CN116459312A - Chinese medicinal composition, water extract, preparation for preventing and treating gynecological diseases and preparation method thereof - Google Patents
Chinese medicinal composition, water extract, preparation for preventing and treating gynecological diseases and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the technical field of traditional Chinese medicines, and discloses a traditional Chinese medicine composition for preventing and treating gynecological diseases, which comprises the following components in parts by weight: 3-7 parts of tree frog powder, 9-18 parts of white bone, 9-18 parts of gallnut, 6-15 parts of fructus kochiae, 1 part of dragon's blood, 9-15 parts of safflower, 6-15 parts of bletilla striata, 3-9 parts of brucea javanica, 12-21 parts of calendula, 12-18 parts of witch hazel and 20-40 parts of paris polyphylla. The traditional Chinese medicine composition, the water extract and the preparation thereof can be used for preparing medicines, are more friendly to human bodies, have fewer adverse reactions, have better effects of preventing and treating gynecological diseases such as bacterial vaginitis, cervicitis and the like, are not easy to relapse after treatment, can regulate the microecological balance of female vagina, inhibit the growth of mould, and can be used for assisting in pelvic floor muscle repair.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition, a water extract, a preparation and a preparation method thereof for preventing and treating gynecological diseases.
Background
Bacterial Vaginitis (BV) is a syndrome of increased vaginal secretion caused by mixed infection of gardnerella vaginalis and anaerobic bacteria, which results in imbalance of microecological balance in vagina, and white with fishy smell and pruritus vulvae. Can be divided into haemophilus vaginitis, corynebacterium vaginitis, anaerobic colpitis, gardnerella vaginitis, etc. The disease can also be transmitted through sexual contact, and the incidence rate is high in people with disordered sexual relation. The secretion smear examination can find a large number of pus balls and find pathogenic bacteria. Severe vaginitis can develop into pelvic inflammation, abnormal uterine bleeding, infertility, abortion and cervicitis.
At present, common medicines for bacterial vaginitis comprise metronidazole, mepamycin, thiamphenicol, lincomycin, ampicillin and the like. However, the above drugs have adverse reactions such as nausea, vomiting, inappetence, abdominal cramps and the like, and meanwhile, due to the application of some antibiotics, the probiotic flora of the human body is disturbed, and bacterial or mould infection is caused at other parts of the body.
Although some common lotions can solve the problems of pruritus vulvae, peculiar smell and the like in a short-term manner, the common lotions cause damage to the acid-base balance in the vagina, and in the long term, the common lotions cause aggravation of female reproductive system diseases.
Therefore, it is still necessary to find a drug for treating gynecological diseases which is more friendly to the human body and less in adverse reaction, and a drug with better curative effects for preventing and treating gynecological diseases such as bacterial vaginitis and the like is more helpful for eliminating or relieving female diseases which are afflicted with gynecological diseases such as bacterial vaginitis and the like.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide a traditional Chinese medicine composition, an aqueous extract and a preparation method thereof for preventing and treating gynecological diseases, wherein the traditional Chinese medicine composition, the aqueous extract and a preparation thereof can be used for preventing and treating the gynecological diseases such as bacterial vaginitis, and the like, and have good curative effect and difficult recurrence.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
a Chinese medicinal composition for preventing and treating gynecological diseases comprises the following components in parts by weight: 3-7 parts of tree frog powder, 9-18 parts of white bone, 9-18 parts of gallnut, 6-15 parts of fructus kochiae, 1 part of dragon's blood, 9-15 parts of safflower, 6-15 parts of bletilla striata, 3-9 parts of brucea javanica, 12-21 parts of calendula, 12-18 parts of witch hazel and 20-40 parts of paris polyphylla. In other words, in the traditional Chinese medicine composition, the weight ratio of the frog powder, the white bone, the gallnut, the fructus kochiae, the dragon's blood, the safflower, the bletilla striata, the brucea javanica, the calendula, the witch hazel and the paris polyphylla is 3-7:9-18:9-18:6-15:1:9-15:6-15:3-9:12-21:12-18:20-40 in sequence.
The traditional Chinese medicine composition for preventing and treating gynecological diseases further comprises: 6-15 parts of fructus cnidii and/or 20-40 parts of radix ginseng.
In other words, the present invention also provides a Chinese medicinal composition comprising: frog powder, white bone, chinese gall, fructus kochiae, fructus cnidii, dragon's blood, safflower, bletilla striata, brucea javanica, calendula officinalis, witch hazel and paris polyphylla; the weight ratio is 3-7:9-18:9-18:6-15:6-15:1:9-15:6-15:3-9:12-21:12-18:20-40 in turn.
The invention provides another traditional Chinese medicine composition, which comprises the following medicines: frog powder, white bone, chinese gall, fructus kochiae, dragon's blood, safflower, bletilla striata, brucea javanica, calendula officinalis, witch hazel, paris polyphylla and radix actinidiae chinensis; the weight ratio is 3-7:9-18:9-18:6-15:1:9-15:6-15:3-9:12-21:12-18:20-40:20-40 in turn.
The invention provides a further traditional Chinese medicine composition, which comprises the following medicines: frog powder, white bone, chinese gall, fructus kochiae, fructus cnidii, dragon's blood, safflower, bletilla striata, brucea javanica, calendula officinalis, witch hazel, paris polyphylla and radix actinidiae chinensis; the weight ratio is 3-7:9-18:9-18:6-15:6-15:1:9-15:6-15:3-9:12-21:12-18:20-40:20-40 in turn.
Optionally, the Chinese medicinal composition provided by the invention, wherein the weight ratio of the frog powder, the white bone, the gallnut, the fructus kochiae, the fructus cnidii, the dragon's blood, the safflower, the bletilla striata, the brucea javanica, the calendula officinalis, the witch hazel, the paris polyphylla and the cattleaf ginseng is 5:15:12:12:12:12:12:12:5:15:15:30:30
Optionally, the traditional Chinese medicine composition provided by the invention comprises tree frog powder, white bone, chinese gall, fructus kochiae, fructus cnidii, dragon's blood, safflower, bletilla striata, brucea javanica, calendula officinalis, hamamelis virginiana, paris polyphylla and radix ranunculi ternati in a weight ratio of 3:18:12:9:6:1:9:6:9:6:6:18:20:20.
