CN1698711A - Preparation for treating hysteromyoma and its preparation method - Google Patents
Preparation for treating hysteromyoma and its preparation method Download PDFInfo
- Publication number
- CN1698711A CN1698711A CN 200510034553 CN200510034553A CN1698711A CN 1698711 A CN1698711 A CN 1698711A CN 200510034553 CN200510034553 CN 200510034553 CN 200510034553 A CN200510034553 A CN 200510034553A CN 1698711 A CN1698711 A CN 1698711A
- Authority
- CN
- China
- Prior art keywords
- radix
- water
- add
- hour
- parts
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
Disclosed is a Chinese medicinal preparation for treating hysteromyoma which employs the following raw materials in combination, immature bitter orange, oyster shell, cattail pollen. The preparation is made into the dosage forms of capsule, dispersible tablet, effervescent tablet, drop pill, soft capsule, tablet and granule.
Description
Technical field
The present invention relates to the field of Chinese medicines, is specifically related to treat the gynecological Chinese medicine compound preparation of hysteromyoma, the invention still further relates to the preparation method of transformation of the way agent.
Technical background
Hysteromyoma is the modal benign tumor of female reproductive system owing to uterine smooth muscle hyperplasia forms.More than 30 years old among the women sickness rate account for 20%.Can cause various symptoms such as dysmenorrhea, metrorrhagia, and have the possibility canceration.
Modern medicine is with operation or hormonal medicaments treatment hysteromyoma, and the operative treatment misery is bigger, the expense costliness, and the relapse rate height, the hormonal medicaments treatment causes that easily human endocrine is unbalance.
Chinese medicine is included in hysteromyoma diseases such as " mass in the abdomen ", by improving the function between each internal organs of human body, channel system, improves the symptom of patients with uterine myoma, thereby the treatment hysteromyoma shows effect repeatedly, but alternative medicine and few.
Summary of the invention:
The object of the invention provides a kind of Chinese medicine composition for the treatment of hysteromyoma, preparation and preparation method thereof.
The present invention takes following design: the component weight proportion that the present invention treats the preparation of hysteromyoma is: 12～36 parts of Radix Et Rhizoma Rhei, 10～30 parts of Hirudos, 9～27 parts in Semen Persicae, 10～30 parts of Eupolyphaga Seu Steleophagas, 9～27 parts of Fructus Aurantii Immaturuss, 6～24 parts of Radix Scutellariaes, 12～36 parts of Concha Ostreaes, 12～36 parts of Radix Rehmanniae, 8～24 parts of Pollen Typhaes, 9～27 parts of the Radix Paeoniae Albas, 3～9 parts in Radix Glycyrrhizae
Above-mentioned component cooperates the pharmaceutically alleged adjuvant or the substrate of the suitable kind of employing to make drop pill or soft capsule or dispersible tablet or other peroral dosage forms respectively.
Radix Et Rhizoma Rhei means: the processed product that makes by pharmacopeia regulation stewed with wine or wine steaming method for the dry root and rhizome of polygonum rheum palmatum Rheum palmatum L., Rheum tanguticum Rheumtanguticum Maxim.ex Balf. or Rheum officinale Rheum officinale Baill., have to rush down and exert oneself to delay the unique function of eliminating fire and detoxication.Other all use by the Chinese Pharmacopoeia regulation.
More can be preferably:
24 parts of Radix Et Rhizoma Rhei, 20 parts of Hirudos, 18 parts in Semen Persicae, 20 parts of Eupolyphaga Seu Steleophagas,
18 parts of Fructus Aurantii Immaturuss, 12 parts of Radix Scutellariaes, 24 parts of Concha Ostreaes, 24 parts of Radix Rehmanniae,
16 parts of Pollen Typhaes, 18 parts of the Radix Paeoniae Albas, 6 parts in Radix Glycyrrhizae
More can be preferably:
The preparation of 1000 units of taking is made by the medical material of following weight proportion:
Radix Et Rhizoma Rhei 240g Hirudo 200g Semen Persicae 180g Eupolyphaga Seu Steleophaga 200g Fructus Aurantii Immaturus 180g
Radix Scutellariae 120g Concha Ostreae 240g Radix Rehmanniae 240g Pollen Typhae 160g Radix Paeoniae Alba 180g
Radix Glycyrrhizae 60g
The extraction of the inventive method medical material contains following processing step preparation:
Get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, boil the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, decocting liquid filters; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, decocting liquid filters.Merge aforementioned decocting liquid, be concentrated into relative density and be about 1.05～1.40.Concha Ostreae decocts with water with same procedure and concentrates, and merges with aforementioned concentrated solution.
More can be preferably:
Get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and put in the decoction device, decoct with water twice, add 10 times of water gagings for the first time, soaked 2 hours, add Semen Persicae, Radix Scutellariae after boiling again, decocted 1 hour, decocting liquid filters; For the second time add 8 times of water gagings, decocted 1 hour, decocting liquid filters, and merges twice decocting liquid, is evaporated to relative density and is about 1.20 under 65 ℃, and Concha Ostreae decocts with water with same procedure and concentrates, and merges with aforementioned concentrated solution.
Being prepared as follows of preparation:
The preparation capsule:
Get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, boil the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, filter; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, and merges with aforementioned concentrated solution, is medicinal substances extract, adds starch, granulate, drying, encapsulated, promptly.
Adjuvant be except that selecting for use the starch, can also be lactose, 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 dispersible tablet:
The preparation drop pill: get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, adding Semen Persicae, Radix Scutellariae decocted 0.5～2 hour after boiling, and filtered; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Get above-mentioned medicinal substances extract (thick paste or dried cream) and mixing granulations such as filler, disintegrating agent, drying is made granule, adds right amount of auxiliary materials, mixing, and tabletting promptly gets dispersible tablet; Or the coated coated dispersing tablet of making.
