CN1814110A - Medicine for treating gynecophathy - Google Patents
Medicine for treating gynecophathy Download PDFInfo
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- CN1814110A CN1814110A CN 200510101861 CN200510101861A CN1814110A CN 1814110 A CN1814110 A CN 1814110A CN 200510101861 CN200510101861 CN 200510101861 CN 200510101861 A CN200510101861 A CN 200510101861A CN 1814110 A CN1814110 A CN 1814110A
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- angelicae sinensis
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Abstract
The invention is a medicine for curing gynaopathy and the preparing method thereof, having characters of good solubility, high human biological utilization ratio, etc, and obtaining medicinal extracts from the eleven medicinal materials- Nutgrass Galingale Rhizome (prepared with vinegar), Rhizoma Chuanxiong, Chinese Angelica, Rhizoma Corydalis(prepared with vinegar), largehead atractylodes Rhizome, liquorice root, Chinese Date, White Paeony Root, Red Paeony Root, Rehmannia(Cooked), calcium carbonate, and making them together with dispersive medium, suspending aid, antiseptic and emulsifier into capsules; or making them together with filling agent, releasing agent, wetter and lubricant into dispersive tablets; or making them into other oral preparations. The process research shows that the peony glucoside content of the medicine can be higher in the accelerated stability test.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of medicine for the treatment of gynaecopathia and preparation method thereof.
Background technology
Gynecological ten flavor is genuine gynecological key medicines such as selected Rhizoma Cyperi, Rhizoma Chuanxiong, Radix Angelicae Sinensis, follow the characteristics of Chinese medical theory and gynaecopathia and develop have liver-smoothing, qi-regulating, a first classics side of the effect of nourishing blood for regulating menstruation.Tablet of ten ingredients for woman diseases is listed " 2005 editions one one of Chinese Pharmacopoeia in.This product is treated the menoxenia that modern women's hepatic depression and blood deficiency stagnation of QI causes, menalgia, and amenorrhea etc. cards is evident in efficacy, and by clinical observation, utilization this product has excellent curative to menoxenia due to the clinical common hepatic depression and blood deficiency stagnation of QI, dysmenorrhea, amenorrhea.But former dosage form technical characterstic be ten simply medicinal substances extract add appropriate amount of auxiliary materials and make tablet.Along with the continuous variation of environment and human to the adaptive variation of medicine, people have had higher requirement for the bioavailability and the drug effect of Chinese medicine.
Summary of the invention
The present invention makes soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or oral cavity disintegration tablet or effervescent tablet or micropill or granule by with adding appropriate amount of auxiliary materials in gynecological's ten flavor prescription Chinese crude drug extracts.
Drug regimen of the present invention is: Rhizoma Cyperi (processed with vinegar), Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Corydalis (processed with vinegar), the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Fructus Jujubae, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Radix Rehmanniae Preparata, the treated medicinal substances extract of making of calcium carbonate, make soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or oral cavity disintegration tablet or effervescent tablet or micropill or granule with pharmaceutically alleged adjuvant or substrate.
Or be preferably:
Rhizoma Cyperi 24～72%, Rhizoma Chuanxiong 1～3%, Radix Angelicae Sinensis 9～26%, Rhizoma Corydalis 2～6%, the Rhizoma Atractylodis Macrocephalae 1～4%,
Radix Glycyrrhizae, the Radix Paeoniae Alba, Radix Paeoniae Rubra each 1～2%, Fructus Jujubae 5～15%, Radix Rehmanniae Preparata, calcium carbonate each 3～9%
Make soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or oral cavity disintegration tablet or effervescent tablet or micropill or granule with pharmaceutically alleged adjuvant or substrate; Or more preferably:
Rhizoma Cyperi (processed with vinegar) 500g Rhizoma Chuanxiong 20g Radix Angelicae Sinensis 180g Rhizoma Corydalis (processed with vinegar) 40g
Rhizoma Atractylodis Macrocephalae 28.75g Radix Glycyrrhizae 13.75g Fructus Jujubae 100g Radix Paeoniae Alba 15g
Radix Paeoniae Rubra 15g Radix Rehmanniae Preparata 60g calcium carbonate 65g makes soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or granule or oral cavity disintegration tablet or effervescent tablet or micropill with pharmaceutically alleged adjuvant or substrate; Make 1000 slice, or its integral multiple.
The present invention is achieved in that
The preparation soft capsule:
1. above ten simply, and 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol; Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder;
2. modulate capsule liquid: get above-mentioned medicinal substances extract, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, additives etc., stir, after the degassing, insulation is left standstill, and makes the capsule material;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
The disperse medium of making soft capsule is: olive oil or other crude vegetals; or triglyceride oils; or oleic acid sorbitol ester; or olein: propylene glycol is 90: 10 mixture by weight; or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters; or Oleum Cocois C8/C10 propylene glycol ester; or Oleum Cocois triglyceride; or the acetylizad monoglyceride of purification; or olein; or glyceryl linoleate, or Polyethylene Glycol glyceryl laurate ester, or in the purification Oleum helianthi monoglyceride one or more.
The suspending agent of soft capsule is: can increase the solid matter of disperse medium viscosity, as Cera Flava, aluminum monostearate, ethyl cellulose, carbomer etc.
The antiseptic of soft capsule is: one or more in glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, the P-hydroxybenzoic acid phenyl ester.
Its adjuvant can preferably use by following proportioning:
A kind of medicinal substances extract 100g that treats gynaecopathia with disperse medium 30～240g, suspending agent 0～45g, antiseptic 0～5.5g, is modulated into stable capsule liquid and makes soft capsule.
Its capsule material is: weight ratio is 1: 0.22: 0.76: 0.12: 1.42 gelatin: arabic gum: glycerol: syrup: distilled water etc. are mixed and made into.
