CN108619471B - Danhuang stasis removing capsule and preparation process thereof - Google Patents

Danhuang stasis removing capsule and preparation process thereof Download PDF

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CN108619471B
CN108619471B CN201810641734.6A CN201810641734A CN108619471B CN 108619471 B CN108619471 B CN 108619471B CN 201810641734 A CN201810641734 A CN 201810641734A CN 108619471 B CN108619471 B CN 108619471B
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parts
danhuang
rhizome
root
capsule
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CN108619471A (en
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柳桂英
徐健
丁海燕
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Jilin Longxin Pharmaceutical Co ltd
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Jilin Longxin Pharmaceutical Co ltd
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    • A—HUMAN NECESSITIES
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    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/90—Smilacaceae (Catbrier family), e.g. greenbrier or sarsaparilla
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Abstract

The invention discloses a Danhuang stasis removing capsule which comprises the following raw materials in parts by weight: 80-100 parts of glabrous greenbrier rhizome, 150 parts of astragalus root, 50-75 parts of Chinese angelica, 150 parts of suberect spatholobus stem, 55-75 parts of gordon euryale seed, 35-45 parts of zedoary, 150 parts of dahurian patrinia herb, 10-15 parts of cinnamon, 30-45 parts of largehead atractylodes rhizome, 150 parts of red sage root, 50-75 parts of pilose asiabell root, 150 parts of heartleaf houttuynia herb, 30-45 parts of common burreed rhizome, 50-75 parts of scorpion, 18-22.5 parts of baked ginger, 30-45 parts of szechwan chinaberry fruit, 50-75 parts of lightyellow sophora root, 50-75 parts of ground beeltle, 50-75 parts of corydalis tuber and 50-75 parts of Chinese yam. The invention also provides a preparation method of the Danhuang stasis removing capsule, the Danhuang stasis removing capsule is not added with any medicine auxiliary component by controlling the weight part ratio of the relevant components, the stability of the medicine can be obviously improved by the arrangement which is unexpectedly found, the medicine dissolution can be obviously improved, and the cure rate is improved.

Description

Danhuang stasis removing capsule and preparation process thereof
Technical Field
The invention relates to the field of modern traditional Chinese medicines, and in particular relates to a Danhuang stasis removing capsule and a preparation process thereof
Background
The Danhuang stasis removing capsule recorded in the national Chinese patent medicine standard compilation is mainly prepared by extracting and processing twenty medicinal materials such as astragalus, salvia miltiorrhiza, corydalis tuber and the like, has the effects of activating blood and relieving pain, softening hardness and dissipating stagnation, and is used for treating chronic pelvic inflammation caused by qi deficiency, blood stasis and phlegm-damp stagnation. The chronic pelvic inflammation is one of the common gynecological diseases, generally refers to inflammation of the upper genital tract except uterus, and comprises adnexitis, pelvic peritonitis, pelvic connective tissue inflammation, pelvic abscess and pelvic thrombophlebitis. It is clinically manifested as menstrual disorder, leukorrhagia, pain in the waist and abdomen and infertility, and can lead to lump if chronic adnexitis is formed. Chronic pelvic inflammatory disease is a chronic condition that is caused by either an acute phase that is not treated in time or by inappropriate treatment. When the disease condition is in the chronic stage, resistance is very important, and it is usually related to kidney deficiency and eight extra meridians loss due to pain in the lower energizer. In the clinical guideline medical record of Yetianshi, all of them are manifested as soreness and pain of waist, soreness and pain of lumbosacral part, and pain of lower abdomen, which are not related to the deficiency of extra pulse,
the eight extra meridians are mainly related to the kidneys, including the liver, and the kidneys govern eight meridians, and the root system is due to the deficiency of the kidney. The traditional Chinese medicine considers that the pathogenesis of the disease is that firstly, the kidney deficiency and blood stasis are the pathogenesis of resistance decline and blood stasis and ice-volt; the other is cold accumulation and blood stasis, which is indeed related to cold-dampness caused by external infection and cold-food consumption in the interior, and the long course of disease is the characteristic of this disease. The chronic pelvic inflammatory disease is stubborn and is usually not cured for a long time and attacks repeatedly, the health of women is seriously affected, and the burden of family and social economy is increased. At present, the treatment of chronic pelvic inflammation in western medicine mainly adopts antibiotic medicine treatment and operation treatment, the antibiotic medicine treatment course is long, patients are easy to generate drug resistance, and the patients are easy to relapse after recovery; the operation treatment has large risk and high cost, and the patients suffer great pain. The traditional Chinese medicine has no disease name of chronic pelvic inflammatory disease, and belongs to the categories of abdominal pain of women, leucorrhea disease, menstrual pain, infertility and the like in the traditional Chinese medicine according to the clinical characteristics of the traditional Chinese medicine. Its pathogenesis is accumulation of damp-heat, qi stagnation and blood stasis. The traditional Chinese medicine dialectical type of chronic pelvic inflammation is more seen in 3 types of clinical qi stagnation and blood stasis type, damp-heat stasis type, cold-damp stasis type and the like. Chronic pelvic inflammatory disease has or shows or has slight symptoms of qi stagnation and blood stasis from the angle of differentiation, so the actions of promoting qi and blood circulation are the constant method for treating the disease, or clearing damp and heat, or warming and resolving cold and dampness, and a certain curative effect can be obtained.
