CN1698716A - Gynecological Chinese medicinal preparation for stopping pain and expelling blood stasis - Google Patents
Gynecological Chinese medicinal preparation for stopping pain and expelling blood stasis Download PDFInfo
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- CN1698716A CN1698716A CN 200510034995 CN200510034995A CN1698716A CN 1698716 A CN1698716 A CN 1698716A CN 200510034995 CN200510034995 CN 200510034995 CN 200510034995 A CN200510034995 A CN 200510034995A CN 1698716 A CN1698716 A CN 1698716A
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Abstract
Disclosed is a gynecological Chinese medicinal preparation for stopping pain and expelling blood stasis, which has the advantages of good dissolving property and high biological availability. The preparing process comprises extracting from Chinese angelica root, Ligusticum wallichii, licorice root, peach kernels, dried ginger, motherwort, safflower, panicled swallowwort root to obtain dried concrete and fine powders, then mixing with dispersion medium, suspension auxiliary agent, preservative agent, emulsifying agent to obtain soft capsule, or mixing with bulking agent, crumbling agent, wetting agent, lubricating agent to obtain dispersible tablet, or micro-pills, or orally disintegrating tablet, or other oral preparations.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of gynecological Chinese medicine preparation and preparation method thereof with stopping pain and expelling blood stasis.
Background technology
The ancient prescription SHENGHUATANG is a first side commonly used of all diseases in treatment women's puerperal, has blood circulation promoting and blood stasis dispelling and the function of setting upright restoration of old ways.Long root and rhizome or the whole herb with root that is Asclepiadaceae plant Radix Cynanchi Paniculati (Cyuanchum panicalatum Bge Kitag.) of Xu.The chemical constituent of Radix Cynanchi Paniculati mainly contains paeonol, also has flavonoid glycoside, aminoacid, saccharide, volatile oil and a small amount of alkaloid.Herb contains paeonol about 1%.Has wind-expelling pain-stopping, promoting blood circulation to remove obstruction in the collateral, effects such as anti-inflammatory and antalgic.Flos Carthami, Radix Cynanchi Paniculati and SHENGHUATANG are compatible, have strengthened the effect that former side's promoting blood circulation and stopping pain is dispeled the wind, and are used for the treatment of disease that postpartum lochia can't go, few abdomen pain, the colporrhagia that causes after also can be used for being fitted with a contraceptive ring, menorrhagia.
Summary of the invention
The present invention by with the SHENGHUATANG prescription and Flos Carthami, Radix Cynanchi Paniculati reasonable combination, make modern form of administration such as soft capsule, dispersible tablet, drop pill, capsule, oral cavity disintegration tablet, micropill, and the gynecological Chinese medicine preparation with ferulic acid, paeonol quantitative target control of quality is provided.
Drug regimen of the present invention is: Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae (processing), Semen Persicae, Rhizoma Zingiberis (charcoal), Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati; 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 with pharmaceutically alleged adjuvant or substrate.
Or more preferably:
240 parts of Radix Angelicae Sinensis, 90 parts of Rhizoma Chuanxiongs, 15 parts in Radix Glycyrrhizae (processing), 24 parts in Semen Persicae,
15 parts of Rhizoma Zingiberiss (charcoal), 300 parts of Herba Leonuris, 50 parts of 15 parts of Radix Cynanchi Paniculatis of Flos Carthami;
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:
Radix Angelicae Sinensis 1538.5g Rhizoma Chuanxiong 576.9g Radix Glycyrrhizae (processing) 96.1g
Semen Persicae 153.8g Rhizoma Zingiberis (charcoal)) 96.1g Herba Leonuri 1923.1g
Flos Carthami 96.1g Radix Cynanchi Paniculati 320.5g.
Make 500 or 1000 slice, or its integral multiple.
The present invention is achieved in that
The preparation soft capsule:
1. get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
2. modulate capsule liquid: get above-mentioned volatile oil, dried cream or thick paste, 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.
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:
Extract 100g with disperse medium 30～350g, suspending agent 0～65g, antiseptic 0～7.5g, is modulated into stable capsule liquid.
Its capsule material is: weight ratio is 1: 0.24: 0.76: 0.12: 1.42 gelatin: arabic gum: glycerol: syrup: distilled water etc. are mixed and made into.
The preparation dispersible tablet:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get above-mentioned dried cream or thick paste, 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.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: the alcoholic solution or the aqueous solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone;
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:
Extract 100g cooperates with filler 0～180g, disintegrating agent 3～75g, lubricant 0～25g.
The preparation drop pill:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get drop pill substrate heating and melting, other gets above-mentioned volatile oil, dried cream or thick paste 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.
Its adjuvant can preferably use by following proportioning:
Extract 100g, with consumption be that the drop pill substrate of 150～460g is used, the best 275g that uses.
The preparation oral cavity disintegration tablet:
Oral cavity disintegration tablet of the present invention is made like this:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get above-mentioned volatile oil, dried cream or thick paste, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned dried cream or thick paste,, 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.
