CN1857677A - Oral medicine for treating hysteromyoma - Google Patents
Oral medicine for treating hysteromyoma Download PDFInfo
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- CN1857677A CN1857677A CNA2006100419735A CN200610041973A CN1857677A CN 1857677 A CN1857677 A CN 1857677A CN A2006100419735 A CNA2006100419735 A CN A2006100419735A CN 200610041973 A CN200610041973 A CN 200610041973A CN 1857677 A CN1857677 A CN 1857677A
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Abstract
The oral medicine for treat hysteromyoma is Chinese medicine preparation prepared with ten kinds of Chinese medicinal materials, including red peony root, Chuanxiong rhizome, peach kernel, cattail pollen, burred tuber, etc in certain weight proportion. The pharmacodynamics experiment on model mouse hysteromyoma and model rat hysteromyoma shows that the oral medicine can inhibit mouse hysteromyoma and rat hysteromyoma, improve the hestopathologic abnormality of the model mouse and rat, inhibit the uteritis of model rat, inhibit xylene caused auricle swelling of moue, reduce acetic acid caused twisting number of mouse, and shorten the bleeding time of tail breaking mouse. The animal experiment proves the functions of inhibiting hysteromyoma, resisting inflammation, relieving pain and arresting bleeding of the medicine, and medicine may be put in clinical test.
Description
Technical field
The invention belongs to the medicinal preparation technical field of the product that contains raw material or itself and not clear structure, be specifically related to derive from the material of plant.
Background technology
Hysteromyoma is a modal benign tumor in the female sex organs palace, also is one of human body most common tumor, account for 51.87% in all benign tumors of women, and age of onset is tending towards rejuvenation.Its good sending out in the women of childbearing age accounted for 70-80% in 30～50 years old, though the rate that cancerates is extremely low, in various degree anemia of the menorrhagia of its initiation, muscular tumor pressure symptom, secondary, spontaneous abortion, infertile etc. has a strong impact on women's physical and mental health.At present, the Therapeutic Method of hysteromyoma has been variation.The doctor trained in Western medicine expectant treatment mainly is to select hormone medicine for use, as GnRh-a preparation Ru-486, tamoxifen, nemestran, androgens etc., treatment such as also useful gossypol, vitamin, Glucosidorum Tripterygll Totorum.Operative treatment has panhysterectomy, subtotal hysterectomy, myomectomy, endoscopic surgery (hysteroscope, laparoscopic surgery), the endometrial operation of reserve part, Jie's human therapy (uterine arterial embolization), hysteromyoma self-solidifying cutter therapy, laser therapy (laser fibers heating and liquefaction muscular tumor tissue) etc.But because of the side effect of treatments such as hormone and because of the patient is reluctant that operation, unmarried and childbearing age do not give birth to, worry to influence reasons such as love life, the receiver is few.And Chinese medicine can obviously improve symptom, even muscular tumor is dissipated, and does not influence fertility again, its effect unique is arranged, and side effect is little, expense is cheap.The unique advantage and the bright prospects that have shown the Chinese medicine primary disease.The technical problem that presses at present solution clinically provides a kind of Chinese medicine preparation for the treatment of hysteromyoma.
Summary of the invention
Technical problem to be solved by this invention is to overcome the shortcoming of said medicine, and a kind of oral drugs of the treatment hysteromyoma that has no side effect evident in efficacy are provided.
It is with the following Chinese medicinal raw materials in portion by weight medicinal preparation for oral administration made of formulation method routinely to solve the problems of the technologies described above the technical scheme that adopted:
5～15 parts of 5～15 parts of Rhizoma Chuanxiongs of Radix Paeoniae Rubra
4～14 parts of 4～14 parts of Pollen Typhaes of Semen Persicae
4～14 parts of 4～14 parts of Rhizoma Curcumae of rhizoma sparganic
3～13 parts of 3～13 portions of Caulis Spatholobis of Herba Verbenae
0.5～3 part of 0.5～3 part of Eupolyphaga Seu Steleophaga of Hirudo.
The preferred raw material of Chinese medicine weight portion proportioning of preparation medicine of the present invention is:
8～14 parts of 8～14 parts of Rhizoma Chuanxiongs of Radix Paeoniae Rubra
8～12 parts of 8～12 parts of Pollen Typhaes of Semen Persicae
6～12 parts of 6～12 parts of Rhizoma Curcumae of rhizoma sparganic
6～10 parts of 6～10 portions of Caulis Spatholobis of Herba Verbenae
1～2 part of 1～2 part of Eupolyphaga Seu Steleophaga of Hirudo.
The best raw material of Chinese medicine weight portion proportioning of preparation medicine of the present invention is:
11 parts of 11 parts of Rhizoma Chuanxiongs of Radix Paeoniae Rubra
9 parts of 10 parts of Pollen Typhaes of Semen Persicae
9 parts of 9 parts of Rhizoma Curcumae of rhizoma sparganic
8 parts of 8 portions of Caulis Spatholobis of Herba Verbenae
1.5 parts of 1.5 parts of Eupolyphaga Seu Steleophagas of Hirudo.
The medicinal preparation for oral administration that above-mentioned each component is made according to a conventional method is said tablet or granule or capsule or an oral solutions on the galenic pharmacy.
