CN1857562A - Kidney invigorating hair restorer preparation its preparing process - Google Patents
Kidney invigorating hair restorer preparation its preparing process Download PDFInfo
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Abstract
The present invention relates to Chinese medicine composition, and especially a kind of Chinese medicine composition for treating kidney deficiency caused hair loss, kidney deficiency caused lumbago, chronic nephritis and neurasthenia and its preparation process. The Chinese medicine composition is preferably prepared into dripping pill and soft capsule.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, the particularly a kind of alopecia of suffering from a deficiency of the kidney, lumbago due to renal deficiency, chronic nephritis, neurasthenic prescription and preparation technology thereof of being used to.
Background technology:
The alopecia of suffering from a deficiency of the kidney, lumbago due to renal deficiency, chronic nephritis, the neurasthenia clinically sees symptom more, and the traditional Chinese medical science is often taked kidney-supplementing liver-boosting, and the means of strong kidney hair growth promoting are treated it, and evident in efficacy.Strong kidney hair-growth ballet 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, its pill that makes can be used for the alopecia of suffering from a deficiency of the kidney, lumbago due to renal deficiency, chronic nephritis, neurasthenia.
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:
27～85.5 parts of 47～152 parts of Fructus Lycii of 118～380 parts of Radix Rehmanniae Preparata of Radix Polygoni Multiflori Preparata
6～19 parts in 9～28.5 portions of Fructus Jujubaes of 15～47.5 parts of Fructus Schisandrae Chinensis of Rhizoma Polygonati
29.5～95 parts of 21～66.5 portions of Fructus Dipsacis of son loyal son (processed with wine) 18～57 parts of Semen Cuscutae
29.5～95 parts of 71～228 parts of Semen Platycladi of 18～57 parts of Radix Angelicae Sinensis of Fructus Mori
19～61 parts in 12～38 parts of Poria of 12～38 parts of Fructus Corni of Rhizoma Dioscoreae (wine steaming)
24～76 parts of 14～44 portions of Radix Rehmanniae of 19～61 parts of Folium Mori of Rhizoma Alismatis (saline stir-fry)
6～19 parts of 6～19 portions of Cortex Phellodendris of 19～61 portions of Rhizoma Coptidis of Cortex Moutan
12～38 parts of 18～57 parts of Radix Dipsacis of 15～47.5 parts of Radix Achyranthis Bidentataes of the Cortex Eucommiae (saline stir-fry)
9～28.5 parts of 12～38 parts of Rhizoma Chuanxiongs of 12～38 portions of Rhizoma Et Radix Notopterygiis of Fructus Chaenomelis
15～47.5 parts in 9～28.5 portions of Radix Glycyrrhizaes of the Radix Paeoniae Alba.
Preferably:
45 parts of 80 parts of Fructus Lycii of 200 parts of Radix Rehmanniae Preparata of Radix Polygoni Multiflori Preparata
10 parts in 15 portions of Fructus Jujubaes of 25 parts of Fructus Schisandrae Chinensis of Rhizoma Polygonati
50 parts of 35 portions of Fructus Dipsacis of son loyal son (processed with wine) 30 parts of Semen Cuscutae
50 parts of 120 parts of Semen Platycladi of 30 parts of Radix Angelicae Sinensis of Fructus Mori
32 parts in 20 parts of Poria of 20 parts of Fructus Corni of Rhizoma Dioscoreae (wine steaming)
40 parts of 23 portions of Radix Rehmanniae of 32 parts of Folium Mori of Rhizoma Alismatis (saline stir-fry)
10 parts of 10 portions of Cortex Phellodendris of 32 portions of Rhizoma Coptidis of Cortex Moutan
20 parts of 30 parts of Radix Dipsacis of 25 parts of Radix Achyranthis Bidentataes of the Cortex Eucommiae (saline stir-fry)
15 parts of 20 parts of Rhizoma Chuanxiongs of 20 portions of Rhizoma Et Radix Notopterygiis of Fructus Chaenomelis
25 parts in 15 portions of Radix Glycyrrhizaes of the Radix Paeoniae Alba.
