CN105362629A - Female climacteric syndrome treatment pharmaceutical composition containing cortex eucommiae and preparation method of female climacteric syndrome treatment pharmaceutical composition containing cortex eucommiae - Google Patents
Female climacteric syndrome treatment pharmaceutical composition containing cortex eucommiae and preparation method of female climacteric syndrome treatment pharmaceutical composition containing cortex eucommiae Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicine and relates to a female climacteric syndrome treatment pharmaceutical composition containing cortex eucommiae and a preparation method of the female climacteric syndrome treatment pharmaceutical composition containing the cortex eucommiae. The pharmaceutical composition is prepared from, by weight, 9-25 parts of the cortex eucommiae, 6-20 parts of herba leonuri, 6-20 parts of myrrh, 6-15 parts of radix rehmanniae preparata, 6-15 parts of bulbus lilii, 6-15 parts of fructus jujubae, 6-15 parts of radix polygalae, 3-12 parts of rhizoma anemarrhenae, 3-12 parts of pericarpium citri reticulatae viride, 3-12 parts of fructus ligustri lucidi, 3-12 parts of fructus schisandrae chinensis and 1-10 parts of radix glycyrrhizae. The female climacteric syndrome treatment pharmaceutical composition containing the cortex eucommiae has efficacies of Qi nourishing, blood circulation invigorating, Yin nourishing, blood replenishing, heart-fire clearing, tranquilizing, spleen nourishing, Qi tonifying and physical fitness improving and has advantages of excellent curative effects, few side effects, convenience in administration and the like in application to treatment of the female climacteric syndrome.
Description
Technical field
The invention belongs to the field of Chinese medicines, particularly relate to pharmaceutical composition of a kind for the treatment of female dimacteric syndrome containing the Cortex Eucommiae 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 CN201410621748 discloses a kind of Chinese medicine composition for the treatment of climacteric syndrome, this Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Salviae Miltiorrhizae, Radix Codonopsis, Radix Asparagi, Fructus Ligustri Lucidi, Herba Ecliptae, Bulbus Lilii, Rhizoma Coptidis, Fructus Tritici Levis, Semen Ziziphi Spinosae, Radix Curcumae, Os Draconis, Fructus Schisandrae Chinensis, Poria, the Radix Paeoniae Alba, Radix Angelicae Sinensis and Rhizoma Sparganii, effect that this Chinese medicine composition has qi-supplementing, blood-engendering, easing the affected liver is invigorated blood circulation, but this pharmaceutical compositions is complicated, and medicine cost is relatively high.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of pharmaceutical composition of the treatment female dimacteric syndrome containing the Cortex Eucommiae, this pharmaceutical composition has inrigorating qi and promoting blood circulation, nourishing YIN and supplementing blood, clearing away heart-fire for tranquillization, invigorating the spleen and replenishing QI and the effect improving 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: Cortex Eucommiae 9-25 part, Herba Leonuri 6-20 part, Myrrha 6-20 part, Radix Rehmanniae Preparata 6-15 part, Bulbus Lilii 6-15 part, Fructus Jujubae 6-15 part, Radix Polygalae 6-15 part, Rhizoma Anemarrhenae 3-12 part, Pericarpium Citri Reticulatae Viride 3-12 part, Fructus Ligustri Lucidi 3-12 part, Fructus Schisandrae Chinensis 3-12 part and Radix Glycyrrhizae 1-10 part.
Preferably, described pharmaceutical composition is made up of the raw materials of following parts by weight: the Cortex Eucommiae 9 parts, Herba Leonuri 6 parts, Myrrha 6 parts, Radix Rehmanniae Preparata 6 parts, Bulbus Lilii 6 parts, 6 parts, Fructus Jujubae, Radix Polygalae 6 parts, the Rhizoma Anemarrhenae 3 parts, 3 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 3 parts, Fructus Schisandrae Chinensis 3 parts and 1 part, Radix Glycyrrhizae.
Preferably, described pharmaceutical composition is made up of the raw materials of following parts by weight: the Cortex Eucommiae 18 parts, Herba Leonuri 15 parts, Myrrha 15 parts, Radix Rehmanniae Preparata 12 parts, Bulbus Lilii 12 parts, 12 parts, Fructus Jujubae, Radix Polygalae 12 parts, the Rhizoma Anemarrhenae 8 parts, 8 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 8 parts, Fructus Schisandrae Chinensis 8 parts and 5 parts, Radix Glycyrrhizae.