Radix Paeoniae Rubra in the proportioning of the present invention, bitter in the mouth, cold nature is returned liver, spleen channel, and merit is arrogated to oneself blood circulation promoting and blood stasis dispelling, arrogates to oneself and controls the amenorrhea dysmenorrhea, and the hernia abdominal mass is gathered, diseases such as metrorrhagia and leukorrhagia stranguria with turbid discharge.Semen Persicae, bitter in the mouth, sweet, property is flat, GUIXIN, liver, large intestine channel, the function blood circulation promoting and blood stasis dispelling is arrogated to oneself and is controlled dysmenorrhea, amenorrhea due to stagnation of blood, the stagnant stomachache of the stasis of blood in puerperal ， mass in the abdomen caking.Herba Verbenae, bitter in the mouth, suffering, cold nature is returned liver, spleen channel, the function promoting blood circulation to restore menstrual flow, heat-clearing and toxic substances removing cures mainly the blood stasis amenorrhea, dysmenorrhea ， mass in the abdomen.Eupolyphaga Seu Steleophaga has the merit of removing blood stasis, cures mainly blood stasis amenorrhea ， lumps in the chest and abdomen.
The preparation method of medicine capsule of the present invention is as follows:
Eupolyphaga Seu Steleophaga, Hirudo powder in the proportioning of the present invention are broken into fine powder, and be standby.Rhizoma Chuanxiong, Rhizoma Curcumae are ground into coarse powder, add 8 times of water gagings and extract volatile oil, and 6 hours extraction times, volatile oil is standby, and medicinal liquid device is in addition collected; When medicinal residues and Radix Paeoniae Rubra, Pollen Typhae, rhizoma sparganic, Herba Verbenae, Caulis Spatholobi add 10 times of water gagings and be heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, each 1.5 hours, the medicinal liquid behind extracting solution and the extraction volatile oil merged, being concentrated into relative density is 1.12～1.30 (60 ℃ of surveys), adds ethanol and makes and contain the alcohol amount and reach 60%, leaves standstill, filter, filtrate recycling ethanol mixes with Eupolyphaga Seu Steleophaga and Hirudo powder to there not being the alcohol flavor, drying is ground into fine powder, granulates, spray into volatile oil again, mixing, encapsulated.Every heavy 0.3g, every gram contains raw material of Chinese medicine 7.8g.
The preparation technology of medicinal tablet of the present invention is as follows:
The used raw material of Chinese medicine of raw material of Chinese medicine that medicinal tablet of the present invention is used and weight proportion and medicine capsule of the present invention is identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of capsule preparation technology raw material of Chinese medicine of the present invention, and used adjuvant and other processing step are undertaken by the conventional preparation technology of tablet.Every heavy 0.5g, every gram contains crude drug 4.68g.
The preparation technology of medicinal granule of the present invention is as follows:
The used raw material of Chinese medicine of raw material of Chinese medicine that medicinal granule of the present invention is used and weight proportion and medicine capsule of the present invention is identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of capsule preparation technology raw material of Chinese medicine of the present invention, and used adjuvant and other processing step are undertaken by the conventional preparation technology of granule.Every bag heavy 5g, every gram contains raw material of Chinese medicine 1.404g.
The preparation technology of medicine oral liquid of the present invention is as follows:
Raw material of Chinese medicine that medicine oral liquid of the present invention is used and weight proportion and medicine capsule of the present invention are identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of capsule preparation technology raw material of Chinese medicine of the present invention, and used adjuvant and other processing step carry out according to the conventional preparation technology of oral liquid.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.702g.
Medicine of the present invention shows through the test of pesticide effectiveness, medicine of the present invention can suppress the hysteromyoma of model mice hysteromyoma and rat model, the histopathology that can improve hysteromyoma model rat and hysteromyoma model mice is unusual, can suppress the rat model inflammation of uterus, suppress the mice caused by dimethylbenzene xylene auricle edema, can reduce the mouse writhing number of times due to the acetic acid, have analgesic activity, can shorten the mice docking bleeding time and not obviously influence of clotting time.Illustrate that medicine of the present invention has the hysteromyoma of inhibition, antiinflammatory, analgesia and anastalsis.Medicine of the present invention can enter clinical trial.
The specific embodiment
The present invention is described in more detail below in conjunction with embodiment, but the invention is not restricted to these embodiment.
Embodiment 1
With 1000 of production medicine capsule products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Paeoniae Rubra 330g Rhizoma Chuanxiong 330g
Semen Persicae 300g Pollen Typhae 270g
Rhizoma sparganic 270g Rhizoma Curcumae 270g
Herba Verbenae 240g Caulis Spatholobi 240g
Hirudo 45g Eupolyphaga Seu Steleophaga 45g
Starch adds to 300g.
Its preparation method is as follows:
Eupolyphaga Seu Steleophaga in the proportioning of the present invention, Hirudo powder are broken into fine powder, standby.Rhizoma Chuanxiong, Rhizoma Curcumae are ground into coarse powder, add 8 times of water gagings and extract volatile oil, and 6 hours extraction times, volatile oil is standby, and medicinal liquid device is in addition collected; When medicinal residues and Radix Paeoniae Rubra, Pollen Typhae, rhizoma sparganic, Herba Verbenae, Caulis Spatholobi add 10 times of water gagings and be heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, each 1.5 hours, the medicinal liquid behind extracting solution and the extraction volatile oil merged, being concentrated into relative density is 1.12～1.30 (60 ℃ of surveys), adds ethanol and makes and contain the alcohol amount and reach 60%, leaves standstill, filter, filtrate recycling ethanol mixes with Eupolyphaga Seu Steleophaga and Hirudo powder to there not being the alcohol flavor, drying is ground into fine powder, granulates, spray into volatile oil again, mixing is adorned 1000 capsules.Every heavy 0.3g, every gram contains raw material of Chinese medicine 7.8g.
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Paeoniae Rubra 330g Rhizoma Chuanxiong 330g
Semen Persicae 300g Pollen Typhae 270g
Rhizoma sparganic 270g Rhizoma Curcumae 270g
Herba Verbenae 240g Caulis Spatholobi 240g
Hirudo 45g Eupolyphaga Seu Steleophaga 45g
Starch adds to 500g.
