CN100342849C - Effervescence tablet for relieving cough and asthma and its preparation process - Google Patents

Effervescence tablet for relieving cough and asthma and its preparation process Download PDF

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CN100342849C
CN100342849C CNB2005100987283A CN200510098728A CN100342849C CN 100342849 C CN100342849 C CN 100342849C CN B2005100987283 A CNB2005100987283 A CN B2005100987283A CN 200510098728 A CN200510098728 A CN 200510098728A CN 100342849 C CN100342849 C CN 100342849C
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tablet
asthma
effervescence tablet
effervescence
relieving cough
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CN1733018A (en
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张保献
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Beijing the Great Wall Pharmaceutical Co.,Ltd.
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BEIJING YINKERUISI BIOLOGICAL PRODUCTS RESEARCH INSTITUTE
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Abstract

The present invention relates to a tetrahydro-isoquinolin; effervescence tablet and a preparation method thereof, which belongs to the field of traditional Chinese medicine. The effervescence tablet is composed of tetrahydro-isoquinolin powdered extracts, acid, an alkaline agent, a sweetening agent, a filling agent and a lubricant agent. The present invention has the advantages of rational matching of the kinds and the dosage of auxiliary materials and basic remedies, simple preparation process, stable quality of the effervescence tablet and good effervescence effect; the present invention is a tetrahydro-isoquinolin; effervescence tablet and a preparation method thereof and the tetrahydro-isoquinolin; effervescence tablet has the characteristics of high bioavailability, rapid effect taking, convenient taking, stable quality, good mouth feelings and convenient transportation and carrying.

