CN1857608B - Preparation of senile dyspneic cough treating capsule - Google Patents
Preparation of senile dyspneic cough treating capsule Download PDFInfo
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- CN1857608B CN1857608B CN2006100205276A CN200610020527A CN1857608B CN 1857608 B CN1857608 B CN 1857608B CN 2006100205276 A CN2006100205276 A CN 2006100205276A CN 200610020527 A CN200610020527 A CN 200610020527A CN 1857608 B CN1857608 B CN 1857608B
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Abstract
The preparation process and quality control method for senile dyspneic cough treating capsule belongs to the field of botanical Chinese medicine technology. The senile dyspneic cough treating capsuleis prepared through grinding partial astragalus root, white atractylodes rhizome and solomonseal into fine powder; twice decocting the rest astragalus root and other four kinds of Chinese medicinal materials, filtering the decoction and concentrating the filtrate; adding the fine powder to the concentrate; palletizing and encapsulating. The present invention has the advantages of high bioavailability, determined curative effect, simplified preparation process, lowered cost and high product quality.
Description
(1) technical field:
The preparation method of LAONIAN KECHUAN JIAONANG belongs to a kind of pharmaceutical composition, especially is the preparation method of the medicine made of raw material with the botanical herbs.
(2) background technology:
Senile chronic bronchitis (abbreviation old-slow-bronchial tube) is meant the chronic nonspecific inflammation of trachea, bronchial mucosa and surrounding tissue thereof.Clinically with the cough, cough up phlegm or with pant and repeatedly the outbreak chronic process be feature.The state of an illness is slowly made progress, Chang Bingfa obstructive emphysema, even pulmonary hypertension, pulmonary heart disease.It is a kind of commonly encountered diseases of serious harm people ' s health, sees with the old people especially more.According to statistics, the old people prevalence of China more than 50 years old can be up to about 15%.Disease mostly occurred in cold season autumn and winter, then alleviated gradually after it cyclostrophic is warm, and the patient has chronic cough, the expectoration history of outbreak repeatedly, pants and can exist throughout the year.
At senile chronic bronchitis, medicine on the market has a lot, Chinese and western medicine Comprehensive Treatment commonly used now, and western medicine has: antipyretic-antalgic, cough-relieving, timid expectorant, relieving asthma, select suitable antibiotic anti-infective therapy for use; The traditional Chinese medical science is advocated determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, suits the remedy to the case.Eliminating phlegm and relieving cough: when using anti-infective therapy, must give expectorant and antitussive medicine, to improve symptoms such as cough, abundant expectoration.Common drug has mixture of ammonium chloride, bromhexine etc., or suits the medicine to the illness with Chinese patent medicines such as fresh Succus Bambusae, Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquiduss.To old unable expectoration person or the more person of amount of expectoration, how to eliminate the phlegm, avoid using strong cough medicine such as codeine and cause that respiratory center suppresses, increase the weight of respiratory tract obstruction or lead to complications and cause that sb.'s illness took a turn for the worse.Spasmolytic is relievingd asthma: the patient is more violent as panting, and available spasmolytic anti-asthmatic aminophylline, terbutaline etc. should conventionally be used bronchodilators if any the reversibility obstructor, suck treatment as aerosols such as ipratropium bromides, help the removing of sputum, improve symptom.If air flue still has lasting the obstruction after using air flue diastole agent, can use prednisone, dexamethasone etc.Hormone can not use easily, and hormone is apparent in view for removing the bronchospasm effect.But hormone has and reduces immunity, causes side effect such as dependence, has only when the severe outbreak, with general antibiotic medicine effect when undesirable again, and could be in standard use under the physician guidance.
Old cough with asthma sheet is produced by many companies, and has been obtained numerous medical personnels and patient's favorable comment because it treats the definite curative effect of senile chronic bronchitis and various body deficient syndromes.But there is following shortcoming in it: 1, the easy moisture absorption of tablet is rotten; 2, tablet has the taste of adverse drug, and the patient is not easy to accept; 3, elderly population is the Susceptible population of diabetes, if coated tablet, the diabetes patient can not take; 4, this in old age the cough with asthma sheet preparation method not good enough, its quality standard control method haves much room for improvement.
