CN104771563B - The compound Chinese medicinal preparation and preparation method of a kind of kidney tonifying - Google Patents

The compound Chinese medicinal preparation and preparation method of a kind of kidney tonifying Download PDF

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CN104771563B
CN104771563B CN201510209588.6A CN201510209588A CN104771563B CN 104771563 B CN104771563 B CN 104771563B CN 201510209588 A CN201510209588 A CN 201510209588A CN 104771563 B CN104771563 B CN 104771563B
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chinese
radix
decoction
cassia tree
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CN104771563A (en
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郭凌云
随裕敏
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YUEYANG XINHUADA PHARMACEUTICAL CO Ltd
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YUEYANG XINHUADA PHARMACEUTICAL CO Ltd
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Abstract

The present invention relates to a kind of compound Chinese medicinal preparation of kidney tonifying, mainly it is made of by weight following traditional Chinese medicines material, wherein:1.5 ~ 6 parts of ginseng;1 ~ 4 part of Radix Codonopsis;3.5 ~ 15 parts of radix astragali;0.2 ~ 1 part of pilose antler;1 ~ 4 part of Chinese cassia tree;3 ~ 12 parts of Herba Epimedii;1 ~ 4 part of cynomorium songaricum;1 ~ 5 part of thizoma curculiginis;1 ~ 5 part of monkshood;5 ~ 20 parts of the fruit of Chinese wolfberry;1.5 ~ 6 parts of Morinda officinalis;1 ~ 4 part of saline cistanche;1 ~ 4 part of gekko;1 ~ 5 part of semen allii tuberosi;2 ~ 8 parts of Angelica sinensis;1 ~ 5 part of Radix Paeoniae Alba;3 ~ 12 parts of prepared rhizome of rehmannia;1 ~ 4 part of Schisandra chinensis;1 ~ 4 part of Fructus Corni;2 ~ 8 parts of stir-baked CORTEX EUCOMMIAE with salt solution.Add pharmaceutic adjuvant oral liquid, tablet, capsule or the granule described in pharmaceutical preparation.

Description

The compound Chinese medicinal preparation and preparation method of a kind of kidney tonifying
Technical field
The present invention relates to a kind of oral liquid being prepared using several kinds of Chinese medicinal materials as main active principle, tablet, capsule and Pharmaceutical preparations such as granule and preparation method thereof.More particularly to ginseng, Radix Codonopsis, radix astragali, pilose antler, Chinese cassia tree, Herba Epimedii, cynomorium songaricum, Thizoma curculiginis, monkshood, the fruit of Chinese wolfberry, Morinda officinalis, saline cistanche, gekko, semen allii tuberosi, Angelica sinensis, Radix Paeoniae Alba, prepared rhizome of rehmannia, Schisandra chinensis, Fructus Corni, salt Totally 20 kinds of Chinese medicines are pharmaceutical preparation and preparation method made of main active principle to bark of eucommia etc..
Background technology
According to the yin-yang theory of traditional Chinese medicine, negative and positive have limitlessly detachable, kidney elder generation acquired essence, and essence belongs to cloudy, so claiming Cloudy essence, QI belonging to YANG, so claiming yang-energy, is collectively referred to as cloudy the vivid YANG QI.Kidney essense belongs to cloudy essence, among cloudy essence again can forked rubbing again, wherein again can It is divided into cloudy smart the yang aspect of yang essence and cloudy smart the yin aspect of yin essence.During cloudy essence the yang aspect of yang essence virtual loss, having soreness of waist and knee joint, spinal column to wither, weak, bone is sour tired The Symptoms such as exhausted, fatiguability, when cloudy essence the yin aspect of yin essence virtual loss have soreness and weakness of waist and knees, talagia, mouth parched and tongue scorched, quench one's thirst, have a sleepless night it is more The Symptoms such as dream.It is how in close relations with kidney-yang deficiency during cloudy essence the yang aspect of yang essence virtual loss, during cloudy essence the yin aspect of yin essence virtual loss more and kidney yin Virtual relation is close.So soreness of waist and knee joint is often accompanied by addition to having the cold grade performance of chilly, spinal column withers, and weak, bone is sour tired during kidney-yang deficiency The symptoms such as exhausted, fatiguability, during kidney-yin deficiency in addition to having that the deficiency of Yin is scorching and waiting performance, are often accompanied by soreness and weakness of waist and knees, talagia, dry tongue The dry, symptom such as quench one's thirst.
China's traditional Chinese medical science thinks that the clinical manifestation of kidney-yang deficiency has many aspects, such as:Spiritlessness and weakness, lassitude, vigor are low Under, fatiguability;Chilly is cold, cold limbs(Severe one summer is also cool), body hair it is heavy;Soreness of waist and knee joint, back crymodynia, muscles and bones are withered It is soft;Hypogona dism, impotence, premature ejaculation, be susceptible to suffer from prostatitis etc.;Clear abundant urine, the heeltap not to the utmost, oliguria or night pollakiuria;Hearing Decline or tinnitus;Failure of memory, drowsiness, dreaminess, spontaneous perspiration;It is susceptible to suffer from pain in the back, arthralgia etc.;Be susceptible to suffer from osteoporosis, cervical spondylosis, Lumbar vertebra disease etc.;Void is breathed short, cough and asthma gurgling weith sputum;Morning diarrhea, or constipation;Body edema, below waist more so, edema of lower extremity;Underbelly Draw testis falling inflation pain, or scrotum is shunk, meet it is cold what for, heat is then delayed;Beard and hair is easy to fall off, morning is white;Body puffiness is thin thin; Being reflected in face, then color is bluish white unglazed or dark.
The clinical manifestation of syndrome of deficiency of kidney yang may be summarized to be ten aspects:
1. soreness and weakness of waist and knees and pain;2. impotence in male premature ejaculation, woman's fertility;3. endless diarrhea, diarrhea with undigested food, diarrhea before dawn Rush down;4. frequent urination, clear long, frequent urination at night;5. edema;6. darkish complexion is without pool;7. aversion to cold and cold limbs, lower limb is very;8. spirit is withered Waste;9. pale complexion, vertigo;10. the fat tongue of pale tongue is white, forceless deep pulse and it is slow.
