CN105497395A - Traditional Chinese medicine preparation for treating dysmenorrheal as well as preparation method and application of traditional Chinese medicine preparation - Google Patents

Traditional Chinese medicine preparation for treating dysmenorrheal as well as preparation method and application of traditional Chinese medicine preparation Download PDF

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CN105497395A
CN105497395A CN201510977319.4A CN201510977319A CN105497395A CN 105497395 A CN105497395 A CN 105497395A CN 201510977319 A CN201510977319 A CN 201510977319A CN 105497395 A CN105497395 A CN 105497395A
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刘可
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    • 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
    • A61K36/13Coniferophyta (gymnosperms)
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    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/24Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid
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Abstract

The invention discloses a traditional Chinese medicine preparation for treating dysmenorrheal as well as a preparation method and an application of the traditional Chinese medicine preparation. The traditional Chinese medicine preparation for treating dysmenorrheal is prepared from platycladi seeds, clematis roots, corydalis tubers, rhizomes of featherleaf rodgersflower, poria cocos, seeds of Ajowan-caraway, trogopterus dung, Chinese ligusticum rhizomes, root-bark of wild banks roses, biond magnolia flowers, nutgrass galingale rhizomes, cowherb seeds and medcinal evodia fruits. During preparation, the root-bark of wild banks roses and the medcinal evodia fruits are juiced, the platycladi seeds, the clematis roots, the corydalis tubers, the seeds of Ajowan-caraway, the trogopterus dung and the Chinese ligusticum rhizomes are subjected to water extraction, the rhizomes of featherleaf rodgersflower, the biond magnolia flowers and the poria cocos are ground into fine powder, and the nutgrass galingale rhizomes and the cowherb seeds are subjected to alcohol extraction. The raw materials perform a synergistic function and have the effects of fast effects, definite curative effects, high safety and simple medication, the preparation process is simple and environment-friendly, and the traditional Chinese medicine preparation can effectively relieve symptoms such as spastic pains of the lower abdomen, fall-swell, nausea, dizziness, vomit, cold sweat, pale complexion and the like caused by dysmenorrheal, does not have toxic or side effects and provides a new choice for clinically pre-relieving various symptoms caused by dysmenorrheal.

Description

A kind of Chinese medicine preparation for the treatment of dysmenorrhea and its production and use
Technical field
The present invention relates to medical applications technical field, specifically a kind of Chinese medicine preparation for the treatment of dysmenorrhea and its production and use.
Background technology
Dysmenorrhea is common gynecological disease, show as before and after passing through clinically and occur that obvious lower abdomen spasmic pain, falling inflation are felt menstrual period, some patients also has soreness of waist pain sense of discomfort, with feeling sick, dizzy, vomiting phenomenon, the symptoms such as being in a cold sweat even appears in severe patient, pale complexion, deadly cold hand and foot and even severe pain faintness.
Dysmenorrhea is divided into primary dysmenorrhea (also claiming primary dysmenorrhea) and secondary dysmenorrhea two class according to pathogeny.The former refers to the dysmenorrhea that genitals produces without significant organic pathological changes, and the latter refers to produce due to genitals the dysmenorrhea that the pathological changes such as endometriosis, adenomyosis, pelvic inflammatory disease produce.
Show according to domestic sampling survey, in China's female population, dysmenorrhea incidence rate is 33.1%, main the young woman that colony is adolescent girls, unmarried or end is educated occurs, and wherein primary dysmenorrhea accounts for 53.2%.The pathogenic factor of primary dysmenorrhea mainly comprises endocrine factors, uterine factors and spirit, neural factors.Wherein endocrine factors comprises the R-endorphins content height etc. in endometrial prostaglandin height, patient body, uterine factors mainly refers to that uterine hypoplasia causes blood supply exception, uterus machine layer tissue hypoxic-ischemic etc., and spirit, neural factors refer to that the external or inherent threshold of pain that stress cause reduces, thought fear, anxiety and biochemical metabolism material all stimulate pelvic pain fiber by central nervous system.
From the Chinese point of view, the generation of primary dysmenorrhea is mainly because volt or essence and blood element lose in pathogen, and the QI and blood change be more worth before and after menstrual period is too fast, cause uterus QI-blood circulation smooth or lack moisten foster.At present, the medicine of commercially available treatment dysmenorrhea is more, but processing technology is comparatively complicated, and expensive, is difficult to effectively promote.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine preparation for the treatment of dysmenorrhea and its production and use.
For achieving the above object, the invention provides following technical scheme:
Treat a Chinese medicine preparation for dysmenorrhea, be made up of the following raw material according to weight portion: Semen Platycladi 20-30 part, Radix Clematidis 10-20 part, Rhizoma Corydalis 10-20 part, Rhizoma Rodgersiae 8-12 part, Poria 8-12 part, Semen Trachyspermi Ammi 8-12 part, Oletum Trogopterori 5-10 part, Rhizoma Ligustici 5-10 part, Cortex Rosae Normalis Radicis 5-7 part, Flos Magnoliae 5-7 part, Rhizoma Cyperi 3-5 part, Semen Vaccariae 3-5 part, Fructus Evodiae 2-4 part.
