fructus Tritici Levis 13-17 gram, Pericarpium Citri Reticulatae 8-12 gram, this Chinese medicine has certain curative effect to alleviation climacteric syndrome, but this Chinese medicine composition curative effect in inrigorating qi and promoting blood circulation, supplementing QI for promoting the production of body fluid, clearing away heat and nourishing YIN is not remarkable.

Summary of the invention

The technical problem to be solved in the present invention is to provide a kind of pharmaceutical composition for the treatment of climacteric syndrome, this pharmaceutical composition has inrigorating qi and promoting blood circulation, menstruction regulating and pain relieving, nourishing YIN and moistening the lung, clearing away heart-fire for tranquillization, tonifying speen and tonifying kidney and improve effect of body constitution, also there is good effect, the advantages such as the low and taking convenience of side effect.In addition, the present invention also provides corresponding manufacturing process to be made and facilitate easy-to-use preparation under the prerequisite ensureing curative effect by this pharmaceutical composition.

Pharmaceutical composition of the present invention is made up of the raw materials of following parts by weight: Folium Ginkgo 8-20 part, Herba Leonuri 6-15 part, Radix Angelicae Sinensis 6-15 part, Radix Rehmanniae Preparata 5-12 part, Radix Adenophorae (Radix Glehniae) 5-12 part, Concha Ostreae 5-12 part, Fructus Jujubae 5-12 part, Fructus Crataegi 3-12 part, Fructus Schisandrae Chinensis 3-12 part, Radix Ginseng 3-12 part, Flos Lonicerae 3-6 part and Radix Glycyrrhizae 1-10 part.

Preferably, described pharmaceutical composition is made up of the raw materials of following parts by weight: Folium Ginkgo 8 parts, Herba Leonuri 6 parts, Radix Angelicae Sinensis 6 parts, Radix Rehmanniae Preparata 5 parts, Radix Adenophorae (Radix Glehniae) 5 parts, Concha Ostreae 5 parts, 5 parts, Fructus Jujubae, Fructus Crataegi 3 parts, Fructus Schisandrae Chinensis 3 parts, Radix Ginseng 3 parts, Flos Lonicerae 3 parts and 1 part, Radix Glycyrrhizae.

Preferably, described pharmaceutical composition is made up of the raw materials of following parts by weight: Folium Ginkgo 20 parts, Herba Leonuri 15 parts, Radix Angelicae Sinensis 15 parts, Radix Rehmanniae Preparata 12 parts, Radix Adenophorae (Radix Glehniae) 12 parts, Concha Ostreae 12 parts, 12 parts, Fructus Jujubae, Fructus Crataegi 12 parts, Fructus Schisandrae Chinensis 12 parts, Radix Ginseng 12 parts, Flos Lonicerae 6 parts and 10 parts, Radix Glycyrrhizae.

Preferably, described pharmaceutical composition is made up of the raw materials of following parts by weight: Folium Ginkgo 14 parts, Herba Leonuri 10 parts, Radix Angelicae Sinensis 10 parts, Radix Rehmanniae Preparata 8 parts, Radix Adenophorae (Radix Glehniae) 8 parts, Concha Ostreae 8 parts, 8 parts, Fructus Jujubae, Fructus Crataegi 6 parts, Fructus Schisandrae Chinensis 6 parts, Radix Ginseng 6 parts, Flos Lonicerae 4 parts and 5 parts, Radix Glycyrrhizae.

Preferably, described pharmaceutical composition is made into capsule, tablet, powder or granule.