Syndrome:Soreness and weakness of waist and knees and pain;Impotence in male premature ejaculation, woman's fertility;Aversion to cold and cold limbs, edema, for very below waist, Lower limb is very;Pale complexion, vertigo;Darkish complexion is without pool, frequent urination, clear long, frequent urination at night;The fat tongue of pale tongue is white, forceless deep pulse It is and slow.
The general kidney-yang deficiency rules for the treatment of:Warming and invigorating kidney Yang.Main side:Chinkuei shin chewan pills;Its prescription is glutinous rehmannia, Chinese yam, Fructus Corni(Wine Process), Poria cocos, moutan bark, rhizoma alismatis, cassia twig, monkshood(System), the root of bidentate achyranthes(Decaptitating), plantain seed(Salt is processed).Auxiliary material is honey.
The kidney deficiency diarrhea rules for the treatment of:Warm kidney antidiarrheal.Main side:Sishen wan;Its prescription is nutmeg (stewing), psoralea corylifolia (salt stir-fry), five Taste (vinegar system), evodia rutaecarpa (system), jujube (stoning).
The edema due to the kidney insufficiency rules for the treatment of:Warming kidney for duresis, main side:Zhen Wu Tang, Decoction for strengthening the Spleen-Yang.Its prescription is Poria cocos, Chinese herbaceous peony, ginger, monkshood, Rhizoma Atractylodis Macrocephalae.
There is the conventional Chinese medicine with warming and invigorating kidney Yang drug action in China's Chinese medicine:It is pilose antler, monkshood, cassia twig, Rhizoma Atractylodis Macrocephalae, sweet Grass, radix astragali, Radix Paeoniae Alba, Poria cocos, dogwood fruit, Chinese yam rhizome, psoralea corylifolia, the fruit of Chinese wolfberry, Semen Cuscutae, cordyceps sinensis, sea otter, hippocampus etc..Mend Sea otter, gekko, pilose antler, Herba Epimedii, saline cistanche, actinolite, cynomorium songaricum, semen allii tuberosi, deer horn glue, the bark of eucommia, Morinda officinalis, bone in kidney Chinese medicine Broken benefit, rhizoma cibotii, thizoma curculiginis etc. have warm kidney sun, Yiyang essence(Cloudy essence the yang aspect of yang essence)Effect, prepared rhizome of rehmannia, RADIX POLYGONI MULTIFLORI PREPARATA, the fruit of Chinese wolfberry, tortoise First glue, fruit of glossy privet etc. have the cloudy essence of nourishing kidney-yin, benefit(Cloudy essence the yin aspect of yin essence)Effect, therefore when wanting kidney tonifying smart for deficiency of kidney-essence Negative and positive are distinguished, select suitable Chinese medicine to nourish.
General influence of the kidney-yang deficiency to people is bigger than kidney-yin deficiency, and sun is main cloudy from interdependence between yin and yang in human body.Kidney-yang deficiency and kidney yin Void is not well-separated, and clinically either kidney-yin deficiency, or kidney-yang deficiency, if deficient, often the moon undermines to a certain extent Sun, the deficiency of yang affecting yin.Therefore kidney yang imaginary time, which has been grown, has kidney-yin deficiency symptom, so having to simultaneous tonifying kidney-yin in kidney-replenishing, does To treating YANG within YIN;And the medicine for only using tonifying kidney-yin that can not be simply when tonifying kidney-yin.
The present invention is intended to provide a kind of utilize Traditional Chinese medical theory and traditional Chinese medicine preparation method, work is produced with reference to modern Chinese herbal medicine Skill, using several kinds of Chinese medicinal materials as compound Chinese medicinal preparation made of main active principle;Its function and predominantly warming and invigorating kidney Yang is cured mainly, fitted For syndrome of deficiency of kidney yang, symptoms include spiritlessness and weakness, soreness and weakness of waist and knees, dizzy spontaneous perspiration, aversion to cold and cold limbs, diarrhea before dawn, enuresis nocturna frequency.
The content of the invention
One, prescriptions
It is an object of the invention to provide one kind using several kinds of Chinese medicinal materials as compound preparation made of main active principle and its Preparation method.Specifically, it is exactly with ginseng, Radix Codonopsis, radix astragali, pilose antler, Chinese cassia tree, Herba Epimedii, cynomorium songaricum, thizoma curculiginis, monkshood, matrimony vine Son, Morinda officinalis, saline cistanche, gekko, semen allii tuberosi, Angelica sinensis, Radix Paeoniae Alba, prepared rhizome of rehmannia, Schisandra chinensis, Fructus Corni, stir-baked CORTEX EUCOMMIAE with salt solution totally 20 kinds of Chinese medicine Material is compound medicinal formulation made of main active principle, is clinically mainly used for syndrome of deficiency of kidney yang, symptoms include spiritlessness and weakness, waist and knee acid It is soft, dizzy spontaneous perspiration, aversion to cold and cold limbs, diarrhea before dawn, enuresis nocturna frequency.
The present invention except main active principle for ginseng, Radix Codonopsis, radix astragali, pilose antler, Chinese cassia tree, Herba Epimedii, cynomorium songaricum, thizoma curculiginis, monkshood, Totally 20 kinds of the fruit of Chinese wolfberry, Morinda officinalis, saline cistanche, gekko, semen allii tuberosi, Angelica sinensis, Radix Paeoniae Alba, prepared rhizome of rehmannia, Schisandra chinensis, Fructus Corni, stir-baked CORTEX EUCOMMIAE with salt solution Outside Chinese medicine, flavouring needed for pharmaceutical preparation, preservative, stabilizer, diluent, adhesive, wetting agent, disintegration are further included The common auxiliary material such as agent, lubricant.