As the present invention's further scheme: the Chinese medicine preparation of described treatment dysmenorrhea, be made up of the following raw material according to weight portion: Semen Platycladi 22-28 part, Radix Clematidis 12-18 part, Rhizoma Corydalis 12-18 part, Rhizoma Rodgersiae 9-11 part, Poria 9-11 part, Semen Trachyspermi Ammi 9-11 part, Oletum Trogopterori 6-9 part, Rhizoma Ligustici 6-9 part, Cortex Rosae Normalis Radicis 5.5-6.5 part, Flos Magnoliae 5.5-6.5 part, Rhizoma Cyperi 3.5-4.5 part, Semen Vaccariae 3.5-4.5 part, Fructus Evodiae 2.5-3.5 part.
As the present invention's further scheme: the Chinese medicine preparation of described treatment dysmenorrhea, be made up of the following raw material according to weight portion: Semen Platycladi 25 parts, Radix Clematidis 15 parts, Rhizoma Corydalis 15 parts, Rhizoma Rodgersiae 10 parts, 10 parts, Poria, Semen Trachyspermi Ammi 10 parts, Oletum Trogopterori 8 parts, Rhizoma Ligustici 8 parts, Cortex Rosae Normalis Radicis 6 parts, Flos Magnoliae 6 parts, Rhizoma Cyperi 4 parts, Semen Vaccariae 4 parts, Fructus Evodiae 3 parts.
The preparation method of the Chinese medicine preparation of described treatment dysmenorrhea, concrete steps are as follows:
(1) each raw material is taken according to weight portion;
(2) Cortex Rosae Normalis Radicis and Fructus Evodiae are cleaned, chopping, strand juice, filter impurity, stays juice for subsequent use;
(3) get Semen Platycladi, Radix Clematidis, Rhizoma Corydalis, Semen Trachyspermi Ammi, Oletum Trogopterori and Rhizoma Ligustici to clean, put into container, add the distilled water of 8-10 times amount, after soaking 2-4h, boil 3-4h, extract; Again add 5-7 times amount distilled water, boil 2-4h, extract; Finally, add 3-5 times amount distilled water, heated and boiled 1-2h, extract; Merge three extracting solution, filter, reserved filtrate is for subsequent use;
(4) get Rhizoma Rodgersiae and Flos Magnoliae to clean, section, dries, puts into mortar, grind into powder, crosses 120-140 order fine powder, for subsequent use;
(5) get Rhizoma Cyperi and Semen Vaccariae is cleaned, immerse the alcohol solution dipping 2-3h of 65% of 5-7 times amount, heated and boiled 1-2h, extract, filter, obtain filtrate for subsequent use;
(6) Poria is pulverized, grind into powder, cross 200-220 order fine powder, for subsequent use;
(7) by juice made for above-mentioned steps (2)-(6), filtrate and fine powder mixing, make peroral dosage form through modern science technique, obtain medicine of the present invention.
As the present invention's further scheme: described peroral dosage form is pill, capsule, tablet, powder, granule or oral liquid.
As the present invention's further scheme: described peroral dosage form is capsule.
As the present invention's further scheme: the application of described Chinese medicine preparation in the anti-dysmenorrhea medicine of preparation treatment.
Compared with prior art, the invention has the beneficial effects as follows:
In the present invention, each crude drug synergism plays and has the high and medication of rapid-action, determined curative effect, safety and simply act on, preparation technology is simple, environmentally friendly, can effectively relieving dysmenorrhea cause lower abdomen spasmic pain, falling inflation, feel sick, dizzy, vomit, be in a cold sweat, the symptom such as pale complexion, do not have toxic and side effects, the various symptoms caused for clinical pre-relieving dysmenorrhea provide a newly selection.
Detailed description of the invention
Be described in more detail below in conjunction with the technical scheme of detailed description of the invention to this patent.
Embodiment 1
Treat a Chinese medicine preparation for dysmenorrhea, be made up of the following raw material according to weight portion: Semen Platycladi 20 parts, Radix Clematidis 10 parts, Rhizoma Corydalis 10 parts, Rhizoma Rodgersiae 8 parts, 8 parts, Poria, Semen Trachyspermi Ammi 8 parts, Oletum Trogopterori 5 parts, Rhizoma Ligustici 5 parts, Cortex Rosae Normalis Radicis 5 parts, Flos Magnoliae 5 parts, Rhizoma Cyperi 3 parts, Semen Vaccariae 3 parts, Fructus Evodiae 2 parts.
The preparation method of the Chinese medicine preparation of described treatment dysmenorrhea, concrete steps are as follows:
(1) each raw material is taken according to weight portion;
(2) Cortex Rosae Normalis Radicis and Fructus Evodiae are cleaned, chopping, strand juice, filter impurity, stays juice for subsequent use;
(3) get Semen Platycladi, Radix Clematidis, Rhizoma Corydalis, Semen Trachyspermi Ammi, Oletum Trogopterori and Rhizoma Ligustici to clean, put into container, add the distilled water of 8 times amount, after soaking 2h, boil 3h, extract; Again add 5 times amount distilled water, boil 2h, extract; Finally, add 3 times amount distilled water, heated and boiled 1h, extract; Merge three extracting solution, filter, reserved filtrate is for subsequent use;
(4) get Rhizoma Rodgersiae and Flos Magnoliae to clean, section, dries, puts into mortar, grind into powder, crosses 120 order fine powders, for subsequent use;
(5) get Rhizoma Cyperi and Semen Vaccariae is cleaned, immerse the alcohol solution dipping 2h of 65% of 5 times amount, heated and boiled 1h, extract, filter, obtain filtrate for subsequent use;
(6) Poria is pulverized, grind into powder, cross 200 order fine powders, for subsequent use;
(7) by juice made for above-mentioned steps (2)-(6), filtrate and fine powder mixing, be made for pill through modern science technique, obtain medicine of the present invention.
