CN1843461A - Pharmaceutical composition, its preparation method and quality control method - Google Patents
Pharmaceutical composition, its preparation method and quality control method Download PDFInfo
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Abstract
The invention discloses a medicinal composition for treating climacteric metancholia and nervous prostration, which is prepared from epimeddium, haw, pilose asiabell root, slice of aconite, fragrant solomonseal rhizome, broomrape, astragalus root, bark of peony root and baras camphor. The invention discloses the method for preparing the Chinese medicinal composition and its quality control method.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, especially a kind of climacteric syndrome and neurasthenic Chinese medicine composition of being used for the treatment of also relates to the preparation method and the method for quality control of this Chinese medicine composition simultaneously.Belong to the field of Chinese medicines.
Background technology
Climacteric is the life process that most women must experience.Around here, the women is prone to such as symptoms such as hectic fever sweating, dysphoria with feverish sensation in the chest palms and soles, soreness of the waist and knees, hyposexuality, irritability, insomnia forgetfulness, menoxenias, is called as climacteric syndrome, and climacteric syndrome is commonly encountered diseases and frequently-occurring disease in the women.Clear and definite already, the appearance of these symptoms is because of ovarian function obviously goes down, and causes estrogen (being mainly estradiol) content to fall sharply and the autonomic nervous dysfunction causes.Though some women does not have classical symptom, estradiol lowly is proved.At present, the main method for the treatment of female climacteric syndrome both at home and abroad is a controversies in hormone replacement in the elderly.Its curative effect is comparatively definite and significantly, but owing to may bring out the female reproductive system tumor, as carcinoma of endometrium etc. and other side reaction, unsuitable prolonged application.The traditional Chinese medical science thinks that climacteric syndrome is that human liver is suffered from a deficiency of the kidney and declined, the vital essence deficiency, and due to the yin and yang imbalance, visceral dysfunction, how can be simultaneously with neurasthenia symptom.Chinese medicine is being regulated the estrogen metabolism, improves climacteric syndrome symptom aspect and has unique curative effect.
The object of the invention is intended to overcome the deficiency of existing medicine, and a kind of effective treatment climacteric syndrome and neurasthenic Chinese medicine composition and preparation method thereof are provided; The object of the invention also is to provide a kind of method of quality control of Chinese medicine composition.
Summary of the invention
The present invention seeks to be achieved through the following technical solutions:
Medicine of the present invention is made (consumption is a weight portion) by following component crude drug:
Herba Epimedii 18-22 weight portion Fructus Crataegi 18-22 weight portion Radix Codonopsis 18-22 weight portion
Radix Aconiti Lateralis Preparata 18-22 weight portion Rhizoma Polygonati Odorati 18-22 weight portion Herba Cistanches 18-22 weight portion
Radix Astragali 18-22 weight portion Cortex Moutan 1.8-2.2 weight portion Borneolum Syntheticum 0.18-0.22 weight portion
Medicine optimum weight part proportioning of the present invention is:
Herba Epimedii 20 weight portion Fructus Crataegis 20 weight portion Radix Codonopsis 20 weight portions
Radix Aconiti Lateralis Preparata 20 weight portion Rhizoma Polygonati Odorati 20 weight portion Herba Cistanches 20 weight portions
The Radix Astragali 20 weight portion Cortex Moutans 2 weight portion Borneolum Syntheticums 0.2 weight portion
Two of purpose of the present invention can realize by following technical measures: above nine flavors, Cortex Moutan with wear into fine powder after Borneolum Syntheticum mixes, other gets four flavors such as Herba Epimedii, Fructus Crataegi, Rhizoma Polygonati Odorati, Herba Cistanches and is ground into coarse grain, ethanol extraction with 40-50%, collect extracting solution, filter, reclaim ethanol, be condensed into thick paste; Get Radix Codonopsis, Radix Aconiti Lateralis Preparata, the Radix Astragali three flavor waters and decoct, extracting solution filters, and is condensed into thick paste, merge with aforesaid alcohol extraction thick paste, mixing, drying is pulverized, and adds the Cortex Moutan Borneolum Syntheticum powder again, mixing, the Chinese medical concrete powder.
