CN1857279A - Hysteromyoma treating suppository and its preparing method - Google Patents
Hysteromyoma treating suppository and its preparing method Download PDFInfo
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- CN1857279A CN1857279A CN 200610025333 CN200610025333A CN1857279A CN 1857279 A CN1857279 A CN 1857279A CN 200610025333 CN200610025333 CN 200610025333 CN 200610025333 A CN200610025333 A CN 200610025333A CN 1857279 A CN1857279 A CN 1857279A
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- hysteromyoma
- suppository
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- danazol
- fatty acid
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Abstract
The present invention discloses a kind of hysteromyoma treating suppository and its preparation process. The hysteromyoma treating suppository is prepared with danozol 10-20 wt%, stearic acid 10-20 wt% and semi-synthetic fatty acid ester 60-80 wt%. The preparation process includes the following steps: heating stearic acid and semi-synthetic fatty acid ester in water bath at 60-90 deg.c; adding danozol after cooling to 40-50 deg.c; preparing in hot smelting process and sealing and packing. The present invention has the beneficial effects of: raised curative effect, reduced toxic side effect on liver of the medicine, less stimulation on stomach, etc.
Description
Technical field
The present invention relates to a kind of suppository for the treatment of hysteromyoma and preparation method thereof.
Background technology
Hysteromyoma (myoma of uterus) is modal a kind of benign tumor in the female sex organ, is more common in the 30-50 women in year, and the about 20%-25% of 35-50 year women suffers from hysteromyoma according to estimates
[1]Randomly draw 335 ages the Switzerland women in 25-40 year, the vagina ultrasound diagnosis finds that the sickness rate of hysteromyoma is 5.4%.The muscular tumor prevalence increases with the increase at age, and 33-40 year is 7.8%.Postmortem muscular tumor incidence rate is 50%.In 10 uterus specimen, find that with the serial section that every interval 2mm does the muscular tumor incidence rate is 77% because of the capable hysterectomy of other reasons.According to ultrasonic and hysterectomy specimens in diagnosis, the incidence rate of Black women's muscular tumor is higher 3 times than the pink toes.Because of hysteromyoma incidence rate among the women of vaginal hemorrhage temporary dwelling palace chamber spectroscopy at 6%-34%, and in infertile inspection women, be 2%-7%
[2]
Most patients with uterine myoma are also asymptomatic, only idol is found when pelvioscopy or ultrasonic examination, then be mainly metrorrhagia if any symptom, can show as hyper-menorrhea, menostaxis or cycle shortening, even lose fully and periodically be irregular colporrhagia, severe patient can cause secondary anemia, in addition, also can have small number of patients such as waist lump and pressure symptom, infertile and miscarriage, leucorrhoea grow in quantity can have lower abdomen to weigh down the sense of expanding.
Up to now, the cause of disease of hysteromyoma is not still understood.According to a large amount of clinical observations and experimental result proof muscular tumor is a kind of estrogen growing tumors that depends on.Be common in the women of child-bearing age as clinical, 30～50 years old, especially in the high estrogen environment, as growth under the situations such as gestation, exogenous high estrogen obviously, and muscular tumor was dwindled gradually after the menopause.Muscular tumor patient often accompanies ovary hyperemia again, swells, endometrium increases longly, discloses this and too much the estrogen stimulation is relevant.
Hysteromyoma and endocrine disturbance have suitable relation.Hysteromyoma increases after using exogenous hormones and clomiphene, suppresses or reduce sex hormone level to prevent the muscular tumor growth, dwindles muscular tumor and improves clinical symptoms.
Take place from tissue, the hysteromyoma cell comes from the smooth muscle cell such as the immature sarcoplast of uterus muscle, blood vessel wall, but the latter's not clear and definite as yet notion on the histology.The generation of human uterus's muscular tumor may be from the atomization of undifferentiated mesenchymal cells to smooth muscle cell.Multiple myomata may be because cells of origin many kitchen ranges in myometrium are hidden.Entering remains in the undifferentiated mesenchymal cells and the sophisticated smooth muscle cell of flesh layer after the period of maturation, occurs self seriality propagation, differentiation and loose process under female, progestogen period effects, carries out repeatedly in long-time, forms tumor at last.
Based on this theory, has the medicine that suppresses the secretion of ovary steroid hormone or suppress its effect by application, muscular tumor is dwindled, reach the purpose of relief of symptoms, Western medicine commonly used clinically at present has following Zoladex, enantone, danazol, dl-18-methyl-norgestrienone, mifepristone, tamoxifen and some androgens medicines thereof, but this therapeutical effect is temporary transient, can not reach the purpose of radical cure hysteromyoma, therefore can not be as the main method of treatment hysteromyoma.