Present invention, which is removed, to be included ginseng, Radix Codonopsis, radix astragali, pilose antler, Chinese cassia tree, Herba Epimedii, cynomorium songaricum, thizoma curculiginis, monkshood, matrimony vine Son, Morinda officinalis, saline cistanche, gekko, semen allii tuberosi, Angelica sinensis, Radix Paeoniae Alba, prepared rhizome of rehmannia, Schisandra chinensis, Fructus Corni, stir-baked CORTEX EUCOMMIAE with salt solution totally 20 kinds of Chinese medicine Material is made outside compound medicinal formulation, further includes the production technology that pharmaceutical preparation is prepared using common drug pharmaceutical adjunct.
The purpose of the present invention is what is completed by following technical proposals.
A kind of compound Chinese medicinal preparation of kidney tonifying, it is characterised in that:Mainly it is made of by weight following traditional Chinese medicines material:
Sequence number Component Part by weight
1 Ginseng 1.5 ~ 6 parts
2 Radix Codonopsis 1 ~ 4 part
3 Radix astragali 3.5 ~ 15 parts
4 Pilose antler 0.2 ~ 1 part
5 Chinese cassia tree 1 ~ 4 part
6 Herba Epimedii 3 ~ 12 parts
7 Cynomorium songaricum 1 ~ 4 part
8 Thizoma curculiginis 1 ~ 5 part
9 Monkshood 1 ~ 5 part
10 The fruit of Chinese wolfberry 5 ~ 20 parts
11 Morinda officinalis 1.5 ~ 6 parts
12 Saline cistanche 1 ~ 4 part
13 Gekko 1 ~ 4 part
14 Semen allii tuberosi 1 ~ 5 part
15 Angelica sinensis 2 ~ 8 parts
16 Radix Paeoniae Alba 1 ~ 5 part
17 Prepared rhizome of rehmannia 3 ~ 12 parts
18 Schisandra chinensis 1 ~ 4 part
19 Fructus Corni 1 ~ 4 part
20 Stir-baked CORTEX EUCOMMIAE with salt solution 2 ~ 8 parts
Add pharmaceutical preparation needed for pharmaceutic adjuvant flavouring, preservative, stabilizer, diluent, adhesive, wetting agent, Disintegrant, lubricant, are made oral solutions, tablet, capsule or granule.
Currently preferred formula is mainly made of by weight following traditional Chinese medicines material:
Sequence number Component Part by weight
1 Ginseng 3 parts
2 Radix Codonopsis 2 parts
3 Radix astragali 7.5 part
4 Pilose antler 0.5 part
5 Chinese cassia tree 2 parts
6 Herba Epimedii 6 parts
7 Cynomorium songaricum 2 parts
8 Thizoma curculiginis 2.5 part
9 Monkshood 2.5 part
10 The fruit of Chinese wolfberry 10 parts
11 Morinda officinalis 3 parts
12 Saline cistanche 2 parts
13 Gekko 2 parts
14 Semen allii tuberosi 2.5 part
15 Angelica sinensis 4 parts
16 Radix Paeoniae Alba 2.5 part
17 Prepared rhizome of rehmannia 6 parts
18 Schisandra chinensis 2 parts
19 Fructus Corni 2 parts
20 Stir-baked CORTEX EUCOMMIAE with salt solution 4 parts
Add pharmaceutical preparation needed for pharmaceutic adjuvant flavouring, preservative, stabilizer, diluent, adhesive, wetting agent, Disintegrant, lubricant, are made oral solutions, tablet, tablet, capsule or granule.
Two, preparation processes
The oral liquid process of the present invention:
1)20 taste Chinese medicine, cleans respectively as described in recipe quantity weighs prescription list, sieves, sterilizing;
2)Take Angelica sinensis, Chinese cassia tree to add 3 times of water, boil 3 it is small when, while collect volatile oil;Aqueous solution is filled with the other container of the dregs of a decoction Contain, it is spare;
3)It is coarse powder to take ginseng, Radix Codonopsis, pilose antler, gekko, 5 taste Chinese medicine of Radix Paeoniae Alba to crush, and adds 80% alcohol reflux to extract 3 times, 8 times of amounts every time, every time 3 it is small when, merge ethanol extract, filtration, filtrate is spare.
4) by 3)In the dregs of a decoction and radix astragali, Herba Epimedii, cynomorium songaricum, thizoma curculiginis, monkshood, the fruit of Chinese wolfberry, Morinda officinalis, saline cistanche, leek Son, prepared rhizome of rehmannia, Schisandra chinensis, Fructus Corni, 13 taste Chinese medicine of stir-baked CORTEX EUCOMMIAE with salt solution merge, and add above-mentioned Angelica sinensis, the Chinese cassia tree dregs of a decoction, add water to cook 3 Secondary, each plus 5 times of amount water, when decoction 2 is small every time, collecting decoction, filters, and filtrate merges with the aqueous solution that Angelica sinensis, Chinese cassia tree are distilled, Relative density is concentrated into as 1.20(80℃)Clear cream.
5)It is 60% that gained clear cream addition ethanol, which is made containing amount of alcohol, when standing 48 is small, is filtered, filtrate and above-mentioned ginseng, party Ginseng, pilose antler, gekko, Radix Paeoniae Alba ethanol extract merge, and recycling ethanol to relative density is 1.05(80℃), it is medicinal auxiliary needed for addition Expect flavouring, preservative, stabilizer and 2)In volatile oil, add water constant volume, stir evenly, stand, filtered with diatomite, fill Dress, sterilizing, obtains solution finished product.
Tablet, capsule and the particle agent producing process of the present invention:
1)20 taste Chinese medicine, cleans respectively as described in recipe quantity weighs prescription list, sieves, sterilizing;
2)Take Angelica sinensis, Chinese cassia tree to add 3 times of water, boil 3 it is small when, while collect volatile oil;Aqueous solution is filled with the other container of the dregs of a decoction Contain, it is spare;
3)It is coarse powder to take ginseng, Radix Codonopsis, pilose antler, gekko, 5 taste Chinese medicine of Radix Paeoniae Alba to crush, and adds 80% alcohol reflux to extract 3 times, 8 times of amounts every time, every time 3 it is small when, merge ethanol extract, filtration, filtrate is spare.
