Pharmaceutical composition for treating hysteromyoma as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a pharmaceutical composition for treating hysteromyoma and a preparation method and application thereof. The pharmaceutical composition for treating hysteromyoma provided by the invention is prepared from the following raw materials in parts by weight: 10 to 30 parts of radix salviae miltiorrhizae, 10 to 20 parts of rhizoma curcumae, 5 to 15 parts of semen persicae, 3 to 10 parts of radix notoginseng, 9 to 15 parts of rhizoma cyperi, 10 to 20 parts of bulbus fritillariae thunbergii, 15 to 30 parts of raw oyster shell, 10 to 20 parts of spica prunellae, 10 to 20 parts of rhizoma atractylodis macrocephalae, 10 to 25 parts of poria cocos, 15 to 30 parts of radix astragali seu hedysari and 5 to 10 parts of liquorice root. The composition has a synergistic curative effect through multiple effects of promoting blood circulation to remove blood stasis, softening hardness to dissipate stagnation, regulating qi to invigorate the spleen, tonifying qi and consolidating basis and the like, and can effectively treat hysteromyoma.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a pharmaceutical composition for treating uterine fibroids, its preparation method and uses. Background Art

[0002] Uterine fibroids are the most common benign tumors in the female reproductive system, with a relatively high incidence rate. The most common clinical symptoms are uterine bleeding, lower abdominal pain and dysmenorrhea, compression symptoms, increased vaginal discharge, anemia, and even infertility, seriously affecting the physical health and daily life and work of women.

[0003] Currently, the etiology and pathogenesis of uterine fibroids are complex. Classical research believes that uterine fibroids are an estrogen-dependent benign tumor of the ovary, and estrogen plays a key adjuvant role in its occurrence. The excessive action of estrogen promotes the development of uterine fibroids. Clinically, surgical resection or hormone drug treatment is mainly used. Surgery brings great trauma to patients, prolongs the recovery period, and patients have poor acceptance; although hormone drugs can shrink fibroids, they have large side effects, fibroids are prone to recurrence after drug withdrawal, and it is difficult to completely cure.

[0004] Traditional Chinese medicine classifies uterine fibroids into the category of "abdominal mass", and believes that its pathogenesis is related to qi stagnation, blood stasis, phlegm dampness, etc. In recent years, the use of traditional Chinese medicine to treat uterine fibroids has achieved certain curative effects. However, there are few existing proprietary Chinese medicine varieties, and the curative effects need to be further improved. Therefore, developing new traditional Chinese medicine varieties with significant curative effects and small toxic and side effects is of great significance for the treatment of uterine fibroids. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a pharmaceutical composition for treating uterine fibroids.

[0006] The pharmaceutical composition provided by the present invention comprises the following raw materials in parts by weight: 10-30 parts by weight of Salvia miltiorrhiza, 10-20 parts by weight of Curcuma zedoaria, 5-15 parts by weight of Prunus persica, 3-10 parts by weight of Panax notoginseng, 9-15 parts by weight of Cyperus rotundus, 10-20 parts by weight of Fritillaria thunbergii, 15-30 parts by weight of raw oyster, 10-20 parts by weight of Prunella vulgaris, 10-20 parts by weight of Atractylodes macrocephala, 10-25 parts by weight of Poria cocos, 15-30 parts by weight of Astragalus membranaceus, 5-10 parts by weight of Glycyrrhiza uralensis.

[0007] Further, the pharmaceutical composition comprises the following raw materials in parts by weight: 15-25 parts by weight of Salvia miltiorrhiza, 10-15 parts by weight of Curcuma zedoaria, 9-12 parts by weight of Prunus persica, 3-8 parts by weight of Panax notoginseng, 9-12 parts by weight of Cyperus rotundus, 10-15 parts by weight of Fritillaria thunbergii, 20-30 parts by weight of raw oyster, 10-15 parts by weight of Prunella vulgaris, 10-15 parts by weight of Atractylodes macrocephala, 10-15 parts by weight of Poria cocos, 20-30 parts by weight of Astragalus membranaceus, 6-8 parts by weight of Glycyrrhiza uralensis.

[0008] Preferably, the pharmaceutical composition comprises the following raw materials in parts by weight: 20 parts by weight of Salvia miltiorrhiza, 15 parts by weight of Rhizoma Curcumae, 10 parts by weight of Semen Persicae, 6 parts by weight of Radix Notoginseng, 10 parts by weight of Rhizoma Cyperi, 15 parts by weight of Bulbus Fritillariae Thunbergii, 25 parts by weight of Concha Ostreae, 18 parts by weight of Spica Prunellae, 15 parts by weight of Rhizoma Atractylodis Macrocephalae, 20 parts by weight of Poria, 25 parts by weight of Radix Astragali, and 6 parts by weight of Radix Glycyrrhizae.

