CN101011495A - Kidney tonifying pill preparation made of fish air bladder and its preparation - Google Patents
Kidney tonifying pill preparation made of fish air bladder and its preparation Download PDFInfo
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- CN101011495A CN101011495A CN 200610144141 CN200610144141A CN101011495A CN 101011495 A CN101011495 A CN 101011495A CN 200610144141 CN200610144141 CN 200610144141 CN 200610144141 A CN200610144141 A CN 200610144141A CN 101011495 A CN101011495 A CN 101011495A
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Abstract
The invention relates to a kidney-tonifying pill containing fish bladder and process for preparations, wherein the pill also comprises the raw material of sodium carboxymethylcellulose as the adjuvant.
Description
Technical field:
The present invention relates to a kind of new preparation of Chinese medicine YUBIAO BUSHEN WAN, particularly do not add the watered pill that processed with honey becomes, YUBIAO BUSHEN WAN of the present invention has wherein added sodium carboxymethyl cellulose as adjuvant.
Background technology:
YUBIAO BUSHEN WAN is a kind of big honeyed pills that has gone on the market, and its function is Yang strengthening and life essence tonifying with curing mainly.Be used for deficiency of kidney yang, giddy, dim eyesight, tinnitus due to the deficiency of the kidney, the lumbago knee joint is soft, sexual impotence, premature ejaculation, emission, sterile, cold womb is infertile, diseases such as complexion blackout.
The prescription of YUBIAO BUSHEN WAN big honeyed pills consists of: Air Bladder pseudosciaenae seu Acipenser, Fructus Lycii, Stamen Nelumbinis, meat desert appearance, Radix Morindae Officinalis, the Cortex Eucommiae, Radix Angelicae Sinensis, Semen Cuscutae, Fructus Psoraleae, Poria, Herba Epimedii, Cortex Cinnamomi, Tong disease Herba chenopodii, Radix Achyranthis Bidentatae, Radix Aconiti Lateralis Preparata.
Big honeyed pills is a conventional formulation, need chew, and mouthfeel is bad, and takes inconvenience, and the present invention has invented a kind of new dosage form-watered pill of bolus for invigorating kidney and improving by the improvement to conventional dosage forms, has overcome above defective.The watered pill also is a conventional formulation, but traditional handicraft makes watered pill instability, and the disintegrate difficulty, quality control also is difficult to reach the requirement of large-scale production, and the present invention is through process modification, overcome above defective, it is good to have made a kind of mouthfeel, taking convenience, and disintegrate is rapid, absorb well the bolus for invigorating kidney and improving watered pill that stability is high.
In addition, existing YUBIAO BUSHEN WAN big honeyed pills preparation exists method of quality control to fall behind the uppity shortcoming of product quality.Can not effectively control the quality of preparation, thereby will influence the production of product and ensure the quality of products.
For effectively controlling product quality, we have set up the new method of quality control of preparation of the present invention, and this method adopts thin layer chromatography to differentiate, adopt high-efficient liquid phase technique to carry out assay.This method of quality control precision, sensitivity, stability are all good, guarantee " safety, the homogeneous, stable, effective, controlled " of product quality.
Summary of the invention:
The invention provides a kind of kidney tonifying pill preparation made of fish air bladder, described preparation is the watered pill, and said preparation is made by following raw material of Chinese medicine:
Air Bladder pseudosciaenae seu Acipenser 20.8g Fructus Lycii 20.8g Stamen Nelumbinis 20.8g
Herba Cistanches 20.8g Radix Morindae Officinalis 20.8g Cortex Eucommiae 20.8g
Radix Angelicae Sinensis 20.8g Semen Cuscutae 20.8g Fructus Psoraleae 15.6g
Poria 15.6g Herba Epimedii 20.8g Cortex Cinnamomi 10.4g
Semen Astragali Complanati 15.6g Radix Achyranthis Bidentatae 15.6g Radix Aconiti Lateralis Preparata 10.4g.