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, capsule, granule, tablet, mixture, fluid extract and extractum, soft extract, powder.
The above new technology of the present invention may further comprise the steps:
(1) gets Radix Polygoni Multiflori, Radix Rehmanniae Preparata, Fructus Lycii, Fructus Ligustri Lucidi, Semen Cuscutae, Folium Mori, Fructus Corni, Rhizoma Alismatis, Radix Rehmanniae, the Cortex Eucommiae, Radix Achyranthis Bidentatae, Fructus Chaenomelis medical material, add ethanol and carry out reflux, extract, twice, the alcohol solvent consumption is 4～10 times of medical material amount, concentration of alcohol is 50～90%, return time 0.5～3.0 hour.The ethanol extract concentrating under reduced pressure gets ethanol extraction; Behind the medicinal residues backflow ethanol after the extraction, the water extraction that adds 10 times of amounts once, extracting solution filters, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys).
(2) water of getting Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Et Radix Notopterygii, 4～15 times of amounts of Cortex Moutan extracts volatile oil with the way of distillation, and extraction time is 4～8 hours, and volatile oil is standby, and extracting liquid filtering is evaporated to the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), and is standby.
(3) get Rhizoma Coptidis, Cortex Phellodendri, Radix Dipsaci medicinal material coarse powder, add 3～7 times of amount 0.5～2% (V/V) aqueous sulfuric acid merceration 12～36h, filter, medicinal residues are merceration 1～3 time repeatedly, merging filtrate, and the adding calcium hydroxide fine powder is transferred pH value to 8～10, left standstill about 30 minutes, sucking filtration gets filtrate for later use.
(4) get the residue medical material, extracting in water 2～4 times, each amount of water is 4～10 times, each extraction time is 0.5～3 hour, merge extractive liquid,, filter, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), puts coldly, and extracts water extract behind the volatile oil and concentrates water extract after clear paste and the alcohol extraction and concentrate clear paste and merge, adding ethanol makes and contains alcohol amount and reach 50～80%, stir evenly, left standstill 8～48 hours, get supernatant recovery ethanol and be concentrated into the thick paste that relative density is 1.25～1.30 (50 ℃ of surveys), drying gets the water extracting alcohol hypostasis.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
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 blood tonification effect of losing blood property blood deficiency mice
20 of mices are divided 2 groups at random, blank group (normal saline), strong kidney hair growth promoting group (0.13g/kg), earlier with each group mice docking blood sampling, measure normocyte (RBC) counting and hemoglobin (Hb) content, every then Mus blood-letting 0.5ml causes acute bleeding, and lose blood back RBC counting and Hb content are measured in docking blood sampling for the second time after 24 hours.After this begin gastric infusion or isometric(al) normal saline.Every day 1 time is continuous 7 days.RBC counted and Fib content after administration was measured in the docking blood sampling once more in the 8th day after the administration, RBC and Hb value were the back minimizing value of losing blood after normal RBC and Hb value deducted respectively and lose blood, to deduct lose blood back RBC and Hb value respectively be value added after the administration for RBC and Hb value after the administration, the results are shown in Table 1 and table 2.
The influence of table 1 couple losing blood property blood deficiency mice RBC (x ± s, n=10)
| Group | RBC(10 12/L) | ||||
| Normally | After losing blood | The minimizing value | After the administration | Value added | |
| Matched group is good for kidney hair growth promoting group | 9.57±0.81 9.72±0.98 | 5.68±1.02 5.82±1.34 | 3.90±1.37 3.90±1.37 | 8.00±0.98 9.57±0.85 | 2.33±1.55 3.75±1.43 * |
The influence of table 2 couple losing blood property blood deficiency mice Hb (x ± s, n=10)
| Group | Hb(g/L) | ||||
| Normally | After losing blood | The minimizing value | After the administration | Value added | |
| Matched group is good for kidney hair growth promoting group | 135.6±12.5 135.5±12.7 | 82.5±17.3 80.8±18.6 | 53.1±10.3 54.7±18.8 | 111.6±19.9 133.7±11.2 | 29.1±19.8 52.9±20.4 * |
The result shows that after chmice acute was lost blood, RBC number and content of hemoglobin obviously reduced in the blood, and strong kidney hair growth promoting group can make the RBC number in the acute bleeding mice blood increase, and content of hemoglobin raises.