(3) summary of the invention:
The problem to be solved in the present invention provides a kind of bioavailability height at above shortcoming exactly, and curative effect is more definite, and preparation method is more simplified, the preparation method of the LAONIAN KECHUAN JIAONANG that reduces production costs, and its technical scheme is:
Medicine of the present invention comprises following component: (consumption is a weight portion)
The Radix Astragali 220 Rhizoma Atractylodis Macrocephalaes 132 Radix Saposhnikoviaes 132 Radix Glycyrrhizaes 88
Rhizoma Polygonati 132 Herba Epimedii 132 Fructus Psoraleaes 132
Its preparation method may further comprise the steps:
1), pulverizes: get 140.8 parts of the Radixs Astragali, with the Rhizoma Atractylodis Macrocephalae, that Rhizoma Polygonati is ground into fine powder is standby;
2), water carries: will remain the Radix Astragali and Radix Saposhnikoviae, Radix Glycyrrhizae, Herba Epimedii, Fructus Psoraleae decocts with water 2 times, adds 6～15 times of water gagings for the first time, decocts 2 hours, adds 3～12 times of water gagings for the second time, decocts collecting decoction, filtration, filtrate for later use 1.5 hours;
3), concentrate thick paste: is 70～85 ℃ with above-mentioned filtrate in temperature, and vacuum is to be concentrated into the thick paste that relative density is 1.20～1.25 (80 ℃) or to concentrate under the condition of 0.08～0.1Mpa to make dried cream powder, and is standby;
4), granulate: in above-mentioned thick paste or dried cream powder, directly add the crude drug fine powder that the first step makes, or add one or more of adjuvant sucrose, lactose, starch, microcrystalline Cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, 30 POVIDONE K 30 BP/USP 30, add again and make granule after the crude drug powder mixes, 60～70 ℃ of oven drying at low temperatures, incapsulate below 60% at relative humidity, promptly.
Its quality standard control method may further comprise the steps:
With the octadecylsilane chemically bonded silica is filler; Acetonitrile-water (5-30: 95-70) be mobile phase; The detection wavelength is 220nm-280n.Number of theoretical plate calculates by the icariin peak should be not less than 3000.
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 0.03mg, promptly.
The preparation of need testing solution: get the content under this product content uniformity item, porphyrize is got about 1.0g, the accurate title, decide, and puts in the tool plug conical flask, the accurate methanol 20ml that adds, claim to decide weight, supersound process 40 minutes is put cold, claim to decide weight again, supply with methanol and to subtract weight loss, shake up, microporous filter membrane (0.45 μ m) filters, get subsequent filtrate, promptly.
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, 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 0.18mg
Compared with prior art the tangible advantage of the present invention is:
1, behind the oral administration, this capsule is fast with respect to disintegration of tablet, and disintegration is easy to control, and after softgel shell broke, medicine disperseed rapidly, so the drug release stripping is fast, produce effects is rapid, the bioavailability height, and curative effect is more definite; 2, light tight capsule and preferably packaging material can make medicine not be subjected to the influence of oxygen, light in dampness and the air, can avoid the rotten shortcoming of the easy moisture absorption of tablet, thereby improve stability of drug; 3, covered the taste of adverse drug, the patient is acceptant 4, the capsule outward appearance is good, is easy to swallow, and the patient is acceptant; Transportation, storage, easy to carry 5, capsular production interlock is strong, intelligent degree height by the optimization technique parameter, has been simplified production technology, has reduced production cost, more meets the requirement of modern pharmaceutical technology; 6, elderly population is the Susceptible population of diabetes, and capsule need not be done adjuvant for sugar, the shortcoming of having avoided the diabetes patient not take; 7, by increasing the qualitative identification of the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Fructus Psoraleae, Herba Epimedii content is controlled, guaranteed this product quality.
(4) description of drawings:
Accompanying drawing is a process chart of the present invention.
(5) specific embodiment:
Embodiment one:
Take by weighing each medicine by following weight portion:
The Radix Astragali 220 Rhizoma Atractylodis Macrocephalaes 132 Radix Saposhnikoviaes 132 Radix Glycyrrhizaes 88 Rhizoma Polygonatis 132 Herba Epimedii 132 Fructus Psoraleaes 132
Its preparation method may further comprise the steps:
1), pulverize: get 140.8 parts of the Radixs Astragali, to be ground into 200 order fine powders standby with the Rhizoma Atractylodis Macrocephalae, Rhizoma Polygonati;
2), water carries: will remain the Radix Astragali and Radix Saposhnikoviae, Radix Glycyrrhizae, Herba Epimedii, Fructus Psoraleae decocts with water 2 times, adds 12 times of water gagings for the first time, decocts 2 hours, adds 10 times of water gagings for the second time, decocts 1.5 hours, collecting decoction is with the filtration of 300 order filter clothes, filtrate for later use;
3), concentrate thick paste: is 80 ℃ with above-mentioned filtrate in temperature, and vacuum is that to be concentrated into relative density under the condition of 0.08～0.1Mpa be that the thick paste of 1.25 (80 ℃) is standby;
4), granulate: directly add the crude drug fine powder that the first step makes in above-mentioned thick paste, make granule, 60 ℃ of oven drying at low temperatures incapsulate at relative humidity 55%, promptly.
