CN106266625B

CN106266625B - A Chinese medicinal composition for treating renal insufficiency, and its preparation method

Info

Publication number: CN106266625B
Application number: CN201510261129.2A
Authority: CN
Inventors: 刘巍
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-05-21
Filing date: 2015-05-21
Publication date: 2019-12-27
Anticipated expiration: 2035-05-21
Also published as: CN106266625A

Abstract

The invention discloses a traditional Chinese medicine composition for treating renal insufficiency and a preparation method thereof, wherein the traditional Chinese medicine composition is prepared from thirty-nine raw material medicines of ginseng, codonopsis pilosula, astragalus mongholicus, leech, lucid ganoderma, lotus stamen, plantain seed, dogwood fruit, pseudo-ginseng, mulberry, red paeony root, poria cocos, fur seal kidney, dragon's blood, tall gastrodia tuber, desertliving cistanche, radix achyranthis bidentatae, bighead atractylodes rhizome, raspberry, common curculigo rhizome, sea horse, ground beeltle, epimedium herb, Chinese angelica, cynomorium songaricum, parasitic loranthus, oriental waterplantain rhizome, tortoise plastron, turtle shell, prepared rehmannia root, sealwort, Chinese magnoliavine fruit, eucommia bark, deer-horn gum, tuber fleecef. The traditional Chinese medicine composition can improve immunity, improve microcirculation, activate glomeruli and restore kidney functions, and the preparation prepared from the traditional Chinese medicine composition has the advantages of short treatment period, good effect, quick response and relapse prevention.

Description

A Chinese medicinal composition for treating renal insufficiency, and its preparation method

Technical Field

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating renal insufficiency and a preparation method thereof.

Technical Field

Kidney diseases, systemic blood circulation disorders, systemic metabolic disorders (such as diabetes) and urinary tract diseases (such as lithangiuria and tumor compression) can cause different types of renal insufficiency, which is mainly characterized in that metabolites are accumulated in the body, glomeruli are seriously damaged, the body is disordered in the aspects of regulating water electrolyte, acid-base balance and the like, the urine volume and urine quality are changed, the disease condition is rapidly developed, renal failure, uremia and the like are easily caused, the prognosis is serious, and the traditional Chinese medicine is one of main diseases threatening life.

In the current clinical medication and treatment process of the nephropathy, drugs with relatively single functions are generally taken as main drugs, the requirement of systemic treatment of the nephropathy cannot be met, and hormone drugs are adopted in modern medicine, so that common people cannot bear the drugs easily due to high cost, toxic and side effects exist, the treatment effect is limited, and the repeated disease condition is caused by treating symptoms and root causes. In order to overcome the defects, the traditional Chinese medicine composition is prepared by screening natural plant medicines for improving microcirculation, activating glomeruli and recovering renal function through the synergistic effect between the medicines according to the theoretical components of the traditional Chinese medicine and processing the natural plant medicines according to a certain weight ratio, and has the advantages of obvious curative effect, quick action and small side effect.

When the traditional Chinese medicine composition is added with auxiliary materials required by preparation of different dosage forms, such as a disintegrating agent, a lubricating agent, an adhesive and the like, the traditional Chinese medicine composition is prepared into any common traditional Chinese medicine dosage form, such as pills, tablets, capsules and the like, by a conventional preparation method.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating renal insufficiency.

The invention also aims to provide a preparation method of the traditional Chinese medicine composition for treating renal insufficiency.

The dosage of the medicine components of the invention is obtained by a great amount of grope and summary of the inventor, and the dosage of each component is in the following weight portion range, which has better curative effect:

10-35 parts of ginseng, 20-45 parts of codonopsis pilosula, 30-55 parts of astragalus mongholicus, 30-45 parts of leech, 20-35 parts of lucid ganoderma, 15-35 parts of lotus stamen, 20-55 parts of plantain seed, 30-65 parts of cornus officinalis, 25-60 parts of pseudo-ginseng, 20-50 parts of mulberry, 15-40 parts of red peony root, 10-40 parts of poria cocos, 10-60 parts of fur seal kidney, 10-60 parts of dragon's blood, 10-25 parts of gastrodia elata, 10-35 parts of cistanche, 20-60 parts of achyranthes bidentata, 20-55 parts of bighead atractylodes rhizome, 10-35 parts of raspberry, 15-45 parts of curculigo orchioides, 10-35 parts of sea horse, 15-30 parts of ground beeltle, 10-45 parts of epimedium, 25-50 parts of angelica sinensis, 15-30 parts of cynomorium songaricum, 20-60 parts of parasitic loranthus, 10-35 parts of rhizoma alismatis, 15-55 parts of tortoise plastron, 10-35 parts of turtle shell, 30 parts of prepared rhizome, 30-65 parts of prepared rehmannia, 20-55 parts, 15-50 parts of salvia miltiorrhiza, 25-55 parts of donkey-hide gelatin, 20-30 parts of burdock, and 10-35 parts of snow lotus herb.

The traditional Chinese medicine composition for treating renal insufficiency provided by the invention is composed of traditional Chinese medicine raw materials, has a good treatment effect on renal insufficiency, has small toxic and side effects, and can recover renal function.