Use these extract powders then, just can make various dosage form, once in extract powder, added disintegrating agent, binding agent, granulate, add lubricant, be pressed into tablet such as the inventor; Or in extract powder, add disintegrating agent, binding agent, be prepared into pill; Or in extract powder, add substrate, suspending agent, wetting agent, be prepared into soft capsule.
Elsewhere, the inventor also finds to extract process for purification by another kind, also can reach above purpose.This method is such: above nine flavors, Cortex Moutan with wear into fine powder after Borneolum Syntheticum mixes, other gets Six-elements such as Herba Epimedii, Fructus Crataegi, Radix Codonopsis, Rhizoma Polygonati Odorati, Herba Cistanches, the Radix Astragali and is ground into coarse grain, ethanol extraction with 30～60% is collected extracting solution, filters, reclaim ethanol, be condensed into thick paste; Get the Radix Aconiti Lateralis Preparata water and decoct, extracting solution filters, and is condensed into thick paste, merge with aforesaid alcohol extraction thick paste, and mixing, drying is pulverized, and adds the Cortex Moutan Borneolum Syntheticum powder again, and mixing gets the Chinese medical concrete powder.
Along with the progress of research process, the inventor has also formulated following content assaying method and qualitative identification method, so that the quality of the pharmaceutical preparations is controlled.
Content assaying method can adopt following method according to the needs of different dosage form:
A, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water 20-30: 80-70 is a mobile phase, detects wavelength 270 ± 2nm.Flow velocity is 1.0 ± 0.2ml/min.Number of theoretical plate calculates by the icariin peak should be not less than 1500.
It is an amount of that the preparation precision of reference substance solution takes by weighing the icariin reference substance, adds methanol and make the solution that every 1ml contains 60 μ g, promptly.
The preparation of need testing solution takes by weighing this product fine powder, 0.5-2g, and accurate the title, decide, put in the conical flask, precision adds methanol or Diluted Alcohol 50ml, claims to decide weight, supersound process 10-30 minute, weigh, supply the weight that subtracts mistake with methanol or Diluted Alcohol, filter, precision is measured subsequent filtrate 10ml, water bath method, residue adds water 15ml makes dissolving, put in the separatory funnel, add the ethyl acetate jolting and extract 5 times, each 15ml, merge ethyl acetate liquid, water bath method, residue adds dissolve with methanol, quantitatively is transferred in the 10ml measuring bottle, add methanol to scale, shake up, filter with microporous filter membrane (0.45 μ m), promptly.
Accurate respectively reference substance and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
B, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water 20-30: 80-70 is a mobile phase, detects wavelength 270 ± 2nm.Flow velocity is 1.0 ± 0.2ml/min.Number of theoretical plate calculates by the icariin peak should be not less than 1500.
It is an amount of that the preparation precision of reference substance solution takes by weighing the icariin reference substance, adds methanol and make the solution that every 1ml contains 60 μ g, promptly.
The preparation of need testing solution takes by weighing this product 0.5-2g, and accurate the title decides, and puts in the conical flask, and precision adds methanol or Diluted Alcohol 50ml, claim to decide weight, supersound process 10-30 minute, weigh, supply the weight that subtracts mistake with methanol or Diluted Alcohol, filter, filter with microporous filter membrane (0.45 μ m), promptly.
Accurate respectively reference substance and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Discrimination method then comprises following several:
A, get the preparation finished product that is equivalent to crude drug 5-15g, put in the conical flask, add methanol 30-50ml, supersound process 10-30 minute, filter water bath method, residue adds water 15ml makes dissolving, in the dislocation separatory funnel, add the ethyl acetate jolting and extract 2-3 time, each 15ml, merge ethyl acetate liquid, water bath method, residue add ethanol 1ml makes dissolving, as need testing solution.Other gets the ursolic acid reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography, draw each 1-5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with toluene-ethyl acetate-formic acid of 20: 4: 0.5 was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
B, get the preparation finished product that is equivalent to crude drug 5-15g, put in the conical flask, the 10-30ml that adds diethyl ether, supersound process 10-30 minute, filter, filtrate volatilizes, and residue adds acetone 1ml makes dissolving, as need testing solution.Other gets the Borneolum Syntheticum reference substance, adds acetone and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography, draw each 1-5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with toluene-acetone of 18: 1 was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid of 5% vanillin, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance on, show the speckle of same color.
