CN1775268A - Kidney-tonifying preparation and preparing method - Google Patents
Kidney-tonifying preparation and preparing method Download PDFInfo
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- CN1775268A CN1775268A CNA2005101159853A CN200510115985A CN1775268A CN 1775268 A CN1775268 A CN 1775268A CN A2005101159853 A CNA2005101159853 A CN A2005101159853A CN 200510115985 A CN200510115985 A CN 200510115985A CN 1775268 A CN1775268 A CN 1775268A
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Abstract
The present invention relates to a Chinese medicine composition and its preparation process. In particular, it relates to a Chinese medicine prescription for curing the diseases of nocturnal emission, kidney sac cold, turbid urine, abdominal pain, mental fatigue, amnesia and sleepless, aching lumbus and leg pain, dizziness, tinnitus and inhibited urine and stool and its preparation process. Said invention can be made into dripping pills and soft capsule preparation.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind of failure of the kidney in receiving QI that is used for, the emission that raw invasion and attack cause, the scrotum is clammy, lose and drench nebulousurine, the umbilicus abdomen is had a pain, tired mind, forgetful insomnia, waist and leg ache, the prescription of dizziness and tinnitus difficulty in urination and defecation and preparation technology thereof.
Background technology:
By failure of the kidney in receiving QI, the various symptoms that raw invasion and attack cause are clinically to see that symptom, the traditional Chinese medical science often take the means of the kidney invigorating cold expelling that it is treated more, and evident in efficacy.KidneyHarmonizing Pill is that it represents medicine.But in the practice, because this medicine is medical material to be beaten powder be used as medicine in preparation, cause impurity many, shortcoming such as dosage is big has a strong impact on its clinical practice.
The preparation of process extraction process preparation of the present invention is easy to dissolving and absorption than elite and thick putting that ordinary pill more can collect medicine, and curative effect is fast, and administration time is short, and therefore, curative effect is better.
The purpose of this invention is to provide a kind of therapeutic domain wide, easily accept, easily absorb, the preparation technology of efficient, low dosage, the Chinese medicine dripping pills that has no side effect, soft capsule, granule, chewable tablet, mixture, its pill that makes can be used for curing mainly failure of the kidney in receiving QI, the emission that raw invasion and attack cause, the scrotum is clammy, loses to drench nebulousurine, and the umbilicus abdomen is had a pain, tired mind, forgetful insomnia, waist and leg ache, dizziness and tinnitus difficulty in urination and defecation.
Summary of the invention:
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, it is characterized in that, the preparation of per 1000 dosage units is prepared from by following proportion raw material:
48～313 parts of 48～313 parts of Herba Cistanches of Radix Morindae Officinalis (Radix Glycyrrhizae is processed) (wine is processed)
24～156.5 parts of 48～313 portions of Radix Aconitis of Fructus Psoraleae (salt is processed) (the Radix Glycyrrhizae Flos Lonicerae is processed)
48～313 parts of 24～156.5 parts of Rhizoma Atractylodis Macrocephalaes of Cortex Cinnamomi (parched with bran)
48～313 parts in 48～313 parts of Poria of Rhizoma Dioscoreae
48～313 parts of 48～313 parts of Rhizoma Dioscoreae Hypoglaucae of Fructus Tribuli (salt is processed)
48～313 parts in 48～313 parts of Semen Persicaes of Herba Dendrobii
Preferably:
96 parts of 96 parts of Herba Cistanches of Radix Morindae Officinalis (Radix Glycyrrhizae is processed) (wine is processed)
48 parts of 96 portions of Radix Aconitis of Fructus Psoraleae (salt is processed) (the Radix Glycyrrhizae Flos Lonicerae is processed)
96 parts of 48 parts of Rhizoma Atractylodis Macrocephalaes of Cortex Cinnamomi (parched with bran)
96 parts in 96 parts of Poria of Rhizoma Dioscoreae
96 parts of 96 parts of Rhizoma Dioscoreae Hypoglaucae of Fructus Tribuli (salt is processed)
96 parts in 96 parts of Semen Persicaes of Herba Dendrobii
