CN103977325A - Chinese medicinal composition for treating nephritis and preparation thereof - Google Patents
Chinese medicinal composition for treating nephritis and preparation thereof Download PDFInfo
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- CN103977325A CN103977325A CN201410225160.6A CN201410225160A CN103977325A CN 103977325 A CN103977325 A CN 103977325A CN 201410225160 A CN201410225160 A CN 201410225160A CN 103977325 A CN103977325 A CN 103977325A
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Abstract
The invention discloses a Chinese medicinal composition for treating nephritis and a preparation thereof. The Chinese medicinal composition is prepared from the following raw materials in parts by weight: 5-15 parts of sharpleaf galangal fruit, 5-15 parts of malaytea scurfpea fruit, 5-25 parts of cicada shell, 20-40 parts of astragalus, 5-25 parts of glossy privet fruit, 20-40 parts of dandelion, 5-25 parts of philippine violet herb, 10-30 parts of honeysuckle flower, 5-25 parts of weeping forsythia, 10-30 parts of isatis root, 5-25 parts of indigowoad leaf, 5-25 parts of dahurian patrinia herb, 5-25 parts of oriental waterplantain rhizome, 5-25 parts of Chinese angelica, 5-15 parts of large-head atractylodes rhizome, 5-15 parts of divaricate saposhnikovia root, 5-15 parts of yellowmouth dutchmanspipe root, 5-15 parts of twotooth achyranthes root and 5-25 parts of liquoric root. The prepared Chinese medicinal composition for treating nephritis is free from stimulation as well as toxic and side effects, has high bioavailability, high safety, high uniformity and high stability, and can be used for effectively treating nephritis; the prepared preparation has stable quality, a good medicinal effect, high patient compliance, short treatment period and high curative rate; the effective rate of the preparation is 100 percent, and the curative rate is 86.7 percent; a preparation method is simple and is easy to operate; by using the modern traditional Chinese medicine extraction technology, the yield and purity of effective components can be increased effectively; the preparation method is low in preparation cost and high in yield, and is suitable for industrial production.
Description
Technical field
The invention belongs to the field of Chinese medicines, particularly a kind of Chinese medicine composition and preparation thereof of the treatment nephritis of preparing with pure plant material.
Technical background
The physiological function of kidney is mainly excretion metabolism product and regulates water, electrolyte and acid-base balance, maintains organismic internal environment stable.Nephritis is to change into basic feature with nephridial tissue structure generation inflammatory, causes one group of kidney disease of renal hypofunction in various degree, can be caused by Different types of etiopathogenises.The main clinic symptoms of nephritis has: weak, flank pain, poor appetite, gross hematuria, edema, hypertension, renal dysfunction, hypourocrinia, congestive heart failure etc., bring a lot of inconvenience to patient, and increase patient's psychological burden.Chinese patent CN1559468A discloses a kind of medicine for the treatment of chronic nephritis and preparation method thereof; with Radix Ginseng, the Rhizoma Atractylodis Macrocephalae, Fructus Corni, Carapax et Plastrum Testudinis, Carapax Trionycis, Radix Scutellariae, Poria, Rhizoma Alismatis, Radix Bupleuri, buddhist clothing, Grifola umbellata, Ramulus Cinnamomi, Semen Plantaginis, Rhizoma Dioscoreae, there is Ootheca Mantidis and make; stomach, clearing away heat-damp and promoting diuresis are grown in spleen invigorating, the loose evil effect of dispeling the wind; can be used for treating chronic nephritis; improve clinical symptoms; improve and renal function protecting, have no side effect.But it can not be common to the nephritis of other types, and do not demonstrate the impact of adjuvant on medicine effect, and impact on absorption of human body.
Summary of the invention
The object of this invention is to provide a kind ofly can effectively control the symptom of nephritis, effectively treat nephritis, be beneficial to absorption of human body, Chinese medicine ingredients utilization rate is high, therapeutic effect good, the healing cycle is short, cure rate is high, have no side effect, the Chinese medicine composition of the treatment nephritis of no dependence.
Another object of the present invention is to provide the preparation being made by the Chinese medicine composition of this treatment nephritis.
The Chinese medicine composition for the treatment of nephritis of the present invention, is mainly prepared from through processing by the raw material of following weight portion:
The Chinese medicine composition for the treatment of nephritis provided by the present invention is made up of pure natural plant Chinese herbal medicine, and said composition has good effect to the treatment of nephritis, no dependence, and toxic and side effects is little.
The Chinese medicine composition for the treatment of nephritis of the present invention, is prepared from through processing by the raw material of following weight portion:
Preferably, the Chinese medicine composition for the treatment of nephritis of the present invention, is mainly made up of the raw material of following weight portion:
Preferably, the Chinese medicine composition for the treatment of nephritis of the present invention, is made up of the raw material of following weight portion:
The Chinese medicine composition of this treatment nephritis can be controlled the symptom of nephritis well, effectively cures nephritis, has no side effect.
The oral formulations of being made up of Chinese medicine composition and the adjuvant for the treatment of nephritis of the present invention, comprises pill, capsule, powder, tablet or oral liquid; The ratio of weight and number of Chinese medicine composition and adjuvant is 1:2-1:3.
The oral formulations of being made up of Chinese medicine composition and the adjuvant for the treatment of nephritis of the present invention is pill, and adjuvant comprises sesbania gum and maltose alcohol, and the ratio of weight and number of sesbania gum and maltose alcohol is 5:1-10:1.