The preparation dispersible tablet:
More than ten simply, 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.Get above-mentioned medicinal substances extract, add adjuvant and granulate, drying adds adjuvants such as lubricant, mixing, and tabletting promptly gets dispersible tablet, or the coated coated dispersing tablet of making; Get 2 of this sheets, put jolting in the 100ml water, in 20 ℃ ± 1 ℃ water, the whole disintegrates of planted agent in 3 minutes are also passed through sieve No. 2.
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, and low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.,
Binding agent in the dispersible tablet is: 40% ethanol～95% alcoholic solution or starch slurry, or the alcoholic solution of polyvinylpyrrolidone or aqueous solution; Or 10～20% alcoholic solution of low-substituted hydroxypropyl cellulose;
Filler is in the dispersible tablet: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch etc.
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc.
Its adjuvant can preferably use by following proportioning:
A kind of medicinal substances extract 100g that treats gynaecopathia is with filler 0～350g, disintegrating agent 3～150g, lubricant 0～25g proportioning;
The preparation drop pill:
More than ten simply, 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.Get drop pill substrate heating and melting, other gets above-mentioned medicinal substances extract and substrate mix homogeneously, splashes into coolant, makes drop pill;
Substrate in its drop pill is polyethylene glycol 6000, can also be: molecular weight be by cured etc. one or more of 400～12000 Polyethylene Glycol, polyoxyethylene monostearate, sodium stearate or glycerin gelatine, poloxamer, stearic acid, glyceryl monostearate, polyvinylpyrrolidone, carboxymethyl cellulose, worm, or the best is a polyethylene glycol 6000: the mixture of PEG400 (10: 0.25).Coolant in its drop pill preparation is one or more of dimethicone or liquid paraffin or Oleum Camelliae or vegetable oil etc.
Its adjuvant can preferably use by following proportioning:
A kind of medicinal substances extract 100g that treats gynaecopathia, with consumption be that the drop pill substrate of 120～300g is used, the best 200g that uses.
The preparation oral cavity disintegration tablet:
Oral cavity disintegration tablet of the present invention is made like this:
More than ten simply, 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.Get above-mentioned medicinal substances extract, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned medicinal substances extract,, make granule, add adjuvant mix homogeneously such as fluidizer with one or more of adjuvants such as filler, disintegrating agent, tabletting, that is, or coating is made coated tablet again.
A kind of medicinal substances extract 100g, filler 15～65g, disintegrating agent 3～45g, correctives 0～25g, lubricant 0.01～20g that treats gynaecopathia;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described lubricant is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use A Basi sweet with citric acid 1: 3.
The preparation effervescent tablet:
More than ten simply, 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.Get above-mentioned medicinal substances extract, with filler, disintegrating agent, effervescent acid-base pair, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned medicinal substances extract,, make granule, add adjuvant mix homogeneously such as effervescent acid-base pair, fluidizer with one or more of adjuvants such as filler, disintegrating agent, tabletting, that is, or coating is made coated tablet again.
The effervescent acid-base pair is formed for two kinds of materials of bronsted lowry acids and bases bronsted lowry of meeting water and can produce gas, as the citric acid of sodium bicarbonate and equivalent or tartaric acid etc.;
Filler is a lactose, or starch, or pregelatinized Starch, or one or more of microcrystalline Cellulose etc., and the best is preferably lactose: mannitol: precoking starch: microcrystalline Cellulose 4: 3: 1: 1 mixture;
Disintegrating agent is: crospolyvinylpyrrolidone, or carboxymethyl starch sodium, or low-substituted hydroxypropyl cellulose, or one or more of cross-linked carboxymethyl cellulose sodium etc.; Or the best crospolyvinylpyrrolidone that uses: low-substituted hydroxypropyl cellulose: the mixture of carboxymethyl starch sodium=4: 1: 1.5.
Its supplementary product consumption proportioning is: a kind of medicinal substances extract 100g, filler 15～90g, disintegrating agent 3～50g, correctives 0～25g, effervescent acid-base pair 5～75g, lubricant 0～20g that treats gynaecopathia.
The preparation granule:
More than ten simply, 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.Get above-mentioned medicinal substances extract, add adjuvant, make granule, drying; Promptly.
The granule adjuvant be except that selecting for use the starch, can also be lactose, dextrin, starch, amylum pregelatinisatum, carboxymethyl starch, microcrystalline Cellulose, methylcellulose, hydroxy methocel, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, micropowder silica gel, xylitol etc. one or more.
Micropill of the present invention or pellet capsule are made like this:
(1) above ten simply, and 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.
(2) preparation of micropill: get above-mentioned medicinal substances extract,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying, or the coating after drying, promptly.
100 parts of medicinal substances extracts, 5～70 parts of carboxymethyl starch sodium, 2～55 parts of precoking starch, wetting agent are 60～95% alcoholic solution of 2～13% polyvinylpyrrolidones; Or be preferably: medicinal substances extract 100g, carboxymethyl starch sodium 35g, precoking starch 40g, wetting agent are 85% alcoholic solution of 11% polyvinylpyrrolidone.
The coating solution of making the various coated preparations of the present invention is a gastric solubility coating material, as Opadry, acrylic resin IV, hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl methylcellulose, polyvinyl alcohol, methylcellulose one or more, or the coating solution formula optimization is:
Polyvinylpyrrolidone 10g, hydroxypropyl methylcellulose 15g, 90% alcoholic solution 200ml, Pulvis Talci 6g, magnesium stearate 2g, titanium dioxide 4～6g, polyethylene glycol 6000 4g, pigment 1～2g.
