CN1253189C - Children used effervescence tablet with functions of removing lung heat and dissolving phlegm and its preparation - Google Patents

Children used effervescence tablet with functions of removing lung heat and dissolving phlegm and its preparation Download PDF

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CN1253189C
CN1253189C CN 200310120056 CN200310120056A CN1253189C CN 1253189 C CN1253189 C CN 1253189C CN 200310120056 CN200310120056 CN 200310120056 CN 200310120056 A CN200310120056 A CN 200310120056A CN 1253189 C CN1253189 C CN 1253189C
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parts
effervescent
semen armeniacae
semen
lung clearing
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CN1546153A (en
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张正生
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Abstract

The present invention discloses a children's effervescent tablet for removing heat from the lung and dissolving phlegm, which is characterized in that the effervescent tablet is prepared from effective parts extracted from eight Chinese medicines such as ephedra herb, hogfennel root, baical skullcap root, etc. The present invention simultaneously discloses a method for preparing the preparation. The children's effervescent tablet for removing heat from the lung and dissolving phlegm, which is prepared by the method, has the advantages of rapid disintegration, stable quality, good mouth feel and easy acceptance by sick children.

Description

A kind of infantile lung clearing phlegm transforming effervescent tablet and preparation method thereof
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, relate to infantile lung clearing phlegm transforming effervescent tablet of a kind of removing heat from the lung and dissipating phlegm, relieving cough and asthma and preparation method thereof.
Background technology
Lung is that illness is children's's commonly encountered diseases, a frequently-occurring disease.Children's's internal organs are tender and lovely, and shape gas does not fill, and skin is dredged thin, and weakened defensive QI adds that children's's changes in temperature can not self-regulated, and the climate change adaptive capacity is relatively poor to external world, catches a cold so easily experience exopathogen.Right lung being a delicate viscus, the easiest quilt is tired and declare respectful not normally behind the being invaded by exogenous pathogen, closes Yu Buxuan, and heat-transformation impairment of body fluid, refining liquid become expectorant, and air flue is obstructed, and the symptom of a series of lung qi obturations such as cough is panted, dyspnea occurs, control suitable relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, dispersing lung-QI and dissipating phlegm.
The infantile lung clearing phlegm transforming oral liquid share with Herba Ephedrae, Radix Peucedani, Radix Scutellariae, Fructus Perillae, Gypsum Fibrosum, Semen Armeniacae Amarum, Semen Lepidii (Semen Descurainiae), Caulis Bambusae In Taenia eight flavor medicines, play the merit of lung qi dispersing Dingchuan, removing heat-phlegm altogether, for the breathing tachypnea that the infantile lung heat flu causes, cough phlegm dyspnea, the curative effect preferably of having made a sound in the larynx, but because it is a liquid preparation, storage period is not long, easily grows mycete, and carries and store inconvenience, mouthfeel is poor, is difficult for accepting for infant.
The infantile lung clearing phlegm transforming oral liquid extracts the method that adopts water extract-alcohol precipitation, and has adopted the processing procedure of Semen Armeniacae Amarum peeling stir-fry and the preparation technology that Gypsum Fibrosum is decocted first in the method.
Have document with regard to Semen Armeniacae Amarum kind skin going or staying the influence of amygdalin content to be studied: 1. the content comparative determination result to contained trace element in Semen Armeniacae Amarum skin and the core and glycoside shows: amygdalin is almost consistent in Semen Armeniacae Amarum skin, the core, and in the skin content of elements than high [Yu Nancai in the core, Guan Jinghuan. Semen Armeniacae Amarum is concocted with the relation of trace element and is inquired into. CHINA JOURNAL OF CHINESE MATERIA MEDICA, 1989,14 (9): 22]; 2. the acute toxicity test that Semen Armeniacae Amarum kind skin is carried out shows: Semen Armeniacae Amarum kind skin toxicity is very little, can not produce toxic reaction because of going into decoct; 3. the influence experiment to amygdalin content shows with regard to the peeling process: Semen Armeniacae Amarum amygdalin loss in the peeling process is 1.69%; 4. planting skin going or staying shows the influence experiment of content: peeling with do not remove the peel, to amygdalin assay result difference do not have significance [Cheng Chaohuan. about the rational research of going or staying of Semen Armeniacae Amarum kind skin. Chinese patent medicine, 1993,15 (3): 19].Illustrating thus that Semen Armeniacae Amarum is concocted need not remove kind of a skin, so the present invention concocts Semen Armeniacae Amarum and do not remove kind of a skin, has both saved medical material, can increase clinical efficacy again.