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 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.
Preparation effervescent tablet: get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add for the first time 6～15 times of water gagings, soaked 0～2 hour, and boiled the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, filter; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Get above-mentioned medicinal substances extract (thick paste or dried cream) and filler, effervescent acid-base pair mixing granulation, add disintegrating agent, lubricant, mixing, tabletting promptly gets effervescent tablet, or the coated coating effervescent tablet of making
The effervescent acid-base pair is that the citric acid or the tartaric acid of sodium bicarbonate and equivalent is formed;
Filler be lactose, mannitol, precoking starch, microcrystalline Cellulose etc. one or more.
Disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.
The preparation drop pill: get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, adding Semen Persicae, Radix Scutellariae decocted 0.5～2 hour after boiling, and filtered; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Get drop pill substrate heating and melting,, splash into coolant, make drop pill with medicinal substances extract (thick paste or dried cream) mix homogeneously.
Substrate in its drop pill is polyethylene glycol 6000, can also for molecular weight by 2000～12000 Polyethylene Glycol, or polyoxyethylene monostearate, or sodium stearate or glycerin gelatine, or poloxamer or stearic acid, or glyceryl monostearate, or cured one or more of worm, or preferably use polyethylene glycol 6000: the mixture of Macrogol 4000=7: 1, consumption is 150～450g; Coolant in its drop pill is one or more of dimethicone or liquid paraffin or Oleum Camelliae or vegetable oil.
The preparation soft capsule: the material of getting it filled, make extract by said extracted technology, get 50～140 parts of the disperse medium that suspending agent (3～20 parts) is dissolved in part, be preheated to 60～65 ℃ standby; The antiseptic (0.1～3 part) of getting the prescription share adds in 10～100 parts of disperse medium of above-mentioned share remainder, stirs, and is mixed to 37 ℃ with above-mentioned disperse medium, adds above-mentioned dried cream powder or thick paste, stirs, and grinds homogenizing, makes soft capsule;
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.
The preparation tablet: get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, adding Semen Persicae, Radix Scutellariae decocted 0.5～2 hour after boiling, and filtered; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Add adjuvant, make granule, mixing, tabletting promptly, or through sugar coating or film-coat, promptly gets coated tablet.
The preparation granule: get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, adding Semen Persicae, Radix Scutellariae decocted 0.5～2 hour after boiling, and filtered; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Add adjuvant, make granule, drying.
The granule adjuvant be except that selecting for use the starch, can also be lactose, starch, amylum pregelatinisatum, carboxymethyl starch, microcrystalline Cellulose, methylcellulose, hydroxy methocel, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, micropowder silica gel, xylitol etc. one or more.
Extracting preparation process can be preferably:
The preparation of (1) 1000 unit of taking is made by the medical material of following weight proportion:
Radix Et Rhizoma Rhei 240g Hirudo 200g Semen Persicae 180g Eupolyphaga Seu Steleophaga 200g Fructus Aurantii Immaturus 180g
Radix Scutellariae 120g Concha Ostreae 240g Radix Rehmanniae 240g Pollen Typhae 160g Chinese herbaceous peony 180g
Radix Glycyrrhizae 60g
(2) extracting method of medical material is:
Get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water twice, add 10 times of water gagings for the first time, soaked 2 hours, boil the back and add Semen Persicae, Radix Scutellariae decoction 1 hour, filter; For the second time add 8 times of amounts of water, decocted 1 hour, filter, merge twice decocting liquid, be evaporated to relative density and be about 1.20 under 65 ℃, Concha Ostreae decocts with water with same procedure and concentrates, and merges with aforementioned concentrated solution.Effect of the present invention:
Extracting method of the present invention is reasonable, and Semen Persicae, Radix Scutellariae boil the back and add, and Concha Ostreae is separately independent to be decocted, and makes that corresponding active constituent content is higher, thus the assurance curative effect of preparation.Drop pill: drop pill is the modern Chinese medicine novel form, belongs to solid dispersion system, and it is big to have specific surface area, and stripping is fast, the characteristics that bioavailability is high.And manufacturing cost is lower.Drops mostly is chemicals and uses, and the development of Chinese medicine dripping pills needs to test the choose reasonable substrate and make flow process by a large amount of.
Soft capsule: be not have a kind of preparation that forms in sealings such as the non-water-soluble liquid of dissolution or suspension and the capsule shells with oils or to the gelatin thing.Soft capsule is the tablet that continues, and a kind of novel form that grows up after the injection, its shell are to form with the gelatin compacting, the aqueous medicinal liquid of bag in the softgel shell.Slower than injection onset, but than tablet, capsule, granule is rapid-action, and oral liquid is easy to carry.
Dispersible tablet: be a kind of solidified liquid form of administration, disintegrate fully in 3 minutes at normal temperatures, the effective ingredient stripping is rapid.But solid state is taken, but also liquid condition is taken, and makes things convenient for the patient.
The development of new drug formulations such as Chinese medicine dripping pills, soft capsule, dispersible tablet need overcome and extract the difficult point that the extractum moisture absorption influences disintegrate, and the present invention is by the screening adjuvant, thereby it is stable to reach end product quality, and disintegrate is characteristics rapidly.One of effect of the present invention:
The comparative study of different process:
For a long time, Chinese medicine preparation adopts the extracting mode that group medicine is fried in shallow oil altogether more.Be directed to preparation of the present invention, investigated according to the index in the medical material and fried in shallow oil altogether and the influence of extract respectively content of baicalin.
1, method: make sample 1,2 by distinct methods, respectively the content of baicalin in the test sample.
2, sample preparation
Sample 1: get 11 flavor medicines such as Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g, Fructus Aurantii Immaturus 180g, Radix Scutellariae 120, Concha Ostreae 240g, Radix Rehmanniae 240g, Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g and add 10 times of amounts of water, decoct, decocting liquid filters, filter, liquid concentrating under reduced pressure, cold drying.