[0009] Salvia miltiorrhiza is the dried root and rhizome of the Labiatae plant Salvia miltiorrhiza Bge. It is bitter and slightly cold in nature, and belongs to the heart and liver meridians. It promotes blood circulation to remove blood stasis, dredges the meridians to relieve pain, clears the heart to remove vexation, and cools the blood to dissipate carbuncles. It is used for chest impediment pain, epigastric and hypochondriac pain, mass accumulation, arthralgia due to heat, restlessness and insomnia, irregular menstruation, dysmenorrhea and amenorrhea, sores and ulcers with swelling and pain.

[0010] Rhizoma Curcumae is the dried rhizome of the Zingiberaceae plants Curcuma phaeocaulis Val., Curcuma kwangsiensis S.G.Lee et C.F.Liang or Curcuma wenyujin Y.H.Chen et C.Ling. It is pungent, bitter and warm in nature, and belongs to the liver and spleen meridians. It promotes qi and breaks blood stasis, eliminates accumulation and relieves pain. It is used for mass and lump, blood stasis amenorrhea, chest impediment pain, abdominal distension and pain due to food accumulation.

[0011] Semen Persicae is the dried ripe seed of the Rosaceae plants Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch. It is bitter, sweet and neutral in nature, and belongs to the heart, liver and large intestine meridians. It promotes blood circulation to remove blood stasis, moistens the intestines to relieve constipation, and relieves cough and asthma. It is used for amenorrhea and dysmenorrhea, mass and lump, lung abscess and intestinal abscess, traumatic injury, intestinal dryness and constipation, cough and asthma.

[0012] Radix Notoginseng is the dried root and rhizome of the Araliaceae plant Panax notoginseng (Burk.) F.H.Chen. It is sweet, slightly bitter and warm in nature, and belongs to the liver and stomach meridians. It dispels stasis and stops bleeding, reduces swelling and relieves pain. It is used for hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia and metrostaxis, traumatic bleeding, chest and abdominal stabbing pain, traumatic injury and swelling pain.

[0013] Rhizoma Cyperi is the dried rhizome of the Cyperaceae plant Cyperus rotundus L. It is pungent, slightly bitter, slightly sweet and neutral in nature, and belongs to the liver, spleen and triple energizer meridians. It soothes the liver and relieves depression, regulates qi and soothes the middle energizer, regulates menstruation and relieves pain. It is used for liver qi stagnation, chest and hypochondriac distending pain, hernia pain, breast distending pain, spleen and stomach qi stagnation, epigastric and abdominal fullness and distending pain, irregular menstruation, amenorrhea and dysmenorrhea.

[0014] Fritillaria thunbergii Miq. is the dried bulb of the liliaceous plant Fritillaria thunbergii Miq. It is bitter in taste and cold in nature. It acts on the lung and heart meridians. It clears heat, resolves phlegm, stops cough, detoxifies, disperses nodules and eliminates carbuncles. It is used for wind-heat cough, phlegm-fire cough, lung abscess, breast abscess, scrofula, and sores and toxins.

[0015] Oyster is the shell of the ostreid animals Ostrea gigas Thunberg, Ostrea talienwhanensis Crosse or Ostrea rivularis Gould. It is salty in taste and slightly cold in nature. It acts on the liver, gallbladder and kidney meridians. It has the functions of calming the mind with heavy substances, suppressing yang and nourishing yin, softening hardness and dissipating nodules. It is used for palpitations with fear and insomnia, dizziness and tinnitus, scrofula and phlegm nodes, and masses and lumps. Calcined oyster has the functions of astringing and consolidating, and relieving acid and pain. It is used for spontaneous sweating and night sweating, spermatorrhea and emission, metrorrhagia and leukorrhea, and stomachache with acid regurgitation.

[0016] Prunella vulgaris L. is the dried spike of the labiate plant Prunella vulgaris L. It is pungent, bitter in taste and cold in nature. It acts on the liver and gallbladder meridians. It clears the liver and purges fire, improves eyesight, and disperses swelling and dissipates nodules. It is used for red and swollen eyes with pain, pain in the eyes at night, headache and dizziness, scrofula, goiter, breast abscess, breast nodulation, and breast distending pain.

[0017] Atractylodes macrocephala Koidz. is the dried rhizome of the compositae plant Atractylodes macrocephala Koidz. It is bitter and sweet in taste and warm in nature. It acts on the spleen and stomach meridians. It invigorates the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and prevents miscarriage.