In more than forming, the weight of medicine is calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of soft capsule preparations, drop pill 1000 balls, granule 1000g etc., also can make big packing as granule, as 100～500 bags, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form, can be made into the preparation of 50～1000 taking doses,, make 125 bags, take 1～2 bag at every turn, can take altogether 62.5～125 times as granule.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The raw material of Chinese medicine of said ratio extracts processing through new technology of the present invention, obtain the active constituents of medicine of preparation of the present invention, add suitable excipient as required and make suitable medicinal any dosage form, said preparation can be drop pill, soft capsule, granule, chewable tablet, mixture.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi two flavor medical materials, adopt supercritical extraction (or steam distillation): the medical material of pulverizing is dropped in the supercritical extraction reactor, basin is cooled off, respectively to extraction kettle, extraction-container I, extraction-container II heat, when temperature reaches 40 ℃, 45 ℃, 45 ℃ respectively, open CO
2Gas cylinder is supplied gas, and opens high-pressure pump to extraction kettle, extraction-container I, extraction-container II pressurization, when pressure reaches 28MPa, 7～8MPa, 6～7MPa respectively, and the beginning cycling extraction, the adjusting flow is 155～180kg/h, constant temperature and pressure extraction 3h discharging gets extract; β-CDBao He, optimised process is: β-CD is 1: 6～10 with the water ratio, and oil is 1: 4～6 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get the residue medical material, soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～4 times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get the Rhizoma Atractylodis Macrocephalae, the Cortex Cinnamomi medical material is beaten powder and is used as medicine;
(2) get prescription residue medical material, decoct with water 2～4 times, each 0.5～2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing the various preparations except that drop pill and soft capsule of the present invention.
The active constituents of medicine of the preparation of the present invention that above method obtains can be prepared into preparation of the present invention through further processing.
Preparation of the present invention, different dosage form method difference below is the preparation method of several preferred dosage form.
(1) preparation of drop pill
Drop pill of the present invention, wherein the ratio of active component and adjuvant is 1: 0.5～10, and preferred ratio is 1: 2～4, and most preferred ratio is 1: 3.The above adjuvant be specially molecular weight polyethylene glycol between 400 to 10000 Polyethylene Glycol and their mixture, as PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture or other suitable other auxiliary elements of making drop pill, as glycerol, gelatin or stearic acid sodium etc.
Following steps are taked in the preparation of drop pill of the present invention:
1. be ready to following raw material: active component, adjuvant and/or other inactive ingredients;
2. with the above-mentioned raw materials mix homogeneously;
3. add the transconversion into heat material, move into the drip irrigation of drop pill machine, medicinal liquid splashes in the liquid sub liquid paraffin by water dropper, removes liquid paraffin, selects ball, promptly.
(2) preparation of soft capsule
Soft capsule preparation of the present invention is that active component and pharmaceutically useful organic solvent and the material of making soft capsule shell are formed.Organic solvent wherein is selected from PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, the material of wherein making soft capsule shell is gelatin or arabic gum, water, plasticizer and antiseptic, the weight ratio of gelatin or arabic gum and plasticizer is 1.0: 0.4～1.0 in the soft capsule shell, and the weight ratio of gelatin and water is 1.0: 0.8～1.2; The content of active component is 50mg～500mg in every soft capsule.
The preparation method of preparation of the present invention, the process following steps:
A. get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
B. get active component and be dissolved in organic solvent, add suitable quantity of water, be prepared into soft capsule through encapsulating machine.
(3) preparation process of granule is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of chewable tablet is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, and drying, tabletting promptly gets chewable tablet.
Filler described in the preparation of granule, chewable tablet is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
Following data declaration beneficial effect of the present invention by experiment:
In order to prove the Clinical feasibility that changes after the technology, we have carried out its main pharmacodynamics, toxicologic study to this medicine, observe its therapeutical effect, and the clinical experimental basis that provides is provided.