There are amygdalin and emulsin in the Semen Armeniacae Amarum simultaneously, amygdalin is that Semen Armeniacae Amarum is used as medicine as the effective ingredient of relieving cough and asthma, but its character is extremely unstable, in decoction process, there is a temperature section to be suitable for the activity of emulsin, makes the rapid enzymolysis of amygdalin become hydrocyanic acid and volatilize, the Semen Armeniacae Amarum drug effect is reduced greatly even lose drug effect, therefore, Semen Armeniacae Amarum needs to reach the purpose that enzyme denaturing is protected glycoside through the process of preparing Chinese medicine.The concocting method that Semen Armeniacae Amarum is commonly used is single method and fries method at present, and these two kinds method is simple, and the suitability is strong, but the enzyme denaturing weak effect, residual enzyme can also continue to decompose glycoside.When single method was concocted, Semen Armeniacae Amarum dropped in the boiling water, caused water temperature to descend, and severe patient can be reduced to 70 ℃, and this provides chance for zymolysis, and water consumption is big, and the part glycoside is water-soluble and lose.The method of frying will be fried to full Huang, just can reach the enzyme denaturing effect, and duration and degree of heating temperature is wayward, and the products appearance yellowing influences drug quality.Because anthropic factor (temperature, time are by artificial judgement) influence is bigger during operation, quality is difficult to homogeneous.Adopt microwave method to concoct Semen Armeniacae Amarum, because Semen Armeniacae Amarum contains 4.2~5.0% moisture content, the heat that these moisture content absorption microwaves produce is enough to reach the purpose of enzyme denaturing, experimental result proves, the satisfaction of microwave processing enzyme denaturing effect (Bao Guolin etc. the Semen Armeniacae Amarum concocting method is inquired into. the Shaanxi traditional Chinese medical science, 2001,22 (12): 758).
Gypsum Fibrosum is hard because of quality, and all kinds of Chinese materia medica all indicate to smash on usage and are decocted first, and is still from its active ingredient and pharmacological research, really not so.The effective ingredient of Gypsum Fibrosum is hydrous calcium sulfate (CaSO 42H 2O), herbal pharmacology experiment showed, that Gypsum Fibrosum has analgesic and enhancing leukocyte and reticuloendothelial system phagocytic function, Gypsum Fibrosum is for oral administration through the gastric acid effect, a part becomes soluble calcium salt and is absorbed, and blood calcium concentration is increased and the irritability of inhibition muscle, reaches purpose calm, spasmolytic.Therefore, Gypsum Fibrosum of the present invention is not taked to be decocted first.
Microwave is a kind of uhf electromagnetic wave, has very strong penetration, can be inside and outside the medical material granule simultaneously evenly, heating promptly.On the one hand, it can make the resonant frequency of molecule generation up to 4.9 * 109 times/second with permanent dipole, and the molecule mean kinetic energy is increased sharply.On the other hand, the ultrahigh speed motion in the hyperfrequency electromagnetic field of Ionized material, because of friction produce the thermal efficiency [Ceng Zhaojun, Li Xiangwen. microwave organic chemistry progress. Shenyang Pharmaceutical University's journal, 1999,16 (4): 304.].Therefore, microwave technology can greatly promote the leaching of Chinese crude drug effective ingredient, and in leaching process, the medical material fine powder does not condense not coking.Therefore, the applied microwave technology extracts Chinese medicine and the natural product chemistry composition can shorten the production time, improve effective ingredient in the natural drug recovery rate, reduce production costs, have very high practical value.Effervescent tablet is to be a kind of tablet that disintegrating agent is made with the effervescent material, in water, produce a large amount of bubbles, and dissolving at short notice, have that outward appearance is good, mouthfeel is good, characteristics such as strong easy to use, interesting, can improve children's's compliance to a certain extent, and effervescent tablet preparation technology is simple, dissolving fully, having overcome the shortcoming of its liquid preparation, is a kind of desirable dosage form of department of pediatrics medication.
Summary of the invention
The object of the present invention is to provide infantile lung clearing phlegm transforming effervescent tablet of a kind of removing heat from the lung and dissipating phlegm, relieving cough and asthma and preparation method thereof.The present invention is reference frame with infantile lung clearing phlegm transforming oral liquid prescription, adopt and use earlier the microwave processing Semen Armeniacae Amarum, pass through microwave extracting again, in conjunction with Polyethylene Glycol parcel carbon dioxide source, the effervescent tablet production technology of isolating acid source and carbon dioxide source, good, the easy absorption of the infantile lung clearing phlegm transforming effervescent tablet stability of making, good, the taking convenience of mouthfeel, drug effect is further enhanced.