C, get the preparation finished product that is equivalent to crude drug 5-15g, put in the conical flask, the 10-30ml that adds diethyl ether, supersound process 10-30 minute, filter, filtrate volatilizes, and residue adds acetone 1ml makes dissolving, as need testing solution.It is an amount of that other gets the paeonol reference substance, adds acetone and make the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography, draw each 4-10 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with cyclohexane extraction-chloroforms of 7: 3: 0.5-ethyl acetate is developing solvent, launch, take out, dry, spray is with 5-10% ferric chloride ethanol test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
This product can be used for treating climacteric syndrome, and the inventor has carried out pharmacodynamics test research to this, specifically test as follows:
Test the influence of a pair of removal ovary rat gonadal hormone
Medicine: this product tablet by optimum prescription proportioning, is divided into A, B group by the extraction and purification process difference.
Animal: female sd inbred rats 200～240g
48 of rats, etherization, in about under the most last rib, midaxillary line and apart from the about 2cm infall in the spinal column outside, cut skin and dorsal muscles, excision both sides ovary is sewed up the incision.Postoperative next day, animal is divided into medicine A group (0.4g/kgd), B group (0.4g/kgd), model control group (waiting capacity to heat up in a steamer water), normal control group (waiting the capacity distilled water) at random.Animal gastric infusion every day 1 time, 28d continuously.1h puts to death animal after the last administration, gets hematometry estrogen.Experimental data adopts the t check.The results are shown in Table 1.
Table 1 this product is to the influence of climacteric syndrome rat model gonadal hormone (.x ± s)
| Group | Estrogen (ng/L) |
| Model control group medicine A group medicine B group normal control group | 4.58±1.70** 6.78±1.90** 6.19±2.29* 8.18±1.66 |
Compare * P＜0.05, * * P＜0.01 with model control group
Test the experiment of two resisting fatigue
Medicine: this product tablet by optimum prescription proportioning, is divided into A, B group by the extraction and purification process difference.
Animal: Kunming mouse
50 of body weight 18～22g mices are divided into 5 groups at random.Every group 10, each 5 of male and female, the grouping situation sees Table 2.Each treated animal ig administration, blank group ig equivalent normal saline, continuous 10 days, 1h after the last administration, it is that 20 ℃ tank is swum that mice is put into water temperature.Sink under water until mice, calculate swimming time.Experimental result sees Table 2.
The influence of table 2 pair mice swimming time (.X ± s)
| Dosage (gkg-1) | Number of animals (only) | Swimming time (min) | |
| Blank group A group B group A+B group FUKANGNING PIAN | -- 3.5 3.5 3.5 3.3 | 10 10 10 10 10 | 6.79±2.03 8.08±3.55* 8.68±3.10* 10.96±3.76** 9.02±4.02* |
Annotate: compare * P＜0.01, * * P＜0.001 with the blank group.
Experimental result shows that two dosage of this product 7.0g/kg and 14.0g/kg are energy significant prolongation mice swimming time all, compares P＜0.01 or P＜0.001 with the blank group.
Test the influence of three pairs of mice pentobarbital sodium lengths of one's sleep
Medicine: this product soft capsule.
Medicine: this product tablet by optimum prescription proportioning, is divided into A, B group by the extraction and purification process difference.
50 of body weight 20～22g mices are divided into 5 groups at random, and 10 every group, male female each 5.The grouping situation sees Table 3.Each treated animal ig administration, blank group ig equivalent normal saline, continuous 5 days.1h behind the last medicine, with the dosage of 35mg/kg, mice ig pentobarbital sodium is an index with the righting reflex loss, the record mouse sleep time.Experimental result sees Table 3.
The influence of table 3 pair mice pentobarbital sodium length of one's sleep (.X ± s)
| Dosage (gkg -1) | Number of animals (only) | The length of one's sleep (min) | |
| Blank group A group B group A+B group FUKANGNING PIAN | -- 3.5 3.5 3.5 3.3 | 10 10 10 10 10 | 27.10±12.20 37.90±8.85* 38.20±7.18* 40.10±5.98* 35.00±8.49 |
Annotate: each group compares * P＜0.05 with the blank group.
Experimental result shows, this product can to a certain degree prolong mice pentobarbital sodium length of one's sleep.