Its supplementary product consumption proportioning is: a kind of gynecological Chinese medicine extract 100g, filler 0～150g of stopping pain and expelling blood stasis, disintegrating agent 3～60g, correctives 0～25g, lubricant 0.01～20g;
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.
The preparation effervescent tablet:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get above-mentioned volatile oil, dried cream or thick paste, 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 or thick paste,, 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.
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 gynecological Chinese medicine extract 100g, filler 0～100g of stopping pain and expelling blood stasis, disintegrating agent 3～60g, correctives 0～25g, effervescent acid-base pair 5～80g, lubricant 0～20g.
The preparation granule:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get above-mentioned volatile oil, dried cream or thick paste, 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.
The preparation capsule:
Get the alleged extract of the present invention; Add suitable adjuvant, granulate, drying, encapsulated, promptly.
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, differential silica gel, Pulvis Talci etc. one or more.
Its adjuvant can preferably use by following proportioning:
Extract 100g of the present invention granulates with starch 0～60g, drying, and 5～25g mixes with differential silica gel, filled capsules.
Micropill of the present invention or pellet capsule are made like this:
(1) get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
(2) preparation of micropill: get above-mentioned volatile oil, dried cream or thick paste,, 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 extracts of the present invention, 5～60 parts of carboxymethyl starch sodium, 2～40 parts of precoking starch, wetting agent are 60～95% alcoholic solution of 2～13% polyvinylpyrrolidones; Or be preferably: woman's moon health extract 100g, carboxymethyl starch sodium 45g, precoking starch 30g, 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 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.Volatile oil in the preparation process of extract can be used for preparation behind cyclodextrin inclusion compound:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; The beta-schardinger dextrin-saturated solution of volatile oil and 6～10 times stirred 1～3 hour down at 30 ℃～50 ℃, cold preservation 12～24 hours, and sucking filtration, cold drying below 50 ℃ promptly gets volatile oil beta cyclodextrin inclusion complex.
Medicinal residues decoct with water secondary again, 1.0～3.0 hours for the first time, 1.0～2.0 hours for the second time, collecting decoction filters, and the aqueous solution after filtrate and the above-mentioned distillation merges, be condensed into thick paste, above-mentioned volatile oil beta cyclodextrin inclusion complex and thick paste are the alleged extract of the present invention, and it is dry maybe can to continue drying, is ground into fine powder.
Effect of the present invention:
1, contains effective ingredient ferulic acid and paeonol in the preparation of the present invention.Ferulic acid, paeonol have effects such as microcirculation improvement, analgesia, blood stasis dispelling preferably, so ferulic acid and paeonol can be controlled the quality of this product.Get with 10 of every capsules that is equivalent to crude drug amount 4.8g, take out content, mix homogeneously, as test sample, other gets ferulic acid and paeonol standard substance respectively, measures ferulic acid, paeonol content with high-efficient liquid phase technique, and every of paeonol content is no less than: 2.5mg; Ferulic acid is no less than: the 165ug/ grain.
Measure the optional ultraviolet method of paeonol or one of high-efficient liquid phase technique or capillary gas chromatography.After using sodium carbonate or reaction of sodium bicarbonate when measuring ferulic acid, use extracted with diethyl ether, the evaporate to dryness ether is used dissolve with methanol, is mobile phase or is mobile phase with methanol-1% glacial acetic acid aqueous solution (30: 70) with acetonitrile-0.1% phosphoric acid (18: 82).
Measure the optional ultraviolet method of paeonol or one of high-efficient liquid phase technique or capillary gas chromatography.
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 ferulic acid, and paeonol content stable.Behind following 12 months of the room temperature, ferulaic acid content is 92% of a preliminary survey content; Paeonol is 85%.
2, the invention preparation is used for the treatment of the observation of curative effect of hysteromyoma:
Hysteromyoma is the common benign tumor of gynecological, and the model that belongs to the doctor of motherland lump in the abdomen is raised.Preparation of the present invention be we on the basis of SHENGHUATANG, be used Flos Carthami, Radix Cynanchi Paniculati, increased blood circulation promoting and blood stasis dispelling analgesic effect.According to the prescription characteristics, we use this medicine to control hysteromyoma 210 examples in August, 2000～2004 year April. and obtain significant curative effect, now be described below.
Clinical data
1.1 diagnostic criteria: tcm diagnosis standard reference " new Chinese medicine clinical research guideline " (first volume) " the clinical research guideline of new Chinese medicine treatment hysteromyoma ".All possess following 5 persons and classify the object of observation as:
1. the course of disease is in 4 years;
2. detect more than twice through B ultrasonic;
3. gynecologial examination is defined as hysteromyoma;
4. the age more than 18 years old to below 60 years old;
5. Chinese medical discrimination has stagnation of QI blood card person bitterly.
Clinical manifestation: menoxenia is many and irregular, and few abdomen and flank pain weigh down and expand, leucorrhoea grow in quantity, and foot's distending pain of the breast, body of the tongue is paid for the Pu or the tinea point is arranged, and pulse condition sinks string or carefully puckery.
