CN102671152B

CN102671152B - Traditional Chinese medicine compound preparation for treating endometriosis and preparation method of traditional Chinese medicine compound preparation

Info

Publication number: CN102671152B
Application number: CN201110060156.5A
Authority: CN
Inventors: 齐聪; 周华
Original assignee: Shuguang Hospital Affiliated to Shanghai University of TCM
Current assignee: Shuguang Hospital Affiliated to Shanghai University of TCM
Priority date: 2011-03-11
Filing date: 2011-03-11
Publication date: 2014-11-26
Anticipated expiration: 2031-03-11
Also published as: CN102671152A

Abstract

The invention belongs to the field of traditional Chinese medicine and relates to a traditional Chinese medicine compound preparation for treating endometriosis and a preparation method of the traditional Chinese medicine compound preparation. According to the traditional Chinese medicine compound preparation, medicine auxiliary materials and extracts of raw material medicine such as astragali radix, cistanche, scabrousstem greenbrier rhizome, salvia chinensis, climbing fig receptacle, cowherb seed, curcuma zedoary, baked ginger, soft-shelled turtle, Chinese polyphaga and leech are prepared into the traditional Chinese medicine compound preparation for treating endometriosis and solid or liquid oral dosage forms of the compound preparation. Animal experiment results show that the compound preparation can obviously reduce the inhibitor of apoptosis protein bc1-2 content and can improve the apoptosis promoting protein bax content, so the bc1-2/bax ratio is reduced, and the ectopic endometrium apoptosis is promoted. Clinical experiment results show that the compound preparation has the effect of shortening the ovarian endometrioid cysts and can be used for treating the endometriosis.

Description

Chinese medicinal compound preparation for treating endometriosis and preparation method thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, and relates to a traditional Chinese medicine compound preparation for treating endometriosis and a preparation method thereof.

Background

The prior art discloses: when endometrial tissue with growth functions appears in other parts of the body except for the uterine cavity tunica mucosa, endometriosis (EMs, for short, endometriosis) is called, wherein the ovarian invasion is most common, also called as endometrioid cyst, and accounts for about 80 percent, and the symptoms mainly include gradually aggravated dysmenorrhea, persistent lower abdominal pain, menstrual disorder, infertility and the like, and are frequently-occurring diseases and difficult diseases in the gynecological field. The pathological features of the endogenous diseases are that the ectopic intima is periodically bleeded, accompanied by the proliferation and adhesion of surrounding fibrous tissues, and purple blue solid nodules and masses are formed in the diseased region. The pathogenesis of endometriosis is not well defined, and several theories exist, such as: the theory of endometrium implantation, the theory of coelomic epithelialization, the theory of embryo remaining and the theory of lymphatic vessel metastasis, the theory of induction, immune factors, endocrine factors, etc., and the recent theory of in-situ intima determination and stem cell origin, all fail to fully explain the clinical classification of various types of EMs. Therefore, the method for treating endometriosis has certain limitations and data statistics, and hormone drugs or surgical treatment relapse within 1 year and the 5-year relapse rate is over 40 percent, which causes great physical and psychological pain and economic burden to patients, so the method has important social and economic significance for actively preventing and treating endometriosis.

However, there is no ideal therapeutic drug with specific effect and little side effect in clinic. Currently, western medicines mainly comprise hormone medicines such as GnRHA medicines, danazol, namedone, tamoxifen, mifepristone and the like, although symptoms can be temporarily relieved, the western medicines cannot radically cure the symptoms, and the practical problems of high recurrence rate after stopping the medicine, large side effect, high cost and the like of the hormone medicines cause difficulty in acceptance of patients.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provides a traditional Chinese medicine compound preparation for treating endometriosis and a preparation method thereof. The traditional Chinese medicine compound preparation has good curative effect on endometriosis.

The invention also aims to provide a preparation method of the traditional Chinese medicine compound preparation for treating endometriosis.