Sesbania gum is made pill together with Chinese medicine composition as substrate with maltose alcohol synergism, significantly improved mouldability and the stability of pill, and patient compliance is good, can effectively treat nephropathy.
The oral formulations of being made up of Chinese medicine composition and the adjuvant for the treatment of nephritis of the present invention is capsule, and capsule comprises capsule shells and capsule 's content; Capsule 's content comprises compositions and adjuvant, and adjuvant comprises that weight portion is the microwax of 3-5 part, maltose alcohol, the pregelatinized starch of 2-5 part and the microcrystalline Cellulose of 1-2 part of 5-10 part; Capsule shells comprises that weight portion is the gelatin of 1-3 part, three rosin triglycerides, the cellulose acetate of 1-2 part and the water of 3-8 part of 2-4 part.
The synergism of microwax and pregelatinized starch, can improve the bioavailability of Chinese medicine composition, further improves the curative effect of capsule; Meanwhile, pregelatinized starch also plays adhesive effect; The mixing of gelatin, three rosin triglycerides and cellulose acetate is used, and can significantly improve the stability of capsule shells, meanwhile, the release of active component is played to the effect of slow release, has improved patient's compliance, has further improved the curative effect of capsule.Capsule stable in properties provided by the invention, naivete taste, lasting medicine, patient compliance is high, the property of medicine good and good effect.
Adjuvant in capsule 's content, also comprises that weight portion is the ethyl succinate of 1-2.
The synergism of microwax, maltose alcohol, pregelatinized starch, microcrystalline Cellulose and ethyl succinate has significantly improved the stability of capsule 's content, has further improved the stability of capsule shells and the stability in the large of capsule.
The oral formulations of being made up of Chinese medicine composition and the adjuvant for the treatment of nephritis of the present invention is oral liquid, prepares the adjuvant that oral liquid uses and comprises that weight portion is sebacic acid di-n monooctyl ester, the tolu of 1-2 part and the Oleum menthae of 2-5 part of 1-3 part.
The use of sebacic acid di-n monooctyl ester and tolu, has improved the medicine uniformity of Chinese medicine composition in oral liquid, has further improved the stability of oral liquid; Meanwhile, tolu and Oleum menthae oral disposition liquid also have flavored action, in improving medicine effect, improve patient's compliance, further improve the bioavailability of oral liquid, and cure rate is high.
The preparation method of the Chinese medicine composition for the treatment of nephritis of the present invention, comprises the steps: to take the crude drug of recipe quantity, decoct with water, for the first time water consumption be crude drug gross weight 10-15 doubly, decoct 2-4h; For the second time water consumption be crude drug gross weight 6-10 doubly, decoct 2-3h; For the third time water consumption be crude drug gross weight 3-5 doubly, decoct 1-2h; Merge decoction liquor, filter, filtrate is concentrated, is spray dried to fine powder, makes Chinese medicine composition.
Preferably, the preparation method of the Chinese medicine composition for the treatment of nephritis of the present invention, comprises the steps:
A) Fructus Alpiniae Oxyphyllae, Radix Isatidis, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Radix Achyranthis Bidentatae, the Radix Astragali that take recipe quantity decoct with water three times, and water consumption is 12 times of crude drug gross weight for the first time, decocts 4h; Water consumption is 8 times of crude drug gross weight for the second time, decocts 3h; Water consumption is 4 times of crude drug gross weight for the third time, decocts 1h, merges three times decocting liquid, filters to get filtrate; 40 DEG C of concentrated described filtrates, concentrated 1h obtains the extractum that relative density is 1.20-1.25; The ethanol that adds 90%-95% carries out precipitate with ethanol, reclaims ethanol concentrated, and at 50 DEG C, spraying is dried, and makes fine powder 1;
B) Fructus Psoraleae, Fructus Ligustri Lucidi, Radix Angelicae Sinensis, Rhizoma Alismatis, Fructus Forsythiae, the Herba Violae that take recipe quantity add ethanol and carry out reflux, extract, three times, add for the first time the ethanol of 10 times of amounts 90%, reflux, extract, 4h, reclaims ethanol concentrated, at 40 DEG C, spraying is dried, and makes fine powder 2;
C) take Periostracum Cicadae, Herba Taraxaci, Flos Lonicerae, Folium Isatidis, Herba Patriniae, Radix Saposhnikoviae and the Radix Stephaniae Tetrandrae of recipe quantity, decoct with water 3 times, add for the first time the water of 10 times of amounts, decoct 3h; Add for the second time the water of 8 times of amounts, decoct 2h; Add for the third time the water of 5 times of amounts, decoct 1h; Merge decoction liquor, filter, filtrate adds ethyl acetate extraction, isolates water layer, and water layer is spray dried to fine powder;
D) then by fine powder 1, fine powder 2 and fine powder 3 mix homogeneously, obtain Chinese medicine composition.
The present invention also provides the preparation method of pill, the pill being made by Chinese medicine composition and the adjuvant for the treatment of nephritis of the present invention, and its preparation method comprises the steps:
A) prepare Chinese medicine composition;
B) sesbania gum and maltose alcohol are placed in to water-bath heating and melting, make fused mass, the Chinese medicine composition that adds step a) to make under stirring, fully stirs Chinese medicine composition is dispersed in fused mass, makes fused solution;
C) fused solution is put in pill dripping machine;
D) carry out dripping with the liquid paraffin of 10 DEG C, make pill.
