CN106377587A - Effervescent granules for infantile asthmatic cough and production method thereof - Google Patents

Effervescent granules for infantile asthmatic cough and production method thereof Download PDF

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Publication number
CN106377587A
CN106377587A CN201510449483.8A CN201510449483A CN106377587A CN 106377587 A CN106377587 A CN 106377587A CN 201510449483 A CN201510449483 A CN 201510449483A CN 106377587 A CN106377587 A CN 106377587A
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kecuanling
xiaoer
production method
semen armeniacae
flos lonicerae
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CN201510449483.8A
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Inventor
甘曙光
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Huangshi Yanwu Pharmaceutical Industry Co Ltd
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Huangshi Yanwu Pharmaceutical Industry Co Ltd
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Priority to CN201510449483.8A priority Critical patent/CN106377587A/en
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Abstract

The invention relates to effervescent granules for infantile asthmatic cough, and is characterized in that the effervescent granules are prepared from the following traditional Chinese medicines and auxiliary materials: herba ephedra, honeysuckle, semen armeniacae amarae, radix isatidis, gypsum, liquorice, trichosanthes kirilowii maxim, dextrin, citric acid, sodium bicarbonate and saccharose. The invention also provides a production method of the effervescent granules for infantile asthmatic cough. The effervescent granules for infantile asthmatic cough have the advantages of fast absorption, high bioavailability and convenience in taking, have a comprehensive treatment effect, can reduce the varieties of use drugs, and effectively reduce drug interaction and toxic and side effects.