[0018] Poria cocos (Schw.) Wolf is the dried sclerotium of the polyporaceae fungus Poria cocos (Schw.) Wolf. It is sweet and bland in taste and neutral in nature. It acts on the heart, lung, spleen and kidney meridians. It promotes diuresis and percolates dampness, strengthens the spleen, and calms the mind. It is used for edema with scanty urine, dizziness and palpitation due to phlegm retention, poor appetite due to spleen deficiency, loose stools and diarrhea, restlessness of mind, palpitation and insomnia.

[0019] Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. is the dried root of the leguminous plant Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. It is sweet in taste and slightly warm in nature. It acts on the lung and spleen meridians. It replenishes qi and raises yang, consolidates the exterior and stops sweating, promotes diuresis and alleviates edema, generates body fluid and nourishes blood, promotes qi circulation and dredges collaterals, expels toxins and discharges pus, and heals sores and generates flesh. It is used for qi deficiency with weakness, poor appetite and loose stools, sinking of middle qi, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, qi deficiency edema, internal heat and polydipsia, sallow complexion due to blood deficiency, hemiplegia, pain and numbness in arthralgia, difficulty in ulceration of carbuncles and sores, and non-healing of chronic ulcers.

[0020] Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. of the Leguminosae family. It is sweet in taste and neutral in nature. It acts on the heart, lung, spleen, and stomach meridians. It invigorates the spleen and replenishes qi, clears heat and detoxifies, reduces phlegm and relieves cough, alleviates spasm and pain, and harmonizes various medicinal herbs. It is used for weakness of the spleen and stomach, lassitude and weakness, palpitations and shortness of breath, excessive phlegm and cough, spasmodic pain in the abdomen and extremities, carbuncles and sores, and relieving the toxicity and potency of drugs.

[0021] In the pharmaceutical composition of the present invention, Salvia miltiorrhiza promotes blood circulation to remove blood stasis, cools blood and reduces swelling; Rhizoma Curcumae promotes blood circulation by breaking blood stasis, activates qi and relieves accumulation and pain; Semen Persicae promotes blood circulation to remove blood stasis and moistens the intestines for defecation; Panax notoginseng removes stasis and stops bleeding, promotes blood circulation and relieves pain. These four are the monarch drugs and can effectively promote blood circulation and improve the symptoms of blood stasis obstruction caused by uterine fibroids. Fritillaria thunbergii clears heat and dissipates phlegm, softens and disperses nodules; Concha Ostreae nourishes yin and suppresses yang, softens and disperses nodules, astringes and consolidates; Prunella vulgaris clears the liver and purges fire, improves eyesight, softens and disperses nodules. Fritillaria thunbergii, Concha Ostreae, and Prunella vulgaris are the ministerial drugs and are suitable for the dissipation of uterine fibroids. Cyperus rotundus soothes the liver and relieves depression, regulates qi and widens the middle energizer, regulates menstruation and relieves pain; Atractylodes macrocephala invigorates the spleen and replenishes qi, dries dampness and promotes diuresis; Poria cocos promotes diuresis and percolates dampness, strengthens the spleen and tranquilizes the mind. Cyperus rotundus, Atractylodes macrocephala, and Poria cocos are the adjuvant drugs to regulate the spleen and stomach, soothe the liver and regulate qi, and can improve the internal environment of the body and enhance immunity. Astragalus membranaceus and Licorice are the guiding drugs to replenish qi and strengthen the root. The composition of the present invention exerts its curative effect synergistically through multiple actions such as promoting blood circulation to remove blood stasis, softening and dispersing nodules, regulating qi and strengthening the spleen, replenishing qi and strengthening the root, etc., to achieve the purpose of treating uterine fibroids.

[0022] The present invention also provides a preparation method of the pharmaceutical composition, comprising the following steps:

[0023] a. Weigh the raw materials according to the prescription, remove impurities, and soak Salvia miltiorrhiza, Rhizoma Curcumae, Semen Persicae, Panax notoginseng, Cyperus rotundus, Fritillaria thunbergii, Prunella vulgaris, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, and Licorice in water;

[0024] b. Decoct Concha Ostreae in water;

[0025] c. Pour the decocted Concha Ostreae and the decoction liquid into the soaked medicinal materials in step a, continue to decoct, filter, concentrate to an extract, and dry to obtain an extract powder.

[0026] Further, in step a, the amount of added water is 8 to 12 times.

[0027] Further, in step a, the soaking time is 30 to 60 minutes.

[0028] Further, in step b, the amount of added water is 3 to 5 cm above the oysters.