The present invention also provides the preparation method of capsule, the capsule being made by Chinese medicine composition and the adjuvant for the treatment of nephritis of the present invention, and its preparation method comprises the steps:
1) preparation of capsule 's content:
I. prepare Chinese medicine composition;
II. the pregelatinized starch of microwax, maltose alcohol and 4/5 weight portion is placed in to mortar, and the compositions that slowly adds step I to provide under grinding, continues to grind 0.5h, and rotating speed is 300rmp, takes out, and crosses 120 mesh sieves, makes solid dispersion;
III. the solid dispersion that step II is made is mixed homogeneously with microcrystalline Cellulose, makes mixed powder;
IV. the pregelatinized starch of 1/5 weight portion is dissolved in dehydrated alcohol to the mixed powder that adds step III to make, mix homogeneously, soft material processed;
V. soft material is crossed to 24 mesh sieves, and wet granular processed, by dry wet granular spraying, carries out granulate, makes granule;
2) preparation of capsule shells:
VI. heat water to 60 DEG C, under stirring, add gelatin, continue to stir, add three rosin triglycerides and cellulose acetate, stir, vacuum outgas, makes glue;
VII. the glue that step VI is made passes through pressing molding, and after 30 DEG C of oven dry, makes capsule shells;
3) preparation of capsule: in the particles filled capsule shells making to step VII that step V is made, make capsule.
Preparation technology provided by the present invention, has used modern Chinese medicine extractive technique, can effectively improve yield and the purity of effective ingredient; Preparation cost is low, and income is high, is applicable to suitability for industrialized production.
Source raw materials used in the present invention is as follows:
Fructus Alpiniae Oxyphyllae (Fructus Alpinae Oxyphyllae): the mature fruit of zingiberaceous plant Fructus Alpiniae Oxyphyllae.Acrid in the mouth; Warm in nature.Enter the heart, spleen; Kidney channel.The kidney warming controlling nocturnal emission with astringent drugs reducing urination, expectorant is taken the photograph in warming the spleen appetizing.Cure mainly: Deficiency and coldness of spleen and stomach; Vomiting; Have loose bowels; Cold educating in abdomen; The many salivas of mouth; Enuresis due to deficiency of the kidney; Frequent micturition; Seminal emission; Nebulousurine, the diseases such as many salivas.
Fructus Psoraleae (Psoralea corylifolia Linn.): the dry mature fruit of the annual upright herbaceous plant Fructus Psoraleae of Rosales pulse family.Acrid in the mouth, hardship, warm in nature; Return kidney, pericardium, spleen, stomach, lung meridian.Kidney invigorating and YANG supporting, controlling nocturnal emission with astringent drugs reducing urination, lumbago due to renal deficiency, frequent micturition, bed-wetting, kidney leaks, warming spleen and stopping diarrha, helping inspiration to relieve asthma.
Periostracum Cicadae (PERIOSTRACUM CICADAE): exuviae shell when the larva of cicada Cryptotympana atrata Fabr. sprouts wings.Sweet in the mouth, cold in nature.Return lung, Liver Channel.Loose wind heat extraction, sore-throat relieving, rash, nebula removing, spasmolytic.For anemopyretic cold, pharyngalgia, hoarseness, measles without adequate eruption, rubella pruritus, conjunctival congestion cataracta, convulsion with spasms, tetanus.
The Radix Astragali (Astragalus membranaceus (Fisch.) Bunge.): Astragalus.Sweet in the mouth, slightly warm in nature; Return lung, spleen, liver, kidney channel.Have enhancing human body immunity function, protect the liver, diuresis, defying age, anti-stress, blood pressure lowering and antibacterial action more widely.
Fructus Ligustri Lucidi (Fructus Ligustri Lucidi): the dry mature fruit of Oleaceae plants Fructus Ligustri Lucidi.Sweet in the mouth, hardship, property is flat; Return liver, kidney channel.Liver and kidney tonifying, clearind deficient heat, strong waist knee joint, improve visual and auditory acuity, black beard and hair; Cure mainly Light-headedness, soreness of the waist and knees, seminal emission, tinnitus, early whitening of beard and hair, osteopyrexia and fever, poor vision.
Herba Taraxaci (Taraxacum mongolicum Hand.-Mazz.): Compositae Dandelion herbaceos perennial.Sweet in the mouth, micro-hardship, cold in nature.Heat-clearing and toxic substances removing, dispersing swelling and dissipating binds.Control acute mastitis, lymphadenitis, scrofula, furuncle carbuncle toxin, acute conjunctivitis, cold, fever, acute tonsillitis, acute bronchitis, gastritis, hepatitis, cholecystitis, urinary tract infection.
Herba Violae (Viola philippica): Violaceae Viola herbaceos perennial.Taste bitter, acrid, cold; GUIXIN, lung meridian.Heat-clearing and toxic substances removing, removing heat from blood detumescence, the effect of clearing away heat-damp and promoting diuresis, cures mainly furuncle, carbuncle, scrofula, jaundice, dysentery, diarrhoea, conjunctival congestion, sore throat, venom.