Optionally, the traditional Chinese medicine composition provided by the invention comprises tree frog powder, white bone, chinese gall, fructus kochiae, fructus cnidii, dragon's blood, safflower, bletilla striata, brucea javanica, calendula officinalis, hamamelis virginiana, paris polyphylla and radix ranunculi ternati in a weight ratio of 6:12:15:6:15:1:15:15:4:12:12:40:40.
In some aspects, the traditional Chinese medicine composition provided by the invention comprises tree frog powder, white bone, chinese gall, fructus kochiae, fructus cnidii, dragon's blood, safflower, bletilla striata, brucea javanica, calendula officinalis, hamamelis virginiana, paris polyphylla and radix ranunculi ternati in a weight ratio of 6:12:15:15:15:1:15:15:4:12:12:40:40.
In some aspects, the traditional Chinese medicine composition provided by the invention comprises wood frog powder, white bone, chinese gall, fructus kochiae, dragon's blood, safflower, bletilla striata, brucea javanica, calendula officinalis, witch hazel, paris polyphylla and cattleaf ginseng in a weight ratio of 3:9:9:6:1:9:9:4:15:9:20:20.
In some aspects, the traditional Chinese medicine composition provided by the invention comprises the following components of tree frog powder, white bone, chinese gall, fructus kochiae, fructus cnidii, dragon's blood, safflower, bletilla striata, brucea javanica, calendula officinalis, witch hazel and paris polyphylla in a weight ratio of 7:12:18:6:12:1:10:9:3:21:12:30.
The invention also provides an aqueous extract of the traditional Chinese medicine composition for preventing and treating gynecological diseases.
In some aspects, the aqueous extract of the traditional Chinese medicine composition as described above is extracted at least 1, 2, 3 or 4 or more times by water decoction, preferably 2 or 3 times by water decoction.
The invention also provides a traditional Chinese medicine composition preparation for preventing and treating gynecological diseases, which is prepared by mixing the water extract of the traditional Chinese medicine composition with a carrier acceptable in treatment; preferably, the therapeutically acceptable carrier is selected from one or more of diluents, lubricants, binders, disintegrants, sweeteners, stabilizers, preservatives, and the like.
In some aspects, a formulation of a traditional Chinese medicine composition as described above is formulated into a hydrogel formulation, an ointment formulation, a suppository, a tablet, a pill, a tincture, a spray or a disintegrant after being mixed with the therapeutically acceptable carrier.
The invention also provides the use of the traditional Chinese medicine composition, the water extract of the traditional Chinese medicine composition or the traditional Chinese medicine composition preparation in the preparation of medicines for preventing or treating bacterial vaginitis or cervicitis.
The invention also provides a preparation method of the water extract of the traditional Chinese medicine composition, which comprises the following steps:
a. weighing and mixing the Chinese medicinal composition according to the above description, and adding into an extraction container;
b. adding purified water according to the weight ratio of the traditional Chinese medicine composition to water of 1:3-1:10 (such as 1:3.5, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9, 1:9.5 and the like), soaking for 30 minutes at normal temperature (approximately 20-25 ℃, such as 20.5 ℃, 21 ℃, 22 ℃, 23 ℃, 24 ℃, 24.5 ℃ and the like), boiling with strong fire, decocting with slow fire for about 25 minutes, and filtering to obtain filtrate;
c. adding purified water into the medicinal filter residues according to the weight ratio of the Chinese medicinal composition to water of 1:3-1:10 (such as 1:3.5, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9, 1:9.5 and the like), boiling with strong fire, decocting with slow fire for about 20 minutes, and filtering to obtain filtrate; repeating step c 0 times, 1 time or 2 times;
d. mixing and concentrating the filtrate obtained in the step b and the step c, wherein the concentration volume value is about 100 times of the weight of the dragon's blood, and refrigerating to obtain the water extract of the traditional Chinese medicine composition, and the concentration volume value is expressed as ml.
Compared with the prior art, the invention has the following beneficial effects:
1) The traditional Chinese medicine composition, the water extract thereof and the preparation thereof can be used for preparing medicines, are more friendly to human bodies, have fewer adverse reactions, have better effects of preventing and treating gynecological diseases such as bacterial vaginitis and the like, and are beneficial to eliminating the puzzles of the gynecological diseases such as bacterial vaginitis and the like;
2) The Chinese medicinal composition, water extract thereof and preparation thereof can be used for assisting pelvic floor muscle repair;
3) The Chinese medicinal composition and its water extract and preparation can regulate female vaginal microecology balance, and inhibit mold growth;
4) The Chinese medicinal composition is not easy to relapse after treatment.
Detailed Description
In order that the invention may be more readily understood, certain technical and scientific terms are defined below. Unless defined otherwise herein, all other technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
A frog powder, also called as urine stick (Gravenhorst), is also called as color-changing frog (Xue Deshang, system animal science), green bamboo stick (Luchuan materia Medica), and Buddha frog (China animal atlas. Amphibian). The habitat is distributed in Sichuan, jiangsu, zhejiang, jiangxi, guizhou, fujian, guangdong, guangxi, yunnan, taiwan and other places. The product is prepared from whole Rana nigromaculata of Rana, oven drying Rana nigromaculata, grinding into powder, and sieving. According to the record of the Chinese medicine dictionary, the function main indications of the urination crutch are as follows: treating traumatic hemorrhage, traumatic injury and fracture. According to the records of Luchuan herbal medicine: salty, slightly cold, bone setting. Treating traumatic injury and fracture.