[0029] Further, in step b, the decocting time is 20 to 30 minutes.

[0030] Further, in step c, decoct 2 to 3 times; each time for 1 to 2 hours.

[0031] Further, in step c, concentrate to an extract with a relative density of 1.10 - 1.20 at 60 °C.

[0032] The present invention also provides the use of the said pharmaceutical composition in the preparation of a medicament for treating uterine fibroids.

[0033] Further, the medicament for treating uterine fibroids is composed of the said pharmaceutical composition and a pharmaceutically acceptable carrier.

[0034] The beneficial effects of the present invention are as follows:

[0035] In the pharmaceutical composition of the present invention, Salvia miltiorrhiza, Curcuma zedoaria, Prunus persica, and Panax notoginseng are used as the monarch drugs, which can effectively promote blood circulation and improve the symptoms of blood stasis caused by uterine fibroids. Fritillaria thunbergii, Ostrea gigas, and Prunella vulgaris are used as the ministerial drugs, which are suitable for the dissipation of uterine fibroids. Cyperus rotundus, Atractylodes macrocephala, and Poria cocos are used as the adjuvant drugs to regulate the spleen and stomach and soothe the liver and regulate qi, which can improve the internal environment of the body and enhance immunity. Astragalus membranaceus and Glycyrrhiza uralensis are used as the guiding drugs to replenish qi and consolidate the root. The composition of the present invention exerts its curative effect through the synergistic effects of promoting blood circulation to remove blood stasis, softening hardness and dissipating nodules, regulating qi and strengthening the spleen, and replenishing qi and consolidating the root, and can effectively treat uterine fibroids. The pharmacodynamic experiment shows that the pharmaceutical composition of the present invention can reduce the uterine coefficient, cervical diameter, and uterine body diameter of rats, and there is a statistical significance P < 0.05 compared with the model group; the pharmaceutical composition of the present invention can also significantly reduce the degree of uterine smooth muscle hyperplasia and the contents of estradiol and progesterone, indicating that the pharmaceutical composition of the present invention has a certain therapeutic effect on uterine fibroids. Detailed implementation mode

[0036] The present invention will be further elaborated in detail through specific examples below. The raw materials and reagents involved in the detailed implementation mode part are all obtained through commercial channels.

[0037] Example 1

[0038] Weigh 20 parts by weight of Salvia miltiorrhiza, 15 parts by weight of Curcuma zedoaria, 10 parts by weight of Prunus persica, 6 parts by weight of Panax notoginseng, 10 parts by weight of Cyperus rotundus, 15 parts by weight of Fritillaria thunbergii, 25 parts by weight of Ostrea gigas, 18 parts by weight of Prunella vulgaris, 15 parts by weight of Atractylodes macrocephala, 20 parts by weight of Poria cocos, 25 parts by weight of Astragalus membranaceus, and 6 parts by weight of Glycyrrhiza uralensis. Remove impurities, add 10 times the weight of water to Salvia miltiorrhiza, Curcuma zedoaria, Prunus persica, Panax notoginseng, Cyperus rotundus, Fritillaria thunbergii, Prunella vulgaris, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, and Glycyrrhiza uralensis and soak for 60 minutes; add water to Ostrea gigas, with the water level 4 cm above the oyster, and decoct for 30 minutes; pour the decocted oyster and the decoction into the soaked medicinal materials, continue to decoct 3 times, each time for 1.5 hours, filter, combine the decoctions, concentrate to an extract with a relative density of 1.20 at 60 °C, and dry to obtain extract powder.

[0039] Example 2

[0040] Weigh 13 parts by weight of Salvia miltiorrhiza, 12 parts by weight of Curcuma zedoaria, 8 parts by weight of Prunus persica, 4 parts by weight of Panax notoginseng, 10 parts by weight of Cyperus rotundus, 10 parts by weight of Fritillaria thunbergii, 15 parts by weight of Ostrea gigas, 12 parts by weight of Prunella vulgaris, 10 parts by weight of Atractylodes macrocephala, 10 parts by weight of Poria cocos, 15 parts by weight of Astragalus membranaceus, and 5 parts by weight of Glycyrrhiza uralensis. Remove impurities, add 8 times the weight of water to Salvia miltiorrhiza, Curcuma zedoaria, Prunus persica, Panax notoginseng, Cyperus rotundus, Fritillaria thunbergii, Prunella vulgaris, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, and Glycyrrhiza uralensis and soak for 40 minutes; add water to Ostrea gigas, with the water level 3 cm above the oyster, and decoct for 20 minutes; pour the decocted oyster and the decoction into the soaked medicinal materials, continue to decoct 2 times, each time for 1 hour, filter, combine the decoctions, concentrate to an extract with a relative density of 1.10 at 60 °C, and dry to obtain an extract powder.