Preferably, the traditional Chinese medicine composition for treating renal insufficiency is prepared by processing the following raw materials in parts by weight:

20 parts of ginseng, 30 parts of codonopsis pilosula, 50 parts of astragalus membranaceus, 40 parts of leech, 30 parts of lucid ganoderma, 20 parts of lotus stamen, 40 parts of plantain seed, 40 parts of cornus officinalis, 30 parts of pseudo-ginseng, 30 parts of mulberry, 25 parts of red paeony root, 20 parts of poria cocos, 20 parts of fur seal kidney, 20 parts of dragon's blood, 20 parts of gastrodia elata, 30 parts of cistanche, 50 parts of achyranthes bidentata, 30 parts of bighead atractylodes rhizome, 20 parts of raspberry, 20 parts of curculigo orchioides, 20 parts of hippocampus, 20 parts of ground beetle, 20 parts of epimedium, 25 parts of angelica, 25 parts of cynomorium songaricum, 30 parts of loranthus parasiticus, 20 parts of rhizoma alismatis, 20 parts of tortoise plastron, 20 parts of turtle shell, 40 parts of prepared rehmannia root, 30 parts of rhizoma polygonati, 30 parts of schisandra chinensis, 20 parts.

The Chinese medicinal composition for treating renal insufficiency can improve immunity, improve microcirculation, activate glomerulus and restore renal function.

The traditional Chinese medicine composition and the auxiliary materials for treating the renal insufficiency can be prepared into oral preparations, tablets, capsules or powder; wherein the weight part ratio of the traditional Chinese medicine composition to the auxiliary materials is 1: 0.5-3.

Preferably, the oral preparation prepared from the traditional Chinese medicine composition for treating renal insufficiency and the auxiliary materials is a pill, wherein the auxiliary materials comprise 10-20 parts by weight of water and 20-40 parts by weight of honey.

The medicinal powder has viscosity, so that the viscosity can be induced by adding wetting agent, and water is used as wetting agent to facilitate preparation of pill. The honey is selected as the adhesive, so that the fine powder of the medicinal materials containing more fibers and grease is smoothly formed, and the stability of the pills is favorably improved.

Further, the auxiliary materials also comprise 20 to 30 parts by weight of carboxymethyl fiber

And (4) vitamin sodium. The application effect of the medicine is improved, and the sodium carboxymethyl cellulose is selected to help the disintegration and the release of the traditional Chinese medicine pills after entering a human body. Further improving the onset time of the tablet.

The pill prepared from the traditional Chinese medicine composition for treating renal insufficiency and the auxiliary materials has the advantages of good stability, high bioavailability, exquisite appearance, good treatment effect on renal insufficiency and quick response.

Preferably, the oral preparation prepared from the traditional Chinese medicine composition for treating renal insufficiency and the auxiliary materials is a capsule, and the capsule comprises a capsule shell and a capsule content; the capsule content comprises a pharmaceutical composition and auxiliary materials; the auxiliary materials comprise 10-20 parts by weight of lactitol and 9-15 parts by weight of hydroxyethyl cellulose. The synergistic effect of lactitol and hydroxyethyl cellulose is beneficial to improving the stability of capsules and the dispersion uniformity of active ingredients in the capsules, improving the bioavailability of active ingredients in the capsules and increasing the using effect of the medicament.

Furthermore, the capsule auxiliary material also comprises 22-30 parts by weight of sodium starch glycolate and 14-20 parts by weight of isopropyl palmitate.

The synergistic effect of the sodium starch glycolate and the isopropyl palmitate can promote the disintegration of the capsule contents and further improve the bioavailability of effective components in the capsule contents; isopropyl palmitate also acts as a lubricant.

The capsule prepared from the traditional Chinese medicine composition for treating renal insufficiency and the auxiliary materials has the advantages of good stability, high bioavailability and long storage time, and can improve immunity, improve microcirculation, activate glomeruli and restore renal function.

The preparation method of the traditional Chinese medicine composition for treating renal insufficiency comprises the following steps:

a) weighing 30 raw material medicines of astragalus, leech, lotus stamen, plantain seed, dogwood fruit, mulberry, red paeony root, tuckahoe, fur seal kidney, dragon's blood, rhizoma gastrodiae, desertliving cistanche, largehead atractylodes rhizome, raspberry, sea horse, ground beeltle, cynomorium songaricum, Chinese taxillus twig, tortoise plastron, turtle shell, prepared rhizome of rehmannia, rhizoma polygonati, Chinese magnoliavine fruit, eucommia bark, deerhorn glue, tuber fleeceflower root, salvia miltiorrhiza, donkey-hide gelatin, great burdock achene and snow lotus flower;

b) extracting the angelica according to the weight ratio by using water vapor to collect volatile oil for later use;

c) decocting 30 raw material medicines in the weight ratio in the step a) in water for 3 times, wherein the water amount is preferably enough to submerge the medicine surface each time, merging the decoction liquid for 3 times, filtering to obtain decoction liquid, merging the volatile oil in the step b) to obtain decoction liquid 1, concentrating to obtain extract with the specific gravity of 1.3, adding 90-95% of ethanol for ethanol precipitation, and drying at 50-60 ℃ to obtain dry extract 1;

d) adding 8 raw material medicines of ginseng, codonopsis pilosula, lucid ganoderma, pseudo-ginseng, radix achyranthis bidentatae, curculigo orchioides, rhizoma alismatis and epimedium herb in the weight ratio into 90-95% of ethanol for reflux extraction, recovering the ethanol from the extracting solution, and drying at 50-60 ℃ to prepare a dry extract 2;

e) mixing the dry extract 1 and the dry extract 2, and pulverizing into powder to obtain the Chinese medicinal composition.