The traditional Chinese medicine is mostly derived from naturally occurring plants in the nature, so that the toxic and side effects are small, and the traditional Chinese medicine has the advantages of treating diseases by taking the traditional Chinese medicine as an active medicine. According to the understanding of different etiology and pathogenesis, the traditional Chinese medicine also selects different prescriptions, for example, Chinese patent application 201510203458.1 discloses a medicine for treating chronic pelvic inflammatory disease, which is prepared from radish seed, cassia twig, tuckahoe, lemongrass, herba patriniae, honeysuckle stem, radix rehmanniae, salvia miltiorrhiza, peach kernel, Chinese mahonia, elecampane, rhizoma atractylodis, trogopterus dung, Chinese pulsatilla root, common fennel fruit, cattail pollen, calcined oyster shell, dysosma versipellis, combined spicebush root, rhizoma cimicifugae, nardostachyos root and herb hypericum japonicum according to a certain weight proportion.
Also, as disclosed in chinese patent application 201710902101.1, a traditional Chinese medicine for treating chronic pelvic inflammatory disease and a preparation method thereof comprises the following traditional Chinese medicine components in parts by weight: 16g of red peony root, 16g of white peony root, 16g of sargentgloryvine stem, 16g of salvia miltiorrhiza, 7g of radix bupleuri, 7g of immature bitter orange, 7g of achyranthes root, 7g of rhubarb, 6g of liquorice, 11g of common burreed rhizome, 11g of zedoary, 11g of nutgrass galingale rhizome and 28g of dahurian patrinia herb, and the invention also discloses a preparation method and a use method of the traditional Chinese medicine composition: firstly, soaking medicinal materials in cold water for 1 hour, wherein the soaking water amount is preferably 3-5 cm higher than the surface of the medicinal materials, then putting the medicinal materials on fire, boiling the medicinal materials with strong fire, keeping the medicinal materials in a slightly boiling state with slow fire after boiling, decocting for 50 minutes for the first time, pouring out the medicinal liquid, adding hot water which just submerges medicinal residues for 2-3cm for the second time, decocting for 30 minutes, pouring out the medicinal liquid, mixing the medicinal liquid for 2 times to obtain about 400ml of medicinal liquid, taking the medicinal liquid warm for 2 times in the morning and evening every day, and taking 15 days as 1 treatment course.
Aiming at the defects of the prior art, the development of the traditional Chinese medicine for treating chronic pelvic inflammation is particularly important for removing stasis by using danhuang which has good moisture resistance and stability and mainly has the functions of clearing heat and promoting diuresis, and activating blood and dissolving stasis and is assisted by promoting qi and activating blood, and tonifying qi and eliminating dampness.
Disclosure of Invention
In order to solve the technical problems, the invention provides a Danhuang stasis removing capsule and a preparation method thereof, wherein the capsule does not contain any medicinal auxiliary component in content in the traditional Chinese medicine formula, and the capsule has good curative effect, obviously shortens the treatment time and has excellent moisture resistance and stability by adjusting the proportion and the adding amount of various traditional Chinese medicine components.
The invention aims to provide a Danhuang stasis removing capsule which comprises the following raw materials in parts by weight: 80-100 parts of glabrous greenbrier rhizome, 150 parts of astragalus root, 50-75 parts of Chinese angelica, 150 parts of suberect spatholobus stem, 55-75 parts of gordon euryale seed, 35-45 parts of zedoary, 150 parts of dahurian patrinia herb, 10-15 parts of cinnamon, 30-45 parts of largehead atractylodes rhizome, 150 parts of red sage root, 50-75 parts of pilose asiabell root, 150 parts of heartleaf houttuynia herb, 30-45 parts of common burreed rhizome, 50-75 parts of scorpion, 18-22.5 parts of baked ginger, 30-45 parts of szechwan chinaberry fruit, 50-75 parts of lightyellow sophora root, 50-75 parts of ground beeltle, 50-75 parts of corydalis tuber and 30-75 parts of Chinese yam.
Preferably, the danhuang stasis removing capsule comprises the following raw materials in parts by weight: 90-100 parts of glabrous greenbrier rhizome, 150 parts of astragalus mongholicus 130-.
In a specific embodiment, the danhuang stasis removing capsule comprises the following raw materials in parts by weight: 100 parts of glabrous greenbrier rhizome, 150 parts of astragalus, 75 parts of Chinese angelica, 150 parts of suberect spatholobus stem, 75 parts of gordon euryale seed, 45 parts of zedoary, 150 parts of dahurian patrinia herb, 15 parts of cassia bark, 45 parts of largehead atractylodes rhizome, 150 parts of salvia miltiorrhiza, 75 parts of pilose asiabell root, 150 parts of heartleaf houttuynia herb, 45 parts of common burreed rhizome, 75 parts of scorpion, 22.5 parts of baked ginger, 45 parts of szechwan chinaberry fruit, 75 parts of lightyellow sophora root, 75 parts of ground beeltle, 75 parts of corydalis tuber and 75 parts of common yam rhizome.
