CN106074609A - A kind of production method treating children's cold granule - Google Patents
A kind of production method treating children's cold granule Download PDFInfo
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
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- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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Abstract
The present invention provides a kind of production method treating children's cold granule, bad to solve product quality, and production efficiency is low, the problem that energy consumption is high;Comprise the following steps: preparation raw material: acetaminophen, sucrose, chlorphenamine maleate, corn starch, artificial Calculus Bovis, binding agent and essence;Pulverize;Mixing: by chlorphenamine maleate with corn starch mix homogeneously, obtain the first mixture, by corn starch and the first mixture mix homogeneously, obtain the second mixture, artificial Calculus Bovis is mixed homogeneously with the second mixture, obtain the 3rd mixture;Pelletize, be dried: with sucrose, the 3rd mixture, remaining corn starch, acetaminophen being added fluid bed granulator, is simultaneously introduced binding agent and pelletizes, system is dry;Granulate;It is mixed and made into semi-finished product;Subpackage;The inventive method cancels pelletization, shortens processing operation time, alleviates the amount of labour, shortens the production cycle, and conforming particle rate improves more than 1.5 times, and production efficiency has had and is greatly improved.
Description
Technical field
The present invention relates to medicine, a kind of production method treating children's cold granule.
Background technology
Children's cold is also named acute upper respiratory tract infection, is the modal disease of child, how based on virus infection, can account for
More than the 90% of upper respiratory tract infection is sent out in source, bacterial more rare, and after virus infects, upper respiratory tract mucosa promotes opposing
Power, antibacterial takes advantage of a weak point, concurrentization pyogenic infection, have a fraction children's Ke Yin cold virus and the nervus centralis that causes infects,
Septic shock or disseminated inravascular coagulation cause death.This disease incubation period is 2-3 days or slightly long, and the whole year all can occur,
Winter-Spring is more, disappears, and its complication can delay or increase the weight of after sometimes the symptom of protopathy takes a turn for the better, must treat ahead of time, carry
High curative effect.Treat at present this disease and mainly use pediatric paracetamol,atificial cowbezoar and chlorphenamine maleate granule, but pediatric paracetamol,atificial cowbezoar and chlorphenamine maleate granule original production process
Using wet granulation, producing one pot of 150kg needs 25 minutes, returns again to fluid bed granulator and carry out 70 DEG C dry about 10 points after blanking
Clock;Dried granule fluid bed blanking, wobbler carries out granulate about 20 minutes, returns again to whirlpool concussion sieve and carries out selecting grain about 40
Minute.The fine powder purified water selected carries out secondary granulation in fluid bed granulator, repeats granulate, selects the process of grain.Step ratio
Cumbersome, the production cycle is longer, directly affects the production capacity of pediatric paracetamol,atificial cowbezoar and chlorphenamine maleate granule;Wet granulator is at long time running
During, causing material heat production melting, caking, conforming particle yield is only 70%--75%, and the production tailing of generation is more, leads
Cause the waste of material;Not only affecting product quality, and cause production efficiency to decline, energy consumption is high, can not meet production and market
On demand, therefore, improvement in production method and innovate imperative.
Summary of the invention
For above-mentioned situation, for overcoming the deficiency of prior art, the purpose of the present invention is to provide one and treats children's cold
The production method of granule, bad to solve product quality, production efficiency is low, the problem that energy consumption is high.
The technical scheme that the present invention solves is: comprise the following steps:
1, preparation raw material: its raw material is following weight meter: acetaminophen 125g~375g, sucrose 2695g~
2720g, chlorphenamine maleate 0.5g~1.5g, corn starch 140g~160g, artificial Calculus Bovis 5g~15g, binding agent
156.25g~225g and essence 1g~3g;
2, pulverize: sucrose is pulverized, cross 60 mesh sieves, obtain Icing Sugar;
3, mixing: mixed homogeneously with the corn starch of 0.5g~1.5g by chlorphenamine maleate, obtain the first mixture, will
The corn starch of 1.0g~3.0g and the first mixture mix homogeneously, obtain the second mixture, by artificial Calculus Bovis and the second mixture
Mix homogeneously, obtains the 3rd mixture;
4, pelletize, be dried: remaining corn starch, acetaminophen are added boiling system with sucrose, the 3rd mixture
Grain machine, is simultaneously introduced binding agent and pelletizes, and at 60-70 DEG C, system is dry;
5, granulate: the granule made is passed through the fluid bed granulate of built-in 14 eye mesh screens;
6, it is mixed and made into semi-finished product: added in mixer by the essence of the granule after granulate and 1g~3g and mix 5 minutes,
Finished particle, subpackage.