Medicinal material extract of the present invention also can adopt following steps:
Rhizoma Cyperi (processed with vinegar) 500g Rhizoma Chuanxiong 20g Radix Angelicae Sinensis 180g Rhizoma Corydalis (processed with vinegar) 40g
Rhizoma Atractylodis Macrocephalae 28.75g Radix Glycyrrhizae 13.75g Fructus Jujubae 100g Radix Paeoniae Alba 15g
Radix Paeoniae Rubra 15g Radix Rehmanniae Preparata 60g calcium carbonate 65g
More than ten simply, 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, Radix Paeoniae Rubra extract volatile oil, calcium carbonate and xylitol are made solid dispersion and are ground into fine powder; The medicinal residues behind the extraction volatile oil such as Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, Radix Paeoniae Rubra and the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Fructus Jujubae, the Radix Paeoniae Alba, Radix Rehmanniae Preparata etc. decoct with water three times, filter merging filtrate; Remaining 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, concentrating under reduced pressure, thick paste to relative density 1.35～1.40 (50 ℃), adding volatile oil and adjuvant continues dry, be ground into the extract that fine powder is the various peroral dosage forms of preparation, and this kind peroral dosage form such as capsule, tablet, granule, dispersible tablet, soft capsule etc. wherein all do not contain the crude drug powder.This gynecological that does not contain the crude drug powder ten flavor preparations kept the characteristics of former preparation, but bioavailability are higher, and dose still less.
Effect of the present invention:
1, contains the effective ingredient peoniflorin in the preparation of the present invention.Peoniflorin has nourishing blood to suppress the hyperactive liver analgesic effect, can be used for effects such as blood-deficiency leading to hyperactivity of the liver side of body rib epigastric pain, spasm of the limbs pain, and modern pharmacological research shows that peoniflorin has analgesia, antiinflammatory action preferably.Therefore the peoniflorin in the Radix Paeoniae Alba and the Radix Paeoniae Rubra can be controlled the quality of this product.Get with 20 in every tablet of tablet that is equivalent to crude drug amount 0.35g, porphyrize is formulated as need testing solution, and other gets the peoniflorin reference substance, measures every of paeoniflorin content with high-efficient liquid phase technique and is no less than: 0.25mg.
With after the Diluted Alcohol supersound extraction, be mobile phase with acetonitrile-0.1% phosphoric acid (12: 88) when measuring peoniflorin, octadecylsilane chemically bonded silica is the agent of filling a vacancy.
Get the soft capsule that makes by the inventive method, carry out this product room temperature and accelerated stability test by the Chinese Pharmacopoeia prescriptive procedure, this kind paeoniflorin content is stable.Behind following 12 months of the room temperature, paeoniflorin content is 91.7% of a preliminary survey content.
Calcium carbonate among the present invention is owing to make solid dispersion, and bioavailability is higher.
2. preparation of the present invention is used for menoxenia, the observation of curative effect of menalgia:
The insufferable lower abdomen paroxysmal pain that dysmenorrhea takes place when being the adolescent girls menstrual onset is clinical common a kind of symptom, often influences life, study and the physical and mental health of adolescent girls, and the adolescent girls dysmenorrhea often be stagnation of QI due to depression of the liver, blood deficiency institute extremely.Feelings will is not relaxed, and hepatic depression heat-transformation of a specified duration can have the soothing liver-QI of nourishing blood and reach the menstruction regulating and pain relieving purpose to qi depression to blood stasis, blood deficiency gynecological ten flavor sides.
According to the prescription characteristics, we use this medicine that modern maiden's dysmenorrhea companion menoxenia 210 examples are treated observation in April, 2003～2005 a year August, obtain significant curative effect, now are described below.
Clinical data
2.1 diagnostic criteria: formulate with reference to " new Chinese medicine clinical research guideline " and " Gynecology of Chinese Medicine " (five editions teaching materials of national high traditional Chinese medical science universities and colleges).All possess following person and classify the object of observation as:
(1) women is in menstrual period or through preceding appearance periodicity hypogastralgia, with diseases such as menoxenias;
(2) through gynecologial examination, ultrasound diagnosis, the genitals does not have the significant organic pathological changes;
(3) Chinese medical discrimination belongs to the hepatic depression and blood deficiency Qi-stagnation type:
Main symptom: the distention and pain in the lower abdomen before or during menstruation tenderness, few through blood volume, through color light red or deep red menses, matter is thick, dysphoria with feverish sensation in the chest palms and soles, parched throat xerostomia or blockage of menstruation, color purple black have piece, pain relief under the stasis of blood piece;
Follow disease: uncomfortable in chest easypro, spiritlessness and weakness or distending pain of the breast;
The tongue pulse condition: tongue fur is purple or ecchymosis or red tongue are arranged, and few tongue no fur or pale tongue print the unable or thready and rapid pulse of stringy pulse or deficient pulse with tooth.
2.1.1 can be divided into 3 degree according to the dysmenorrhea degree:
(1) slight: menstrual period or its front and back lower abdomen pain are obvious, and companion's waist is ached, but can adhere to work, and no General Symptoms needs to obey analgesic sometimes.
(2) moderate: menstrual period or its front and back lower abdomen pain accompany waist to ache unbearably, and nausea and vomiting, extremity are not warm, postpone with pain relieving measure pain.
(3) severe: menstrual period or its front and back lower abdomen pain are felt restless unbearably, have a strong impact on work and study and daily life, must lie up, companion's waist is ached pale complexion, dripping cold sweat, extreme cold of the limbs, vomiting and diarrhoea, or rectal tenesmus adopt the pain relieving measure not have obvious alleviation
2.2 the standard of including in:
(1) meets above-mentioned diagnostic criteria;
(2) 13～40 one full year of life of age;
(3) through gynecologial examination, ultrasound diagnosis, the genitals does not have the significant organic pathological changes;
(4) signature Informed Consent Form.
2.3 exclusion standard (comprising inadaptation or rejecting standard):
(1) menoxenia that causes for genitals's organic disease on inspection, dysmenorrhea;
(2) merge serious primary disease such as cardiovascular, liver, kidney and hemopoietic system and psychotic;
(3) allergic constitution or to multiple drug allergy person.
2.4 physical data 210 examples are divided into two groups at random.