1.2 exclusion standard (comprising inadaptation or rejecting standard):
1. Chinese medical discrimination is deficiency of vital energy syndrome of blood depletion person;
2. the person is not made a definite diagnosis in ultrasound diagnosis or gynecologial examination as yet;
3. suspicious through B ultrasonic or gynecologial examination diagnosis is adenomyosis of uterus and lump person;
4. it is little to surpass 3 months pregnant Luda in the palace body, and sick body is person more than 6 centimetres;
5. the age becomes person more than 60 years old below 18 one full year of life;
6. pregnant shake phase or women breast-feeding their children;
7. to this medicine person that crosses the olive;
8. be associated with cardiovascular, liver, kidney and hemopoietic system tight 1 primary disease is arranged
9. psychosis breath person, and all standards of including in that do not meet, not medication in accordance with regulations can't be judged the not congruent person of affecting the treatment of curative effect or data.
1.3 physical data 300 examples are divided into two groups at random.
Treatment group (preparation of the present invention) 180 examples, 18～59 years old age, 40.5 years old mean age; The course of disease 3 months to 4 years, average 2.6 years.
Matched group (GUIZHI FULING JIAONANG group) 30 examples, 18～59 years old age, average 42 years old; The course of disease 4 months to 3 years, average 2.4 years.Two groups of patient's sexes, age, courses of disease all do not have significant difference (P＞0.05), and comparability is arranged.
2 Therapeutic Method:
2.1 treatment group: preparation of the present invention, each 4, 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 capsule of preparation of the present invention respectively.(dose all is equivalent to the amount of 4.8g crude drug)
2.2 each 3 of matched group GUIZHI FULING JIAONANG (production of Jiangsu Kang Yuan Pharmaceutical), every day 3 times.
It is 1 course of treatment that two groups of patients took medicine 2 months, judges curative effect after two courses of treatment of all taking medicine.
3 observation of curative effect:
3.1 curative effect determinate standard is pressed recovery from illness, produce effects, effective, invalid 4 grades of evaluations with reference to " the clinical research principle of new Chinese medicine treatment hysteromyoma ":
Recovery from illness: muscular tumor disappears, and clinical symptoms, sign and inspection recover normal, and the main symptom of tcm syndrome, inferior card disappear.
Produce effects: transference cure, muscular tumor reduces, and sign and gynecologial examination have obvious change, and muscular tumor is dwindled 1/2nd above persons.
Effectively: revolve shape and alleviate or disappear, sign and gynecologial examination take a favorable turn, and muscular tumor is dwindled 1/3rd above persons.
Invalid: every index does not all have improvement, and muscular tumor is not seen the person of dwindling.
3.2 therapeutic outcome
3.2.1 two groups of clinical efficacies see Table 1,
Table 1 treatment group and matched group curative effect are relatively
| Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate | Total obvious effective rate |
| Treatment group 1 | 30 examples | ??5 | ??17 | ??5 | ??3 | ??90.0 | ??73.3 |
| Treatment group 2 | 30 examples | ??4 | ??19 | ??5 | ??2 | ??93.3 | ??76.7 |
| Treatment group 3 | 30 examples | ??5 | ??18 | ??6 | ??1 | ??96.7 | ??76.7 |
| Treatment group 4 | 30 examples | ??5 | ??17 | ??6 | ??2 | ??93.3 | ??73.3 |
| Treatment group 5 | 30 examples | ??4 | ??18 | ??5 | ??3 | ??90.0 | ??73.3 |
| Treatment group 6 | 30 examples | ??4 | ??17 | ??5 | ??4 | ??86.7 | ??70.0 |
| Matched group | 30 examples | ??4 | ??14 | ??7 | ??5 | ??83.3 | ??66.7 |
Adopt the T check, the total obvious effective rate of treatment group and matched group is P＜0.01 relatively, has the significance meaning.
3.2.2 two groups of menoxenias, leucorrhea abnormal curative effect are relatively:
180 examples are organized in treatment, recovery from illness (it is normal that menstruation, leucorrhea all recover) 66 examples, produce effects 84 examples, effective 21 examples. invalid 9 examples, total effective rate 95%.
Matched group 30 examples, produce effects 11 examples, effective 8 examples, invalid 7 examples, total effective rate 77.7%.Two groups of total effective rates compare P＜0.01, have utmost point significance meaning.
3.2.3 two groups of dimly red tongue, the petechia ecchymosis, deep and stringy pulse, thin puckery curative effect relatively treatment are organized 180 examples, recovery from illness (it is normal that the tongue arteries and veins recovers fully) 78 examples, produce effects 54 examples, effective 39 examples, invalid 9 examples, total effective rate is 95%.