Be exactly operative treatment in addition, comprise myomectomy, uterectomy and less invasive techniques treatment, all the body and mind injury to the patient is bigger for these.
Chinese medicine thinks, the cause of disease of hysteromyoma is based on cold, cold being a kind of YIN pathogen, and the property master stagnates, cold-evil visitor dashes and appoints disorder of QI and blood in the uterus, and the passages through which vital energy circulates QI and blood does not freely form and becomes silted up, the long-pending tumor that forms, treatment is based on the warm nature medicine, and warm nature can be opened, can loose, can manage it, and helps the tumor piece and dissipates.So, the effect of circulation of qi promoting, promoting the circulation of blood is arranged with Rhizoma Cyperi, Rhizoma Zingiberis Preparatum, Radix Glycyrrhizae Preparata, Radix Paeoniae Rubra, Radix Achyranthis Bidentatae isothermal medicine.
But all there is following shortcoming in above-mentioned Therapeutic Method:
1. medicine is big to the toxic and side effects of liver;
2. medicine is big to the stimulation of stomach;
3. medicine is subjected to the destruction of Digestive system easily;
4. absorb slowly, onset is slow, long action time.
List of references:
[1]Masahiko?kikuchi，Fumitoshi?Hirayama?and?kaneto?Uekama?Improvement?oforal?and?rectal?biovailabilities?of?carmofor?by?methylatedβ-cyclodextrincomplexations，International?Journal?of?Pharmaceutics，1977(38)：191
[2] Masahiko kikuchi and kaneto Uekami.Effect of Dimethyl β-Cyclodextrin onoral or Rectal Absorption of 1-Hexylcarbamoyl-5-fluorouracil (HCFU) pharmaceutical journal .YAKUGAKU ZASSHI.1988,108 (2): 156
Summary of the invention
Technical problem to be solved of the present invention provides a kind of suppository for the treatment of hysteromyoma and preparation method thereof, to remedy the deficiencies in the prior art or defective, satisfies the needs that relevant crowd treats disease.
In order to solve the problems of the technologies described above, one of the technical solution used in the present invention is: a kind of suppository for the treatment of hysteromyoma, and its composition and mass percentage content are as follows:
Danazol 10%～20%
Stearic acid 10%～20%
Semi-synthetic fatty acid ester 60%～80%
In order to solve the problems of the technologies described above, two of the technical solution used in the present invention is: a kind of preparation method for the treatment of the suppository of hysteromyoma comprises the steps: to take by weighing stearic acid and semi-synthetic fatty acid ester, heat fused in 60-90 ℃ water-bath; Treat to add when temperature is reduced to 40～50 ℃ danazol; The quality proportioning of danazol, stearic acid and semi-synthetic fatty acid ester is 1: 0.5～2: 3～8, by the hot melt preparation, packs, and shady and cool place preserves.
The suitable especially following crowd's of this product treatment:
(1) uterus＜2 a month gestation size has symptom but not serious person;
(2) factor palace muscular tumor and cause infertile patient, operation is dwindled and postponed to muscular tumor after the medication, improves the condition of becoming pregnant, and increases the chance of becoming pregnant;
(3) have big hysteromyoma to merge the temporarily unsuitable operator of serious anemia, premedicate is corrected anemia to improve symptom, reduces intraoperative hemorrhage;
(4) need to keep the uterus and the bigger young patient of muscular tumor, medication can make muscular tumor dwindle, and is beneficial to capable muscular tumor and divests the hands art;
(5) serious internal medicine complication is arranged and the greater risk person that should not perform the operation or perform the operation;
(6) patient in nearly menopause who has that symptom and being reluctant undergos surgery.
The invention has the beneficial effects as follows:
1. reduce medicine to the toxic and side effects of liver and the curative effect of raising medicine;
2. reduce the stimulation of medicine to stomach;
3. make medicine avoid the destruction of Digestive system;
4. can promote the absorption of medicine, improve the curative effect of medicine and seek.
5. absorb soon, rapid-action, long action time.
The specific embodiment
Below in conjunction with specific embodiment the present invention is further elaborated.
Embodiment 1
The preparation of the suppository of danazol of the present invention comprises the steps:
1) prescription:
Danazol 15g
Stearic acid 15g
Semi-synthetic fatty acid ester 120g
2) method for making:
Take by weighing stearic acid and semi-synthetic fatty acid ester, heat fused in 60 ℃ water-bath by above-mentioned prescription; Treat to add when temperature is reduced to 40 ℃ danazol, by the hot melt preparation, pack, shady and cool place preserves.
(1), the visual examination in the quality control of danazol suppository of the present invention comprises the steps:
Character: white is to off-white color, and uniform and smooth, hardness suits.