Preferably, described pharmaceutical composition is made up of the raw materials of following parts by weight: the Cortex Eucommiae 25 parts, Herba Leonuri 20 parts, Myrrha 20 parts, Radix Rehmanniae Preparata 15 parts, Bulbus Lilii 15 parts, 15 parts, Fructus Jujubae, Radix Polygalae 15 parts, the Rhizoma Anemarrhenae 12 parts, 12 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 12 parts, Fructus Schisandrae Chinensis 12 parts and 10 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: get the Cortex Eucommiae, Herba Leonuri, Myrrha, Radix Rehmanniae Preparata, Bulbus Lilii, Fructus Jujubae, Radix Polygalae, the Rhizoma Anemarrhenae, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi, Fructus Schisandrae Chinensis and Radix Glycyrrhizae, clean, crushed after being dried becomes coarse powder, add the water soaking 45-60 minute of described coarse powder gross weight 6-12 times amount, reflux, extract, 2-3 time, each 3-7 hour, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S2: adding described filtering residue gross weight 6-12 times amount volume fraction in the filtering residue in S1 is the ethanol of 70-85%, reflux, extract, 2-3 time, each 3-7 hour, filter, merging filtrate, obtains alcohol extract;
S3: merge Aqueous extracts and alcohol extract, after stirring, leaves standstill 12-24 hour, the centrifugal 20-30 minute of 2000g, gets supernatant, carries out hyperfiltration treatment, temperature is 25-40 DEG C, material liquid pH is 6-8, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.1-0.2MPa, when feed liquid stock solution reduces 1/7-1/5, then ultrafiltration 1-2 time that adds water, merge ultrafiltrate;
S4: be the extractum of 1.20-1.30 by relative density at ultrafiltrate vacuum-concentrcted to 60 DEG C, to obtain final product.
Correspondingly, the preparation method of described pharmaceutical composition comprises the following steps:
S1: get the Cortex Eucommiae, Herba Leonuri, Myrrha, Radix Rehmanniae Preparata, Bulbus Lilii, Fructus Jujubae, Radix Polygalae, the Rhizoma Anemarrhenae, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi, Fructus Schisandrae Chinensis and Radix Glycyrrhizae, clean, crushed after being dried becomes coarse powder, add the water soaking 45-60 minute of described coarse powder gross weight 6-12 times amount, reflux, extract, 2-3 time, each 3-7 hour, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S2: adding described filtering residue gross weight 6-12 times amount volume fraction in the filtering residue in S1 is the ethanol of 70-85%, reflux, extract, 2-3 time, each 3-7 hour, filter, merging filtrate, obtains alcohol extract;
S3: merge Aqueous extracts and alcohol extract, after stirring, leaves standstill 12-24 hour, the centrifugal 20-30 minute of 2000g, gets supernatant, carries out hyperfiltration treatment, temperature is 25-40 DEG C, material liquid pH is 6-8, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.1-0.2MPa, when feed liquid stock solution reduces 1/7-1/5, then ultrafiltration 1-2 time that adds water, merge ultrafiltrate;
S4: be the extractum of 1.20-1.30 by relative density at ultrafiltrate vacuum-concentrcted to 60 DEG C, to obtain final product.
Source, the nature and flavor of the present invention's component used, return through and effect:
The Cortex Eucommiae: this product is the dry bark of the Eucommiaceae plant Cortex Eucommiae; Its sweet in the mouth, warm in nature; Return liver, kidney channel; Liver and kidney tonifying, bone and muscle strengthening, Chong and Ren Meridians regulating, Gu through antiabortive.
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, heart channel; Promoting blood flow to regulate menstruation, inducing diuresis to remove edema.
Myrrha: this product is the oleo-gum-resin that Burseraceae bdellium plant myrrh and the trunk skin zone that belongs to his kind of plant together ooze out, its bitter in the mouth, and property is put down; Eliminating stasis to stop pain.
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.
Bulbus Lilii: this product is the dry meat scale leaf of liliaceous plant Lilium lancifo1ium Thunb or Lilium tenuifolium; Its sweet in the mouth, cold in nature; GUIXIN, lung meridian; Nourishing YIN and moistening the lung, clearing away heart-fire for tranquillization.
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.
