CN105412823A - Pharmaceutical preparation for treating male climacteric syndrome - Google Patents

Pharmaceutical preparation for treating male climacteric syndrome Download PDF

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Publication number
CN105412823A
CN105412823A CN201510907168.5A CN201510907168A CN105412823A CN 105412823 A CN105412823 A CN 105412823A CN 201510907168 A CN201510907168 A CN 201510907168A CN 105412823 A CN105412823 A CN 105412823A
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parts
pharmaceutical preparation
climacteric syndrome
preparation
male climacteric
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吴兴连
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Qingdao Mairuite Medicine Technology Co Ltd
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Qingdao Mairuite Medicine Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/80Scrophulariaceae (Figwort family)
    • A61K36/804Rehmannia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/02Medicinal preparations containing materials or reaction products thereof with undetermined constitution from inanimate materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/618Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/39Convolvulaceae (Morning-glory family), e.g. bindweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/40Cornaceae (Dogwood family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537Salvia (sage)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/57Magnoliaceae (Magnolia family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/79Schisandraceae (Schisandra family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9066Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Abstract

The invention belongs to the technical field of medicine, and particularly relates to a pharmaceutical preparation for treating the male climacteric syndrome and a preparation method thereof. The pharmaceutical preparation is prepared from prepared rehmannia roots, semen cuscutae, cornus officinalis, mothers of pearl, Chinese magnoliavine fruit, calcined keel, curcuma aromatica and salviae miltiorrhizae. The pharmaceutical preparation is reasonable in composition, rigorous in compatibility and easy to prepare, has remarkable treatment effects of nourishing livers and kidneys, nourishing qi to generate fluid and suppressing hyperactive liver and subsiding yang, is rapid in effect, treats both symptoms and root causes, and is an effective medicine for treating the male climacteric syndrome, especially the liver-kidney yin deficiency type male climacteric syndrome.

Description

A kind of pharmaceutical preparation for the treatment of male climacteric syndrome
Technical field
The invention belongs to medical art, be specifically related to a kind of pharmaceutical preparation for the treatment of male climacteric syndrome.
Background technology
Male climacteric syndrome refer to due to atrophy of testis, and testosterone secretion reduces, and the secretory function of feedback Stimulation of Pituitary Gland increases, and the testis of atrophy reduces the reaction of promoting sexual gland hormone, makes the regulatory function of gonadal hormone in body unbalance and the series of symptoms that causes.Clinical main manifestations is hectic fever night sweat, irritable, gloomyly not relax, the symptoms such as neurasthenia such as melancholy, the cardiopalmus dreaminess of anxiety, soreness of the waist and knees, hyposexuality, hoariness and alopecia, timid envy are suspected.Its age of onset generally 55-65 year about, clinical manifestation weight differs, the lighter even without perceiveed, severe one impact life and work, patient feels very painful.
The western medical treatment mode of current male climacteric syndrome is Oral testosterone class medicines, but should be noted that supplementary testosterone may increase the weight of the prostatosis of hiding, as prostatic hyperplasia and carcinoma of prostate, and the ratio that middle-aged men and old men people suffers from prostatosis is very large, therefore, unsatisfactory in therapeutic effect and safety.
The traditional Chinese medical science, without this name of disease of male climacteric syndrome, is belonged to the category of " cardiopalmus ", " being insomnia ", " melancholia ", " dizzy ", " hysteria " etc. more.The traditional Chinese medical science thinks that male climacteric syndrome are with kidney asthenia as the principal aspect, and in close relations with the heart, liver, all dirty changing functions of spleen, its etiology and pathogenesis is: the smart degradation of Liver and kidney, menses is for exhausting, and negative and positive are become estranged, disharmony of Chong and Conception Channels.Differentiation of symptoms and signs for classification of syndrome mainly contains: liver-kidney yin deficiency, deficiency of both YIN and YANG type, yang deficiency of spleen and stomache, caused by hepatic stagnation qi stagnation, type of failure of the heart and kidney integrating etc.Long and rich experience for this disease of Chinese traditional treatment.According to the dialectical administration of the different disease types of patient, by Mutiple Targets, too many levels works, treating both the principal and secondary aspects of a disease, and side effect is little, thus now increasing patient to seek curative effect more definite, this disease treated by safe and reliable Chinese medicine.
Summary of the invention
In order to solve the problem, the present invention aims to provide a kind of Chinese medicine preparation and preparation method thereof for the treatment of male climacteric syndrome particularly liver-kidney yin deficiency male climacteric syndrome.