Treatment group (preparation of the present invention) 180 examples all are the outpatient, age reckling 15 years old, the maximum 38 years old.164 examples of person below 30 years old wherein account for that person 16 falls more than 91.1%, 30 years old, account for 8.9%; The shortest person of course of disease half a year, elder 7.5 years; Through preceding pain person's 45 examples (25.0%), pain person's 126 examples in menstrual period (70.0%), through after pain person's 9 examples (5.0%); Severe pain 94 examples (52.2%), moderate pain 71 examples (39.5%), mild pain 15 examples (8.3%), most menoxenias with in various degree.
Matched group (tablet of ten ingredients for woman diseases) 30 examples, 15～37 years old age.26 examples of person below 30 years old wherein account for that person 4 falls more than 86.7%, 30 years old, account for 13.3%; Its course of disease length and dysmenorrhea degree all do not have significant difference (P＞0.05) with matched group, and comparability is arranged.
3 Therapeutic Method:
3.1 treatment group: preparation of the present invention, each 4 slices/, every day 3 times.
Be divided into 6 groups at random, use soft capsule, drop pill, dispersible tablet, pellet capsule, oral cavity disintegration tablet, the granule of preparation of the present invention respectively.(dose all is equivalent to the amount of 1.4g crude drug).
3.2 each 5 of matched group tablet of ten ingredients for woman diseases (Harbin Pharmaceutical Group's three smart thousand crane pharmacy) company limited, every day 3 times.
Two groups of patients all in preceding 1 week of passing through begin to take medicine, take continuously to menstrual onset the 3rd day be 1 treatment cycle, continuous 3 cycles are 1 course of treatment, judge curative effect after two courses of treatment of all taking medicine.
4 observation of curative effect:
4.1 curative effect determinate standard is formulated with reference to " new Chinese medicine clinical research guideline " and " Gynecology of Chinese Medicine " (five editions teaching materials of national high traditional Chinese medical science universities and colleges)
4.1.1 curative effect of disease is judged: press healing, effective, invalid 3 grades of evaluations:
Cure: take medicine back stomachache and other transference cures, menstrual cycle, recover normal through amount, menstrual period, drug withdrawal not recurrence in 3 months;
Effectively: stomachache obviously alleviates after treating, menstrual cycle, improvement before treating in amount, menstrual period, and all the other symptoms take a turn for the better, or recidivist in half a year;
Invalid: as stomachache or menstrual cycle, not have an improver through amount, menstrual period.
4.1.2 individual event symptom curative effect determinate standard:
Expand the soreness of waist etc. as lower abdomen pain, bob.
(1) cures hypogastralgia, the bloated disappearance of bob, with the slight soreness of waist;
(2) effective hypogastralgia, bob are expanded and are disappeared substantially, with the soreness of waist;
(3) invalid hypogastralgia, weigh down to expand, the soreness of waist does not have obviously and alleviates.
4.2 therapeutic outcome
4.2.1 two groups of clinical efficacies see Table 1:
Table 1 treatment group and matched group curative effect are relatively
| Group | The example number | Cure | Effectively | Invalid | Total effective rate (%) | Total cure rate (%) |
| Treatment group 1 | 30 examples | 15 | 12 | 3 | 90.0 | 50.0 |
| Treatment group 2 | 30 examples | 14 | 13 | 3 | 90.0 | 46.7 |
| Treatment group 3 | 30 examples | 15 | 13 | 2 | 93.3 | 50.0 |
| Treatment group 4 | 30 examples | 15 | 12 | 3 | 90.0 | 50.0 |
| Treatment group 5 | 30 examples | 16 | 11 | 3 | 90.0 | 53.3 |
| Treatment group 6 | 30 examples | 17 | 12 | 1 | 96.7 | 56.7 |
| Matched group | 30 examples | 11 | 14 | 5 | 83.3 | 36.7 |
Adopt the T check, the total obvious effective rate of treatment group and matched group is P＜0.05 relatively, has the significance meaning.
4.2.2 two groups of hypogastralgias, bobs are expanded, soreness of waist curative effect compares:
180 examples are organized in treatment, cure (soreness of waist is expanded in hypogastralgia, bob) 93 examples, effective 74 examples, invalid 13 examples, total effective rate 92.8%.Matched group 30 examples are cured (soreness of waist is expanded in hypogastralgia, bob) 14 examples, effective 10 examples, invalid 6 examples, total effective rate 80.0%.Two groups of total effective rates compare P＜0.05, have the significance meaning.
5. model case:
Lee * *, 21 years old, unmarried, the teacher.Dysmenorrhea 7 years is surplus, and few through blood volume, delay menstrual period.Come to go to a doctor on February 3rd, 2004.The patient was a dysmenorrhea 14 time of tide the beginning of the year, and blockage of menstruation increases the weight of or alleviates with the fluctuation of emotion, and is few through blood volume, color is light red.Symptoms such as Chang Yujing occurred lower abdomen, distending pain of the breast in preceding 3～5 days, uncomfortable in chestly do not relax, sound of sighing gas, first day lower abdomen severe pain of menstruation unbearably, tenderness, with symptoms such as the soreness of waist, Mental fatigue, even brothers occur and feel cold diseases such as nausea and vomiting, collapse.All be diagnosed as " primary dysmenorrhea " through how tame examination in hospital.Once obeyed multiple Drug therapys such as " YUANHU ZHITONG PIAN ", " YIMUCAO CHONGJI ", poor effect.Have a medical check-up: uterus, adnexa are normal; Ultrasound diagnosis does not have the significant organic pathological changes.Lmp:2004 January 10.
The dispersible tablet of medicinal preparation of the present invention, each 4,3 times on the one.After 2 courses of treatment of taking medicine, symptoms such as soreness of waist stomachache obviously alleviate, and increase through amount, and menstrual period are normal, advise it to continue at through about the last week to menstrual onset and take 1～2 course of treatment of this product on the 3rd day, and outpatient service is thereafter followed up a case by regular visits to does not have recurrence so far.