Description

A kind of effervescence tablet for relieving cough and asthma and preparation method thereof
Technical field
The invention belongs to field of traditional Chinese medicine pharmacy, more specifically relate to a kind of effervescence tablet for relieving cough and asthma and preparation method thereof.
Background technology
Kechuanning Granules has relieving cough and reducing sputum effect, is used for cough due to common cold, acute and chronic bronchitis. But because the easy moisture absorption of particle, and mouthfeel is not good, has limited its use. Effervescence tablet for relieving cough and asthma both has, and but effervesce is dissolved in hot water, is dissolvable in water again the advantage of directly taking behind the cold water, and sweet mouthfeel, is particularly suitable for child administration. This product is solid pharmaceutical preparation in addition, transportation, easy to carry, steady quality.
Oral effervescent tablet is the novel quick-release tablet take effervescent agent as disintegrant, effervesce is dissolved in hot water but both have, but effervesce is dissolved in the advantage of directly taking behind the cold water again, and onset is rapid, bioavilability is high, and mouthfeel is good, is particularly suitable for child, old people garment usefulness. With Kechuanning Granules make into effervescent tablet both can keep former formulation be easy to oral, absorb rapidly characteristics, simultaneously again because it is solid pharmaceutical preparation, transportation, easy to carry, steady quality, overcome the shortcoming that former preparation is preserved, carried inconvenience, meet the modern requirement of Chinese medicine preparation, have wide market prospects. Chinese medicine effervescent tablet Chinese traditional medicine medicinal extract proportion is very large, difficult point is the selection of drug extract powder and pharmaceutic adjuvant kind and ratio, selected suitable auxiliary material and appropriate ratio, can reduce supplementary product consumption, preparation technology is simple, easy-formation, be difficult for moisture absorption, effervesce speed is fast, and effervesce is effective, liquid clarity is good behind the effervesce, without particle.
Summary of the invention
For solving not easy-formation of Chinese medicine effervescent tablet, disintegration is slow, and clarity is bad, and the problems such as poor stability the invention provides a kind of main ingredient, supplementary product kind reasonable mixture ratio, forming, good stability, effervescence tablet for relieving cough and asthma that clarity is good after the disintegration and preparation method thereof.
The present invention is implemented by the following technical programs.
A kind of effervescence tablet for relieving cough and asthma of the present invention, it is comprised of methoxyphenamini hydrochloridum extract powder, tartaric acid, sodium acid carbonate, sweetener, filler, lubricant, and the ratio of each component is:
Methoxyphenamini hydrochloridum extract powder, tartaric acid, sodium acid carbonate be 80-84 part altogether, lubricant 0.5-1 part, and sweetener 0.5-1 part, filler 15-18 part, wherein methoxyphenamini hydrochloridum extract powder: tartaric acid: sodium acid carbonate is 2: 1.5: 1.5.
Wherein said methoxyphenamini hydrochloridum extract powder is made by 2.04 parts of 1 portion of semen armeniacae amaraes of 3.5 portions of Radix Glycyrrhizaes of Chinese ephedra 2.1 parts of tubers of stemona of 2.8 portions of asters (steaming).
Sweetener is selected from a kind of in rebaudioside, betaine, the aspartame, is preferably aspartame; Filler is selected from a kind of in lactose, sweet mellow wine, the xylitol, is preferably sweet mellow wine, xylitol; Lubricant is selected from a kind of in PEG6000, PEG4000, the dolomol.
Its preparation method mainly comprises following process steps:
(1) five tastes such as Chinese ephedra add 8 times of water gagings and decoct 2 times, and semen armeniacae amarae adds when water boils. 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.26~1.28 thick paste that filtrate is concentrated into that relative density heat surveys, and drying under reduced pressure is pulverized, and gets the methoxyphenamini hydrochloridum extract powder.
(2) the equal 80 ℃ of oven dry of used auxiliary material in the prescription, sieving for standby; Methoxyphenamini hydrochloridum medicinal extract fine powder and sour agent, alkaline agent, sweetener, filler are carried out proportion optimization by the umber of above-mentioned each component of effervescent tablet, to determine optimum formula. Filler is used for adjustment sheet heavily, and sweetener is used for improving mouthfeel, and lubricant plays when compressing tablet and helps stream and lubrication.
Below be effervescence tablet for relieving cough and asthma prescription screening experiment:
One, the selection of sour agent and alkaline agent
In the selection of effervescent agent, sodium acid carbonate is as alkali source, and consumption is few, and gas production is large, and the present invention adopts sodium acid carbonate as alkali source. Because the easy moisture absorption of traditional Chinese medicinal extract powder, viscosity is large, so the selection of acid source is very important. Take by weighing a certain amount of medicinal powder and mix evenly with acid, alkali, granulate with absolute ethyl alcohol, carry out different preparations shaping prescriptions and screen, the results are shown in Table 1.
The screening of the different preparations shaping soda acid of table 1 prescription
The prescription number Medicinal powder (g) Acid kind (g) Alkali kind (g) The result
1 2 3 4 5 6 20 20 20 20 20 20 Tartaric acid 14.5 adipic acids 14.5 succinic acid 14.5 malic acid 14.5 fumaric acid 14.5 citric acids 14.5 Sodium acid carbonate 14.5 sodium acid carbonates 14.5 sodium acid carbonates 14.5 sodium acid carbonates 14.5 sodium acid carbonates 14.5 sodium acid carbonates 14.5 Granulation, compressing tablet, effervesce all good effervesce are too slow, the bad moisture absorption of effect, and the moisture absorption of can't granulating can't be granulated better, and effervesce lumps slowly, can't granulate