Usage and dosage: half an hour is oral after meal.A 3-5g, 3 times on the one one month is a course for the treatment of.
Embodiment 2
Treat a Chinese medicine preparation for dysmenorrhea, be made up of the following raw material according to weight portion: Semen Platycladi 22 parts, Radix Clematidis 12 parts, Rhizoma Corydalis 12 parts, Rhizoma Rodgersiae 9 parts, 9 parts, Poria, Semen Trachyspermi Ammi 9 parts, Oletum Trogopterori 6 parts, Rhizoma Ligustici 6 parts, Cortex Rosae Normalis Radicis 5.5 parts, Flos Magnoliae 5.5 parts, Rhizoma Cyperi 3.5 parts, Semen Vaccariae 3.5 parts, Fructus Evodiae 2.5 parts.
The preparation method of the Chinese medicine preparation of described treatment dysmenorrhea, concrete steps are as follows:
(1) each raw material is taken according to weight portion;
(2) Cortex Rosae Normalis Radicis and Fructus Evodiae are cleaned, chopping, strand juice, filter impurity, stays juice for subsequent use;
(3) get Semen Platycladi, Radix Clematidis, Rhizoma Corydalis, Semen Trachyspermi Ammi, Oletum Trogopterori and Rhizoma Ligustici to clean, put into container, add the distilled water of 8.5 times amount, after soaking 2.5h, boil 3.2h, extract; Again add 5.5 times amount distilled water, boil 2.5h, extract; Finally, add 3.5 times amount distilled water, heated and boiled 1.2h, extract; Merge three extracting solution, filter, reserved filtrate is for subsequent use;
(4) get Rhizoma Rodgersiae and Flos Magnoliae to clean, section, dries, puts into mortar, grind into powder, crosses 125 order fine powders, for subsequent use;
(5) get Rhizoma Cyperi and Semen Vaccariae is cleaned, immerse the alcohol solution dipping 2.2h of 65% of 5.5 times amount, heated and boiled 1.2h, extract, filter, obtain filtrate for subsequent use;
(6) Poria is pulverized, grind into powder, cross 205 order fine powders, for subsequent use;
(7) by juice made for above-mentioned steps (2)-(6), filtrate and fine powder mixing, be made for tablet through modern science technique, obtain medicine of the present invention.
Usage and dosage: half an hour is oral after meal.A 3-5g, 3 times on the one one month is a course for the treatment of.
Embodiment 3
Treat a Chinese medicine preparation for dysmenorrhea, be made up of the following raw material according to weight portion: Semen Platycladi 25 parts, Radix Clematidis 15 parts, Rhizoma Corydalis 15 parts, Rhizoma Rodgersiae 10 parts, 10 parts, Poria, Semen Trachyspermi Ammi 10 parts, Oletum Trogopterori 8 parts, Rhizoma Ligustici 8 parts, Cortex Rosae Normalis Radicis 6 parts, Flos Magnoliae 6 parts, Rhizoma Cyperi 4 parts, Semen Vaccariae 4 parts, Fructus Evodiae 3 parts.
The preparation method of the Chinese medicine preparation of described treatment dysmenorrhea, concrete steps are as follows:
(1) each raw material is taken according to weight portion;
(2) Cortex Rosae Normalis Radicis and Fructus Evodiae are cleaned, chopping, strand juice, filter impurity, stays juice for subsequent use;
(3) get Semen Platycladi, Radix Clematidis, Rhizoma Corydalis, Semen Trachyspermi Ammi, Oletum Trogopterori and Rhizoma Ligustici to clean, put into container, add the distilled water of 9 times amount, after soaking 3h, boil 3.5h, extract; Again add 6 times amount distilled water, boil 3h, extract; Finally, add 4 times amount distilled water, heated and boiled 1.5h, extract; Merge three extracting solution, filter, reserved filtrate is for subsequent use;
(4) get Rhizoma Rodgersiae and Flos Magnoliae to clean, section, dries, puts into mortar, grind into powder, crosses 130 order fine powders, for subsequent use;
(5) get Rhizoma Cyperi and Semen Vaccariae is cleaned, immerse the alcohol solution dipping 2.5h of 65% of 6 times amount, heated and boiled 1.5h, extract, filter, obtain filtrate for subsequent use;
(6) Poria is pulverized, grind into powder, cross 210 order fine powders, for subsequent use;
(7) by juice made for above-mentioned steps (2)-(6), filtrate and fine powder mixing, be made for capsule through modern science technique, obtain medicine of the present invention.
Usage and dosage: half an hour is oral after meal.A 3-5g, 3 times on the one one month is a course for the treatment of.
Embodiment 4
Treat a Chinese medicine preparation for dysmenorrhea, be made up of the following raw material according to weight portion: Semen Platycladi 28 parts, Radix Clematidis 18 parts, Rhizoma Corydalis 18 parts, Rhizoma Rodgersiae 11 parts, 11 parts, Poria, Semen Trachyspermi Ammi-11 parts, Oletum Trogopterori 9 parts, Rhizoma Ligustici 9 parts, Cortex Rosae Normalis Radicis 6.5 parts, Flos Magnoliae 6.5 parts, Rhizoma Cyperi 4.5 parts, Semen Vaccariae 4.5 parts, Fructus Evodiae 3.5 parts.