Matched group 30 examples, 10 examples of fully recovering, produce effects 9 examples, effective 7 examples, invalid 4 examples, total effective rate is relatively P＜0.05 of 86.7%, two group of total effective rate, and significant difference is arranged.
4 model cases:
Liu * *, woman, 38 years old, first visit on October 5 in 2002.Readme is menorrhagia over the past two years, the dark red folder clot of color, menstrual cycle 20 days, 9～10 days menstrual period; Distending pain of the breast, lower abdomen drops and expands; Last menstrual period JIUYUE 25 days was to October 4.Purplish tongue limit point has petechia yellow fur, stringy and hesitant pulse.Woman's inspection: vagina is unimpeded. and cervix uteri is smooth, and body right position in palace increases as pregnant 60 days, and matter is hard.Blood examination: Hb76g/L, all the other are normal.B ultrasonic: uterus 7.5cm * 6.2cm * 8.2cm, echo inequality in utero, the uterus rear wall is visited (3.2 * 2.2) two low echo areas, and light group is arranged, and belongs to fleshy polyp.
The soft capsule of medicinal preparation of the present invention, each 2, every day 3 times.Through taking medicine 4 months. the eumenorrhea.Ultrasound diagnosis on March 2 in 2004; The uterus size is normal, and in utero echo is even, does not see space occupying lesion.Through 1 year follow-up study, all were normal.
5 conclusions:
Qi as the commander of blood, blood is capable with gas, the nutrition whole body by meridians.Primary disease is many because of vessels of the uterus inanition in puerperal, or the open pathogen invasion and attack in an opponent's defence through the chamber, causes QI and blood stasis, and the blood deficiency stagnation of QI all can cause menses and be detained, and gradually amasss into disease.Disease sees that menstruation spreads out the phase, and few abdomen weighs down pain, and long-pending piece is strong, fixingly disease such as does not move.
According to " interior warp " disease caused by accumulations of pathogen should be treated with therapy of dispersion, disease with retention of pathogen in the body should be treated by elimination therapy's treatment rule, according to the prosperity and decline of healthy energy, but reinforcement and elimination in combination, from attacking in benefit, or tonification involving purgation.The present invention is with Radix Angelicae Sinensis, Rhizoma Chuanxiong blood circulation promoting and enriching, Semen Persicae, Radix Cynanchi Paniculati, Flos Carthami stasis-dispelling and pain-killing, Rhizoma Zingiberis, Radix Glycyrrhizae strengthen the spleen and stomach make biochemical active, so treatment hysteromyoma effect is remarkable.Set about executing controlling from edema caused by disorder of QI with cassia twig tuckahoe and compare, we start with from blood system, and the stasis of blood is attacked in revisal, and is slim and frahile in makings, and the women's that QI and blood is not transported hysteromyoma symptom is more suitable.And still applicable to diseases such as disease that postpartum lochia can't go, few abdomen pain.
The specific embodiment:
Embodiment 1: a kind of preparation of gynecological Chinese medicine extract of stopping pain and expelling blood stasis:
Radix Angelicae Sinensis 120g, 45 parts of Rhizoma Chuanxiongs, 7.5 parts in Radix Glycyrrhizae (processing),
12 parts in Semen Persicae, 7.5 parts of Rhizoma Zingiberiss (charcoal), 150 parts of Herba Leonuris,
7.5 parts on Flos Carthami, 25 parts of Radix Cynanchi Paniculatis,
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1.0 hours for the first time, 1.0 hours for the second time, collecting decoction, filter, the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, above-mentioned volatile oil and thick paste are the alleged extract of the present invention, and it is dry maybe can to continue drying, is ground into fine powder.
Embodiment 2: a kind of preparation of gynecological Chinese medicine extract of stopping pain and expelling blood stasis:
240 parts of Radix Angelicae Sinensis, 90 parts of Rhizoma Chuanxiongs, 15 parts in Radix Glycyrrhizae (processing), 24 parts in Semen Persicae,
15 parts of Rhizoma Zingiberiss (charcoal), 300 parts of Herba Leonuris, 15 parts on Flos Carthami, 50 parts of Radix Cynanchi Paniculatis;
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, above-mentioned volatile oil and thick paste are the alleged extract of the present invention, and it is dry maybe can to continue drying, is ground into fine powder.
Embodiment 3: a kind of preparation of gynecological Chinese medicine extract of stopping pain and expelling blood stasis:
360 parts of Radix Angelicae Sinensis, 135 parts of Rhizoma Chuanxiongs, 22.5 parts in Radix Glycyrrhizae (processing),
36 parts in Semen Persicae, 22.5 parts of Rhizoma Zingiberiss (charcoal), 450 parts of Herba Leonuris,
22.5 parts on Flos Carthami, 75 parts of Radix Cynanchi Paniculatis,
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 3.0 hours for the first time, 2.0 hours for the second time, collecting decoction, filter, the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, above-mentioned volatile oil and thick paste are the alleged extract of the present invention, and it is dry maybe can to continue drying, is ground into fine powder.