The result shows: the effect of prescription 1 is better, and namely effervescent agent selects tartaric acid as acid source, and sodium acid carbonate is as alkali source.
Two, medicinal powder, the screening of effervescent agent proportioning
To effervescent tablet quality influence maximum in the Chinese medicine effervescent tablet is soda acid ratio in effervescent agent and drug ratios and the effervescent agent, be screening formula, take above-mentioned prescription 1 as the basis, be factor in soda acid ratio in the ratio of shared weight of effervescent agent and the effervescent agent, do 4 horizontal comprehensive tests.
Test method: get respectively the medicinal powder of different amounts and the soda acid (the prescription total amount is 45g) of different proportionings, evenly mixed, granulate with absolute ethyl alcohol, drying, compressing tablet the results are shown in Table 2.
Table 2 medicinal powder, effervescent agent proportioning screening table
Sequence number Medicinal powder accounts for sheet anharmonic ratio example Effervescent agent accounts for sheet anharmonic ratio example Acid accounts for the effervescent agent ratio The effervesce effect Disintegration time
    1     2     3     4     5     6     7     8     9     10     11     12     13     14     15     16   2/5   2/5   2/5   2/5   1/2   1/2   1/2   1/2   3/5   3/5   3/5   3/5   2/3   2/3   2/3   2/3   3/5   3/5   3/5   3/5   1/2   1/2   1/2   1/2   2/5   2/5   2/5   2/5   1/3   1/3   1/3   1/3   40%   45%   50%   55%   40%   45%   50%   55%   40%   45%   50%   55%   40%   45%   50%   55%   +++   +++   ++++   ++++   +++   +++   ++   ++   +   +   +   +   ±   ±   ±   ± Exceeded in 1 minute 33 seconds 1 minute 37 seconds 1 minute 45 seconds 1 minute 47 seconds 4 minutes 19 seconds 4 minutes 38 seconds 4 minutes 43 seconds 4 minutes 51 seconds to exceed in limited time to exceed in limited time to exceed in limited time to exceed in limited time to exceed in limited time to exceed in limited time and exceed in limited time in limited time
It is comprehensive that relatively the effervesce effect is better with 3,4,5,6,7,8 also can, 3,4 is moderate, 5,6 a little less than, so 3,4 prescriptions are further groped.
Three, effervescent agent consumption screening
Know according to above-mentioned result of the test, effervescent tablet of the present invention is namely plastic without filler, and different batches Chinese medicine paste-forming rate is variant in consider producing, and according to the present invention the character of effervescent tablet extract powder, 15-18% filler Space adjustment total amount need be arranged, also be easy to moulding. For improving mouthfeel, can add the sweetener of 0.5-1% simultaneously, the flowability of particle when increasing compressing tablet can add the lubricant of 0.5-1%.
Test method: every group of test all feeds intake by 100, take by weighing prescription dried cream powder 140g, tartaric acid, sodium acid carbonate and an amount of filler, the sweetener mixing that add different amounts, with absolute ethyl alcohol granulation, drying, add lubricant, mixing, compressing tablet, every heavy 4.5g/ sheet the results are shown in following table, the consumption during the consumption of table traditional Chinese medicine powder, acid, alkali is every.
Table 3 effervescent agent consumption screening table
Sequence number Medicinal powder (g) Acid (g) Alkali (g) Disintegration time Liquid evaluation behind the effervesce
1 2 3  1.4  1.4  1.4  1.01  1.05  1.10  1.09  1.05  1.00 1 minute 20 seconds 1 minute 39 seconds 1 minute 38 seconds Liquid is slightly muddy, and mouthfeel is poor. The liquid clarification, mouthfeel is good. Liquid has a small amount of floccule, and mouthfeel is general.
4   1.4     1.16   0.94 1 minute 47 seconds Liquid is slightly muddy, and mouthfeel is general.
Table 3 result of the test shows that the optimal proportion of medicinal powder and soda acid is 2: 1.5: 1.5 in the prescription.
Four, preparation stabilization Journal of Sex Research
In order to investigate the stability of moulding process, we place 40 ℃, relative humidity with the effervescent tablet of two aluminium laminated films packings is 75% climatic chamber, places 1 month, takes out, and appearance character, effervesce time of measuring its test front and back the results are shown in Table 4.
Comparing result before and after table 4 accelerated test
Sample Appearance character The effervesce time
After testing before the test The agent of yellow tablet erotic film 1 minute 40 seconds 1 minute 42 seconds
The result shows: this medicine has no significant change at aspects such as outward appearance color, physical behavior, effervesce times before and after the accelerated test, illustrates that this medicine is basicly stable, and moulding process is reasonable.
Effervescence tablet for relieving cough and asthma main ingredient of the present invention, auxiliary material form with proportioning to be selected rationally, and effervesce is effective, and liquid clarity is good behind the effervesce. The effervescence tablet for relieving cough and asthma preparation technology who makes by the present invention is simple, steady quality.
The specific embodiment
The present invention is described further by embodiment
Embodiment 1
Take off that to state raw material for subsequent use:
The Chinese ephedra 2.1kg aster 1.575kg tuber of stemona (steaming) 2.625kg Radix Glycyrrhizae 0.75kg semen armeniacae amarae 1.53kg
The effervescence tablet for relieving cough and asthma preparation method comprises following processing step:
(1) five tastes such as Chinese ephedra add 8 times of water gagings and decoct 2 times, and semen armeniacae amarae adds when water boils, 2 hours first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.26~1.28 thick paste that filtrate is concentrated into that relative density heat surveys, drying under reduced pressure is pulverized, and gets methoxyphenamini hydrochloridum extract powder 1440g.