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every gram contains raw material of Chinese medicine 4.68g.
With production granule product of the present invention 1000g is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Radix Paeoniae Rubra 198g Rhizoma Chuanxiong 198g
Semen Persicae 180g Pollen Typhae 162g
Rhizoma sparganic 162g Rhizoma Curcumae 162g
Herba Verbenae 144g Caulis Spatholobi 144g
Hirudo 27g Eupolyphaga Seu Steleophaga 27g
Sucrose 400g
Dextrin adds to 1000g.
Its preparation technology is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every gram contains raw material of Chinese medicine 1.404g.
With production oral liquid product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Radix Paeoniae Rubra 99g Rhizoma Chuanxiong 99g
Semen Persicae 90g Pollen Typhae 81g
Rhizoma sparganic 81g Rhizoma Curcumae 81g
Herba Verbenae 72g Caulis Spatholobi 72g
Hirudo 13.5g Eupolyphaga Seu Steleophaga 13.5g
Sucrose 400g
Distilled water adds to 1000g.
Its preparation technology is undertaken by the preparation technology of oral liquid of the present invention.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.702g.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
11 parts of 11 parts of Rhizoma Chuanxiongs of Radix Paeoniae Rubra
9 parts of 10 parts of Pollen Typhaes of Semen Persicae
9 parts of 9 parts of Rhizoma Curcumae of rhizoma sparganic
8 parts of 8 portions of Caulis Spatholobis of Herba Verbenae
1.5 parts of 1.5 parts of Eupolyphaga Seu Steleophagas of Hirudo.
Embodiment 2
With 1000 of production medicine capsule products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Paeoniae Rubra 297g Rhizoma Chuanxiong 297g
Semen Persicae 278g Pollen Typhae 278g
Rhizoma sparganic 278g Rhizoma Curcumae 278g
Herba Verbenae 258g Caulis Spatholobi 258g
Hirudo 59g Eupolyphaga Seu Steleophaga 59g
Starch adds to 300g.
Its preparation technology is identical with the preparation technology of embodiment 1 capsule.Every heavy 0.3g, every gram contains raw material of Chinese medicine 7.8g.
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Paeoniae Rubra 297g Rhizoma Chuanxiong 297g
Semen Persicae 278g Pollen Typhae 278g
Rhizoma sparganic 278g Rhizoma Curcumae 278g
Herba Verbenae 258g Caulis Spatholobi 258g
Hirudo 59g Eupolyphaga Seu Steleophaga 59g
Starch adds to 500g.
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every gram contains crude drug 4.68g.
With production granule product of the present invention 1000g is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Radix Paeoniae Rubra 178g Rhizoma Chuanxiong 178g
Semen Persicae 167g Pollen Typhae 167g
Rhizoma sparganic 167g Rhizoma Curcumae 167g
Herba Verbenae 154g Caulis Spatholobi 154g
Hirudo 36g Eupolyphaga Seu Steleophaga 36g
Sucrose 400g
Dextrin adds to 1000g.
Its preparation technology is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every gram contains raw material of Chinese medicine 1.404g.
With production oral liquid product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Radix Paeoniae Rubra 90g Rhizoma Chuanxiong 90g
Semen Persicae 83g Pollen Typhae 83g
Rhizoma sparganic 83g Rhizoma Curcumae 83g
Herba Verbenae 77g Caulis Spatholobi 77g
Hirudo 18g Eupolyphaga Seu Steleophaga 18g
Sucrose 400g
Distilled water adds to 1000g.
Its preparation technology is undertaken by the conventional preparation technology of oral liquid of the present invention.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.702g.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
15 parts of 15 parts of Rhizoma Chuanxiongs of Radix Paeoniae Rubra
14 parts of 14 parts of Pollen Typhaes of Semen Persicae
14 parts of 14 parts of Rhizoma Curcumae of rhizoma sparganic
13 parts of 13 portions of Caulis Spatholobis of Herba Verbenae
3 parts of 3 parts of Eupolyphaga Seu Steleophagas of Hirudo.
Embodiment 3
With 1000 of production medicine capsule products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Paeoniae Rubra 354g Rhizoma Chuanxiong 354g
Semen Persicae 284g Pollen Typhae 284g
Rhizoma sparganic 284g Rhizoma Curcumae 284g
Herba Verbenae 213g Caulis Spatholobi 213g
Hirudo 35g Eupolyphaga Seu Steleophaga 35g
Starch adds to 300g
Its preparation technology is identical with the preparation technology of embodiment 1 capsule.Every heavy 0.3g, every gram contains raw material of Chinese medicine 7.8g.
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Paeoniae Rubra 354g Rhizoma Chuanxiong 354g
Semen Persicae 284g Pollen Typhae 284g
Rhizoma sparganic 284g Rhizoma Curcumae 284g
Herba Verbenae 213g Caulis Spatholobi 213g
Hirudo 35g Eupolyphaga Seu Steleophaga 35g
Starch adds to 500g.
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every gram contains crude drug 4.68g.
With production granule product of the present invention 1000g is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Radix Paeoniae Rubra 213g Rhizoma Chuanxiong 213g
Semen Persicae 170g Pollen Typhae 170g
Rhizoma sparganic 170g Rhizoma Curcumae 170g
Herba Verbenae 128g Caulis Spatholobi 128g
Hirudo 21g Eupolyphaga Seu Steleophaga 21g
Sucrose 400g
Dextrin adds to 1000g.
Its preparation technology is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every gram contains raw material of Chinese medicine 1.404.