The preparation method of the Chinese medicine preparation of described treatment dysmenorrhea, concrete steps are as follows:
(1) each raw material is taken according to weight portion;
(2) Cortex Rosae Normalis Radicis and Fructus Evodiae are cleaned, chopping, strand juice, filter impurity, stays juice for subsequent use;
(3) get Semen Platycladi, Radix Clematidis, Rhizoma Corydalis, Semen Trachyspermi Ammi, Oletum Trogopterori and Rhizoma Ligustici to clean, put into container, add the distilled water of 9.5 times amount, after soaking 3.5h, boil 3.8h, extract; Again add 6.5 times amount distilled water, boil 3.5h, extract; Finally, add 4.5 times amount distilled water, heated and boiled 1.8h, extract; Merge three extracting solution, filter, reserved filtrate is for subsequent use;
(4) get Rhizoma Rodgersiae and Flos Magnoliae to clean, section, dries, puts into mortar, grind into powder, crosses 135 order fine powders, for subsequent use;
(5) get Rhizoma Cyperi and Semen Vaccariae is cleaned, immerse the alcohol solution dipping 2.8h of 65% of 6.5 times amount, heated and boiled 1.8h, extract, filter, obtain filtrate for subsequent use;
(6) Poria is pulverized, grind into powder, cross 215 order fine powders, for subsequent use;
(7) by juice made for above-mentioned steps (2)-(6), filtrate and fine powder mixing, be made for oral liquid through modern science technique, obtain medicine of the present invention.
Usage and dosage: half an hour is oral after meal.A 3-5g, 3 times on the one one month is a course for the treatment of.
Embodiment 5
Treat a Chinese medicine preparation for dysmenorrhea, be made up of the following raw material according to weight portion: Semen Platycladi 30 parts, Radix Clematidis 20 parts, Rhizoma Corydalis 20 parts, Rhizoma Rodgersiae 12 parts, 12 parts, Poria, Semen Trachyspermi Ammi 12 parts, Oletum Trogopterori 10 parts, Rhizoma Ligustici 10 parts, Cortex Rosae Normalis Radicis 7 parts, Flos Magnoliae 7 parts, Rhizoma Cyperi 5 parts, Semen Vaccariae 5 parts, Fructus Evodiae 4 parts.
The preparation method of the Chinese medicine preparation of described treatment dysmenorrhea, concrete steps are as follows:
(1) each raw material is taken according to weight portion;
(2) Cortex Rosae Normalis Radicis and Fructus Evodiae are cleaned, chopping, strand juice, filter impurity, stays juice for subsequent use;
(3) get Semen Platycladi, Radix Clematidis, Rhizoma Corydalis, Semen Trachyspermi Ammi, Oletum Trogopterori and Rhizoma Ligustici to clean, put into container, add the distilled water of 10 times amount, after soaking 4h, boil 4h, extract; Again add 7 times amount distilled water, boil 4h, extract; Finally, add 5 times amount distilled water, heated and boiled 2h, extract; Merge three extracting solution, filter, reserved filtrate is for subsequent use;
(4) get Rhizoma Rodgersiae and Flos Magnoliae to clean, section, dries, puts into mortar, grind into powder, crosses 140 order fine powders, for subsequent use;
(5) get Rhizoma Cyperi and Semen Vaccariae is cleaned, immerse the alcohol solution dipping 3h of 65% of 7 times amount, heated and boiled 2h, extract, filter, obtain filtrate for subsequent use;
(6) Poria is pulverized, grind into powder, cross 220 order fine powders, for subsequent use;
(7) by juice made for above-mentioned steps (2)-(6), filtrate and fine powder mixing, be made for granule through modern science technique, obtain medicine of the present invention.
Usage and dosage: half an hour is oral after meal.A 3-5g, 3 times on the one one month is a course for the treatment of.
Comparative example 1
Treat a Chinese medicine preparation for dysmenorrhea, be made up of the following raw material according to weight portion: Semen Platycladi 22 parts, Radix Clematidis 12 parts, Rhizoma Corydalis 12 parts, 9 parts, Poria, Semen Trachyspermi Ammi 9 parts, Oletum Trogopterori 6 parts, Rhizoma Ligustici 6 parts, Cortex Rosae Normalis Radicis 5.5 parts, Flos Magnoliae 5.5 parts, Rhizoma Cyperi 3.5 parts, Semen Vaccariae 3.5 parts, Fructus Evodiae 2.5 parts.
The preparation method of the Chinese medicine preparation of described treatment dysmenorrhea, concrete steps are as follows:
(1) each raw material is taken according to weight portion;
(2) Cortex Rosae Normalis Radicis and Fructus Evodiae are cleaned, chopping, strand juice, filter impurity, stays juice for subsequent use;
(3) get Semen Platycladi, Radix Clematidis, Rhizoma Corydalis, Semen Trachyspermi Ammi, Oletum Trogopterori and Rhizoma Ligustici to clean, put into container, add the distilled water of 8.5 times amount, after soaking 2.5h, boil 3.2h, extract; Again add 5.5 times amount distilled water, boil 2.5h, extract; Finally, add 3.5 times amount distilled water, heated and boiled 1.2h, extract; Merge three extracting solution, filter, reserved filtrate is for subsequent use;
(4) get Flos Magnoliae to clean, section, dries, puts into mortar, grind into powder, crosses 125 order fine powders, for subsequent use;
(5) get Rhizoma Cyperi and Semen Vaccariae is cleaned, immerse the alcohol solution dipping 2.2h of 65% of 5.5 times amount, heated and boiled 1.2h, extract, filter, obtain filtrate for subsequent use;
(6) Poria is pulverized, grind into powder, cross 205 order fine powders, for subsequent use;
(7) by juice made for above-mentioned steps (2)-(6), filtrate and fine powder mixing, be made for tablet through modern science technique, obtain medicine of the present invention.