(2) the equal 80 ℃ of oven dry of used auxiliary material in the prescription, sieving for standby; With recipe quantity methoxyphenamini hydrochloridum medicinal extract fine powder 1440g and tartaric acid 1080g, sodium acid carbonate 1080g, A Sibapatan 45g, lactose 810g mixing, with absolute ethyl alcohol granulate, drying, add PEG4000 45g mixing, be pressed into 1000, and get final product.
Embodiment 2
Take off that to state raw material for subsequent use:
The Chinese ephedra 2.1kg aster 1.575kg tuber of stemona (steaming) 2.625kg Radix Glycyrrhizae 0.75kg semen armeniacae amarae 1.53kg
The effervescence tablet for relieving cough and asthma preparation method comprises following processing step:
(1) five tastes such as Chinese ephedra add 8 times of water gagings and decoct 2 times, and semen armeniacae amarae adds when water boils, 2 hours first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.26~1.28 thick paste that filtrate is concentrated into that relative density heat surveys, drying under reduced pressure is pulverized, and gets methoxyphenamini hydrochloridum extract powder 1512g.
(2) the equal 80 ℃ of oven dry of used auxiliary material in the prescription, sieving for standby; With recipe quantity methoxyphenamini hydrochloridum medicinal extract fine powder 1512g and tartaric acid 1134g, sodium acid carbonate 1134g, betaine 22.5g, xylitol 675g mixing, with absolute ethyl alcohol granulate, drying, add PEG6000 22.5g mixing, be pressed into 1000, and get final product.
Embodiment 3
Take off that to state raw material for subsequent use:
The Chinese ephedra 2.1kg aster 1.575kg tuber of stemona (steaming) 2.625kg Radix Glycyrrhizae 0.75kg semen armeniacae amarae 1.53kg
The effervescence tablet for relieving cough and asthma preparation method comprises following processing step:
(1) five tastes such as Chinese ephedra add 8 times of water gagings and decoct 2 times, and semen armeniacae amarae adds when water boils, 2 hours first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.26~1.28 thick paste that filtrate is concentrated into that relative density heat surveys, drying under reduced pressure is pulverized, and gets methoxyphenamini hydrochloridum extract powder 1476g.
(2) the equal 80 ℃ of oven dry of used auxiliary material in the prescription, sieving for standby; With recipe quantity methoxyphenamini hydrochloridum medicinal extract fine powder 1476g and tartaric acid 1107g, sodium acid carbonate 1107g, betaine 33.75g, sweet mellow wine 742.5g mixing, with absolute ethyl alcohol granulate, drying, add dolomol 33.75g mixing, be pressed into 1000, and get final product.
Embodiment 4
Take off that to state raw material for subsequent use:
The Chinese ephedra 2.1kg aster 1.575kg tuber of stemona (steaming) 2.625kg Radix Glycyrrhizae 0.75kg semen armeniacae amarae 1.53kg
The effervescence tablet for relieving cough and asthma preparation method comprises following processing step:
(1) five tastes such as Chinese ephedra add 8 times of water gagings and decoct 2 times, and semen armeniacae amarae adds when water boils, 2 hours first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.26~1.28 thick paste that filtrate is concentrated into that relative density heat surveys, drying under reduced pressure is pulverized, and gets methoxyphenamini hydrochloridum extract powder 1504g.
(2) the equal 80 ℃ of oven dry of used auxiliary material in the prescription, sieving for standby; With recipe quantity methoxyphenamini hydrochloridum medicinal extract fine powder 1504g and tartaric acid 1125g, sodium acid carbonate 1125, rebaudioside 26g, lactose 675g mixing, with absolute ethyl alcohol granulate, drying, add dolomol 45g mixing, be pressed into 1000, and get final product.
Embodiment 5
Take off that to state raw material for subsequent use:
The Chinese ephedra 2.1kg aster 1.575kg tuber of stemona (steaming) 2.625kg Radix Glycyrrhizae 0.75kg semen armeniacae amarae 1.53kg
The effervescence tablet for relieving cough and asthma preparation method comprises following processing step:
(1) five tastes such as Chinese ephedra add 8 times of water gagings and decoct 2 times, and semen armeniacae amarae adds when water boils, 2 hours first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.26~1.28 thick paste that filtrate is concentrated into that relative density heat surveys, drying under reduced pressure is pulverized, and gets methoxyphenamini hydrochloridum extract powder 1458g.
(2) the equal 80 ℃ of oven dry of used auxiliary material in the prescription, sieving for standby; With recipe quantity methoxyphenamini hydrochloridum medicinal extract fine powder 1458g and tartaric acid 1093.5g, sodium acid carbonate 1093.5, Aspartame 38.25g, xylitol 787.5g mixing, with absolute ethyl alcohol granulate, drying, add PEG4000 29.25g mixing, be pressed into 1000, and get final product.
Embodiment 6
Take off that to state raw material for subsequent use:
The Chinese ephedra 2.1kg aster 1.575kg tuber of stemona (steaming) 2.625kg Radix Glycyrrhizae 0.75kg semen armeniacae amarae 1.53kg
The effervescence tablet for relieving cough and asthma preparation method comprises following processing step:
(1) five tastes such as Chinese ephedra add 8 times of water gagings and decoct 2 times, and semen armeniacae amarae adds when water boils, 2 hours first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.26~1.28 thick paste that filtrate is concentrated into that relative density heat surveys, drying under reduced pressure is pulverized, and gets methoxyphenamini hydrochloridum extract powder 1494g.
(2) the equal 80 ℃ of oven dry of used auxiliary material in the prescription, sieving for standby; With recipe quantity methoxyphenamini hydrochloridum medicinal extract fine powder 1494g and tartaric acid 1120.5g, sodium acid carbonate 1120.5, Aspartame 29.25g, sweet mellow wine 697.5g mixing, with absolute ethyl alcohol granulate, drying, add PEG6000 38.25g mixing, be pressed into 1000, and get final product.