Sample 2: get Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g, Fructus Aurantii Immaturus 180g, Radix Scutellariae 120, Concha Ostreae 240g, Radix Rehmanniae 240g, Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g etc., except that Semen Persicae, Radix Scutellariae, Concha Ostreae, add 10 times of water gagings for the first time, soaked 2 hours, boil the back and add Semen Persicae, Radix Scutellariae decoction 1 hour, filter; For the second time add 8 times of amounts of water, decocted 1 hour, filter, merge twice decocting liquid, under 65 ℃, be evaporated to relative density and be about 1.20; Concha Ostreae decocts 2 times with 10 times of water gagings separately, decocts and concentrates, and merges with aforementioned concentrated solution.Concentrating under reduced pressure, cold drying.
3, content of baicalin measurement result:
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Methanol-water-phosphoric acid (47: 53: 0.2) is mobile phase; The detection wavelength is 280nm.Number of theoretical plate calculates by the baicalin peak should be not less than 2500.
The preparation precision of reference substance solution takes by weighing at 4 hours baicalin reference substance of 60 ℃ of drying under reduced pressure an amount of, adds methanol and makes the solution that every 1ml contains 60 μ g, promptly.
This product sample 1,2 about 5.0g are got in the preparation of need testing solution respectively, the accurate title, decide, add 70% ethanol 60ml, reflux 3 hours is put cold, filter, filtrate is put in the 100ml measuring bottle, and with a small amount of 70% ethanol gradation washing container and residue, washing liquid is filtered in the same measuring bottle, add 70% ethanol to scale, shake up.Precision is measured 1ml, puts in the 10ml measuring bottle, adds methanol to scale, shakes up, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
| Sequence number | Sample 1 baicalin average content (mg/10g) | Sample 2 baicalin average contents (mg/10g) |
| ??1 | ??6.5 | ??24.8 |
| ??2 | ??7.8 | ??22.4 |
| ??3 | ??6.2 | ??21.6 |
| Mean | ??6.83 | ??22.9 |
Interpretation of result:
In sample 2 preparation process, Concha Ostreae is extracted separately, and the baicalin water back of boiling adds, and makes in the extractum content of baicalin apparently higher than sample 1.Radix scutellariae medicinal materials boils the back and adds, and helps the destruction of enzyme in the medical material, so the baicalin yield is improved.
Reason is sample 1 all flavour of a drug and Concha Ostreae when frying in shallow oil altogether, and it is more that each composition forms precipitation, more according to loss of effective components.
Two of effect of the present invention:
Clinical research: preparation of the present invention (the clear XLQ soft capsule of dispersing tumor) treatment hysteromyoma face the observation clinical data
1 clinical data
60 examples are the outpatient service female patient, are divided into treatment group and matched group at random.
30 examples are organized in treatment: 26～51 years old age, average 34 years old.Unmarried's 10 examples, the married's 32 examples.The course of disease the shortest half a year, the longest 5 years.
Matched group 30 examples: 25～55 years old age, average 36 years old.Unmarried's 8 examples, the married's 22 examples.The course of disease the shortest half a year, the longest 4 years.
Two groups of physical data compare, and difference does not have significance meaning (P＞0.05), has comparability.
1.2 diagnostic criteria with reference in the reference new Chinese medicine clinical research guideline about " guideline of treatment by Chinese herbs hysteromyoma ", in conjunction with the diagnostic criteria of lump in the abdomen in relevant A female reproductive system tumor and the traditional Chinese medical science institution of higher learning state-compiled textbooks " Gynecology of Chinese Medicine " in the doctor trained in Western medicine institution of higher learning state-compiled textbooks " obstetrics and gynecology " the 5th edition the 6th edition.
1.2.1 Western medicine diagnose standard: comprehensive clinical symptoms, gynecologial examination and more than twice, the B ultrasonic clinical diagnosis is uterus intermural myoma or Subserous myoma.
1.2.2 differential diagnosis in tcm standard: the hypogastric region enclosed mass, to fix and do not move, lower abdomen waist sacrum weighs down the dull pain that expands, leucorrhoea grow in quantity, yellow skin has abnormal flavour, and menorrhagia or menostaxis are scarlet or dark red through color, and abdominal pain in menstruation increases the weight of, yellowish urine, dimly red tongue, limit have the ecchymosis point, and sublingual vessel increases thick growth, tongue is white thick or yellow greasy, wiry and frequent pulse or sliding number.
1.2.3 case is selected: at 28～54 years old age, body of uterus does not surpass a gestation size in March, tumor body diameter≤6cm, myomatosis maximum gauge≤6cm.
Case exclusion standard: (comprising inadaptation or rejecting standard)
Body of uterus surpasses 3 months gestation sizes, and tumor body diameter is 〉=above the person of 6.1cm, and the age is below 28 years old, or person more than 54 years old, trimester of pregnancy or women breast-feeding their children, patients with uterine myoma under the mucosa, the patients with uterine myoma of menopause, the B ultrasonic diagnosis is associated with the adenomyosis patient, serious primary disease such as malignant tumor, cardiovascular, liver, kidney and hemopoietic system is arranged, endocrinopathy, as diabetes, hyperthyroidism, pituitary tumor, anthropometic waits and the psychotic unusually.
2 Therapeutic Method
2.1 the clear XLQ soft capsule of oral dispersing tumor, each 2, every day 3 times are organized in treatment.
2.2 the oral GUIZHI FULING JIAONANG of matched group, Kang Yuan Pharma Inc. in Jiangsu produces, and is oral, one time 3,3 times on the one, taking medicine after meal.