Description

A kind of XIAOER KECUANLING effervescent granule and production method
Technical field
The present invention relates to a kind of XIAOER KECUANLING effervescent granule and production method.
Background technology
Infusion grain for cough and asthma of children agent is a kind of water-soluble granular formulation, infusion grain for cough and asthma of children adapt to children's physiology and Pathological characteristic, infantile asthma mostly by wind heat attack lung or wind and cold strongly fragrant and change heat stop up hold back caused by lung, control with lung heat clearing Expel the heat-evil, relieving cough and resolving phlegm, depressed lung-energy dispersing.Infusion grain for cough and asthma of children is by Herba Ephedrae, Flos Lonicerae, Semen Armeniacae Amarum, Baphicacanthus cusia Root, Gypsum Fibrosum, Radix Glycyrrhizae, Fructus Trichosanthis composition.According to State Food and Drug Administration's standard YBZ05622008 Prescription:Herba Ephedrae 62.5g, Flos Lonicerae 625g, Semen Armeniacae Amarum 312.5g, Radix Isatidis 625g, Gypsum Fibrosum 937.5g, Radix Glycyrrhizae 312.5g, Fructus Trichosanthis 312.5g.Square epheday intermedia bitter sweet temperature, diffusing lung, relieving exterior syndrome is relievingd asthma, and Gypsum Fibrosum is pungent Sweet Great Cold, the heat letting out clearly lung stomach to promote the production of body fluid, Semen Armeniacae Amarum bitter in the mouth, the sharp lung qi of fall and relieving asthma and cough, match then with Herba Ephedrae Xuan Jiangxiang is solid, and Gypsum Fibrosum matches then respectful clearly collaborative, Fructus Trichosanthis resolving sputum purging FU-organs, and Flos Lonicerae and Radix Isatidis are evacuated, clearly Thermal detoxification.All medicines share curative effect is distinguished.
Content of the invention
The invention provides a kind of XIAOER KECUANLING effervescent granule and production method, absorb fast, bioavailability Height, taking convenience.There is Comprehensive Treatment effect, medicine variety can be reduced, effectively reduce between medicine mutually Effect and toxic and side effects.
On the one hand, the invention provides a kind of XIAOER KECUANLING effervescent granule, it is by following Chinese medicines and adjuvant system Become:Herba Ephedrae, Flos Lonicerae, Semen Armeniacae Amarum, Radix Isatidis, Gypsum Fibrosum, Radix Glycyrrhizae, Fructus Trichosanthis, dextrin, citric acid, carbon Sour hydrogen sodium, sucrose.
Further, Chinese medicine and adjuvant parts by weight are:1~25 part of Herba Ephedrae, 1~250 part of Flos Lonicerae, 1~125 part of Semen Armeniacae Amarum, 1~250 part of Radix Isatidis, 1~375 part of Gypsum Fibrosum, 1~125 part of Radix Glycyrrhizae, melon 1~125 part of beach wormwood, 1~24 part of dextrin, 1~18 part of citric acid, 1~14 part of sodium bicarbonate, appropriate sucrose.
In addition, additionally providing a kind of XIAOER KECUANLING effervescent granule production method, comprise the steps:
Step one:By following net medical materials:Herba Ephedrae, Flos Lonicerae, Semen Armeniacae Amarum, Radix Isatidis, Gypsum Fibrosum, Radix Glycyrrhizae, Fructus Trichosanthis make thick paste;
Step 2:The dextrin of half, the thick paste of half, appropriate sucrose, citric acid are made granulates; Second half dextrin, second half thick paste, appropriate sucrose, sodium bicarbonate are made alkali granule;
Step 3:Granulates and alkali granule are pressed 1:1 ratio mix homogeneously.
Further, first by raw material of Chinese medicine:Herba Ephedrae, Flos Lonicerae, Semen Armeniacae Amarum, Radix Isatidis, Gypsum Fibrosum, Radix Glycyrrhizae, Fructus Trichosanthis make net medical material through processing procedure, then net medical material process is decocted, filters, concentrating, Precipitate with ethanol, recovery ethanol make thick paste.
Further, in decoction process:Take first net medical material Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis decoct releasing medicinal liquid to tank, then with decoction in Herba Ephedrae, Flos Lonicerae to tank, medicinal residues are released medicinal liquid, Finally standing will be merged by medicinal liquid twice.
Further, when carrying out step 2 and step 3, the humidity that environment is prepared in control is less than 30%.
Further, the moisture Control of granulates and alkali granule is below 2.0%.
Further, following net medical materials and adjuvant parts by weight are:1~25 part of Herba Ephedrae, Flos Lonicerae 1~ 250 parts, 1~125 part of Semen Armeniacae Amarum, 1~250 part of Radix Isatidis, 1~375 part of Gypsum Fibrosum, Radix Glycyrrhizae 1~125 Part, 1~125 part of Fructus Trichosanthis, 1~24 part of dextrin, 1~18 part of citric acid, 1~14 part of sodium bicarbonate, sugarcane Sugar is appropriate.
A kind of XIAOER KECUANLING effervescent granule and production method that the present invention provides, are a kind of brand-new safeties The matured product having concurrently with therapeutic effect, reduces child's simple function drug combination, it is to avoid thus may produce Drug interaction and drug resistance problems.Absorb fast, bioavailability is high, taking convenience.Surmount general Traditional Chinese patent medicine in meaning, has good lung qi dispersing, heat clearing away, cough-relieving, eliminating the phlegm effect, take safety, Effectively, conveniently, have good stability.Medicine variety can be reduced, effectively reduce drug drug interaction and poison Side effect.
Brief description
The accompanying drawing constituting the part of the present invention is used for providing a further understanding of the present invention, and the present invention shows Meaning property embodiment and its illustrate for explaining the present invention, does not constitute inappropriate limitation of the present invention.In accompanying drawing In:
Fig. 1 is XIAOER KECUANLING effervescent granule pre-treatment and the extraction production technology flow chart of the present invention;
Fig. 2 is the XIAOER KECUANLING effervescent granule production method flow chart of the present invention.
Specific embodiment
It should be noted that in the case of not conflicting, the embodiment in the present invention and the feature in embodiment Can be mutually combined.To describe the present invention below with reference to the accompanying drawings and in conjunction with the embodiments in detail.
As depicted in figs. 1 and 2, a kind of currently preferred XIAOER KECUANLING effervescent granule production method, little Youngster's cough with asthma spirit effervescent granule is made up of following Chinese medicines and adjuvant parts by weight:
Preferably employ the first formula:25 parts of Herba Ephedrae, 250 parts of Flos Lonicerae, 125 parts of Semen Armeniacae Amarum, plate 250 parts of blue root, 375 parts of Gypsum Fibrosum, 125 parts of Radix Glycyrrhizae, 125 parts of Fructus Trichosanthis, 24 parts of dextrin, citric acid 18 Part, 14 parts of sodium bicarbonate, appropriate sucrose.
Suitably can also be adjusted on the first formula, for example:24 parts of Herba Ephedrae, 240 parts of Flos Lonicerae, 122 parts of Semen Armeniacae Amarum, 248 parts of Radix Isatidis, 365 parts of Gypsum Fibrosum, 115 parts of Radix Glycyrrhizae, 115 parts of Fructus Trichosanthis, paste 23 parts of essence, 17 parts of citric acid, 13 parts of sodium bicarbonate, appropriate sucrose.
Its manufacturing technique method of XIAOER KECUANLING effervescent granule is as follows:
1st, by crude drug Herba Ephedrae, Flos Lonicerae, Semen Armeniacae Amarum, Radix Isatidis, Gypsum Fibrosum, Radix Glycyrrhizae, Fructus Trichosanthis net Xian big gun System.The foundation processing:《Pharmacopoeia of People's Republic of China》Version one in 2005,《Chinese crude drug concocted specification》.
1.1 concocting methods and process are as follows:
Herba Ephedrae:Remove woody stems, undesirable root and impurity, cutting.
Flos Lonicerae:Remove impurity.
Semen Armeniacae Amarum:Remove impurity.
Radix Isatidis:Remove impurity, clean, run through, cut sheet, be dried.
Gypsum Fibrosum:Cleaning, drying, smash, except roguing stone.
Radix Glycyrrhizae:Remove impurity, clean, run through, cut sheet, be dried.
Fructus Trichosanthis:Except destemming and silt, flattening, shredding or stripping and slicing.
1.2 pre-treating technology operations require as follows:
1.2.1 choose operation:According to production ordering drawing Chinese traditional medicine material, it is placed on sorting table, will choose Medical material divide and be put in container, hang up material card (the dated name of an article, quantity etc.), hand over next procedure.
1.2.2 washing procedure:The Chinese crude drug of select is respectively put in wash pond, opens and drink water valve, Punching, until cleaning up, is put in clean container, is drained and carry out labelling while washing, sends into next procedure, And fill record and delivery receitp.
1.2.3 cutting operation:During Chinese crude drug cutting, except fresh-cut, dry cut in addition to, it infiltrated must be made soft, Should steep less and moisten more, prevent effective ingredient to run off.Note grasping the conditions such as temperature, the water yield, time.Should after cutting It is dried it is ensured that quality in time.Quality Inspector please proceed to net medical material storehouse after the assay was approved.
1.2.4 drying process:The medical material draining will be cleaned, be laid on the pallet of cleaning, load in baking oven Row drying, baking temperature no more than 80 DEG C, containing volatile material less than 60 DEG C.
2nd, pharmaceutical practice process and process conditions, material balance and be calculated as follows:
2.2 Chinese crude drug neck material feed intake:Qualified net medical material is got according to prescription, loads in clean container, hang Upper label, all indicates the name of an article, lot number, weight, number of packages, whole for net medical material friendships is boiled and puies forward operation.
2.3 decocting:Take net medical material Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis to multi-function extractor In, add 8 10 times of water, decoct 1 hour, stop heating, release medicinal liquid, filtration, medicinal residues and Herba Ephedrae, Flos Lonicerae adds drinking water 68 times amount, and heating decocts 1 hour, stops heating, releases medicinal liquid, filtration, closes And above-mentioned secondary medicinal liquid, standing.
2.4 concentrating:After decoction liquor is filtered, take supernatant, squeeze in cylinder concentrated in vacuo with pump, It is concentrated into the clear paste that relative density is 1.1-1.15 (50 DEG C of survey).
2.5 precipitate with ethanol:After solution to be concentrated is cooled to 35 DEG C, stirring, it is slowly added into >=75% ethanol, make containing alcohol For 65% (value of calculation), computing formula is:Volume=(medicine liquid volume × 65%)/(need of ethanol need to be added Add concentration of alcohol -65%), stir evenly, stand 12-48 hour.
2.6 receipts cream:Take supernatant, filtration, put recovery ethanol in spherical tank, to no alcohol taste, be concentrated to phase To density be 1.25-1.30 (50 DEG C) thick paste, put into cleaning Plastic Drum in cover tightly, fill in delivery receitp and To be verified, be placed in the Holding Area between depositing, and notify intermediate coroner chemical examination, handle after the assay was approved into Storehouse formality.