1, to the influence of yang deficiency mice
1.1 method
Healthy male LACA mice 40, three monthly ages, mice is divided into 5 groups at random, be normal control group, hydrogenation can 1. 2. extractum group (1.1g/kg) of extractum group (0.5g/kg) and technology of orange yang deficiency group, longevity powder yang-tonifying drug matched group (above three groups equal 0.5ml/ time/day), technology, gastric infusion, normal group and yang deficiency group give the tap water administration the 4th day of equivalent except that normal group, each group all begins the intramuscular injection hydrocortisone, 0.25mg/10g body weight. 2 weeks of successive administration, the normal saline of normal group intramuscular injection equivalent.Measure body weight, the body temperature (anus temperature) of animal, and write down its low temperature (10 ℃) swimming time.
1.2 result
1.2.1 influence to the mice body weight
Normal group mice 2 in week weight averages increase 3.0g, the yang deficiency group then reduces 2.0g, promptly hydrocortisone can make the mice body weight obviously alleviate the treatment group all can to suppress losing weight due to the hydrocortisone.The results are shown in Table 1.
The influence of table 1 pair yang deficiency mice body weight (x ± s)
| Group | Number of animals (only) | Body weight (g) before the administration | Body weight after the administration (g) | Difference (g) |
| Normal group yang deficiency group positive controls technology is 2. extractum group of extractum group technology 1. | 8 8 8 8 8 | 31.7±3.0 32.2±2.6 31.8±3.0 32.4±3.0 31.9±3.3 | 34.7±3.2 30.2±2.0 30.0±1.7 32.3±2.3 31.7±3.4 | +3.0 -2.0 -1.8 -0.1 -0.2 |
1.2.2 influence to body temperature
Model of yang asthenia group mouse temperature is starkly lower than normal group (P＜0.001), each medicine descends to the mouse temperature due to the hydrocortisone all certain antagonism, wherein with the 1. 2. effect comparatively significantly (P＜0.01) of extractum group of extractum group and technology of positive controls, technology, and 1. the extractum effect is the most obvious for technology, table 2.
1.2.3 influence to the low temperature swimming time
Model group mice low temperature swimming time obviously shortens (P＜0.001), and yang deficiency mice tolerance to cold and muscle power all obviously descend.Each administration group all has significant prolongation effect (P＜0.01 or P＜0.001) to the low temperature swimming time of model mice.But, see Table 2 with 1. extractum effect the best of technology.
The influence of table 2 pair yang deficiency mouse temperature and low temperature swimming (x ± s)
| Group | Number of animals (only) | Body temperature (℃) | Swimming time (min) |
| Matched group yang deficiency group positive controls technology is 2. extractum group of extractum group technology 1. | 8 8 8 8 8 | 36.1±0.4 34.6±0.9 △△△ 35.8±0.4 ** 36.2±0.6 ** 35.7±0.4 ** | 8.39±1.04 6.03±0.63 △△△ 9.59±0.98 *** 10.42±1.77 *** 8.04±1.76 ** |
Compare with normal group:
△ △ △P＜0.001; Compare with the yang deficiency group:
*P＜0.01,
* *P＜0.001.
2, toxicological study
Acute toxicity test shows that rat oral gavage extract of the present invention fails to measure LD
50
Long term toxicity test: rat grouping, extract of the present invention is irritated stomach, every day three times, connect and annotate 90d, the result, administration group rat and control rats movable, search for food, drinking-water, body weight and multinomial observation indexs such as substantial viscera pathologic finding and histopathology detect, result of the test is not all found any toxicity; Hemogram and hepatic and renal function index and the equal no significant difference of matched group.
The blood vessel irritation of this medicine, allergy and hemolytic test all are negative.