An object of the present invention is to provide a kind of Chinese medicine preparation for the treatment of liver-kidney yin deficiency male climacteric syndrome.
Another object of the present invention is to provide a kind of preparation method for the treatment of the Chinese medicine preparation of liver-kidney yin deficiency male climacteric syndrome.
The present invention treats the Chinese medicine preparation of liver-kidney yin deficiency male climacteric syndrome, its active ingredient is made up of the crude drug of following weight proportion: Radix Rehmanniae Preparata 12-16 part, Semen Cuscutae 10-14 part, Fructus Corni 6-8 part, Concha Margaritifera 8-12 part, Fructus Schisandrae Chinensis 10-14 part, Os Draconis (calcined) 8-12 part, Radix Curcumae 4-6 part, Radix Salviae Miltiorrhizae 4-6 part.
Optimal technical scheme of the present invention is that Chinese medicine preparation of the present invention is obtained by the crude drug of following weight proportion: Radix Rehmanniae Preparata 14 parts, Semen Cuscutae 12 parts, Fructus Corni 7 parts, Concha Margaritifera 10 parts, Fructus Schisandrae Chinensis 12 parts, Os Draconis (calcined) 10 parts, Radix Curcumae 5 parts, Radix Salviae Miltiorrhizae 5 parts.
The Chinese medicine preparation that the present invention treats male climacteric syndrome can also contain pharmaceutically acceptable carrier, is prepared into conventional formulation, as capsule, granule or oral liquid, is preferably granule.
The preparation method step of described Chinese medicine comprises as follows: take above Chinese medicine component according to aforesaid weight and be ground into coarse powder respectively, bind up with gauze; Add the water of medical material gross weight 8 times amount for the first time, warm macerating 4h, decoct 2h, filter while hot; Medicinal residues add the water of 4 times amount again, decoct 2h, filter while hot; Merge twice and decoct filtrate; When filtrate is concentrated into 55 DEG C, relative density is the extractum of 1.10 ~ 1.15, then adds pharmaceutically acceptable carrier, is prepared into clinical acceptable dosage form by conventional method.
The present invention relatively and prior art, has following clear superiority:
First, Chinese medicine preparation prescription of the present invention is mainly according to liver-kidney yin deficiency male climacteric syndrome Liver and kidney degradation, and the pathogenic characteristic that negative and positive are become estranged develops.Invention formulation reasonable recipe, compatibility is rigorous, and all medicines share, play nourishing the liver and kidney altogether, supplementing QI for promoting the production of body fluid, the special effect of suppressing the hyperactive liver and subsiding YANG, to male climacteric syndrome particularly liver-kidney yin deficiency male climacteric syndrome have extremely strong specific aim curative effect, and onset is rapid, treating both the principal and secondary aspects of a disease.
Secondly, Chinese medicine preparation of the present invention adopts sophisticated equipment and technique preparation, and dosage form is advanced, and taking convenience, patient tolerability is good.
3rd, after 1 course for the treatment of of clinical observation, total effective rate comparison therapy group 95%, contrast a group 55%, contrast b group 72.5%, can find that treatment group therapeutic effect is obviously better than matched group, change prescription of the present invention and also have considerable influence to therapeutic effect, do not reach the equal excellent effect of the present invention, in safety evaluatio, treatment group occurs without uncomfortable sensation and complication in the therapeutic process of the whole course for the treatment of simultaneously, show that our clinical application is safely and effectively, be worth studying and applying further.
Further, in Chinese medicine preparation of the present invention, the function of each crude drug cures mainly:
Radix Rehmanniae Preparata, sweet, tepor.Return liver, kidney channel.Nourishing YIN and supplementing blood, beneficial essence fills out marrow.For the hepatic and renal YIN deficiency, soreness of the waist and knees, osteopyrexia and fever, night sweat is passed out semen, and interior-heat is quenched one's thirst, blood deficiency and yellow complexion, severe palpitation, menoxenia, and metrostaxis is dizzy, tinnitus, early whitening of beard and hair.
Semen Cuscutae, sweet, temperature.Return liver,kidney,spleen warp.Nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.For impotence and seminal emission, dripping urination, enuresis frequent micturition, soreness of the waist and knees, blurred vision tinnitus, vaginal bleeding due to deficiency of the kidney during pregnancy, frequent fetal movement, spleen is suffered from a deficiency of the kidney and is rushed down; Externally treating leucoderma.
Fructus Corni, sour, puckery, tepor.Return liver, kidney channel.Liver and kidney tonifying, essence astringing and desertion stemming.For vertigo and tinnitus, soreness of waist and knee joint, impotence and seminal emission, enuresis frequent micturition, bleeding not during menses, profuse sweating is collapsed.Interior-heat is quenched one's thirst.