The specific embodiment:
Embodiment 1: a kind of preparation for the treatment of the drug extract of gynaecopathia:
Rhizoma Cyperi 24～72% Rhizoma Chuanxiongs 1～3% Radix Angelicae Sinensis 9～26% Rhizoma Corydalis 2～6%
The Rhizoma Atractylodis Macrocephalae 1～4% Radix Glycyrrhizae, the Radix Paeoniae Alba, each 1～2% Fructus Jujubae 5～15% of Radix Paeoniae Rubra
Radix Rehmanniae Preparata, calcium carbonate each 3～9%
More than ten simply, 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.25～1.45 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.
Embodiment 2: a kind of preparation for the treatment of the drug extract of gynaecopathia:
Rhizoma Cyperi (processed with vinegar) 500g Rhizoma Chuanxiong 20g Radix Angelicae Sinensis 180g Rhizoma Corydalis (processed with vinegar) 40g
Rhizoma Atractylodis Macrocephalae 28.75g Radix Glycyrrhizae 13.75g Fructus Jujubae 100g Radix Paeoniae Alba 15g
Radix Paeoniae Rubra 15g Radix Rehmanniae Preparata 60g calcium carbonate 65g
More than ten simply, 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae add 10 times of amounts of water and decoct three times, each 1.5 hours, filter merging filtrate; 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 6 times of amounts of 70% alcohol reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.
Embodiment 3: a kind of preparation for the treatment of the drug extract of gynaecopathia:
Rhizoma Cyperi (processed with vinegar) 500g Rhizoma Chuanxiong 20g Radix Angelicae Sinensis 180g Rhizoma Corydalis (processed with vinegar) 40g
Rhizoma Atractylodis Macrocephalae 28.75g Radix Glycyrrhizae 13.75g Fructus Jujubae 100g Radix Paeoniae Alba 15g
Radix Paeoniae Rubra 15g Radix Rehmanniae Preparata 60g calcium carbonate 65g
More than ten simply, 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, that Radix Paeoniae Rubra extracts volatile oil with steam distillation is standby; The xylitol heating is melt and dissolved, adds the calcium carbonate fine powder, and cooling is pulverized, and makes solid dispersion and is ground into fine powder; The medicinal residues behind the extraction volatile oil such as Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, Radix Paeoniae Rubra and the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Fructus Jujubae, the Radix Paeoniae Alba, Radix Rehmanniae Preparata etc. decoct with water 10 times of amounts three times, each 1.5 hours, filter merging filtrate; Remaining 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 8 times of amounts of 70% ethanol reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, and concentrating under reduced pressure to the thick paste of relative density 1.35～1.40 (50 ℃), adds volatile oil and adjuvant and continues drying, is ground into the extract that fine powder is the various peroral dosage forms of preparation.
Embodiment 4: a kind of medicinal soft capsule preparation for the treatment of gynaecopathia:
Rhizoma Cyperi (processed with vinegar) 500g Rhizoma Chuanxiong 20g Radix Angelicae Sinensis 180g Rhizoma Corydalis (processed with vinegar) 40g
Rhizoma Atractylodis Macrocephalae 28.75g Radix Glycyrrhizae 13.75g Fructus Jujubae 100g Radix Paeoniae Alba 15g
Radix Paeoniae Rubra 15g Radix Rehmanniae Preparata 60g calcium carbonate 65g
Said extracted thing 100g
Cera Flava 15g
Olive oil 210g
Propylene glycol 2g
Soybean lecithin 8g
Make 1000
1. above ten simply, and 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.
2. modulate capsule liquid: get above-mentioned medicinal substances extract, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, insulation is left standstill, and it is standby to make the capsule material;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
Embodiment 5: a kind of medicinal soft capsule preparation for the treatment of gynaecopathia:
Medicinal substances extract 100g
Peach kernel oil 15g
Soybean oil 90g
Cera Flava: 1.5: 3.5 12g of ethyl cellulose weight ratio
Ethylparaben 0.7g
Make 1000
1. above ten simply, and 70% Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, that Radix Paeoniae Rubra extracts volatile oil with steam distillation is standby; The xylitol heating is melt and dissolved, adds the calcium carbonate fine powder, and cooling is pulverized, and makes solid dispersion and is ground into fine powder; The medicinal residues behind the extraction volatile oil such as Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, Radix Paeoniae Rubra and the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Fructus Jujubae, the Radix Paeoniae Alba, Radix Rehmanniae Preparata etc. decoct with water 10 times of amounts three times, each 1.5 hours, filter merging filtrate; Remaining 30% Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 8 times of amounts of 70% alcohol reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, and concentrating under reduced pressure to the thick paste of relative density 1.35～1.40 (50 ℃), adds volatile oil and adjuvant and continues drying, is ground into the extract that fine powder is the preparation soft capsule.
2. modulate capsule liquid: get above-mentioned medicinal substances extract, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. its capsule material formula is weight ratio 1: 0.23: 0.76: 0.12: 1.42 gelatin: arabic gum: glycerol: syrup: distilled water etc. are mixed and made into.Get gelatin, water in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
Embodiment 6: a kind of medicinal soft capsule preparation for the treatment of gynaecopathia:
Rhizoma Cyperi (processed with vinegar) 500g Rhizoma Chuanxiong 20g Radix Angelicae Sinensis 180g Rhizoma Corydalis (processed with vinegar) 40g
Rhizoma Atractylodis Macrocephalae 28.75g Radix Glycyrrhizae 13.75g Fructus Jujubae 100g Radix Paeoniae Alba 15g
Radix Paeoniae Rubra 15g Radix Rehmanniae Preparata 60g calcium carbonate 65g
Medical material is made extract (comprising: volatile oil and thick paste) 300g by embodiment 1～3.
Peach kernel oil 50g
Soybean oil 240g:
Make 3000
Embodiment 7: a kind of preparation for the treatment of the medicine dispersible tablet of gynaecopathia:
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.