Preferably, described pharmaceutical composition is obtained by following steps:

S1: take Folium Ginkgo 8-20 part, Herba Leonuri 6-15 part, Radix Angelicae Sinensis 6-15 part, Radix Rehmanniae Preparata 5-12 part, Radix Adenophorae (Radix Glehniae) 5-12 part, Concha Ostreae 5-12 part, Fructus Jujubae 5-12 part, Fructus Crataegi 3-12 part, Fructus Schisandrae Chinensis 3-12 part, Radix Ginseng 3-12 part, Flos Lonicerae 3-6 part and Radix Glycyrrhizae 1-10 part, mixing is ground into coarse powder, for subsequent use;

S2: the purified water adding above-mentioned coarse powder total amount 6-12 times amount, soaks 12-24 hour, decocts 2-6 hour, filters and retains residue; Add the purified water of described residue total amount 3-8 times amount, decoct 2-4 hour, filter and retain filtering residue, merging filtrate, being concentrated into 55 DEG C of-60 DEG C of relative densities is that the concentrated solution of 1.10-1.25 is for subsequent use;

S3: the volume parts filtering residue in S2 being added described filtering residue total amount 3-8 times amount is the ethanol of 65-80%, reflux, extract, 2-3 time, each 3-8 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 55 DEG C of-60 DEG C of relative densities be that the concentrated solution of 1.10-1.25 is for subsequent use;

S4: merged by the concentrated solution of S2, S3 gained, continuing to be concentrated into 55 DEG C of-60 DEG C of relative densities is the Chinese medical concrete of 1.20-1.30, obtains pharmaceutical composition of the present invention.

Correspondingly, present invention also offers the preparation method of the pharmaceutical composition of described treatment climacteric syndrome, it comprises the steps:

S1: take Folium Ginkgo 8-20 part, Herba Leonuri 6-15 part, Radix Angelicae Sinensis 6-15 part, Radix Rehmanniae Preparata 5-12 part, Radix Adenophorae (Radix Glehniae) 5-12 part, Concha Ostreae 5-12 part, Fructus Jujubae 5-12 part, Fructus Crataegi 3-12 part, Fructus Schisandrae Chinensis 3-12 part, Radix Ginseng 3-12 part, Flos Lonicerae 3-6 part and Radix Glycyrrhizae 1-10 part, mixing is ground into coarse powder, for subsequent use;

S2: the purified water adding above-mentioned coarse powder total amount 6-12 times amount, soaks 12-24 hour, decocts 2-6 hour, filters and retains residue; Add the purified water of described residue total amount 3-8 times amount, decoct 2-4 hour, filter and retain filtering residue, merging filtrate, being concentrated into 55 DEG C of-60 DEG C of relative densities is that the concentrated solution of 1.10-1.25 is for subsequent use;

S3: the volume parts filtering residue in S2 being added described filtering residue total amount 3-8 times amount is the ethanol of 65-80%, reflux, extract, 2-3 time, each 3-8 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 55 DEG C of-60 DEG C of relative densities be that the concentrated solution of 1.10-1.25 is for subsequent use;

S4: merged by the concentrated solution of S2, S3 gained, continuing to be concentrated into 55 DEG C of-60 DEG C of relative densities is the Chinese medical concrete of 1.20-1.30, obtains pharmaceutical composition of the present invention.

Source, the nature and flavor of the present invention's component used, return through and effect:

Folium Ginkgo: this product is the dried leaves of Ginkgoaceae plant Ginkgo biloba; Property is put down; Sweet in the mouth, hardship, puckery; GUIXIN, lung meridian; Blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain, astringes the lung and relievings asthma, and changes turbid blood fat reducing.

Herba Leonuri: this product is the fresh of labiate Herba Leonuri or dry aerial parts; Its bitter in the mouth, pungent, cold nature; Return liver, pericardium channel; Promoting blood flow to regulate menstruation, inducing diuresis to remove edema.

Radix Angelicae Sinensis: this product is the dry root of umbelliferae angelica; Its sweet in the mouth, pungent, warm in nature; Return liver, the heart, spleen channel; Inrigorating qi and promoting blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.

Radix Rehmanniae Preparata: this product is the Preparation process product of Radix Rehmanniae; Its sweet in the mouth, slightly warm in nature; Return liver, kidney channel; Nourishing YIN and supplementing blood, beneficial essence fills out marrow.