Embodiment 4: a kind of preparation of gynecological Chinese medicine extract of stopping pain and expelling blood stasis:
240 parts of Radix Angelicae Sinensis, 90 parts of Rhizoma Chuanxiongs, 15 parts in Radix Glycyrrhizae (processing), 24 parts in Semen Persicae,
15 parts of Rhizoma Zingiberiss (charcoal), 300 parts of Herba Leonuris, 15 parts on Flos Carthami, 50 parts of Radix Cynanchi Paniculatis;
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; The beta-schardinger dextrin-saturated solution of volatile oil and 6～10 times stirred 1～3 hour down at 30 ℃～50 ℃, cold preservation 12～24 hours, and sucking filtration, cold drying below 50 ℃ promptly gets volatile oil beta cyclodextrin inclusion complex.
Medicinal residues decoct with water secondary again, and 1.0～3.0 hours for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, and it is dry maybe can to continue drying, is ground into fine powder.
Above-mentioned clathrate and dried cream powder are the extract of the various dosage forms of preparation.
Embodiment 5: a kind of gynecological Chinese medicine preparation of soft capsule of stopping pain and expelling blood stasis
Radix Angelicae Sinensis 1538.5g Rhizoma Chuanxiong 576.9g Radix Glycyrrhizae (processing) 96.1g
Semen Persicae 153.8g Rhizoma Zingiberis (charcoal)) 96.1g Herba Leonuri 1923.1g
Flos Carthami 96.1g Radix Cynanchi Paniculati 320.5g
Cera Flava 20g;
Olive oil 215g
Propylene glycol 2g
Soybean lecithin 8g
Make 1000
1. get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
2. modulate capsule liquid: get above-mentioned volatile oil, dried cream or thick paste, 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 6: a kind of gynecological Chinese medicine preparation of soft capsule of stopping pain and expelling blood stasis
Medicinal substances extract 300g:
Peach kernel oil 25g
Soybean oil 200g:
Cera Flava: 1.5: 3.5 30g of ethyl cellulose weight ratio
Ethylparaben 1.5g
Make 1000
1. get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
2. modulate capsule liquid: get above-mentioned volatile oil, dried cream or thick paste, 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 7: a kind of gynecological Chinese medicine preparation of soft capsule of stopping pain and expelling blood stasis
Radix Angelicae Sinensis 1538.5g Rhizoma Chuanxiong 576.9g Radix Glycyrrhizae (processing) 96.1g
Semen Persicae 153.8g Rhizoma Zingiberis (charcoal)) 96.1g Herba Leonuri 1923.1g
Flos Carthami 96.1g Radix Cynanchi Paniculati 320.5g
Medical material is made extract (comprising: volatile oil and thick paste) 300g by embodiment 1～4.
Peach kernel oil 50g
Soybean oil 240g:
Make 1500
Embodiment 8: a kind of preparation of gynecological Chinese medicine dispersible tablet of stopping pain and expelling blood stasis:
Radix Angelicae Sinensis 1538.5g Rhizoma Chuanxiong 576.9g Radix Glycyrrhizae (processing) 96.1g
Semen Persicae 153.8g Rhizoma Zingiberis (charcoal)) 96.1g Herba Leonuri 1923.1g
Flos Carthami 96.1g Radix Cynanchi Paniculati 320.5g
Lactose: 100g
Microcrystalline Cellulose: 65g
Mannitol: 45g
Carboxymethyl starch sodium: 10g
Polyvinylpyrrolidone: 35g
Sodium lauryl sulphate: 2.5g
Magnesium stearate: 3.0g
Make extract by embodiment 1～4, use 75% alcohol granulation with lactose, carboxymethyl starch sodium, microcrystalline Cellulose, mannitol etc., drying adds polyvinylpyrrolidone, sodium lauryl sulphate, and the magnesium stearate mix homogeneously is pressed into 1000, promptly.
Embodiment 9: a kind of preparation of gynecological Chinese medicine dispersible tablet of stopping pain and expelling blood stasis:
Medicinal substances extract (comprising: volatile oil and dried cream powder) 300g
Lactose: 65g
Hydroxypropyl emthylcellulose: 20g
Microcrystalline Cellulose: 55g
Crospolyvinylpyrrolidone: 25g
Micropowder silica gel: 5.0g
Make the extract thick paste by embodiment 1～4, with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, add volatile oil, dry, add polyvinylpyrrolidone, differential silica gel mix homogeneously, tabletting, coating is made 1000, 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 10: a kind of preparation of gynecological Chinese medicine drop pill of stopping pain and expelling blood stasis
Radix Angelicae Sinensis 1538.5g Rhizoma Chuanxiong 576.9g Radix Glycyrrhizae (processing) 96.1g
Semen Persicae 153.8g Rhizoma Zingiberis (charcoal)) 96.1g Herba Leonuri 1923.1g
Flos Carthami 96.1g Radix Cynanchi Paniculati 320.5g
Polyethylene glycol 6000 22g
Macrogol 4000 20g
Poloxamer 10g
Make 5000.