[0041] Example 3

[0042] Weigh 28 parts by weight of Salvia miltiorrhiza, 20 parts by weight of Curcuma zedoaria, 15 parts by weight of Prunus persica, 9 parts by weight of Panax notoginseng, 15 parts by weight of Cyperus rotundus, 20 parts by weight of Fritillaria thunbergii, 28 parts by weight of Ostrea gigas, 20 parts by weight of Prunella vulgaris, 20 parts by weight of Atractylodes macrocephala, 25 parts by weight of Poria cocos, 30 parts by weight of Astragalus membranaceus, and 10 parts by weight of Glycyrrhiza uralensis. Remove impurities, add 12 times the weight of water to Salvia miltiorrhiza, Curcuma zedoaria, Prunus persica, Panax notoginseng, Cyperus rotundus, Fritillaria thunbergii, Prunella vulgaris, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, and Glycyrrhiza uralensis and soak for 60 minutes; add water to Ostrea gigas, with the water level 5 cm above the oyster, and decoct for 30 minutes; pour the decocted oyster and the decoction into the soaked medicinal materials, continue to decoct 3 times, each time for 2 hours, filter, combine the decoctions, concentrate to an extract with a relative density of 1.20 at 60 °C, and dry to obtain an extract powder.

[0043] Example 4 Tablets

[0044] Prepare the extract powder obtained in Example 1 into tablets by referring to the conventional traditional Chinese medicine preparation method.

[0045] Example 5 Granules

[0046] Prepare the extract powder obtained in Example 1 into granules by referring to the conventional traditional Chinese medicine preparation method.

[0047] Example 6 Capsules

[0048] Prepare the extract powder obtained in Example 1 into capsules by referring to the conventional traditional Chinese medicine preparation method.

[0049] Comparative Example 1

[0050] Weigh 10 parts by weight of Cyperus rotundus, 15 parts by weight of Fritillaria thunbergii, 25 parts by weight of raw oyster, 18 parts by weight of Prunella vulgaris, 15 parts by weight of Atractylodes macrocephala, 20 parts by weight of Poria cocos, 25 parts by weight of Astragalus membranaceus, and 6 parts by weight of Glycyrrhiza uralensis. Remove impurities, add 10 times the weight of water to Cyperus rotundus, Fritillaria thunbergii, Prunella vulgaris, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, and Glycyrrhiza uralensis and soak for 60 minutes; add water to the raw oyster, with the water level 4 cm above the oyster, and decoct for 30 minutes; pour the decocted oyster and the decoction into the soaked medicinal materials, continue to decoct 3 times, each time for 1.5 hours, filter, combine the decoctions, concentrate to an extract with a relative density of 1.20 at 60 °C, and dry to obtain an extract powder.

[0051] Comparative Example 2

[0052] Weigh 20 parts by weight of Salvia miltiorrhiza, 15 parts by weight of Curcuma zedoaria, 10 parts by weight of Prunus persica, 6 parts by weight of Panax notoginseng, 10 parts by weight of Cyperus rotundus, 15 parts by weight of Atractylodes macrocephala, 20 parts by weight of Poria cocos, 25 parts by weight of Astragalus membranaceus, and 6 parts by weight of Glycyrrhiza uralensis. Remove impurities, add 10 times the weight of water to Salvia miltiorrhiza, Curcuma zedoaria, Prunus persica, Panax notoginseng, Cyperus rotundus, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, and Glycyrrhiza uralensis and soak for 60 minutes, decoct 3 times, each time for 1.5 hours, filter, combine the decoctions, concentrate to an extract with a relative density of 1.20 at 60 °C, and dry to obtain an extract powder.

[0053] Comparative Example 3

[0054] Weigh 20 parts by weight of Salvia miltiorrhiza, 15 parts by weight of Curcuma zedoaria, 10 parts by weight of Prunus persica, 6 parts by weight of Panax notoginseng, 15 parts by weight of Fritillaria thunbergii, 25 parts by weight of raw oyster, 18 parts by weight of Prunella vulgaris, 25 parts by weight of Astragalus membranaceus, and 6 parts by weight of Glycyrrhiza uralensis. Remove impurities, add 10 times the weight of water to Salvia miltiorrhiza, Curcuma zedoaria, Prunus persica, Panax notoginseng, Fritillaria thunbergii, Prunella vulgaris, Astragalus membranaceus, and Glycyrrhiza uralensis and soak for 60 minutes; add water to the raw oyster, with the water level 4 cm above the oyster, and decoct for 30 minutes; pour the decocted oyster and the decoction into the soaked medicinal materials, continue to decoct 3 times, each time for 1.5 hours, filter, combine the decoctions, concentrate to an extract with a relative density of 1.20 at 60 °C, and dry to obtain an extract powder.