Radix Adenophorae (Radix Glehniae): this product is campanulaceae Lady bell plant four leaf Radix Adenophorae (Radix Glehniae), Folium Pruni Radix Adenophorae (Radix Glehniae) or its congener dry root; Nature and flavor are sweet, cool; Clearing away heat and nourishing YIN, nourishing the lung to arrest cough.

Concha Ostreae: this product is the shell of the long Concha Ostreae of Ostreidae animal, Dalian Bay Concha Ostreae or Crassostrea rivularis; Salty in the mouth, cold nature; Return liver, gallbladder, kidney channel; Tranquillization with heavy prescription, YANG hyperactivity suppressing nourishing YIN, hard masses softening and resolving.

Fructus Jujubae: this product is the dry mature fruit of Rhamnaceae jujube Fructus Jujubae; Its sweet in the mouth, warm in nature; Return spleen, stomach warp; Invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.

Fructus Crataegi: this product is the dry mature fruit of rosaceous plant Fructus Pyri Pashiae or Fructus Crataegi; Nature and flavor are sour, sweet, tepor; Return spleen, stomach, Liver Channel; Promoting digestion and invigorating the stomach, circulation of qi promoting dissipating blood stasis.

Fructus Schisandrae Chinensis: this product is the dry mature fruit of magnoliaceae schisandra or schisandra chinensis; Its sour in the mouth, sweet, warm in nature; Return lung, the heart, kidney channel; Restrain astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.

Radix Ginseng: this product is the dry root of Araliaceae Radix Ginseng; Its sweet in the mouth, micro-hardship, property is put down; Return spleen, lung, heart channel; Strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung, promotes the production of body fluid, and calms the nerves.

Flos Lonicerae: the flower that this product is caprifoliaceae plant Radix Ophiopogonis, Flos Lonicerae, Flos Lonicerae (hair calyx Radix Ophiopogonis) or the dry flower of hair style Radix Ophiopogonis or band are just opened; Sweet in the mouth, cold in nature; Return lung, the heart, stomach warp; Heat-clearing and toxic substances removing, wind-heat dissipating.

Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L.; Its sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.

The prescription analysis of Chinese prescription of the present invention:

In side of the present invention with Folium Ginkgo and Herba Leonuri for monarch drug, dispersing cold for relieving pain, removing damp to relieve itching, dredge the meridian passage, promoting blood flow to regulate menstruation; With Radix Angelicae Sinensis, Radix Rehmanniae Preparata, Radix Adenophorae (Radix Glehniae), Concha Ostreae and Fructus Jujubae for ministerial drug, menstruction regulating and pain relieving, nourishing YIN and supplementing blood, beneficial essence fills out marrow, spleen reinforcing nourishing the stomach, and promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission, invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind; With Fructus Crataegi, Fructus Schisandrae Chinensis, Radix Ginseng and Flos Lonicerae for adjuvant drug, clearing away heat-fire, promotes the production of body fluid and moisturizes, soothing the liver dispelling the stagnated QI, and removing food stagnancyization is stagnant, restrains astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming; With Radix Glycyrrhizae for making medicine, invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, coordinating the actions of various ingredients in a prescription.The all medicines of monarch coordinate, and collaborative promotion, complements each other, and finally reaches effect for the treatment of female dimacteric syndrome.

Compared with prior art, the present invention has following technical advantage:

1, results of animal display, pharmaceutical composition of the present invention can improve Ovariectomized Rat Serum estradiol significantly and reduce its follicle stimulating hormone content, and visible, medicine of the present invention is significantly improved effect to castrated rats estrogen;

2, pharmaceutical composition of the present invention is natural Chinese medicines compositions, and toxic and side effects is little, obvious to female climacteric syndrome therapeutic effect, stable, and treatment cycle is short, relapse rate is low;

3, pharmaceutical composition of the present invention has enriching yin and nourishing kidney, nourishing blood for regulating menstruation, clearing away heart-fire for tranquillization, resolving heat and reducing pathogenic fire, invigorating spleen and reinforcing stomach and improve the effects such as body constitution.