2, improve the experimentation of chronic renal insufficiency
2.1 method
Male rat, body weight is 200～230g, except that the normal control group, all the other treated animals adopt the Plant method, the most of excision of row 5/6 kidney is made and is given the plain particles feedstuff after the operation of chronic kidney hypofunction rat model modeling rat and freely drink water, be divided into 4 groups after 1 week at random, grouping sees Table 3, and the normal control group does not add any processing factor; 1 week beginning administration after all the other rat modelings, model control group (distilled water), benazepril group (10mg/kg), strong kidney hair growth promoting group (0.06g/kg), gastric infusion.Weigh 1 per two weeks to adjust dosage, 8 weeks of the course of treatment.Observation index comprises ordinary circumstance (ergasia, chroma of hair, body weight etc.) and blood test.
2.2 result
2.2.1 ordinary circumstance
The performance of normal control treated animal is alert, and reaction is fast, the fur densification, and neat and glossy, diet is normal; Each treated animal lethargy after the modeling, movable slow, fur is fluffy, withered tarnish, inappetence.Wherein model control group is the most obvious, and the benazepril group is taken second place, and the extractum group is better than model control group and benazepril group.
2.2.2 renal function
After the modeling, model group rat blood serum creatinine, blood urea nitrogen are apparently higher than normal control group (P＜0.01), and after the treatment, benazepril group and extractum group serum Scr, Bun obviously descend.Although with normal group more variant (P＜0.01), but significantly be lower than model control group, the remaining kidney compensatory hypertrophy of modeling reserve group is obvious, with the normal group comparing difference highly significant (P＜0.01) is arranged, rat body weight then descends to some extent, especially obviously (compare P＜0.05 with normal group) with model group and benazepril group weight loss, strong kidney hair growth promoting group does not then relatively have significant difference with the normal control group; In addition, respectively organize kidney of rats weight/weight ratio after the modeling and obviously increase, highly significant (P＜0.01) is arranged, see table 3 for details with normal control group comparing difference.
The influence of table 3 pair chronic kidney hypofunction kidney of rats function (x ± s)
| Group | n | Bun(mmol/L) | Scr(μmol/L) | Kidney heavy (g) | Body weight (g) | Kidney weight/body weight (* 10 -3) |
| Normal control group model matched group is good for kidney hair growth promoting group benazepril group | 10 7 9 8 | 7.34±0.94 14.22±2.56 ** 10.99±2.71 **△ 10.51±1.74 **△ | 43.19±6.09 134.83±9.08 ** 74.57±13.86 **△△ 90.27±13.81 ** | 0.33±0.06 0.95±0.25 ** 0.89±0.33 ** 0.88±0.15 ** | 280.63±40.49 236.71±31.78 * 278.62±41.13 △ 259.57±39.11 * | 1.19±0.29 4.07±1.09 ** 3.27±1.14 ** 3.41±0.36 ** |
Compare with normal group
*P＜0.01; Compare with model group,
△P＜0.05,
△ △P＜0.01
3, 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 alopecias of suffering from a deficiency of the kidney, lumbago due to renal deficiency, chronic nephritis, neurasthenic medicine, and change preparation technology, can obviously strengthen its kidney-supplementing liver-boosting, clinical efficacies such as strong kidney hair growth promoting, 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 Polygoni Multiflori Preparata 118g Radix Rehmanniae Preparata 47g Fructus Lycii 27g
Rhizoma Polygonati 15g Fructus Schisandrae Chinensis 9g Fructus Jujubae 6g
Sub-chastity is given (processed with wine) 18g Semen Cuscutae 21g Fructus Dipsaci 29.5g
Fructus Mori 18g Radix Angelicae Sinensis 71g Semen Platycladi 29.5g
Rhizoma Dioscoreae 12g Fructus Corni (wine steaming) 12g Poria 19g
Rhizoma Alismatis (saline stir-fry) 19g Folium Mori 14g Radix Rehmanniae 24g
Cortex Moutan 19g Rhizoma Coptidis 6g Cortex Phellodendri 6g