The invention adopts the extracts of the following traditional Chinese medicinal materials to prepare the compound preparation for treating endometriosis.

The compound preparation comprises the following raw medicinal materials: raw astragalus root, broomrape, turtle shell, Siberian cocklebur, Chinese sage herb, wood steamed bread, wood louse, leech, seed of cowherb, zedoary and baked ginger.

The weight/weight ratio of the raw medicinal materials is as follows: 10-30% of raw astragalus membranaceus, 3-15% of cistanche, 3-15% of roasted turtle shell, 3-15% of polyporus ferroportinus, 3-15% of Chinese sage herb, 3-15% of wood steamed bun, 3-15% of ground beetle, 1-10% of leech, 3-15% of cowherb seed, 8-25% of curcuma zedoary and 1-10% of roasted ginger.

The invention adopts the extracts of the traditional Chinese medicinal materials and adds medicinal auxiliary materials to prepare oral solid preparations such as granules, tablets, capsules, effervescent tablets and the like.

The auxiliary materials used for forming the preparation comprise dextrin, lactose, sodium bicarbonate, citric acid, hydroxymethyl starch sodium, superfine silica gel powder, starch, soluble starch and magnesium stearate which are medicinal specification auxiliary materials.

The quality of the traditional Chinese medicine materials (except that the turtle shell, the ground beetle, the leech and the baked ginger are in accordance with the processing specification of the Shanghai city medicines (1994 version)) adopted by the invention is in accordance with the relevant regulations under the corresponding medicinal material item of the first part of the Chinese pharmacopoeia in 2005. Wherein,

the radix astragali is root of Astragalus membranaceus (Fisch.) Bge. belonging to Leguminosae perennial herbaceous plant, Astragalus membranaceus (Fisch.) Bge.

Cistanche deserticola is succulent stem with scaly leaves of Cistanche deserticola Y.C.Ma which is a year-old parasitic herb of Orobanchaceae.

The carapax Trionycis preparata is the dorsal scale of Trionyx sinensis Wiegmann of Trionychidae.

The rhizoma Smilacis Glabrae is rhizome of Smilax china L.

The herba Salviae chinensis is whole plant of Salvia chinensis Benth.

The wood steamed bread is stem and leaf of Ficus pumila Linn of Moraceae.

The Eupolyphaga Seu Steleophaga is female dry body of Eupolyphagasinensis Walker or Steleophaga plancyi (Boleny) belonging to family Trionychidae.

The Hirudo is the whole body of Whitman, Whitmania pigra Whitman, Whitman or Whitman W.aurantiaca Whitman of Whitmania pigra of Annelida.

Vaccaria segetalis (Neck.) Garke mature seed of annual or perennial herb of Dianthus vaccia of Dianthus family.

The Curcumae rhizoma is rhizome of Curcuma zedoaria Curcuma phaeocaulis Val, Curcuma kwangsiensis C.kwangsiensis S.Lee et C.F.Liang or Curcuma wenyujin C.wenyujin Y.H.Chen et C.Ling.

The baked ginger is a dried old root processed product of ginger.

The invention provides a preparation method of the traditional Chinese medicine compound preparation.

The invention is prepared by the following method:

weighing eight medicines of raw astragalus, cistanche, Indian bread with iron thorns, Chinese sage herb, wood steamed bread, cowherb seed and rhizoma zedoariae baked ginger according to a formula, and adding ethanol for extraction for 3 times, wherein the extraction lasts for 1-2 hours each time; decocting and extracting roasted turtle shells, ground beetles and leeches, namely soaking the roasted turtle shells, the ground beetles and the leeches in water for 1 hour, adding 8-10 times of the water, extracting for three times, concentrating a water extracting solution to the relative density of 1.08-1.12, and then carrying out purification treatment, wherein the purification method can be an ethanol precipitation method, a centrifugation method or a chitosan clarification method; mixing the above ethanol extract and water extract, mixing, adding adjuvant, and making into solid or liquid oral dosage form by the following method: mixing the above extracts, adding dextrin, spray drying to obtain fine powder, and granulating by dry method to obtain granule; or adding sodium hydroxymethyl starch, silica gel micropowder, soluble starch, lactose, and magnesium stearate, mixing, and making into granule with 95% ethanol; drying and tabletting; adding appropriate amount of silica gel micropowder, mixing, and making into capsule; or adding citric acid and starch into part of the fine powder to make granule; adding sodium bicarbonate and starch into the rest fine powder, and granulating. Adding magnesium stearate into the two granules, mixing, and tabletting.