With production oral liquid product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Radix Paeoniae Rubra 106g Rhizoma Chuanxiong 106g
Semen Persicae 85g Pollen Typhae 85g
Rhizoma sparganic 85g Rhizoma Curcumae 85g
Herba Verbenae 64g Caulis Spatholobi 64g
Hirudo 11g Eupolyphaga Seu Steleophaga 11g
Sucrose 400g
Distilled water adds to 1000mL.
Its preparation technology is undertaken by the conventional preparation technology of oral liquid of the present invention.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.702g.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
5 parts of 5 parts of Rhizoma Chuanxiongs of Radix Paeoniae Rubra
4 parts of 4 parts of Pollen Typhaes of Semen Persicae
4 parts of 4 parts of Rhizoma Curcumae of rhizoma sparganic
3 parts of 3 portions of Caulis Spatholobis of Herba Verbenae
0.5 part of 0.5 part of Eupolyphaga Seu Steleophaga of Hirudo.
In order to verify the therapeutic effect of medicine of the present invention to hysteromyoma, the applicant entrusts Shanglou, Shaanxi to climb the medicine capsule of the present invention (name is called peace palace tumor eliminating capsule during test) that the Ming Kangsheng institute of Pharmaceutical Research adopts the preparation of the embodiment of the invention 1 proportioning, climb the Ming Kangsheng institute of Pharmaceutical Research by Shanglou, Shaanxi and entrust department of pharmacy of Xi'an Jiaotong University Medical College to carry out pharmacodynamics test, various test situation are as follows:
Test objective: adopt the whole animal test, observe the influence of medicine of the present invention to the hysteromyoma animal model, antiinflammatory action to inflammation of uterus model and acute inflammation model, Dichlorodiphenyl Acetate causes the analgesic activity of mouse writhing number of times, and to the influence of bleeding time and clotting time, the reflection medicine of the present invention effect with cure mainly, for clinical trial provides theoretical foundation.
Experimental drug: GONGLIUQING capsule, Zhonghui Pharmacy Co., Ltd., Chengdu produces, and lot number is 050601, and specification is the 0.37g/ grain; Prednisone acetate tablets, the sharp monarch in Xi'an pharmaceutical Co. Ltd produces, and lot number is 0506256, and specification is the 5mg/ sheet; Aspirin Enteric-coated Tablets, Bailu Pharmaceutical Co., Ltd., Shaanxi produces, and lot number is 050731, and specification is the 25mg/ sheet; Estradiol benzoate injection, Shanghai General Pharmaceutical Co., ltd. produces, and lot number is 040101, and specification is that 1ml/ props up; Progesterone injection, Zhejiang Province XianJu Pharmacy stock Co., Ltd produces, and lot number is 050803, and specification is that 1ml/ props up; Medicine of the present invention, climbing the Ming Kangsheng institute of Pharmaceutical Research by Shanglou, Shaanxi provides, and lot number is 050301, and specification is the 0.3g/ grain, the suitable 7.8g crude drug of every gram medicated powder amount.
Preparation: medicine of the present invention is mixed with suspension with tap water, faces with facing and join.
Laboratory animal: ICR strain white mice, body weight 18～22g, the male and female dual-purpose is provided by Xi'an Communications University's medical experiment animal center, the quality certification number: the moving card of Shan doctor word 08-004 number; SD strain rat, body weight 180～220g, female, provide the quality certification number by Xi'an Communications University's medical experiment animal center: the moving card of Shan doctor word 08-005 number.
Laboratory temperature is 22-26 ℃, relative humidity 35%-70%, and lamp, ventilation fan ventilates, the drink tap water, food full price solid feed is provided by Xi'an Communications University's medical experiment animal center, and animal is by the sex sub-cage rearing.
1, medicine of the present invention is to the influence of hysteromyoma model
(1) medicine of the present invention is to the influence of hysteromyoma rat model
60 of female rats, body weight 200 scholar 20g are divided into 6 groups at random, 10 every group.The normal control group is given the equal-volume tap water; Model control group is given the equal-volume tap water; Positive controls (GONGLIUQING capsule group) is given GONGLIUQING capsule 0.56g/kg; Dosage group, medicine low dose group of the present invention in medicine high dose group of the present invention, the medicine of the present invention are given medicine 0.9g/kg of the present invention, 0.45g/kg, 0.225g/kg (being equivalent to crude drug in whole 7.02g/kg, 3.51g/kg, 1.75g/kg) respectively.The modeling of reference literature method, except that normal group, each is organized rat and gives estradiol benzoate intramuscular injection (0.2mg/ is only), and 3 times/week, after continuous 3 weeks, every intramuscular injection filling Progesterone 2mg 3 times/week, in continuous 1 week, duplicates the uterine fibroid disease rat model.Continuous 30 days of modeling administration simultaneously 1ml/100g body weight.Behind the last medicine 40 minutes, rat was with pentobarbital sodium 40mg/kg intraperitoneal anesthesia, abdominal aortic blood, and separation of serum by the test kit requirement, adopts radioimmunology survey serum estradiol (E
2) and the content of progesterone (P).Cut open the belly behind the sacrifice of animal, get the uterus, weigh, calculate uterus index (uterus weight/100g body weight).The results are shown in Table 1.The uterus is fixed in the 10% neutral formalin solution, the above same area crosscut of the uterus subangle 0.5cm that draws materials, paraffin embedding, HE dyeing is examined under a microscope the uterine cancer cell pathology and is changed.
The result of histopathologic examination is attached.