4) by 3)In the dregs of a decoction and radix astragali, Herba Epimedii, cynomorium songaricum, thizoma curculiginis, monkshood, the fruit of Chinese wolfberry, Morinda officinalis, saline cistanche, leek Son, prepared rhizome of rehmannia, Schisandra chinensis, Fructus Corni, 13 taste Chinese medicine of stir-baked CORTEX EUCOMMIAE with salt solution merge, and add above-mentioned Angelica sinensis, the Chinese cassia tree dregs of a decoction, add water to cook 3 Secondary, each plus 5 times of amount water, when decoction 2 is small every time, collecting decoction, filters, and filtrate merges with the aqueous solution that Angelica sinensis, Chinese cassia tree are distilled, Relative density is concentrated into as 1.20(80℃)Clear cream.
5)It is 60% that gained clear cream addition ethanol, which is made containing amount of alcohol, when standing 48 is small, is filtered, filtrate and above-mentioned ginseng, party Ginseng, pilose antler, gekko, Radix Paeoniae Alba ethanol extract merge, and recycling ethanol to relative density is 1.05(80℃)Clear cream, add 2)In Volatile oil, stir evenly.It is dried under vacuum to the blocks of solid that moisture is 8%.
6)Blocks of solid is moistened with the ethanol solution of 75-85%, is sufficiently stirred 30 minutes, makes to be uniformly mixed;Wet method system Grain, whole grain after drying;Pharmaceutic adjuvant flavouring, diluent, adhesive, wetting agent, disintegrant, lubricant needed for sequentially adding, Tablet, capsule or granule is made.
Required pharmaceutic adjuvant in production technology of the present invention refer to flavouring, preservative, stabilizer, diluent, adhesive, Wetting agent, disintegrant, lubricant.
Flavouring refers to the one or more in honey, sucrose, aspartame, saccharin sodium, Sucralose.
Preservative refers to the one or more in benzoic acid, sodium benzoate, sorbic acid, methyl hydroxybenzoate, ethylparaben.
Stabilizer refers to one kind or several in polyethylene glycol 200, polyethylene glycol 400, polyethylene glycol-800, polyoxyethylene sorbitan monoleate Kind.
Diluent refers to starch, pregelatinized starch, lactose, dextrin, microcrystalline cellulose, mannitol, D-sorbite, sulfuric acid One or more in calcium, calcium bisulfate.
Adhesive refers to the one or more in starch slurry, hydroxymethyl cellulose, povidone, gelatin, polyethylene glycol.
Wetting agent refers to ethanol.
Disintegrant refers to Sodium Hydroxymethyl Stalcs, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl fiber One or more in plain sodium, crospovidone.
Lubricant refers to the one or more in magnesium stearate, talcum powder, superfine silica gel powder, hydrogenated vegetable oil.
Three, quality controls
The primary quality measure of product of the present invention is with containing ginsenoside Rg1(C42H72O14)And ginsenoside Re(C48H82O18) Total amount meter, oral liquid is no less than 25 μ g per ml;Every of tablet, capsule and granule(Grain, bag)Containing ginsenoside Rg1 (C42H72O14)And ginsenoside Re(C48H82O18)Total amount meter, no less than 250 μ g.
Assay method:According to high performance liquid chromatography(One annex I J of Chinese Pharmacopoeia version in 2010)
It is filler with octadecylsilane chemically bonded silica;The phosphoric acid of acetonitrile -0.05%(18:82)For mobile phase;Detection wavelength For 203nm.Theoretical cam curve is calculated by ginsenoside Re peak should be not less than 2500.Precision weighs ginsenoside Rg1Compareed with Re Product, are separately added into the solution that every ml0.15mg, 0.1mg is made in methanol, as reference substance solution.Precision weighs this product and contains Rg1 (C42H72O14)And ginsenoside Re(C48H82O18)Total amount be about 1.25mg amounts product of the present invention, to water saturated positive fourth Alcohol shaking extraction 4 times, each 30ml, is washed 2 times with ammonia solution, discards ammonia washing lotion.N-butanol liquid is put and is evaporated in water-bath, and residue adds Water 5ml dissolves, with D101Resin adsorption, with 50ml water elutions, discards eluent, is eluted after with 70% ethanol 80ml, collection is washed De- liquid, puts and is evaporated in water-bath, residue adds methanol to dissolve in right amount, moves in 5ml measuring bottles, adds methanol to scale;Shake up, filter, continue Filtrate is test solution.Above-mentioned reference substance solution and each 5 μ l of test solution are drawn respectively, injects liquid chromatograph, are surveyed It is fixed, to obtain the final product.
Portioned product assay result of the present invention:
By carrying out the embodiment of the present invention of continuous 9 batches, the product of each 3 lot numbers of oral liquid, tablets and capsules is obtained, Through examining, all meet the quality criteria requirements that the present invention works out.Illustrate that present invention process is stable, reliable, 3 of each formulation The content of lot number is basically identical, illustrates that the preparation process of the present invention is reproducible.
Portioned product study on the stability result of the present invention:
Investigation condition:According to《Chinese Pharmacopoeia》The two annex XIX C of version in 2010 " bulk pharmaceutical chemicals and pharmaceutical preparation stability test The condition of guideline " defined, product is put by commercially available back under conditions of 40 ± 2 DEG C of temperature, relative humidity 75 ± 5% Put 6 months, examine ginsenoside Rg1With ginsenoside Re's total amount, and with 0 day results contrast, it is as a result as follows:
The accelerated study on the stability of product of 9 lot numbers is after 6 months, its ginsenoside Rg1With ginsenoside Re's total amount and 0 It compares, and significant changes do not occur, and illustrates present invention process products obtained therefrom stable quality, controllable.
Four, clinical researches
Major function of the present invention is cured mainly as syndrome of deficiency of kidney yang, symptoms include spiritlessness and weakness, soreness and weakness of waist and knees, dizzy sweat, aversion to cold and cold limbs, and five More rush down, enuresis nocturna frequency.We select 67 kidney-yang deficiencies using the oral solutions in 9 batches of products of embodiment and tablet in hospital Person is treated, to observe clinical effectiveness.