More than prescription can be made the watered pill 1000 balls.
Preparation of the present invention wherein also comprises the disintegrating agent of total formulation weight amount 1-5% also needing to add an amount of water during preparation.Described an amount of water is the amount that pill is reached be suitable for preparing, and can be the water of 10-300g in above-mentioned prescription, and adding mode and amount belong to routine techniques.
Disintegrating agent of the present invention is the disintegrating agent that is fit to uniqueness of the present invention, sodium carboxymethyl cellulose most preferably, and its most preferred adding two is 1.5% of a gross weight.
Preparation of the present invention after making the watered pill, also will be wrapped the bag film-coat at the pill skin.
Film-coat of the present invention is with conventional film-coat technology processing and preparing.
Preparation of the present invention is used for orally, and taking dose is in the ball number, and preferred consumption is one time 15 ball, 2 times on the one.
The present invention also comprises the preparation method of preparation of the present invention, and this preparation method uses operating procedure to limit, and main operational steps is as follows:
Take by weighing medical material, evenly mixed, pulverize, cross 16～120 mesh sieves, add disintegrating agent, pill, drying is made 1000 balls, the bag film-coat, promptly.
Preferred step is: take by weighing medical material, and evenly mixed, pulverize, cross 100 mesh sieves, add sodium carboxymethyl cellulose, mould pill or general pill, drying is made 1000 balls, the bag film-coat, promptly.
Contain Herba Epimedii, Fructus Lycii in the present invention's prescription, this two flavors prescription is solely pulverized, and difficulty is bigger, and it is low to receive the powder rate, so the present invention adopts mixed flushing to pulverize.Promptly take by weighing the 15 flavor medical materials such as Air Bladder pseudosciaenae seu Acipenser of recipe quantity, evenly mixed, pulverize, cross 100 mesh sieves.
It is binding agent that the present invention selects deionized water for use.Add 1.5% sodium carboxymethyl cellulose through screening, as disintegrating agent.Adopt general pill or mould the method pill of pill.Baking temperature of the present invention is 80 ℃.Moisture content is controlled in 9%.
General pill described in the above preparation method: be meant that being about to medical material fine powder appropriate liquid is the pill that the general system of adhesive forms with general method for making preparation.
The described pill of moulding: be meant with moulding method for making preparation, be about to the medical material fine powder and make the suitable plasticity ball piece of soft or hard, make the ball bar more successively, cut apart and make the pill of pill with suitable adhesive mix homogeneously.
The invention has the advantages that, taking convenience, dosage is accurate, and disintegrate is rapid, absorbs well, and stability is high, and storage period is long.
In addition, the present invention is through groping, find a kind of new method of quality control, the watered pill of the present invention has been carried out quality control in process of production, can reach work under supervision, guarantee the purpose of product quality, for this reason, the invention provides a kind of method of quality control, method of quality control provided by the invention, at characteristics of the present invention and the present invention's prescription, method of quality control of the present invention may further comprise the steps:
The observation of character, the discriminating of content, the inspection of content is carried out assay to the composition that contains, and therefore, the main step of method of quality control of the present invention is:
[character] this product is the film-coat ball, removes to show pitchy behind the film-coat; Distinguish the flavor of sweet, little hardship, fiber crops slightly.
This product is got in [discriminating] (1), remove film-coat after, put microscopically and observe: the dendritic agglomerate of irregular branch is colourless, meets chloral hydrate and dissolves; Hyphae colorless or light brown, diameter 4 ~ 6 μ m.Parenchyma cell spindle, wall are slightly thick, and there is atomic thin oblique cross lamination on the surface.Needle-like calcium oxalate crystal bunchy or be dispersed in, needle is about 184 μ m.Pollen grain circle, surface have the carving stricture of vagina.