The mass ratio of the salvia miltiorrhiza to the codonopsis pilosula is 1.5-3: 1; preferably, the mass ratio of the salvia miltiorrhiza to the codonopsis pilosula is 2: 1.
the mass ratio of the rhizoma zedoariae to the rhizoma sparganii is 1: 1.
the mass ratio of the astragalus to the caulis spatholobi is 1: 1.
the mass ratio of the cinnamon to the szechwan chinaberry fruit is 1: 2.5-4; preferably, the mass ratio of the cinnamon to the szechwan chinaberry fruit is 1: 3.
the mass ratio of the herba patriniae to the ground beetle is 1.5-3: 1; preferably, the mass ratio of the patrinia to the ground beeltle is 2: 1.
the mass ratio of the angelica sinensis to the Chinese yam is 1: 1.
the invention also aims to provide a method for preparing the danhuang stasis removing capsule, which comprises the following specific steps:
(1) cleaning Scorpio, Eupolyphaga Seu Steleophaga, rhizoma corydalis and Curcumae rhizoma, air drying, pulverizing respectively to obtain Scorpio, Eupolyphaga Seu Steleophaga, rhizoma corydalis and Curcumae rhizoma fine powder, and mixing to obtain mixed powder A;
(2) adding a certain amount of water into a mixture B of astragalus, glabrous greenbrier rhizome, Chinese angelica, suberect spatholobus stem, gordon euryale seed, dahurian patrinia herb, cassia bark, largehead atractylodes rhizome, Chinese yam, common burreed rhizome, red-rooted salvia root, pilose asiabell root, heartleaf houttuynia herb, baked ginger, szechwan chinaberry fruit and lightyellow sophora root according to the formula dosage, decocting, filtering to obtain filtrate, and concentrating to obtain a traditional Chinese medicine extract with the relative density of 1.25-1.35 (70-80;
(3) then placing the extract obtained in the step (2) into a vacuum belt dryer for fluidized drying, and carrying out combined transportation and crushing to obtain mixed powder C with specified fineness;
(4) and (3) uniformly mixing the mixed powder A obtained in the step (1) and the mixed powder C obtained in the step (3), and filling the mixture into capsules to obtain finished products.
The particle size of the pulverized scorpion, the ground beeltle and the corydalis tuber in the step (1) is 120 meshes of fine powder, preferably the particle size of the pulverized scorpion, the ground beeltle and the corydalis tuber is 120 meshes of fine powder; the pulverized curcuma zedoary is fine powder with the particle size of 80-100 meshes, and preferably the pulverized curcuma zedoary is fine powder with the particle size of 90 meshes.
The water adding amount in the step (2) is 13 times of the total weight of the mixture B; the temperature is controlled at 98-100 ℃, and the extraction time is 6 hours.
In the step (3), the fluid drying temperature of the extract is set by sections, and the first section and the second section are 135 ℃; the temperature of the three-section zone is 85 ℃ and the temperature of the four-section zone is 16 ℃; the heating time was 65 minutes per whole zone.
Furthermore, the functions of the raw materials in the capsule for removing blood stasis containing danhuang according to the invention are as follows:
glabrous greenbrier rhizome: sweet and bland, neutral. The functions are as follows: remove toxicity, remove dampness, and benefit joints. The main treatment is as follows: treating syphilis, stranguria with turbid urine, spasm and pain of muscles and bones, tinea pedis, furuncle, carbuncle, lymphoid tuberculosis, spasm of limbs due to syphilis and mercury poisoning, and pain of muscles and bones.
Astragalus root: sweet and warm. The functions are as follows: radix astragali has effects of invigorating qi, consolidating exterior, arresting sweating, promoting granulation, inducing diuresis, and relieving swelling. Can be used for treating deficiency of vital energy, asthenia, collapse of middle-warmer energy, chronic diarrhea, proctoptosis, hematochezia, metrorrhagia, superficial deficiency, spontaneous perspiration, carbuncle, cellulitis, intractable ulcer, blood deficiency, sallow complexion, internal heat, diabetes, chronic nephritis, albuminuria, diabetes, etc. Huang Qi Zhi has the actions of tonifying qi and strengthening middle energizer, while the raw one is used for strengthening exterior and relieving sore.
Chinese angelica: sweet, pungent and warm. Enriching the blood; promoting blood circulation; regulating menstruation and relieving pain; moistening dryness and smoothing intestine. The main symptoms are blood deficiency; menoxenia; amenorrhea; dysmenorrhea; the accumulation of symptoms; (ii) metrorrhagia and metrostaxis; abdominal pain due to deficiency-cold; flaccidity and paralysis; numbness of the skin; intestinal dryness and difficult defecation; severe dysentery with diarrhea; carbuncle, cellulitis, sore and ulcer; injury from falling.
Caulis spatholobi: bitter, sweet and warm. It enters liver and kidney meridians. The functional indications are as follows: tonify blood, activate blood and dredge collaterals, and is used for irregular menstruation, blood deficiency and sallow complexion, numbness and paralysis and rheumatism and arthralgia.
Gorgon fruit: the functions are as follows: has effects in invigorating kidney, stopping nocturnal emission, invigorating spleen, relieving diarrhea, eliminating dampness, and stopping leukorrhagia, and can be used for treating nocturnal emission, spermatorrhea, enuresis, frequent micturition, chronic diarrhea due to spleen deficiency, whitish and turbid urine, and leukorrhagia.
Zedoary turmeric: pungent, bitter and warm. It enters liver and spleen meridians. The functions are as follows: (1) break blood and move qi, resolve food stagnation and alleviate pain. Can be used for treating abdominal pain due to blood stasis, hepatosplenomegaly, abdominal distention and pain, abdominal accumulation, amenorrhea due to blood stasis, traumatic injury, and food stagnation. (2) Promoting qi circulation to relieve pain, removing blood stasis and removing food retention: can be used for treating amenorrhea, chest and hypochondriac pain, abdominal mass, etc. due to qi stagnation and blood stasis. Rhizoma Sparganii is usually added. (3) Promoting digestion and relieving stasis: for stomach and abdomen distending pain due to food stagnation, it is combined with charred malt and charred betel nut.