Detailed description of the invention

It will be understood by those skilled in the art that technology disclosed in following examples represents the technology playing good action in the practice of the invention of the present inventor's discovery.But, many changes can be made in disclosed specific embodiments, and still obtain same or analogous result, and not depart from the spirit and scope of the present invention.

embodiment 1:

The embodiment of the present invention 1 pharmaceutical composition is made up of the raw materials of following parts by weight: Folium Ginkgo 8 parts, Herba Leonuri 6 parts, Radix Angelicae Sinensis 6 parts, Radix Rehmanniae Preparata 5 parts, Radix Adenophorae (Radix Glehniae) 5 parts, Concha Ostreae 5 parts, 5 parts, Fructus Jujubae, Fructus Crataegi 3 parts, Fructus Schisandrae Chinensis 3 parts, Radix Ginseng 3 parts, Flos Lonicerae 3 parts and 1 part, Radix Glycyrrhizae.

Preparation method is as follows:

S1: take Folium Ginkgo 8 parts, Herba Leonuri 6 parts, Radix Angelicae Sinensis 6 parts, Radix Rehmanniae Preparata 5 parts, Radix Adenophorae (Radix Glehniae) 5 parts, Concha Ostreae 5 parts, 5 parts, Fructus Jujubae, Fructus Crataegi 3 parts, Fructus Schisandrae Chinensis 3 parts, Radix Ginseng 3 parts, Flos Lonicerae 3 parts and 1 part, Radix Glycyrrhizae, mixing is ground into coarse powder, for subsequent use;

S2: the purified water adding above-mentioned coarse powder total amount 6 times amount, soaks 12 hours, decocts 2 hours, filters and retains residue; Add the purified water of described residue total amount 3 times amount, decoct 2 hours, filter and retain filtering residue, merging filtrate, be concentrated into 55 DEG C of relative densities be 1.10 concentrated solution for subsequent use;

S3: the volume parts filtering residue in S2 being added described filtering residue total amount 3 times amount is the ethanol of 65%, reflux, extract, 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and be concentrated into 55 DEG C of relative densities be 1.10 concentrated solution for subsequent use;

S4: merged by the concentrated solution of S2, S3 gained, continuing to be concentrated into 55 DEG C of relative densities is the Chinese medical concrete of 1.20;

S5: the Chinese medical concrete of S4 is added capsule and commonly uses adjuvant, mixing, blood pressure lowering dry, pulverize, and cross 100 mesh sieves, incapsulate in shell, every capsule medicated amount is 0.30g, obtains the capsule of the embodiment of the present invention 1 pharmaceutical composition.

embodiment 2:

The embodiment of the present invention 2 pharmaceutical composition is made up of the raw materials of following parts by weight: Folium Ginkgo 20 parts, Herba Leonuri 15 parts, Radix Angelicae Sinensis 15 parts, Radix Rehmanniae Preparata 12 parts, Radix Adenophorae (Radix Glehniae) 12 parts, Concha Ostreae 12 parts, 12 parts, Fructus Jujubae, Fructus Crataegi 12 parts, Fructus Schisandrae Chinensis 12 parts, Radix Ginseng 12 parts, Flos Lonicerae 6 parts and 10 parts, Radix Glycyrrhizae.