2.7 pulverizing:Qualified sucrose, citric acid are got according to supplementary material core material list, decortication enters between pulverizing, According to grindability, slowly blowing is separately pulverized and is crossed 80 mesh sieves, and fine powder is contained in the appearance ware of cleaning, covers tightly, Fill out transfer single, hang up material card, the dated name of an article, lot number, quantity, friendship next process.
2.8 antacid granules:Take the Fructus Citri Limoniae of the dextrin, appropriate cane sugar powder and batch recipe quantity of batch recipe quantity half Sour powder, after fully mixing, adds the thick paste of batch recipe quantity half, mix homogeneously, makes soft material color and luster consistent, Dry, humidity is moderate, then puts in granulator the medicine of mix homogeneously with the wet grain of 16 mesh sieve series.
2.9 are dried, granulate:The wet granular making is sent into about 20 points of 75-80 DEG C of drying in boiling drier Clock, controls moisture (fast tester for water content) below 2%, dried granule is entered by vertical vibration screen Row sieves, and gained semi-finished product are put in clean stainless steel cask, weigh, and is listed, and is handed over to and always mixes operation.
2.10 alkaline granule:Take the carbonic acid of the dextrin, appropriate cane sugar powder and batch recipe quantity of batch recipe quantity half Hydrogen sodium, after fully mixing, adds the thick paste of batch recipe quantity half, mix homogeneously, makes soft material color and luster consistent, Dry, humidity is moderate, then puts in granulator the medicine of mix homogeneously with the wet grain of 16 mesh sieve series.
2.11 are dried, granulate:The wet granular making is sent into 75-80 DEG C of drying about 20 in boiling drier Minute, control moisture (fast tester for water content) below 2%, dried granule is passed through vertical vibration screen Sieved, gained semi-finished product are put in clean stainless steel cask, weigh, be listed, be handed over to and always mix operation.
2.12 always mixing:Granulates after sieving, alkali granule are by 1:1 ratio, is placed in two-dimensional mixing machine Mixed, after mix homogeneously, gained semi-finished product are put in clean stainless steel cask, fill in delivery receitp and to be verified, put Holding Area between depositing, notifies semi-finished product laboratorian chemical examination.After the assay was approved, it is handed over to inner packing operation.
2.13 granule inner packing:Qualified inner packaging material is singly got according to batch packaging material neck, by interior bag Packed after package material decortication.Packing specification is often packed 2 grams, and the humidity first controlling room is less than 30%, then debugging of starting shooting, content uniformity is in the range of 2g ± 5.0%, and checks sealing, qualified after can Formally produced.The medicine wrapped, is contained in the plastic crate of cleaning, weighed weight, fills in delivery receitp, It is handed over to outer package operation.
2.14 outer package:According to batch packaging directive, get housing material and packed, verification label is said Bright book content and packaging quantity, the material balance such as label description should be 100%, and lot number, has the date of manufacture The effect phase is correct, and writing is clear, and accurately, joint sealing is tight for packing number, and packing is firmly.If any mould assembling, Then it is limited to the two neighboring batch of same kind same specification, and indicate on packing list and outer container, with middle box or middle bag For unit.Outsourcing installs rearmounted Holding Area and deposits, and notifies central laboratory to inspect by random samples, puts in storage after the assay was approved, And handle warehouse-in handing over procedure.
2.15 clearing out a gathering place:Each operation is cleared out a gathering place by rule of operation of clearing out a gathering place, and hangs sign board of clearing out a gathering place, fills in note of clearing out a gathering place Record and equipment log.
A kind of XIAOER KECUANLING effervescent granule that the present invention provides, entrusts Hubei Province food supervision and inspection academy Inspection, survey report is as follows:
A kind of XIAOER KECUANLING effervescent granule that the present invention provides:Take 1 bag of test sample, put and fill 200ml water Beaker in, water temperature be 15-25 DEG C, gas should be able to be produced rapidly, endoparticle can be completely dispersed within 5 minutes, molten In Xie Shui.
A kind of XIAOER KECUANLING effervescent granule that the present invention provides, is a kind of brand-new safety and therapeutic effect The matured product having concurrently, reduces child's simple function drug combination, it is to avoid thus issuable medicine is mutual Effect and drug resistance problems.Absorb fast, bioavailability is high, taking convenience.Surmount biography in general sense System Chinese patent medicine, has good lung qi dispersing, heat clearing away, cough-relieving, eliminating the phlegm effect, takes safely, effectively, conveniently, Have good stability.Medicine variety can be reduced, effectively reduce drug drug interaction and toxic and side effects.
The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all at this Within bright spirit and principle, any modification, equivalent substitution and improvement made etc., should be included in this Within bright protection domain.