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get drop pill substrate heating and melting, add medicinal substances extract dried cream powder, volatile oil, poloxamer mix homogeneously with it, under 95 ℃ of conditions, be incubated, mix homogeneously, splash in the coolant and be shaped, 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 50 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 of gynecological Chinese medicine oral cavity disintegration tablet of stopping pain and expelling blood stasis:
Radix Angelicae Sinensis 1538.5g Rhizoma Chuanxiong 576.9g Radix Glycyrrhizae (processing) 96.1g
Semen Persicae 153.8g Rhizoma Zingiberis (charcoal)) 96.1g Herba Leonuri 1923.1g
Flos Carthami 96.1g Radix Cynanchi Paniculati 320.5g
Get extract (comprising: volatile oil and the thick paste) 280g that said ratio makes,
Lactose: 85g
Microcrystalline Cellulose: 35g
Mannitol: 75g
Carboxymethyl starch sodium: 30g
Polyvinylpyrrolidone: 45g
The sweet 8.0g of A Basi
Citric acid 15.0g
Magnesium stearate: 15g
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get above-mentioned dried cream or thick paste, 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 1000, promptly.
Embodiment 12: a kind of preparation of gynecological Chinese medicine oral cavity disintegration tablet of stopping pain and expelling blood stasis:
The material extract 350g that gets it filled,
Carboxymethyl starch sodium: 35g
Polyvinylpyrrolidone: 45g
Magnesium stearate: 0.05g
Get above-mentioned volatile oil, use 75% alcohol granulation with carboxymethyl starch sodium etc., drying, adding polyvinylpyrrolidone, magnesium stearate mix homogeneously are pressed into 1000, promptly.
Embodiment 13: the particulate preparation of a kind of gynecological Chinese medicine of stopping pain and expelling blood stasis
The material extract 300g that gets it filled,
Lactose: 100g
Mannitol: 60g
Precoking starch: 30g
Crospolyvinylpyrrolidone: 15g
Low-substituted hydroxypropyl cellulose 30g
Sodium bicarbonate 25g
Citric acid 20g
Tartaric acid 30g
Make 250 bags.
Make extract and volatile oil by embodiment 1～4, use 75% alcohol granulation with lactose, mannitol, precoking starch, sodium bicarbonate etc., drying adds citric acid, tartaric acid etc., promptly.
Embodiment 14: a kind of preparation of gynecological Chinese medicine micropill of stopping pain and expelling blood stasis
The material extract 300g that gets it filled,
Carboxymethyl starch sodium 45g
Precoking starch 30g
85% alcoholic solution, the 60～80ml of 11% polyvinylpyrrolidone
(1) gets above-mentioned volatile oil, dried cream or thick paste,, 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.
Embodiment 15: the particulate preparation of a kind of gynecological Chinese medicine of stopping pain and expelling blood stasis
Radix Angelicae Sinensis 1538.5g Rhizoma Chuanxiong 576.9g Radix Glycyrrhizae (processing) 96.1g
Semen Persicae 153.8g Rhizoma Zingiberis (charcoal)) 96.1g Herba Leonuri 1923.1g
Flos Carthami 96.1g Radix Cynanchi Paniculati 320.5g
Dextrin: 30g
Starch: 60g
Microcrystalline Cellulose: 70g
Make 250 bags.
Above-mentioned medical material is made extract by embodiment 4, and dextrin, starch, microcrystalline Cellulose: use 75% alcohol granulation, drying, promptly.
Embodiment 16: the capsular preparation of a kind of gynecological Chinese medicine of stopping pain and expelling blood stasis
240 parts of Radix Angelicae Sinensis, 90 parts of Rhizoma Chuanxiongs, 15 parts in Radix Glycyrrhizae (processing), 24 parts in Semen Persicae,
15 parts of Rhizoma Zingiberiss (charcoal), 300 parts of Herba Leonuris, 15 parts on Flos Carthami, 50 parts of Radix Cynanchi Paniculatis;
Starch: 100g
Make 1000
Medical material is made extract dried cream powder and volatile oil by embodiment 2, with starch mixing granulation, drying, fill capsule, promptly.
Embodiment 17: the capsular preparation of a kind of gynecological Chinese medicine of stopping pain and expelling blood stasis
Radix Angelicae Sinensis 1538.5g Rhizoma Chuanxiong 576.9g Radix Glycyrrhizae (processing) 96.1g
Semen Persicae 153.8g Rhizoma Zingiberis (charcoal)) 96.1g Herba Leonuri 1923.1g
Flos Carthami 96.1g Radix Cynanchi Paniculati 320.5g
Starch 135g
Differential silica gel 50g
Medical material is made extract by embodiment 2,, add differential silica gel with starch mixing granulation, drying, the fill capsule, promptly.