Preparation method is as follows:

S1: take Folium Ginkgo 20 parts, Herba Leonuri 15 parts, Radix Angelicae Sinensis 15 parts, Radix Rehmanniae Preparata 12 parts, Radix Adenophorae (Radix Glehniae) 12 parts, Concha Ostreae 12 parts, 12 parts, Fructus Jujubae, Fructus Crataegi 12 parts, Fructus Schisandrae Chinensis 12 parts, Radix Ginseng 12 parts, Flos Lonicerae 6 parts and 10 parts, Radix Glycyrrhizae, mixing is ground into coarse powder, for subsequent use;

S2: the purified water adding above-mentioned coarse powder total amount 12 times amount, soaks 24 hours, decocts 6 hours, filters and retains residue; Add the purified water of described residue total amount 8 times amount, decoct 4 hours, filter and retain filtering residue, merging filtrate, be concentrated into 60 DEG C of relative densities be 1.25 concentrated solution for subsequent use;

S3: the volume parts filtering residue in S2 being added described filtering residue total amount 8 times amount is the ethanol of 80%, reflux, extract, 3 times, each 8 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and be concentrated into 60 DEG C of relative densities be 1.25 concentrated solution for subsequent use;

S4: merged by the concentrated solution of S2, S3 gained, continuing to be concentrated into 60 DEG C of relative densities is the Chinese medical concrete of 1.30;

S5: the Chinese medical concrete in S4 is added capsule and commonly uses adjuvant, mixing, blood pressure lowering dry, pulverize, and cross 100 mesh sieves, incapsulate in shell, every capsule medicated amount is 0.30g, obtains the capsule of the embodiment of the present invention 2 pharmaceutical composition.

embodiment 3:

The embodiment of the present invention 3 pharmaceutical composition is made up of the raw materials of following parts by weight: Folium Ginkgo 14 parts, Herba Leonuri 10 parts, Radix Angelicae Sinensis 10 parts, Radix Rehmanniae Preparata 8 parts, Radix Adenophorae (Radix Glehniae) 8 parts, Concha Ostreae 8 parts, 8 parts, Fructus Jujubae, Fructus Crataegi 6 parts, Fructus Schisandrae Chinensis 6 parts, Radix Ginseng 6 parts, Flos Lonicerae 4 parts and 5 parts, Radix Glycyrrhizae.

Preparation method:

S1: take Folium Pruni 14 parts, Herba Leonuri 10 parts, Radix Angelicae Sinensis 10 parts, Radix Rehmanniae Preparata 8 parts, Radix Adenophorae (Radix Glehniae) 8 parts, Concha Ostreae 8 parts, 8 parts, Fructus Jujubae, Fructus Crataegi 6 parts, Fructus Schisandrae Chinensis 6 parts, Radix Ginseng 6 parts, Flos Lonicerae 4 parts and 5 parts, Radix Glycyrrhizae, mixing is ground into coarse powder, for subsequent use;

S2: the purified water adding above-mentioned coarse powder total amount 8 times amount, soaks 12 hours, decocts 4 hours, filters and retains residue; Add the purified water of described residue total amount 5 times amount, decoct 3 hours, filter and retain filtering residue, merging filtrate, be concentrated into 60 DEG C of relative densities be 1.20 concentrated solution for subsequent use;

S3: the volume parts filtering residue in S2 being added described filtering residue total amount 5 times amount is the ethanol of 75%, reflux, extract, 3 times, each 5 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and be concentrated into 60 DEG C of relative densities be 1.20 concentrated solution for subsequent use;

S4: merged by the concentrated solution of S2, S3 gained, continuing to be concentrated into 60 DEG C of relative densities is the Chinese medical concrete of 1.25;

S5: the Chinese medical concrete in S4 is added capsule and commonly uses adjuvant, mixing, blood pressure lowering dry, pulverize, and cross 100 mesh sieves, incapsulate in shell, every capsule medicated amount is 0.30g, obtains the capsule of the embodiment of the present invention 3 pharmaceutical composition.

the research experiment that pharmaceutical composition of the present invention affects castrated rats estrogen level

1, experimental drug: Chinese medicine capsules obtained by the embodiment of the present invention 3, abolishes capsule shells, adds water and be modulated into magma.Positive control drug is Kuntai capsule (Guiyang Xintian Pharmaceutical Industry Co., Ltd., the accurate word Z20000083 of traditional Chinese medicines), processes equally.