Radix Polygalae: this product is the dry root of milk wort Radix Polygalae; Its bitter in the mouth, pungent, warm in nature; GUIXIN, kidney, lung meridian; To calm the nerves Fructus Alpiniae Oxyphyllae, eliminate the phlegm, detumescence.
The Rhizoma Anemarrhenae: this product is the dry rhizome of the liliaceous plant Rhizoma Anemarrhenae; Its bitter in the mouth, sweet, cold in nature; Return lung, stomach, kidney channel; Clearing away heat-fire, promotes the production of body fluid and moisturizes.
Pericarpium Citri Reticulatae Viride: this product is the dry young fruit of rutaceae orange and variety thereof or the peel of immature fruit; Its bitter in the mouth, pungent, warm in nature; Return liver, gallbladder, stomach warp; Soothing the liver dispelling the stagnated QI, removing food stagnancyization is stagnant.
Fructus Ligustri Lucidi: this product is the dry mature fruit of Oleaceae plants Fructus Ligustri Lucidi; Its sweet in the mouth, hardship, cool in nature; Return liver, kidney channel; Nourishing the liver and kidney, improving eyesight black hair.
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 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 prescription of the present invention with Herba Leonuri and the Cortex Eucommiae for monarch drug, promoting blood flow to regulate menstruation, dredge the meridian passage, liver and kidney tonifying; With Radix Rehmanniae Preparata, Bulbus Lilii, Fructus Jujubae, Myrrha and Radix Polygalae for ministerial drug, eliminating stasis to stop pain, nourishing YIN and supplementing blood, beneficial essence fills out marrow, invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind; With the Rhizoma Anemarrhenae, Pericarpium Citri Reticulatae Viride and Fructus Ligustri Lucidi 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; With Fructus Schisandrae Chinensis and Radix Glycyrrhizae for making medicine, invigorating the spleen and replenishing QI, 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 beneficial effect:
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 pure Chinese medicine composition, 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 can 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 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: the Cortex Eucommiae 9 parts, Herba Leonuri 6 parts, Myrrha 6 parts, Radix Rehmanniae Preparata 6 parts, Bulbus Lilii 6 parts, 6 parts, Fructus Jujubae, Radix Polygalae 6 parts, the Rhizoma Anemarrhenae 3 parts, 3 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 3 parts, Fructus Schisandrae Chinensis 3 parts and 1 part, Radix Glycyrrhizae.
Preparation method is as follows:
S1: get the Cortex Eucommiae 9 parts, Herba Leonuri 6 parts, Myrrha 6 parts, Radix Rehmanniae Preparata 6 parts, Bulbus Lilii 6 parts, 6 parts, Fructus Jujubae, Radix Polygalae 6 parts, the Rhizoma Anemarrhenae 3 parts, 3 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 3 parts, Fructus Schisandrae Chinensis 3 parts and 1 part, Radix Glycyrrhizae, clean, crushed after being dried becomes coarse powder, add the water soaking 45 minutes of described coarse powder gross weight 6 times amount, reflux, extract, 2 times, each 3 hours, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S2: adding described filtering residue gross weight 6 times amount volume fraction in the filtering residue in S1 is the ethanol of 70%, reflux, extract, 2 times, each 3 hours, filter, merging filtrate, obtains alcohol extract;
S3: merge Aqueous extracts and alcohol extract, after stirring, leaves standstill 12 hours, centrifugal 20 minutes of 2000g, gets supernatant, carries out hyperfiltration treatment, temperature is 25 DEG C, material liquid pH is 6, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.1MPa, when feed liquid stock solution reduces 1/7, then the ultrafiltration 1 time that adds water, merge ultrafiltrate;
S4: be the extractum of 1.20 by relative density at ultrafiltrate vacuum-concentrcted to 60 DEG C, to obtain final product;
S5: add capsule to above-mentioned Chinese medical concrete and commonly use 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: the Cortex Eucommiae 18 parts, Herba Leonuri 15 parts, Myrrha 15 parts, Radix Rehmanniae Preparata 12 parts, Bulbus Lilii 12 parts, 12 parts, Fructus Jujubae, Radix Polygalae 12 parts, the Rhizoma Anemarrhenae 8 parts, 8 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 8 parts, Fructus Schisandrae Chinensis 8 parts and 5 parts, Radix Glycyrrhizae.