3, observation index:
(1) symptom: observe sagging distention in the smaller abdomen by integration method, lower abdomen dull pain, menorrhagia, menostaxis, leucorrhea yellow skin, sublingual vessel etc., respectively at the change situation that observes the symptoms before and after the treatment,
(2) the B ultrasonic employing is decided the people and is decided the machine method, measures muscular tumor size and body of uterus volume in clean 1 week of menstruation, and both all calculate by irregular ellipsoid, and multiple myomata is pressed a plurality of muscular tumor volume sums and calculated,
(3) lab testing: measure blood, routine urinalysis before and after the treatment, liver, renal function, gonadal hormone, hemorheology, indexs such as insulin like growth factor, minute all carried out in the clean back of menstruation on the 3rd～5 day.
(4) untoward reaction! Patient's untoward reaction and persistent period etc. during the observation medication.
4, statistical method: uniform data input computer, with spss10 software kit statistics and analysis, enumeration data Lie Lianbiao X 2 test, measurement data compares with the t check, and the curative effect data is analyzed with Ridit.
5 curative effect determinate standards:
Symptom integral changes: recovery from illness: transference cure, and menstruation (amount, cycle) recovers normal,
Produce effects: symptom integral descends＞2/3 before the treatment.
Effectively: symptom integral descends 1/3～2/3 before the treatment,
Invalid: symptom integral descends less than 1/3 before the treatment;
Tumor body size variation: recovery from illness: the ultrasound diagnosis muscular tumor disappears, and the uterus size recovers normal,
Produce effects: ultrasound diagnosis muscular tumor volume-diminished is more than 1/2,
Effectively: ultrasound diagnosis muscular tumor volume-diminished 1/4～1/2,
Invalid: ultrasound diagnosis muscular tumor volume-diminished: less than 1/4.
Improve clinical symptoms: adopt the symptom scoring method to collect the light and heavy degree of clinicing symptom observation sagging distention in the smaller abdomen, lower abdomen dull pain, menorrhagia, menostaxis, leucorrhea yellow skin, sublingual vessel, obvious and the longer duration of symptom, influence the meter 3 minutes of work, the persistent period is short and do not influence the meter 2 minutes of work; The lighter meter of symptom 1 minute, the doing well,improving situation of observing observation group and matched group before and after the treatment.
6 therapeutic outcomes:
Table 1: treatment back tcm symptom curative effect compares:
| Group | Tcm symptom | The example number | Recovery from illness+recovery from illness | Percentage ratio (%) |
| The treatment group | Menostaxis | 9 | ?8 | ?88.89 |
| Menorrhagia | 12 | ?10 | ?83.33 | |
| Sagging distention in the smaller abdomen | 5 | ?4 | ?80.0 |
| Lower abdomen dull pain | 12 | ?8 | ?66.67 | |
| The leucorrhea yellow skin | 20 | ?14 | ?70.0 | |
| The my humble abode channels | 19 | ?15 | ?78.95 | |
| Matched group | Menostaxis | 8 | ?7 | ?87.5 |
| Menorrhagia | 13 | ?7 | ?53.8 | |
| Sagging distention in the smaller abdomen | 6 | ?5 | ?83.33 | |
| Lower abdomen dull pain | 10 | ?5 | ?50.0 | |
| The leucorrhea yellow skin | 19 | ?11 | ?57.9 | |
| The my humble abode channels | 20 | ?12 | ?60.0 |
6.1 the clear XLQ of dispersing tumor can obviously improve clinical symptoms, the symptom score obviously is better than matched group, and statistical significance is arranged.Table 1: the improvement of observation group's tcm symptom obviously is better than matched group, is especially improving aspect sagging distention in the smaller abdomen, lower abdomen dull pain, the leucorrhea yellow skin
Table 2: tumor body size compares (cm) before and after the treatment
| Group | The example number | The muscular tumor size | Uterine volume | |
| The treatment group | 30 | Before the treatment | 42.24±8.52 | ?178.54±10.42 |
| 30 | After the treatment | 24.32±4.32 | ?146.14±6.32 | |
| Matched group | 30 | Before the treatment | 41.48±6.48 | ?168.58±12.06 |
| 30 | After the treatment | 28.86±2.38 | ?153.22±9.32 | |
6.2 the efficacy analysis of treatment hysteromyoma: mensuration muscular tumor size and body of uterus volume, multiple myomata calculate by a plurality of muscular tumor volume sums in clean 1 week of menstruation.The result shows: the effect that the clear XLQ of dispersing tumor dwindles the muscular tumor volume obviously is better than matched group.
Table 2 shows: hysteromyoma volume before and after observation group and the treatment of control group, there are statistical significance in own control, observation group to the body of uterus volume respectively.The matched group not statistically significant.
After treatment, observation group's 7 examples of fully recovering, effective 18 examples, 3 invalid examples, total effective rate is 83.5%.Matched group 2 examples of fully recovering, effective 11 examples, invalid 8 examples, total effective rate is 68%.The curative effect that observation group is described obviously is better than matched group.
Insulin-like growth factor binding protein, insulin like growth factor level are relatively before and after table 3 treatment:
| Group | The example number | Insulin-like growth factor binding protein IGFBP-3 (ug/ml) | Insulin-like growth factor I GF-1 (ug/ml) | |
| The treatment group | 30 | Before the treatment | 3268.12±44.36 | 286.48±22.24 |
| ?30 | After the treatment | 3926.18±74.84 | ?231.12±16.68 | |
| Matched group | ?30 | Before the treatment | 3327.26±34.22 | ?284.60±15.86 |
| ?30 | After the treatment | 3882.20±54.25 | ?246.14±22.08 |
6.3 insulin-like growth factor binding protein, insulin like growth factor horizontal expression in the adjusting blood:
The generation and the insulin like growth factor of hysteromyoma are in close relations, its mechanism may be that the insulin-like growth factor binding protein in the blood reduces, free insulin like growth factor level is raise, and then act on myometrial tissue, by bringing into play the effect that it promotes hysteromyoma growth from/paracrine mode or as the estrogen medium.Found that two groups all have the rise insulin-like growth factor binding protein after taking medicine; And the horizontal expression of downward modulation insulin like growth factor in blood, thereby cause dwindling of hysteromyoma.