Lactose: 100g
Microcrystalline Cellulose: 65g
Mannitol: 45g
Carboxymethyl starch sodium: 10g
Polyvinylpyrrolidone: 35g
Sodium lauryl sulphate: 2.5g
Magnesium stearate: 3.0g
Make medicinal substances extract by embodiment 1～3, with 75% alcohol granulation, drying such as lactose, carboxymethyl starch sodium, microcrystalline Cellulose, mannitol, add polyvinylpyrrolidone, sodium lauryl sulphate, the magnesium stearate mix homogeneously is pressed into 3000, promptly.
Embodiment 8: a kind of preparation for the treatment of the medicine dispersible tablet of gynaecopathia:
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.
Lactose: 30g
Hydroxypropyl emthylcellulose: 8g
Microcrystalline Cellulose: 25g
Crospolyvinylpyrrolidone: 12g
Micropowder silica gel: 2.3g
Make medicinal substances extract by embodiment 3, with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate drying with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, add polyvinylpyrrolidone, differential silica gel mix homogeneously, tabletting, coating is made 3000, and coating solution is:
Polyvinylpyrrolidone 12g
Hydroxypropyl methylcellulose 4～8g
90% alcoholic solution 200ml
Pulvis Talci 4～8g
Magnesium stearate 2g
Titanium dioxide 4～6g
Polyethylene glycol 6000 4g
Pigment 1～2g.
Embodiment 9: a kind of preparation for the treatment of the medicinal dropping ball of gynaecopathia:
Rhizoma Cyperi (processed with vinegar) 500g Rhizoma Chuanxiong 20g Radix Angelicae Sinensis 180g Rhizoma Corydalis (processed with vinegar) 40g
Rhizoma Atractylodis Macrocephalae 28.75g Radix Glycyrrhizae 13.75g Fructus Jujubae 100g Radix Paeoniae Alba 15g
Radix Paeoniae Rubra 15g Radix Rehmanniae Preparata 60g calcium carbonate 65g
Medical material is made extract 100g by embodiment 1～3.
Polyethylene glycol 6000 235g
Macrogol 4000 15g
Poloxamer 5g
Make 5000.
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.
Get drop pill substrate heating and melting, add above-mentioned medicinal substances extract, poloxamer mix homogeneously with it, be incubated under 95 ℃ of conditions, mix homogeneously splashes in the coolant and is shaped, and remove liquid coolant and promptly get drop pill, or coated again technology is made coated drop pill.
Keep 90 centimetres of cooling column effective column lengths when dripping system, 5 ℃ of liquid coolants are dripped 55 on every part of clock of speed, dropper mouth external diameter 2.5mm, and internal diameter 2.2mm, then dripping the drop pill of making does not have the tail of taking off, and outward appearance is bright and clean shaped.
Coating solution can be made by following proportioning:
Polyvinylpyrrolidone 30g
Hydroxypropyl methylcellulose 8g
95% alcoholic solution 200ml
Magnesium stearate 2g
Titanium dioxide 6g
Polyethylene glycol 6000 2g
Pigment 3g
Embodiment 11: a kind of preparation for the treatment of the drug port disintegrating tablet of gynaecopathia:
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.
Lactose: 40g
Microcrystalline Cellulose: 20g
Mannitol: 30g
Carboxymethyl starch sodium: 12g
Polyvinylpyrrolidone: 20g
The sweet 3.5g of A Basi
Citric acid 7.0g
Magnesium stearate: 7.0g
Get above-mentioned medicinal substances extract, with 75% alcohol granulation, drying such as lactose, carboxymethyl starch sodium, microcrystalline Cellulose, mannitol, add volatile oil polyvinylpyrrolidone, sodium lauryl sulphate, A Basi is sweet, the magnesium stearate mix homogeneously, is pressed into 3000, promptly.
Embodiment 12: a kind of preparation for the treatment of the drug port disintegrating tablet of gynaecopathia:
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.
Carboxymethyl starch sodium: 17g
Polyvinylpyrrolidone: 22g
Magnesium stearate: 0.03g
Get above-mentioned medicinal substances extract and carboxymethyl starch sodium 75% alcohol granulation, drying adds polyvinylpyrrolidone, magnesium stearate mix homogeneously, is pressed into 3000, promptly.
Embodiment 13: a kind of preparation for the treatment of the drug particles of gynaecopathia
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol.Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃).By Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder.
Lactose: 45g
Mannitol: 27g
Precoking starch: 17g
Crospolyvinylpyrrolidone: 7g
Low-substituted hydroxypropyl cellulose 17g
Sodium bicarbonate 12g
Citric acid 9g
Tartaric acid 17g
Make 250 bags.
Make medicinal substances extract and lactose, mannitol, precoking starch, sodium bicarbonate etc. by embodiment 1～3 and use 75% alcohol granulation, drying adds citric acid, tartaric acid etc., promptly.
Embodiment 14: a kind of preparation for the treatment of the drug particles of gynaecopathia
Rhizoma Cyperi (processed with vinegar) 500g Rhizoma Chuanxiong 20g Radix Angelicae Sinensis 180g Rhizoma Corydalis (processed with vinegar) 40g
Rhizoma Atractylodis Macrocephalae 28.75g Radix Glycyrrhizae 13.75g Fructus Jujubae 100g Radix Paeoniae Alba 15g
Radix Paeoniae Rubra 15g Radix Rehmanniae Preparata 60g calcium carbonate 65g
Dextrin: 12g
Starch: 25g
Microcrystalline Cellulose: 30g
Make 250 bags.
Above-mentioned medical material is made medicinal substances extract by embodiment 3, and dextrin, starch, microcrystalline Cellulose: use 75% alcohol granulation, drying, promptly.