1 Liu's ×× of model case, man, 36 years old.Low Back Pain, frequent dizzy, headache, soft foot is soft, night pollakiuria, every night 8 ~ 10 times.Differential diagnosis in tcm is syndrome of deficiency of kidney yang.After oral liquor for spleen and kidney(20ml/ branch), it is daily 2 times, sooner or later each after one, 4 days In addition to the slight soreness of waist, other symptoms are clearly better.
2 Lee's ×× of model case, man, 57 years old.Weakness of the lower extremities, upper 3 buildings shortness of breath pectoralgias, easily sweating are weak especially bright Aobvious, insomnia has difficulty in going to sleep.Differential diagnosis in tcm is syndrome of deficiency of kidney yang.After kidney invigorating tablet, daily 2 times, 2 tablets once, and symptom is complete after 7 days Portion disappears.
The clinical therapeutic efficacy of 67 Patients with Kidney-Yang Deficiency Syndrome is as follows altogether:
Total case load Cure number of cases Effective number of cases Effective number of cases Invalid number of cases Total effective rate
67 19 34 11 3 94.03%
Through being counted to 67 Patients with Kidney-Yang Deficiency Syndrome using oral liquor for spleen and kidney clinical treatment, its clinical cure 19, effective 34 Example, effective 11, invalid 3, total effective rate 94.03%.Illustrate that the present invention has higher treatment in terms of syndrome of deficiency of kidney yang is treated Effect.
During clinical treatment observation, obvious adverse reaction is not found after 67 patient's medications, shows that poison of the invention is secondary Act on it is low, safely and effectively.
Five, it is characteristic of the invention that:
1. the compound preparation of innovation
By ginseng, Radix Codonopsis, radix astragali, pilose antler, Chinese cassia tree, Herba Epimedii, cynomorium songaricum, thizoma curculiginis, monkshood, the fruit of Chinese wolfberry, Morinda officinalis, meat desert Totally 20 kinds of Chinese medicines are used in tradition for Rong, gekko, semen allii tuberosi, Angelica sinensis, Radix Paeoniae Alba, prepared rhizome of rehmannia, Schisandra chinensis, Fructus Corni, stir-baked CORTEX EUCOMMIAE with salt solution etc. Medicine preparation process, is made the compound medicinal formulation of innovation, including oral liquid, tablet, capsule and granule.
2. the production technology of innovation
The production technology of the present invention combines traditional Chinese medicine concocting method and advanced modern Chinese herbal medicine extraction and preparation technique.
3. significant therapeutic effect
Through being counted to 67 Patients with Kidney-Yang Deficiency Syndrome using oral liquor for spleen and kidney clinical treatment, its clinical cure 19, effective 34 Example, effective 11, invalid 3, total effective rate 94.03%.
4. the production technology stablized
Oral liquid, tablet and the accelerated study on the stability of capsule product of 9 lot numbers of the invention are after 6 months, its ginseng soap Glycosides Rg1With ginsenoside Re's total amount compared with 0 day, significant changes do not occur, illustrate that present invention process is ripe, reliable, gained Product quality is stable, controllable.
Embodiment
Embodiment 1
Ginseng 3g, Radix Codonopsis 2g, radix astragali 7.5g, pilose antler 0.5g, Chinese cassia tree 2g, Herba Epimedii 6g, cynomorium songaricum 2g, thizoma curculiginis are weighed respectively 2.5g, monkshood 2.5g, fruit of Chinese wolfberry 10g, Morinda officinalis 3g, saline cistanche 2g, gekko 2g, semen allii tuberosi 2.5g, Angelica sinensis 4g, Radix Paeoniae Alba 2.5g, Prepared rhizome of rehmannia 6g, Schisandra chinensis 2g, Fructus Corni 2g, stir-baked CORTEX EUCOMMIAE with salt solution 4g totally 20 kinds of Chinese medicines, " oral liquid of the invention produces work according to foregoing Skill " the step, is made 1000ml solution, is distributed into the oral liquor for spleen and kidney of 100 bottles 10ml/ bottles or 50 bottles 20ml/ bottles.
Embodiment 2
Ginseng 6g, Radix Codonopsis 4g, radix astragali 7.5g, pilose antler 1g, Chinese cassia tree 3g, Herba Epimedii 4g, cynomorium songaricum 1g, thizoma curculiginis are weighed respectively 2.5g, monkshood 2.5g, fruit of Chinese wolfberry 8g, Morinda officinalis 3g, saline cistanche 2g, gekko 1g, semen allii tuberosi 2.5g, Angelica sinensis 8g, Radix Paeoniae Alba 5g, cultivated land Yellow 4g, Schisandra chinensis 2g, Fructus Corni 2g, stir-baked CORTEX EUCOMMIAE with salt solution 3g totally 20 kinds of Chinese medicines, according to foregoing " oral liquid process of the invention " institute Step is stated, 1000ml solution is made, is distributed into the oral liquor for spleen and kidney of 100 bottles 10ml/ bottles or 50 bottles 20ml/ bottles.
Embodiment 3
Ginseng 3kg, Radix Codonopsis 2kg, radix astragali 7.5kg, pilose antler 0.5kg, Chinese cassia tree 2kg, Herba Epimedii 6kg, cynomorium songaricum are weighed respectively 2kg, thizoma curculiginis 2.5kg, monkshood 2.5kg, fruit of Chinese wolfberry 10kg, Morinda officinalis 3kg, saline cistanche 2kg, gekko 2kg, semen allii tuberosi 2.5kg, when Return 4kg, Radix Paeoniae Alba 2.5kg, prepared rhizome of rehmannia 6kg, Schisandra chinensis 2kg, Fructus Corni 2kg, stir-baked CORTEX EUCOMMIAE with salt solution 4kg totally 20 kinds of Chinese medicines, according to foregoing " this The oral liquid process of the invention " step, is made 1000L solution, is distributed into 100000 bottles 10ml/ bottles or 50000 bottles 20ml/ bottles of oral liquor for spleen and kidney.