Weight differential: every heavy 2.5g of suppository, weight differential ± 7.5%.
Melt and become the time limit: press 1995 editions two appendix XB methods of Chinese Pharmacopoeia and measure, all melt in the 60min.
(2), the medicine in the quality control of suppository of the present invention is differentiated and is comprised the steps:
Get danazol suppository an amount of (being equivalent to suppository 10mg approximately), put in the 100ml volumetric flask, it is an amount of to add chloroform, jolting makes dissolving, is diluted to scale with chloroform, shakes up, filter, discard filtrate just, precision is measured subsequent filtrate 2ml, puts in the 50ml volumetric flask, be diluted to scale with chloroform, shake up, according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia nineteen ninety-five version), solution has absorption maximum at 285 wavelength place.
(3), danazol suppository assay of the present invention comprises the steps:
Prepare blank substrate in the prescription ratio, accurately take by weighing danazol 40mg again, join in the 1g substrate, stir, add dehydrated alcohol 20ml, the heated and stirred dissolving places the 100ml volumetric flask while hot in water-bath.Add dehydrated alcohol again to scale 100ml place, shake up, filter, discard filtrate just with dry filter paper.Last accurate filtrate 2.0,3.0,4.0,5.0, the 6.0ml of drawing, respectively place the 100ml volumetric flask, be diluted to 100ml scale place with dehydrated alcohol, promptly get concentration and be respectively 5 kinds of solution of 8,12,16,20,24 μ g/ml, measure trap in 285nm wavelength place, with method operation 3 times, substitution regression equation calculation content.
(4) stability of danazol suppository of the present invention is measured and is comprised the steps:
3 batches in sample was placed 6 months in refrigerator 4-10 ℃ and room temperature 10-25 ℃ respectively, its outward appearance, the equal no change of color, average content changes＜1%.
Embodiment 2
1) prescription:
Danazol 20g
Stearic acid 10g
Semi-synthetic fatty acid ester 70g
2) method for making:
Take by weighing stearic acid and semi-synthetic fatty acid ester, heat fused in 70 ℃ water-bath by above-mentioned prescription; Treat to add when temperature is reduced to 50 ℃ danazol, by the hot melt preparation, pack, shady and cool place preserves.
Method of testing is with embodiment 1.
Embodiment 3
1) prescription:
Danazol 10g
Stearic acid 20g
Semi-synthetic fatty acid ester 30g
2) method for making:
Take by weighing stearic acid and semi-synthetic fatty acid ester, heat fused in 90 ℃ water-bath by above-mentioned prescription; Treat to add when temperature is reduced to 35 ℃ danazol, by the hot melt preparation, pack, shady and cool place preserves.
Method of testing is with embodiment 1.
Claims (2)
1, a kind of suppository for the treatment of hysteromyoma is characterized in that its composition and mass percentage content are as follows:
Danazol 10%～20%
Stearic acid 10%～20%
Semi-synthetic fatty acid ester 60%～80%.
2, a kind of preparation method of suppository as claimed in claim 1 is characterized in that comprising the steps: to take by weighing stearic acid and semi-synthetic fatty acid ester, heat fused in 60-90 ℃ water-bath; Treat to add when temperature is reduced to 40～50 ℃ danazol; The quality proportioning of danazol, stearic acid and semi-synthetic fatty acid ester is 1: 0.5～2: 3～8, by the hot melt preparation, packs, and shady and cool place preserves.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610025333 CN1857279A (en) | 2006-03-31 | 2006-03-31 | Hysteromyoma treating suppository and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200610025333 CN1857279A (en) | 2006-03-31 | 2006-03-31 | Hysteromyoma treating suppository and its preparing method |
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| CN1857279A true CN1857279A (en) | 2006-11-08 |
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| CN 200610025333 Pending CN1857279A (en) | 2006-03-31 | 2006-03-31 | Hysteromyoma treating suppository and its preparing method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103739819A (en) * | 2013-11-15 | 2014-04-23 | 安徽淮化股份有限公司 | Soft PU foamed plastic |
| CN110179839A (en) * | 2019-07-03 | 2019-08-30 | 上海美哈医药科技有限公司 | A kind of anti-myomata gelling agent and preparation method thereof |
-
2006
- 2006-03-31 CN CN 200610025333 patent/CN1857279A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103739819A (en) * | 2013-11-15 | 2014-04-23 | 安徽淮化股份有限公司 | Soft PU foamed plastic |
| CN110179839A (en) * | 2019-07-03 | 2019-08-30 | 上海美哈医药科技有限公司 | A kind of anti-myomata gelling agent and preparation method thereof |
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Open date: 20061108 |