But the effect of observation group obviously is better than matched group.Has statistical significance.
Table 4: blood index is relatively before and after the treatment:
| The hematodinamics index | Before the treatment | After the treatment |
| The low value of cutting whole blood viscosity ratio | 8.29±1.82 | ?7.23±1.34 |
| The high value of cutting whole blood viscosity ratio | 5.96±1.12 | ?5.48±0.42 |
| The plasma viscosity ratio | 1.88±0.74 | ?1.82±0.63 |
| The hemocyte aggregate index | 1.48±0.20 | ?1.34±0.12 |
| Packed cell volume | 0.40±0.14 | ?0.41±0.06 |
6.4 improve hemodynamics: the state dense, that glue, gather, coagulate slow, blood of blood flow is to cause thrombotic principal element in the blood vessel.The traditional Chinese medical science is thought: but but the stagnation of QI hyperamization stasis of blood, the damp and hot hyperamization stasis of blood.Discover: the microcirculation that the treatment group can be improved hysteromyoma stagnant heat type, improve hemodynamics, alleviate the state of blood adhesive aggregation and muscular tumor is dwindled.Table 4 is as seen: every hemorheology index relatively before and after the treatment.
The specific embodiment:
Embodiment 1: a kind of preparation for the treatment of the preparation extract of hysteromyoma:
12 parts of Radix Et Rhizoma Rhei, 10 parts of Hirudos, 9 parts in Semen Persicae, 10 parts of Eupolyphaga Seu Steleophagas,
9 parts of Fructus Aurantii Immaturuss, 6 parts of Radix Scutellariaes, 12 parts of Concha Ostreaes, 12 parts of Radix Rehmanniae,
8 parts of Pollen Typhaes, 9 parts of the Radix Paeoniae Albas, 3 parts in Radix Glycyrrhizae,
Get above-mentioned medicinal materials in part by weight, get wherein 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2 times, add 6 times of water gagings for the first time, boil that the back adds Semen Persicae, Radix Scutellariae decocted 0.5 hour, filter; For the second time add 6 times of amounts of water, decocted 0.5 hour, filter.Merge twice decocting liquid, be evaporated to relative density and be about 1.15.Concha Ostreae decocts with water with same procedure and concentrates, and merges with aforementioned concentrated solution, and drying is a kind of extract for the treatment of the hysteromyoma preparation.
Embodiment 2: a kind of preparation for the treatment of the preparation extract of hysteromyoma:
36 parts of Radix Et Rhizoma Rhei, 30 parts of Hirudos, 27 parts in Semen Persicae, 30 parts of Eupolyphaga Seu Steleophagas,
27 parts of Fructus Aurantii Immaturuss, 24 parts of Radix Scutellariaes, 36 parts of Concha Ostreaes, 36 parts of Radix Rehmanniae,
24 parts of Pollen Typhaes, 27 parts of the Radix Paeoniae Albas, 9 parts in Radix Glycyrrhizae,
Get above-mentioned medicinal materials in part by weight, get wherein 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 3 times, add 15 times of water gagings for the first time, soaked 2 hours, boil that the back adds Semen Persicae, Radix Scutellariae decocted 2 hours, filtration; Second and third time adds 13 times of amounts of water, decocts 2 hours, filters.Merge twice decocting liquid, be evaporated to relative density and be about 1.40.Concha Ostreae decocts with water with same procedure and concentrates, and merges with aforementioned concentrated solution, and drying is a kind of extract for the treatment of the hysteromyoma preparation.
Embodiment 3: a kind of preparation for the treatment of hysteromyoma preparation extract:
24 parts of Radix Et Rhizoma Rhei, 20 parts of Hirudos, 18 parts in Semen Persicae, 20 parts of Eupolyphaga Seu Steleophagas,
18 parts of Fructus Aurantii Immaturuss, 12 parts of Radix Scutellariaes, 24 parts of Concha Ostreaes, 24 parts of Radix Rehmanniae,
16 parts of Pollen Typhaes, 18 parts of the Radix Paeoniae Albas, 6 parts in Radix Glycyrrhizae
Get above-mentioned medicinal materials in part by weight, get wherein 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water twice, add 10 times of water gagings for the first time, soaked 2 hours, boil that the back adds Semen Persicae, Radix Scutellariae decocted 1 hour, filtration; For the second time add 8 times of amounts of water, decocted 1 hour, filter, merge twice decocting liquid, be evaporated to relative density and be about 1.20 under 65 ℃, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, drying is a kind of extract for the treatment of the preparation of hysteromyoma.
Embodiment 4: a kind of preparation for the treatment of the preparation extract of hysteromyoma:
Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Get above-mentioned medicinal materials in part by weight, get wherein 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water twice, add 10 times of water gagings for the first time, soaked 2 hours, boil that the back adds Semen Persicae, Radix Scutellariae decocted 1 hour, filtration; Add for the second time 8 times of amounts of water, decocted 1 hour, filter, merge twice decocting liquid, be evaporated to relative density and be about 1.20 under 65 ℃, Concha Ostreae decocts with water with same procedure and concentrates, and merges with aforementioned concentrated solution, drying is a kind of extract for the treatment of 1000 units of taking of hysteromyoma preparation.
Embodiment 5: a kind of capsular preparation of preparation for the treatment of hysteromyoma:
Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Starch 50g
Make extract by embodiment 4, with starch 85% alcohol granulation, drying incapsulates, promptly.