Usage and dosage: half an hour is oral after meal.A 3-5g, 3 times on the one one month is a course for the treatment of.
Comparative example 2
Treat a Chinese medicine preparation for dysmenorrhea, be made up of the following raw material according to weight portion: Semen Platycladi 28 parts, Radix Clematidis 18 parts, Rhizoma Corydalis 18 parts, Rhizoma Rodgersiae 11 parts, 11 parts, Poria, Semen Trachyspermi Ammi-11 parts, Oletum Trogopterori 9 parts, Rhizoma Ligustici 9 parts, Cortex Rosae Normalis Radicis 6.5 parts, Rhizoma Cyperi 4.5 parts, Semen Vaccariae 4.5 parts, Fructus Evodiae 3.5 parts.
The preparation method of the Chinese medicine preparation of described treatment dysmenorrhea, concrete steps are as follows:
(1) each raw material is taken according to weight portion;
(2) Cortex Rosae Normalis Radicis and Fructus Evodiae are cleaned, chopping, strand juice, filter impurity, stays juice for subsequent use;
(3) get Semen Platycladi, Radix Clematidis, Rhizoma Corydalis, Semen Trachyspermi Ammi, Oletum Trogopterori and Rhizoma Ligustici to clean, put into container, add the distilled water of 9.5 times amount, after soaking 3.5h, boil 3.8h, extract; Again add 6.5 times amount distilled water, boil 3.5h, extract; Finally, add 4.5 times amount distilled water, heated and boiled 1.8h, extract; Merge three extracting solution, filter, reserved filtrate is for subsequent use;
(4) get Rhizoma Rodgersiae to clean, section, dries, puts into mortar, grind into powder, crosses 135 order fine powders, for subsequent use;
(5) get Rhizoma Cyperi and Semen Vaccariae is cleaned, immerse the alcohol solution dipping 2.8h of 65% of 6.5 times amount, heated and boiled 1.8h, extract, filter, obtain filtrate for subsequent use;
(6) Poria is pulverized, grind into powder, cross 215 order fine powders, for subsequent use;
(7) by juice made for above-mentioned steps (2)-(6), filtrate and fine powder mixing, be made for oral liquid through modern science technique, obtain medicine of the present invention.
Usage and dosage: half an hour is oral after meal.A 3-5g, 3 times on the one one month is a course for the treatment of.
Embodiment 6
Clinical trial
(1) subjects: adopt the present invention to treat 300 examples altogether, the oldest person 32 years old, age reckling 14 years old;
(2) diagnostic criteria: Western medicine diagnose is according to " newly organized practical gynecology " (Su Yingkuan, Shandong science tech publishing house, 2005).Menstrual period or before and after row lower abdomen pain, pain and waist energy, very then faint, in periodical attack; Tcm diagnosis is according to " stomach faces card record by heavenly maiden section to be wanted " (stomach capital is raw, stomach ripple, Wang Maoni, etc., People's Health Publisher, 2010:193).
(3) exclusion standard: have significant organic pathological changes person through gynecologial examination; Those who are allergic to this drug; Be associated with cardiovascular; Severe primary disease, the psychotics such as liver, kidney and hemopoietic system; Menstrual cycle is irregular, and affect the treatment judgement person; Do not take medicine by regulation, cannot judge that curative effect or data are not congruent and affect the treatment or safety judgement person.
(4) Therapeutic Method: 300 routine patients are equally divided into five groups, often organize 60 examples, one group, two groups and three groups are test group, one group, two groups and three components do not take the Chinese medicine preparation of the treatment dysmenorrhea of the present invention that embodiment 1-embodiment 3 prepares, four groups and five groups is matched group, four groups and the five groups Chinese medicine preparation taken comparative example 1 and comparative example 2 respectively and prepare, usage and dosage: half an hour is oral after meal.A 3-5g, 3 times on the one one month is a course for the treatment of.After taking 3 courses for the treatment of continuously, add up the therapeutic outcome of five groups, observe the untoward reaction that treatments period patient occurs simultaneously.
(5) standard is observed: clinical symptoms, scoring situation, untoward reaction.
(6) criterion of therapeutical effect and tcm symptom improve situation:
Dysmenorrhea criterion of therapeutical effect formulates dysmenorrhea curative effect determinate standard with reference to " guideline of clinical investigations for the treatment of by Chinese herbs dysmenorrhea ": dysmenorrhea integration evaluation criteria is as shown in table 1:
Table 1: dysmenorrhea integration evaluation criteria
(7) therapeutic effect: curative effect determinate standard adopts in " guideline of clinical investigations for the treatment of by Chinese herbs dysmenorrhea ", therapeutic index=[before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100.