Result of the test shows that this product can improve the estrogen level of the low animal of gonad function, has the antifatigue effect, can hypnotic, and for this product clinical treatment climacteric syndrome has been established pharmacological basis.
The specific embodiment:
Embodiment 1
[prescription] Herba Epimedii 220g Fructus Crataegi 220g Radix Codonopsis 220g
Radix Aconiti Lateralis Preparata 180g Rhizoma Polygonati Odorati 180g Herba Cistanches 180g
Radix Astragali 180g Cortex Moutan 22g Borneolum Syntheticum 2.2g
[method for making] above nine flavors, Cortex Moutan with wear into fine powder after Borneolum Syntheticum mixes, other gets four flavors such as Herba Epimedii, Fructus Crataegi, Rhizoma Polygonati Odorati, Herba Cistanches and is ground into coarse grain, the ethanol extraction with 45%, the collection extracting solution, filtration, recovery ethanol is condensed into thick paste; Get Radix Codonopsis, Radix Aconiti Lateralis Preparata, the Radix Astragali three flavor waters decoctions, extracting solution filters, and is condensed into thick paste, merges with aforesaid alcohol extraction thick paste, mixing, drying is pulverized, and adds the Cortex Moutan Borneolum Syntheticum powder again, mixing adds carboxymethylstach sodium 15g, microcrystalline Cellulose 45g, granulate drying, granulate, add magnesium stearate 1g, add starch appropriate supplement heavy sensation in the foot amount again to 380g, mixing, tabletting, the bag film-coat, promptly.
Embodiment 2
[prescription] Herba Epimedii 180g Fructus Crataegi 180g Radix Codonopsis 180g
Radix Aconiti Lateralis Preparata 220g Rhizoma Polygonati Odorati 220g Herba Cistanches 220g
Radix Astragali 220g Cortex Moutan 18g Borneolum Syntheticum 1.8g
[method for making] above nine flavors, Cortex Moutan with wear into fine powder after Borneolum Syntheticum mixes, other gets Six-elements such as Herba Epimedii, Fructus Crataegi, Radix Codonopsis, Rhizoma Polygonati Odorati, Herba Cistanches, the Radix Astragali and is ground into coarse grain, the ethanol extraction with 45%, the collection extracting solution, filtration, recovery ethanol is condensed into thick paste; Get the Radix Aconiti Lateralis Preparata water and decoct, extracting solution filters, and is condensed into thick paste, merges with aforesaid alcohol extraction thick paste, mixing, drying is pulverized, and adds Cortex Moutan, Borneolum Syntheticum powder again, mixing adds carboxymethylstach sodium 15g, microcrystalline Cellulose 45g, granulate drying, granulate, add magnesium stearate 1g, add starch appropriate supplement heavy sensation in the foot amount again to 380g, mixing, be pressed into 1500, the bag film-coat, promptly.
[qualitative identification]
(1) get 5 of this product, porphyrize is put in the conical flask, add methanol 40ml, supersound process 20 minutes filters, water bath method, residue add water 15ml makes dissolving, in the dislocation separatory funnel, adding the ethyl acetate jolting extracts 3 times, each 15ml merges ethyl acetate liquid, water bath method, residue adds ethanol 1ml makes dissolving, as need testing solution.Other gets the ursolic acid reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with toluene-ethyl acetate-formic acid of 20: 4: 0.5 was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2), get 5 of this product, porphyrize is put in the conical flask, the 20ml that adds diethyl ether, supersound process 20 minutes filters, filtrate volatilizes, residue adds acetone 1ml makes dissolving, as need testing solution.Other gets the Borneolum Syntheticum reference substance, adds acetone and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with toluene-acetone of 18: 1 was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid of 5% vanillin, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance on, show the speckle of same color.
(3), get 5 of this product, put in the conical flask, the 20ml that adds diethyl ether, supersound process 20 minutes filters, filtrate volatilizes, residue adds acetone 1ml makes dissolving, as need testing solution.It is an amount of that other gets the paeonol reference substance, adds acetone and make the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography test, draw each 510 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with cyclohexane extraction-chloroforms of 7: 3: 0.5-ethyl acetate is developing solvent, launches, and takes out, dry, spray is with 10% ferric chloride ethanol test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
[assay]
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water is a mobile phase at 27: 73, detects wavelength 270nm.Flow velocity is 1.0ml/min.Number of theoretical plate calculates by the icariin peak should be not less than 1500.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the icariin reference substance, adds methanol and make the solution that every 1ml contains 60 μ g, promptly.