Flos Lonicerae (Lonicera japonica): the flower that Caprifoliaceae woodbine Radix Ophiopogonis and congener dry flower or band are just opened.Cold in nature, sweet in the mouth, enters lung, the heart, stomach warp; The effect with heat-clearing and toxic substances removing, antiinflammatory, tonify deficiency treatment wind, cures mainly disease under distension, epidemic febrile disease heating, the diseases such as pyretic toxicity carbuncle and ulcer and tumor.
Fructus Forsythiae (Forsythia suspensa (Thunb.) Vahl): Oleaceae forsythia.Bitter in the mouth, cool in nature, nontoxic.GUIXIN, gallbladder, lung meridian.Heat-clearing and toxic substances removing, mass dissipating and swelling eliminating.For calentura from the beginning of, anemopyretic cold, heating, vexed, laryngopharynx swelling and pain, macule, erysipelas, scrofula, carbuncle pyogenic infections from tumour or sore, acute nephritis, pyretic stranguria.
Radix Isatidis (Isatis tinctoria): the root of cruciferae isatis (Isatis tinctoria L.) and careless Folium Isatidis (I.indigotica Fort.); Rhizoma Et Radix Baphicacanthis Cusiae is rhizome and the root of acanthaceous vegetable acanthaceous indigo (Baphicacanthus cusia (Nees) Brem.).Bitter in the mouth, cold in nature, nontoxic.Return liver, stomach warp.Heat clearing away, removing toxic substances, removing heat from blood, sore-throat relieving.For maculae caused by violent heat pathogen; High heat headache; Major part pestilence; Crimson tongue is purple dark, scarlet fever; Erysipelas; Mumps; Sore throat; Skin ulcer is swollen, carbuncle; Chickenpox; Measles; Hepatitis; Influenza, epidemic encephalitis, encephalitis b, pneumonia, coma is told nosebleed, pharyngeal swelling, acute catarrhal conjunctivitis, skin ulcer rash; Can prevent and treat epidemic encephalitis type B, acute, chronic hepatitis, mumps, osteomyelitis.
Folium Isatidis (Isatis indigotica Fortune): the leaf of the plants such as acanthaceous vegetable acanthaceous indigo, cruciferae isatis and Folium Isatidis, polygonaceae plant polygonum tinctorium ait., leguminous plant Folium et Caulis Indigoferae Tinctoriae, all uses as Folium Isatidis.Bitter in the mouth, Great Cold, nontoxic; Return liver, the heart, stomach warp.Heat clearing away, removing toxic substances, removing heat from blood, hemostasis.For epidemic febrile disease intenseness of heat excessive thirst, influenza, acute infectious hepatitis, bacillary dysentery, acute gastroenteritis, acute pneumonia, erysipelas, spits blood, epistaxis, jaundice, dysentery, sore throat, aphtha, swollen ulcer drug.
Herba Patriniae (Thlaspi arvense Linn.): Valerianaceae plant.Acrid in the mouth, hardship, cool in nature.Heat-clearing and toxic substances removing, removing blood stasis and expelling pus.For heat-clearing and toxic substances removing, removing blood stasis and expelling pus.For appendicitis, dysentery, enteritis, hepatitis, eye conjunctivitis, postnatal blood stasis stomachache, carbuncle furuncle.
Rhizoma Alismatis (Alisma plantago-aquatica): the dry tuber of Notes On Alism At Aceae Rhizoma Alismatis.Sweet in the mouth, light; Cold in nature.Return kidney, urinary bladder channel.Promoting diuresis to eliminate damp pathogen, expels the heat-evil treating stranguria.For promoting diuresis to eliminate damp pathogen; Expel the heat-evil treating stranguria.Main dysuria; The puckery pain of pyretic stranguria; Edema distension; Have loose bowels; Dizziness due to fluid-retention; Seminal emission.
Radix Angelicae Sinensis (Angelica sinensis): the root of Umbelliferae archangel Radix Angelicae Sinensis.Sweet in the mouth, pungent, bitter, warm in nature; Return liver, the heart, spleen channel.Enrich blood, invigorate blood circulation, menstruction regulating and pain relieving, moisturize laxation; Weight, ulcer sores, injury from falling down after, metrorrhagia poly-for all cards of blood deficiency, menoxenia, amenorrhea, dysmenorrhea, lump in the abdomen knot, asthenia cold abdominalgia, flaccidity syndrome and arthralgia syndrome, numbness of the skin, dryness of the intestine dyschezia, bloody dysentery.
The Rhizoma Atractylodis Macrocephalae (Atractylodes macrocephala Koidz.): Compositae, [WTBX herbaceos perennial, root stock nodositas.Bitter in the mouth, sweet, warm in nature; Return spleen, stomach warp.Spleen reinforcing, stomach reinforcing, dampness, and in, antiabortive.For deficient QI of the spleen and stomach, anorexia, asthenia weak breath, deficiency-distension, has loose bowels, phlegm retention, edema, jaundice, arthralgia chiefly caused by damp pathogen, dysuria, dizziness, spontaneous perspiration, nausea uneasiness.
Radix Saposhnikoviae (Saposhnikovia divaricata (Trucz.) Schischk.): the root of Umbelliferae Radix Saposhnikoviae platymiscium Radix Saposhnikoviae.Acrid in the mouth, sweet, slightly warm in nature; Return bladder, lung, spleen, Liver Channel.Expelling pathogenic wind from the body surface, removing dampness to relieve pain, spasmolytic, antipruritic, for affection of exogenous wind-cold, headache general pain, rheumatic arthralgia, joint ache, stomachache is had loose bowels, discharging fresh blood stool, tetanus, rubella pruritus, skin infection from the beginning of.