Claims (8)

1. a kind of XIAOER KECUANLING effervescent granule is it is characterised in that be made up of following Chinese medicines and adjuvant: Herba Ephedrae, Flos Lonicerae, Semen Armeniacae Amarum, Radix Isatidis, Gypsum Fibrosum, Radix Glycyrrhizae, Fructus Trichosanthis, dextrin, citric acid, bicarbonate Sodium, sucrose.
2. XIAOER KECUANLING effervescent granule according to claim 1 is it is characterised in that Chinese medicine and auxiliary Expect that parts by weight are:1~25 part of Herba Ephedrae, 1~250 part of Flos Lonicerae, 1~125 part of Semen Armeniacae Amarum, Baphicacanthus cusia 1~250 part of root, 1~375 part of Gypsum Fibrosum, 1~125 part of Radix Glycyrrhizae, 1~125 part of Fructus Trichosanthis, dextrin 1~24 Part, 1~18 part of citric acid, 1~14 part of sodium bicarbonate, appropriate sucrose.
3. a kind of XIAOER KECUANLING effervescent granule production method is it is characterised in that comprise the steps:
Step one:By following net medical materials:Herba Ephedrae, Flos Lonicerae, Semen Armeniacae Amarum, Radix Isatidis, Gypsum Fibrosum, Radix Glycyrrhizae, Fructus Trichosanthis make thick paste;
Step 2:The dextrin of half, the thick paste of half, appropriate sucrose, citric acid are made granulates; Second half dextrin, second half thick paste, appropriate sucrose, sodium bicarbonate are made alkali granule;
Step 3:Granulates and alkali granule are pressed 1:1 ratio mix homogeneously.
4. XIAOER KECUANLING effervescent granule production method according to claim 3 it is characterised in that First by raw material of Chinese medicine:Herba Ephedrae, Flos Lonicerae, Semen Armeniacae Amarum, Radix Isatidis, Gypsum Fibrosum, Radix Glycyrrhizae, Fructus Trichosanthis are through big gun Technique processed makes net medical material, then by net medical material through decoction, filtration, concentration, precipitate with ethanol, recovery ethanol work Skill makes thick paste.
5. XIAOER KECUANLING effervescent granule production method according to claim 4 it is characterised in that In decoction process:Take first in net medical material Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis to tank and decoct Release medicinal liquid, then will medicinal residues and Herba Ephedrae, decoct in Flos Lonicerae to tank and release medicinal liquid, finally will medicinal liquid twice Merge standing.
6. XIAOER KECUANLING effervescent granule production method according to claim 3 it is characterised in that When carrying out step 2 and step 3, the humidity that environment is prepared in control is less than 30%.
7. XIAOER KECUANLING effervescent granule production method according to claim 3 it is characterised in that The moisture Control of granulates and alkali granule is below 2.0%.
8., according to the arbitrary described XIAOER KECUANLING effervescent granule production method of claim 3 to 7, it is special Levy and be, following net medical materials and adjuvant parts by weight are:1~25 part of Herba Ephedrae, 1~250 part of Flos Lonicerae, 1~125 part of Semen Armeniacae Amarum, 1~250 part of Radix Isatidis, 1~375 part of Gypsum Fibrosum, 1~125 part of Radix Glycyrrhizae, melon 1~125 part of beach wormwood, 1~24 part of dextrin, 1~18 part of citric acid, 1~14 part of sodium bicarbonate, appropriate sucrose.
CN201510449483.8A 2015-07-28 2015-07-28 Effervescent granules for infantile asthmatic cough and production method thereof Pending CN106377587A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112618612A (en) * 2021-01-05 2021-04-09 海南海力制药有限公司 Traditional Chinese medicine granule for treating infantile cough and asthma and preparation method thereof
CN116392448A (en) * 2023-04-17 2023-07-07 黄石燕舞药业有限公司 An effervescent granule for treating infantile cough and asthma, and its preparation method

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101897732A (en) * 2009-05-27 2010-12-01 北京因科瑞斯医药科技有限公司 Chinese medicinal effervescence medicament and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101897732A (en) * 2009-05-27 2010-12-01 北京因科瑞斯医药科技有限公司 Chinese medicinal effervescence medicament and preparation method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112618612A (en) * 2021-01-05 2021-04-09 海南海力制药有限公司 Traditional Chinese medicine granule for treating infantile cough and asthma and preparation method thereof
CN116392448A (en) * 2023-04-17 2023-07-07 黄石燕舞药业有限公司 An effervescent granule for treating infantile cough and asthma, and its preparation method
CN116392448B (en) * 2023-04-17 2024-01-16 黄石燕舞药业有限公司 An effervescent granule for treating infantile cough and asthma, and its preparation method

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