Preparation method:
S1: get the Cortex Eucommiae 18 parts, Herba Leonuri 15 parts, Myrrha 15 parts, Radix Rehmanniae Preparata 12 parts, Bulbus Lilii 12 parts, 12 parts, Fructus Jujubae, Radix Polygalae 12 parts, the Rhizoma Anemarrhenae 8 parts, 8 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 8 parts, Fructus Schisandrae Chinensis 8 parts and 5 parts, Radix Glycyrrhizae, clean, crushed after being dried becomes coarse powder, add the water soaking 50 minutes of described coarse powder gross weight 9 times amount, reflux, extract, 2 times, each 5 hours, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S2: adding described filtering residue gross weight 9 times amount volume fraction in the filtering residue in S1 is the ethanol of 75%, reflux, extract, 2 times, each 5 hours, filter, merging filtrate, obtains alcohol extract;
S3: merge Aqueous extracts and alcohol extract, after stirring, leaves standstill 12 hours, centrifugal 25 minutes of 2000g, gets supernatant, carries out hyperfiltration treatment, temperature is 36 DEG C, material liquid pH is 7, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.1MPa, when feed liquid stock solution reduces 1/6, then the ultrafiltration 1 time that adds water, merge ultrafiltrate;
S4: be the extractum of 1.25 by relative density at ultrafiltrate vacuum-concentrcted to 60 DEG C, to obtain final product;
S5: add capsule to above-mentioned Chinese medical concrete and commonly use adjuvant, mixing, blood pressure lowering dry, pulverize, and cross 150 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: the Cortex Eucommiae 25 parts, Herba Leonuri 20 parts, Myrrha 20 parts, Radix Rehmanniae Preparata 15 parts, Bulbus Lilii 15 parts, 15 parts, Fructus Jujubae, Radix Polygalae 15 parts, the Rhizoma Anemarrhenae 12 parts, 12 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 12 parts, Fructus Schisandrae Chinensis 12 parts and 10 parts, Radix Glycyrrhizae.
Preparation method:
S1: get the Cortex Eucommiae 25 parts, Herba Leonuri 20 parts, Myrrha 20 parts, Radix Rehmanniae Preparata 15 parts, Bulbus Lilii 15 parts, 15 parts, Fructus Jujubae, Radix Polygalae 15 parts, the Rhizoma Anemarrhenae 12 parts, 12 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 12 parts, Fructus Schisandrae Chinensis 12 parts and 10 parts, Radix Glycyrrhizae, clean, crushed after being dried becomes coarse powder, add the water soaking 60 minutes of described coarse powder gross weight 12 times amount, reflux, extract, 3 times, each 7 hours, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S2: adding described filtering residue gross weight 12 times amount volume fraction in the filtering residue in S1 is the ethanol of 85%, reflux, extract, 3 times, each 7 hours, filter, merging filtrate, obtains alcohol extract;
S3: merge Aqueous extracts and alcohol extract, after stirring, leaves standstill 24 hours, centrifugal 30 minutes of 2000g, gets supernatant, carries out hyperfiltration treatment, temperature is 40 DEG C, material liquid pH is 8, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.2MPa, when feed liquid stock solution reduces 1/5, then the ultrafiltration 2 times that adds water, merge ultrafiltrate;
S4: be the extractum of 1.30 by relative density at ultrafiltrate vacuum-concentrcted to 60 DEG C, to obtain final product;
S5: add capsule to above-mentioned Chinese medical concrete and commonly use adjuvant, mixing, blood pressure lowering dry, pulverize, and cross 150 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: the Chinese medicine capsules obtained by the embodiment of the present invention 2, abolishes capsule shells, adds water and be modulated into magma.Positive control drug is Kuntai capsule (Guiyang Xintian Pharmaceutical Industry Co., Ltd., accurate word Z20000083, the 0.5g*24 grain/box of traditional Chinese medicines), processes equally.