[0055] Comparative Example 4

[0056] Weigh 20 parts by weight of Salvia miltiorrhiza, 15 parts by weight of Curcuma zedoaria, 10 parts by weight of Prunus persica, 6 parts by weight of Panax notoginseng, 10 parts by weight of Cyperus rotundus, 15 parts by weight of Fritillaria thunbergii, 25 parts by weight of raw oyster, 18 parts by weight of Prunella vulgaris, 15 parts by weight of Atractylodes macrocephala, and 20 parts by weight of Poria cocos. Remove impurities, add 10 times the weight of water to Salvia miltiorrhiza, Curcuma zedoaria, Prunus persica, Panax notoginseng, Cyperus rotundus, Fritillaria thunbergii, Prunella vulgaris, Atractylodes macrocephala, and Poria cocos and soak for 60 minutes; add water to the raw oyster, with the water level 4 cm above the oyster, and decoct for 30 minutes; pour the decocted oyster and the decoction into the soaked medicinal materials, continue to decoct 3 times, each time for 1.5 hours, filter, combine the decoctions, concentrate to an extract with a relative density of 1.20 at 60 °C, and dry to obtain an extract powder.

[0057] Comparative Example 5

[0058] Weigh 20 parts by weight of Sparganii Rhizoma, 15 parts by weight of Leonuri Herba, 10 parts by weight of Persicae Semen, 6 parts by weight of Notoginseng Radix et Rhizoma, 10 parts by weight of Bupleuri Radix, 15 parts by weight of Scrophulariae Radix, 25 parts by weight of Concha Ostreae, 18 parts by weight of Prunellae Spica, 15 parts by weight of Atractylodis Macrocephalae Rhizoma, 20 parts by weight of Poria, 25 parts by weight of Astragali Radix, and 6 parts by weight of Glycyrrhizae Radix. Remove impurities, add 10 times the weight of water to Sparganii Rhizoma, Leonuri Herba, Persicae Semen, Notoginseng Radix et Rhizoma, Bupleuri Radix, Scrophulariae Radix, Prunellae Spica, Atractylodis Macrocephalae Rhizoma, Poria, Astragali Radix, and Glycyrrhizae Radix, and soak for 60 minutes; add water to Concha Ostreae, with the water level 4 cm above the oyster, and decoct for 30 minutes; pour the decocted oyster and the decoction into the soaked medicinal materials, continue to decoct 3 times, each time for 1.5 hours, filter, combine the decoctions, concentrate to an extract with a relative density of 1.20 at 60 °C, and dry to obtain an extract powder.

[0059] Pharmacodynamic experiment

[0060] Animal grouping and model establishment

[0061] 100 clean-grade female Wistar rats, weighing 150 - 180 g, were purchased from the Henan Experimental Animal Center and randomly divided into a normal control group, a model group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, and Comparative Example 5 group, with 10 rats in each group.

[0062] In the model group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, and Comparative Example 5 group, estradiol benzoate was intramuscularly injected at a dose of 0.1 mg / d on Mondays, Wednesdays, and Fridays every week for 20 weeks. From the 14th week, progesterone was intramuscularly injected once a week at a dose of 0.5 mg / d for 7 weeks. In the normal control group, high-pressure sterilized peanut oil was intramuscularly injected at a dose of 0.2 mL on Mondays, Wednesdays, and Fridays every week for 20 weeks.

[0063] Experimental method

[0064] In the 11th week, the extract powders prepared in Examples 1 - 3 were respectively given to the rats in Example 1 - 3 groups, and the extract powders prepared in Comparative Examples 1 - 5 were respectively given to the rats in Comparative Examples 1 - 5 groups, all by gavage at a dose of 4.5 g / kg·d; the normal control group and the model group were only given an equal amount of normal saline by gavage; each dosing group was administered once a day for 10 consecutive weeks. At the end of the 10th week of medication, the rats were intraperitoneally anesthetized with sodium pentobarbital at a dose of 30 mg / kg, a midline cervical incision was made, blood was taken from the carotid artery, centrifuged at 2000 r / min for 10 min, the supernatant was taken and stored at -20 °C for estradiol and progesterone detection. The uterus was removed and weighed, and the uterine coefficient was calculated by dividing the uterine weight by the body weight of the rat. The maximum diameters at the cervix and uterine body were measured.