The Cortex Eucommiae (saline stir-fry) 15g Radix Achyranthis Bidentatae 18g Radix Dipsaci 12g
Fructus Chaenomelis 12g Rhizoma Et Radix Notopterygii 12g Rhizoma Chuanxiong 9g
Radix Paeoniae Alba 9g Radix Glycyrrhizae 15g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Radix Polygoni Multiflori, Radix Rehmanniae Preparata, Fructus Lycii, Fructus Ligustri Lucidi, Semen Cuscutae, Folium Mori, Fructus Corni, Rhizoma Alismatis, Radix Rehmanniae, the Cortex Eucommiae, Radix Achyranthis Bidentatae, Fructus Chaenomelis medical material, add ethanol and carry out reflux, extract, twice, the alcohol solvent consumption is 6 times of medical material amount, and concentration of alcohol is 75%, return time 1.5 hours.The ethanol extract concentrating under reduced pressure gets ethanol extraction; Behind the medicinal residues backflow ethanol after the extraction, the water extraction that adds 10 times of amounts once, extracting solution filters, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys).
(2) water of getting Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Et Radix Notopterygii, 10 times of amounts of Cortex Moutan extracts volatile oil with the way of distillation, and extraction time is 6 hours, and volatile oil is standby, and extracting liquid filtering is evaporated to the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), and is standby.
(3) get Rhizoma Coptidis, Cortex Phellodendri, Radix Dipsaci medicinal material coarse powder, add 5 times of amount 1% (V/V) aqueous sulfuric acid merceration 24h, filter, medicinal residues are merceration 1 time repeatedly, merging filtrate, the adding calcium hydroxide fine powder is transferred pH value to 9, left standstill about 30 minutes, sucking filtration, filtrate for later use.
(4) get the residue medical material, extracting in water 3 times, each amount of water is 6 times, each extraction time is 1 hour, merge extractive liquid,, filter, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), puts coldly, and extracts water extract behind the volatile oil and concentrates water extract after clear paste and the alcohol extraction and concentrate clear paste and merge, adding ethanol makes and contains alcohol amount and reach 70%, stir evenly, left standstill 24 hours, get supernatant recovery ethanol and be concentrated into the thick paste that relative density is 1.25～1.30 (50 ℃ of surveys), drying gets the water extracting alcohol hypostasis.
(5) 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 Polygoni Multiflori Preparata 380g Radix Rehmanniae Preparata 152g Fructus Lycii 85.5g
Rhizoma Polygonati 47.5g Fructus Schisandrae Chinensis 28.5g Fructus Jujubae 19g
The loyal son of son (processed with wine) 57g Semen Cuscutae 66.5g Fructus Dipsaci 95g
Fructus Mori 57g Radix Angelicae Sinensis 228g Semen Platycladi 95g
Rhizoma Dioscoreae 38g Fructus Corni (wine steaming) 38g Poria 61g
Rhizoma Alismatis (saline stir-fry) 61g Folium Mori 44g Radix Rehmanniae 76g
Cortex Moutan 61g Rhizoma Coptidis 19g Cortex Phellodendri 19g
The Cortex Eucommiae (saline stir-fry) 47.5g Radix Achyranthis Bidentatae 57g Radix Dipsaci 38g
Fructus Chaenomelis 38g Rhizoma Et Radix Notopterygii 38g Rhizoma Chuanxiong 28.5g
Radix Paeoniae Alba 28.5g Radix Glycyrrhizae 47.5g
PEG400 330g
Make 1000
Preparation method:
(1) gets Radix Polygoni Multiflori, Radix Rehmanniae Preparata, Fructus Lycii, Fructus Ligustri Lucidi, Semen Cuscutae, Folium Mori, Fructus Corni, Rhizoma Alismatis, Radix Rehmanniae, the Cortex Eucommiae, Radix Achyranthis Bidentatae, Fructus Chaenomelis medical material, add ethanol and carry out reflux, extract, twice, the alcohol solvent consumption is 6 times of medical material amount, and concentration of alcohol is 75%, return time 1.5 hours.The ethanol extract concentrating under reduced pressure gets ethanol extraction; Behind the medicinal residues backflow ethanol after the extraction, the water extraction that adds 10 times of amounts once, extracting solution filters, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys).