Embodiment 15: a kind of preparation for the treatment of the medicament pellet of gynaecopathia
Rhizoma Cyperi (processed with vinegar) 500g Rhizoma Chuanxiong 20g Radix Angelicae Sinensis 180g Rhizoma Corydalis (processed with vinegar) 40g
Rhizoma Atractylodis Macrocephalae 28.75g Radix Glycyrrhizae 13.75g Fructus Jujubae 100g Radix Paeoniae Alba 15g
Radix Paeoniae Rubra 15g Radix Rehmanniae Preparata 60g calcium carbonate 65g
Above-mentioned medical material is made medicinal substances extract by embodiment 3,
Carboxymethyl starch sodium 20g
Precoking starch 12g
Xylitol 100g
85% alcoholic solution, the 25～35ml of 11% polyvinylpyrrolidone
(1) gets above-mentioned medicinal substances extract,, make the micropill of diameter less than 2.0mm with agitation procedure with mix homogeneously such as carboxymethyl starch sodium, precoking starch;
(2) with gained micropill drying, or the coating after drying, promptly.Or the micropill filled capsules made pellet capsule.
Claims (13)
1, a kind of medicine for the treatment of gynaecopathia is characterized in that used medical material is:
Rhizoma Cyperi (processed with vinegar) szechuan lovage rhizome-angelica Rhizoma Corydalis (processed with vinegar) Rhizoma Atractylodis Macrocephalae Radix Glycyrrhizae
Fructus Jujubae Radix Paeoniae Alba Radix Paeoniae Rubra Radix Rehmanniae Preparata calcium carbonate
The treated medicinal substances extract of making is made soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or oral cavity disintegration tablet or effervescent tablet or micropill or granule with pharmaceutically alleged adjuvant or substrate.
2, a kind of medicine for the treatment of gynaecopathia according to claim 1 is characterized in that percentage by weight is preferably:
Rhizoma Cyperi 24～72%, Rhizoma Chuanxiong 1～3%, Radix Angelicae Sinensis 9～26%, Rhizoma Corydalis 2～6%, the Rhizoma Atractylodis Macrocephalae 1～4%,
Radix Glycyrrhizae, the Radix Paeoniae Alba, Radix Paeoniae Rubra each 1～2%, Fructus Jujubae 5～15%, Radix Rehmanniae Preparata, calcium carbonate each 3～9%
Make soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or oral cavity disintegration tablet or effervescent tablet or micropill with pharmaceutically alleged adjuvant or substrate; Or more preferably:
Rhizoma Cyperi (processed with vinegar) 500g Rhizoma Chuanxiong 20g Radix Angelicae Sinensis 180g Rhizoma Corydalis (processed with vinegar) 40g
Rhizoma Atractylodis Macrocephalae 28.75g Radix Glycyrrhizae 13.75g Fructus Jujubae 100g Radix Paeoniae Alba 15g
Radix Paeoniae Rubra 15g Radix Rehmanniae Preparata 60g calcium carbonate 65g.
3, a kind of preparation method for the treatment of the medicinal soft capsule of gynaecopathia according to claim 1 is characterized in that:
1. above ten simply, and 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong are with 70% pure reflux secondary, filter, merging filtrate, reclaim ethanol, above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃), by Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder;
2. modulate capsule liquid: get above-mentioned medicinal substances extract, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, insulation is left standstill, and it is standby to make the capsule material;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
4, according to claim 3 medicinal soft capsule for the treatment of gynaecopathia, it is characterized in that: the supplementary product consumption of making soft capsule can be preferably: a kind of drug extract 100g that treats gynaecopathia, with disperse medium 30～350g, suspending agent 0～65g, antiseptic 0～7.5g, be modulated into stable capsule liquid and make soft capsule.
5. a kind of medicine dispersible tablet for the treatment of gynaecopathia according to claim 1 is characterized in that this dispersible tablet preparation method is:
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong are with 70% alcohol heating reflux secondary, filter, merging filtrate, reclaim ethanol, above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃), by Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder;
Get above-mentioned dried cream, add adjuvant and granulate, drying adds adjuvants such as volatile oil, lubricant, mixing, and tabletting promptly gets dispersible tablet, or the coated coated dispersing tablet of making; Get 2 of this sheets, put jolting in the 100ml water, in 20 ℃ ± 1 ℃ water, the whole disintegrates of planted agent in 3 minutes are also passed through sieve No. 2.
6. according to a kind of medicine dispersible tablet for the treatment of gynaecopathia described in the claim 5, it is characterized in that:
Its adjuvant can be preferably: a kind of drug extract 100g that treats gynaecopathia, with filler 0～350g, disintegrating agent 3～150g, lubricant 0～25g proportioning;
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.
7. a kind of medicinal dropping ball for the treatment of gynaecopathia according to claim 1 is characterized in that:
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong are with 70% alcohol heating reflux secondary, filter, merging filtrate reclaims ethanol, and above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃), by Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder
Get drop pill substrate heating and melting, other gets above-mentioned medicinal substances extract and substrate mix homogeneously, splashes into coolant, makes drop pill;
Substrate in its drop pill is polyethylene glycol 6000, can also be: molecular weight be by cured etc. one or more of 2000～12000 Polyethylene Glycol, polyoxyethylene monostearate, sodium stearate or glycerin gelatine, poloxamer, stearic acid, glyceryl monostearate, polyvinylpyrrolidone, carboxymethyl cellulose, worm, or the best is a Macrogol 4000: polyethylene glycol 6000: the mixture of poloxamer (1: 11: 0.5);
Coolant in its drop pill preparation is one or more of dimethicone or liquid paraffin or Oleum Camelliae or vegetable oil etc.
8. treat the drug port disintegrating tablet of gynaecopathia according to one kind of claim 1, it is characterized in that:
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong are with 70% alcohol heating reflux secondary, filter, merging filtrate, reclaim ethanol, above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃), by Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder;
Get above-mentioned medicinal substances extract, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned dried cream,, make granule, add adjuvant mix homogeneously such as volatile oil, fluidizer with one or more of adjuvants such as filler, disintegrating agent, tabletting, that is, or coating is made coated tablet again.