Table 1 medicine of the present invention is to hysteromyoma rat uterus coefficient, E
2, P content influence (x ± s)
| Group | Dosage (g/kg) | Example number n | The uterus coefficient | Estradiol (ng/ml) | Progesterone (ng/ml) |
| Normal control group model matched group GONGLIUQING group medicine group of the present invention medicine group of the present invention medicine group of the present invention | - - 0.56 0.9 0.45 0.225 | 10 10 10 10 10 10 | 239.67±92.68 ** 621.26±190.43 413.60±143.45 * 390.44±69.19 ** 439.49±136.65 * 505.86±146.15 | 16.65±6.23 ** 128.12±48.64 67.89±24.63 ** 64.39±24.65 ** 71.80±18.49 ** 87.65±25.73 * | 13.26±3.46 ** 35.84±20.24 17.82±3.42 * 15.76±3.38 ** 18.93±10.16 * 20.15±6.52 * |
Annotate: compare * P＜0.05, * * P＜0.01 with model control group
Table 1 result shows that pathological model group rat blood serum estradiol, progesterone level obviously raise, and compares P＜0.01 with the normal control group; The uterus coefficient increases, and compares P＜0.01 with the normal control group.Medicine of the present invention can reduce estradiol, progesterone levels level in the uterus coefficient of hysteromyoma model rat and the serum, compare with model control group, dosage group, medicine low dose group of the present invention can significantly reduce the level (P＜0.05 or P＜0.01) of estradiol in the serum, progesterone in medicine high dose group of the present invention, the medicine of the present invention; The dosage group can significantly reduce uterus coefficient (P＜0.05 or P＜0.01) in medicine high dose group of the present invention, the medicine of the present invention, and medicine small dose group of the present invention also has reduction trend (P＞0.05).The positive drug GONGLIUQING capsule also can reduce the level of estradiol, progesterone in the uterus coefficient of rat model and the serum.
The histopathology observed result is thought: peace large, medium and small dosage group of palace tumor eliminating capsule and model group relatively can obviously suppress hysteromyoma model rat smooth muscle cell hypertrophy, suppress its disorderly hypertrophy, suppress glandular hyperplasia and its intimal thickening that causes; With positive controls relatively, in the dispersing tumor of peace palace, small dose group is suitable with it.Prompting peace palace tumor eliminating capsule has certain drug effect to the rat uterus muscular tumor.The histopathology report is attached.
(2) medicine of the present invention is to the influence of hysteromyoma model mice
60 of female mices, body weight 18～22g is divided into 6 groups at random, 10 every group.The normal control group is given the equal-volume tap water; Model control group is given the equal-volume tap water; Positive controls (GONGLIUQING capsule group) is given GONGLIUQING capsule 1.0g/kg; Dosage group, medicine low dose group of the present invention in medicine high dose group of the present invention, the medicine of the present invention are given medicine 1.62g/kg of the present invention, 0.81g/kg, 0.405g/kg (being equivalent to crude drug in whole 12.64g/kg, 6.32g/kg, 3.16g/kg respectively) respectively.The modeling of list of references method, except that the normal control group, all the other respectively organize the every day of intramuscular injection estradiol benzoate (volume injected is 0.1ml/10g) all, modeling simultaneously every day gastric infusion 0.1ml/10g, totally 15 days.
After the last administration 40 minutes, all mices are weighed, to win eyeball and get blood, separation of serum according to the test kit requirement, adopts radioimmunology to survey serum estradiol (E
2) content.Cut open the belly behind the sacrifice of animal, get the uterus, weigh, calculate uterus index (uterus weight/body weight * 1000).Result of the test sees Table 2.The uterus is fixed in the 10% neutral formalin solution, paraffin embedding after subangle above same area crosscut in uterus is drawn materials, HE dyeing is examined under a microscope the uterine cancer cell pathology and is changed.The result of histopathologic examination is attached.
Table 2 result shows that pathological model group mice serum estradiol level obviously raises, and the uterus coefficient increases, and These parameters and normal group contrast all have significant difference.Medicine of the present invention can reduce the level of estradiol in the uterus coefficient of hysteromyoma model mice and the serum, compare with model control group, the dosage group has significant difference (P＜0.05 or P＜0.01) in medicine high dose group of the present invention, the medicine of the present invention, and small dose group also has reduction trend.The positive drug GONGLIUQING also can reduce the level of estradiol in the uterus coefficient of rat model and the serum.
The histopathology observed result is thought: dosage group, medicine small dose group of the present invention and model group are relatively in the heavy dose of group of medicine of the present invention, the medicine of the present invention, the dosage group can obviously press down the Mouse Uterus smooth muscle cell proliferation that uterus system muscular tumor model causes in the heavy dose of group of medicine of the present invention, the medicine of the present invention, suppress its disorderly hypertrophy, suppress glandular hyperplasia and its intimal thickening that causes, medicine small dose group of the present invention and matched group relatively do not have significant difference; Compare with positive controls, the dosage group is suitable with it in the heavy dose of group of medicine of the present invention, the medicine of the present invention.Point out medicine of the present invention that Mouse Uterus muscular tumor model is had certain drug effect.
The histopathology report is attached.