(2) get this product 25 balls, remove film-coat, be ground into fine powder, put in the tool plug conical flask, add methanol 40ml, reflux 30 minutes filters, the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, extracts the extracting solution evaporate to dryness with ethyl acetate 15ml jolting, residue adds ethyl acetate 2ml makes dissolving, as need testing solution.Other gets psoralen, isopsoralen reference substance, divides the broken mirror of footwear to add ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw each 5 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, with normal hexane-ethyl acetate (4: 1) is developing solvent, launches, and takes out, dry, spray is with 10% potassium hydroxide methanol solution, and 105 ℃ were heated about 5 minutes, and put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
(3) get this product 25 balls, remove film-coat, be ground into fine powder, put in the tool plug conical flask, add methanol 50ml, reflux 30 minutes filters, the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, extracts n-butyl alcohol liquid evaporate to dryness with water saturated n-butyl alcohol 30ml jolting, residue adds methanol 2ml makes dissolving, as need testing solution.Other gets Stamen Nelumbinis control medicinal material 0.5g, adds methanol 5ml, and reflux 30 minutes is shone medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw each 3 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with ethyl acetate-methanol-glacial acetic acid (10: 2: 0.5) is developing solvent, launches, and takes out, dry, spray is with 10% ethanol solution of sulfuric acid, and about 10 minutes of 105 ℃ of heating are put under the ultra-violet lamp (365nm) and inspected.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(4) get this product 15 balls, remove film-coat, be ground into fine powder, put in the tool plug conical flask, the 30ml that adds diethyl ether, supersound process 20 minutes filters, and filtrate is as need testing solution.Other gets Radix Angelicae Sinensis control medicinal material 0.4g, the 20ml that adds diethyl ether, and supersound process 20 minutes is shone medical material solution in pairs with legal system.According to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005) test, draw each 3 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with normal hexane-ethyl acetate (9: 1) is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
[inspection] should meet every regulation relevant under the pill item (appendix IA of Chinese Pharmacopoeia version in 2005).
[assay] measured according to high performance liquid chromatography (appendix VID of Chinese Pharmacopoeia version in 2005).
Chromatographic condition and system suitability test are filler with the octadecylsilane chemically bonded silica; With methanol one water (45: 55) is mobile phase; The detection wavelength is 246nm.Number of theoretical plate calculates by the isopsoralen peak should be not less than 3000.
It is an amount of that the isopsoralen reference substance is got in the preparation of reference substance solution, and accurate the title decides, and adds methanol and makes the solution that every 1ml contains 6 μ g, promptly.
This product under the weight differential item is got in the preparation of need testing solution, and porphyrize is got about 0.8g, and accurate the title decides, and puts in the tool plug conical flask, the accurate methanol 25ml that adds, close plug claims to decide weight, and reflux 1 hour is put cold, claim again to decide weight, supply the weight that subtracts mistake, shake up, filter with methanol.Get subsequent filtrate, put refrigerator and cooled and hid 2 hours, filter with microporous filter membrane (0.45 μ m), promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
More than this product described in the method for quality control of the present invention, be meant the watered pill according to prepared of the present invention, method of the present invention also can be measured other dosage forms, when other dosage forms are measured, refers to corresponding other dosage forms.
The invention has the advantages that: the quality inspection standard that has guaranteed preparation of the present invention can have accuracy and advance than the qualitative character of effectively controlling preparation comprehensively, can be used as the effective technology means of the stability of quality control and investigation technology.Be of great importance to improving the quality of products.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention:
Embodiment 1
Prescription:
Air Bladder pseudosciaenae seu Acipenser (stir-baked in powder of CONCHA MERETRICIS SEU CYCLINAE) 20.8g Fructus Lycii 20.8g Stamen Nelumbinis 20.8g
Herba Cistanches 20.8g halberd sky (salt is processed) the 20.8g Cortex Eucommiae (salt is processed) 20.8g
Radix Angelicae Sinensis 20.8g Semen Cuscutae (salt is processed) 20.8g Fructus Psoraleae (salt is processed) 15.6g
Poria 15.6g Herba Epimedii (Adeps Caprae seu ovis is processed) 20.8g Cortex Cinnamomi 10.4g
Semen Astragali Complanati (salt is processed) 15.6g Radix Achyranthis Bidentatae (stir-fry) 15.6g Radix Aconiti Lateralis Preparata (stir-baking with sand) 10.4g
1.5% sodium carboxymethyl cellulose water is an amount of
Preparation:
Take by weighing medical material, evenly mixed, pulverize, cross 100 mesh sieves, add sodium carboxymethyl cellulose, mould pill, drying is made 1000 balls, the bag film-coat, promptly.