Embodiment 6: a kind of capsular preparation of preparation for the treatment of hysteromyoma:
Radix Et Rhizoma Rhei 240g, Hirudo 198g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 198g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Starch 20g
Lactose 25g
Hydroxypropyl methylcellulose 10g
Micropowder silica gel 5g
Make extract by embodiment 4, with starch, lactose, hydroxypropyl methylcellulose 75% alcohol granulation, drying, add micropowder silica gel, mix homogeneously incapsulates 1000, promptly.
Embodiment 7: a kind of preparation for the treatment of the preparation dispersible tablet of hysteromyoma:
Radix Et Rhizoma Rhei 240g, Hirudo 198g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 198g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Lactose: 35g
Microcrystalline Cellulose: 25g
Mannitol: 20g
Carboxymethyl starch sodium: 10g
Polyvinylpyrrolidone: 25g
Sodium lauryl sulphate: 2.5g
Magnesium stearate: 3.0g
Make extract by embodiment 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 8: a kind of preparation for the treatment of the preparation dispersible tablet of hysteromyoma:
Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Lactose: 35g
Hydroxypropyl emthylcellulose: 15g
Microcrystalline Cellulose: 25g
Polyvinylpyrrolidone: 15g
Cetyl sulfo-sodium succinate: 2.0g
Differential silica gel: 3.0g
Make extract by embodiment 4, with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, dry, add polyvinylpyrrolidone, cetyl sulfo-sodium succinate, differential silica gel mix homogeneously, be pressed into 1000, that is, or coating is made coated dispersing tablet.Coating solution is pressed following preparation:
HPMC:7.1%, PEG400:0.8%, red iron oxide powder: 4.1, distilled water: 88%.
Embodiment 9: a kind of preparation for the treatment of the preparation effervescent tablet of hysteromyoma:
Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Filler: lactose 50g
Mannitol 50g
Precoking starch 20g
Microcrystalline Cellulose 10g
Effervescent: sodium bicarbonate 45g
Tartaric acid 35g
Citric acid 20g
Disintegrating agent: crospolyvinylpyrrolidone 20g
Carboxymethyl starch sodium 10g
Lubricant: magnesium stearate 4g
Correctives: aspartame 0.5g
Make extract by embodiment 4, with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, dry, add polyvinylpyrrolidone, cetyl sulfo-sodium succinate, differential silica gel mix homogeneously, be pressed into 1000, that is, or coating is made coated dispersing tablet.
Embodiment 10: a kind of preparation for the treatment of the preparation drop pill of hysteromyoma
Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Polyethylene glycol 6000 49g
Macrogol 4000 7g
Poloxamer 0.5g
Medical material is made extract by embodiment 4, get drop pill substrate heating and melting, add medicinal substances extract dried cream powder, poloxamer mix homogeneously with it, be incubated under 95 ℃ of conditions, mix homogeneously splashes in the coolant and is shaped, remove liquid coolant and promptly get drop pill, or coated again technology is made coated drop pill.
Embodiment 11: a kind of preparation for the treatment of the preparation drop pill of hysteromyoma
Radix Et Rhizoma Rhei 240g, Hirudo 198g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 198g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Polyethylene glycol 6000 75g
Macrogol 4000 15g
Poloxamer 1.0g
Medical material is made extract by embodiment 4, get drop pill substrate heating and melting, add medicinal substances extract dried cream powder, poloxamer mix homogeneously with it, be incubated under 95 ℃ of conditions, mix homogeneously splashes in the coolant and is shaped, remove liquid coolant and promptly get drop pill, 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 2.1mm, 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 35g
Hydroxypropyl methylcellulose 5g
95% alcoholic solution 205ml
Magnesium stearate 2g
Titanium dioxide 6g
Polyethylene glycol 6000 2g
Pigment 3g
Embodiment 12: a kind of preparation preparation of soft capsule for the treatment of hysteromyoma
Radix Et Rhizoma Rhei 240g, Hirudo 198g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 198g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Cera Flava 15g
Olive oil 220g
Propylene glycol 2g
Soybean lecithin 8g
Make 1000
I) modulation capsule liquid: medical material is made extract by embodiment 4, add disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) 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;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Control capsule grain is heavy, makes and makes 1000, promptly.
Embodiment 13: a kind of preparation preparation of soft capsule for the treatment of hysteromyoma
Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Peach kernel oil 55g
Oleum Sesami 120g:
Cera Flava: ethyl cellulose weight ratio 1.5: 3.5 30
Ethylparaben 1.0g
Make 1000
I) modulation capsule liquid: medical material is made extract by embodiment 4, add disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
ii)
Get gelatin, water (capsule casing material: gelatin 58%, glycerol 1.3%, additives 0.2% and water 40.5% are formed), in heating in water bath dissolving down, mix homogeneously, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Promptly get soft capsule.
Embodiment 14: a kind of preparation preparation of soft capsule for the treatment of hysteromyoma
Radix Et Rhizoma Rhei 240g, Hirudo 198g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 198g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Oleum Arachidis hypogaeae semen: 1: 1 80g of Oleum Sesami:
Cera Flava: 1.5: 3.5 4g of ethyl cellulose weight ratio
Ethylparaben 1.5g
Make 1000
I) modulation capsule liquid: medical material is made extract by embodiment 4, add disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) 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;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Promptly get soft capsule.
Embodiment 15: a kind of preparation for the treatment of the preparation tablet of hysteromyoma
Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Lactose: 45g
Microcrystalline Cellulose: 20g
Mannitol: 10g
Carboxymethyl starch sodium: 10g
Sodium lauryl sulphate: 2.5g
Magnesium stearate: 3.0g
Make extract by embodiment 4, use 75% alcohol granulation with lactose, carboxymethyl starch sodium, microcrystalline Cellulose, mannitol etc., drying adds sodium lauryl sulphate, and the magnesium stearate mix homogeneously is pressed into 1000, promptly.