2, test animal used: SD rat, original body mass 220 ± 5g, female, female rats is all without pregnant.

3, experimental technique: get 90 SD rats, randomly draws 15 as Normal group, all the other 75 rats underwent bilateral oophorectomies, for subsequent use.The rat of getting row ovarian resection after 3 months after operation is divided into 5 groups at random, often organizes 15, is respectively model control group, positive controls, the embodiment of the present invention 3 Chinese medicine capsules high dose group, middle dosage group, low dose group.The embodiment of the present invention 3 Chinese medicine capsules high dose group, middle dosage group and low dose group press 25g/kg, 10g/kg, 5g/kg dosage gastric infusion respectively at after grouping, positive controls gives 25g/kg dosage gastric infusion, and Normal group and model control group gavage give isometric normal saline.Every day 1 time, successive administration 30 days.Last administration is after 2 hours, and abdomen arterial blood extracting prepares serum, detects serum estradiol and follicle stimulating hormone content with test kit.

4, the results are shown in Table 1

The comparision contents of each serum hormone of table 1

5, conclusion (of pressure testing):

Model control group compares with Normal group, and the serum estradiol content of modeling rat reduces, and serum follicle stimulating hormone content raises, and has significant difference, and this experimental animal model modeling success is described.Experimental data shows, pharmaceutical composition of the present invention significantly can promote modeling rat blood serum estradiol content, and the content of follicle stimulating hormone can be reduced simultaneously, illustrate that medicine of the present invention is significantly improved effect to castrated rats estrogen, and action effect is better than positive controls.

pharmaceutical composition of the present invention is to the observation of curative effect of female dimacteric syndrome clinical volunteers patient

One, diagnostic criteria

Diagnostic criteria with reference to climacteric syndrome in People's Republic of China's traditional Chinese medicine industry standard " Chinese medical disease Standardization of diagnosis and curative effect ": 1, mostly occur more than 45 years old, irregular menses or amenorrhea, hectic fever, perspiration, cardiopalmus, emotional, insomnia or the symptom such as depressed; 2, genitals and secondary sex characteristics have atrophy in various degree; 3, urine, blood estrogen reduce, and follicle stimulating hormone and lutropin obviously raise.

Two, criterion of therapeutical effect

Efficacy assessment standard with reference to climacteric syndrome in People's Republic of China's traditional Chinese medicine industry standard " Chinese medical disease Standardization of diagnosis and curative effect ":

Cure: warm, sweating, the transference cure such as agitation, feel comfortable;

Effective: to warm, sweating, the symptom such as agitation alleviate;

Invalid: after taking medicine, the state of an illness is unchanged.

Three, clinical trial

1, physical data

240 selected female dimacteric syndrome clinical volunteers patients are divided into 4 groups at random, often organize 60 people, be respectively treatment A group, treatment B group, treatment C group and matched group, the age be 43-60 year, 45 years old mean age, the each group of influence factor such as age, symptom, through statistical procedures, there was no significant difference, meets a point set condition.

2, Therapeutic Method

Treatment A group: take the capsule (0.30g*24 grain/box) that embodiment 1 prepares, every day 2 times, each 3, serve on 30 days;

Treatment B group: take the capsule (0.30g*24 grain/box) that embodiment 2 prepares, every day 2 times, each 3, serve on 30 days;

Treatment C group: take the capsule (0.30g*24 grain/box) that embodiment 3 prepares, every day 2 times, each 3, serve on 30 days;

Matched group: take Kuntai capsule (Guiyang Xintian Pharmaceutical Industry Co., Ltd., accurate word Z20000083, the 0.5g*24 grain/box of traditional Chinese medicines), one time 3,2 times on the one, serve on 30 days.