Herba Patriniae: pungent, bitter and cool. Enter stomach, large intestine and liver meridians. The functions are as follows: clearing away heat and toxic material, eliminating carbuncle, expelling pus, promoting blood circulation and removing blood stasis. Can be used for treating abdominal pain, pain in chest and abdomen due to excessive heat and blood stasis, and puerperal abdominal pain due to intestinal carbuncle, pulmonary abscess, sore, carbuncle, and toxic swelling.
Cinnamon: tonify primordial yang, warm spleen and stomach, remove cold accumulation, and promote blood circulation. It is indicated for decline of vital gate fire, cold limbs and pulse, yang exhaustion and collapse, abdominal pain and diarrhea, cold hernia and dolphin, cold pain in waist and knee, amenorrhea, deep rooted carbuncle, abscess, and floating yang, upper heat and lower cold.
White atractylodes rhizome: bitter and sweet in taste and warm in nature. It enters spleen and stomach meridians. The functions are as follows: invigorate spleen, replenish qi, dry dampness, induce diuresis, stop sweating, prevent abortion. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and threatened abortion. Tu Bai Zhu strengthens spleen, harmonizes stomach and prevents abortion. Can be used for treating spleen deficiency, anorexia, diarrhea, loose stool, and threatened abortion.
Red sage root: salvia miltiorrhiza is bitter and slightly pungent in taste and slightly cold in nature; the functions are as follows: has the effects of promoting blood circulation, removing blood stasis, nourishing blood, tranquilizing mind, cooling blood, and relieving swelling.
Codonopsis pilosula: sweet, slightly sour and neutral in nature. The efficacy is as follows: invigorating spleen and replenishing qi, invigorating spleen and replenishing lung, and can be used for treating spleen and lung deficiency, short breath, palpitation, anorexia, loose stool, asthma, cough, internal heat, diabetes, etc.
Houttuynia cordata: pungent taste and cold nature. The efficacy is as follows: has effects in clearing away heat and toxic materials, relieving pain, relieving swelling, treating sore, promoting urination, removing dampness, invigorating stomach, and promoting digestion. It is indicated for lung abscess, sores and ulcers, swelling and toxin, hemorrhoids, hematochezia, accumulated heat in spleen and stomach due to excess heat, heat toxin, damp pathogen and disease heat.
Three-edge: break blood and move qi, resolve food stagnation and alleviate pain. The functions are as follows: can be used for treating abdominal mass, dysmenorrhea, blood stasis, amenorrhea, thoracic obstruction, heart pain, and pain due to food stagnation.
Scorpion: pungent and mild; is toxic. It enters liver meridian. The efficacy is as follows: extinguish wind and relieve spasm, counteract toxic pathogen and dissipate nodulation, dredge meridians to stop pain.
Baked ginger: bitter, astringent and warm in nature. Pungent and hot. It enters spleen, stomach, kidney, heart and lung meridians. The functions are as follows: warm middle energizer and dispel cold, warm meridians to stop bleeding. Can be used for treating deficiency-cold of spleen and stomach, abdominal pain, emesis, diarrhea, epistaxis, metrorrhagia, and yang deficiency with hemorrhage.
Toosendan fruit: the nature and taste are cold and bitter; has little toxicity. The functions are as follows: soothing liver, moving qi and alleviating pain, expelling parasites. Can be used for treating chest and hypochondrium, abdominal distention and pain, hernia pain, and abdominal pain due to parasitic infestation.
Flavescent sophora root: clear heat, dry dampness and kill parasites. It is used to treat dysentery due to heat and blood, intestinal wind, jaundice, leucorrhea with red and white discharge, infantile pneumonia, malnutritional stagnation, acute tonsillitis, anal fistula, rectocele, skin pruritus, scabies, malignant sore, eczema and pruritus vulvae, scrofula, and scald.
Ground beetle: salty and cold; has little toxicity. It enters liver meridian. The efficacy is as follows: to break blood stasis and continue the muscles and bones. Can be used for treating fracture of tendons and bones, amenorrhea due to blood stasis, and abdominal mass.
Rhizoma corydalis: pungent taste; bitter; warming; is nontoxic. Liver; the stomach; a core; a lung; spleen meridian. The efficacy is as follows: promoting blood circulation; dissipating blood stasis; regulating the flow of qi; can be used for relieving pain. Pain in the heart, abdomen, waist and knees; menoxenia; (iii) a symptom; collapse; postpartum anemic fainting; the lochiorrhea is endless; traumatic injury.
Chinese yam: sweet and neutral. It enters spleen, lung and kidney meridians. The efficacy is as follows: tonify spleen and stomach, promote the production of body fluid and nourish lung, tonify kidney and astringe essence. Can be used for treating spleen deficiency, anorexia, chronic diarrhea, lung deficiency, cough, asthma, spermatorrhea, leukorrhagia, frequent micturition, asthenic fever, and diabetes.
Has the advantages that:
(1) the invention uses a plurality of modern Chinese medicine components and reasonably controls the adding amount of each component, so that the prepared modern Chinese medicine capsule has good medicine effect, the release rate of the effective components of the medicine is high, and the medicine has strong pertinence and good medicine treatment effect.
(2) In the implementation process, the mass ratio of the salvia miltiorrhiza to the codonopsis pilosula is reasonably controlled to be 1.5-3: 1 can obviously improve the stasis removing effect of the capsule, and can ensure that the medicine achieves the effect in a short time, thereby relieving the pain of patients.