9. a kind of according to Claim 8 drug port disintegrating tablet for the treatment of gynaecopathia is characterized in that: its supplementary product consumption proportioning is: a kind of drug extract 100g, filler 0～150g, disintegrating agent 3～60g, correctives 0～25g, lubricant 0.01～20g that treats gynaecopathia;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described fluidizer is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use A Basi sweet with citric acid 1: 1.2.
10. treat the medicine effervescent tablet of gynaecopathia according to one kind of claim 1, it is characterized in that:
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong are with 70% alcohol heating reflux secondary, filter, merging filtrate reclaims ethanol, and above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃), by Six-element fine powders such as quantitative adding Rhizoma Cyperis, be medicinal substances extract with quantitative thick paste mixing, maybe can continue drying, be ground into fine powder
Get above-mentioned medicinal substances extract, with filler, disintegrating agent, effervescent acid-base pair, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned dried cream,, make granule, add adjuvant mix homogeneously such as volatile oil, effervescent acid-base pair, fluidizer with one or more of adjuvants such as filler, disintegrating agent, tabletting, that is, or coating is made coated tablet again.
11. treat the medicine effervescent tablet of gynaecopathia according to one kind of claim 10, it is characterized in that:
The effervescent acid-base pair is formed for two kinds of materials of bronsted lowry acids and bases bronsted lowry of meeting water and can produce gas, as the citric acid of sodium bicarbonate and equivalent or tartaric acid etc.;
Filler is a lactose, or starch, or pregelatinized Starch, or one or more of microcrystalline Cellulose etc., and the best is preferably lactose: mannitol: precoking starch: microcrystalline Cellulose 3: 4: 1: 1 mixture;
Disintegrating agent is: crospolyvinylpyrrolidone, or carboxymethyl starch sodium, or low-substituted hydroxypropyl cellulose, or one or more of cross-linked carboxymethyl cellulose sodium etc.; Or the best crospolyvinylpyrrolidone that uses: low-substituted hydroxypropyl cellulose: the mixture of carboxymethyl starch sodium=3: 1: 0.5;
Its supplementary product consumption proportioning is: a kind of drug extract 100g, filler 0～100g, disintegrating agent 3～60g, correctives 0～25g, effervescent acid-base pair 5～80g, lubricant 0～20g that treats gynaecopathia.
12, according to claim 1 medicament pellet for the treatment of gynaecopathia, it is characterized in that:
(1) above ten simply, and 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol; Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃),, be medicinal substances extract, maybe can continue drying, be ground into fine powder with quantitative thick paste mixing by Six-element fine powders such as quantitative adding Rhizoma Cyperis;
(2) preparation of micropill: get above-mentioned medicinal substances extract,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying, or the coating after drying, promptly.
13, according to claim 1 medicinal granule for the treatment of gynaecopathia, it is characterized in that:
More than ten simply, 126g Radix Angelicae Sinensis, Rhizoma Cyperi, Rhizoma Corydalis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Paris white are broken into fine powder; Radix Glycyrrhizae, Fructus Jujubae decoct with water three times, filter merging filtrate; 54g Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata, Rhizoma Chuanxiong filter with 70% alcohol heating reflux secondary, and merging filtrate reclaims ethanol; Above two kinds of filtrates are merged, be evaporated to the thick paste of relative density 1.35～1.40 (50 ℃),, be medicinal substances extract, maybe can continue drying, be ground into fine powder with quantitative thick paste mixing by Six-element fine powders such as quantitative adding Rhizoma Cyperis;
Get above-mentioned medicinal substances extract, add adjuvant, make granule, drying;
The granule adjuvant be except that selecting for use the starch, can also be lactose, dextrin, starch, amylum pregelatinisatum, carboxymethyl starch, microcrystalline Cellulose, methylcellulose, hydroxy methocel, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, micropowder silica gel, xylitol etc. one or more.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510101861XA CN100443098C (en) | 2005-11-26 | 2005-11-26 | Medicine for treating gynecophathy |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510101861XA CN100443098C (en) | 2005-11-26 | 2005-11-26 | Medicine for treating gynecophathy |
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| CN1814110A true CN1814110A (en) | 2006-08-09 |
| CN100443098C CN100443098C (en) | 2008-12-17 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103394013A (en) * | 2013-07-19 | 2013-11-20 | 苏州市天灵中药饮片有限公司 | Traditional Chinese medicine containing corydalis tuber and preparation method thereof |
| CN103505315A (en) * | 2013-09-25 | 2014-01-15 | 桂林恒保健康用品有限公司 | Multifunctional condom and preparation method thereof |
| CN113893224A (en) * | 2020-06-22 | 2022-01-07 | 九芝堂股份有限公司 | Preparation method of gynecological ten-ingredient tablet |
| CN115486446A (en) * | 2022-09-27 | 2022-12-20 | 武汉地美达环境科技有限公司 | Efficient cyhalothrin and preparation method thereof |
-
2005
- 2005-11-26 CN CNB200510101861XA patent/CN100443098C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103394013A (en) * | 2013-07-19 | 2013-11-20 | 苏州市天灵中药饮片有限公司 | Traditional Chinese medicine containing corydalis tuber and preparation method thereof |
| CN103505315A (en) * | 2013-09-25 | 2014-01-15 | 桂林恒保健康用品有限公司 | Multifunctional condom and preparation method thereof |
| CN103505315B (en) * | 2013-09-25 | 2015-04-15 | 桂林恒保健康用品有限公司 | Multifunctional condom and preparation method thereof |
| CN113893224A (en) * | 2020-06-22 | 2022-01-07 | 九芝堂股份有限公司 | Preparation method of gynecological ten-ingredient tablet |
| CN115486446A (en) * | 2022-09-27 | 2022-12-20 | 武汉地美达环境科技有限公司 | Efficient cyhalothrin and preparation method thereof |
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| Publication number | Publication date |
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| CN100443098C (en) | 2008-12-17 |
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