In sum, preparation of the present invention, dropping pill formulation particularly of the present invention and soft capsule preparation are a kind of good treatment failure of the kidney in receiving QI, the emission that raw invasion and attack cause, the scrotum is clammy, loses to drench nebulousurine, the umbilicus abdomen is had a pain, tired mind, forgetful insomnia, waist and leg ache, the medicine of dizziness and tinnitus difficulty in urination and defecation, and change preparation technology, can obviously strengthen clinical efficacies such as its kidney invigorating cold expelling, its hypotoxicity in addition, prolonged application safety, therefore, be worth clinical application.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of drop pill of the present invention:
Prescription:
Radix Morindae Officinalis (Radix Glycyrrhizae is processed) 69g Herba Cistanches (wine is processed) 69g
Fructus Psoraleae (salt is processed) 69g Radix Aconiti (the Radix Glycyrrhizae Flos Lonicerae is processed) 34.5g
The Cortex Cinnamomi 34.5g Rhizoma Atractylodis Macrocephalae (parched with bran) 69g
Rhizoma Dioscoreae 69g Poria 69g
Fructus Tribuli (salt is processed) 69g Rhizoma Dioscoreae Hypoglaucae 69g
Herba Dendrobii 69g Semen Persicae 69g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi two flavor medical materials, adopt supercritical extraction (or steam distillation): the medical material of pulverizing is dropped in the supercritical extraction reactor, basin is cooled off, respectively to extraction kettle, extraction-container I, extraction-container II heat, when temperature reaches 40 ℃, 45 ℃, 45 ℃ respectively, open CO
2Gas cylinder is supplied gas, and opens high-pressure pump to extraction kettle, extraction-container I, extraction-container II pressurization, when pressure reaches 28MPa, 7MPa, 6MPa respectively, and the beginning cycling extraction, the adjusting flow is 155～180kg/h, constant temperature and pressure extraction 3h discharging gets extract; β-CDBao He, optimised process is: β-CD is 1: 6 with the water ratio, and oil is 1: 5 with β-CD ratio, and ultrasonic 50min gets clathrate;
(2) get the residue medical material, soaked 40 minutes earlier with 75% ethanol, reheat reflux, extract, three times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) with above-mentioned extract obtained, the PEG4000 that adds recipe quantity puts into the vessel in heating dissolving, and jolting makes and dissolves into uniform solution, inserts in the fluid reservoir.Keep 80 ℃ the system of dripping temperature, and a control speed, condensed fluid is a liquid paraffin, drips system promptly.
Embodiment 2:
Preparation of soft capsule method of the present invention:
Prescription:
Radix Morindae Officinalis (Radix Glycyrrhizae is processed) 313g Herba Cistanches (wine is processed) 313g
Fructus Psoraleae (salt is processed) 313g Radix Aconiti (the Radix Glycyrrhizae Flos Lonicerae is processed) 156.5g
The Cortex Cinnamomi 156..5g Rhizoma Atractylodis Macrocephalae (parched with bran) 313g
Rhizoma Dioscoreae 313g Poria 313g
Fructus Tribuli (salt is processed) 313g Rhizoma Dioscoreae Hypoglaucae 313g
Herba Dendrobii 313g Semen Persicae 313g
PEG400 550g
Make 1000
Preparation method:
(1) gets the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi two flavor medical materials, adopt supercritical extraction (or steam distillation): the medical material of pulverizing is dropped in the supercritical extraction reactor, basin is cooled off, respectively to extraction kettle, extraction-container I, extraction-container II heat, when temperature reaches 40 ℃, 45 ℃, 45 ℃ respectively, open CO
2Gas cylinder is supplied gas, and opens high-pressure pump to extraction kettle, extraction-container I, extraction-container II pressurization, when pressure reaches 28MPa, 7MPa, 6MPa respectively, and the beginning cycling extraction, the adjusting flow is 155～180kg/h, constant temperature and pressure extraction 3h discharging gets extract; β-CDBao He, optimised process is: β-CD is 1: 6 with the water ratio, and oil is 1: 5 with β-CD ratio, and ultrasonic 50min gets clathrate;
(2) get the residue medical material, soaked 40 minutes earlier with 75% ethanol, reheat reflux, extract, three times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) with above-mentioned extract obtained, add an amount of PEG400 and mix and mixing, add the PEG400 of surplus then, promptly get medicinal liquid.It is standby in addition to join gelatin solution by certain prescription.The condition that control is suitable is regulated content weight, obtains soft capsule in the soft capsule machine.