The inventive method cancels pelletization, shortens processing operation time, alleviates the amount of labour, shorten the production cycle,
Conforming particle rate improves more than 1.5 times, and production efficiency has had and is greatly improved.
Detailed description of the invention
Below in conjunction with concrete condition, the detailed description of the invention of the present invention is elaborated:
The present invention, in being embodied as, can be given by following example:
Embodiment 1: the present invention, in being embodied as, is realized by following steps:
1, preparation raw material: its raw material is following weight meter: acetaminophen 125g, sucrose 2705g, maleic acid chlorobenzene
That quick 0.5g, corn starch 150g, artificial Calculus Bovis 5g, binding agent 156.25g and essence 2g;
2, pulverize: sucrose is pulverized, cross 60 mesh sieves, obtain Icing Sugar;
3, mixing: chlorphenamine maleate is mixed homogeneously with the corn starch of 0.5g, obtains the first mixture, by 1.0g's
Corn starch and the first mixture mix homogeneously, obtain the second mixture, artificial Calculus Bovis mixed homogeneously with the second mixture, obtains
Three mixture;
4, pelletize, be dried: remaining corn starch, acetaminophen are added boiling system with sucrose, the 3rd mixture
Grain machine, is simultaneously introduced binding agent (binding agent be mass fraction be the aqueous solution of the PVP K30 of 8%) and pelletizes, at 60-70 DEG C
System is dry;
5, granulate: the granule made is passed through the fluid bed granulate of built-in 14 eye mesh screens;
6, it is mixed and made into finished product: the granule after granulate and essence are added in mixer and mix 5 minutes, obtain finished particle;
7, packaging: every bag of 3g, loads granule good for subpackage in carton.
Embodiment 2: the present invention is in being embodied as, it is possible to realized by following steps:
1, preparation raw material: its raw material is following weight meter: acetaminophen 375g, sucrose 2705, maleic acid chlorobenzene
That quick 1.5g, corn starch 150g, artificial Calculus Bovis 15g, binding agent 225g and essence 2g;
2, pulverize: sucrose is pulverized, cross 60 mesh sieves, obtain Icing Sugar;
3, mixing: chlorphenamine maleate is mixed homogeneously with the corn starch of 1.5g, obtains the first mixture, by 3.0g's
Corn starch and the first mixture mix homogeneously, obtain the second mixture, artificial Calculus Bovis mixed homogeneously with the second mixture, obtains
Three mixture;
4, pelletize, be dried: remaining corn starch, acetaminophen are added boiling system with sucrose, the 3rd mixture
Grain machine, is simultaneously introduced binding agent and pelletizes, and at 60-70 DEG C, system is dry;
5, granulate: the granule made is passed through the fluid bed granulate of built-in 14 eye mesh screens;
6, it is mixed and made into semi-finished product: added in mixer by the essence of the granule after granulate and 2g and mix 5 minutes, obtain finished product
Granule, subpackage.