Embodiment 4
Ginseng 2kg, Radix Codonopsis 1kg, radix astragali 12kg, pilose antler 1kg, Chinese cassia tree 2kg, Herba Epimedii 4kg, cynomorium songaricum 2kg, celestial being are weighed respectively Thatch 3kg, monkshood 2.5kg, fruit of Chinese wolfberry 15kg, Morinda officinalis 4kg, saline cistanche 3kg, gekko 2kg, semen allii tuberosi 4kg, Angelica sinensis 2kg, Radix Paeoniae Alba 2.5kg, prepared rhizome of rehmannia 6kg, Schisandra chinensis 1kg, Fructus Corni 2kg, stir-baked CORTEX EUCOMMIAE with salt solution 3kg totally 20 kinds of Chinese medicines, " of the invention is oral according to foregoing Liquid production technology " the step, is made 1000L solution, is distributed into 100000 bottles 10ml/ bottles or 50000 bottles 20ml/ bottles Oral liquor for spleen and kidney.
Embodiment 5
Ginseng 3g, Radix Codonopsis 2g, radix astragali 7.5g, pilose antler 0.5g, Chinese cassia tree 2g, Herba Epimedii 6g, cynomorium songaricum 2g, thizoma curculiginis are weighed respectively 2.5g, monkshood 2.5g, fruit of Chinese wolfberry 10g, Morinda officinalis 3g, saline cistanche 2g, gekko 2g, semen allii tuberosi 2.5g, Angelica sinensis 4g, Radix Paeoniae Alba 2.5g, Prepared rhizome of rehmannia 6g, Schisandra chinensis 2g, Fructus Corni 2g, stir-baked CORTEX EUCOMMIAE with salt solution 4g totally 20 kinds of Chinese medicines, according to it is foregoing " tablet of the invention, capsule and Granula production technology " the step, is made 100 or 50 kidney invigorating tablets.
Embodiment 6
Ginseng 3g, Radix Codonopsis 2g, radix astragali 7.5g, pilose antler 0.5g, Chinese cassia tree 2g, Herba Epimedii 6g, cynomorium songaricum 2g, thizoma curculiginis are weighed respectively 2.5g, monkshood 2.5g, fruit of Chinese wolfberry 10g, Morinda officinalis 3g, saline cistanche 2g, gekko 2g, semen allii tuberosi 2.5g, Angelica sinensis 4g, Radix Paeoniae Alba 2.5g, Prepared rhizome of rehmannia 6g, Schisandra chinensis 2g, Fructus Corni 2g, stir-baked CORTEX EUCOMMIAE with salt solution 4g totally 20 kinds of Chinese medicines, according to it is foregoing " tablet of the invention, capsule and Granula production technology " the step, is made 100 or 50 capsule for tonifying kidney.
Embodiment 7
Ginseng 3g, Radix Codonopsis 2g, radix astragali 7.5g, pilose antler 0.5g, Chinese cassia tree 2g, Herba Epimedii 6g, cynomorium songaricum 2g, thizoma curculiginis are weighed respectively 2.5g, monkshood 2.5g, fruit of Chinese wolfberry 10g, Morinda officinalis 3g, saline cistanche 2g, gekko 2g, semen allii tuberosi 2.5g, Angelica sinensis 4g, Radix Paeoniae Alba 2.5g, Prepared rhizome of rehmannia 6g, Schisandra chinensis 2g, Fructus Corni 2g, stir-baked CORTEX EUCOMMIAE with salt solution 4g totally 20 kinds of Chinese medicines, according to it is foregoing " tablet of the invention, capsule and Granula production technology " the step, is made 100 bags or 50 bags of Bushen granules.
Embodiment 8
Ginseng 3kg, Radix Codonopsis 2kg, radix astragali 7.5kg, pilose antler 0.5kg, Chinese cassia tree 2kg, Herba Epimedii 6kg, cynomorium songaricum are weighed respectively 2kg, thizoma curculiginis 2.5kg, monkshood 2.5kg, fruit of Chinese wolfberry 10kg, Morinda officinalis 3kg, saline cistanche 2kg, gekko 2kg, semen allii tuberosi 2.5kg, when Return 4kg, Radix Paeoniae Alba 2.5kg, prepared rhizome of rehmannia 6kg, Schisandra chinensis 2kg, Fructus Corni 2kg, stir-baked CORTEX EUCOMMIAE with salt solution 4kg totally 20 kinds of Chinese medicines, according to foregoing " this Tablet, capsule and the particle agent producing process of the invention " step, is made 100000 or 50000 kidney invigorating tablets.
Embodiment 9
Ginseng 3kg, Radix Codonopsis 2kg, radix astragali 7.5kg, pilose antler 0.5kg, Chinese cassia tree 2kg, Herba Epimedii 6kg, cynomorium songaricum are weighed respectively 2kg, thizoma curculiginis 2.5kg, monkshood 2.5kg, fruit of Chinese wolfberry 10kg, Morinda officinalis 3kg, saline cistanche 2kg, gekko 2kg, semen allii tuberosi 2.5kg, when Return 4kg, Radix Paeoniae Alba 2.5kg, prepared rhizome of rehmannia 6kg, Schisandra chinensis 2kg, Fructus Corni 2kg, stir-baked CORTEX EUCOMMIAE with salt solution 4kg totally 20 kinds of Chinese medicines, according to foregoing " this Tablet, capsule and the particle agent producing process of the invention " step, is made 100000 or 50000 capsule for tonifying kidney.
Embodiment 10
Ginseng 1.5kg, Radix Codonopsis 1kg, radix astragali 4kg, pilose antler 0.3kg, Chinese cassia tree 1kg, Herba Epimedii 3kg, cynomorium songaricum are weighed respectively 1kg, thizoma curculiginis 1.5kg, monkshood 1.5kg, fruit of Chinese wolfberry 5kg, Morinda officinalis 1.5kg, saline cistanche 1kg, gekko 1kg, semen allii tuberosi 1.5kg, Totally 20 kinds of Chinese medicines, photograph are foregoing by Angelica sinensis 2kg, Radix Paeoniae Alba 1.5kg, prepared rhizome of rehmannia 3kg, Schisandra chinensis 1kg, Fructus Corni 1kg, stir-baked CORTEX EUCOMMIAE with salt solution 2kg " tablet, capsule and particle agent producing process of the invention " described step, is made 100000 or 50000 kidney invigorating tablets.