The results of animal experiments show that the compound preparation: can obviously reduce the content of the apoptosis inhibiting protein bcl-2 and increase the content of the apoptosis promoting protein bax, thereby reducing the ratio of bcl-2/bax and promoting the ectopic intimal apoptosis, and the effect is better than that of a contrast medicament (danazol). Table 1 shows the changes in the ectopic intima tissue bcl-2/bax of each group of EMs model rats

TABLE 1

Note: p < 0.01, P < 0.05, vs model group; # P < 0.01, vs danazol group.

The clinical test result shows that the compound preparation comprises the following components: can reduce endometrioid cyst of ovary, and has therapeutic effect on contrast drug such as Daphne (GnRHA). TABLE 2 Change in maximum radial line before and after endometrioid ovarian treatment

TABLE 2

Note: p < 0.05, vs pre-treatment.

Detailed Description

Example 1

Taking the traditional Chinese medicinal materials in a formula amount, wherein the weight/weight ratio of the traditional Chinese medicinal materials is as follows: 15% of raw astragalus root, 10% of cistanche, 10% of polyporus sibiricus, 10% of Chinese sage herb, 10% of wood steamed bun, 10% of cowherb seed, 10% of curcuma zedoary, 5% of baked ginger, 10% of baked turtle shell, 5% of ground beetle and 5% of leech; wherein the eight medicines of raw astragalus root, desertliving cistanche, Indian bread with iron thorn, Chinese sage herb, wood steamed bread, cowherb seed and rhizoma zedoariae are extracted by adding ethanol for 3 times, and each extraction is carried out for 2 hours; decocting and extracting roasted turtle shells, ground beetles and leeches, namely soaking the roasted turtle shells, the ground beetles and the leeches in water for 1 hour, adding 10 times of water, extracting for three times, concentrating a water extracting solution to the relative density of 1.08-1.12, and purifying by adopting an ethanol precipitation method, a centrifugation method or a chitosan clarification method; mixing the above ethanol extract and water extract, mixing, drying, adding adjuvant, and making into solid or liquid oral dosage form.

The preparation formulation is prepared by adopting the following preparation method: mixing the extracts, adding dextrin, spray drying to obtain fine powder, and granulating by dry method to obtain granule; or adding sodium hydroxymethyl starch, silica gel micropowder, soluble starch, lactose, and magnesium stearate, mixing, and making into granule or tablet with 95% ethanol; or adding appropriate amount of silica gel micropowder, mixing, and making into capsule; or adding citric acid and starch into part of the fine powder, granulating, adding sodium bicarbonate and starch into the rest fine powder, granulating, adding magnesium stearate into the two granules, mixing, and tabletting.

Example 2

Taking the traditional Chinese medicinal materials in a formula amount, wherein the weight/weight ratio of the traditional Chinese medicinal materials is as follows: 15% of raw astragalus root, 10% of cistanche, 10% of polyporus sibiricus, 10% of Chinese sage herb, 10% of wood steamed bun, 10% of cowherb seed, 10% of curcuma zedoary, 5% of baked ginger, 10% of baked turtle shell, 5% of ground beetle and 5% of leech;

wherein the eight medicines of raw astragalus root, desertliving cistanche, Indian bread with iron thorn, Chinese sage herb, wood steamed bread, cowherb seed and rhizoma zedoariae are extracted by adding ethanol for 3 times, and each extraction time is 1.5 hours; decocting and extracting roasted turtle shells, ground beeltles and leeches, namely soaking the roasted turtle shells, the ground beeltles and the leeches in water for 1 hour, adding 8 times of water, extracting for three times, concentrating a water extracting solution to the relative density of 1.08-1.12, and purifying by adopting an ethanol precipitation method, a centrifugation method or a chitosan clarification method; mixing the above ethanol extract and water extract, mixing, drying, adding adjuvant, and making into solid or liquid oral dosage form.