Radix Stephaniae Tetrandrae (Aristolochia fangchi Y.C.Wu ex L.D.Chow et S.M.): Menispermaceae Chondodendron plant.Bitter in the mouth, cold in nature, returns bladder, spleen, kidney channel; Inducing diuresis to remove edema, wind-expelling pain-stopping.For edema beriberi, dysuria, eczema sore, rheumatic arthralgia, vascular hypertension.
Radix Achyranthis Bidentatae (Achyranthes bidentata): the root of the plant Radix Achyranthis Bidentatae of Amaranthaceae, Achyranthes.Bitter in the mouth, acid, property is flat.Return liver, kidney channel.Medicine, blood circulation and stasis-eliminating medicine dispel the wind.For eliminating blood stasis and inducing menstruation, invigorating the liver and kidney, bone and muscle strengthening, inducing diuresis for treating stranguria syndrome, conducting blood to flow downwards; For amenorrhea, dysmenorrhea, soreness of waist and knee joint, muscles and bones is without, stranguria, edema, headache, dizzy, toothache, aphtha, spits blood, epistaxis.
Radix Glycyrrhizae (Glycyrrhiza uralensis Fisch.): pulse family, Glycyrrhiza herbaceos perennial.Sweet in the mouth, property is flat; Nontoxic.Return spleen, stomach, lung meridian.Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
Beneficial effect of the present invention is:
(1) adopt raw material mostly to be pure plant or the pure plant extracts that degree of safety is high, the Chinese medicine composition of the treatment nephritis of preparation is non-stimulated, have no side effect, and bioavailability and degree of safety are high, and the uniformity and good stability can effectively be treated nephritis; The preparation being made by the Chinese medicine composition for the treatment of nephritis of the present invention, steady quality, good drug efficacy, patient compliance is good, and treatment cycle is short, and cure rate is high.
(2) Chinese medicine composition for the treatment of nephritis of the present invention, preparation method is simple, easy to operate, has used modern Chinese medicine extractive technique, can effectively improve yield and the purity of effective ingredient; Preparation cost is low, and income is high, is applicable to suitability for industrialized production.
Brief description of the drawings
The vitro release result of the test of capsule described in Fig. 1 embodiment 9-12.
Detailed description of the invention
Below in conjunction with embodiment, the invention will be further described:
Embodiment 1 Chinese medicine composition
Treat a Chinese medicine composition for nephritis, be mainly prepared from through processing by the raw material of following weight portion:
Preparation method:
A) Fructus Alpiniae Oxyphyllae, Radix Isatidis, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Radix Achyranthis Bidentatae, the Radix Astragali that take recipe quantity decoct with water three times, and water consumption is 12 times of crude drug gross weight for the first time, decocts 4h; Water consumption is 8 times of crude drug gross weight for the second time, decocts 3h; Water consumption is 4 times of crude drug gross weight for the third time, decocts 1h, merges three times decocting liquid, filters to get filtrate; 40 DEG C of concentrated described filtrates, concentrated 1h obtains the extractum that relative density is 1.20-1.25; The ethanol that adds 90%-95% carries out precipitate with ethanol, reclaims ethanol concentrated, and at 50 DEG C, spraying is dried, and makes fine powder 1;
B) Fructus Psoraleae, Fructus Ligustri Lucidi, Radix Angelicae Sinensis, Rhizoma Alismatis, Fructus Forsythiae, the Herba Violae that take recipe quantity add ethanol and carry out reflux, extract, three times, add for the first time the ethanol of 10 times of amounts 90%, reflux, extract, 4h, reclaims ethanol concentrated, at 40 DEG C, spraying is dried, and makes fine powder 2;
C) take Periostracum Cicadae, Herba Taraxaci, Flos Lonicerae, Folium Isatidis, Herba Patriniae, Radix Saposhnikoviae and the Radix Stephaniae Tetrandrae of recipe quantity, decoct with water 3 times, add for the first time the water of 10 times of amounts, decoct 3h; Add for the second time the water of 8 times of amounts, decoct 2h; Add for the third time the water of 5 times of amounts, decoct 1h; Merge decoction liquor, filter, filtrate adds ethyl acetate extraction, isolates water layer, and water layer is spray dried to fine powder;
D) then by fine powder 1, fine powder 2 and fine powder 3 mix homogeneously, obtain Chinese medicine composition.
Embodiment 2 Chinese medicine compositions
Treat a Chinese medicine composition for nephritis, be prepared from through processing by the raw material of following weight portion:
Preparation method: the preparation method according to embodiment 1 makes Chinese medicine composition.
Embodiment 3 Chinese medicine compositions
Treat a Chinese medicine composition for nephritis, be mainly prepared from through processing by the raw material of following weight portion:
Preparation method: the preparation method according to embodiment 1 makes Chinese medicine composition.
Embodiment 4 Chinese medicine compositions
Treat a Chinese medicine composition for nephritis, be prepared from through processing by the raw material of following weight portion:
Preparation method: the preparation method according to embodiment 1 makes Chinese medicine composition.