Concha Margaritifera is salty, cold.Return liver, heart channel.Suppressing the hyperactive liver and subsiding YANG, arresting convulsion improving eyesight.Dizzy for having a headache, irritated insomnia, liver-heat conjunctival congestion, deficiency of the liver blurred vision.
Fructus Schisandrae Chinensis, sour, sweet, temperature.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.For chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Tianjin wound is thirsty, and deficient pulse of losing heart, interior-heat is quenched one's thirst, palpitation and insomnia.
Os Draconis (calcined) is sweet, puckery, flat.Calmness, arresting sweating arresting seminal emission, promoting tissue regeneration and ulcer healing.For neurasthenia, cardiopalmus, insomnia, dreaminess, spontaneous perspiration, night sweat, seminal emission, the enuresis, metrorrhagia, leukorrhagia; External control skin infection for a long time burst do not hold back.
Radix Curcumae, pungent, bitter, cold.Return liver, the heart, lung meridian.Regulating qi to disperse stagnation, heart fire-clearing upset-relieving, promoting the function of the gallbladder to alleviate jaundice.For amenorrhea dysmenorrhea, chest and abdomen swelling and pain, twinge, calentura coma, epilepsy is gone mad, jaundice dark coloured urine.
Radix Salviae Miltiorrhizae, bitter, be slightly cold.GUIXIN, Liver Channel.Stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.For menoxenia, amenorrhea dysmenorrhea , lumps in the chest and abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, but the present invention is not limited only to following specific embodiment.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1 capsule
The each crude drug of the present invention is taken: Radix Rehmanniae Preparata 14 parts, Semen Cuscutae 12 parts, Fructus Corni 7 parts, Concha Margaritifera 10 parts, Fructus Schisandrae Chinensis 12 parts, Os Draconis (calcined) 10 parts, Radix Curcumae 5 parts, Radix Salviae Miltiorrhizae 5 parts by following weight portion.
Preparation technology is as follows:
Take above Chinese medicine component according to aforesaid weight and be ground into coarse powder respectively, bind up with gauze; Add the water of medical material gross weight 8 times amount for the first time, warm macerating 4h, decoct 2h, filter while hot; Medicinal residues add the water of 4 times amount again, decoct 2h, filter while hot; Merge twice and decoct filtrate; When filtrate is concentrated into 55 DEG C, relative density is the extractum of 1.10 ~ 1.15, then adds pharmaceutically acceptable carrier, and technique obtains capsule of the present invention routinely.
When using Chinese medicine preparation of the present invention to treat male climacteric syndrome, take the capsule of preparation, every contains crude drug amount 0.2g, and each 2-3 grain, every day 3 times, takes after meal half an hour.
Embodiment 2 oral liquid
The each crude drug of the present invention is taken: Radix Rehmanniae Preparata 14 parts, Semen Cuscutae 12 parts, Fructus Corni 7 parts, Concha Margaritifera 10 parts, Fructus Schisandrae Chinensis 12 parts, Os Draconis (calcined) 10 parts, Radix Curcumae 5 parts, Radix Salviae Miltiorrhizae 5 parts by following weight portion.
Preparation technology is as follows:
Take above Chinese medicine component according to aforesaid weight and be ground into coarse powder respectively, bind up with gauze; Add the water of medical material gross weight 8 times amount for the first time, warm macerating 4h, decoct 2h, filter while hot; Medicinal residues add the water of 4 times amount again, decoct 2h, filter while hot; Merge twice and decoct filtrate; When filtrate is concentrated into 55 DEG C, relative density is the extractum of 1.10 ~ 1.15, then adds pharmaceutically acceptable carrier, and technique obtains oral solutions of the present invention routinely.
When using Chinese medicine preparation of the present invention to treat male climacteric syndrome, take the oral liquid of preparation, every bottle of 10ml, containing crude drug amount 0.5g, each 1 bottle, every day 3 times, take half an hour after meal.
Embodiment 3 granule
The each crude drug of the present invention is taken: Radix Rehmanniae Preparata 14 parts, Semen Cuscutae 12 parts, Fructus Corni 7 parts, Concha Margaritifera 10 parts, Fructus Schisandrae Chinensis 12 parts, Os Draconis (calcined) 10 parts, Radix Curcumae 5 parts, Radix Salviae Miltiorrhizae 5 parts by following weight portion.