3, therapeutic outcome, as shown in table 2.

Table 2 therapeutic effect

4, conclusion (of pressure testing)

This test adopts Kuntai capsule as a control group, Kuntai capsule is meticulously refined by Chinese medicines such as Radix Rehmanniae Preparata, Rhizoma Coptidis, the Radix Paeoniae Alba, Radix Scutellariae, Colla Corii Asini, Poria and forms, there is nourishing YIN and clearing away heat, the effect of relieving restlessness of calming the nerves, cure mainly climacteric syndrome, by comparing with medicine composite for curing effect of the present invention, highlight the curative effect of pharmaceutical composition of the present invention in treatment climacteric syndrome.Experimental data shows, the cure rate of medicine composite for curing A group of the present invention, treatment B group and treatment C group is all greater than 75%, total effective rate is all greater than 90%, therapeutic effect is significantly better than matched group, wherein, the pharmaceutical composition effect of the present invention prepared with treatment group C group and the embodiment of the present invention 3 is best.Visible, pharmaceutical composition good effect of the present invention, cure rate is high, can as the drug use for the treatment of climacteric syndrome.

Owing to describing the present invention by above preferred embodiment, in spirit of the present invention and/or scope, any for replacement/of the present invention or combination implement the present invention, be all apparent for a person skilled in the art, and be included among the present invention.

Claims (7)

1. treat the pharmaceutical composition of climacteric syndrome for one kind, it is characterized in that, described pharmaceutical composition is made up of the raw materials of following parts by weight: Folium Ginkgo 8-20 part, Herba Leonuri 6-15 part, Radix Angelicae Sinensis 6-15 part, Radix Rehmanniae Preparata 5-12 part, Radix Adenophorae (Radix Glehniae) 5-12 part, Concha Ostreae 5-12 part, Fructus Jujubae 5-12 part, Fructus Crataegi 3-12 part, Fructus Schisandrae Chinensis 3-12 part, Radix Ginseng 3-12 part, Flos Lonicerae 3-6 part and Radix Glycyrrhizae 1-10 part.

2. the pharmaceutical composition for the treatment of climacteric syndrome as claimed in claim 1, it is characterized in that, described pharmaceutical composition is made up of the raw materials of following parts by weight: Folium Ginkgo 8 parts, Herba Leonuri 6 parts, Radix Angelicae Sinensis 6 parts, Radix Rehmanniae Preparata 5 parts, Radix Adenophorae (Radix Glehniae) 5 parts, Concha Ostreae 5 parts, 5 parts, Fructus Jujubae, Fructus Crataegi 3 parts, Fructus Schisandrae Chinensis 3 parts, Radix Ginseng 3 parts, Flos Lonicerae 3 parts and 1 part, Radix Glycyrrhizae.

3. the pharmaceutical composition for the treatment of climacteric syndrome as claimed in claim 1, it is characterized in that, described pharmaceutical composition is made up of the raw materials of following parts by weight: Folium Ginkgo 20 parts, Herba Leonuri 15 parts, Radix Angelicae Sinensis 15 parts, Radix Rehmanniae Preparata 12 parts, Radix Adenophorae (Radix Glehniae) 12 parts, Concha Ostreae 12 parts, 12 parts, Fructus Jujubae, Fructus Crataegi 12 parts, Fructus Schisandrae Chinensis 12 parts, Radix Ginseng 12 parts, Flos Lonicerae 6 parts and 10 parts, Radix Glycyrrhizae.

4. the pharmaceutical composition for the treatment of climacteric syndrome as claimed in claim 1, it is characterized in that, described pharmaceutical composition is made up of the raw materials of following parts by weight: Folium Ginkgo 14 parts, Herba Leonuri 10 parts, Radix Angelicae Sinensis 10 parts, Radix Rehmanniae Preparata 8 parts, Radix Adenophorae (Radix Glehniae) 8 parts, Concha Ostreae 8 parts, 8 parts, Fructus Jujubae, Fructus Crataegi 6 parts, Fructus Schisandrae Chinensis 6 parts, Radix Ginseng 6 parts, Flos Lonicerae 4 parts and 5 parts, Radix Glycyrrhizae.