White bone (Asystasiella neesiana (wall.) Lindau, asystasiella chinensis (S.Moore) E.Hossain [ Asystasia chinensis S.Moore ]), also known as Yulong dish, boehmeria nivea, scutellaria barbata (Baicaomirror), yuzhu Cheng, yuqian Cao, eucheuma Gelatinosum, yulian (Lintei), jielian, jiangjiegu, jiang river folk Chinese herbal medicine, rubber grass (Jiangxi Zhongcao pharmaceutical), which is the root and stem of white bone or whole grass of Acanthaceae. According to the record of the Chinese medicine Dathesaurus, the white bone has sweet and light taste and flat nature; the main functions are as follows: hemostasis, removing blood stasis, clearing heat and detoxicating; for hematemesis, hematochezia, traumatic hemorrhage, sprain, furuncle, swelling and sore throat. The main functions are as follows: removing blood stasis and stopping bleeding; reunion of fractured bones; induce diuresis to alleviate edema; clear away heat and toxic materials. Main hematemesis; hematochezia; traumatic hemorrhage; stasis and swelling caused by traumatic injury; sprain fracture; rheumatic limb swelling; ascites; sores and ulcers; furuncle; swelling; sore throat. In addition, according to the record of Chinese herbal medicine assembly, the main functions are as follows: clearing away heat and toxic materials, removing blood stasis, stopping bleeding, and promoting urination; can be used for treating pulmonary tuberculosis, sore throat, diabetes, and ascites; it is used for treating traumatic hemorrhage, sprain, and furuncle.
Galla chinensis, which is a insect gall on leaves of Rhus chinensis (Rhus chinensis Mill.), rhus poninii maxim, or Rhus punjabensis Stew. Var. Sinica (Diels) Rehd. Et Wils, is mainly formed by parasitism of Rhus chinensis aphid (Melaphis chinensis (Bell) Baker). Distributed in Sichuan, guizhou, yunnan, shaanxi, guangxi and other places. According to the records of Chinese pharmacopoeia (2020), the Chinese gall is sour and astringent in taste and cold in nature, and enters lung, large intestine and kidney channels; the functions and the main indications are as follows: astringing lung to reduce fire, astringing intestine to check diarrhea, arresting sweating, stopping bleeding, astringing dampness and astringing sores; can be used for treating cough due to lung deficiency, cough due to lung heat and phlegm, chronic diarrhea and dysentery, spontaneous perspiration and night sweat, diabetes, hematochezia, hemorrhoid, traumatic hemorrhage, carbuncle, swelling, and skin ulcer.
Kochia scoparia (L.) is the dried mature fruit of Kochia scoparia (L.) Schrad.) belonging to Chenopodiaceae. Harvesting plants in autumn when the fruits are ripe, sun-drying, beating the fruits, and removing impurities. According to the records of Chinese pharmacopoeia (2020), kochiae fructus is pungent and bitter in taste and cold in nature, enters kidney and bladder meridians; the functions and the main indications are as follows: clearing heat and promoting diuresis, dispelling wind and relieving itching; can be used for relieving pain, pudendum itch, leukorrhagia, rubella, eczema, and skin pruritus.
Fructus Cnidii is a dried mature fruit of Cnidium monnieri (L.) of Umbelliferae. Distributed in the east, south and middle China, south and west, northwest, north and northeast China, etc. According to the records of Chinese pharmacopoeia (2020), fructus Cnidii is pungent and bitter in taste and warm in nature and enters kidney meridian; has effects of eliminating dampness, dispelling pathogenic wind, killing parasites, relieving itching, warming kidney, and supporting yang; it is commonly used for pruritus vulvae, leukorrhagia, eczema, pruritus, damp arthralgia, lumbago, impotence due to kidney deficiency, cold womb and infertility.
Sanguis Draxonis is prepared from resin exuded from fruit of sanguis Draxonis (Daemonoroptsdaco Bl.) of caulis Fibraureae of Palmae. Distributed in Indonesia Java, su Men Fang, etc. According to the records of Chinese pharmacopoeia (2020), the dragon's blood has the effects of activating blood, relieving pain, removing blood stasis, stopping bleeding, promoting granulation and healing sore; can be used for treating traumatic injury, pain of heart and abdomen, traumatic hemorrhage, and unhealed pyocutaneous disease; it is sweet and salty in flavor, neutral in nature, and enters heart and liver meridians.
Safflower, a dried flower of the asteraceae plant safflower (Carthamus tinctorius l.). The flowers are picked when the flowers turn from yellow to red, and dried in the shade or sun-dried. Cultivation is widely carried out in various places throughout the country. According to the records of Chinese pharmacopoeia (2020), safflower is pungent in taste and warm in nature, enters heart and liver meridian; the functions and the main indications are as follows: promoting blood circulation, dredging channels, removing blood stasis and relieving pain; can be used for treating amenorrhea, dysmenorrhea, lochia, abdominal mass, chest pain, abdominal pain due to stagnation, chest and hypochondrium stabbing pain, traumatic injury, and pyocutaneous disease swelling and pain.
Bletilla striata, also commonly written as Bletilla striata, also known as rhizoma coptidis, rhizoma glycyrrhizae, and the like, is a dry tuber of the orchid plant Bletilla striata (thunder.) striata. Mainly distributed in China, japan and North Burmese. According to the records of Chinese pharmacopoeia (2020), bletilla is bitter, sweet and astringent in taste and cold in nature, and enters lung, liver and stomach meridians; the functions and the main indications are as follows: astringing to stop bleeding, detumescence and promoting granulation. Can be used for treating hemoptysis, hematemesis, traumatic hemorrhage, pyocutaneous disease, toxic swelling, and chapped skin. According to the records of Chinese herbal medicine assembly, the main function of rhizoma bletillae is convergence and hemostasis, detumescence and granulation promotion. Can be used for treating hemoptysis, hematemesis, traumatic hemorrhage, pyocutaneous disease, toxic swelling, and chapped skin; tuberculosis hemoptysis, ulcer bleeding). According to the records of the Chinese medicine dictionary, the function main indications of the rhizoma bletillae are as follows: tonifying lung, stopping bleeding, detumescence, promoting tissue regeneration and healing sore. For lung injury, hemoptysis, epistaxis, golden sore, hemorrhage, carbuncle, abscess, ulcer, pain, burn due to decoction fire, and rhagadia manus et pedis. According to the description of Chinese herbal medicine, the main function of rhizoma bletillae is convergence hemostasis; detumescence and granulation promoting. Main hemoptysis; hematemesis; epistaxis blood; hematochezia; traumatic hemorrhage; carbuncle, sore and swelling; scalding and burning; rhagades of hands and feet; anal fissure).