In order to exert the efficacy better, 8 kinds of raw materials of ginseng, codonopsis pilosula, ganoderma lucidum, pseudo-ginseng, radix achyranthis bidentatae, rhizoma curculiginis, rhizoma alismatis and herba epimedii are preferably subjected to special extraction such as ethanol extraction, and angelica is subjected to steam distillation to extract volatile oil, but the invention is not limited in scope.

The preparation method of the oral preparation for treating renal insufficiency comprises the following steps:

a) preparation of capsule contents:

1) preparing a pharmaceutical composition;

2) placing lactitol and 4/5 parts by weight of hydroxyethyl cellulose into a mortar, slowly adding the pharmaceutical composition under grinding, continuously grinding for 0.5h at the rotation speed of 300rmp, taking out, and sieving with a 120-mesh sieve to obtain a solid dispersion;

3) 1/5 parts by weight of hydroxyethyl cellulose is dissolved in absolute ethyl alcohol, the solid dispersion is added, and the mixture is uniformly mixed to prepare a soft material;

4) sieving the soft material with 24 mesh sieve, making wet granules, spray drying the wet granules, and grading to obtain granules;

5) preparation of capsules: filling the granules prepared in the step a) into capsule shells to prepare capsules.

a) preparing a traditional Chinese medicine composition;

b) refining honey, namely taking water accounting for 20-35% of the total weight of the traditional Chinese medicine composition obtained in the step a), and mixing the water and the traditional Chinese medicine composition according to the weight ratio of 1: 2 mixing with honey, and heating to boil under normal pressure;

c) adding sodium carboxymethylcellulose into the Chinese medicinal composition powder, stirring with the material obtained in step b), and extruding with a die box to obtain 10 g/pill;

d) packaging and storing, packaging with edible wax, and storing at below 25 deg.C in dark. (ii) a

The invention relates to application of a traditional Chinese medicine composition in preparing a medicine for treating renal insufficiency.

The preparation process provided by the invention adopts the modern traditional Chinese medicine extraction technology, and can achieve the purpose of improving the yield and purity of the effective components; meanwhile, the low toxicity and radical cure of the traditional Chinese medicine composition and the preparation are realized, and the preparation process has the advantages of low cost and simple operation and is suitable for industrial production; the obtained capsule and pill have good stability and high bioavailability, and can improve immunity, improve microcirculation, activate glomerulus, and restore renal function.

The main raw materials used in the invention are as follows:

ginseng: dried root of Panax ginseng C.A.Meyer belonging to family Araliaceae. Neutral in nature, sweet in taste, slightly bitter and warm, and can tonify primordial qi, recover pulse to arrest collapse, tonify spleen and lung, promote fluid production and calm the nerves. Can be used for treating asthenia, collapse, cold limbs, weak pulse, spleen deficiency, anorexia, internal heat, diabetes, asthenia, palpitation, insomnia, sexual impotence, and cold womb; heart failure, cardiogenic shock.

Codonopsis pilosula: is root of Codonopsis pilosula (Franch.) Pilosula) Franch of Campanulaceae. Sweet and neutral in nature and taste, and enter spleen and lung channels, tonify middle-jiao, replenish qi and promote the production of body fluid. For deficiency of spleen and stomach, deficiency of both qi and blood

Astragalus root: is dried root of Astragalus membranaceus bge or Astragalus membranaceus bge of Leguminosae. Warm in nature, sweet in flavor, invigorating qi, consolidating superficial resistance, expelling toxin, expelling pus, promoting urination, and promoting granulation. Can be used for treating deficiency of vital energy, asthenia, chronic diarrhea, proctoptosis, spontaneous perspiration, edema, prolapse of nasal mucosa and nasal mucosa, chronic nephritis, albuminuria, diabetes, and unhealed wound.

Leech: is dried body of Hirudo family animal Hirudo, Hirudo or Hirudo nipponica. Salty, bitter and neutral in nature, entering liver meridian, breaking blood, removing blood stasis and unblocking meridians. It is indicated for blood accumulation, abdominal mass, accumulation, amenorrhea and tuberculosis.

Ganoderma lucidum: is dried fruiting body of Ganoderma lucidum or Ganoderma sinensis of Polyporaceae. Sweet in nature and taste, neutral in nature and flavor, enter heart, lung, liver and kidney meridians and tonify and strengthen. It has brain strengthening, antiinflammatory, diuretic, and kidney invigorating effects.

Stamen nelumbinis: is dry stamen of Nymphaeaceae plant Nelumbo nucifera Gaertn. Sweet, astringent and neutral in nature and flavor, enter heart and kidney meridians, and tonify kidney to arrest seminal emission. Can be used for treating spermatorrhea, leukorrhagia, and frequent micturition.

Plantain seed: is dry mature seed of Plantago asiatica or Plantago depressa of Plantaginaceae. Sweet in nature and taste, slightly cold, entering liver, kidney, lung and small intestine channels, inducing diuresis, clearing heat, improving eyesight and eliminating phlegm. It is indicated for urinary obstruction, stranguria with turbid urine, leukorrhagia and hematuria.

Dogwood fruit: is dried mature pulp of Cornaceae plant fructus Corni. Sour, astringent and slightly warm in nature and taste, enter liver and kidney meridians, tonify liver and kidney, and astringe essence to check depletion. Can be used for treating vertigo, tinnitus, soreness of waist and knees, sexual impotence, spermatorrhea, enuresis, frequent micturition, metrorrhagia, leukorrhagia, and sweating. Internal heat and thirst.