2, test animal used: SD rat, body weight 220 ± 8g, 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 2 high dose group, middle dosage group and low dose group.The embodiment of the present invention 2 high dose group, middle dosage group and low dose group press 30g/kg, 15g/kg, 7.5g/kg dosage gastric infusion respectively at after grouping, positive controls gives 20g/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
| Group | Number of animals (only) | Dosage (g/kg) | Follicle stimulating hormone (ng/ml) | Serum estradiol (pg/ml) |
| Normal group | 15 | - | 2.315±0.336 | 56.3±2.4 |
| Model control group | 15 | - | 5.768±0.207 △△ | 26.3±1.5 △△ |
| Positive controls | 15 | 20 | 4.072±0.290 ** | 44.1±3.4 ** |
| High dose group of the present invention | 15 | 30 | 2.901±0.405 **## | 50.6±4.1 **## |
| Dosage group in the present invention | 15 | 15 | 3.204±0.351 **## | 43.6±5.2 ** |
| Low dose group of the present invention | 15 | 7.5 | 3.789±0.541 **# | 37.9±4.2 ** |
Note: compare with Normal group,
△p<0.05,
△ △p<0.01; Compare with model control group,
*p<0.05,
*p<0.01; Compare with positive controls,
#p<0.05,
##p<0.01.
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, contrast with model group, the embodiment of the present invention 2 pharmaceutical composition 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 42-60 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 4,2 times on the one, serve on 30 days.
3, therapeutic outcome, as shown in table 2.
Table 2 therapeutic effect
| Group | Number of cases | Cure (rate) | Effectively | Invalid | Total effective rate |
| Treatment A group | 60 | 49(81.7%) | 6 | 5 | 91.7% |
| Treatment B group | 60 | 53(88.3%) | 4 | 3 | 95% |
| Treatment C group | 60 | 52(85.0%) | 4 | 4 | 93.3% |
| Matched group | 60 | 37(63.3%) | 6 | 17 | 71.7% |
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 80%, total effective rate is all greater than 90%, therapeutic effect is significantly better than matched group, wherein, best with the pharmaceutical composition effect of the present invention that treatment group B group and the embodiment of the present invention 2 prepare, therefore embodiment 2 is preferred embodiment.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. the pharmaceutical composition of the treatment female dimacteric syndrome containing the Cortex Eucommiae, it is characterized in that, described pharmaceutical composition is made up of the raw materials of following parts by weight: Cortex Eucommiae 9-25 part, Herba Leonuri 6-20 part, Myrrha 6-20 part, Radix Rehmanniae Preparata 6-15 part, Bulbus Lilii 6-15 part, Fructus Jujubae 6-15 part, Radix Polygalae 6-15 part, Rhizoma Anemarrhenae 3-12 part, Pericarpium Citri Reticulatae Viride 3-12 part, Fructus Ligustri Lucidi 3-12 part, Fructus Schisandrae Chinensis 3-12 part and Radix Glycyrrhizae 1-10 part.
2. the pharmaceutical composition of the treatment female dimacteric syndrome containing the Cortex Eucommiae 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: the Cortex Eucommiae 9 parts, Herba Leonuri 6 parts, Myrrha 6 parts, Radix Rehmanniae Preparata 6 parts, Bulbus Lilii 6 parts, 6 parts, Fructus Jujubae, Radix Polygalae 6 parts, the Rhizoma Anemarrhenae 3 parts, 3 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 3 parts, Fructus Schisandrae Chinensis 3 parts and 1 part, Radix Glycyrrhizae.
3. the pharmaceutical composition of the treatment female dimacteric syndrome containing the Cortex Eucommiae 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: the Cortex Eucommiae 18 parts, Herba Leonuri 15 parts, Myrrha 15 parts, Radix Rehmanniae Preparata 12 parts, Bulbus Lilii 12 parts, 12 parts, Fructus Jujubae, Radix Polygalae 12 parts, the Rhizoma Anemarrhenae 8 parts, 8 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 8 parts, Fructus Schisandrae Chinensis 8 parts and 5 parts, Radix Glycyrrhizae.
4. the pharmaceutical composition of the treatment female dimacteric syndrome containing the Cortex Eucommiae 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: the Cortex Eucommiae 25 parts, Herba Leonuri 20 parts, Myrrha 20 parts, Radix Rehmanniae Preparata 15 parts, Bulbus Lilii 15 parts, 15 parts, Fructus Jujubae, Radix Polygalae 15 parts, the Rhizoma Anemarrhenae 12 parts, 12 parts, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi 12 parts, Fructus Schisandrae Chinensis 12 parts and 10 parts, Radix Glycyrrhizae.
5. the pharmaceutical composition of the treatment female dimacteric syndrome containing the Cortex Eucommiae as described in any one of claim 1-4, it is characterized in that, described pharmaceutical composition is made into capsule, tablet, powder or granule.