Brucea javanica (l.) merr is a dried mature fruit of Brucea javanica (l.) of Brucea genus of family quassiaceae. Brucea javanica is distributed from southeast asia to north asia; distributed in china in the provinces of foci, taiwan, guangdong, guangxi, hainan and yunnan. In Yunnan of China, the plant is grown in the open field or foot shrubs or in the forests at the altitude of 950-1000 meters. According to the records of Chinese pharmacopoeia (2020), brucea javanica is bitter in taste, cold in nature and has little toxicity; enter large intestine and liver meridian; the functions and the main indications are as follows: clearing heat and detoxicating, checking malaria and stopping diarrhea; external use is used for corroding warts; for diarrhea, malaria; it is used for treating wart and clavus. According to the description of the Chinese medicine dictionary, the brucea javanica has the main functions of: clearing heat, drying dampness, killing parasites and detoxifying; it is indicated for diarrhea, malaria, hemorrhoid, furuncle, wart, and corn. According to the record of Chinese herbal, the main functions of the brucea javanica are as follows: clearing heat, detoxicating, killing parasites and checking malaria; diarrhea due to heat toxin, dysentery with blood, cold dysentery, resting dysentery, malaria, hemorrhoid, carbuncle, pruritus vulvae, leucorrhea, wart, and clavus.
Calendula (Calendula officinalis l.) is a two-year old herb of the family Compositae, the whole plant is pubescent. She Husheng, oblong. Yellow or orange, 4-9 months in flowering period and 6-10 months in fruit period. Is advantaged by mild and cool climate, heat resistance and cold resistance. Is native to the coastal zone of south Europe, mediterranean. Calendula is rich in multiple vitamins, especially vitamin A and vitamin C, and can prevent pigmentation, improve skin luster and elasticity, slow aging, and prevent skin from loosening and wrinkling. The calendula flower has antibacterial and antiinflammatory effects, and its polysaccharide component has strong immunostimulation effect, and can accelerate wound healing. The calendula used in the invention is the flower of calendula.
Hamamelis (Hamamelis mollis Oliver), the name Murraya paniculata, rumex, rosales, hamamelidaceae, hamamelis deciduous shrubs or small trees, up to 8 meters; the tender branch is provided with star-shaped villus; old branch baldness; the bud is oval in shape and beautiful in shape of a wide inverted oval leaf. Because of its cold-resistant ability, it is also known as "honeysuckle". The Yangtze river basin is distributed in each province. The medicament taking part of the witch hazel is the root of the witch hazel. According to the description of the schema of Xinhua Ben Cao, hamamelis mollis is sweet in nature and smell and enters spleen channels; the main functions are as follows: qi tonifying, fatigue relieving and debilitating effects.
Paris polyphylla is Paris polyphylla Paris polyphylla Smith var chinensis (Franch.) Hara or Paris polyphylla P.polyphela Smith of Paris of Liliaceae, and is used as root stem. The aliases include rhizoma paridis, lamp stand, iron lamp stand, grass-river car, white-river car, head of Paris, conch, screw, etc. According to the records of national Chinese herbal medicine assembly, 1) the taste: bitter, cool, and less toxic; 2) The main functions are as follows: clearing away heat and toxic materials, relieving swelling and pain, and treating epidemic encephalitis B, gastralgia, appendicitis, tuberculous lymphadenitis, tonsillitis, parotitis, mastitis, snake and insect bite, and pyocutaneous disease. According to the records of Chinese pharmacopoeia (2020), rhizoma paridis is bitter in taste and slightly cold in nature; the Chinese medicinal composition has small toxicity; enter liver meridian; the functions and the main indications are as follows: clearing away heat and toxic materials, relieving swelling and pain, cooling liver, and arresting convulsion; can be used for treating furuncle, carbuncle, swelling, sore throat, snake and insect bite, traumatic injury, convulsion, and convulsion.
Radix Actinidiae chinensis is root of Actinidia valvata (Actinidia valvataDunn) belonging to genus Actinidia of family Actinidiaceae. For the calyx kiwi fruits, also called tweezer kiwi fruits, are distributed in Anhui, zhejiang, jiangxi, hubei, hunan and other places. According to the records of Chinese herbal medicine assembly and Chinese medicine dictionary, mao ren Shen is bitter and astringent in taste and cool in nature; the main functions of the medicine are clearing heat and detoxicating; can be used for treating carbuncle, furuncle, abscess, female leucorrhea, and leprosy. According to the record of Chinese herbal medicine, bitter and astringent in taste, cool in nature and enters liver meridian; the main functions are as follows: clearing heat and detoxicating; detumescence. Primary respiratory tract infections; heat in summer; stagnation; carbuncle, sore and furuncle; leprosy.
The specific description of the raw materials of the traditional Chinese medicine composition can be found in Chinese pharmacopoeia (2020 edition), chinese Dathesaurus, chinese herbal medicine assembly, chinese materia medica and the like.
The invention combines the medicines, can generate synergistic effect of the efficacy of each medicine, has better prevention and treatment effects on gynecological diseases such as bacterial vaginitis, cervicitis and the like, and is not easy to relapse after healing.
The preparation method of the water extract of the traditional Chinese medicine composition comprises the following steps:
a. weighing and mixing the Chinese medicinal composition according to the above description, and adding into an extraction container;
b. adding purified water into the traditional Chinese medicine composition obtained in the step a according to the weight ratio of 1:3-1:10, soaking for 30 minutes at normal temperature (20-25 ℃), boiling with strong fire, decocting with slow fire for about 25 minutes, and filtering to obtain filtrate;
c. adding purified water into the medicine filter residue according to the weight ratio of the traditional Chinese medicine composition obtained in the step a to water of 1:3-1:10, boiling with strong fire, decocting with slow fire for about 20 minutes, filtering to obtain filtrate, and repeating the step c for 0 times, 1 time or 2 times;
d. mixing and concentrating the filtrate obtained in the step b and the step c, wherein the concentration volume value is about 100 times of the weight of the dragon's blood, and the water extract of the traditional Chinese medicine composition is obtained, and the concentration volume value is expressed in ml.
The concentrated stock solution is prepared through decompression drying, crushing, adding volatile oil excipient powder and mannitol as supplementary material, mixing, pelletizing, drying, pelletizing and packing. The Chinese medicinal composition preparation is added with one or more of diluent, lubricant, binder, disintegrating agent, sweetener, stabilizer, antiseptic, etc.
The concentration method and the drying method used are any methods available in the art, for example, vacuum concentration or reduced pressure concentration at ordinary temperature, for example, spray drying or freeze drying.