Pseudo-ginseng: is dried root of Panax notoginseng (Burk.) F.H.Chen of Araliaceae. Sweet in nature and taste, bitter and warm in taste, and has the effects of promoting blood circulation, removing blood stasis, stopping bleeding, relieving swelling and pain. Can be used for treating epistaxis, hematemesis, hemoptysis, and hematochezia.

And (3) mulberry fruit: is dried fruit cluster of Morus alba L. Sweet, sour and cold in nature and taste, and can enter heart, liver and kidney meridians, tonify liver, tonify kidney, extinguish wind and nourish fluid. It is indicated for deficiency of liver-yin and kidney-yin, diabetes, constipation, dim eyesight, tinnitus, scrofula and joint disorders.

Radix paeoniae rubra: is root of Ranunculaceae plant radix Paeoniae (wild species), radix Paeoniae alba, and radix Paeoniae Rubra. Sour and bitter in nature, cool, remove blood stasis, alleviate pain, cool blood and relieve swelling. It is indicated for amenorrhea due to stasis, hernia and mass, abdominal pain, hypochondriac pain, epistaxis, bloody dysentery, intestinal wind and blood, conjunctival congestion, carbuncle and swelling.

Tuckahoe, poria cocos: is dried sclerotium of Poria cocos (Schw.) wolf of Polyporaceae. Sweet, bland and neutral in nature and taste, enter heart, lung, spleen and kidney meridians, excrete dampness and promote diuresis, benefit spleen and stomach, calm heart and tranquilize mind. It is indicated for dysuria, edema and distention.

Seal kidney: is male external genitalia of seal family animal such as seal or seal. Salty and hot in nature, enter liver and kidney meridians, warm kidney and strengthen yang, supplement essence and tonify marrow. It is indicated for deficiency, fatigue, impotence, essence weakness, and weakness of waist and knees.

Dragon's blood: is prepared from resin exuded from fruit of daemonorops draco of Palmae by processing. Sweet, salty and neutral in nature and flavor, enter heart and liver meridians, dispel stasis and relieve pain, stop bleeding and promote tissue regeneration. Can be used for treating traumatic injury, internal injury, blood stasis and pain.

Gastrodia elata: is dried tuber of Gastrodia elata Blume of Orchidaceae. Sweet in nature and flavor, mild in nature and entering liver meridian, pacify liver and extinguish wind and stop spasm. Can be used for treating headache, vertigo and numbness of limbs.

Cistanche deserticola: is dry succulent stem with scaly leaf of cistanche deserticola Ma of Orobanchaceae. Sweet in nature, salty and warm in nature, entering kidney and large intestine meridians, tonifying kidney yang, replenishing essence and blood, moistening intestines and relaxing bowels. Can be used for treating sexual impotence, infertility, soreness of waist and knees, weakness of tendons and bones, constipation due to intestinal dryness.

Achyranthes root: is dried root of Achyranthis radix of Amaranthaceae. Bitter, sour and neutral in nature, entering liver and kidney meridians, nourishing liver and kidney, strengthening tendons and bones, removing blood stasis and dredging channels, and guiding blood downward. Can be used for treating soreness of waist and knees, weakness of tendons and bones, amenorrhea, abdominal mass, and vertigo due to liver-yang.

Atractylodis rhizoma is dried rhizome of Atractylodes macrocephala Koidz of Compositae. Bitter, sweet and warm in nature and flavor, entering spleen and stomach meridians, tonifying spleen, benefiting stomach, eliminating dampness, regulating stomach and preventing miscarriage. It is indicated for qi deficiency of spleen and stomach, anorexia, listlessness, qi deficiency, distention, diarrhea, phlegm and fluid retention, edema, jaundice, damp arthralgia, dysuria.

Raspberry: is dried fruit of Rubus chingii Hu of Rubus of Rosaceae. Sweet, sour and warm in nature and flavor, entering kidney and bladder meridians, tonifying kidney, securing essence and reducing urination. Can be used for treating enuresis due to kidney deficiency, frequent micturition, sexual impotence, premature ejaculation, spermatorrhea, and spermatorrhea.

Rhizoma curculiginis: is the dried rhizome of common curculigo rhizome of Amaryllidaceae, pungent in nature and hot in nature, enters kidney, liver and spleen channels, tonifies kidney yang, strengthens muscles and bones, and dispels cold-dampness. Can be used for treating sexual impotence, cold essence, flaccidity of tendons and bones, cold arthralgia of waist and knees, and cold diarrhea due to yang deficiency.

Sea horse: is dried body of Hippocampus kelloggi, Hippocampus spinosus, Hippocampus megalosa, Hippocampus trimaculatus or Hippocampus minuta (sea maggot) belonging to Syngnathidae.

Ground beetle: dried female insect of Eupolyphaga of Corynodidae. Salty taste and cold nature, enters liver meridian, and is used for treating traumatic injury, muscle injury and fracture, amenorrhea due to blood stasis, postpartum abdominal pain due to blood stasis, and addiction to abdominal mass.

Herba epimedii: is dried aerial part of Epimedium brevicornum Maxim, Epimedium sagittatum Maxim, Epimedium pubescens Maxim, Epimedium wushanense T.S. Wushan or Epimedium koreanum nakai of berberidaceae. Pungent, sweet and warm in nature and flavor, enter liver and kidney meridians, tonify kidney yang, strengthen tendons and bones, and dispel wind-damp.