Embodiment 5 Chinese medicine compositions
Treat a Chinese medicine composition for nephritis, be mainly prepared from through processing by the raw material of following weight portion:
Preparation method: the preparation method according to embodiment 1 makes Chinese medicine composition.
Embodiment 6 Chinese medicine compositions
Treat a Chinese medicine composition for nephritis, be prepared from through processing by the raw material of following weight portion:
Preparation method: the preparation method according to embodiment 1 makes Chinese medicine composition.
Embodiment 7 pills
Prescription:
Chinese medicine composition 20g prepared by embodiment 1
Adjuvant: sesbania gum 50g
Maltose alcohol 10g
Preparation method:
A) sesbania gum and maltose alcohol are placed in to water-bath heating and melting, make fused mass, the Chinese medicine composition that adds step a) to make under stirring, fully stirs Chinese medicine composition is dispersed in fused mass, makes fused solution;
B) fused solution is put in pill dripping machine;
C) carry out dripping with the liquid paraffin of 10 DEG C, make pill.
Embodiment 8 pills
Prescription:
Chinese medicine composition 20g prepared by embodiment 4
Adjuvant: sesbania gum 27g
Maltose alcohol 3g
Preparation method: the preparation method according to embodiment 7 makes Chinese medicine composition.
Embodiment 9 capsules
Prescription:
Preparation method:
1) preparation of capsule 's content:
I. prepare Chinese medicine composition;
II. the pregelatinized starch of microwax, maltose alcohol and 4/5 weight portion is placed in to mortar, and the compositions that slowly adds step I to provide under grinding, continues to grind 0.5h, and rotating speed is 300rmp, takes out, and crosses 120 mesh sieves, makes solid dispersion;
III. the solid dispersion that step II is made is mixed homogeneously with microcrystalline Cellulose, makes mixed powder;
IV. the pregelatinized starch of 1/5 weight portion is dissolved in dehydrated alcohol to the mixed powder that adds step III to make, mix homogeneously, soft material processed;
V. soft material is crossed to 24 mesh sieves, and wet granular processed, by dry wet granular spraying, carries out granulate, makes granule;
2) preparation of capsule shells:
VI. heat water to 60 DEG C, under stirring, add gelatin, continue to stir, add three rosin triglycerides and cellulose acetate, stir, vacuum outgas, makes glue;
VII. the glue that step VI is made passes through pressing molding, and after 30 DEG C of oven dry, makes capsule shells;
3) preparation of capsule: in the particles filled capsule shells making to step VII that step V is made, make capsule.
Embodiment 10 capsules
Prescription:
Preparation method: the preparation method according to embodiment 9 makes capsule.
Embodiment 11 capsules
Prescription:
Preparation method:
1) preparation of capsule 's content:
I. prepare Chinese medicine composition;
II. the pregelatinized starch of microwax, maltose alcohol, ethyl succinate and 4/5 weight portion is placed in to mortar, and the compositions that slowly adds step I to provide under grinding, continues to grind 0.5h, and rotating speed is 300rmp, takes out, and crosses 120 mesh sieves, makes solid dispersion;
III. the solid dispersion that step II is made is mixed homogeneously with microcrystalline Cellulose, makes mixed powder;
IV. the pregelatinized starch of 1/5 weight portion is dissolved in dehydrated alcohol to the mixed powder that adds step III to make, mix homogeneously, soft material processed;
V. soft material is crossed to 24 mesh sieves, and wet granular processed, by dry wet granular spraying, carries out granulate, makes granule;
2) preparation of capsule shells:
VI. heat water to 60 DEG C, under stirring, add gelatin, continue to stir, add three rosin triglycerides and cellulose acetate, stir, vacuum outgas, makes glue;
VII. the glue that step VI is made passes through pressing molding, and after 30 DEG C of oven dry, makes capsule shells;
3) preparation of capsule: in the particles filled capsule shells making to step VII that step V is made, make capsule.
Embodiment 12 capsules
Prescription:
Preparation method: the preparation method according to embodiment 11 makes capsule.
Embodiment 13 oral liquids
Prescription:
Preparation method: Chinese medicine composition is dissolved in 100ml purified water, after it dissolves completely, adds sebacic acid di-n monooctyl ester, tolu and Oleum menthae, stirring and dissolving, filtration, add purified water to 1000ml, obtains oral liquid; Be distributed into 10 bottles through 1000ml oral liquid, every bottle of 100ml.
Embodiment 14 oral liquids
Prescription:
Preparation method: the preparation method according to embodiment 13 makes oral liquid.
For this situation is described, now further illustrate effect of the present invention by test example as follows:
Test example 1 stability test
1. accelerated test
Get the capsule of embodiment 9, be divided into 3 batches, be numbered respectively sample 1, sample 2 and sample 3, at 40 DEG C ± 2 DEG C of temperature, under the condition that relative humidity is 75% ± 5%, place 6 months, sample respectively once 1 month, 2 months, 3 months, 6 the end of month at duration of test, by the regulation in Chinese Pharmacopoeia, detect the character of capsule, the content (labelled amount %) of astragaloside, found that, indices has no significant change.
2. long term test
Get the capsule of embodiment 9, be divided into 3 batches, be numbered respectively sample 1, sample 2 and sample 3, at 40 DEG C ± 2 DEG C of temperature, under the condition that relative humidity is 75% ± 5%, place 6 months, sample respectively once 0 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 the end of month at duration of test, by the regulation in Chinese Pharmacopoeia, detect the character of capsule, the content (labelled amount %) of astragaloside, found that, indices has no significant change.