A kind of infantile lung clearing phlegm transforming effervescent tablet of the present invention is achieved through the following technical solutions:
(1) a kind of infantile lung clearing phlegm transforming effervescent sheet of the present invention is made up of medicated powder and effervescent.Medicated powder and effervescent weight ratio are 0.5~1: 1~2.Preferred effervescent is organic acid, sodium bicarbonate and/or sodium carbonate.Organic acid: sodium bicarbonate and/or sodium carbonate are 0.5~1: 1.Technology to sodium bicarbonate and/or sodium carbonate employing polyethylene glycol 6000 parcel.
(2) medicine of the present invention is made (consumption is a weight portion) by following component: 90 parts in Herba Ephedrae, 225 parts of Radix Peucedanis, 225 parts of Radix Scutellariaes, 225 parts of Fructus Perillae (parched), 675 parts in Gypsum Fibrosum, 225 parts of the Semen Armeniacae Amarums of microwave processing, 279 parts of Semen Lepidii (Semen Descurainiae)s, 225 parts of Caulis Bambusae In Taenia.
Medicine of the present invention is raw material with the said medicine, adds 5-10 times of water gaging, reuse 300~600W microwave treatment 10~20min.After pressing said process and handling 2-3 time, merge aqueous extract, concentrate, add ethanol and make and contain the alcohol amount and reach 60~80%, stir evenly, left standstill 48 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, concentrates, spray drying, pulverizing, gets medicated powder.
(3) with after the polyethylene glycol 6000 fusion, add sodium bicarbonate and/or sodium carbonate, stir, cooling is pulverized, and crosses 80 mesh sieves.In addition organic acid is crossed 80 mesh sieves,, granulate with medicated powder, Polyethylene Glycol wrappage fine powder mixing, drying, compacting is in flakes promptly.
A kind of infantile lung clearing phlegm transforming effervescent method for preparing tablet thereof applied microwave of the present invention is concocted Semen Armeniacae Amarum, and employing microwave-assisted extraction technique, the utilization rate and the content thereof of effective ingredient have been improved to the full extent, shortened the production time simultaneously, save production cost, be better than the aqueous extraction-alcohol precipitation technology of traditional method.Simultaneously, adopt Polyethylene Glycol parcel carbon dioxide source, isolate the technology of acid source and carbon dioxide source, place difficult the inefficacy, guaranteed the stability of this effervescent tablet.Experiment shows, use the infantile lung clearing phlegm transforming effervescent sheet that the inventive method makes, its performance is better than the infantile lung clearing phlegm transforming oral liquid, simultaneously, use infantile lung clearing phlegm transforming effervescent sheet disintegrate that the inventive method makes rapidly, steady quality, mouthfeel be good, easily accepted by infant.
Below by a kind of infantile lung clearing phlegm transforming effervescent sheet of the present invention and infantile lung clearing phlegm transforming oral liquid to the animal cough-relieving, eliminate the phlegm, the comparison of antiasthmatic effect, the invention will be further described.
1 experiment material and instrument
150 of Male Kunming strain mice, 20 of female mices are provided by No.1 Military Medical Univ.'s Experimental Animal Center, body weight 20~25g; 60 of Cavia porcelluss are provided by No.1 Military Medical Univ.'s Experimental Animal Center, and body weight 150~200g is male.Infantile lung clearing phlegm transforming effervescent sheet (the contained crude drug amount of infantile lung clearing phlegm transforming effervescent sheet 9g and infantile lung clearing phlegm transforming oral liquid 10ml is suitable), Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides; The infantile lung clearing phlegm transforming oral liquid, Beijing Changcheng Pharmaceutical Factory produces.
2 experimental techniques and result
2.1 protection experiment to the mouse experiment cough
6 groups of 60 branches of mice: blank group, infantile lung clearing phlegm transforming effervescent tablet group (2.7g/kg, 5.4g/kg), infantile lung clearing phlegm transforming oral liquid group (3ml/kg, 6ml/kg), ketelin group (0.7g/kg).Every day 2 times, continuous ig administration 7d, after the last administration 1 hour, drawing the method for coughing by ammonia tests, mice is placed in the bell glass, in ultrasound atomizer constant-pressure atomization 10s, immediately mice is taken out with 25% ammonium hydroxide, shrinking, dehisce with mouse peritoneal is the cough index, cough number of times in record cough latent period and the 2min.Experimental result sees Table 1.
Table 1 mouse experiment cough protection experiment (x ± s)
Group Dosage Cough latent period (s) Cough number of times in the 2min
The blank group - 10.5±8.1 17.2±5.4
Infantile lung clearing phlegm transforming oral liquid group 3ml/kg 32.3±15.2* 10.5±7.4***
6ml/kg 39.1±11.6** 8.3±7.8***
Infantile lung clearing phlegm transforming effervescent sheet group 2.7g/kg 55.5±26.9*** 6.7±8.6***