Chinese angelica: is dried root of Angelica sinensis (oliv.) Diels of Umbelliferae, has sweet and pungent taste, is warm, enters heart, liver and spleen channels, and has effects of nourishing blood and regulating menstruation, relieving pain, moistening dryness and smoothing intestine, and can be used for treating intestinal dryness, constipation, and dysentery with severe diarrhea; carbuncle, deep-rooted carbuncle, sore, traumatic injury.

And (3) locking the positive: is dry succulent stem of Cynomorium songaricum of Cynomoriaceae. Sweet in nature and taste, warm in nature, entering spleen, kidney and large intestine meridians, tonifying kidney yang, benefiting essence and blood, moistening intestines and relaxing bowels. Can be used for treating waist and knee atrophy, sexual impotence, spermatorrhea, intestinal dryness and constipation.

Parasitic loranthus: is dry stem branch with leaves of herba Taxilli of Taxaceae. Bitter, sweet and neutral in nature and flavor, enters liver and kidney meridians, tonifies liver and kidney, strengthens muscles and bones, dispels wind-damp, and is used for treating rheumatic arthralgia, soreness and weakness of waist and knees, weakness of muscles and bones, and profuse uterine bleeding.

Rhizoma alismatis: is dried tuber of Alismatis rhizoma of Alismataceae. Sweet in nature and taste, cold in nature, entering kidney and bladder meridians, promoting urination, and clearing away damp-heat. Can be used for treating dysuria, edema, abdominal distention, diarrhea, oliguria, phlegm retention, vertigo, and pain due to stranguria and heat; hyperlipidemia.

Tortoise shell: is the shell of tortoise of the family of the turtle. Salty and sweet in nature, neutral in nature, enter liver and kidney meridians, nourish yin, suppress yang, tonify kidney and strengthen bone. It is indicated for kidney yin deficiency, bone-steaming, excessive heat, hematemesis, epistaxis, chronic cough, seminal emission, metrorrhagia, leukorrhagia, lumbago, bone atrophy, and yin deficiency with wind movement.

Turtle shell: is the dorsal scale of Amyda sinensis of Trionychidae. Salty in nature and slightly cold in nature, enter liver and kidney meridians, nourish yin and suppress yang, soften hardness and dissipate nodulation, defervesce and remove steaming. Can be used for treating fever due to yin deficiency, internal stirring of deficiency wind, amenorrhea, abdominal mass, and malaria.

Prepared rehmannia root: the processed rehmannia root is sweet in nature and taste, slightly warm, enters liver and kidney channels, nourishes yin and blood, and supplements essence and fills marrow. Can be used for treating deficiency of liver-yin and kidney-yin, soreness and weakness of waist and knees, hectic fever, night sweat, nocturnal emission, internal heat, diabetes, blood deficiency, sallow complexion, cardiopalmus, severe palpitation, metrorrhagia, and metrostaxis.

Rhizoma polygonati: is dried rhizome of Polygonatum kingianum, Polygonatum sibiricum or Polygonatum cyrtonema of Liliaceae. Sweet in nature and taste, neutral, and entering spleen, lung and kidney channels, invigorating qi and nourishing yin, invigorating spleen, moistening lung and invigorating kidney. Can be used for treating weakness of spleen and stomach, asthenia, xerostomia, anorexia, lung deficiency, cough, essence and blood deficiency, and internal heat diabetes.

Schisandra chinensis: is dried mature fruit of Schisandra chinensis or Schisandra sphenanthera of Magnoliaceae. Sour, sweet and warm in nature and taste, enters lung, heart and kidney channels, astringes, promotes qi and production of body fluid, tonifies kidney and calms heart. Can be used for treating chronic cough, asthma, nocturnal emission, enuresis, frequent micturition, chronic diarrhea, spontaneous perspiration, night sweat, thirst due to body fluid consumption, short breath, weak pulse, internal heat, diabetes, palpitation, and insomnia.

Eucommia ulmoides: is dry bark of eucommia ulmoides oliv of Eucommiaceae, with sweet and warm nature, and has effects of nourishing liver and kidney, strengthening tendons and bones, and preventing miscarriage. Can be used for treating lumbago due to kidney deficiency, and weakness of tendons and bones.

Deer-horn glue: is prepared from cornu Cervi by decocting with water, and concentrating to obtain solid gelatin. Sweet, salty and warm in nature and flavor, enter kidney and liver meridians, warm and nourish liver and kidney, benefit essence and nourish blood. Can be used for treating sexual impotence, spermatorrhea, soreness of waist and knees, asthenia, marasmus, metrorrhagia, hematochezia, hematuria, dorsal furuncle, and swelling and pain.

Polygonum multiflorum: is dried root tuber of Polygonum multiflorum Thunb of Polygonaceae. Bitter, sweet, astringent and warm in nature and flavor, enter liver, heart and kidney meridians, detoxify, cure carbuncle, moisten intestines and relieve constipation. Used for scrofula, sores and carbuncles, rubella and pruritus, and constipation due to intestinal dryness; hyperlipidemia.

Red sage root: is dry root and rhizome of Salvia miltiorrhiza Bunge of Labiatae, is bitter in nature and slightly cold, enters heart and liver channels, removes blood stasis and relieves pain, promotes blood circulation and clears channels, and clears heart and relieves restlessness. Symptoms and accumulation, thoracico-abdominal stabbing pain, heat arthralgia pain, sore and ulcer, swelling and pain, vexation and insomnia; hepatosplenomegaly.