Recovery from illness: stomachache and other transference cures, drug withdrawal 3 non-recidivists of menstrual cycle, integration reduces >=95%;
Effective: stomachache obviously alleviates, all the other symptoms take a turn for the better, and drug withdrawal 3 menstrual cycle symptoms do not increase the weight of, and after 90% > treatment, integration reduces >=70%;
Effective: stomachache alleviates, other symptoms take a turn for the better, though symptom repeatedly, comparatively alleviates before treatment after drug withdrawal, after 70% > treatment, integration reduces >=30%;
Invalid: stomachache and other symptoms are without change or add severe one, and after treatment, integration reduces < 30%.
(8) therapeutic outcome: how to take effect after 5 days after taking medicine in Patients with 300 Cases case, 2-3 the course for the treatment of cures; Wherein cure 107 examples, effective 76 examples, effective 62 examples, invalid 55 examples, total effective rate reaches 81.6%, and therapeutic outcome is as shown in table 2:
Table 2: clinical trial therapeutic outcome
As shown in Table 2, the average effectiveness level adopting the Chinese medicine preparation for the treatment of dysmenorrhea of the present invention to carry out treating reaches 95%, and the effective percentage of the pharmaceutical composition adopting comparative example to prepare only has 61.7%, therefore, between medicine of the present invention, there is synergistic function, add the effective percentage of Chinese medicine preparation.
Model case:
(1) Zhu, 17 years old.Patient is from 15 the beginning of the year tides, and at every turn through row lower abdomen sharp ache, menoxenia, more or less, pain is radiated to waist and femoribus internus to amount, especially acute through row the 1st day pain, recovery after clean.After before in the period and use Chinese medicine preparation of the present invention menstrual period, pain obviously alleviates, and within second month, continues to use, and time in the period to three month, dysmenorrhea transference cure, after drug withdrawal, follows up a case by regular visits to and do not recur again.
(2) Zhang, 35 years old, oneself wedded, and closely over the past half year during menstrual onset, lower abdomen hurt like hell, the companion whole body is weak, and lower abdomen falling inflation is obvious, and many through measuring, color is dark red block.Ultrasound diagnosis is shown: left side attachment is shown in inflammatory mass.Examine as chronic pelvic inflammatory disease.Give invention formulation, take 2 courses for the treatment of continuously, the eumenorrhea, inflammation disappears, and pain disappears, and follows up a case by regular visits to have no and do not recur after half a year.
(3) grandson so-and-so, 26 years old, lower abdominal pain was examined for 4 hours.Be on tenterhooks, lusterless complexion, face pain, pitching must not.Tell lower abdominal pain violent unbearably, distending pain is main, and menstruation is fitted extremely, accompanies clot.The rule of menstruation usually, a folder clot, amount is many.Be in a very depressed state and do not dredge, often to menstruation, then hypogastralgia feeling of distension and oppression is uncomfortable, and medical history for many years.Body of the tongue is dark and gloomy livid purple, while there is tired purple, and thin fur and yellow, deep and hesitant pulse.Dialectical analysis: patient menstrual measures many, consumption impairment of YIN blood, deficiency of YIN-blood, Liver Channel loses supports, thus depressed joyless, and irritability is not dredged, the cloudy stagnation of QI of fainting, uterus insufficiency of vital energy and blood in addition tired stagnant obstructed so that sharp ache.Deficiency of YIN-blood is then shown in lusterless complexion.Menstruation accompanies clot, and picture of the tongue, pulse condition are outside deficiency of YIN-blood, the tired stagnation of QI of blood and resemble.Control with easing the affected liver yin nourishing, loose tired method of regulating the flow of vital energy.According to the prescription of above-described embodiment 3,1 dose of alleviation of pain of taking medicine, serve on 6 doses, and all cards are eliminated.
(4) bent certain, 32 years old, dysmenorrhea healed for a long time and not, stomachache pain lower abdomen under umbilicus, and first day of rising stomachache is very acute, and to finding that film sample is shown in again a burst of severe pain before coming off, clot falls then alleviation of pain then, red tongue, stringy pulse, is diagnosed as hot pain; Yu Jinghang starts to take Chinese medicine preparation of the present invention for first 5 days, and after taking 3 menstrual cycle, dysmenorrhea transference cure, continuous 3 menstrual cycle do not recur.
(5) Korea Spro so-and-so, female, 23 years old, the recent exacerbation of symptoms of the long-term dysmenorrhea of patient's readme, during dysmenorrhea complexion turn white, be in a cold sweat, general weakness, extreme cold of the limbs, within nearly two months, there is metrorrhagia symptom continuously.After three courses for the treatment of of patient consumes, during the physiology phase, dysmenorrhea symptom makes moderate progress, and after continuing again to take medicine one month, physiology phase glucose recovery is normal, after follow up a case by regular visits in this year without recurring.
The present invention is the good effect that has in treatment dysmenorrhea, below by animal efficacy data in addition further instruction:
One, Chinese medicine preparation animal acute toxicity test of the present invention:
1. trial drug: the Traditional Chinese medicine capsule preparation that in the present invention, embodiment 3 prepares.
2. experimental animal: regular grade NIH mice 12, body weight 19 ± 3g, male and female half and half.