(2) water of getting Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Et Radix Notopterygii, 10 times of amounts of Cortex Moutan extracts volatile oil with the way of distillation, and extraction time is 6 hours, and volatile oil is standby, and extracting liquid filtering is evaporated to the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), and is standby.
(3) get Rhizoma Coptidis, Cortex Phellodendri, Radix Dipsaci medicinal material coarse powder, add 5 times of amount 1% (V/V) aqueous sulfuric acid merceration 24h, filter, medicinal residues are merceration 1 time repeatedly, merging filtrate, the adding calcium hydroxide fine powder is transferred pH value to 9, left standstill about 30 minutes, sucking filtration, filtrate for later use.
(4) get the residue medical material, extracting in water 3 times, each amount of water is 6 times, each extraction time is 1 hour, merge extractive liquid,, filter, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), puts coldly, and extracts water extract behind the volatile oil and concentrates water extract after clear paste and the alcohol extraction and concentrate clear paste and merge, adding ethanol makes and contains alcohol amount and reach 70%, stir evenly, left standstill 24 hours, get supernatant recovery ethanol and be concentrated into the thick paste that relative density is 1.25～1.30 (50 ℃ of surveys), drying gets the water extracting alcohol hypostasis.
(5) 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 Polygoni Multiflori Preparata 800g Radix Rehmanniae Preparata 320g Fructus Lycii 180g
Rhizoma Polygonati 100g Fructus Schisandrae Chinensis 60g Fructus Jujubae 40g
The loyal son of son (processed with wine) 120g Semen Cuscutae 140g Fructus Dipsaci 200g
Fructus Mori 120g Radix Angelicae Sinensis 480g Semen Platycladi 200g
Rhizoma Dioscoreae 80g Fructus Corni (wine steaming) 80g Poria 128g
Rhizoma Alismatis (saline stir-fry) 128g Folium Mori 92g Radix Rehmanniae 160g
Cortex Moutan 128g Rhizoma Coptidis 40g Cortex Phellodendri 40g
The Cortex Eucommiae (saline stir-fry) 100g Radix Achyranthis Bidentatae 120g Radix Dipsaci 80g
Fructus Chaenomelis 80g Rhizoma Et Radix Notopterygii 80g Rhizoma Chuanxiong 65g
Radix Paeoniae Alba 60g Radix Glycyrrhizae 100g
Make 1000g
Preparation method:
(1) gets Radix Polygoni Multiflori, Radix Rehmanniae Preparata, Fructus Lycii, Fructus Ligustri Lucidi, Semen Cuscutae, Folium Mori, Fructus Corni, Rhizoma Alismatis, Radix Rehmanniae, the Cortex Eucommiae, Radix Achyranthis Bidentatae, Fructus Chaenomelis medical material, add ethanol and carry out reflux, extract, twice, the alcohol solvent consumption is 6 times of medical material amount, and concentration of alcohol is 75%, return time 1.5 hours.The ethanol extract concentrating under reduced pressure gets ethanol extraction; Behind the medicinal residues backflow ethanol after the extraction, the water extraction that adds 10 times of amounts once, extracting solution filters, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys).
(2) water of getting Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Et Radix Notopterygii, 10 times of amounts of Cortex Moutan extracts volatile oil with the way of distillation, and extraction time is 6 hours, and volatile oil is standby, and extracting liquid filtering is evaporated to the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), and is standby.