Embodiment two:
Take by weighing each medicine by following weight portion:
The Radix Astragali 220 Rhizoma Atractylodis Macrocephalaes 132 Radix Saposhnikoviaes 132 Radix Glycyrrhizaes 88 Rhizoma Polygonatis 132 Herba Epimedii 132 Fructus Psoraleaes 132
Its preparation method may further comprise the steps:
1), pulverize: get 140.8 parts of the Radixs Astragali, to be ground into 200 order fine powders standby with the Rhizoma Atractylodis Macrocephalae, Rhizoma Polygonati;
2), water carries: will remain the Radix Astragali and Radix Saposhnikoviae, Radix Glycyrrhizae, Herba Epimedii, Fructus Psoraleae decocts with water 2 times, adds 8 times of water gagings for the first time, decocts 2 hours, adds 6 times of water gagings for the second time, decocts 1.5 hours, collecting decoction is with the filtration of 300 order filter clothes, filtrate for later use;
3), concentrate thick paste: is 70 ℃ with above-mentioned filtrate in temperature, and vacuum is to be concentrated into the thick paste that relative density is 1.25 (80 ℃) under the condition of 0.08～0.1Mpa, and drying is pulverized, and it is standby to make dried cream powder;
4), granulate: add the starch of dried cream powder weight 10% in above-mentioned dried cream powder, add the crude drug fine powder mixing that the first step makes again, make granule, 65 ℃ of oven drying at low temperatures incapsulate below 60% at relative humidity, promptly.
Embodiment three:
Take by weighing each medicine by following weight portion:
The Radix Astragali 220 Rhizoma Atractylodis Macrocephalaes 132 Radix Saposhnikoviaes 132 Radix Glycyrrhizaes 88 Rhizoma Polygonatis 132 Herba Epimedii 132 Fructus Psoraleaes 132
Its preparation method may further comprise the steps:
1), pulverize: get 140.8 parts of the Radixs Astragali, to be ground into 200 order fine powders standby with the Rhizoma Atractylodis Macrocephalae, Rhizoma Polygonati;
2), water carries: will remain the Radix Astragali and Radix Saposhnikoviae, Radix Glycyrrhizae, Herba Epimedii, Fructus Psoraleae decocts with water 2 times, adds 10 times of water gagings for the first time, decocts 2 hours, adds 8 times of water gagings for the second time, decocts 1.5 hours, collecting decoction is with the filtration of 300 order filter clothes, filtrate for later use;
3), concentrate thick paste: is 85 ℃ with above-mentioned filtrate in temperature, and vacuum is that to be concentrated into relative density under the condition of 0.08～0.1Mpa be that the thick paste of 1.25 (80 ℃) is standby;
4), granulate: add the lactose of thick paste weight 10% in above-mentioned thick paste, add the crude drug fine powder mixing that the first step makes again, make granule, 70 ℃ of oven drying at low temperatures incapsulate below 60% at relative humidity, promptly.
Above target level of product quality control method may further comprise the steps:
With octadecylsilane chemically bonded silica is filler; Acetonitrile-water (27: 73) is a mobile phase; Detecting wavelength is that the 250nm. number of theoretical plate should be not less than 3000 by the calculating of icariin peak.
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 0.03mg, promptly.
The preparation of need testing solution: get the content under this product content uniformity item, porphyrize is got about 1.0g, the accurate title, decide, and puts in the tool plug conical flask, the accurate methanol 20ml that adds, claim to decide weight, supersound process 40 minutes is put cold, claim to decide weight again, supply with methanol and to subtract weight loss, shake up, microporous filter membrane (0.45 μ m) filters, get subsequent filtrate, promptly.
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, 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 0.18mg.
Product of the present invention should carry out packing in 300,000 grades of clean areas (18～25 ℃ of room temperatures, relative humidity is below 60%).
Product of the present invention is brown xanchromatic granule and powder, sweet, little hardship of distinguishing the flavor of.
Function cures mainly: YIN nourishing and YANG strengthening, strengthening the body resistance.Improve immunocompetence, promote the sick body rehabilitation.Be used for senile chronic bronchitis and various body deficient syndrome.
Specification: every dress 0.46g.Usage and dosage: oral, one time 2～3,3 times on the one.
Product of the present invention for preventing that effective ingredient is subjected to heat damage for a long time, in conjunction with the commercial production condition, adopts triple effect concentrating under reduced pressure equipment to concentrate in preparation process, is concentrated into the thick paste shape.The spissated condition of medicinal liquid is: temperature is 70～85 ℃, and vacuum is 0.08～0.1Mpa.
Because a large amount of crude drug powder of Fang Zhongyou directly is used as medicine, in order to save man-hour, selection is concentrated into finite concentration with extracting solution, directly adding the medical material fine powder granulates, by changing the relative density of extracting solution, investigate the molding situation of granulating, investigate and learn the extractum relative density when 1.20～1.25 (80 ℃), it is easier to granulate.