(3) According to the invention, the mass ratio of the zedoary to the rhizoma sparganii is controlled to be 1: the invention has the advantages that 1, the stability of the medicine can be improved, no auxiliary medicine component is added into the medicine formula, the curcuma zedoary and the rhizoma sparganii are adopted to be used as the whole medicine materials in the implementation process, the particle sizes of the two medicines are reasonably controlled, the stability of the medicine can be obviously improved by the arrangement, the invention is unexpectedly found, in order to further improve the stability of the medicine and further improve the medicine effect, the whole medicine materials are also used for preparing the scorpion, the ground beetle and the corydalis tuber in the implementation process, the arrangement can obviously improve the medicine dissolution rate, and the cure rate is improved.
(4) Because the pharmaceutical composition has certain hygroscopicity, the invention controls the mass ratio of the astragalus and the suberect spatholobus stem to be 1: 1; the mass ratio of the cinnamon to the szechwan chinaberry fruit is 1: 2.5-4, the moisture absorption performance of the pharmaceutical composition can be improved by the interaction of the medicaments by setting the mass ratio, and the stability of the medicaments is further improved.
(5) The invention improves the treatment effect of the pharmaceutical composition by controlling the mass ratio of the herba patriniae to the ground beeltle, the herba patriniae has the functions of promoting blood circulation and removing blood stasis, and the curative effect of the pharmaceutical composition can be obviously improved by controlling the mass ratio of the herba patriniae to the ground beeltle and interacting with other medicines.
Detailed Description
Example 1 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the material comprises the following raw materials in parts by weight: 100 parts of glabrous greenbrier rhizome, 150 parts of astragalus, 75 parts of Chinese angelica, 150 parts of suberect spatholobus stem, 75 parts of gordon euryale seed, 45 parts of zedoary, 150 parts of dahurian patrinia herb, 15 parts of cassia bark, 45 parts of largehead atractylodes rhizome, 150 parts of salvia miltiorrhiza, 75 parts of pilose asiabell root, 150 parts of heartleaf houttuynia herb, 45 parts of common burreed rhizome, 75 parts of scorpion, 22.5 parts of baked ginger, 45 parts of szechwan chinaberry fruit, 75 parts of lightyellow sophora root, 75 parts of ground beeltle, 75 parts of corydalis tuber and 75 parts of common yam rhizome.
The preparation method comprises the following steps: the method comprises the following specific steps:
(1) cleaning Scorpio, Eupolyphaga Seu Steleophaga, rhizoma corydalis and Curcumae rhizoma, air drying, pulverizing respectively to obtain Scorpio, Eupolyphaga Seu Steleophaga, rhizoma corydalis and Curcumae rhizoma fine powder, and mixing to obtain mixed powder A;
(2) mixing radix astragali, rhizoma Smilacis Glabrae, radix Angelicae sinensis, caulis Spatholobi, semen euryales, herba Patriniae, cortex Cinnamomi, Atractylodis rhizoma, rhizoma Dioscoreae, rhizoma Sparganii, Saviae Miltiorrhizae radix, radix Codonopsis, herba Houttuyniae, rhizoma Zingiberis Preparata, fructus Toosendan and radix Sophorae Flavescentis to obtain mixture B, adding a certain amount of water, decocting, filtering to obtain filtrate, and concentrating to obtain Chinese medicinal extract with relative density of 1.25-1.35(70-80 deg.C);
(3) then placing the extract obtained in the step (2) into a vacuum belt dryer for fluidized drying, and carrying out combined transportation and crushing to obtain mixed powder C with specified fineness;
(4) and (3) uniformly filling the mixed powder A obtained in the step (1) and the mixed powder C obtained in the step (3) into capsules to obtain finished products.
The scorpio, the ground beeltle and the corydalis tuber which are crushed in the step (1) are fine powder with the particle size of 120 meshes; the crushed curcuma zedoary is fine powder with the particle size of 90 meshes.
The water adding amount in the step (2) is 13 times of the total weight of the mixture B; the temperature is controlled at 100 ℃, and the extraction time is 6 hours.
The heating temperature for fluidized drying of the extract in the step (3) is set by sections, and the first section and the second section are 135 ℃; the temperature of the three-section zone is 85 ℃ and the temperature of the four-section zone is 16 ℃; the heating time was 65 minutes per whole zone.
Example 2 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the material comprises the following raw materials in parts by weight: 100 parts of glabrous greenbrier rhizome, 150 parts of astragalus, 75 parts of Chinese angelica, 150 parts of suberect spatholobus stem, 75 parts of gordon euryale seed, 45 parts of zedoary, 150 parts of dahurian patrinia herb, 15 parts of cassia bark, 45 parts of largehead atractylodes rhizome, 150 parts of salvia miltiorrhiza, 75 parts of pilose asiabell root, 150 parts of heartleaf houttuynia herb, 45 parts of common burreed rhizome, 75 parts of scorpion, 22.5 parts of baked ginger, 45 parts of szechwan chinaberry fruit, 75 parts of lightyellow sophora root, 75 parts of ground beeltle, 75 parts of corydalis tuber and 75 parts of common yam rhizome.
The preparation method comprises the following steps: the difference from example 1 is that: the scorpio, the ground beeltle and the corydalis tuber which are crushed in the step (1) are fine powder with the particle size of 100 meshes; the particle size of the crushed zedoary is 80 meshes of fine powder; the other steps and operations were the same as in example 1.