Test example 2 slow release tests
Get respectively the capsule described in embodiment 9-12, put in medicament dissolution instrument, sample respectively in 1h, 2h, 4h, 6h, 12h, 16h, 24h, detect stripping percentage rate by high performance liquid chromatography, and calculate the cumulative release percentage rate of medicine, the results are shown in Figure 1.
As can be seen from the figure described in embodiment 9-12, capsule slowly discharges in 24h.
Test example 3 clinical trials
1. case selection: treatment group 30 examples, 6～60 years old age, average 25 years old, the course of disease 1～10 month;
Treatment group 30 examples, 7～60 years old age, average 26 years old, the course of disease 1～9 month.
2. take mode: treatment group: the Chinese medicine composition of oral embodiment 1, each 50g/ people, every day 3 times, one week is a course for the treatment of, two courses for the treatment of of medication.Matched group: oral shenyankangfu tablet (composition: Radix Panacis Quinquefolii, Radix Ginseng, Radix Rehmanniae, the Cortex Eucommiae (stir-fry), Rhizoma Dioscoreae, Herba Hedyotidis Diffusae, Semen sojae atricolor, Rhizoma Smilacis Glabrae, Herba Leonuri, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Rhizoma Imperatae, Radix Platycodonis), 0.48 gram/piece, one time 5,3 times on the one, within one week, be a course for the treatment of, four courses for the treatment of of medication.
3. classical symptom: weak, flank pain, poor appetite, gross hematuria, edema, hypertension, renal dysfunction, hypourocrinia, congestive heart failure.
4. diagnostic criteria:
Cure: symptom disappears completely, and indices is normal, antisecosis;
Effective: clinical cardinal symptom obviously alleviates, muscle power part is recovered;
Effective: cardinal symptom alleviates, muscle power is not recovered;
Invalid: unchanged before and after treatment.
5. result:
The curative effect comparative result for the treatment of group and matched group is in table 1;
The curative effect comparison of table 1 treatment group and matched group
Treatment group and matched group relatively have significant difference (P < 0.01).
6. efficacy evaluation: the preparation that the Chinese medicine composition for the treatment of nephritis of the present invention makes, effective percentage 100%, cure rate 86.7%, can effectively eliminate nephritis symptom, good to the therapeutic effect of nephritis, and treatment cycle is short, and curative effect is significantly better than matched group.
Model case 1:
Wang, man, 18 years old, the student of Yutian County, suffered from the nephrotic syndrome 1.5 years, fail to cure through multi-treatment, the rear oral oral formulations being made by Chinese medicine composition of the present invention, the symptom two days later of taking medicine alleviates, and basic healing after two weeks paid a return visit not recurrence for 1 year afterwards.
Model case 2:
Liu, 39 years old, female, people from Beichen District, Tianjin, suffers from the nephrotic syndrome 1 year, and multi-treatment is invalid, the rear oral oral formulations being made by Chinese medicine composition of the present invention, after taking medicine 1 week, the state of an illness takes a turn for the better to some extent, after two weeks, cures, and within 1 year, pays a return visit afterwards without recurrence.
Model case 3:
History, man, 22 years old, people from Luannan County, Tangshan City, suffered from the nephrotic syndrome 4 years, fail to cure through multi-treatment, the rear oral oral formulations being made by Chinese medicine composition of the present invention, after taking medicine 4 days, the state of an illness takes a turn for the better to some extent, after two weeks, cures, and within 1 year, pays a return visit afterwards without recurrence.
Claims (10)
1. a Chinese medicine composition for the treatment of nephritis, is characterized in that, described Chinese medicine composition is mainly prepared from through processing by the raw material of following weight portion:
2. the Chinese medicine composition for the treatment of nephritis according to claim 1, is characterized in that, described Chinese medicine composition is mainly made up of the raw material of following weight portion:
3. by the Chinese medicine composition of the treatment nephritis described in claim 1 or 2 and the oral formulations that adjuvant is made, it is characterized in that, described oral formulations comprises pill, capsule, powder, tablet or oral liquid; The ratio of weight and number of described Chinese medicine composition and adjuvant is 1:2-1:3.
4. oral formulations according to claim 3, is characterized in that, described oral formulations is pill, and described adjuvant comprises sesbania gum and maltose alcohol, and the ratio of weight and number of described sesbania gum and maltose alcohol is 5:1-10:1.
5. oral formulations according to claim 3, is characterized in that, described oral formulations is capsule, and described capsule comprises capsule shells and capsule 's content; Described capsule 's content comprises compositions and adjuvant, and described adjuvant comprises that weight portion is the microwax of 3-5 part, maltose alcohol, the pregelatinized starch of 2-5 part and the microcrystalline Cellulose of 1-2 part of 5-10 part; Described capsule shells comprises that weight portion is the gelatin of 1-3 part, three rosin triglycerides, the cellulose acetate of 1-2 part and the water of 3-8 part of 2-4 part.
6. oral formulations according to claim 3, is characterized in that, described oral formulations is oral liquid, and described adjuvant comprises that weight portion is the sebacic acid di-n monooctyl ester of 1-3 part, the tolu of 1-2 part, the Oleum menthae of 2-5 part.