[0065] Detection indexes

[0066] 1. General indicators: The uterine coefficient is calculated by dividing the uterine weight by the body weight of the rats. At the same time, the maximum diameters at the cervix and uterine body are measured, and the measurement results are shown in Table 1.

[0067] 2. Pathological indicators: For each PAS-stained section, the uterine diameter, uterine wall thickness, myometrium thickness, the proliferation status of uterine wall smooth muscle, the type and proliferation of endothelial cells, and the degree of inflammatory cell infiltration in the uterine wall are observed and measured under an optical microscope (×200). The proliferation and hypertrophy status of uterine wall smooth muscle are marked as +, ++, +++, ++++ from mild to severe, and scored as 1 point, 2 points, 3 points, 4 points respectively. For those with uterine wall dilation and muscle cell atrophy, they are scored according to the degree of atrophy from mild to severe. The scores of each group are accumulated, and x±sd is calculated. The higher the score, the more severe the proliferation of uterine smooth muscle. See Table 2.

[0068] 3. Biochemical indicators: Estradiol and progesterone are detected by radioimmunoassay. Taking P < 0.05 as the sign of significant difference, the statistical results of the experimental data are shown in Table 2.

[0069] Table 1 Comparison of uterine coefficients, cervical diameters, and uterine body diameters of rats in each group (x±sd)

[0070] Group Quantity Uterus Coefficient (%) Cervical Diameter (cm) Uterine Body Diameter (cm) Normal Control Group 10 0.44±0.25 0.62±0.16 0.38±0.94 Model Group 10 <![CDATA[4.32±1.46 * > <![CDATA[1.58±0.78 * > <![CDATA[1.97±0.42 * > Example 1 Group 10 <![CDATA[0.83±2.34 # > <![CDATA[0.58±0.37 # > <![CDATA[0.52±0.51 # > Example 2 Group 10 <![CDATA[1.95±1.68 # > <![CDATA[0.61±0.22 # > <![CDATA[0.67±0.23 # > Example 3 Group 10 <![CDATA[1.56.±2.27 # > <![CDATA[0.59±0.23 # > <![CDATA[0.55±0.28 # > Comparative Example 1 Group 10 3.82±1.23 0.97±0.46 1.11±0.34 Comparative Example 2 Group 10 3.55.±0.77 0.93±0.57 0.92±0.62 Comparative Example 3 Group 10 3.26±2.41 0.86±0.34 0.83±0.37 Comparative Example 4 Group 10 2.81±1.68 0.82±0.28 0.78±0.46 Comparative Example 5 Group 10 <![CDATA[2.47±2.64 # > <![CDATA[0.79±0.37 # > <![CDATA[0.74±0.64 # >

[0071] Compared with the normal group, * P < 0.05; compared with the model group, # P < 0.05.

[0072] As can be seen from Table 1, compared with the normal control group, the uterine coefficient, cervical diameter, and uterine body diameter in the model group increased, and the difference was statistically significant (P < 0.05), indicating that the model was successfully established. In Examples 1 - 3 of the present invention, the uterine coefficient, cervical diameter, and uterine body diameter of rats could be reduced, and compared with the model group, it was statistically significant (P < 0.05), indicating that the pharmaceutical composition of the present invention had a significant effect on the uterine coefficient, cervical diameter, and uterine body diameter of rats with uterine fibroids. Moreover, compared with the comparative example group, the experimental example group of the present invention could significantly reduce the uterine coefficient, cervical diameter, and uterine body diameter, and each component of the traditional Chinese medicine composition of the present invention had a synergistic effect in the treatment of uterine fibroids.

[0073] Table 2 Comparison of changes in uterine pathology and hormone levels of rats in each group (mean±sd)

[0074] Group Quantity Degree of Uterine Smooth Muscle Hyperplasia Estradiol (pg / mL) Progesterone (ng / mg) Normal Control Group 10 4.61±1.26 20.22±10.68 13.54±7.43 Model Group 10 <![CDATA[1.47±0.64 * > <![CDATA[26.45±11.21 * > <![CDATA[6.87±4.23 * > Example 1 Group 10 <![CDATA[0.78±1.92 # > <![CDATA[18.26±7.62 # > <![CDATA[5.31±7.64 # > Example 2 Group 10 <![CDATA[0.83±1.18 # > <![CDATA[20.68±12.37 # > <![CDATA[5.79±6.36 # > Example 3 Group 10 <![CDATA[0.91±0.34 # > <![CDATA[19.43±10.26 # > <![CDATA[5.88.±8.13 # > Comparative Example 1 Group 10 2.51±0.67 26.12±12.45 6.41±3.68 Comparative Example 2 Group 10 2.48±1.53 25.37±13.41 6.29±4.71 Comparative Example 3 Group 10 2.13±1.72 24.64±15.69 6.24±3.54 Comparative Example 4 Group 10 1.92±1.63 23.98±11.37 6.13±3.26 Comparative Example 5 Group 10 1.88±0.89 23.24±9.88 6.06±4.29

[0075] Compared with the normal group, * P < 0.05; compared with the model group, # P < 0.05.