The preparation of need testing solution takes by weighing this product, is ground into fine powder, gets 0.1g, the accurate title, decide, and puts in the conical flask, and precision adds methanol or Diluted Alcohol 50ml, claim to decide weight, supersound process 20 minutes is weighed, supply the weight that subtracts mistake with methanol or Diluted Alcohol, filter, precision is measured subsequent filtrate 10ml, water bath method, residue add water 15ml makes dissolving, puts in the separatory funnel, adding the ethyl acetate jolting extracts 5 times, each 15ml merges ethyl acetate liquid, water bath method, residue adds dissolve with methanol, quantitatively be transferred in the 10ml measuring bottle, add methanol, shake up to scale, filter with microporous filter membrane (0.45 μ m), promptly.
Accurate respectively reference substance and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Every of this product contains Herba Epimedii with icariin (C
33H
40O
15) meter, must not be less than 0.50mg.
Embodiment 3
[prescription] Herba Epimedii 100g Fructus Crataegi 100g Radix Codonopsis 100g
Radix Aconiti Lateralis Preparata 100g Rhizoma Polygonati Odorati 100g Herba Cistanches 100g
Radix Astragali 100g Cortex Moutan 10g Borneolum Syntheticum 1g
[method for making] above nine flavors, Cortex Moutan with wear into fine powder after Borneolum Syntheticum mixes, other gets Six-elements such as Herba Epimedii, Fructus Crataegi, Radix Codonopsis, Rhizoma Polygonati Odorati, Herba Cistanches, the Radix Astragali and is ground into coarse grain, the ethanol extraction with 45%, the collection extracting solution, filtration, recovery ethanol is condensed into thick paste; Get the Radix Aconiti Lateralis Preparata water and decoct, extracting solution filters, and is condensed into thick paste, merge with aforesaid alcohol extraction thick paste, and mixing, drying is pulverized, and adds Cortex Moutan, Borneolum Syntheticum powder again, and mixing adds an amount of Cera Flava and vegetable oil, and colloid mill grinds evenly, is pressed into soft capsule, promptly.
Claims (9)
1. a treatment climacteric syndrome and neurasthenic Chinese medicine composition is characterized in that this Chinese medicine composition made by following raw material medicaments:
Herba Epimedii 18-22 weight portion Fructus Crataegi 18-22 weight portion Radix Codonopsis 18-22 weight portion
Radix Aconiti Lateralis Preparata 18-22 weight portion Rhizoma Polygonati Odorati 18-22 weight portion Herba Cistanches 18-22 weight portion
Radix Astragali 18-22 weight portion Cortex Moutan 1.8-2.2 weight portion Borneolum Syntheticum 0.18-0.22 weight portion.
2. Chinese medicine composition according to claim 1 is characterized in that this Chinese medicine composition made by following raw material medicaments:
Herba Epimedii 20 weight portion Fructus Crataegis 20 weight portion Radix Codonopsis 20 weight portions
Radix Aconiti Lateralis Preparata 20 weight portion Rhizoma Polygonati Odorati 20 weight portion Herba Cistanches 20 weight portions
The Radix Astragali 20 weight portion Cortex Moutans 2 weight portion Borneolum Syntheticums 0.2 weight portion.
3. the preparation method of Chinese medicine composition as claimed in claim 1 or 2 is characterized in that this method contains one of following two kinds of steps:
A, get crude drug, Cortex Moutan with wear into fine powder after Borneolum Syntheticum mixes, other gets four flavors such as Herba Epimedii, Fructus Crataegi, Rhizoma Polygonati Odorati, Herba Cistanches and is ground into coarse grain, with the ethanol extraction of 40-50%, collects extracting solution, filters, and reclaims ethanol, is condensed into thick paste; Get Radix Codonopsis, Radix Aconiti Lateralis Preparata, the Radix Astragali three flavor waters decoctions, extracting solution filters, and is condensed into thick paste, merge with aforesaid alcohol extraction thick paste, and mixing, drying is pulverized, and adds the Cortex Moutan Borneolum Syntheticum powder again, and mixing obtains medicated powder;
B, get crude drug, Cortex Moutan with wear into fine powder after Borneolum Syntheticum mixes, other gets Six-elements such as Herba Epimedii, Fructus Crataegi, Radix Codonopsis, Rhizoma Polygonati Odorati, Herba Cistanches, the Radix Astragali and is ground into coarse grain, with the ethanol extraction of 40-50%, collects extracting solution, filters, and reclaims ethanol, is condensed into thick paste; Get the Radix Aconiti Lateralis Preparata water and decoct, extracting solution filters, and is condensed into thick paste, merge with aforesaid alcohol extraction thick paste, and mixing, drying is pulverized, and adds the Cortex Moutan Borneolum Syntheticum powder again, and mixing obtains medicated powder.