Be monarch drug with the sweet using warming therapy Radix Astragali among the we, the interior gas of spleen reinforcing lung greatly, but outer consolidating superficial resistance; The Rhizoma Atractylodis Macrocephalae, Rhizoma Polygonati, Herba Epimedii, Fructus Psoraleae all are product warm in nature, but invigorating the spleen and benefiting QI helps the Radix Astragali to strengthen the power of benefiting QI for strengthening the superficies, make the prosperous table of gas real, exopathogen is invaded in being difficult for, but wherein also the kidney invigorating essence of Rhizoma Polygonati, Herba Epimedii and Fructus Psoraleae warming the kidney to activate YANG, helping inspiration to relieve asthma is to improve the disease of failure of the kidney in receiving QI; In addition assistant is walked table and dispelling wind evil with Radix Saposhnikoviae, makes our consolidating superficial resistance and does not stay heresy, and is eliminating evil and just do not hinder; Give birth to for making coordinating the actions of various ingredients in a prescription with a small amount of Radix Glycyrrhizae again.Each medicine is shared in the side, reaches YIN nourishing and YANG strengthening, the effect of strengthening the body resistance.
Carry out three batches of investigations of pilot scale trial-production by above-mentioned technology, wherein three batch datas and run-of-the-mill check result see Table one, table two:
Table one three batch samples trial-production data
Three batches of pilot scale sample surveys of table two
Pilot-scale experiment shows that gained preparation technology is reasonable, feasible.
Product LAONIAN KECHUAN JIAONANG of the present invention and commercially available prod old cough with asthma tablet quality standard relatively sees the following form
Claims (1)
1. the preparation method of a LAONIAN KECHUAN JIAONANG is characterized in that may further comprise the steps:
1), takes by weighing each medicine: the Radix Astragali 220 Rhizoma Atractylodis Macrocephalaes 132 Radix Saposhnikoviaes 132 Radix Glycyrrhizaes 88 Rhizoma Polygonatis 132 Herba Epimedii 132 Fructus Psoraleaes 132 by following weight portion;
2), pulverize: get 140.8 parts of the Radixs Astragali, to be ground into 200 order fine powders standby with the Rhizoma Atractylodis Macrocephalae, Rhizoma Polygonati;
3), water carries: will remain the Radix Astragali and Radix Saposhnikoviae, Radix Glycyrrhizae, Herba Epimedii, Fructus Psoraleae decocts with water 2 times, adds 8 times of water gagings for the first time, decocts 2 hours, adds 6 times of water gagings for the second time, decocts 1.5 hours, collecting decoction is with the filtration of 300 order filter clothes, filtrate for later use;
4), concentrate thick paste: is 70 ℃ with above-mentioned filtrate in temperature, and vacuum is that to be concentrated into relative density under the condition of 0.08～0.1Mpa be 1.25 thick paste, and drying is pulverized, and it is standby to make dried cream powder;
5), granulate: add the starch of dried cream powder weight 10% in above-mentioned dried cream powder, add the crude drug fine powder mixing that second step made again, make granule, 65 ℃ of oven drying at low temperatures incapsulate below 60% at relative humidity, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2006100205276A CN1857608B (en) | 2006-03-21 | 2006-03-21 | Preparation of senile dyspneic cough treating capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2006100205276A CN1857608B (en) | 2006-03-21 | 2006-03-21 | Preparation of senile dyspneic cough treating capsule |
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| CN1857608A CN1857608A (en) | 2006-11-08 |
| CN1857608B true CN1857608B (en) | 2010-04-21 |
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| CN2006100205276A Expired - Fee Related CN1857608B (en) | 2006-03-21 | 2006-03-21 | Preparation of senile dyspneic cough treating capsule |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103083597B (en) * | 2011-10-28 | 2014-11-26 | 北京六盛合医药科技有限公司 | Chronic bronchitis treatment drug composition and preparation method thereof |
| CN103860656A (en) * | 2012-12-11 | 2014-06-18 | 洛阳惠中兽药有限公司 | Traditional Chinese medicinal composition, and preparation method and application thereof |
| CN103432389B (en) * | 2013-08-30 | 2015-04-22 | 香河县气管炎哮喘医院 | Chinese medicinal composition for treating diffuse panbronchiolitis and preparation thereof |
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2006
- 2006-03-21 CN CN2006100205276A patent/CN1857608B/en not_active Expired - Fee Related
Non-Patent Citations (1)
| Title |
|---|
| 中华人民共和国卫生部药典委员会.中华人民共和国卫生部药品标准第九册.1994,70. * |
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Granted publication date: 20100421 Termination date: 20160321 |