Embodiment 3:
The preparation method of granule of the present invention:
Prescription:
Radix Morindae Officinalis (Radix Glycyrrhizae is processed) 240g Herba Cistanches (wine is processed) 240g
Fructus Psoraleae (salt is processed) 240g Radix Aconiti (the Radix Glycyrrhizae Flos Lonicerae is processed) 120g
The Cortex Cinnamomi 120g Rhizoma Atractylodis Macrocephalae (parched with bran) 240g
Rhizoma Dioscoreae 240g Poria 240g
Fructus Tribuli (salt is processed) 240g Rhizoma Dioscoreae Hypoglaucae 240g
Herba Dendrobii 240g Semen Persicae 240g
Make 1000g
Preparation method:
(1) get the Rhizoma Atractylodis Macrocephalae, the Cortex Cinnamomi medical material is beaten powder and is used as medicine;
(2) get prescription residue medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component is merged, add aspartame 5.0g, dextrin 220.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Radix Morindae Officinalis (Radix Glycyrrhizae is processed) 125g Herba Cistanches (wine is processed) 125g
Fructus Psoraleae (salt is processed) 125g Radix Aconiti (the Radix Glycyrrhizae Flos Lonicerae is processed) 34.5g
The Cortex Cinnamomi 34.5g Rhizoma Atractylodis Macrocephalae (parched with bran) 125g
Rhizoma Dioscoreae 125g Poria 125g
Fructus Tribuli (salt is processed) 125g Rhizoma Dioscoreae Hypoglaucae 125g
Herba Dendrobii 125g Semen Persicae 125g
Make 1000
Preparation method:
(1) get the Rhizoma Atractylodis Macrocephalae, the Cortex Cinnamomi medical material is beaten powder and is used as medicine;
(2) get prescription residue medical material, decoct with water 3 times, each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component is merged, add aspartame 3.0g, mannitol 100.0g, granulation, drying adds magnesium stearate 3.0g, mixing, and tabletting promptly gets 1000 of chewable tablet.
Claims (10)
1, a kind of Chinese medicine preparation is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
48～313 parts of 48～313 parts of Herba Cistanches of Radix Morindae Officinalis (Radix Glycyrrhizae is processed) (wine is processed)
24～156.5 parts of 48～313 portions of Radix Aconitis of Fructus Psoraleae (salt is processed) (the Radix Glycyrrhizae Flos Lonicerae is processed)
48～313 parts of 24～156.5 parts of Rhizoma Atractylodis Macrocephalaes of Cortex Cinnamomi (parched with bran)
48～313 parts in 48～313 parts of Poria of Rhizoma Dioscoreae
48～313 parts of 48～313 parts of Rhizoma Dioscoreae Hypoglaucae of Fructus Tribuli (salt is processed)
48～313 parts in 48～313 parts of Semen Persicaes of Herba Dendrobii.
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
96 parts of 96 parts of Herba Cistanches of Radix Morindae Officinalis (Radix Glycyrrhizae is processed) (wine is processed)
48 parts of 96 portions of Radix Aconitis of Fructus Psoraleae (salt is processed) (the Radix Glycyrrhizae Flos Lonicerae is processed)
96 parts of 48 parts of Rhizoma Atractylodis Macrocephalaes of Cortex Cinnamomi (parched with bran)
96 parts in 96 parts of Poria of Rhizoma Dioscoreae
96 parts of 96 parts of Rhizoma Dioscoreae Hypoglaucae of Fructus Tribuli (salt is processed)
96 parts in 96 parts of Semen Persicaes of Herba Dendrobii.
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet, mixture.
4, the Chinese medicine preparation of claim 3 through described raw material is extracted processing, obtains active component, adds suitable adjuvant as required and makes.
5, the Chinese medicine preparation of claim 4 is characterized in that, described active component prepares through following steps:
Method a:(technology 1.)