3. test method: be divided into blank group at random, fasting was tested after 16 hours, administration group gives capsule suspension of the present invention (capsule 's content and water 1:1 are in harmonious proportion and form) by the dosage gavage of 0.4g/l0g, presses the dosage gastric infusion of 0.4g/l0g more once, twice totally after 6 hours.Meanwhile blank group gavage gives consubstantiality hydrops, raises seven days to observation post administration, the reaction of record mouse toxicity and death condition, and observes the change of its main organs and tissue.
4. result of the test: after seven days, mice is without death in administration, and behavior is active, and food ration is as usual, hair color light is without loose dirty, and without fainting from fear addicted to saliva, eye, mouth, nose, ear and crissum secretions without exception, without the rotten toe of docking.Put to death mice, dissect, observe the main organs such as its heart, liver, lung, kidney and organize and see exception, show the oral safety of this medicine.
Two, Chinese medicine preparation long-term toxicity test for animals of the present invention:
1. trial drug: the Traditional Chinese medicine capsule preparation that in the present invention, embodiment 3 prepares.
2. experimental animal: regular grade SD rat 36, body weight 175 scholar 16g, male and female half and half, are divided into 3 groups at random.
3. test method:
Pharmaceutical formulations: point high and low, blank three dosage groups, are respectively 100,50,0 times of clinical application amount.
Experiment adopts gastric infusion mode, all by the capacity gastric infusion of 1m1/100g, and successive administration 90 days; Give blank group every day the distilled water of the capacity of grade, then every treated animal puts to death 4, becomes celestial to carry out perusal to each organs and tissues of animal, and makes pathologic finding to organs such as the heart, liver, spleen, lung, kidney, adrenal gland, thymus.
4. result of the test:
1) each treated animal tested period feed, drinking-water, defecation are all normal, and sport health is active, by hair gloss, do not find death and other ANOMALOUS VARIATIONS.
2) each treated animal body weight increases normal, and administration group compares there was no significant difference (P>0.05) with matched group.
3) after experiment, each treated animal hepatic and renal function and serum biochemistry measurement result compare there was no significant difference with matched group.
4) after experiment, each treated animal hemogram checking compares there was no significant difference with matched group.
5) each treated animal heart, liver, spleen, lung, kidney, adrenal gland, thymus outward appearance and its organ index there are no significant difference.
6) each treated animal is the same with matched group, the size and form of the organs such as the heart, liver, spleen, lung, kidney is normal, smooth surface, without hemorrhage, adhesion or necrosis, histological examination is respectively organized internal organs and is showed no organic disease, cardiac muscle fiber is without degeneration or necrosis, and structure is normal, and lung tissue and spleen organize also no abnormality seen to change, hepatocyte and the change all without exception of the structure such as glomerule, renal tubules, namely relevant with drug metabolism important organ is all without obviously changing.
Three, Chinese medicine preparation of the present invention is on the impact of syndrome of qi stagnation and blood stasis rat ovary function:
1. trial drug: invention Chinese medicine preparation; Animals administer dosage is pressed body surface area conversion coefficient and is calculated: the multiple (the clinical every consumption per day of people calculates by 3g, and body weight gets 60kg) of animals administer dosage=people quantity × 0.018/200 × 1000 × clinical equivalent amount.
2. laboratory animal: female sd inbred rats, body weight 180-220g.
3. modeling and grouping: after rat adaptability raises 7d, be divided into matched group, model group, positive drug control group (aspirin 0.1g/kg), medicine high dose group (5.4g/kg of the present invention at random, be equivalent to 20 times of people's consumption), dosage group (2.7g/kg in medicine of the present invention, be equivalent to 10 times of people's consumption), medicine low dose group (1.35g/kg of the present invention, be equivalent to 5 times of people's consumption), often organize 8.Except matched group, all the other five groups, all inject hydrochloric acid epinephrine inj by 0.8mg/kgd, chronic unpredictable sexual stimulus (A: put upside down round the clock is accepted after 4h, B:0-4 DEG C of frozen water swimming 4min, C:50 DEG C of baking oven baking the affected part after applying some drugs l0min, D:60dB noise stimulation 3h, E: outstanding tail l0min, give a kind of stimulation at random) at every turn, continuous 14d, from 7d, this is not by the dosage gastric infusion of each group of regulation, continuous 7d, after the 15th day chloral hydrate anesthesia, common carotid artery gets blood, measures the content of plasma estradiol (E2), progesterone (P).
4. statistical method application SPSS16.0 statistical software statistics, all data represent with x ± s, compare and adopt t inspection between group.
5. result: Chinese medicine preparation of the present invention on syndrome of qi stagnation and blood stasis rat ovary function to affect result as shown in table 3;
Table 3: Chinese medicine preparation of the present invention is on the impact of syndrome of qi stagnation and blood stasis rat ovary function
Group E2(μg/L) P(μg/L)
Matched group 158.64±22.43 115.22±13.15
Model group 58.12±20.48** 169.77±20.44**
Positive drug control group 103.61±18.69** 141.32±17.15**
High dose group of the present invention 115.23±18.47**# 130.69±18.24**##
Dosage group in the present invention 107.36±17.41**# 134.62±17.19**#
Low dose group of the present invention 98.55±20.46**# 143.54±18.91**
Note: compared with matched group, * * P<0.01, compared with positive drug control group, #P<0.05, ##P<0.01.
As shown in Table 3, compared with matched group, model group rats blood plasma E2 content significantly reduces (P<0.01), and P content significantly raises, and ((P<0.01) shows modeling success.