Table 2 medicine of the present invention is to the influence of hysteromyoma Mouse Uterus coefficient and estrogen content (x ± s)
| Group | Dosage (g/kg) | Example number (n) | The uterus coefficient | Estradiol (ng/ml) |
| Normal control group model matched group GONGLIUQING group medicine group of the present invention medicine group of the present invention medicine group of the present invention | - - 1.0 1.62 0.81 0.405 | 10 10 10 10 10 10 | 2.42±1.15 ** 5.93±1.10 4.56±0.96 ** 4.33±0.88 ** 4.82±1.30 * 5.00±1.11 | 31.58±7.06 ** 830.97±360.00 472.87±116.45 ** 433.30±167.03 ** 562.15±171.67 * 641.5±227.73 |
Annotate: compare * P＜0.05, * * P＜0.01 with model control group
2, medicine of the present invention is to the influence of inflammatory model
(1) medicine of the present invention is to the influence of rat uterus inflammation
With body weight is the female rats ether light anaesthesia of 200 scholar 20g, the hypogastric region cropping, 75% ethanol skin degerming, pubic symphysis top is in median incision of lower abdomen 2cm, expose the uterus, make a transverse incision along 1cm place on the uterus, left side, with a plastic tube (caliber 2mm, long 0.5cm, heavy 2mg, use preceding alcohol disinfecting) be positioned over intrauterine, with the uterine incision sutured, with slip-off preventing.Wound splashes into penicillin 0.1mg (being dissolved among the water for injection 0.2ml), in case infect.At random be divided into 5 group with animal next day: the blank group, give the equal-volume tap water; Positive controls (GONGLIUQING capsule) is given GONGLIUQING capsule 0.56g/kg; Dosage group, medicine low dose group of the present invention in medicine high dose group of the present invention, the medicine of the present invention are given medicine 0.9g/kg of the present invention, 0.45g/kg, 0.225g/kg (being equivalent to crude drug in whole 7.02g/kg, 3.51g/kg, 1.75g/kg respectively) respectively.Animal is put to death in the cervical vertebra dislocation after 7 days, to uterus, clip both sides, fallopian tube junction, takes out plastic tube from the uterus subangle, and 1/1000 balance weighing bilateral uterus is heavy.
Result of the test sees Table 3.
Table 3 medicine of the present invention is to the influence of rat uterus inflammation swelling (x ± s)
| Group | Dosage (g/kg) | Number of animals (n) | Uterus (g), a left side | Right uterus (g) | Swelling rate (%) | Inhibitory rate of intumesce (%) |
| 1 2 3 4 5 | - 0.56 0.9 0.45 0.225 | 10 10 10 10 10 | 0.196±0.073 0.179±0.052 0.183±0.066 0.200±0.050 0.197±0.061 | 0.155±0.054 0.156±0.050 0.159±0.063 0.170±0.046 0.164±0.054 | 25.5±7.4 15.8±6.4** 16.5±5.9** 18.5±6.6* 20.6±7.0 | - 38.2 35.5 27.5 19.2 |
Annotate: compare * P＜0.05, * * P＜0.01 with the blank group
1 is that blank group 2 is a medicine group of the present invention for GONGLIUQING group 3.4.5
By table 3 result as seen, GONGLIUQING capsule is 38.2% to the suppression ratio of rat uterus inflammation swelling, and medicine 0.9g/kg group of the present invention, 0.45g/kg group and 0.225 group of suppression ratio to the swelling of rat uterus inflammation are respectively 35.5%, 27.5% and 19.2%.Swelling has the obvious suppression effect to the GONGLIUQING capsule group to the rat uterus inflammation, compares with the blank group, and difference has significance (P＜0.01).Swelling has the obvious suppression effect to medicine of the present invention to the rat uterus inflammation, compare with the blank group, and 0.9g/kg group and 0.45g/kg group, the difference of swelling rate all has significance (P＜0.01 or P＜0.05).Medicine of the present invention has the Mus inflammation of uterus effect of the significant Chinese People's Anti-Japanese Military and Political College before the prompting.
(2) influence of medicine xylol induced mice auricle inflammation of the present invention
Get 60 of ICR strain white mice, body weight 18-22g, male and female half and half are divided into 6 groups at random by body weight, 10 every group.Be respectively: model control group, give the isometric(al) tap water; The prednisolone acetate positive controls is given prednisolone acetate 10.8mg/kg; The GONGLIUQING capsule positive controls is given GONGLIUQING capsule 1.0g/kg; Dosage group, medicine small dose group of the present invention are given medicine 1.62g/kg of the present invention, 0.81g/kg, 0.405g/kg (being equivalent to crude drug in whole 12.64g/kg, 6.32g/kg, 3.16g/kg respectively) respectively in the heavy dose of group of medicine of the present invention, the medicine of the present invention.Each is organized all by the 0.2ml/10g gastric infusion, once a day, and for three days on end.After the last administration 1 hour, the outside was coated with dimethylbenzene 0.05ml and causes inflammation in every Mus auris dextra, and left ear compares, and mice is put to death in the cervical vertebra dislocation after 1 hour.Cut two ears along the auricle baseline, lay auricle with card punch (8mm), weigh, be calculated as follows mice auricle swelling degree and swelling rate, analyze the effect of the anti-Mice Auricle dimethylbenzene swelling of medicine of the present invention with analytical balance in left and right sides ear same area.The results are shown in Table 4.
Swelling degree=auris dextra sheet weight-left auricle is heavy
The influence of table 4 medicine xylol of the present invention induced mice auricle edema (x ± s, n=10)
| Group | Dosage (g/kg) | Left side ear heavy (g) | Auris dextra heavy (g) | Swelling degree (g) | Swelling rate (%) |
| Blank group prednisone group GONGLIUQING group medicine group of the present invention medicine group of the present invention medicine group of the present invention | - - 1.0 1.62 0.81 0.405 | 7.59±0.57 7.36±0.63 7.55±0.62 7.41±0.70 7.74±1.65 7.63±1.09 | 15.30±1.89 11.67±1.41 12.40±2.46 12.03±1.71 12.73±2.77 13.11±2.94 | 7.71±2.29 4.31±1.68 **4.85±2.73 *4.62±1.54 **4.99±2.55 *5.48±2.21 * | 103.76±37.82 58.89±25.49 ** 66.01±39.24 * 62.78±22.69 ** 66.92±36.61 * 71.18±24.87 * |
Annotate: compare * P＜0.05, * * P＜0.01 with the blank group
By table 4 result as seen, prednisone sheet group and GONGLIUQING group xylol cause mice auricle swelling the obvious suppression effect, compares with model control group, and the difference of auricle swelling degree and swelling rate all has significance (P＜0.01 or P＜0.05).Drug administration group xylol of the present invention causes mice auricle swelling the obvious suppression effect, compare with model control group, the difference of medicine 1.62g/kg dosage group of the present invention, 0.81g/kg dosage group and 0.405g/kg dosage group auricle swelling degree and swelling rate all has significance (P＜0.01 or P＜0.05).Point out medicine of the present invention to have significant antiinflammatory action.