Embodiment 2
Prescription:
Air Bladder pseudosciaenae seu Acipenser (stir-baked in powder of CONCHA MERETRICIS SEU CYCLINAE) 20.8g Fructus Lycii 20.8g Stamen Nelumbinis 20.8g
Herba Cistanches 20.8g halberd sky (salt is processed) the 20.8g Cortex Eucommiae (salt is processed) 20.8g
Radix Angelicae Sinensis 20.8g Semen Cuscutae (salt is processed) 20.8g Fructus Psoraleae (salt is processed) 15.6g
Poria 15.6g Herba Epimedii (Adeps Caprae seu ovis is processed) 20.8g Cortex Cinnamomi 10.4g
Semen Astragali Complanati (salt is processed) 15.6g Radix Achyranthis Bidentatae (stir-fry) 15.6g Radix Aconiti Lateralis Preparata (stir-baking with sand) 10.4g
1.5% sodium carboxymethyl cellulose water is an amount of
Preparation:
Take by weighing medical material, evenly mixed, pulverize, cross 100 mesh sieves, add sodium carboxymethyl cellulose, general pill, drying is made 1000 balls, the bag film-coat, promptly.
Claims (8)
1, a kind of kidney tonifying pill preparation made of fish air bladder is characterized in that, is the watered pill of being made by following raw material of Chinese medicine,
Air Bladder pseudosciaenae seu Acipenser 20.8g Fructus Lycii 20.8g Stamen Nelumbinis 20.8g
Herba Cistanches 20.8g Radix Morindae Officinalis 20.8g Cortex Eucommiae 20.8g
Radix Angelicae Sinensis 20.8g Semen Cuscutae 20.8g Fructus Psoraleae 15.6g
Poria 15.6g Herba Epimedii 20.8g Cortex Cinnamomi 10.4g
Semen Astragali Complanati 15.6g Radix Achyranthis Bidentatae 15.6g Radix Aconiti Lateralis Preparata 10.4g.
2, the preparation of claim 1 is characterized in that, 1000 balls are made by following raw material:
Air Bladder pseudosciaenae seu Acipenser 20.8g Fructus Lycii 20.8g Stamen Nelumbinis 20.8g
Herba Cistanches 20.8g Radix Morindae Officinalis 20.8g Cortex Eucommiae 20.8g
Radix Angelicae Sinensis 20.8g Semen Cuscutae 20.8g Fructus Psoraleae 15.6g
Poria 15.6g Herba Epimedii 20.8g Cortex Cinnamomi 10.4g
Semen Astragali Complanati 15.6g Radix Achyranthis Bidentatae 15.6g Radix Aconiti Lateralis Preparata 10.4g
Disintegrating agent 1-5% water is an amount of
3, the preparation of claim 2 is characterized in that, wherein said disintegrating agent is a sodium carboxymethyl cellulose.
4, the preparation of claim 3 is characterized in that, the amount of wherein said sodium carboxymethyl cellulose is 1.5% of a gross weight.
5, the preparation of claim 4 is characterized in that, the outsourcing film-coat.
6, the preparation of claim 5 is characterized in that, said preparation is used for oral, and taking dose is in the ball number, and usage and dosage is: one time 15 ball, 2 times on the one.
7, the preparation method of the preparation of claim 1 is characterized in that, step is as follows: take by weighing medical material, and evenly mixed, pulverize, cross 16～120 mesh sieves, add sodium carboxymethyl cellulose, pill, drying is made 1000 balls, the bag film-coat, promptly.