Embodiment 16: a kind of preparation for the treatment of the preparation tablet of hysteromyoma
Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Lactose: 85g
Hydroxypropyl emthylcellulose: 65g
Microcrystalline Cellulose: 75g
Polyethylene glycol 6000 15g
Differential silica gel: 4.5g
Make extract by embodiment 4, granulate with the alcoholic solution moistening of 9% poly-second ketopyrrolidine with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, polyethylene glycol 6000 etc., drying adds differential silica gel mix homogeneously, be pressed into 1000, coating is made Film coated tablets.
Coating solution is pressed following preparation:
HPMC:7.1%, PEG400:0.8%, red iron oxide powder: 4.1, distilled water: 88%.
Embodiment 17: a kind of preparation for the treatment of the preparation granules of hysteromyoma
Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Starch 20g
Lactose 25g
Hydroxypropyl methylcellulose 10g
Make extract by embodiment 4, with starch, lactose, hydroxypropyl methylcellulose 75% alcohol granulation, drying, granulate is distributed into 200 bags, promptly.
Embodiment 18: a kind of preparation for the treatment of the preparation granules of hysteromyoma
Radix Et Rhizoma Rhei 240g, Hirudo 200g, Semen Persicae 180g, Eupolyphaga Seu Steleophaga 200g,
Fructus Aurantii Immaturus 180g, Radix Scutellariae 120g, Concha Ostreae 240g, Radix Rehmanniae 240g,
Pollen Typhae 160g, Radix Paeoniae Alba 180g, Radix Glycyrrhizae 60g
Starch 40g
Lactose 25g
Hydroxypropyl methylcellulose 10g
Xylitol 15g
Make extract by embodiment 4, with starch, lactose, hydroxypropyl methylcellulose 75% alcohol granulation, drying, granulate is distributed into 200 bags, promptly.
Claims (12)
1, a kind of preparation for the treatment of hysteromyoma is characterized in that used medical material weight is:
12～36 parts of Radix Et Rhizoma Rhei, 10～30 parts of Hirudos, 9～27 parts in Semen Persicae, 10～30 parts of Eupolyphaga Seu Steleophagas,
9～27 parts of Fructus Aurantii Immaturuss, 6～24 parts of Radix Scutellariaes, 12～36 parts of Concha Ostreaes, 12～36 parts of Radix Rehmanniae,
8～24 parts of Pollen Typhaes, 9～27 parts of the Radix Paeoniae Albas, 3～9 parts in Radix Glycyrrhizae,
The medical material of above-mentioned component cooperates adjuvant that adopts suitable kind or the peroral dosage form that substrate is made after extracting.
2, a kind of preparation for the treatment of hysteromyoma according to claim 1 is characterized in that used medical material weight is: 24 parts of Radix Et Rhizoma Rhei, 20 parts of Hirudos, 18 parts in Semen Persicae, 20 parts of Eupolyphaga Seu Steleophagas,
18 parts of Fructus Aurantii Immaturuss, 12 parts of Radix Scutellariaes, 24 parts of Concha Ostreaes, 24 parts of Radix Rehmanniae,
16 parts of Pollen Typhaes, 18 parts of the Radix Paeoniae Albas, 6 parts in Radix Glycyrrhizae
Deng making peroral dosage form through extraction is capsule, dispersible tablet, effervescent tablet, drop pill, soft capsule, tablet, granule.
3, a kind of preparation extracting method for the treatment of hysteromyoma according to claim 1, it is characterized in that: medical material is by decocting with water extraction, and wherein Concha Ostreae decocts with water separately.
4, a kind of preparation extracting method for the treatment of hysteromyoma according to claim 3, it is characterized in that: get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add for the first time 6～15 times of water gagings, soaked 0～2 hour, boil the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, decocting liquid filters; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, decocting liquid filters, and merges aforementioned decocting liquid, is concentrated into relative density and is about 1.05～1.40.Concha Ostreae decocts with water with same procedure and concentrates, and merges with aforementioned concentrated solution.
5, a kind of preparation extracting method for the treatment of hysteromyoma according to claim 4, it is characterized in that: get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and put in the decoction device, decoct with water twice, add for the first time 10 times of water gagings, soaked 2 hours, add Semen Persicae, Radix Scutellariae after boiling again, decocted 1 hour, decocting liquid filters; For the second time add 8 times of water gagings, decocted 1 hour, decocting liquid filters, and merges twice decocting liquid, is evaporated to relative density and is about 1.20 under 65 ℃, and Concha Ostreae decocts with water with same procedure and concentrates, and merges with aforementioned concentrated solution.
6, a kind of preparation method for the treatment of the capsule preparations of hysteromyoma according to claim 2 is characterized in that:
Get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, boil the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, filter; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, and merges with aforementioned concentrated solution, is medicinal substances extract, adds starch, granulate, drying, encapsulated, promptly.
7, a kind of preparation method for the treatment of the dispersible tablet formulation of hysteromyoma according to claim 2 is characterized in that:
Get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, boil the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, filter; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Get above-mentioned medicinal substances extract (thick paste or dried cream) and mixing granulations such as filler, disintegrating agent, drying is made granule, adds right amount of auxiliary materials, mixing, and tabletting promptly gets dispersible tablet; Or the coated coated dispersing tablet of making.
8, a kind of preparation method for the treatment of the dispersible tablet formulation of hysteromyoma according to claim 2, it is characterized in that: get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add for the first time 6～15 times of water gagings, soaked 0～2 hour, boil the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, filter; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Get above-mentioned medicinal substances extract (thick paste or dried cream) and filler, effervescent acid-base pair mixing granulation, add disintegrating agent, lubricant, mixing, tabletting promptly gets effervescent tablet, or the coated coating effervescent tablet of making.
9, a kind of preparation method for the treatment of the dropping pill formulation of hysteromyoma according to claim 2 is characterized in that:
Get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, boil the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, filter; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Get drop pill substrate heating and melting,, splash into coolant, make drop pill with medicinal substances extract (thick paste or dried cream) mix homogeneously.