Example 3 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the material comprises the following raw materials in parts by weight: 100 parts of glabrous greenbrier rhizome, 140 parts of astragalus, 60 parts of Chinese angelica, 140 parts of suberect spatholobus stem, 65 parts of gordon euryale seed, 40 parts of zedoary, 140 parts of dahurian patrinia herb, 14 parts of cassia bark, 35 parts of largehead atractylodes rhizome, 140 parts of salvia miltiorrhiza, 60 parts of radix codonopsitis, 140 parts of heartleaf houttuynia herb, 40 parts of common burreed rhizome, 65 parts of scorpion, 20 parts of baked ginger, 40 parts of szechwan chinaberry fruit, 60 parts of lightyellow sophora root, 65 parts of ground beeltle, 65 parts of corydalis tuber and 50 parts of Chinese yam.
The preparation method comprises the following steps: the difference from example 1 is that: the scorpio, the ground beeltle and the corydalis tuber which are crushed in the step (1) are fine powder with the particle size of 110 meshes; the curcuma zedoary is crushed into fine powder with the particle size of 90 meshes; the other steps and operations were the same as in example 1.
Example 4 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the material comprises the following raw materials in parts by weight: 90 parts of glabrous greenbrier rhizome, 150 parts of astragalus, 65 parts of Chinese angelica, 150 parts of suberect spatholobus stem, 70 parts of gordon euryale seed, 45 parts of zedoary, 150 parts of dahurian patrinia herb, 15 parts of cassia bark, 40 parts of largehead atractylodes rhizome, 150 parts of salvia miltiorrhiza, 70 parts of pilose asiabell root, 150 parts of heartleaf houttuynia herb, 45 parts of common burreed rhizome, 70 parts of scorpion, 21 parts of baked ginger, 45 parts of szechwan chinaberry fruit, 70 parts of lightyellow sophora root, 75 parts of ground beeltle, 70 parts of corydalis tuber and 60 parts of Chinese yam.
The preparation method comprises the following steps: same as in example 1.
Example 5 Danhuang stasis removing capsules and preparation method thereof
The formula is as follows: the material comprises the following raw materials in parts by weight: 100 parts of glabrous greenbrier rhizome, 135 parts of astragalus, 70 parts of Chinese angelica, 135 parts of suberect spatholobus stem, 75 parts of gordon euryale seed, 40 parts of zedoary, 135 parts of dahurian patrinia herb, 13 parts of cassia bark, 45 parts of largehead atractylodes rhizome, 135 parts of salvia miltiorrhiza, 75 parts of pilose asiabell root, 135 parts of heartleaf houttuynia herb, 40 parts of common burreed rhizome, 75 parts of scorpion, 22.5 parts of baked ginger, 40 parts of szechwan chinaberry fruit, 75 parts of lightyellow sophora root, 70 parts of ground beeltle, 75 parts of corydalis tuber and 70 parts of Chinese yam.
The preparation method comprises the following steps: same as in example 1.
Example 6 Danhuang stasis removing capsules and preparation method thereof
The formula is as follows: the material comprises the following raw materials in parts by weight: 95 parts of glabrous greenbrier rhizome, 125 parts of astragalus, 64 parts of Chinese angelica, 125 parts of suberect spatholobus stem, 60 parts of gordon euryale seed, 42 parts of zedoary, 135 parts of dahurian patrinia herb, 11 parts of cassia bark, 38 parts of largehead atractylodes rhizome, 145 parts of salvia miltiorrhiza, 65 parts of pilose asiabell root, 135 parts of heartleaf houttuynia herb, 42 parts of common burreed rhizome, 62 parts of scorpion, 22 parts of baked ginger, 42 parts of szechwan chinaberry fruit, 65 parts of lightyellow sophora root, 72 parts of ground beeltle, 58 parts of corydalis tuber and 62 parts of Chinese yam.
The preparation method comprises the following steps: same as in example 1.
Example 7 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the material comprises the following raw materials in parts by weight: 85 parts of glabrous greenbrier rhizome, 128 parts of astragalus, 56 parts of Chinese angelica, 128 parts of suberect spatholobus stem, 64 parts of gordon euryale seed, 39 parts of zedoary, 132 parts of dahurian patrinia herb, 11 parts of cassia bark, 36 parts of largehead atractylodes rhizome, 138 parts of red-rooted salvia root, 64 parts of pilose asiabell root, 136 parts of heartleaf houttuynia herb, 39 parts of common burreed rhizome, 58 parts of scorpion, 21.5 parts of baked ginger, 38 parts of szechwan chinaberry fruit, 64 parts of lightyellow sophora root, 62 parts of ground beeltle, 72 parts of corydalis tuber and 56 parts of Chinese yam.
The preparation method comprises the following steps: same as in example 1.
Comparative example 1 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the difference from example 1 is that: the weight portion ratio of the salvia miltiorrhiza to the codonopsis pilosula is 1: 1; the weight portion ratio of the zedoary to the rhizoma sparganii is 3: 1.
the preparation method comprises the following steps: same as in example 1.
Comparative example 2 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the difference from example 1 is that: the weight portion ratio of the salvia miltiorrhiza to the codonopsis pilosula is 5: 1; the weight portion ratio of the zedoary to the rhizoma sparganii is 1: 3.
the preparation method comprises the following steps: same as in example 1.
Comparative example 3 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the difference from example 3 is that: the weight portion ratio of the astragalus to the suberect spatholobus stem is 1: 3; the weight portion ratio of cinnamon to szechwan chinaberry fruit is 1: 1.
the preparation method comprises the following steps: same as in example 3.
Comparative example 4 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the difference from example 3 is that: the weight portion ratio of the astragalus to the suberect spatholobus stem is 3: 1; the weight portion ratio of cinnamon to szechwan chinaberry fruit is 1: 6.
the preparation method comprises the following steps: same as in example 3.