E, donkey-hide gelatin: is solid gum prepared from skin of donkey of Equidae by decocting and concentrating. Sweet in nature and flavor, neutral in nature and entering lung, liver and kidney meridians. Tonify blood, nourish yin, moisten dryness and stop bleeding. Can be used for treating blood deficiency, sallow complexion, giddiness, cardiopalmus, muscle weakness, vexation, insomnia, deficient wind stirring, lung dryness, cough, overstrain cough, hemoptysis, hematemesis, hematuria, hematochezia, metrorrhagia, and metrostaxis.

And (3) burdock: is dried mature fruit of Arctium lappa L of Compositae. Pungent, bitter and cold in nature and flavor, entering lung and stomach meridians, dispelling wind and heat, dispersing lung qi, promoting eruption, relieving swelling and removing toxicity. Abscess, swelling and sore.

Snow lotus herb: herba Saussureae Involueratae and herba Adonidis of saussurea of Compositae are prepared from whole plant with root. Sweet in nature, slightly bitter and warm in nature, tonifying kidney and yang, regulating menstruation and stopping bleeding. Can be used for treating snowy blind, sexual impotence, metrorrhagia, and traumatic hemorrhage by external application.

The invention has the beneficial effects that:

the invention takes 'regulating and nourishing qi and blood yin and yang, regulating viscera functions' and 'promoting diuresis, removing dampness, dissolving turbidity, removing blood stasis and discharging toxic factors' as basic principles, and the thirty-nine pure natural Chinese herbal medicines are selected to prepare the traditional Chinese medicine composition, and the composition improves ischemia and anoxia of kidney, repairs kidney inherent cells, blocks fibrosis development, further improves microcirculation, improves blood and anoxia, plays the role of substance regulation and physiological function in cells, thereby activating glomerulus, repairing kidney qi damage and kidney essence loss and recovering kidney function through the synergistic effect of the component effects. The traditional Chinese medicine composition has no stimulation and toxic or side effect, and has high safety and high cure rate for treating renal insufficiency. Meanwhile, the preparation process disclosed by the invention is simple to operate and suitable for industrial production, and the prepared oral preparations such as pills, capsules and the like are convenient to use, good in effect, quick in effect, safe and free of toxic and side effects.

Detailed Description

The invention is further illustrated by the following examples:

EXAMPLE 1 Chinese medicinal composition

Prescription:

20g of ginseng, 30g of codonopsis pilosula, 50g of astragalus membranaceus, 40g of leech, 30g of lucid ganoderma, 20g of lotus stamen, 40g of plantain seed, 40g of cornus officinalis, 30g of pseudo-ginseng, 30g of mulberry, 25g of red peony root, 20g of poria cocos, 20g of fur seal kidney, 20g of dragon's blood, 20g of gastrodia elata, 30g of cistanche, 50g of radix achyranthis bidentatae, 30g of bighead atractylodes rhizome, 20g of raspberry, 20g of curculigo orchioides, 20g of hippocampus, 20g of ground beetle, 20g of epimedium, 25g of angelica, 25g of cynomorium songaricum, 30g of parasitic loranthus, 20g of rhizoma alismatis, 20g of turtle shell, 40g of rehmannia glutinosa, 30g of rhizoma polygonati, 30g of schisandra chinensis, 20g of eucommia ulmoides, 20 g.

The preparation method comprises the following steps:

a) weighing 50g of astragalus mongholicus, 40g of leech, 20g of lotus stamen, 40g of semen plantaginis, 40g of cornus officinalis, 30g of mulberry, 25g of radix paeoniae rubra, 20g of poria cocos, 20g of fur seal kidney, 20g of dragon's blood, 20g of rhizoma gastrodiae, 30g of cistanche, 30g of bighead atractylodes rhizome, 20g of raspberry, 20g of sea horse, 20g of ground beeltle, 25g of cynomorium songaricum, 30g of parasitic loranthus, 20g of tortoise plastron, 20g of turtle shell, 40g of prepared rehmannia root, 30g of rhizoma polygonati, 30g of schisandra chinensis, 20g of eucommia ulmoides, 20g of deer-horn glue, 30g of polygonum multiflorum, 30g of;

b) extracting 25g of angelica sinensis with water vapor, and collecting volatile oil for later use;

c) decocting the 31 raw material medicines in the step a) in water for 3 times, wherein the water amount is preferably enough to submerge the medicine surface each time, merging the decoction of 3 times, filtering to obtain decoction, merging the volatile oil in the step b) to obtain decoction 1, concentrating to obtain extract with the specific gravity of 1.3, adding 90-95% of ethanol for alcohol precipitation, and drying at 50-60 ℃ to obtain dry extract 1;

d) adding 90-95% ethanol into 8 raw material medicines of 20g of ginseng, 30g of codonopsis pilosula, 30g of lucid ganoderma, 30g of pseudo-ginseng, 50g of radix achyranthis bidentatae, 20g of rhizoma curculiginis, 20g of rhizoma alismatis and 20g of herba epimedii for reflux extraction, recovering ethanol from an extracting solution, and drying at 50-60 ℃ to prepare a dry extract 2;

e) mixing the dry extract 1 and the dry extract 2, and pulverizing into powder to obtain the Chinese medicinal composition for treating renal insufficiency.