Embodiment 18: the capsular preparation of a kind of gynecological Chinese medicine of stopping pain and expelling blood stasis
Radix Angelicae Sinensis 1538.5g Rhizoma Chuanxiong 576.9g Radix Glycyrrhizae (processing) 96.1g
Semen Persicae 153.8g Rhizoma Zingiberis (charcoal)) 96.1g Herba Leonuri 1923.1g
Flos Carthami 96.1g length slowly is 320.5g
Starch 135g
Differential silica gel 50g
Make 1000.
Medical material is made extract by embodiment 4,, add differential silica gel with starch mixing granulation, drying, the fill capsule, promptly.
The capsular quality control of gained can detect ferulic acid, reach paeonol.Every of paeonol content is no less than: 2.5mg; Ferulic acid is no less than: the 165ug/ grain.
After using sodium carbonate or reaction of sodium bicarbonate when measuring ferulic acid, use extracted with diethyl ether, the evaporate to dryness ether is used dissolve with methanol, is mobile phase or is mobile phase with methanol-1% glacial acetic acid aqueous solution (30: 70) with acetonitrile-0.1% phosphoric acid (18: 82).
Measure the optional ultraviolet method of paeonol or one of high-efficient liquid phase technique or capillary gas chromatography.After using sodium carbonate or reaction of sodium bicarbonate when measuring ferulic acid, use extracted with diethyl ether, the evaporate to dryness ether is used dissolve with methanol, is mobile phase or is mobile phase with methanol-1% glacial acetic acid aqueous solution (30: 70) with acetonitrile-0.1% phosphoric acid (18: 82).
Measure the optional ultraviolet method of paeonol or one of high-efficient liquid phase technique or capillary gas chromatography.
Embodiment 19: a kind of gynecological Chinese medicine soft capsule stability test of stopping pain and expelling blood stasis
Get the soft capsule (wherein volatile oil solidifies through enclose in the preparation process) that makes by the inventive method, carry out this product room temperature and accelerated stability test by the Chinese Pharmacopoeia prescriptive procedure, this kind ferulic acid, and paeonol content stable.Behind following 12 months of the room temperature, ferulaic acid content is 92% of a preliminary survey content; Paeonol is 85%.
Claims (14)
1, a kind of gynecological Chinese medicine preparation of stopping pain and expelling blood stasis is characterized in that used medical material is:
Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae (processing), Semen Persicae, Rhizoma Zingiberis (charcoal), Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati
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 with pharmaceutically alleged adjuvant or substrate.
2,, it is characterized in that the component weight proportion is preferably according to the gynecological Chinese medicine preparation of the described a kind of stopping pain and expelling blood stasis of claim 1:
240 parts of Radix Angelicae Sinensis, 90 parts of Rhizoma Chuanxiongs, 15 parts in Radix Glycyrrhizae (processing), 24 parts in Semen Persicae,
15 parts of Rhizoma Zingiberiss (charcoal), 300 parts of Herba Leonuris, 50 parts of 15 parts of Radix Cynanchi Paniculatis of Flos Carthami;
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:
Radix Angelicae Sinensis 1538.5g Rhizoma Chuanxiong 576.9g Radix Glycyrrhizae (processing) 96.1g
Semen Persicae 153.8g Rhizoma Zingiberis (charcoal)) 96.1g Herba Leonuri 1923.1g
Flos Carthami 96.1g Radix Cynanchi Paniculati 320.5g.
3, according to the gynecological Chinese medicine preparation preparation of soft capsule method of claim 1 stopping pain and expelling blood stasis, it is characterized in that:
1. get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
2. modulate capsule liquid: get above-mentioned volatile oil, dried cream or thick paste, 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 the gynecological Chinese medicine soft capsule of claim 3 stopping pain and expelling blood stasis, it is characterized in that: the supplementary product consumption of making soft capsule can be preferably: a kind of gynecological Chinese medicine extract 100g of stopping pain and expelling blood stasis, with disperse medium 30～350g, suspending agent 0～65g, antiseptic 0～7.5g, be modulated into stable capsule liquid and make soft capsule.