8, the preparation method of the preparation of claim 7 is characterized in that, step is as follows: take by weighing medical material, and evenly mixed, pulverize, cross 100 mesh sieves, add sodium carboxymethyl cellulose, mould pill or general pill, drying is made 1000 balls, the bag film-coat, promptly.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2006101441416A CN101011495B (en) | 2006-11-28 | 2006-11-28 | Kidney tonifying pill preparation made of fish air bladder and its preparation |
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| CN2006101441416A CN101011495B (en) | 2006-11-28 | 2006-11-28 | Kidney tonifying pill preparation made of fish air bladder and its preparation |
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| CN101011495A true CN101011495A (en) | 2007-08-08 |
| CN101011495B CN101011495B (en) | 2010-09-08 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614347A (en) * | 2012-03-27 | 2012-08-01 | 王存玉 | Chinese medicine for treating chronic lumbar strain |
| CN104459011A (en) * | 2014-12-22 | 2015-03-25 | 上海市徐汇区中心医院 | Detecting method for leucoderma treatment tablet containing eight traditional Chinese medicines |
| CN104523986A (en) * | 2014-12-03 | 2015-04-22 | 李伟 | Swim bladder seed pill for treatment of infertility and a preparation method thereof |
| CN110018269A (en) * | 2019-04-29 | 2019-07-16 | 四川新绿色药业科技发展有限公司 | A kind of thin-layer identification method of salt semen astragali complanati granule |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1824035A (en) * | 2006-01-12 | 2006-08-30 | 北京阜康仁生物制药科技有限公司 | Swim bladder kidney nourishing preparation and its preparation method |
-
2006
- 2006-11-28 CN CN2006101441416A patent/CN101011495B/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614347A (en) * | 2012-03-27 | 2012-08-01 | 王存玉 | Chinese medicine for treating chronic lumbar strain |
| CN102614347B (en) * | 2012-03-27 | 2013-10-16 | 王存玉 | Chinese medicine for treating chronic lumbar strain |
| CN104523986A (en) * | 2014-12-03 | 2015-04-22 | 李伟 | Swim bladder seed pill for treatment of infertility and a preparation method thereof |
| CN104459011A (en) * | 2014-12-22 | 2015-03-25 | 上海市徐汇区中心医院 | Detecting method for leucoderma treatment tablet containing eight traditional Chinese medicines |
| CN110018269A (en) * | 2019-04-29 | 2019-07-16 | 四川新绿色药业科技发展有限公司 | A kind of thin-layer identification method of salt semen astragali complanati granule |
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| Publication number | Publication date |
|---|---|
| CN101011495B (en) | 2010-09-08 |
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Assignee: Jilin Tianqiang Pharmaceutical Co.,Ltd. Assignor: Wang Yujin Contract record no.: 2010220000042 Denomination of invention: Kidney tonifying pill preparation made of fish air bladder and its preparation License type: Exclusive License Open date: 20070808 Record date: 20100819 |
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Owner name: JILIN TIANQIANG PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: WANG YUJIN Effective date: 20130423 |
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Effective date of registration: 20130423 Address after: The people of the street 135300 Liuhe County of Jilin province Liuhe Town, No. 309 Patentee after: Jilin Tianqiang Pharmaceutical Co.,Ltd. Address before: 100071, Beijing, Fengtai District, West Fourth Ring Road, 63-4 Li Feng Lou, 2 floor Patentee before: Wang Yujin |
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Effective date of registration: 20140423 Address after: The people of the street 135300 Tonghua City Liuhe County Jilin province No. 309 Patentee after: DIAOYUTAI MEDICAL GROUP JILIN TIANQIANG PHARMACEUTICAL CO., LTD. Address before: The people of the street 135300 Liuhe County of Jilin province Liuhe Town, No. 309 Patentee before: Jilin Tianqiang Pharmaceutical Co.,Ltd. |