3, medicine Dichlorodiphenyl Acetate of the present invention causes the influence of pain mouse writhing number of times
Get 50 of ICR strain white mice, body weight 18～22g, male and female half and half.Be divided into 5 groups at random by body weight, be dosage group, medicine small dose group of the present invention in the heavy dose of group of medicine of the present invention, the medicine of the present invention, give medicine 1.62g/kg of the present invention, 0.81g/kg, 0.405g/kg (being equivalent to crude drug in whole 12.64g/kg, 6.32g/kg, 3.16g/kg respectively) respectively; The aspirin positive controls is given aspirin 0.2g/kg; The blank group is given the equal-volume tap water.Each group is pressed the 0.1ml/kg gastric infusion, for three days on end.After the last administration 30 minutes, each organized lumbar injection 0.6% acetum 0.2ml, observe and record injection acetum after 20 minutes, mouse writhing reaction times, and calculate the analgesia percentage rate.
Result of the test sees Table 5.
Table 5 medicine Dichlorodiphenyl Acetate of the present invention causes the influence (x ± s) of pain mouse writhing number of times
| Group | Dosage (g/kg) | Number of animals (n) | Turn round the body number of times (inferior/20min) | Analgesia rate (%) |
| Blank group aspirin group medicine group of the present invention medicine group of the present invention medicine group of the present invention | - 0.2 1.62 0.81 0.405 | 10 10 10 10 10 | 19.2±7.7 4.2±2.5 ** 9.9±4.3 * 11.5±4.5 * 13.8±6.3 | - 78.13 48.44 40.10 28.13 |
Annotate: compare * P＜0.05, * * P＜0.01 with the blank group
By table 5 result as seen, aspirin group Dichlorodiphenyl Acetate causes pain mouse writhing number of times tangible minimizing effect, compares with the blank group, and the difference of turning round the body number of times has significance (P＜0.01).The mouse writhing that drug administration group Dichlorodiphenyl Acetate of the present invention causes pain has the obvious suppression effect, drug administration group xylol of the present invention causes mice auricle swelling the obvious suppression effect, compare with the blank group, the difference that medicine 1.62g/kg dosage group of the present invention and 0.81g/kg dosage group are turned round the body number of times all has significance (P＜0.05).Point out medicine of the present invention to have analgesic activity.
4, the influence of medicine of the present invention, clotting time hemorrhage to mice
(1) medicine of the present invention is to the mice influence in docking bleeding time
Get 50 of ICR strain white mice, body weight 18-22g, male and female half and half are divided into 5 groups at random by body weight, 10 every group.Be respectively: the normal control group, give the isometric(al) tap water; The GONGLIUQING capsule matched group is given GONGLIUQING capsule 1.0g/kg; Dosage group, medicine small dose group of the present invention in the heavy dose of group of medicine of the present invention, the medicine of the present invention are given respectively and are given medicine 1.62g/kg of the present invention, 0.81g/kg, 0.405g/kg (being equivalent to crude drug in whole 12.64g/kg, 6.32g/kg, 3.16g/kg respectively) respectively.Each is organized all by the 0.2ml/10g gastric infusion, once a day, and for three days on end.After the last administration 2 hours, cross-section in order to cutting respectively with mouse tail point 0.5cm place, when treating that blood flows out voluntarily, inhaled with filter paper every 15 seconds and to dehematize droplet for 1 time, stop naturally until blood, respectively organize the bleeding time.Result of the test sees Table 6.
Table 6 result shows, drug administration group of the present invention can shorten the docking bleeding time of mice, compare with the blank group, medicine high dose group of the present invention has significant difference (P＜0.05), and dosage group, medicine low dose group of the present invention also have the trend of shortening in the medicine of the present invention.The GONGLIUQING group has the trend in shortening mice docking bleeding time.
(2) medicine of the present invention is to the influence of clotting time of mice
Get 50 of ICR strain white mice, body weight 18-22g, male and female half and half are divided into 5 groups at random by body weight, 10 every group.Be respectively: the normal control group, give the isometric(al) tap water; The GONGLIUQING capsule matched group is given GONGLIUQING capsule 1.0g/kg; Dosage group, medicine small dose group of the present invention are given medicine 1.62g/kg of the present invention, 0.81g/kg, 0.405g/kg (being equivalent to crude drug in whole 12.64g/kg, 6.32g/kg, 3.16g/kg respectively) respectively in the heavy dose of group of medicine of the present invention, the medicine of the present invention.Each is organized all by the 0.2ml/10g gastric infusion, once a day, and for three days on end.Last administration adopted the blood capillary method to survey clotting time after 2 hours: get long 5cm, adjoin venous plexus in the internal diameter 1mm glass-tube insertion mice and get blood, fractureed every 15 seconds one section of glass-tube of full back, inspection has or not the blood clotting silk to occur, and calculates the blood clotting silk time to occur from taking a blood sample to, is clotting time.Respectively organize clotting time, result of the test sees Table 6.