5.4g/kg 68.3±28.1*** 3.9±7.4***
The ketelin group 0.7g/kg 67.5±15.4*** 4.5±8.7***
Compare with the blank group: * P<0.05 * * P<0.01 * * * P<0.001
2.2 phlegm-dispelling functions experiment
Adopt the interior phenol red excretion of mice trachea mensuration.6 groups of 60 branches of mice: blank group, infantile lung clearing phlegm transforming effervescent tablet group (2.7g/kg, 5.4g/kg), infantile lung clearing phlegm transforming oral liquid group (3ml/kg, 6ml/kg), ketelin group (0.7g/kg).Every day 2 times, continuous ig administration 7d, behind the last administration 30min, ip 2% phenol red 0.5ml puts to death behind the 30min, separates trachea, uses 5%NaHCO 3Flushing, each 0.5ml takes out and washes 3 times, and phenol red OD value (λ=546nm) is measured with 722 type grating spectrophotometers in the centrifugal back of the washing liquid of collecting.Experimental result sees Table 2.
The experiment of table 2 phlegm-dispelling functions (x ± s)
Group Dosage Phenol red OD value
The blank group - 0.106±0.031
Infantile lung clearing phlegm transforming oral liquid group 3ml/kg 0.203±0.033*
6ml/kg 0.205±0.052*
Infantile lung clearing phlegm transforming effervescent sheet group 2.7g/kg 0.255±0.037*
5.4g/kg 0.342±0.051**
The ketelin group 0.7g/kg 0.287±0.043**
Compare with the blank group: * P<0.01 * * P<0.001
2.3 antiasthmatic effect experiment
Cavia porcellus causes by the integral body spraying and breathes heavily the method experiment.With 0.4% histamine phosphate and 1: 1 mixed liquor of 2% acecoline, put Cavia porcellus in the 4L bell glass, with the ultrasound atomizer constant voltage 3s that sprays continuously, select 48 of qualified animals that incubation period in 2min, occurs IV level asthma reaction (being that dyspnea and tic are fallen), be divided into 6 groups at random.Blank group, infantile lung clearing phlegm transforming effervescent tablet group (2.7g/kg, 5.4g/kg), infantile lung clearing phlegm transforming oral liquid group (3ml/kg, 6ml/kg), aminophylline group (0.15g/kg).Every day 2 times, continuous ig administration 7d sprays to cause by last method behind the last administration 1h again and breathes heavily, and IV order reaction incubation period appears in record.Experimental result sees Table 3.
The experiment of table 3 antiasthmatic effect (x ± s)
Group Dosage Draw and breathe heavily the prolongation of latency time (s)
The blank group - 2.5±8.1
Infantile lung clearing phlegm transforming oral liquid group 3ml/kg 5.3±6.0
6ml/kg 10.1±7.6*
Infantile lung clearing phlegm transforming effervescent sheet group 2.7g/kg 8.6±6.2
5.4g/kg 14.3±5.1**
The aminophylline group 0.15g/kg 35.5±13.4***
Compare with the blank group: * P<0.05 * * P<0.01 * * * P<0.001
2.4 acute toxicity testing
Get 30 of mices, male and female half and half are divided 2 groups at random, give infantile lung clearing phlegm transforming effervescent tablet (54g/kg), infantile lung clearing phlegm transforming oral liquid (60ml/kg) respectively and irritate in the gastric capacity 1 day the ig administration 2 times with maximum, observe the toxic reaction of animal in the 7d, do not see any poisoning symptom and animal dead.
The specific embodiment
Embodiment one:
Herba Ephedrae 90g, Radix Peucedani 225g, Radix Scutellariae 225g, Fructus Perillae (stir-fry) 225g, Gypsum Fibrosum 675g, Semen Armeniacae Amarum (400W microwave 3min) 225g, Semen Lepidii (Semen Descurainiae) 279g, Caulis Bambusae In Taenia 225g adds 10 times of water gagings, reuse 500W microwave treatment 10min.After pressing said process and handling 3 times, merge aqueous extract, concentrate, add ethanol and make and contain the alcohol amount and reach 70%, stir evenly, left standstill 48 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, concentrate, spray drying, pulverizing, medicated powder.After the fusion of 90g polyethylene glycol 6000, add sodium bicarbonate 180g, sodium carbonate 20g stirs, and cooling is pulverized, and crosses 80 mesh sieves.Anhydrous citric acid 150g, cyclamate, fragrant citrus essence are crossed 80 mesh sieves,, granulate with medicated powder, Polyethylene Glycol wrappage fine powder mixing, drying, compacting is in blocks, the heavily about 3g of sheet.
Embodiment two
Herba Ephedrae 90g, Radix Peucedani 225g, Radix Scutellariae 225g, Fructus Perillae (stir-fry) 225g, Gypsum Fibrosum 675g, Semen Armeniacae Amarum (400W microwave 3min) 225g, Semen Lepidii (Semen Descurainiae) 279g, Caulis Bambusae In Taenia 225g adds 8 times of water gagings, reuse 400W microwave treatment 20min.After pressing said process and handling 2 times, merge aqueous extract, concentrate, add ethanol and make and contain the alcohol amount and reach 75%, stir evenly, left standstill 48 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, concentrate, spray drying, pulverizing, medicated powder.After the fusion of 90g polyethylene glycol 6000, add sodium bicarbonate 200g, stir, cooling is pulverized, and crosses 80 mesh sieves.Tartaric acid 170g, sweetleaf centautin, Fructus Citri Limoniae essence are crossed 80 mesh sieves,, granulate with medicated powder, Polyethylene Glycol wrappage fine powder mixing, drying, compacting is in blocks, the heavily about 3g of sheet.