6. the pharmaceutical composition of the treatment female dimacteric syndrome containing the Cortex Eucommiae as described in any one of claim 1-4, is characterized in that, obtained by following steps:
S1: get the Cortex Eucommiae, Herba Leonuri, Myrrha, Radix Rehmanniae Preparata, Bulbus Lilii, Fructus Jujubae, Radix Polygalae, the Rhizoma Anemarrhenae, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi, Fructus Schisandrae Chinensis and Radix Glycyrrhizae, clean, crushed after being dried becomes coarse powder, add the water soaking 45-60 minute of described coarse powder gross weight 6-12 times amount, reflux, extract, 2-3 time, each 3-7 hour, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S2: adding described filtering residue gross weight 6-12 times amount volume fraction in the filtering residue in S1 is the ethanol of 70-85%, reflux, extract, 2-3 time, each 3-7 hour, filter, merging filtrate, obtains alcohol extract;
S3: merge Aqueous extracts and alcohol extract, after stirring, leaves standstill 12-24 hour, the centrifugal 20-30 minute of 2000g, gets supernatant, carries out hyperfiltration treatment, temperature is 25-40 DEG C, material liquid pH is 6-8, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.1-0.2MPa, when feed liquid stock solution reduces 1/7-1/5, then ultrafiltration 1-2 time that adds water, merge ultrafiltrate;
S4: be the extractum of 1.20-1.30 by relative density at ultrafiltrate vacuum-concentrcted to 60 DEG C, to obtain final product.
7. the preparation method of the pharmaceutical composition of the treatment female dimacteric syndrome containing the Cortex Eucommiae as described in any one of claim 1-4, is characterized in that, comprise the steps:
S1: get the Cortex Eucommiae, Herba Leonuri, Myrrha, Radix Rehmanniae Preparata, Bulbus Lilii, Fructus Jujubae, Radix Polygalae, the Rhizoma Anemarrhenae, Pericarpium Citri Reticulatae Viride, Fructus Ligustri Lucidi, Fructus Schisandrae Chinensis and Radix Glycyrrhizae, clean, crushed after being dried becomes coarse powder, add the water soaking 45-60 minute of described coarse powder gross weight 6-12 times amount, reflux, extract, 2-3 time, each 3-7 hour, filters and retains filtering residue, merging filtrate, obtains Aqueous extracts;
S2: adding described filtering residue gross weight 6-12 times amount volume fraction in the filtering residue in S1 is the ethanol of 70-85%, reflux, extract, 2-3 time, each 3-7 hour, filter, merging filtrate, obtains alcohol extract;
S3: merge Aqueous extracts and alcohol extract, after stirring, leaves standstill 12-24 hour, the centrifugal 20-30 minute of 2000g, gets supernatant, carries out hyperfiltration treatment, temperature is 25-40 DEG C, material liquid pH is 6-8, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.1-0.2MPa, when feed liquid stock solution reduces 1/7-1/5, then ultrafiltration 1-2 time that adds water, merge ultrafiltrate;
S4: be the extractum of 1.20-1.30 by relative density at ultrafiltrate vacuum-concentrcted to 60 DEG C, to obtain final product.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105816638A (en) * | 2016-04-19 | 2016-08-03 | 文学忠 | Composition for delaying female climacteric syndrome and preparation method |
| CN115429843A (en) * | 2022-10-27 | 2022-12-06 | 广东罗浮山国药股份有限公司 | Composition for improving woman climacteric symptoms and preparation method thereof |
-
2015
- 2015-12-07 CN CN201510886705.2A patent/CN105362629A/en active Pending
Non-Patent Citations (1)
| Title |
|---|
| 朱世敏: "六子汤为主治疗更年期综合征", 《上海中医药杂志》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105816638A (en) * | 2016-04-19 | 2016-08-03 | 文学忠 | Composition for delaying female climacteric syndrome and preparation method |
| CN115429843A (en) * | 2022-10-27 | 2022-12-06 | 广东罗浮山国药股份有限公司 | Composition for improving woman climacteric symptoms and preparation method thereof |
| CN115429843B (en) * | 2022-10-27 | 2023-08-15 | 广东罗浮山国药股份有限公司 | Composition for improving female climacteric symptom and preparation method thereof |
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