Claims (3)

1, a kind of effervescence tablet for relieving cough and asthma is characterized in that this effervescent tablet is comprised of the component of following weight portion:
Methoxyphenamini hydrochloridum extract powder, tartaric acid, sodium acid carbonate be 80-84 part altogether, lubricant 0.5-1 part, sweetener 0.5-1 part, filler 15-18 part, methoxyphenamini hydrochloridum extract powder wherein: tartaric acid: sodium acid carbonate is 2: 1.5: 1.5, and wherein said methoxyphenamini hydrochloridum extract powder is made by following method:
Raw material weight part consists of: 2.04 parts of 1 portion of semen armeniacae amaraes of 2.8 portions of asters of Chinese ephedra, 2.1 parts of steamings, 3.5 portions of Radix Glycyrrhizaes of the tuber of stemona; The five tastes such as Chinese ephedra add 8 times of water gagings and decoct 2 times, and semen armeniacae amarae adds when water boils, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and it is 1.26~1.28 thick paste that filtrate is concentrated into that relative density heat surveys, drying under reduced pressure is pulverized, and gets the methoxyphenamini hydrochloridum extract powder.
2, effervescence tablet for relieving cough and asthma according to claim 1, sweetener is selected from a kind of in rebaudioside, betaine, the aspartame, filler is selected from a kind of in lactose, sweet mellow wine, the xylitol, and lubricant is selected from a kind of in PEG6000, PEG4000, the dolomol.
3, according to claim 1 and 2 the preparation method of effervescence tablet for relieving cough and asthma is characterized in that comprising following processing step:
The equal 80 ℃ of oven dry of used auxiliary material in the prescription, sieving for standby; With methoxyphenamini hydrochloridum medicinal extract fine powder and tartaric acid, sodium acid carbonate, sweetener, filler mixing, with absolute ethyl alcohol granulate, drying, add the lubricant mixing, compressing tablet, and get final product.
CNB2005100987283A 2005-09-07 2005-09-07 Effervescence tablet for relieving cough and asthma and its preparation process Active CN100342849C (en)

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Publication number Priority date Publication date Assignee Title
CN105311353A (en) * 2014-07-30 2016-02-10 陈立云 Chinese herbal compound for treating acute bronchitis
CN104352773A (en) * 2014-11-28 2015-02-18 陈富强 Traditional Chinese medicine preparation for treating chronic bronchitis and bronchial asthma
CN105343214A (en) * 2015-12-09 2016-02-24 济南思拓新源医药科技有限公司 Medicine used for treating chronic bronchitis caused by phlegm-heat accumulated in lung

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1362097A (en) * 2001-01-05 2002-08-07 杨孟君 Nano Guilong Kechuanning medicine and its preparation

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1362097A (en) * 2001-01-05 2002-08-07 杨孟君 Nano Guilong Kechuanning medicine and its preparation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
中华人民共和国药典委员会 中华人民共和国卫生部药品标准 中药成方制剂 第20册 1998 *

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