(3) get Rhizoma Coptidis, Cortex Phellodendri, Radix Dipsaci medicinal material coarse powder, add 5 times of amount 1% (V/V) aqueous sulfuric acid merceration 24h, filter, medicinal residues are merceration 1 time repeatedly, merging filtrate, the adding calcium hydroxide fine powder is transferred pH value to 9, left standstill about 30 minutes, sucking filtration, filtrate for later use.
(4) get the residue medical material, extracting in water 3 times, each amount of water is 6 times, each extraction time is 1 hour, merge extractive liquid,, filter, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), puts coldly, and extracts water extract behind the volatile oil and concentrates water extract after clear paste and the alcohol extraction and concentrate clear paste and merge, adding ethanol makes and contains alcohol amount and reach 70%, stir evenly, left standstill 24 hours, get supernatant recovery ethanol and be concentrated into the thick paste that relative density is 1.25～1.30 (50 ℃ of surveys), drying gets the water extracting alcohol hypostasis.
(5) above active component is merged, add aspartame 5.0g, dextrin 318.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
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:
27～85.5 parts of 47～152 parts of Fructus Lycii of 118～380 parts of Radix Rehmanniae Preparata of Radix Polygoni Multiflori Preparata
6～19 parts in 9～28.5 portions of Fructus Jujubaes of 15～47.5 parts of Fructus Schisandrae Chinensis of Rhizoma Polygonati
29.5～95 parts of 21～66.5 portions of Fructus Dipsacis of son loyal son (processed with wine) 18～57 parts of Semen Cuscutae
29.5～95 parts of 71～228 parts of Semen Platycladi of 18～57 parts of Radix Angelicae Sinensis of Fructus Mori
19～61 parts in 12～38 parts of Poria of 12～38 parts of Fructus Corni of Rhizoma Dioscoreae (wine steaming)
24～76 parts of 14～44 portions of Radix Rehmanniae of 19～61 parts of Folium Mori of Rhizoma Alismatis (saline stir-fry)
6～19 parts of 6～19 portions of Cortex Phellodendris of 19～61 portions of Rhizoma Coptidis of Cortex Moutan
12～38 parts of 18～57 parts of Radix Dipsacis of 15～47.5 parts of Radix Achyranthis Bidentataes of the Cortex Eucommiae (saline stir-fry)
9～28.5 parts of 12～38 parts of Rhizoma Chuanxiongs of 12～38 portions of Rhizoma Et Radix Notopterygiis of Fructus Chaenomelis
15～47.5 parts in 9～28.5 portions of Radix Glycyrrhizaes of the Radix Paeoniae Alba.
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
45 parts of 80 parts of Fructus Lycii of 200 parts of Radix Rehmanniae Preparata of Radix Polygoni Multiflori Preparata
10 parts in 15 portions of Fructus Jujubaes of 25 parts of Fructus Schisandrae Chinensis of Rhizoma Polygonati
50 parts of 35 portions of Fructus Dipsacis of son loyal son (processed with wine) 30 parts of Semen Cuscutae
50 parts of 120 parts of Semen Platycladi of 30 parts of Radix Angelicae Sinensis of Fructus Mori
32 parts in 20 parts of Poria of 20 parts of Fructus Corni of Rhizoma Dioscoreae (wine steaming)
40 parts of 23 portions of Radix Rehmanniae of 32 parts of Folium Mori of Rhizoma Alismatis (saline stir-fry)
10 parts of 10 portions of Cortex Phellodendris of 32 portions of Rhizoma Coptidis of Cortex Moutan
20 parts of 30 parts of Radix Dipsacis of 25 parts of Radix Achyranthis Bidentataes of the Cortex Eucommiae (saline stir-fry)
15 parts of 20 parts of Rhizoma Chuanxiongs of 20 portions of Rhizoma Et Radix Notopterygiis of Fructus Chaenomelis
25 parts in 15 portions of Radix Glycyrrhizaes of the Radix Paeoniae Alba.