Table 6 medicine of the present invention is hemorrhage to mice, the influence of clotting time (x ± s)
| Group | Dosage (g/kg) | Number of animals (n) | Bleeding time (min) | Clotting time (s) |
| Blank group GONGLIUQING group medicine group of the present invention medicine group of the present invention medicine group of the present invention | - 1.0 1.62 0.81 0.405 | 10 10 10 10 10 | 13.40±4.17 10.81±2.92 9.35±3.79 * 10.93±3.41 12.66±4.33 | 30.00±5.71 31.60±5.01 31.35±7.91 33.14±6.63 34.84±9.72 |
Annotate: compare * P＜0.05, * * P＜0.01 with the blank group
Table 6 result shows that three dosed administration groups of medicine of the present invention and GONGLIUQING administration group do not have obvious influence to the clotting time of mice.
5, conclusion (of pressure testing)
Medicine of the present invention can suppress the hysteromyoma of model mice hysteromyoma and rat model, the histopathology that can improve hysteromyoma model rat and hysteromyoma model mice is unusual, can suppress the rat model inflammation of uterus, suppress the mice caused by dimethylbenzene xylene auricle edema, can reduce the mouse writhing number of times due to the acetic acid, have analgesic activity, can shorten the mice docking bleeding time and not obviously influence of clotting time.Illustrate that medicine of the present invention has the hysteromyoma of inhibition, antiinflammatory, analgesia and anastalsis.Point out medicine of the present invention to can be used for the treatment of hysteromyoma.
The function of medicine of the present invention with cure mainly: blood circulation promoting and blood stasis dispelling ， Xiao Disorder eliminating stagnation.Be used for the lower abdomen pain due to the hysteromyoma, distending pain of the breast, even eumenorrhea or menorrhagia are diseases such as metrorrhagia or persistent vaginal bloody discharges.
The specification of medicine of the present invention: every heavy 0.3g of medicine capsule of the present invention, every gram contains raw material of Chinese medicine 7.8g; Every heavy 0.5g of medicinal tablet of the present invention, every gram contains raw material of Chinese medicine 4.68g; Every bag heavy 5g of medicinal granule of the present invention, every gram contains raw material of Chinese medicine 1.404g; Every bottle of 10mL of medicine oral liquid of the present invention, every milliliter contains raw material of Chinese medicine 0.702g.
The usage of medicine of the present invention and consumption: oral medicine capsule of the present invention, one time 3,3 times on the one; Oral medicinal tablet of the present invention, one time 3,3 times on the one; Oral medicinal granule of the present invention, one time 1 bag, 3 times on the one; Oral medicine oral liquid of the present invention, one time 1 bottle, 3 times on the one.
The effect duration of medicine of the present invention: 24 months.
Claims (4)
1, a kind of oral drugs for the treatment of hysteromyoma is characterized in that it is by the following weight parts Chinese medicinal raw materials medicament of formulation method preparation routinely:
5～15 parts of 5～15 parts of Rhizoma Chuanxiongs of Radix Paeoniae Rubra
4～14 parts of 4～14 parts of Pollen Typhaes of Semen Persicae
4～14 parts of 4～14 parts of Rhizoma Curcumae of rhizoma sparganic
3～13 parts of 3～13 portions of Caulis Spatholobis of Herba Verbenae
0.5～3 part of 0.5～3 part of Eupolyphaga Seu Steleophaga of Hirudo.
2,, it is characterized in that wherein the weight portion proportioning of each raw material of Chinese medicine is according to the oral drugs of the described treatment hysteromyoma of claim 1:
8～14 parts of 8～14 parts of Rhizoma Chuanxiongs of Radix Paeoniae Rubra
8～12 parts of 8～12 parts of Pollen Typhaes of Semen Persicae
6～12 parts of 6～12 parts of Rhizoma Curcumae of rhizoma sparganic
6～10 parts of 6～10 portions of Caulis Spatholobis of Herba Verbenae
1～2 part of 1～2 part of Eupolyphaga Seu Steleophaga of Hirudo.
3,, it is characterized in that wherein the weight portion proportioning of each raw material of Chinese medicine is according to the oral drugs of the described treatment hysteromyoma of claim 1:
11 parts of 11 parts of Rhizoma Chuanxiongs of Radix Paeoniae Rubra
9 parts of 10 parts of Pollen Typhaes of Semen Persicae
9 parts of 9 parts of Rhizoma Curcumae of rhizoma sparganic
8 parts of 8 portions of Caulis Spatholobis of Herba Verbenae
1.5 parts of 1.5 parts of Eupolyphaga Seu Steleophagas of Hirudo.
4, according to the oral drugs of the described treatment hysteromyoma of claim 1, it is characterized in that: said medicinal preparation for oral administration is said capsule or tablet or granule or an oral solutions on the galenic pharmacy.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101195011B (en) * | 2007-11-28 | 2010-06-09 | 韩曙光 | Chinese medicine for treating prostatitis and hyperplasia |
| CN103893692A (en) * | 2014-03-05 | 2014-07-02 | 魏茂芳 | Pharmaceutical composition for treating myoma of uterus |
| CN104352950A (en) * | 2014-10-11 | 2015-02-18 | 胥琴 | Traditional Chinese medicine composition for treating gynecological inflammation |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1302801C (en) * | 2002-11-12 | 2007-03-07 | 王红波 | Compound traditional Chinese medicine formulation for curing hysteromyoma |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101195011B (en) * | 2007-11-28 | 2010-06-09 | 韩曙光 | Chinese medicine for treating prostatitis and hyperplasia |
| CN103893692A (en) * | 2014-03-05 | 2014-07-02 | 魏茂芳 | Pharmaceutical composition for treating myoma of uterus |
| CN104352950A (en) * | 2014-10-11 | 2015-02-18 | 胥琴 | Traditional Chinese medicine composition for treating gynecological inflammation |
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