5. the gynecological Chinese medicine dispersible tablet of a kind of stopping pain and expelling blood stasis according to claim 1 is characterized in that this dispersible tablet preparation method is:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get above-mentioned dried cream or thick paste, 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 the gynecological Chinese medicine dispersible tablet of a kind of stopping pain and expelling blood stasis described in the claim 6,, it is characterized in that:
Its adjuvant can be preferably: a kind of gynecological Chinese medicine extract 100g of stopping pain and expelling blood stasis, with filler 0～180g, disintegrating agent 3～75g, 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. the gynecological Chinese medicine drop pill of a kind of stopping pain and expelling blood stasis according to claim 1 is characterized in that:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get drop pill substrate heating and melting, other gets above-mentioned volatile oil, dried cream or thick paste 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. according to the gynecological Chinese medicine oral cavity disintegration tablet of claim 1 stopping pain and expelling blood stasis, it is characterized in that:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get above-mentioned volatile oil, dried cream or thick paste, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned dried cream or thick paste,, 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 gynecological Chinese medicine oral cavity disintegration tablet of stopping pain and expelling blood stasis according to Claim 8, it is characterized in that: its supplementary product consumption proportioning is: a kind of gynecological Chinese medicine extract 100g, filler 0～150g of stopping pain and expelling blood stasis, disintegrating agent 3～60g, correctives 0～25g, lubricant 0.01～20g;
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. according to the gynecological Chinese medicine effervescent tablet of claim 1 stopping pain and expelling blood stasis, it is characterized in that:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get above-mentioned volatile oil, dried cream or thick paste, 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 or thick paste,, 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. the gynecological Chinese medicine effervescent tablet according to claim 10 stopping pain and expelling blood stasis 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 gynecological Chinese medicine extract 100g, filler 0～100g of stopping pain and expelling blood stasis, disintegrating agent 3～60g, correctives 0～25g, effervescent acid-base pair 5～80g, lubricant 0～20g.
12, according to the gynecological Chinese medicine granule of claim 1 stopping pain and expelling blood stasis, it is characterized in that:
Get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
Get above-mentioned volatile oil, dried cream or thick paste, 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.
13, according to the gynecological Chinese medicine micropill of claim 1 stopping pain and expelling blood stasis, it is characterized in that:
(1) get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, the aqueous solution after distillation device is in addition collected; Medicinal residues decoct with water secondary again, and 1～3 hour for the first time, 1.0～2.0 hours for the second time, collecting decoction filtered, and the aqueous solution after filtrate and the above-mentioned distillation merges, and is condensed into thick paste, promptly gets thick paste; Or dry, pulverize, promptly get dry extract; Above-mentioned dried cream or thick paste and volatile oil are medicinal substances extract;
(2) preparation of micropill: get above-mentioned volatile oil, dried cream or thick paste,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying, or the coating after drying, promptly.
14, the gynecological Chinese medicine preparation of a kind of stopping pain and expelling blood stasis according to claim 1, earlier with behind the medicinal material extract volatile oil, continuation is made extract thick paste or dried cream powder with medical material, it is characterized in that: get eight flavors such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Glycyrrhizae, Semen Persicae, Rhizoma Zingiberis, Herba Leonuri, Flos Carthami, Radix Cynanchi Paniculati, be ground into coarse powder, extract volatile oil with the way of distillation, volatile oil solidifies the back with cyclodextrin inclusion compound to be used.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN 200510034995 CN1698716A (en) | 2005-05-30 | 2005-05-30 | Gynecological Chinese medicinal preparation for stopping pain and expelling blood stasis |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510034995 CN1698716A (en) | 2005-05-30 | 2005-05-30 | Gynecological Chinese medicinal preparation for stopping pain and expelling blood stasis |
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| CN1698716A true CN1698716A (en) | 2005-11-23 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100438903C (en) * | 2005-12-29 | 2008-12-03 | 贵州益佰制药股份有限公司 | Quality control method of fuyuekang Chinese medicinal preparation |
| CN102085352A (en) * | 2011-01-28 | 2011-06-08 | 浙江大学 | Traditional Chinese medicine composition for preventing and controlling intrauterine residues after medicinal abortion and application thereof |
| CN102512649A (en) * | 2011-12-28 | 2012-06-27 | 石圣洪 | Composition of Chinese medicinal herbs for treating postpartum blood stasis and preparation method thereof |
| CN107823155A (en) * | 2017-11-21 | 2018-03-23 | 荆晓玉 | A kind of simple micropill and preparation method thereof |
| CN110946897A (en) * | 2019-12-21 | 2020-04-03 | 江西九华药业有限公司 | Cihang tablet and preparation method thereof |
-
2005
- 2005-05-30 CN CN 200510034995 patent/CN1698716A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100438903C (en) * | 2005-12-29 | 2008-12-03 | 贵州益佰制药股份有限公司 | Quality control method of fuyuekang Chinese medicinal preparation |
| CN102085352A (en) * | 2011-01-28 | 2011-06-08 | 浙江大学 | Traditional Chinese medicine composition for preventing and controlling intrauterine residues after medicinal abortion and application thereof |
| CN102512649A (en) * | 2011-12-28 | 2012-06-27 | 石圣洪 | Composition of Chinese medicinal herbs for treating postpartum blood stasis and preparation method thereof |
| CN107823155A (en) * | 2017-11-21 | 2018-03-23 | 荆晓玉 | A kind of simple micropill and preparation method thereof |
| CN107823155B (en) * | 2017-11-21 | 2021-06-11 | 河南泓医药业有限公司 | Preparation method of single-medicine micro-pills |
| CN110946897A (en) * | 2019-12-21 | 2020-04-03 | 江西九华药业有限公司 | Cihang tablet and preparation method thereof |
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