After giving positive control drug and invention formulation, compared with model group, each administration group rat plasma E2 content significantly raises (P<0.01), and P content significantly reduces (P<0.01).Each administration group is compared, certain dose-effect relationship is there is between the dosage of pharmaceutical preparation of the present invention and E2 and P content, senior middle school's dosage group is compared with positive control drug group, E2 content and P content have significant difference (P<0.05), illustrate that medicine of the present invention can be treated qi stagnation and blood stasis type rat ovary and be had regulating action, make it regulate to normal level.
In the present invention, each crude drug synergism plays and has the high and medication of rapid-action, determined curative effect, safety and simply act on, preparation technology is simple, environmentally friendly, can effectively relieving dysmenorrhea cause lower abdomen spasmic pain, falling inflation, feel sick, dizzy, vomit, be in a cold sweat, the symptom such as pale complexion, do not have toxic and side effects, the various symptoms caused for clinical pre-relieving dysmenorrhea provide a newly selection.
Above the better embodiment of this patent is explained in detail, but this patent is not limited to above-mentioned embodiment, in the ken that one skilled in the relevant art possesses, various change can also be made under the prerequisite not departing from this patent aim.

Claims (7)

1. treat the Chinese medicine preparation of dysmenorrhea for one kind, it is characterized in that, be made up of the following raw material according to weight portion: Semen Platycladi 20-30 part, Radix Clematidis 10-20 part, Rhizoma Corydalis 10-20 part, Rhizoma Rodgersiae 8-12 part, Poria 8-12 part, Semen Trachyspermi Ammi 8-12 part, Oletum Trogopterori 5-10 part, Rhizoma Ligustici 5-10 part, Cortex Rosae Normalis Radicis 5-7 part, Flos Magnoliae 5-7 part, Rhizoma Cyperi 3-5 part, Semen Vaccariae 3-5 part, Fructus Evodiae 2-4 part.
2. the Chinese medicine preparation for the treatment of dysmenorrhea according to claim 1, it is characterized in that, be made up of the following raw material according to weight portion: Semen Platycladi 22-28 part, Radix Clematidis 12-18 part, Rhizoma Corydalis 12-18 part, Rhizoma Rodgersiae 9-11 part, Poria 9-11 part, Semen Trachyspermi Ammi 9-11 part, Oletum Trogopterori 6-9 part, Rhizoma Ligustici 6-9 part, Cortex Rosae Normalis Radicis 5.5-6.5 part, Flos Magnoliae 5.5-6.5 part, Rhizoma Cyperi 3.5-4.5 part, Semen Vaccariae 3.5-4.5 part, Fructus Evodiae 2.5-3.5 part.
3. according to the Chinese medicine preparation of the arbitrary described treatment dysmenorrhea of claim 1-2, it is characterized in that, be made up of the following raw material according to weight portion: Semen Platycladi 25 parts, Radix Clematidis 15 parts, Rhizoma Corydalis 15 parts, Rhizoma Rodgersiae 10 parts, 10 parts, Poria, Semen Trachyspermi Ammi 10 parts, Oletum Trogopterori 8 parts, Rhizoma Ligustici 8 parts, Cortex Rosae Normalis Radicis 6 parts, Flos Magnoliae 6 parts, Rhizoma Cyperi 4 parts, Semen Vaccariae 4 parts, Fructus Evodiae 3 parts.
4. a preparation method for the Chinese medicine preparation of the treatment dysmenorrhea as described in as arbitrary in claim 1-2, it is characterized in that, concrete steps are as follows:
(1) each raw material is taken according to weight portion;
(2) Cortex Rosae Normalis Radicis and Fructus Evodiae are cleaned, chopping, strand juice, filter impurity, stays juice for subsequent use;
(3) get Semen Platycladi, Radix Clematidis, Rhizoma Corydalis, Semen Trachyspermi Ammi, Oletum Trogopterori and Rhizoma Ligustici to clean, put into container, add the distilled water of 8-10 times amount, after soaking 2-4h, boil 3-4h, extract; Again add 5-7 times amount distilled water, boil 2-4h, extract; Finally, add 3-5 times amount distilled water, heated and boiled 1-2h, extract; Merge three extracting solution, filter, reserved filtrate is for subsequent use;
(4) get Rhizoma Rodgersiae and Flos Magnoliae to clean, section, dries, puts into mortar, grind into powder, crosses 120-140 order fine powder, for subsequent use;
(5) get Rhizoma Cyperi and Semen Vaccariae is cleaned, immerse the alcohol solution dipping 2-3h of 65% of 5-7 times amount, heated and boiled 1-2h, extract, filter, obtain filtrate for subsequent use;
(6) Poria is pulverized, grind into powder, cross 200-220 order fine powder, for subsequent use;
(7) by juice made for above-mentioned steps (2)-(6), filtrate and fine powder mixing, make peroral dosage form through modern science technique, obtain medicine of the present invention.
5. the preparation method of the Chinese medicine preparation for the treatment of dysmenorrhea according to claim 4, is characterized in that, described peroral dosage form is pill, capsule, tablet, powder, granule or oral liquid.
6. the preparation method of the Chinese medicine preparation for the treatment of dysmenorrhea according to claim 5, is characterized in that, described peroral dosage form is capsule.
7. one kind as arbitrary in claim 1-2 as described in the application of Chinese medicine preparation in preparation treatment dysmenorrhea medicine.
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