4. the preparation method of Chinese medicine composition according to claim 3 is characterized in that adding available adjuvant on the galenic pharmacy in the medicated powder that obtains at last, makes required dosage form.
5. the preparation method of Chinese medicine composition according to claim 4 is characterized in that and can the medicated powder that obtain at last be made required dosage form by in following several modes any:
Add disintegrating agent, binding agent in a, the medicated powder, granulate, add lubricant, be pressed into tablet;
Add disintegrating agent, binding agent in b, the medicated powder, be prepared into pill;
Add substrate, suspending agent, wetting agent in c, the medicated powder, be prepared into soft capsule.
6. the preparation method of Chinese medicine composition according to claim 5, it is characterized in that: the disintegrating agent of adding comprises one or more in starch, carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose, polyvidone, polyvinylpolypyrrolidone, Explotab, low-substituted hydroxypropyl cellulose, the alginic acid; Binding agent comprises one or more in different concentration ethanol, water, starch slurry, dextrin, high-purity dextrin slurry, starch and sucrose mixing slurry, starch and arabic gum mixing slurry, mucialga of arabic gummy, syrup, maltose, gelatine size, polyvinylpyrrolidone, Polyethylene Glycol, methylcellulose, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, the sucrose dextrin copolymer; Lubricant comprises stearic acid and calcium thereof, magnesium, zinc salt, hydrogenated vegetable oil, sodium laurylsulfate, magnesium laurylsulfate, single Laurel sucrose acid ester, adipic acid, fumaric acid, triacetyl glycerine, Macrogol 4000, polyethylene glycol 6000, Polyethylene Glycol 8000, polyoxyethylene monostearate, light mineral oil, liquid Paraffin, the wax class, boric acid, sodium chloride, sodium benzoate, sodium acetate, one or more in the enuatrol; Substrate comprises vegetable oil, polyethylene glycols; Suspending agent comprises Cera Flava, polyethylene glycols; Wetting agent comprises one or both in Tweens, the spans.
7. according to the method for quality control of claim 1 or 2 described a kind of Chinese medicine compositions, it is characterized in that this method comprises following one or both content assaying methods:
A, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water 20-30: 80-70 is a mobile phase, detects wavelength 270 ± 2nm, and flow velocity is 1.0 ± 0.2ml/min, and number of theoretical plate calculates by the icariin peak should be not less than 1500;
It is an amount of that the preparation precision of reference substance solution takes by weighing the icariin reference substance, adds methanol and make the solution that every 1ml contains 60 μ g, promptly;
The preparation of need testing solution takes by weighing this product fine powder, 0.5-2g, and accurate the title, decide, put in the conical flask, precision adds methanol or Diluted Alcohol 50ml, claims to decide weight, supersound process 10-30 minute, weigh, supply the weight that subtracts mistake with corresponding solvent, filter, precision is measured subsequent filtrate 10ml, water bath method, residue adds water 15ml makes dissolving, put in the separatory funnel, add the ethyl acetate jolting and extract 5 times, each 15ml, merge ethyl acetate liquid, water bath method, residue adds dissolve with methanol, quantitatively is transferred in the 10ml measuring bottle, add methanol to scale, shake up, filter with 0.45 μ m microporous filter membrane, promptly;
Accurate respectively reference substance and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly;
B, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water 20-30: 80-70 is a mobile phase, detects wavelength 270 ± 2nm, and flow velocity is 1.0 ± 0.2ml/min, and number of theoretical plate calculates by the icariin peak should be not less than 1500;
It is an amount of that the preparation precision of reference substance solution takes by weighing the icariin reference substance, adds methanol and make the solution that every 1ml contains 60 μ g, promptly;
The preparation of need testing solution takes by weighing this product 0.5-2g, and accurate the title decides, and puts in the conical flask, and precision adds methanol or Diluted Alcohol 50ml, claim to decide weight, supersound process 10-30 minute, weigh, supply the weight that subtracts mistake with corresponding solvent, filter, filter with 0.45 μ m microporous filter membrane, promptly;