10, a kind of preparation method for the treatment of the soft capsule preparation of hysteromyoma according to claim 2 is characterized in that:
Get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, boil the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, filter; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Get one or more mix homogeneously of above-mentioned medicinal substances extract (thick paste or dried cream) and disperse medium, suspending agent, antiseptic, surfactant, make soft capsule, promptly get soft capsule.
11, a kind of preparation method for the treatment of the tablet of hysteromyoma according to claim 2 is characterized in that:
Get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, boil the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, filter; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Get above-mentioned medicinal substances extract (thick paste or dried cream) and add adjuvant, make granule, mixing, tabletting promptly, or through sugar coating or film-coat, promptly gets coated tablet.
12, a kind of preparation method for the treatment of the granule of hysteromyoma according to claim 2 is characterized in that:
Get 8 flavor medicines such as Radix Et Rhizoma Rhei, Eupolyphaga Seu Steleophaga, Hirudo, Fructus Aurantii Immaturus, Radix Rehmanniae, Pollen Typhae, the Radix Paeoniae Alba, Radix Glycyrrhizae and decoct with water 2～3 times, add 6～15 times of water gagings for the first time, soaked 0～2 hour, boil the back and add Semen Persicae, Radix Scutellariae decoction 0.5～2 hour, filter; Add 6～13 times of amounts of water for the second～three time, decocted 0.5～2 hour, filter, merge aforementioned decocting liquid, be concentrated into relative density and be about 1.10～1.40, Concha Ostreae decocts with water with same procedure and concentrates, merge with aforementioned concentrated solution, be medicinal substances extract (thick paste), or drying, pulverize, promptly get medicinal substances extract (dried cream); Getting above-mentioned medicinal substances extract (thick paste or dried cream) adds adjuvant, makes granule, drying.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510034553XA CN100518780C (en) | 2005-05-07 | 2005-05-07 | Preparation for treating hysteromyoma and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510034553XA CN100518780C (en) | 2005-05-07 | 2005-05-07 | Preparation for treating hysteromyoma and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1698711A true CN1698711A (en) | 2005-11-23 |
| CN100518780C CN100518780C (en) | 2009-07-29 |
Family
ID=35475063
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB200510034553XA Expired - Fee Related CN100518780C (en) | 2005-05-07 | 2005-05-07 | Preparation for treating hysteromyoma and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100518780C (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100443894C (en) * | 2005-12-05 | 2008-12-17 | 浙江大德药业集团有限公司 | Chinese medicine dispersible tablets for treating hysteromyoma, preparing method and quality control method |
| CN104208349A (en) * | 2014-08-21 | 2014-12-17 | 任有德 | Traditional Chinese medicine composition for treating cancers and preparation method thereof |
-
2005
- 2005-05-07 CN CNB200510034553XA patent/CN100518780C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100443894C (en) * | 2005-12-05 | 2008-12-17 | 浙江大德药业集团有限公司 | Chinese medicine dispersible tablets for treating hysteromyoma, preparing method and quality control method |
| CN104208349A (en) * | 2014-08-21 | 2014-12-17 | 任有德 | Traditional Chinese medicine composition for treating cancers and preparation method thereof |
| CN104208349B (en) * | 2014-08-21 | 2017-09-01 | 任有德 | A kind of Chinese medicine composition for the treatment of cancer and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100518780C (en) | 2009-07-29 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1686267A (en) | Chinese medicinal preparation for channel warming and blood nourishing and its preparation method | |
| CN100349598C (en) | Medicine for treating high lipemia and its production method | |
| CN1872150A (en) | Composition of Chinese traditional medicine for replenishing qi and the blood | |
| CN1745797A (en) | Medicine for treating menstrual irregularities and menalgia | |
| CN1698716A (en) | Gynecological Chinese medicinal preparation for stopping pain and expelling blood stasis | |
| CN1876161A (en) | Pharmaceutical formulation and preparing method for breast nodules for treating hyperplasia of mammary glands, and its quality control method | |
| CN1679807A (en) | Heat-clearing and stranguria-relieving Chinese medicine preparation and production thereof | |
| CN1698709A (en) | Compound preparation of baikal skullcap root | |
| CN1682885A (en) | Hemostatic preparation for gynecology department | |
| CN1679802A (en) | Preparation of strengthening waist and health-caring kidney and its making method | |
| CN1698714A (en) | 'Rukuaixiao' preparation for treating mammary disease and its preparation process | |
| CN1814110A (en) | Medicine for treating gynecophathy | |
| CN1698711A (en) | Preparation for treating hysteromyoma and its preparation method | |
| CN1319560C (en) | Chinese medicine compound rheumatism preparation for improving bioavailability and medicine effect and preparing method | |
| CN1679901A (en) | Compound preparation of Jianganling for liver and its making method | |
| CN1698715A (en) | Heat-clearing abortion-preventing Chinese medicine and its preparation method | |
| CN1923270A (en) | Medicine for treating benign prostate hyperplasia and method of prepn. of the same | |
| CN101077384A (en) | Application of traditional Chinese medicine preparation in preparing medicine for treating and preventing gynaecologic disease | |
| CN1316997C (en) | Preparation for free flowing ginew and bone and its preparation method | |
| CN1220163A (en) | Drug for curing premenstrual tension | |
| CN1586598A (en) | Wuqi fat regulation oral liquid | |
| CN1660248A (en) | Dan e Fukang preparation and preparing method | |
| CN1736411A (en) | Pharmaceutical preparation with functions of clearing heat, removing dampness and benefiting gallbladder | |
| CN1724013A (en) | Traditional Chinese medicinal prepn. for treating obstruction of qi in the chest | |
| CN1709373A (en) | Formulation for treating mammary gland proliferation |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20090729 Termination date: 20150507 |
|
| EXPY | Termination of patent right or utility model |