Claims (2)

1. infantile lung clearing phlegm transforming effervescent sheet is characterized in that it is prepared from by following method:
(1) weight portion of crude drug is: 90 parts in Herba Ephedrae, 225 parts of Radix Peucedanis, 225 parts of Radix Scutellariaes, 225 parts of Fructus Perillae (parched), 675 parts in Gypsum Fibrosum, 225 parts of the Semen Armeniacae Amarums of microwave processing, 279 parts of Semen Lepidii (Semen Descurainiae)s, 225 parts of Caulis Bambusae In Taenia;
(2) elder generation placed the 400W microwave processing 3 minutes with the Semen Armeniacae Amarum of above-mentioned umber, added above-mentioned bulk drugs again, with 8-10 times of water gaging, in the 300-600W microwave, handled 10-20 minute, after press said process and handling 2-3 time, the merging aqueous extract, concentrate, add ethanol and make and contain the alcohol amount and reach 60%-80%, stir, left standstill 48 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, concentrate, spray drying, pulverizing, medicated powder;
(3) with after the polyethylene glycol 6000 fusion, add sodium bicarbonate and/or sodium carbonate, stir, cooling is pulverized, and crosses 80 mesh sieves; In addition organic acid is crossed 80 mesh sieves,, granulate with medicated powder, Polyethylene Glycol parcel powder mixing, drying, compacting is in flakes promptly.
2. according to a kind of infantile lung clearing phlegm transforming effervescent sheet of claim 1, described effervescent consumption is an organic acid: sodium bicarbonate and/or sodium carbonate are 0.5-1: 1.
CN 200310120056 2003-12-04 2003-12-04 Children used effervescence tablet with functions of removing lung heat and dissolving phlegm and its preparation Expired - Fee Related CN1253189C (en)

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Publication number Priority date Publication date Assignee Title
CN1320902C (en) * 2005-08-12 2007-06-13 山东鲁泰环中制药有限公司 Chinese medicinal composition for clearing heat, dispersing phlegm, ventilating the lung and relieving asthma and process for preparing the same
CN106417794A (en) * 2015-08-11 2017-02-22 哈尔滨灵丹鸿运茶品有限公司 Lung-clearing and phlegm-reducing bryozoatum tea substitute and preparation method thereof
CN105920394A (en) * 2016-05-10 2016-09-07 葵花药业集团(冀州)有限公司 Fruit-flavored lung clearing and phlegm eliminating gel for children and preparation method of gel

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