Accurate respectively reference substance and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
8. according to the method for quality control of the described Chinese medicine composition of claim 7, it is characterized in that this method comprises one or more following discrimination methods:
A, get the preparation finished product that is equivalent to crude drug 5-15g, put in the conical flask, add methanol 30-50ml, supersound process 10-30 minute, filter water bath method, residue adds water 15ml makes dissolving, in the dislocation separatory funnel, add the ethyl acetate jolting and extract 2-3 time, each 15ml, merge ethyl acetate liquid, water bath method, residue add ethanol 1ml makes dissolving, as need testing solution; Other gets the ursolic acid reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography, draw each 1-5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with toluene-ethyl acetate-formic acid of 20: 4: 0.5 was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear that hot blast blows to the speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
B, get the preparation finished product that is equivalent to crude drug 5-15g, put in the conical flask, the 10-30ml that adds diethyl ether, supersound process 10-30 minute, filter, filtrate volatilizes, and residue adds acetone 1ml makes dissolving, as need testing solution; Other gets the Borneolum Syntheticum reference substance, adds acetone and makes the solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography, draw each 1-5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with toluene-acetone of 18: 1 was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid of 5% vanillin, and it is clear that hot blast blows to the speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance on, show the speckle of same color;
C, get the preparation finished product that is equivalent to crude drug 5-15g, put in the conical flask, the 10-30ml that adds diethyl ether, supersound process 10-30 minute, filter, filtrate volatilizes, and residue adds acetone 1ml makes dissolving, as need testing solution; It is an amount of that other gets the paeonol reference substance, adds acetone and make the solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography, draw each 4-10 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with cyclohexane extraction-chloroforms of 7: 3: 0.5-ethyl acetate is developing solvent, launch, take out, dry, spray is with 5-10% ferric chloride ethanol test solution; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
9. a kind of as claimed in claim 1 or 2 Chinese medicine composition is used for the treatment of application in climacteric syndrome and the neurasthenic medicine in preparation.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101417081A (en) * | 2007-10-22 | 2009-04-29 | 广州奇星药业有限公司 | Quality control method of Longfengbao capsule |
| CN106442749A (en) * | 2016-07-14 | 2017-02-22 | 北京雷力海洋生物新产业股份有限公司 | Brown algae and detection method for detecting alginic acid content of brown algae product |
| CN113117020A (en) * | 2021-04-22 | 2021-07-16 | 广州白云山奇星药业有限公司 | Application of Longfengbao capsule in preparing medicine for preventing and treating cardiovascular disease |
| CN115919966A (en) * | 2021-08-19 | 2023-04-07 | 广州白云山奇星药业有限公司 | Traditional Chinese medicine composition for treating climacteric syndrome and preparation method thereof |
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2005
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101417081A (en) * | 2007-10-22 | 2009-04-29 | 广州奇星药业有限公司 | Quality control method of Longfengbao capsule |
| CN101417081B (en) * | 2007-10-22 | 2013-05-29 | 广州奇星药业有限公司 | Quality detection method of Longfengbao capsule |
| CN106442749A (en) * | 2016-07-14 | 2017-02-22 | 北京雷力海洋生物新产业股份有限公司 | Brown algae and detection method for detecting alginic acid content of brown algae product |
| CN106442749B (en) * | 2016-07-14 | 2019-06-21 | 北京雷力海洋生物新产业股份有限公司 | The detection method of seaweed acid content in a kind of brown alga and its product |
| CN113117020A (en) * | 2021-04-22 | 2021-07-16 | 广州白云山奇星药业有限公司 | Application of Longfengbao capsule in preparing medicine for preventing and treating cardiovascular disease |
| CN115919966A (en) * | 2021-08-19 | 2023-04-07 | 广州白云山奇星药业有限公司 | Traditional Chinese medicine composition for treating climacteric syndrome and preparation method thereof |
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