Embodiment 11
Weigh respectively ginseng 6kg, Radix Codonopsis 4kg, radix astragali 15kg, pilose antler 1kg, Chinese cassia tree 4kg, Herba Epimedii 12kg, cynomorium songaricum 4kg, Thizoma curculiginis 5kg, monkshood 5kg, fruit of Chinese wolfberry 18kg, Morinda officinalis 6kg, saline cistanche 4kg, gekko 4kg, semen allii tuberosi 5kg, Angelica sinensis 8kg, Radix Paeoniae Alba 5kg, prepared rhizome of rehmannia 12kg, Schisandra chinensis 4kg, Fructus Corni 4kg, stir-baked CORTEX EUCOMMIAE with salt solution 8kg totally 20 kinds of Chinese medicines, according to it is foregoing " tablet of the invention, The capsule and particle agent producing process " step, is made 100000 or 50000 kidney invigorating tablets.
Embodiment 12
Ginseng 1.5kg, Radix Codonopsis 1kg, radix astragali 4kg, pilose antler 0.3kg, Chinese cassia tree 1kg, Herba Epimedii 3kg, cynomorium songaricum are weighed respectively 1kg, thizoma curculiginis 1.5kg, monkshood 1.5kg, fruit of Chinese wolfberry 5kg, Morinda officinalis 1.5kg, saline cistanche 1kg, gekko 1kg, semen allii tuberosi 1.5kg, Totally 20 kinds of Chinese medicines, photograph are foregoing by Angelica sinensis 2kg, Radix Paeoniae Alba 1.5kg, prepared rhizome of rehmannia 3kg, Schisandra chinensis 1kg, Fructus Corni 1kg, stir-baked CORTEX EUCOMMIAE with salt solution 2kg " tablet, capsule and particle agent producing process of the invention " described step, is made 100000 or 50000 capsule for tonifying kidney.
Embodiment 13
Weigh respectively ginseng 6kg, Radix Codonopsis 4kg, radix astragali 15kg, pilose antler 1kg, Chinese cassia tree 4kg, Herba Epimedii 12kg, cynomorium songaricum 4kg, Thizoma curculiginis 5kg, monkshood 5kg, fruit of Chinese wolfberry 18kg, Morinda officinalis 6kg, saline cistanche 4kg, gekko 4kg, semen allii tuberosi 5kg, Angelica sinensis 8kg, Radix Paeoniae Alba 5kg, prepared rhizome of rehmannia 12kg, Schisandra chinensis 4kg, Fructus Corni 4kg, stir-baked CORTEX EUCOMMIAE with salt solution 8kg totally 20 kinds of Chinese medicines, according to it is foregoing " tablet of the invention, The capsule and particle agent producing process " step, is made 100000 bags or 50000 bags of Bushen granules.
Embodiment 14
Weigh respectively ginseng 6kg, Radix Codonopsis 4kg, radix astragali 15kg, pilose antler 1kg, Chinese cassia tree 4kg, Herba Epimedii 12kg, cynomorium songaricum 4kg, Thizoma curculiginis 5kg, monkshood 5kg, fruit of Chinese wolfberry 18kg, Morinda officinalis 6kg, saline cistanche 4kg, gekko 4kg, semen allii tuberosi 5kg, Angelica sinensis 8kg, Radix Paeoniae Alba 5kg, prepared rhizome of rehmannia 12kg, Schisandra chinensis 4kg, Fructus Corni 4kg, stir-baked CORTEX EUCOMMIAE with salt solution 8kg totally 20 kinds of Chinese medicines, " of the invention is oral according to foregoing Liquid production technology " the step, is made 1000L solution, is distributed into 100000 bottles 10ml/ bottles or 50000 bottles 20ml/ bottles Oral liquor for spleen and kidney.
Embodiment 15
Ginseng 1.5kg, Radix Codonopsis 1kg, radix astragali 4kg, pilose antler 0.3kg, Chinese cassia tree 1kg, Herba Epimedii 3kg, cynomorium songaricum are weighed respectively 1kg, thizoma curculiginis 1.5kg, monkshood 1.5kg, fruit of Chinese wolfberry 5kg, Morinda officinalis 1.5kg, saline cistanche 1kg, gekko 1kg, semen allii tuberosi 1.5kg, Totally 20 kinds of Chinese medicines, photograph are foregoing by Angelica sinensis 2kg, Radix Paeoniae Alba 1.5kg, prepared rhizome of rehmannia 3kg, Schisandra chinensis 1kg, Fructus Corni 1kg, stir-baked CORTEX EUCOMMIAE with salt solution 2kg " oral liquid process of the invention " described step, is made 1000L solution, be distributed into 100000 bottles 10ml/ bottles or 50000 bottles 20ml/ bottles of oral liquor for spleen and kidney.