Embodiment 3: the present invention, in being embodied as, also can be realized by following steps:
1, preparation raw material: its raw material is following weight meter: acetaminophen 250g, sucrose 2705g, maleic acid chlorobenzene
That quick 1.0g, corn starch 150g, artificial Calculus Bovis 10g, binding agent 190.5g and essence 2g;
2, pulverize: sucrose is pulverized, cross 60 mesh sieves, obtain Icing Sugar;
3, mixing: chlorphenamine maleate is mixed homogeneously with the corn starch of 1.0g, obtains the first mixture, by 2.0g's
Corn starch and the first mixture mix homogeneously, obtain the second mixture, artificial Calculus Bovis mixed homogeneously with the second mixture, obtains
Three mixture;
4, pelletize, be dried: remaining corn starch, acetaminophen are added boiling system with sucrose, the 3rd mixture
Grain machine, is simultaneously introduced binding agent and pelletizes, and at 60-70 DEG C, system is dry;
5, granulate: the granule made is passed through the fluid bed granulate of built-in 14 eye mesh screens;
6, it is mixed and made into semi-finished product: added in mixer by the essence of the granule after granulate and 2g and mix 5 minutes, obtain finished product
Granule, subpackage.
Relevant pilot production data is as follows:
1, pelletization uses fluid bed granulator, through tens of lab scales, pilot scales, equipment is carried out intermediary operation simultaneously
Docking, it is not necessary to middle circular flow, shortens processing operation time, successfully solves a granulation difficult problem in prior art, than
Front conforming particle rate improves more than 1.5 times, and production efficiency has had and is greatly improved.Concrete creation data, as shown in table 1, table 2, is tested
Production efficiency contrast is as shown in table 3:
Creation data under the former process conditions of table 1
Data under table 2 boiling granulating working condition
Production efficiency contrast tested by table 3
2, cancel after using boiling granulating and select grain, the granule not selecting grain after granulate is directly carried out granularity Detection, defective
Granule is about 3.3%, investigates result as shown in table 4: grain graininess is far smaller than the numerical value that standard specifies, it can be ensured that granule
Granularity meet the requirements, therefore need not after pediatric paracetamol,atificial cowbezoar and chlorphenamine maleate granule boiling granulating select grain after granulate, can be directly with interior point
Dress.Substantially increase production efficiency, alleviate the amount of labour, shorten the production cycle.
The grain graininess summary sheet after selecting grain cancelled by table 4
3, the finished product stability prepared by the inventive method is good, and it is as shown in table 5 that it investigates result:
5 three batches of product accelerated stabilities of table investigate result
Pediatric paracetamol,atificial cowbezoar and chlorphenamine maleate granule clinical efficacy:
1. physical data
Choose flu infant 64 example, take random packet principle that patient is divided into observation group and matched group, often group patient 32
Example, selected patient all meets flu diagnostic criteria.Man's infant 36 example, female's infant 28 example, children age 1 years old-12 in 64 example infants
Year, patient's mean age (6.7 ± 1.4) year.Two groups of infants are poor without significance in terms of the physical data such as age, sex, the course of disease
Different, P > 0.05, there is comparability.
2. therapeutic scheme
Observation group's infant is administered orally the pediatric paracetamol,atificial cowbezoar and chlorphenamine maleate granule that the inventive method prepares, 1 years old-3 years old infants each 0.5
Bag-1 bag, 4-6 year each 1 bag-1.5 bags of infant, 7-9 year each 1.5 bags-2 bags of infant, 10-12 year infant each 2-2.5 bag, 3
Secondary/d.It within 5 days, it is 1 course for the treatment of.
Matched group infant is administered orally pediatric paracetamol,atificial cowbezoar and chlorphenamine maleate granule in prior art, 1 years old-3 years old each 0.5 bag-1 bag of infants,
4-6 each 1 bag-1.5 bags of infant of year, 7-9 each 1.5 bags-2 bags of infant of year, 10-12 year infant each 2-2.5 bag, 3 times/d.5
It is 1 course for the treatment of.
3. efficacy assessment standard
Recovery from illness: infant flu sign all disappears, and abnormal laboratory indexes full recovery is normal;
Effective: cold symptoms disappears substantially, abnormal laboratory indexes recovers normal substantially;
Effective: cold symptoms sign has been alleviated, abnormal laboratory indexes part recovers normal;
Invalid: flu sign even increases the weight of without improving, abnormal laboratory indexes is without taking a turn for the better;
Comparative control group and observation group's infant TCM syndrome integration.When observing resolution of symptoms such as suffering from cough, heating, nasal mucus
Between, compare.