Comparative example 5 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the difference from example 5 is that: the weight portion ratio of cinnamon to szechwan chinaberry fruit is 1: 6; the weight part ratio of the herba patriniae to the ground beetle is 5: 1.
the preparation method comprises the following steps: same as in example 5.
Comparative example 6A capsule containing radix Salviae Miltiorrhizae and radix Scutellariae with blood stasis dispelling effects, and its preparation method
The formula is as follows: the difference from example 5 is that: the weight portion ratio of cinnamon to szechwan chinaberry fruit is 1: 1; the weight portion ratio of the herba patriniae to the ground beetle is 1: 1.
the preparation method comprises the following steps: same as in example 5.
Comparative example 7 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the difference from example 7 is that: the weight portion ratio of the astragalus to the suberect spatholobus stem is 1: 5; the weight part ratio of the angelica and the Chinese yam is 0.5: 1.
the preparation method comprises the following steps: same as in example 7.
Comparative example 8 Danhuang stasis removing capsule and preparation method thereof
The formula is as follows: the difference from example 7 is that: the weight portion ratio of the astragalus to the suberect spatholobus stem is 4: 1; the weight part ratio of the angelica and the Chinese yam is 5: 1.
the preparation method comprises the following steps: same as in example 7.
Performance testing
1. Long term stability test
The finished products of the Danhuang stasis-dispelling capsules prepared in examples 1-7 were tested for long-term stability of the content of astragaloside contained therein under the conditions of 25 ℃. + -. 2 ℃ and humidity of 60% + -10%.
TABLE 1
Figure GDA0002617582240000111
Figure GDA0002617582240000121
Figure GDA0002617582240000131
According to the detection data in the table 1, it is obvious that the Chinese medicinal composition has good stability under the condition that no auxiliary material or auxiliary agent is added by using various important components disclosed by the invention and controlling the adding amount of various Chinese medicinal components and the weight part ratio of the individual components, and the phenomenon that a large amount of active ingredients are lost after long-term storage does not occur, and the detection data in the table 1 show that even if the Chinese medicinal capsule is stored for 3 years, the active ingredients still can reach the standard requirement (greater than or equal to 40 mug/granule), namely the Chinese medicinal composition and the capsule disclosed by the invention have long shelf life and cannot be deteriorated after long-term storage.
Long-term stability test of Danhuang stasis-removing capsules prepared in example 1 and comparative examples 1-2
TABLE 2
Long-term stability test conditions: the temperature is 30 ℃ plus or minus 2 ℃, and the humidity is 65% + orminus 5%.
Figure GDA0002617582240000132
Figure GDA0002617582240000141
As is apparent from the detection data in table 2 above, the traditional Chinese medicine composition capsule disclosed in example 1 of the present invention still has high stability under the conditions of a temperature of 30 ℃ ± 2 ℃ and a humidity of 65% ± 5%, but when the weight portion ratio of individual components of the traditional Chinese medicine composition disclosed in the present invention is changed out of the range disclosed in the present invention, the stability of the traditional Chinese medicine composition capsule is affected under the high temperature condition, the effective components in the pharmaceutical composition are reduced to a certain extent, and although the content of the effective components does not exceed the normal range, the efficacy is also affected to a certain extent.
Stability test of Danhuang stasis removing capsules prepared in example 3 and comparative examples 3-4
TABLE 3
Accelerated test conditions: the temperature is 40 ℃ plus or minus 2 ℃, and the humidity is 75 percent plus or minus 5 percent.
Figure GDA0002617582240000142
Figure GDA0002617582240000151
As is apparent from the detection data in table 3 above, the traditional Chinese medicine composition capsule disclosed in embodiment 3 of the present invention still has high stability under accelerated test conditions, and when the weight ratio of the individual components of the traditional Chinese medicine composition disclosed in the present invention is changed to be out of the range disclosed in the present invention, the stability of the traditional Chinese medicine composition capsule is affected under accelerated test conditions, the active ingredients in the pharmaceutical composition are reduced to a certain extent, and although the content reduction of the active ingredients does not exceed the normal range, the drug effect is affected to a certain extent.
Stability test of Danhuang stasis removing capsules prepared in example 5 and comparative examples 5-6
TABLE 4
And (3) testing conditions are as follows: the temperature is 10-30 ℃, and the humidity is 35-75 percent
Figure GDA0002617582240000161
As is apparent from the monitoring data in table 4 above, the stability of the pharmaceutical capsule of the traditional Chinese medicine composition prepared in example 5 of the present invention is high in the environment of the traditional Chinese medicine library, and even if the pharmaceutical capsule is placed for a long time, the stability of the pharmaceutical capsule is still good, the active ingredients of the pharmaceutical capsule still remain above the standard requirements (not less than 40 μ g/each granule) after being placed for 3 years, and the active ingredients of the pharmaceutical capsule can be guaranteed to be almost unchanged. In contrast, the comparative examples 5 and 6 change the weight ratio of the related medicinal components in the medicaments out of the range disclosed by the invention, which can affect the stability of the medicaments to a certain extent, and can still affect the efficacy of the medicaments to a certain extent although the weight ratio does not exceed the normal range. Stability test of Danhuang stasis removing capsules prepared in example 7 and comparative examples 7-8
TABLE 5
And (3) testing conditions are as follows: the temperature is 10-30 ℃, and the humidity is 35-75%.