Claims (6)

  1. A kind of 1. compound Chinese medicinal preparation of kidney tonifying, it is characterised in that:It is made of by weight following traditional Chinese medicines material:
    The production technology of its oral liquid is:
    1)20 taste Chinese medicine, cleans respectively as described in recipe quantity weighs prescription list, sieves, sterilizing;
    2)Take Angelica sinensis, Chinese cassia tree to add 3 times of water, boil 3 it is small when, while collect volatile oil;Aqueous solution and the other containers hold of the dregs of a decoction, it is standby With;
    3)It is coarse powder to take ginseng, Radix Codonopsis, pilose antler, gekko, 5 taste Chinese medicine of Radix Paeoniae Alba to crush, and adds 80% alcohol reflux extraction 3 times, every time 8 times of amounts, every time 3 it is small when, merge ethanol extract, filtration, filtrate is spare;
    4) by 3)In the dregs of a decoction and radix astragali, Herba Epimedii, cynomorium songaricum, thizoma curculiginis, monkshood, the fruit of Chinese wolfberry, Morinda officinalis, saline cistanche, semen allii tuberosi, ripe Glutinous rehmannia, Schisandra chinensis, Fructus Corni, 13 taste Chinese medicine of stir-baked CORTEX EUCOMMIAE with salt solution merge, and add above-mentioned Angelica sinensis, the Chinese cassia tree dregs of a decoction, add water to cook 3 times, often Secondary plus 5 times of amount water, when decoction 2 is small every time, collecting decoction, filters, and filtrate merges with the aqueous solution that Angelica sinensis, Chinese cassia tree are distilled, and concentrates The clear cream for being 1.20 to 80 DEG C of relative densities;
    5)It is 60% that gained clear cream addition ethanol, which is made containing amount of alcohol, stand 48 it is small when, filtration, filtrate and above-mentioned ginseng, Radix Codonopsis, Pilose antler, gekko, Radix Paeoniae Alba ethanol extract merge, the clear cream that recycling ethanol is 1.05 to 80 DEG C of relative densities, medicinal needed for addition Auxiliary material flavouring, preservative, stabilizer and 2)In volatile oil, add water constant volume, stir evenly uniformly, stand, filtered with diatomite, fill Dress, sterilizing, obtains solution finished product;
    Its tablet, capsule and particle agent producing process are:
    1)20 taste Chinese medicine, cleans respectively as described in recipe quantity weighs prescription list, sieves, sterilizing;
    2)Take Angelica sinensis, Chinese cassia tree to add 3 times of water, boil 3 it is small when, while collect volatile oil;Aqueous solution and the other containers hold of the dregs of a decoction, it is standby With;
    3)It is coarse powder to take ginseng, Radix Codonopsis, pilose antler, gekko, 5 taste Chinese medicine of Radix Paeoniae Alba to crush, and adds 80% alcohol reflux extraction 3 times, every time 8 times of amounts, every time 3 it is small when, merge ethanol extract, filtration, filtrate is spare;
    4) by 3)In the dregs of a decoction and radix astragali, Herba Epimedii, cynomorium songaricum, thizoma curculiginis, monkshood, the fruit of Chinese wolfberry, Morinda officinalis, saline cistanche, semen allii tuberosi, ripe Glutinous rehmannia, Schisandra chinensis, Fructus Corni, 13 taste Chinese medicine of stir-baked CORTEX EUCOMMIAE with salt solution merge, and add above-mentioned Angelica sinensis, the Chinese cassia tree dregs of a decoction, add water to cook 3 times, often Secondary plus 5 times of amount water, when decoction 2 is small every time, collecting decoction, filters, and filtrate merges with the aqueous solution that Angelica sinensis, Chinese cassia tree are distilled, and concentrates The clear cream for being 1.20 to 80 DEG C of relative densities;
    5)It is 60% that gained clear cream addition ethanol, which is made containing amount of alcohol, stand 48 it is small when, filtration, filtrate and above-mentioned ginseng, Radix Codonopsis, Pilose antler, gekko, Radix Paeoniae Alba ethanol extract merge, and the clear cream that recycling ethanol is 1.05 to 80 DEG C of relative densities, adds 2)In wave Hair oil, stirs evenly, and is dried under vacuum to the blocks of solid that moisture is 8%;
    6)Blocks of solid is moistened with the ethanol solution of 75-85%, is sufficiently stirred 30 minutes, makes to be uniformly mixed;Wet granulation, does Whole grain after dry;Pharmaceutic adjuvant flavouring, diluent, adhesive, wetting agent, disintegrant, lubricant, are made piece needed for sequentially adding Agent, capsule or granule.
  2. 2. compound Chinese medicinal preparation according to claim 1, it is characterised in that:Preferably it is formulated by following traditional Chinese medicines material by weight Part composition:
    Sequence number Component Part by weight 1 Ginseng 3 parts 2 Radix Codonopsis 2 parts 3 Radix astragali 7.5 part 4 Pilose antler 0.5 part 5 Chinese cassia tree 2 parts 6 Herba Epimedii 6 parts 7 Cynomorium songaricum 2 parts 8 Thizoma curculiginis 2.5 part 9 Monkshood 2.5 part 10 The fruit of Chinese wolfberry 10 parts 11 Morinda officinalis 3 parts 12 Saline cistanche 2 parts 13 Gekko 2 parts 14 Semen allii tuberosi 2.5 part 15 Angelica sinensis 4 parts 16 Radix Paeoniae Alba 2.5 part 17 Prepared rhizome of rehmannia 6 parts 18 Schisandra chinensis 2 parts 19 Fructus Corni 2 parts 20 Stir-baked CORTEX EUCOMMIAE with salt solution 4 parts
  3. 3. compound Chinese medicinal preparation according to claim 1, it is characterised in that:The flavouring refer to honey, sucrose, Ah One or more in Si Patan, saccharin sodium, Sucralose;The preservative refer to benzoic acid, sodium benzoate, sorbic acid, One or more in methyl hydroxybenzoate, ethylparaben;The stabilizer refer to polyethylene glycol 200, polyethylene glycol 400, One or more in polyethylene glycol-800, polyoxyethylene sorbitan monoleate.
  4. 4. compound Chinese medicinal preparation according to claim 1, it is characterised in that:The diluent refers to starch, pregelatinated One or more in starch, lactose, dextrin, microcrystalline cellulose, mannitol, D-sorbite, calcium sulfate, calcium bisulfate;It is described Adhesive refer to one or more in starch slurry, hydroxymethyl cellulose, povidone, gelatin, polyethylene glycol;The moistening Agent refers to ethanol.
  5. 5. compound Chinese medicinal preparation according to claim 1, it is characterised in that:The disintegrant refers to hydroxymethyl starch One kind or several in sodium, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, Ac-Di-Sol, crospovidone Kind.
  6. 6. compound Chinese medicinal preparation according to claim 1, it is characterised in that:The lubricant refers to magnesium stearate, cunning One or more in mountain flour, superfine silica gel powder, hydrogenated vegetable oil.
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