[0076] As can be seen from Table 2, in Examples 1 to 3 of the present invention, the degree of uterine smooth muscle hyperplasia can be significantly reduced, and the contents of estradiol and progesterone can be decreased, indicating that the pharmaceutical composition of the present invention has a certain therapeutic effect on uterine fibroids.

[0077] In summary, it shows that the components of the traditional Chinese medicine composition of the present invention have a synergistic effect in the treatment of uterine fibroids. The composition of the present invention exerts its curative effect through the synergistic action of various functions such as promoting blood circulation to remove blood stasis, softening hardness and dissipating stasis, regulating qi and strengthening the spleen, and replenishing qi and consolidating the root, so as to achieve the purpose of treating uterine fibroids.

Claims

1. A pharmaceutical composition for treating uterine fibroids, characterized in that: The invention comprises the following raw materials in parts by weight: 10-30 parts by weight of salvia miltiorrhiza, 10-20 parts by weight of zedoaria, 5-15 parts by weight of peach kernel, 3-10 parts by weight of panax notoginseng, 9-15 parts by weight of cyperus rotundus, 10-20 parts by weight of fritillaria thunbergii, 15-30 parts by weight of raw oyster, 10-20 parts by weight of selfheal, 10-20 parts by weight of atractylodes macrocephala, 10-25 parts by weight of poria, 15-30 parts by weight of astragalus, and 5-10 parts by weight of liquorice.

2. The pharmaceutical composition according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 15-25 parts by weight of salvia miltiorrhiza, 10-15 parts by weight of zedoaria, 9-12 parts by weight of peach kernel, 3-8 parts by weight of panax notoginseng, 9-12 parts by weight of cyperus rotundus, 10-15 parts by weight of fritillaria thunbergii, 20-30 parts by weight of raw oyster, 10-15 parts by weight of selfheal, 10-15 parts by weight of atractylodes macrocephala, 10-15 parts by weight of poria, 20-30 parts by weight of astragalus, and 6-8 parts by weight of liquorice.

3. The pharmaceutical composition according to claim 2, characterized in that: The invention comprises the following raw materials in parts by weight: 20 parts by weight of salvia miltiorrhiza, 15 parts by weight of curcuma zedoaria, 10 parts by weight of peach kernel, 6 parts by weight of panax notoginseng, 10 parts by weight of cyperus rotundus, 15 parts by weight of thunbergii bulbs, 25 parts by weight of raw oyster, 18 parts by weight of selfheal, 15 parts by weight of atractylodes macrocephala, 20 parts by weight of poria, 25 parts by weight of astragalus, and 6 parts by weight of liquorice.

4. The method for preparing the pharmaceutical composition according to any one of claims 1 to 3, characterized in that: The steps include: a. Weigh the raw materials according to the prescription, remove impurities, and soak the radix salviae miltiorrhizae, zedoariae, persicae, notoginseng, cyperus rotundus, fritillariae thunbergii, herba prunellae, atractylodes macrocephalae, poria, astragalus, and licorice in water; b. Add water to the raw oysters and boil them; c. Pour the boiled raw oysters and the decoction into the medicinal materials soaked in step a, continue to boil, filter, concentrate to extract, and dry to obtain extract powder.

5. The method for preparing the pharmaceutical composition according to claim 4, characterized in that: In step a, the soaking time is 30 to 60 minutes.

6. The method for preparing the pharmaceutical composition according to claim 4, characterized in that: In step b, the decocting time is 20 to 30 minutes.

7. The method for preparing the pharmaceutical composition according to claim 4, characterized in that: In step c, decoct 2 to 3 times, each time for 1 to 2 hours.

8. The method for preparing the pharmaceutical composition according to claim 4, characterized in that: In step c, the extract is concentrated to a relative density of 1.10 to 1.20 at 60°C.

9. Use of the pharmaceutical composition according to any one of claims 1 to 3 in the preparation of a drug for treating uterine fibroids.

10. The use according to claim 9, characterized in that: The medicine for treating uterine fibroids is composed of the medicine composition and a pharmaceutically acceptable carrier.