EXAMPLE 2 pellets

Prescription:

example 1 the prepared Chinese medicinal composition 30g

Auxiliary materials: 10g of water

Honey 20g

Sodium carboxymethylcellulose 25g

The preparation method comprises the following steps:

a) preparing a traditional Chinese medicine composition;

b) mixing 10g of water with 20g of honey, heating to boil under normal pressure to obtain refined honey, and removing floating foam with luster;

c) adding 25g of sodium carboxymethylcellulose into the Chinese medicinal composition powder, uniformly stirring with the material obtained in the step b), and extruding by using a die box to prepare pills of 10g per pill;

d) packaging and storing, packaging with edible wax, and storing at below 25 deg.C in dark.

EXAMPLE 3 capsules

Prescription:

example 2 the prepared Chinese medicinal composition 20g

Auxiliary materials: lactitol 15g

Hydroxyethyl cellulose 15g

Starch glycolate 20g

Isopropyl palmitate 15g

The preparation method comprises the following steps:

a) preparation of capsule contents:

1) preparing a pharmaceutical composition;

2) placing 10g of lactitol and 10g of hydroxyethyl cellulose in a mortar, slowly adding the medicinal composition under grinding, continuously grinding for 0.5h at the rotating speed of 300rmp, taking out, and sieving with a 120-mesh sieve to obtain a solid dispersion;

3) uniformly mixing sodium starch glycolate and isopropyl palmitate with the solid dispersion to prepare mixed powder;

4) dissolving 5g of hydroxyethyl cellulose in absolute ethyl alcohol, adding the mixed powder, and uniformly mixing to prepare a soft material;

5) sieving the soft material with 24 mesh sieve, making wet granules, spray drying the wet granules, and grading to obtain granules; b) preparation of capsules: filling the granules prepared in the step a) into capsule shells to prepare capsules, wherein each capsule is 0.5 g.

Test example clinical test

1. Renal insufficiency

1. Case selection: the total 100 patients with renal insufficiency are divided into a treatment group and a control group,

wherein: 50 treatment groups, wherein the ages of the treatment groups are 20 to 78 years old, the average age is 42 years old, 32 cases of men and 18 cases of women have the disease course of 6 months to 3 years, and the average age is 1 year;

the control group comprises 50 cases, the ages of which are 20 to 78 years, the average age is 44 years, 32 cases of men, 18 cases of women, the course of disease is 3 months to 3 years, and the average age is 1.1 years.

According to statistical treatment, there was no difference in gender, age and course of disease between groups.

2. The treatment method comprises the following steps:

treatment groups: the pill prepared from the traditional Chinese medicine composition for treating renal insufficiency is taken three times a day, 10g (one pill) is taken each time, thirty days are a treatment course, and the pill is continuously used for 3 treatment courses.

Control group: shenshuaining tablet (prepared from radix Pseudostellariae, Coptidis rhizoma, rhizoma Pinelliae (preparata), pericarpium Citri Tangerinae, Poria, radix et rhizoma Rhei, Saviae Miltiorrhizae radix, Achyranthis radix, Carthami flos, and Glycyrrhrizae radix) is administered orally. 4-6 tablets are taken once, 3-4 times a day, 45 days are taken as a treatment course, and 2 treatment courses are continuously taken.

3. Clinical efficacy observation index

Before and after administration, pathological biopsy and renal function examination are performed.

4. Diagnostic criteria:

and (3) healing: after the treatment is finished, the clinical symptoms completely disappear, all indexes are recovered to be normal, and the color Doppler ultrasound shows to be normal;

the effect is shown: clinical symptoms basically disappear, hematuria and urine protein are obviously relieved, urine volume and blood urea nitrogen are recovered to be normal, blood creatinine is reduced by more than 30 percent compared with before-treatment, and urine creatinine is increased by more than 30 percent compared with before-treatment;

the method has the following advantages: the clinical symptoms are relieved, the hematuria and the urine protein are relieved, the urine volume is increased, the edema disappears, the blood urea nitrogen is basically normal, the blood creatinine is reduced by more than 20 percent compared with the blood creatinine before treatment, and the urine creatinine is increased by more than 20 percent compared with the urine creatinine before treatment;

and (4) invalidation: there was no significant improvement or deterioration in both clinical and laboratory findings.

5. And (3) test results:

the results of comparing the therapeutic effects of the treatment group and the control group are shown in table 1;

TABLE 1 comparison of the therapeutic effects of the treatment groups and the control group

6. And (3) judging the effect: the traditional Chinese medicine composition for treating renal insufficiency has the effective rate of 100 percent and the cure rate of 92 percent, can effectively treat the renal insufficiency, has higher effective rate and cure rate, good curative effect and short period, and has the cure effect obviously better than that of a control group.

Typical applications 1:

pengzhi, female, 35 years old, visual blood urine were admitted for a plurality of days, color Doppler shows diffuse lesion of double kidneys, and pathological renal biopsy shows: IgA nephropathy grade IV, with crescent formation. The glucocorticoid plus immune preparation is taken for one year, and the medicine is not effective, namely the medicine is taken three times a day, one pill is taken every time, and the medicine is reviewed by a hospital at regular intervals. The medicine can be taken for five courses and then can be cured. After two years of follow-up, no recurrence occurs.

Typical applications 2:

bordetella, female, age 31, admission examination of macroscopic blood and urine for multiple days, blood conventional erythrocyte count 313/ul, urine examination, total urine protein 588mg/L, hyperchromia display diffuse lesion of double kidneys, glomerular mesangial region and renal interstitial argentiphilic fiber increase, renal tubular atrophy. The prescription is changed to be used for treatment when various medicines are not effective, the medicines are taken three times a day, one pill is taken every time, and the medicines are reviewed at regular intervals in hospitals. The medicine is taken for three courses of treatment and then is cured. After two years of follow-up, no recurrence occurs.