7. a preparation method for Chinese medicine composition claimed in claim 1, is characterized in that, described method comprises the steps: to take the crude drug of recipe quantity, decoct with water, for the first time water consumption be crude drug gross weight 10-15 doubly, decoct 2-4h; For the second time water consumption be crude drug gross weight 6-10 doubly, decoct 2-3h; For the third time water consumption be crude drug gross weight 3-5 doubly, decoct 1-2h; Merge decoction liquor, filter, filtrate is concentrated, is spray dried to fine powder, makes Chinese medicine composition.
8. a preparation method for Chinese medicine composition claimed in claim 1, is characterized in that,
Described method comprises the steps:
A) Fructus Alpiniae Oxyphyllae, Radix Isatidis, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Radix Achyranthis Bidentatae, the Radix Astragali that take recipe quantity decoct with water three times, and water consumption is 12 times of crude drug gross weight for the first time, decocts 4h; Water consumption is 8 times of crude drug gross weight for the second time, decocts 3h; Water consumption is 4 times of crude drug gross weight for the third time, decocts 1h, merges three times decocting liquid, filters to get filtrate; 40 DEG C of concentrated described filtrates, concentrated 1h obtains the extractum that relative density is 1.20-1.25; The ethanol that adds 90%-95% carries out precipitate with ethanol, reclaims ethanol concentrated, and at 50 DEG C, spraying is dried, and makes fine powder 1;
B) Fructus Psoraleae, Fructus Ligustri Lucidi, Radix Angelicae Sinensis, Rhizoma Alismatis, Fructus Forsythiae, the Herba Violae that take recipe quantity add ethanol and carry out reflux, extract, three times, add for the first time the ethanol of 10 times of amounts 90%, reflux, extract, 4h, reclaims ethanol concentrated, at 40 DEG C, spraying is dried, and makes fine powder 2;
C) take Periostracum Cicadae, Herba Taraxaci, Flos Lonicerae, Folium Isatidis, Herba Patriniae, Radix Saposhnikoviae and the Radix Stephaniae Tetrandrae of recipe quantity, decoct with water 3 times, add for the first time the water of 10 times of amounts, decoct 3h; Add for the second time the water of 8 times of amounts, decoct 2h; Add for the third time the water of 5 times of amounts, decoct 1h; Merge decoction liquor, filter, filtrate adds ethyl acetate extraction, isolates water layer, and water layer is spray dried to fine powder;
D) then by fine powder 1, fine powder 2 and fine powder 3 mix homogeneously, obtain Chinese medicine composition.
9. a preparation method for oral formulations claimed in claim 4, is characterized in that, described method comprises the steps:
A) prepare Chinese medicine composition;
B) sesbania gum and maltose alcohol are placed in to water-bath heating and melting, make fused mass, the Chinese medicine composition that adds step a) to make under stirring, fully stirs Chinese medicine composition is dispersed in fused mass, makes fused solution;
C) fused solution is put in pill dripping machine;
D) carry out dripping with the liquid paraffin of 10 DEG C, make pill.
10. a preparation method for oral formulations claimed in claim 5, is characterized in that, described method comprises the steps:
1) preparation of capsule 's content:
I. prepare Chinese medicine composition;
II. the pregelatinized starch of microwax, maltose alcohol and 4/5 weight portion is placed in to mortar, and the compositions that slowly adds step I to provide under grinding, continues to grind 0.5h, and rotating speed is 300rmp, takes out, and crosses 120 mesh sieves, makes solid dispersion;
III. the solid dispersion that step II is made is mixed homogeneously with microcrystalline Cellulose, makes mixed powder;
IV. the pregelatinized starch of 1/5 weight portion is dissolved in dehydrated alcohol to the mixed powder that adds step III to make, mix homogeneously, soft material processed;
V. soft material is crossed to 24 mesh sieves, and wet granular processed, by dry wet granular spraying, carries out granulate, makes granule;
2) preparation of capsule shells:
VI. heat water to 60 DEG C, under stirring, add gelatin, continue to stir, add three rosin triglycerides and cellulose acetate, stir, vacuum outgas, makes glue;
VII. the glue that step VI is made passes through pressing molding, and after 30 DEG C of oven dry, makes capsule shells;
3) preparation of capsule: in the particles filled capsule shells making to step VII that step V is made, make capsule.
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| CN106138260A (en) * | 2015-04-13 | 2016-11-23 | 周海腾 | A kind of Chinese medicine oral liquid treating hepatitis |
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| CN101085339A (en) * | 2007-06-26 | 2007-12-12 | 北京艺信堂医药研究所 | Traditional Chinese medicine composition for curing chronic nephritis |
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| CN101352518A (en) * | 2008-08-26 | 2009-01-28 | 荣玉明 | Chinese medicine for treating nephritis, kidney deficiency and renal failure and production method |
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| CN101085339A (en) * | 2007-06-26 | 2007-12-12 | 北京艺信堂医药研究所 | Traditional Chinese medicine composition for curing chronic nephritis |
| CN101167997A (en) * | 2007-11-05 | 2008-04-30 | 张旭明 | Chinese medicinal herb oral liquid cold tea preparation for preventing and treating acute and chronic damp-heat virus type nephritic edema |
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| CN106138260A (en) * | 2015-04-13 | 2016-11-23 | 周海腾 | A kind of Chinese medicine oral liquid treating hepatitis |
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