Example 3

Taking the traditional Chinese medicinal materials in a formula amount, wherein the weight/weight ratio of the traditional Chinese medicinal materials is as follows: 15% of raw astragalus root, 10% of cistanche, 10% of polyporus sibiricus, 10% of Chinese sage herb, 10% of wood steamed bun, 10% of cowherb seed, 10% of curcuma zedoary, 5% of baked ginger, 10% of baked turtle shell, 5% of ground beetle and 5% of leech; wherein the eight medicines of raw astragalus root, desertliving cistanche, Indian bread with iron thorn, Chinese sage herb, wood steamed bread, cowherb seed and rhizoma zedoariae are extracted by adding ethanol for 3 times, and each extraction is carried out for 1 hour; decocting and extracting roasted turtle shells, ground beeltles and leeches, namely soaking the roasted turtle shells, the ground beeltles and the leeches in water for 2 hours, adding 10 times of water, extracting for three times, concentrating a water extracting solution to the relative density of 1.08-1.12, and purifying by adopting an ethanol precipitation method, a centrifugation method or a chitosan clarification method; mixing the above ethanol extract and water extract, mixing, drying, adding adjuvant, and making into solid or liquid oral dosage form.

Claims

1. A traditional Chinese medicine compound preparation for treating endometriosis is characterized by being prepared from the following extracts of raw material medicines in weight/weight ratio and medicinal auxiliary materials: 10-30% of raw astragalus membranaceus, 3-15% of cistanche, 3-15% of roasted turtle shell, 3-15% of polyporus ferroportinus, 3-15% of Chinese sage herb, 3-15% of wood steamed bun, 3-15% of ground beetle, 1-10% of leech, 3-15% of cowherb seed, 8-25% of curcuma zedoary and 1-10% of baked ginger;

is prepared by the following method: taking eight Chinese medicinal materials of raw astragalus, cistanche, polyporus iron-spine, Chinese sage herb, wood steamed bun, cowherb seed, zedoary and baked ginger according to a formula amount, adding ethanol for extraction for 3 times, extracting for 1.5 hours each time, decocting and extracting roasted turtle shell, ground beeltle and leech, namely soaking the roasted turtle shell, the ground beeltle and the leech in water for 1 hour, adding 8 times of water, extracting for three times, concentrating a water extracting solution to a relative density of 1.08-1.12, and purifying by adopting an ethanol precipitation method, a centrifugation method or a chitosan clarification method; mixing the above ethanol extract and water extract, mixing, drying, adding adjuvant, and making into solid or liquid oral dosage form.

2. The compound traditional Chinese medicine preparation for treating endometriosis according to claim 1, wherein the weight/weight ratio of the raw material medicines is as follows: 15% of raw astragalus root, 10% of cistanche, 10% of polyporus sibiricus, 10% of Chinese sage herb, 10% of wood steamed bun, 10% of cowherb seed, 10% of curcuma zedoary, 5% of baked ginger, 10% of baked turtle shell, 5% of ground beetle and 5% of leech.

3. The compound Chinese medicinal preparation for treating endometriosis according to claim 1, wherein the dosage form is granules, tablets or capsules.

4. The compound Chinese medicinal preparation for treating endometriosis according to claim 1, wherein the auxiliary materials are selected from dextrin, lactose, sodium bicarbonate, citric acid, sodium hydroxymethyl starch, aerosil, starch or magnesium stearate.