(1) gets the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi two flavor medical materials, adopt supercritical extraction (or steam distillation): the medical material of pulverizing is dropped in the supercritical extraction reactor, basin is cooled off, respectively to extraction kettle, extraction-container I, extraction-container II heat, when temperature reaches 40 ℃, 45 ℃, 45 ℃ respectively, open CO
2Gas cylinder is supplied gas, and opens high-pressure pump to extraction kettle, extraction-container I, extraction-container II pressurization, when pressure reaches 28MPa, 7～8MPa, 6～7MPa respectively, and the beginning cycling extraction, the adjusting flow is 155～180kg/h, constant temperature and pressure extraction 3h discharging gets extract; β-CDBao He, optimised process is: β-CD is 1: 6～10 with the water ratio, and oil is 1: 4～6 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get the residue medical material, soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～4 times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get the Rhizoma Atractylodis Macrocephalae, the Cortex Cinnamomi medical material is beaten powder and is used as medicine;
(2) get prescription residue medical material, decoct with water 2～4 times, each 0.5～2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing the various preparations except that drop pill and soft capsule of the present invention.
6, the Chinese medicine preparation of claim 5 is characterized in that:
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5～10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60～115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10～5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that:
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg～500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
8, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of described granule is as follows: with above-mentioned extract obtained, add a certain amount of filler, correctives, lubricant, granulate, promptly get granule;
The preparation method of chewable tablet is as follows: with above-mentioned extract obtained, adds a certain amount of filler, correctives, lubricant, granulates, and drying, tabletting promptly gets chewable tablet.
9, the Chinese medicine preparation of claim 8 is characterized in that:
Described filler is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
10, the preparation method of any one Chinese medicine preparation of claim 1～9 is characterized in that, the process following steps:
Described raw material of Chinese medicine is extracted processing, obtain active component, add suitable adjuvant and make; Wherein said active component prepares through following steps:
Method a:(technology 1.)
(1) gets the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi two flavor medical materials, adopt supercritical extraction (or steam distillation): the medical material of pulverizing is dropped in the supercritical extraction reactor, basin is cooled off, respectively to extraction kettle, extraction-container I, extraction-container II heat, when temperature reaches 40 ℃, 45 ℃, 45 ℃ respectively, open CO
2Gas cylinder is supplied gas, and opens high-pressure pump to extraction kettle, extraction-container I, extraction-container II pressurization, when pressure reaches 28MPa, 7～8MPa, 6～7MPa respectively, and the beginning cycling extraction, the adjusting flow is 155～180kg/h, constant temperature and pressure extraction 3h discharging gets extract; β-CDBao He, optimised process is: β-CD is 1: 6～10 with the water ratio, and oil is 1: 4～6 with β-CD ratio, and ultrasonic 30～70min gets clathrate;
(2) get the residue medical material, soaked 30～60 minutes earlier with 50～85% ethanol, reheat reflux, extract, 2～4 times, each 0.5～2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get the Rhizoma Atractylodis Macrocephalae, the Cortex Cinnamomi medical material is beaten powder and is used as medicine;
(2) get prescription residue medical material, decoct with water 2～4 times, each 0.5～2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing the various preparations except that drop pill and soft capsule of the present invention.
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5～10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60～115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10～5 ℃.
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg～500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: active constituents of medicine is mixed with proper auxiliary materials, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2005101159853A CN1775268A (en) | 2005-11-18 | 2005-11-18 | Kidney-tonifying preparation and preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2005101159853A CN1775268A (en) | 2005-11-18 | 2005-11-18 | Kidney-tonifying preparation and preparing method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1775268A true CN1775268A (en) | 2006-05-24 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2005101159853A Pending CN1775268A (en) | 2005-11-18 | 2005-11-18 | Kidney-tonifying preparation and preparing method |
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| Country | Link |
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| CN (1) | CN1775268A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103638322A (en) * | 2013-11-28 | 2014-03-19 | 常州科立信医疗器械有限公司 | Preparation method and application of kidney-harmonizing pill |
| CN105581136A (en) * | 2014-10-31 | 2016-05-18 | 镇江泰飞尔医药有限公司 | Kidney-invigorating and body-strengthening buccal tablet and preparation method thereof |
-
2005
- 2005-11-18 CN CNA2005101159853A patent/CN1775268A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103638322A (en) * | 2013-11-28 | 2014-03-19 | 常州科立信医疗器械有限公司 | Preparation method and application of kidney-harmonizing pill |
| CN105581136A (en) * | 2014-10-31 | 2016-05-18 | 镇江泰飞尔医药有限公司 | Kidney-invigorating and body-strengthening buccal tablet and preparation method thereof |
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