5. the pharmaceutical composition of the treatment climacteric syndrome as described in any one of claim 1-4, is characterized in that, described pharmaceutical composition is made into capsule, tablet, powder or granule.

6. the pharmaceutical composition of the treatment climacteric syndrome as described in any one of claim 1-4, is characterized in that, described pharmaceutical composition is obtained by following steps:

S1: take Folium Ginkgo 8-20 part, Herba Leonuri 6-15 part, Radix Angelicae Sinensis 6-15 part, Radix Rehmanniae Preparata 5-12 part, Radix Adenophorae (Radix Glehniae) 5-12 part, Concha Ostreae 5-12 part, Fructus Jujubae 5-12 part, Fructus Crataegi 3-12 part, Fructus Schisandrae Chinensis 3-12 part, Radix Ginseng 3-12 part, Flos Lonicerae 3-6 part and Radix Glycyrrhizae 1-10 part, mixing is ground into coarse powder, for subsequent use;

S2: the purified water adding above-mentioned coarse powder total amount 6-12 times amount, soaks 12-24 hour, decocts 2-6 hour, filters and retains residue; Add the purified water of described residue total amount 3-8 times amount, decoct 2-4 hour, filter and retain filtering residue, merging filtrate, being concentrated into 55 DEG C of-60 DEG C of relative densities is that the concentrated solution of 1.10-1.25 is for subsequent use;

S3: the volume parts filtering residue in S2 being added described filtering residue total amount 3-8 times amount is the ethanol of 65-80%, reflux, extract, 2-3 time, each 3-8 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 55 DEG C of-60 DEG C of relative densities be that the concentrated solution of 1.10-1.25 is for subsequent use;

S4: merged by the concentrated solution of S2, S3 gained, continuing to be concentrated into 55 DEG C of-60 DEG C of relative densities is the Chinese medical concrete of 1.20-1.30, obtains pharmaceutical composition of the present invention.

7. the preparation method of the pharmaceutical composition of the treatment climacteric syndrome as described in any one of claim 1-4, is characterized in that, comprise the steps:

S1: take Folium Ginkgo 8-20 part, Herba Leonuri 6-15 part, Radix Angelicae Sinensis 6-15 part, Radix Rehmanniae Preparata 5-12 part, Radix Adenophorae (Radix Glehniae) 5-12 part, Concha Ostreae 5-12 part, Fructus Jujubae 5-12 part, Fructus Crataegi 3-12 part, Fructus Schisandrae Chinensis 3-12 part, Radix Ginseng 3-12 part, Flos Lonicerae 3-6 part and Radix Glycyrrhizae 1-10 part, mixing is ground into coarse powder, for subsequent use;

S2: the purified water adding above-mentioned coarse powder total amount 6-12 times amount, soaks 12-24 hour, decocts 2-6 hour, filters and retains residue; Add the purified water of described residue total amount 3-8 times amount, decoct 2-4 hour, filter and retain filtering residue, merging filtrate, being concentrated into 55 DEG C of-60 DEG C of relative densities is that the concentrated solution of 1.10-1.25 is for subsequent use;

S3: the volume parts filtering residue in S2 being added described filtering residue total amount 3-8 times amount is the ethanol of 65-80%, reflux, extract, 2-3 time, each 3-8 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 55 DEG C of-60 DEG C of relative densities be that the concentrated solution of 1.10-1.25 is for subsequent use;

S4: merged by the concentrated solution of S2, S3 gained, continuing to be concentrated into 55 DEG C of-60 DEG C of relative densities is the Chinese medical concrete of 1.20-1.30, obtains pharmaceutical composition of the present invention.