The method of separating the filtrate from the residue may be any method available in the art, such as filtration or centrifugation.
The invention also provides the use of the traditional Chinese medicine composition, the water extract of the traditional Chinese medicine composition or the traditional Chinese medicine composition preparation in the preparation of medicines for preventing or treating bacterial vaginitis or cervicitis.
The invention is further described below in connection with examples, which are not intended to limit the scope of the invention. The experimental method without specific conditions being noted in the examples of the present invention is generally carried out according to conventional conditions and methods, such as hydrogel preparation, ointment preparation, suppository, tablet, pill, tincture, spray or disintegrant, in particular, can be prepared according to conventional methods for external use of human medicine; the hydrogel, ointment, suppository preparation methods described herein are not limiting as to the formulation of application of the compositions of the present invention; the raw materials or reagents used are in accordance with the conditions recommended by the manufacturer of the raw materials or goods. The reagents of specific origin are not noted and are commercially available conventional reagents.
The strong fire is the strong fire in the traditional Chinese medicine decoction field, and can be used for heating the liquid medicine to severe boiling; the slow fire in the invention is slow fire in the traditional Chinese medicine decoction field, and can keep the liquid medicine slightly boiling.
Example 1 preparation of concentrated stock solution of aqueous extract of Chinese medicinal composition
Experimental example 1
5g of tree frog powder, 15g of white bone, 12g of Chinese gall, 12g of fructus kochiae, 12g of fructus cnidii, 1g of dragon's blood, 12g of safflower, 12g of bletilla striata, 5g of brucea javanica, 15g of calendula officinalis, 15g of witch hazel, 30g of paris polyphylla and 30g of radix actinidiae chinensis. Adding 1L of purified water, soaking for 30 minutes at normal temperature (20-25 ℃), boiling with strong fire, decocting with slow fire for 25 minutes, sterilizing, and filtering to obtain filtrate for later use; adding 800ml purified water into the filter residue, boiling with strong fire, decocting with slow fire for 20min, sterilizing, and filtering to obtain filtrate. Mixing the two filtrates, concentrating to obtain 100ml concentrated stock solution 1, and refrigerating.
Experimental example 2
Taking 3g of tree frog powder, 18g of white bone, 12g of Chinese gall, 9g of fructus kochiae, 6g of fructus cnidii, 1g of dragon's blood, 9g of safflower, 6g of bletilla striata, 9g of brucea javanica, 6g of calendula officinalis, 18g of witch hazel, 20g of paris polyphylla and 20g of radix actinidiae chinensis. Adding 1L of purified water, soaking for 30 minutes at normal temperature (20-25 ℃), boiling with strong fire, decocting with slow fire for 25 minutes, sterilizing, and filtering to obtain filtrate for later use; adding 800ml purified water into the filter residue, boiling with strong fire, decocting with slow fire for 20min, sterilizing, and filtering to obtain filtrate. Mixing the two filtrates, concentrating to obtain 100ml concentrated stock solution 2, and refrigerating.
Experimental example 3
6g of tree frog powder, 12g of white bone, 15g of Chinese gall, 6g of fructus kochiae, 15g of fructus cnidii, 1g of dragon's blood, 15g of safflower, 15g of bletilla striata, 4g of brucea javanica, 12g of calendula officinalis, 12g of witch hazel, 40g of paris polyphylla and 40g of radix actinidiae chinensis. Adding 1L of purified water, soaking for 30 minutes at normal temperature (20-25 ℃), boiling with strong fire, decocting with slow fire for 25 minutes, sterilizing, and filtering to obtain filtrate for later use; adding 800ml purified water into the filter residue, boiling with strong fire, decocting with slow fire for 20min, sterilizing, and filtering to obtain filtrate. Mixing the two filtrates, concentrating to obtain 100ml concentrated stock solution 3, and refrigerating.
Experimental example 4
6g of tree frog powder, 12g of white bone, 15g of Chinese gall, 15g of fructus kochiae, 15g of fructus cnidii, 1g of dragon's blood, 15g of safflower, 15g of bletilla striata, 4g of brucea javanica, 12g of calendula officinalis, 12g of witch hazel, 40g of paris polyphylla and 40g of radix actinidiae chinensis. Adding 1L of purified water, soaking for 30 minutes at normal temperature (20-25 ℃), boiling with strong fire, decocting with slow fire for 25 minutes, sterilizing, and filtering to obtain filtrate for later use; adding 800ml purified water into the filter residue, boiling with strong fire, decocting with slow fire for 20min, sterilizing, and filtering to obtain filtrate. Mixing the two filtrates, concentrating to obtain 100ml concentrated stock solution 4, and refrigerating.
Experimental example 5
Taking 3g of tree frog powder, 9g of white bone, 9g of Chinese gall, 6g of fructus kochiae, 1g of dragon's blood, 9g of safflower, 9g of bletilla striata, 4g of brucea javanica, 15g of calendula officinalis, 9g of witch hazel, 20g of paris polyphylla and 20g of radix actinidiae chinensis. Adding 1L of purified water, soaking for 30 minutes at normal temperature (20-25 ℃), boiling with strong fire, decocting with slow fire for 25 minutes, sterilizing, and filtering to obtain filtrate for later use; adding 800ml purified water into the filter residue, boiling with strong fire, decocting with slow fire for 20min, sterilizing, and filtering to obtain filtrate. Mixing the two filtrates, concentrating to obtain 100ml concentrated stock solution 5, and refrigerating.
Experimental example 6
Taking 7g of tree frog powder, 12g of white bone, 18g of Chinese gall, 6g of belvedere fruit, 12g of common cnidium fruit, 1g of dragon's blood, 10g of safflower, 9g of bletilla striata, 3g of brucea javanica, 21g of calendula, 12g of witch hazel and 30g of paris polyphylla. Adding 1L of purified water, soaking for 30 minutes at normal temperature (20-25 ℃), boiling with strong fire, decocting with slow fire for 25 minutes, sterilizing, and filtering to obtain filtrate for later use; adding 800ml purified water into the filter residue, boiling with strong fire, decocting with slow fire for 20min, sterilizing, and filtering to obtain filtrate. Mixing the two filtrates, concentrating to obtain 100ml concentrated stock solution 6, and refrigerating.