Typical applications 3:

the urine volume is below 500ml every day, the laboratory examination index is abnormal, the blood creatinine value and the blood urea nitrogen value are higher, the urine creatinine value is lower, and the color Doppler ultrasound shows diffuse lesion of double kidneys. The traditional Chinese medicine composition is not effective when being taken, namely the traditional Chinese medicine composition is used for treating the urinary creatinine, the traditional Chinese medicine composition is taken three times a day, one pill is taken each time, the patient is examined again in a hospital after taking the traditional Chinese medicine composition for three courses of treatment, the blood creatinine is reduced by more than 30% compared with the blood creatinine before treatment, and the urinary creatinine is increased by more than 30% compared with the urine. The application is continued for two treatment courses for consolidation. Follow-up survey found no recurrence after one year.

Claims

1. The traditional Chinese medicine composition for treating renal insufficiency is characterized by being prepared by processing the following raw materials in parts by weight:

10-35 parts of ginseng, 20-45 parts of codonopsis pilosula, 30-55 parts of astragalus mongholicus, 30-45 parts of leech, 20-35 parts of lucid ganoderma, 15-35 parts of lotus stamen, 20-55 parts of plantain seed, 30-65 parts of cornus officinalis, 25-60 parts of pseudo-ginseng, 20-50 parts of mulberry, 15-40 parts of red peony root, 10-40 parts of poria cocos, 10-60 parts of fur seal kidney, 10-60 parts of dragon's blood, 10-25 parts of gastrodia elata, 10-35 parts of cistanche, 20-60 parts of achyranthes bidentata, 20-55 parts of bighead atractylodes rhizome, 10-35 parts of raspberry, 15-45 parts of curculigo orchioides, 10-35 parts of sea horse, 15-30 parts of ground beeltle, 10-45 parts of epimedium, 25-50 parts of angelica sinensis, 15-30 parts of cynomorium songaricum, 20-60 parts of parasitic loranthus, 10-35 parts of rhizoma alismatis, 15-55 parts of tortoise plastron, 10-35 parts of turtle shell, 30 parts of prepared rhizome, 30-65 parts of prepared rehmannia, 20-55 parts, 15-50 parts of salvia miltiorrhiza, 25-55 parts of donkey-hide gelatin, 20-30 parts of burdock, and 10-35 parts of snow lotus herb; the traditional Chinese medicine composition is prepared by the following steps:

2. The traditional Chinese medicine composition for treating renal insufficiency according to claim 1, which is prepared by processing the following raw materials in parts by weight:

20 parts of ginseng, 30 parts of codonopsis pilosula, 50 parts of astragalus membranaceus, 40 parts of leech, 30 parts of lucid ganoderma, 20 parts of lotus stamen, 40 parts of plantain seed, 40 parts of cornus officinalis, 30 parts of pseudo-ginseng, 30 parts of mulberry, 25 parts of red peony root, 20 parts of poria cocos, 20 parts of fur seal kidney, 20 parts of dragon's blood, 20 parts of gastrodia elata, 30 parts of cistanche, 50 parts of achyranthes bidentata, 30 parts of bighead atractylodes rhizome, 20 parts of raspberry, 20 parts of curculigo orchioides, 20 parts of hippocampus, 20 parts of ground beeltle, 20 parts of epimedium, 25 parts of angelica, 25 parts of cynomorium songaricum, 30 parts of loranthus parasiticus, 20 parts of rhizoma alismatis, 20 parts of tortoise plastron, 20 parts of turtle shell, 40 parts of prepared rehmannia root, 30 parts of rhizoma polygonati, 30 parts of schisandra chinensis, 20 parts of.

3. The oral preparation prepared from the traditional Chinese medicine composition for treating renal insufficiency and auxiliary materials according to any one of claims 1 to 2, wherein the oral preparation is a pill, a tablet, a capsule or powder; the weight part ratio of the traditional Chinese medicine composition to the auxiliary materials is 1: 0.5-3.

4. The oral preparation according to claim 3, wherein the oral preparation is a pill, and the adjuvant comprises 10-20 parts by weight of water and 20-40 parts by weight of honey.

5. The oral preparation of claim 4, wherein the adjuvant further comprises 20-30 parts by weight of sodium carboxymethylcellulose.

6. The oral formulation of claim 3, wherein the oral formulation is a capsule comprising a capsule shell and capsule contents; the capsule content comprises a pharmaceutical composition and auxiliary materials; the auxiliary materials comprise 10-20 parts by weight of lactitol and 9-15 parts by weight of hydroxyethyl cellulose.

7. The oral preparation of claim 6, wherein the adjuvant further comprises 22-30 parts by weight of sodium starch glycolate and 14-20 parts by weight of isopropyl palmitate.

8. A method of preparing an oral formulation for the treatment of renal insufficiency of claim 5, comprising the steps of:

a) preparing a traditional Chinese medicine composition;

c) adding sodium carboxymethylcellulose into the Chinese medicinal composition powder, mixing with the material obtained in step b), stirring, and making into pill by die box extrusion;

9. Use of a Chinese medicinal composition according to claim 1 or 2 for the manufacture of a medicament for the treatment of renal insufficiency.