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, capsule, granule, tablet, mixture, fluid extract and extractum, soft extract, powder.
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:
(1) gets Radix Polygoni Multiflori, Radix Rehmanniae Preparata, Fructus Lycii, Fructus Ligustri Lucidi, Semen Cuscutae, Folium Mori, Fructus Corni, Rhizoma Alismatis, Radix Rehmanniae, the Cortex Eucommiae, Radix Achyranthis Bidentatae, Fructus Chaenomelis medical material, add ethanol and carry out reflux, extract, twice, the alcohol solvent consumption is 4～10 times of medical material amount, concentration of alcohol is 50～90%, return time 0.5～3.0 hour.The ethanol extract concentrating under reduced pressure gets ethanol extraction; Behind the medicinal residues backflow ethanol after the extraction, the water extraction that adds 10 times of amounts once, extracting solution filters, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys).
(2) water of getting Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Et Radix Notopterygii, 4～15 times of amounts of Cortex Moutan extracts volatile oil with the way of distillation, and extraction time is 4～8 hours, and volatile oil is standby, and extracting liquid filtering is evaporated to the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), and is standby.
(3) get Rhizoma Coptidis, Cortex Phellodendri, Radix Dipsaci medicinal material coarse powder, add 3～7 times of amount 0.5～2% (V/V) aqueous sulfuric acid merceration 12～36h, filter, medicinal residues 1～3 time repeatedly, merging filtrate, the adding calcium hydroxide fine powder is transferred pH value to 8～10, left standstill about 30 minutes, sucking filtration gets filtrate for later use.
(4) get the residue medical material, extracting in water 2～4 times, each amount of water is 4～10 times, each extraction time is 0.5～3 hour, merge extractive liquid,, filter, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), puts coldly, and extracts water extract behind the volatile oil and concentrates water extract after clear paste and the alcohol extraction and concentrate clear paste and merge, adding ethanol makes and contains alcohol amount and reach 50～80%, stir evenly, left standstill 8～48 hours, get supernatant recovery ethanol and be concentrated into the thick paste that relative density is 1.25～1.30 (50 ℃ of surveys), drying gets the water extracting alcohol hypostasis.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
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:
(1) gets Radix Polygoni Multiflori, Radix Rehmanniae Preparata, Fructus Lycii, Fructus Ligustri Lucidi, Semen Cuscutae, Folium Mori, Fructus Corni, Rhizoma Alismatis, Radix Rehmanniae, the Cortex Eucommiae, Radix Achyranthis Bidentatae, Fructus Chaenomelis medical material, add ethanol and carry out reflux, extract, twice, the alcohol solvent consumption is 4～10 times of medical material amount, concentration of alcohol is 50～90%, return time 0.5～3.0 hour.The ethanol extract concentrating under reduced pressure gets ethanol extraction; Behind the medicinal residues backflow ethanol after the extraction, the water extraction that adds 10 times of amounts once, extracting solution filters, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys).
(2) water of getting Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Et Radix Notopterygii, 4～15 times of amounts of Cortex Moutan extracts volatile oil with the way of distillation, and extraction time is 4～8 hours, and volatile oil is standby, and extracting liquid filtering is evaporated to the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), and is standby.
(3) get Rhizoma Coptidis, Cortex Phellodendri, Radix Dipsaci medicinal material coarse powder, add 3～7 times of amount 0.5～2% (V/V) aqueous sulfuric acid merceration 12～36h, filter, medicinal residues are merceration 1～3 time repeatedly, merging filtrate, and the adding calcium hydroxide fine powder is transferred pH value to 8～10, left standstill about 30 minutes, sucking filtration gets filtrate for later use.