Preparation technology is as follows:
Take above Chinese medicine component according to aforesaid weight and be ground into coarse powder respectively, bind up with gauze; Add the water of medical material gross weight 8 times amount for the first time, warm macerating 4h, decoct 2h, filter while hot; Medicinal residues add the water of 4 times amount again, decoct 2h, filter while hot; Merge twice and decoct filtrate; When filtrate is concentrated into 55 DEG C, relative density is the extractum of 1.10 ~ 1.15, then adds pharmaceutically acceptable carrier, and technique obtains granule of the present invention routinely.
When using Chinese medicine preparation of the present invention to treat male climacteric syndrome, take the granule of preparation, containing crude drug amount 0.5g, each 1 bag, every day 3 times, take half an hour after meal for every bag.
Embodiment 4 granule
The each crude drug of the present invention is taken: Radix Rehmanniae Preparata 12 parts, Semen Cuscutae 10 parts, Fructus Corni 6 parts, Concha Margaritifera 8 parts, Fructus Schisandrae Chinensis 10 parts, Os Draconis (calcined) 8 parts, Radix Curcumae 4 parts, Radix Salviae Miltiorrhizae 4 parts by following weight portion.
Preparation technology is with embodiment 3.
Embodiment 5 granule
The each crude drug of the present invention is taken: Radix Rehmanniae Preparata 16 parts, Semen Cuscutae 14 parts, Fructus Corni 8 parts, Concha Margaritifera 12 parts, Fructus Schisandrae Chinensis 14 parts, Os Draconis (calcined) 12 parts, Radix Curcumae 6 parts, Radix Salviae Miltiorrhizae 6 parts by following weight portion.
Preparation technology is with embodiment 3.
Comparative example's granule
The each crude drug of the present invention is taken: Herba Epimedii 14 parts, Semen Cuscutae 12 parts, Fructus Corni 7 parts, Concha Margaritifera 10 parts, Os Draconis (calcined) 10 parts, Radix Curcumae 5 parts, Radix Sophorae Flavescentis 5 parts by following weight portion.
Preparation technology is with embodiment 3.
Embodiment 6 clinical observation
1, physical data:
Select 2013-to meet subject 120 routine male climacteric syndrome patients as object of study at my Out-patient Department and ward during 2014, age 55-70 year.Adopt the table of random numbers 120 routine patients to be equally divided into treatment group and contrast a group, contrast b group, often organize 40 examples.56 ~ 66 years old treatment group age, average (60.4 ± 2.8) year, the course of disease 3 months-2 years; Contrast 58 ~ 65 years old group age of a, on average (61.2 ± 3.6) year, the course of disease 4 months-2.5 years; Contrast 55 ~ 67 years old group age of b, on average (59.8 ± 3.1) year, the course of disease 3 months-1.8 years.The data of three groups of patients comprises age, the course of disease, state of an illness aspect etc. and compares, and there was no significant difference, P > 0.05, has comparability.
2, diagnostic criteria:
Clinical symptoms: disposition changes, as depressed, worried sentiment, oppressiveness for crying or psychentonia, nervousness, being happy and angry uncertainly, or being given free rein to fancy, being spoken or acted on hearsay evidence, lacks sense of trust etc.; Severe palpitation, pareordia are uncomfortable, or fluctuation of blood pressure, dizziness and tinnitus, warm antiperspirant and go out; Let out time secret when inappetence, abdomen gastral cavity feeling of distension and oppression, stool; Neurasthenia show, as insomnia, little sleep disturbed by dreams, easily wake up with a start, hypomnesis, forgetful, bradykinesia; Hyposexuality, sexual impotence, premature ejaculation, lack of quantity of spermatic fluid; Whole-body muscle starts to relax, and subcutaneous fat enriches than before, and health becomes fat.
Tcm diagnosis meets liver-kidney yin deficiency disease to be seen: waist soreness, dizziness and tinnitus, hypomnesis, being irritable and irascible, dysphoria with feverish sensation in the chest palms and soles, the few Tianjin of xerostomia, and penis is easily lifted, and easily weak after vigorous, seminal fluid is discharged day by day rare, and red tongue tongue is few, thready and stringy pulse.
3, Therapeutic Method:
Treatment group: granule prepared by the oral embodiment of the present invention 3, containing crude drug amount 0.5g, each 1 bag, every day 3 times, takes for every bag after meal half an hour.
Contrast a group: oral western medicine fluoxetine Hydrochloride 10mg/ time, once a day, take in the morning; Treatment adds oryzanol 30mg/ time, every day three times simultaneously; Vitamin B 120mg/ time, every day 3 times; Vitamin B 620mg/ time, day 3 times.