Experimental example 7
6g of tree frog powder, 12g of white bone, 15g of Chinese gall, 15g of fructus kochiae, 1g of dragon's blood, 15g of safflower, 15g of bletilla striata, 4g of brucea javanica, 12g of calendula officinalis, 12g of witch hazel and 30g of paris polyphylla. Adding 1L of purified water, soaking for 30 minutes at normal temperature (20-25 ℃), boiling with strong fire, decocting with slow fire for 25 minutes, sterilizing, and filtering to obtain filtrate for later use; adding 800ml purified water into the filter residue, boiling with strong fire, decocting with slow fire for 20min, sterilizing, and filtering to obtain filtrate. Mixing the two filtrates, concentrating to obtain 100ml concentrated stock solution 7, and refrigerating.
EXAMPLE 2 preparation of hydrogel preparation of Chinese medicinal composition
15g of glycerol, 3g of chitosan quaternary ammonium salt, 0.2g of polyhexamethylene guanidine and 80ml of different concentrated stock solutions (namely, the concentrated stock solutions 1 to 7 prepared in the embodiment 1) are weighed, purified water is added to fix the volume to 100ml, and the mixture is stirred uniformly and is kept stand for 20min, so that the traditional Chinese medicine composition hydrogel preparation (the hydrogel preparations prepared by the concentrated stock solutions 1 to 7 correspond to the hydrogel preparations 1 to 7 respectively) is obtained.
Example 3 preparation of Chinese medicinal composition ointment preparation
The concentrated stock solution obtained according to the method of example 1 was dried and pulverized into a powdery drug, diethyl ether was added to the powdery drug to carry out leaching to obtain a leaching solution, and the leaching solution was vacuum-filtered to obtain a drug filtrate. Adding methyl parahydroxybenzoate into the medicinal filtrate according to parts by weight, stirring uniformly to obtain mixed filtrate, and concentrating the mixed filtrate into thick paste in vacuum to prepare the ointment preparation.
EXAMPLE 4 preparation of suppositories of Chinese medicinal composition
The concentrated stock solution obtained in the method of example 1 was dried and pulverized into a powder (sieved with a 120 mesh sieve), 3g of borneol and 5g of borax were taken, and mixed with the above 50 g of the powder of the Chinese medicinal composition uniformly, 2g was taken and poured into a built-in tampon having one end sealed, the other end (leading end) was fastened with a thin wire, and a thread end having a length of about 10cm was left, thereby obtaining a vaginal suppository.
Example 5 animal model test of bacterial inflammation
1. Experimental animals: SPF clean class Wistar rats, females, weight 200-300g;
2. experimental materials:
the concentrated stock solutions obtained in experimental examples 1 to 7 were prepared as hydrogel formulations, i.e., hydrogel formulations 1 to 7, according to the method of example 2; comparative example 1 is a Jieeryin lotion (prepared as a hydrogel); comparative example 2 was folium Callicarpae Formosanae, boric acid, radix Sophorae Flavescentis, camphora, herba et Gemma Agrimoniae, alumen, radix Stemonae, borneolum Syntheticum, fructus Cnidii, and benzalkonium bromide, and prepared into hydrogel by the method of example 2;
aqueous hydrogels (without other drugs);
paraffin oil;
ofloxacin;
staphylococcus aureus (ATCC 25923), escherichia coli (ATCC 25922), pseudomonas aeruginosa (ATCC 27853), purchased from the department of microbiology of the chinese sciences.
3. Experimental grouping:
120 rats were randomly divided into: normal control group, model group, positive control group, experimental examples 1-7, comparative examples 1, 2, 10 each. Wherein:
the positive control group is subjected to vaginal administration of ofloxacin, and the dosage is 0.005g/kg; the vaginal administration of each of experimental examples 1-7, comparative examples 1 and 2 was performed at a dose of 0.2ml, and the administration methods of twelve groups such as positive control group, each of examples 1-7, comparative examples 1 and 2 were as follows: weighing rats respectively, calculating corresponding dosage, and then using 0.2ml volume for vaginal administration; the normal control group and the model group were each dosed with 0.2ml of aqueous hydrogel.
4. Preparation of bacterial vaginitis rat model:
resuscitates and passages 3 strains, namely Staphylococcus aureus (ATCC 25923), escherichia coli (ATCC 25922) and Pseudomonas aeruginosa (ATCC 27853), respectively, and prepares the strain into 1.5X10-concentration with sterile physiological saline 9 The bacteria liquid/mL is mixed into the infectious bacteria liquid according to the proportion of 1:1:1.
Treatment of rats in each group, except for normal control group rats: the vagina of the rat was rinsed 3 times (5 min each time) with sterile PBS (phosphate buffer solution at pH 8.5), then a 5-gauge scalp needle silicone tube was coated with sterile paraffin oil, and the solution was slowly inserted into the vagina of the rat at about 1.0cm-1.5cm, with bacterial injection amount of 0.025ml/100g per rat, 1 time per day.
After inoculation of bacteria, rats were observed daily for vaginal lesions and vaginal secretion smears were stained with color.
When the vagina of the rat is obviously engorged with blood and red swelling and is accompanied by a large amount of purulent secretion, a secretion smear is taken, and after the rats in the model group and each administration group are injected with bacteria for 5 days, a large amount of infectious bacteria and necrotic cells can be seen under the lens, which indicates that the preparation of the bacterial vaginitis model of the rat is successful.
After the appearance of typical vaginitis symptoms. Each group was given either drug therapy or aqueous hydrogel, respectively, for 14 consecutive days according to the experimental design.
2h after the last administration, the vagina is locally photographed, the vaginal swab is taken for smear color inspection, then the rat is sacrificed, the vagina tissue is fixed by 10% neutral formaldehyde, paraffin embedding, slicing and HE staining are used for pathological inspection. Rat kidneys, uterus, hearts and spleens were taken for comparison and toxicity effect detection.
5. Standard of efficacy:
and (3) healing: the appearance of the vagina is free from congestion and redness, no purulent secretion is caused, infectious bacteria and necrotic cells are not seen in smear microscopy of the vaginal swab, and the mucous membrane in the vaginal tissue section is complete and the submucosal tissue is basically normal.