(4) get the residue medical material, extracting in water 2～4 times, each amount of water is 4～10 times, each extraction time is 0.5～3 hour, merge extractive liquid,, filter, filtrate decompression is concentrated into the clear paste of relative density 1.15～1.22 (50 ℃ of surveys), puts coldly, and extracts water extract behind the volatile oil and concentrates water extract after clear paste and the alcohol extraction and concentrate clear paste and merge, adding ethanol makes and contains alcohol amount and reach 50～80%, stir evenly, left standstill 8～48 hours, get supernatant recovery ethanol and be concentrated into the thick paste that relative density is 1.25～1.30 (50 ℃ of surveys), drying gets the water extracting alcohol hypostasis.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
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.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101361863B (en) * | 2008-09-04 | 2010-12-22 | 南京中医药大学 | Mulberry cypress hair growth liniment and preparation method thereof |
| CN101152432B (en) * | 2006-09-27 | 2011-04-27 | 马骥先 | Traditional Chinese medicine for treating alopecia and white hair |
| CN102614486A (en) * | 2012-04-18 | 2012-08-01 | 李佃场 | Traditional Chinese medical liquor for treatment of deficiency of liver-yin and kidney-yin |
| CN103301284A (en) * | 2012-03-15 | 2013-09-18 | 刘瑞林 | Radix polygni multiflori and salvia miltiorrhiza anti-alopecia powder |
| CN103385988A (en) * | 2013-07-19 | 2013-11-13 | 苏州市天灵中药饮片有限公司 | Traditional Chinese medicine additive for treating alopecia |
| CN103877259A (en) * | 2014-03-31 | 2014-06-25 | 韩世荣 | Traditional Chinese pills for treating alopecia |
| CN103990086A (en) * | 2014-05-13 | 2014-08-20 | 于法周 | Soluble granules for treating postpartum alopecia and preparing method thereof |
| CN104906310A (en) * | 2015-06-09 | 2015-09-16 | 徐艳 | Medicine granules for treating neurasthenia |
| CN105343647A (en) * | 2015-12-17 | 2016-02-24 | 李林林 | Traditional Chinese medicine preparation for treating neurasthenia |
| CN106138250A (en) * | 2016-08-17 | 2016-11-23 | 禹州市合同泰药业有限公司 | The Chinese medicine composition of a kind of growing and blacking hair and preparation technology thereof |
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2006
- 2006-04-11 CN CN 200610072845 patent/CN1857562A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101152432B (en) * | 2006-09-27 | 2011-04-27 | 马骥先 | Traditional Chinese medicine for treating alopecia and white hair |
| CN101361863B (en) * | 2008-09-04 | 2010-12-22 | 南京中医药大学 | Mulberry cypress hair growth liniment and preparation method thereof |
| CN103301284A (en) * | 2012-03-15 | 2013-09-18 | 刘瑞林 | Radix polygni multiflori and salvia miltiorrhiza anti-alopecia powder |
| CN102614486A (en) * | 2012-04-18 | 2012-08-01 | 李佃场 | Traditional Chinese medical liquor for treatment of deficiency of liver-yin and kidney-yin |
| CN102614486B (en) * | 2012-04-18 | 2013-10-23 | 李佃场 | Traditional Chinese medical liquor for treatment of deficiency of liver-yin and kidney-yin |
| CN103385988A (en) * | 2013-07-19 | 2013-11-13 | 苏州市天灵中药饮片有限公司 | Traditional Chinese medicine additive for treating alopecia |
| CN103877259A (en) * | 2014-03-31 | 2014-06-25 | 韩世荣 | Traditional Chinese pills for treating alopecia |
| CN103990086A (en) * | 2014-05-13 | 2014-08-20 | 于法周 | Soluble granules for treating postpartum alopecia and preparing method thereof |
| CN104906310A (en) * | 2015-06-09 | 2015-09-16 | 徐艳 | Medicine granules for treating neurasthenia |
| CN105343647A (en) * | 2015-12-17 | 2016-02-24 | 李林林 | Traditional Chinese medicine preparation for treating neurasthenia |
| CN106138250A (en) * | 2016-08-17 | 2016-11-23 | 禹州市合同泰药业有限公司 | The Chinese medicine composition of a kind of growing and blacking hair and preparation technology thereof |
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