Figure GDA0002617582240000171
As is apparent from the monitoring data in table 5 above, the pharmaceutical capsule of the traditional Chinese medicine composition prepared in example 7 of the present invention has high stability when placed in a room temperature sample retention chamber, and even if the capsule is placed for a long time, the pharmaceutical capsule still has good stability, and the active ingredients of the pharmaceutical capsule after being placed for 3 years are still above the standard requirement (not less than 40 μ g/capsule), so that the active ingredients of the pharmaceutical capsule are almost unchanged. In contrast, comparative examples 7 and 8 change the weight ratio of the relevant drug components in the drug out of the range disclosed by the invention, which can affect the stability of the drug to a certain extent, and even if the weight ratio is not beyond the normal range, the drug effect can still be affected to a certain extent.
2. Clinical efficacy testing
The Danhuang stasis removing capsules disclosed in embodiments 1, 5 and 7 of the invention are taken as examples to carry out clinical treatment effect research
90 volunteers diagnosed with stasis type chronic pelvic inflammatory disease; the age is 30-50 years, and the average age is 35 years; the shortest disease course is 6 months, the longest disease course is 5 years
The curative effect is as follows: stasis type chronic pelvic inflammatory disease: (1) the curative effect is remarkable: the clinical symptoms are obviously improved, and no obvious abnormality is found in the examination of various clinical indexes; (2) the method has the following advantages: the clinical symptoms are improved, and various clinical indexes are improved; (3) and (4) invalidation: clinical symptoms are not improved or even worsened.
The treatment time is as follows: and 3, three months.
TABLE 6
Examples Number of examples Significant efficacy/case (%) Effective/example (%) None/case (%) The total effective rate%
Example 1 30 21(70％) 7(23.33％) 2(6.67％) 93.33％
Example 5 30 20(66.67％) 9(30％) 1(3.33％) 96.67％
Example 7 30 22(73.33％) 8(26.67％) 0(0％) 100.00％
From the test data in table 6 above, it can be seen that the capsule prepared by the invention has good therapeutic effect, the total effective rate can reach more than 95%, and the pain of the patient can be obviously relieved.
The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes performed by the present specification and drawings, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims (1)

1. The Danhuang stasis removing capsule is characterized in that: the Danhuang stasis removing capsule is composed of the following raw materials in parts by weight: 90 parts of glabrous greenbrier rhizome, 150 parts of astragalus, 65 parts of Chinese angelica, 150 parts of suberect spatholobus stem, 70 parts of gordon euryale seed, 45 parts of zedoary, 150 parts of dahurian patrinia herb, 15 parts of cassia bark, 40 parts of largehead atractylodes rhizome, 150 parts of salvia miltiorrhiza, 70 parts of pilose asiabell root, 150 parts of heartleaf houttuynia herb, 45 parts of common burreed rhizome, 70 parts of scorpion, 21 parts of baked ginger, 45 parts of szechwan chinaberry fruit, 70 parts of lightyellow sophora root, 75 parts of ground beeltle, 70 parts of corydalis tuber and 60 parts of Chinese yam;
the Danhuang stasis removing capsule is prepared by the following method, and comprises the following specific steps:
(1) cleaning Scorpio, Eupolyphaga Seu Steleophaga, rhizoma corydalis and Curcumae rhizoma, air drying, pulverizing respectively to obtain Scorpio, Eupolyphaga Seu Steleophaga, rhizoma corydalis and Curcumae rhizoma fine powder, and mixing to obtain mixed powder A;
(2) adding a certain amount of water into a mixture B of astragalus, glabrous greenbrier rhizome, Chinese angelica, suberect spatholobus stem, gordon euryale seed, dahurian patrinia herb, cassia bark, largehead atractylodes rhizome, Chinese yam, common burreed rhizome, red-rooted salvia root, pilose asiabell root, heartleaf houttuynia herb, baked ginger, szechwan chinaberry fruit and lightyellow sophora root according to the formula dosage, decocting, filtering to obtain filtrate, and concentrating to obtain a traditional Chinese medicine extract with the relative density of 1.25-1.35;
(3) then placing the extract obtained in the step (2) into a vacuum belt dryer for fluidized drying, and carrying out combined transportation and crushing to obtain mixed powder C with specified fineness;
(4) uniformly mixing the mixed powder A obtained in the step (1) and the mixed powder C obtained in the step (3), and filling the mixture into capsules to obtain finished products;
the scorpio, the ground beeltle and the corydalis tuber in the step (1) are ground into fine powder with the particle size of 120 meshes, and the curcuma zedoary is ground into fine powder with the particle size of 90 meshes;
the water adding amount in the step (2) is 13 times of the total weight of the mixture B; the temperature is controlled at 100 ℃, and the extraction time is 6 hours;
in the step (3), the fluid drying temperature of the extract is set by sections, and the first section and the second section are 135 ℃; the temperature of the three-section zone is 85 ℃ and the temperature of the four-section zone is 16 ℃; the heating time was 65 minutes per whole zone.
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CN1966052A (en) * 2005-11-17 2007-05-23 大连天山药业有限公司 Tablet containing red sage root and astragalus root for removing blood stasis and preparation process thereof
CN103638483A (en) * 2013-11-21 2014-03-19 吉林龙鑫药业有限公司 Blood stasis removing capsule containing Salvia miltiorrhiza and Radix Astragali, and preparation method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1966052A (en) * 2005-11-17 2007-05-23 大连天山药业有限公司 Tablet containing red sage root and astragalus root for removing blood stasis and preparation process thereof
CN103638483A (en) * 2013-11-21 2014-03-19 吉林龙鑫药业有限公司 Blood stasis removing capsule containing Salvia miltiorrhiza and Radix Astragali, and preparation method thereof

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