Improvement: the appearance of the vagina is slightly hyperemic and red, a small amount of purulent secretion is generated, a small amount of infectious bacteria and a small amount of necrotic cells are visible by smear microscopy of the vagina swab, a small amount of defect is visible by tissue section microscopy, capillary expansion and erythrocyte increase are generated in the submucosal tissue, and a small amount of neutrophil infiltration is generated in the tissue.
Invalidation: the appearance of the vagina is engorged with blood and red swelling, a large amount of purulent secretion is generated, a large amount of infectious bacteria and necrotic cells are detected by smear microscopy of a vaginal swab, a mucous membrane is defective by microscopic examination of a vaginal tissue section, a large amount of capillary expansion and erythrocyte increase are generated in the submucosal tissue, and a large amount of neutrophil infiltration is generated.
6. Experimental results:
the experimental results are shown in Table 1.
TABLE 1 comparison of effective against bacterial vaginosis in rats
The results in Table 1 show that the model groups were all infected with bacteria and bacterial vaginitis models were successfully established. The total effective rate of vaginitis was 90-100% in rats of each of experimental examples 1-6 compared with the model group, and it was extremely significantly different (P < 0.001) compared with the model group. The total effective rate of colpitis in the rats in the experimental example 7 is 80%, and the total effective rate is extremely different from that in the model group. Compared with the comparative examples 1 and 2, the rats in the experimental groups 1 to 6 have higher effective rate of colpitis treatment and obvious difference. Compared with the comparative examples 1 and 2, the cure rates of the experimental groups 1 to 6 are significantly higher (P < 0.01). Numerically, the cure rate was higher for the experimental example 7 group than for the comparative example 1 group.
The results show that: the traditional Chinese medicine composition provided by the invention has the effect of treating bacterial vaginitis, and the effect is better than that of a comparative example group.
The size, color and pathological sections of the kidneys, uterus, heart and spleen of each group of rats are compared, wherein each organ of the rats in the experimental groups 1-7 and the rats in the comparison examples 1 and 2 is normal, and has no obvious difference from the normal control group. The vagina, kidney and uterus of the rats in the model group are obviously damaged. The positive control group rats had essentially normal organs, but showed signs of mold infection in the vagina of 2 rats, possibly related to severe disruption of normal microbial balance in the vaginal mucosa of the rats.
Example 6 clinical trial validity test
The formulation of the traditional Chinese medicine composition of experimental example 1 (5 g of frog powder, 15g of white bone, 12g of gallnut, 12g of fructus kochiae, 12g of fructus cnidii, 1g of dragon's blood, 12g of safflower, 12g of bletilla striata, 5g of brucea javanica, 15g of calendula officinalis, 15g of witch hazel, 30g of paris polyphylla and 30g of cattleaf ginseng) was selected to prepare a traditional Chinese medicine composition, and a hydrogel preparation was prepared according to the method of example 2, and used for clinical test to preliminarily test the safety and effectiveness of medicines.
All 18 cases were outpatient clinics (signed informed consent and privacy agreement) to whom applicant belongs from 1 month in 2020 to 3 months in 2020. Age 32-60 years, average 41 years, 18 cases of parturients. The control group 21 persons (retrospective cases) aged 30-65 years, average 43 years, were 21 cases past parturients.
BV diagnostic criteria: (1) vaginal secretion is homogeneous and rarefaction; (2) vaginal secretion amine test positive; (3) vaginal pH > 4.5; (4) clue cells were found. The first 3 items have 2 items, and clue cells account for more than 10% of the diagnostic.
1. The treatment method comprises the following steps:
control group: after cleaning the vulva before sleeping, 500mg of metronidazole is placed in the deep vagina, 1 time a day, and 20 days are taken as 1 course of treatment.
Treatment group: after the vulva is cleaned before sleeping, 3ml of the traditional Chinese medicine composition hydrogel of experimental example 1 is placed in the deep vagina, 1 time a day, and 20 days are taken as 1 treatment course.
2. Curative effect judgment standard: both groups of subjects were re-examined for vaginal secretion 2 weeks after 1 course of treatment and after the next menstrual cycle was clean.
And (3) healing: all 4 of the BV diagnostic criteria were negative and the clinical symptoms disappeared.
The effect is shown: only 1 of the BV diagnostic criteria were positive and clinical symptoms disappeared.
The method is effective: only 2 positive BV diagnostic criteria and significantly improved clinical symptoms.
Invalidation: 3 of BV diagnostic criteria were positive and no improvement in clinical symptoms was observed.
Table 2 comparison of total efficacy for two groups of patients
| Group of | The number of people | Healing of the wound | Has obvious effect | Effective and effective | Invalidation of | Total effective rate |
| Treatment group | 18 | 11 | 4 | 2 | 1 | 17/18 |
| Control group | 21 | 9 | 4 | 4 | 4 | 17/21 |
The results show (see Table 2) that the total effective rate of the two groups is p < 0.05, the treatment effect of the treatment group is better than that of the control group, and the cure rate (11/18) of the treatment group is obviously better than that of the control group (9/21). One of the patients in the treatment group was diagnosed with cervicitis in addition to bacterial vaginitis, and the drugs used in this example cured the patients of bacterial vaginitis and cervicitis.
3. Comparison of recurrence rates in two groups:
after 3 months, selecting a treatment group and a control group to conduct relapse rate investigation, wherein 4 persons relapse in the control group, and the relapse rate is 4/17; the treatment group had 1 person relapsed, the recurrence rate was 1/17. The recurrence rate of the treatment group was lower than that of the control group.
Claims (10)
1. A Chinese medicinal composition for preventing and treating gynecological diseases is characterized by comprising a therapeutically effective amount by weight
Frog powder, white bone, chinese gall, broom cypress fruit, dragon's blood and safflower bletilla striata, brucea javanica, calendula officinalis, witch hazel and paris polyphylla; preferably, the traditional Chinese medicine composition comprises 3-7 parts of tree frog powder, 9-18 parts of white bone, 9-18 parts of Chinese gall, 6-15 parts of fructus kochiae, 1 part of dragon's blood, 9-15 parts of safflower, 6-15 parts of bletilla striata, 3-9 parts of brucea javanica, 12-21 parts of calendula, 12-18 parts of witch hazel and 20-40 parts of paris polyphylla.