Contrast b group: granule prepared by oral comparative example of the present invention, containing crude drug amount 0.5g, each 1 bag, every day 3 times, takes for every bag after meal half an hour.
Three groups of equal continuous application of medicine 30 days are a course for the treatment of, observe comprehensive therapeutic effect after 1 course for the treatment of.
4, curative effect determinate standard:
Effective: clinical symptom disappearance, drink, food, two just and sleep normal, phychology is gentle, and do not affect work and life, sexual life is normal;
Take a turn for the better: symptom major part disappears or improves, and spirit takes a turn for the better, and sexual life improves;
Invalid: symptom has no obvious improvement, and sexual function is without improvement.
Total effective rate=(effective number of cases+improvement number of cases)/total number of cases × 100%.
5, therapeutic effect:
120 routine patients all complete clinical observation, without coming off, exiting case.
Carry out observation and comparison to the therapeutic effect of two groups of patients after 1 course for the treatment of, the routine patient for the treatment of group 40,26 examples are effective, and effectively, 2 examples are invalid, total effective rate 95%, the routine patient of contrast a group 40 for 12 examples, and 10 examples are effective, and effectively, 18 examples are invalid, total effective rate 55% for 12 examples.The routine patient of contrast b group 40,14 examples are effective, and effectively, 11 examples are invalid, total effective rate 72.5% for 15 examples.
6, safety and untoward reaction:
Detect general health check-up projects (temperature pulse respiration, blood pressure etc.) and blood before and after three groups of treatments, urine, stool routine are all no abnormal; Do not find that Liver and kidney function is abnormal before and after treatment group treatment; The routine mild nausea of contrast a group appearance 2, epigastric discomfort, unprocessed, remission, does not affect continuation medication treatment.
Above-mentioned clinical effectiveness shows, treatment group therapeutic effect is obviously better than matched group, by treatment group with contrast b group and relatively can find, change prescription of the present invention and also have considerable influence to therapeutic effect, do not reach the equal excellent effect of the present invention, in safety evaluatio, treatment group occurs without uncomfortable sensation and complication in the therapeutic process of the whole course for the treatment of simultaneously, shows that the clinical application of we is safely and effectively, is worth studying and applying further.

Claims (7)

1. treat a pharmaceutical preparation for male climacteric syndrome, it is characterized in that, it is obtained by the crude drug of following weight portion: Radix Rehmanniae Preparata 12-16 part, Semen Cuscutae 10-14 part, Fructus Corni 6-8 part, Concha Margaritifera 8-12 part, Fructus Schisandrae Chinensis 10-14 part, Os Draconis (calcined) 8-12 part, Radix Curcumae 4-6 part, Radix Salviae Miltiorrhizae 4-6 part.
2. pharmaceutical preparation as claimed in claim 1, it is characterized in that, it is obtained by the crude drug of following weight portion: Radix Rehmanniae Preparata 14 parts, Semen Cuscutae 12 parts, Fructus Corni 7 parts, Concha Margaritifera 10 parts, Fructus Schisandrae Chinensis 12 parts, Os Draconis (calcined) 10 parts, Radix Curcumae 5 parts, Radix Salviae Miltiorrhizae 5 parts.
3. the pharmaceutical preparation as described in claim 1 or 2, is characterized in that, described pharmaceutical preparation is capsule, granule or oral liquid.
4. the pharmaceutical preparation as described in claim 3, it is characterized in that, described pharmaceutical preparation is preferably granule.
5. pharmaceutical preparation as claimed in claim 4, it is characterized in that, the preparation method of described pharmaceutical preparation comprises following steps: take above Chinese medicine component according to aforesaid weight and be ground into coarse powder respectively, bind up with gauze; Add the water of medical material gross weight 8 times amount for the first time, warm macerating 4h, decoct 2h, filter while hot; Medicinal residues add the water of 4 times amount again, decoct 2h, filter while hot; Merge twice and decoct filtrate; When filtrate is concentrated into 55 DEG C, relative density is the extractum of 1.10 ~ 1.15, then adds pharmaceutically acceptable carrier, is prepared into clinical acceptable dosage form by conventional method.
6. the purposes of pharmaceutical preparation as claimed in claim 1 or 2 in the medicine of preparation treatment male climacteric syndrome.
7. the purposes of pharmaceutical preparation as claimed in claim 1 or 2 in the medicine of preparation treatment liver-kidney yin deficiency male climacteric syndrome.
CN201510907168.5A 2015-12-09 2015-12-09 Pharmaceutical preparation for treating male climacteric syndrome Pending CN105412823A (en)

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