2. The traditional Chinese medicine composition for preventing and treating gynecological diseases according to claim 1, further comprising: fructus Cnidii and/or radix Ranunculi Ternati preferably comprises 6-15 parts of fructus Cnidii and/or 20-40 parts of radix Ranunculi Ternati.
3. The Chinese medicinal composition for preventing and treating gynecological diseases according to claim 2, wherein the weight ratio of the frog powder, the white bone, the gallnut, the fructus kochiae, the fructus cnidii, the dragon's blood, the safflower, the bletilla striata, the brucea javanica, the calendula officinalis, the witch hazel, the paris polyphylla and the catchment is 5:15:12:12:12:12:12:5:15:15:15:30:30; or the weight ratio of the frog powder, the white bone, the Chinese gall, the fructus kochiae, the fructus cnidii, the dragon's blood, the safflower, the bletilla striata, the brucea javanica, the calendula, the witch hazel, the paris polyphylla and the cattleaf ginseng in the traditional Chinese medicine composition is 3:18:12:9:6:1:9:6:9:9:6:18:20:20; or the weight ratio of the frog powder, the white bone, the Chinese gall, the fructus kochiae, the fructus cnidii, the dragon's blood, the safflower, the bletilla striata, the brucea javanica, the calendula, the witch hazel, the paris polyphylla and the cattleaf ginseng in the traditional Chinese medicine composition is 6:12:15:6:15:1:15:15:4:12:12:40:40; or the weight ratio of the frog powder, the white bone, the Chinese gall, the fructus kochiae, the fructus cnidii, the dragon's blood, the safflower, the bletilla striata, the brucea javanica, the calendula, the witch hazel, the paris polyphylla and the cattleaf ginseng in the traditional Chinese medicine composition is 6:12:15:15:15:1:15:15:4:12:12:40:40; or the weight ratio of the frog powder, the white bone, the Chinese gall, the fructus kochiae, the dragon's blood, the safflower, the bletilla striata, the brucea javanica, the calendula officinalis, the witch hazel, the paris polyphylla and the catginseng in the traditional Chinese medicine composition is 3:9:9:6:1:9:9:4:15:9:20:20; or the weight ratio of the frog powder, the white bone, the Chinese gall, the fructus kochiae, the fructus cnidii, the dragon's blood, the safflower, the bletilla striata, the brucea javanica, the calendula, the witch hazel and the paris polyphylla in the traditional Chinese medicine composition is 7:12:18:6:12:1:10:9:3:21:12:30.
4. An aqueous extract of a Chinese medicinal composition for preventing and treating gynecological diseases, characterized in that it is an aqueous extract of a Chinese medicinal composition according to any one of claims 1 to 3.
5. The water extract of a Chinese medicinal composition of claim 4, wherein the extraction is performed at least 1, 2, 3 or 4 or more times by water decoction; preferably, the extract is prepared by decocting with water for 2 times or 3 times.
6. A Chinese medicinal composition preparation for preventing and treating gynecological diseases, which is prepared by mixing the water extract of the Chinese medicinal composition according to claim 4 or 5 with a therapeutically acceptable carrier; preferably, the therapeutically acceptable carrier is selected from one or more of diluents, lubricants, binders, disintegrants, sweeteners, stabilizers, preservatives.
7. The formulation of claim 6, wherein the dosage form is a hydrogel formulation, an ointment formulation, a suppository, a tablet, a pill, a tincture, a spray, or a disintegrant.
8. Use of a traditional Chinese medicine composition according to any one of claims 1 to 3, an aqueous extract of a traditional Chinese medicine composition according to claim 4 or 5 or a traditional Chinese medicine composition preparation according to claim 6 or 7 for the preparation of a medicament for the prevention or treatment of bacterial vaginitis or cervicitis.
9. A method for preparing an aqueous extract of a traditional Chinese medicine composition, which is characterized by comprising the following steps:
a. weighing and mixing the Chinese medicinal composition according to any one of claims 1-3, and adding to an extraction vessel;
b. adding purified water according to the weight ratio of the traditional Chinese medicine composition to water of 1:3-1:10, soaking at normal temperature, boiling with strong fire, decocting with slow fire, and filtering to obtain filtrate;
c. adding purified water into the medicine filter residue according to the weight ratio of the traditional Chinese medicine composition to water of 1:3-1:10, boiling with strong fire, decocting with slow fire, and filtering to obtain filtrate; repeating step c 0 times, 1 time or 2 times;
d. mixing and concentrating the filtrate obtained in the step b and the step c, wherein the concentration volume value is about 100 times of the weight of the dragon's blood, and refrigerating to obtain the water extract of the traditional Chinese medicine composition, and the concentration volume value is expressed as ml.
10. The method of preparing an aqueous extract of a pharmaceutical composition according to claim 9, wherein in step b, the soaking time is about 30 minutes, and the decocting is performed with slow fire for about 25 minutes; and c, decocting with slow fire for about 20 minutes.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101417046A (en) * | 2008-12-09 | 2009-04-29 | 曹莹莹 | Traditional Chinese medicine suppository special for gynecology colpitis and preparation method thereof |
| CN103751532A (en) * | 2013-10-17 | 2014-04-30 | 杜江 | Traditional Chinese medicine composition for treating gynecological inflammation and preparation method thereof |
| CN113181336A (en) * | 2021-06-11 | 2021-07-30 | 陕西秦岭七药协同创新中心有限公司 | Traditional Chinese medicine composition and preparation for treating gynecological diseases and preparation method and application thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101417046A (en) * | 2008-12-09 | 2009-04-29 | 曹莹莹 | Traditional Chinese medicine suppository special for gynecology colpitis and preparation method thereof |
| CN103751532A (en) * | 2013-10-17 | 2014-04-30 | 杜江 | Traditional Chinese medicine composition for treating gynecological inflammation and preparation method thereof |
| CN113181336A (en) * | 2021-06-11 | 2021-07-30 | 陕西秦岭七药协同创新中心有限公司 | Traditional Chinese medicine composition and preparation for treating gynecological diseases and preparation method and application thereof |
Non-Patent Citations (1)
| Title |
|---|
| 黎伟金;陈胜林;: "妇洁洗液的研制及临床疗效观察", 北方药学, vol. 10, no. 08, 1 August 2013 (2013-08-01), pages 58 - 59 * |
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