4. statistical analysis
Using SPSS13.0 software to carry out statistical procedures, enumeration data uses × 2 inspections;Measurement data employing () represent, compare employing t inspection between group.P > 0.05, represents not statistically significant.
5. result
5.1. clinical effectiveness
Observation group's treatment total effective rate is 93.8%, and matched group patient treatment total effective rate is 81.2%.Tool is compared between group
There were significant differences (P < 0.05).There is statistical significance.Refer to table 6
6 liang of table group Clinical efficacy comparison (example %)
5.2. patient cures the desease time integration
Treat front two groups of patient's TCM syndrome integrations without significant difference (P > 0.05), two groups of patient's TCM syndrome after treatment
Integration is all significantly improved, P < 0.05, has statistical significance, and observation group patient outcomes is significantly better than matched group (P
< 0.05).Refer to table 7
7 liang of table group treatment before and after TCM syndrome integral contrast (Point)
5.3. two groups of patient clinical resolution of symptoms time
The symptoms such as heating in various degree, cough, rhinorrhea all it are presented with, through treatment future trouble before two groups for the treatment of patients
Youngster's clinical symptoms all has improvement, clinical symptom disappearance time observation group patient more shorter than matched group patient's time (P < 0.05), tool
Statistically significant, observation group is better than matched group, refers to table 8
8 liang of table group the patient clinical resolution of symptoms time compare (d)
6. conclusion
Matched group infant uses Xiao ' er Anfen Huangnamin granule therapy in prior art, observation group's infant to use side of the present invention
The pediatric paracetamol,atificial cowbezoar and chlorphenamine maleate granule treatment that method prepares.After treatment, two groups of patients all have improvement, observation group's infant treatment before relatively treating
Effect becomes apparent from, and total effective rate is 93.8%, and matched group infant treatment total effective rate is 81.2%.Compare between group and have significantly
Difference (P < 0.05), has statistical significance.After treatment, observation group's infant TCM syndrome integration is substantially less than matched group, P <
0.05, there is statistical significance.Two groups of infant clinical symptoms elimination times compare, and observation group's symptom eliminates the time significantly lower than right
According to group, P < 0.05, there is statistical significance.
The inventive method compared with prior art has a following Advantageous Effects:
1, the inventive method use fluid bed granulator replace original wet granulator, pelletize, be dried synchronization carry out, granule matter
Amount stability is more preferable, and conforming particle rate improves more than 1.5 times, produces tailing few, meets " two high one low " (high-quality and high-efficiency low consumption)
Production standard, shortens the production cycle, improves production efficiency.
2, cancel after using boiling granulating and select grain, substantially increase production efficiency, alleviate the amount of labour, shorten production week
Phase.
3, the inventive method has the high efficiency of the stability of technique, operability and production, and quality has obtained significantly carrying
Height, good effect, hence it is evident that be better than existing product, economic and social benefit is notable.
Claims (4)
1. treat a production method for children's cold granule, it is characterized in that: comprise the following steps:
(1), preparation raw material: its raw material is following weight meter: acetaminophen 125g ~ 375g, sucrose 2695g ~ 2720g,
Chlorphenamine maleate 0.5g ~ 1.5g, corn starch 140g ~ 160g, artificial Calculus Bovis 5g ~ 15g, binding agent 156.25g ~ 225g and
Essence 1g ~ 3g;
(2), pulverize: sucrose is pulverized, cross 60 mesh sieves, obtain Icing Sugar;
(3), mix: chlorphenamine maleate is mixed homogeneously with the corn starch of 0.5g ~ 1.5g, obtains the first mixture, will
The corn starch of 1.0g ~ 3.0g and the first mixture mix homogeneously, obtain the second mixture, artificial Calculus Bovis mixed with the second mixture
Close uniformly, obtain the 3rd mixture;
(4), pelletize, be dried: remaining corn starch, acetaminophen are added boiling granulating with sucrose, the 3rd mixture
Machine, is simultaneously introduced binding agent and pelletizes, and at 60-70 DEG C, system is dry;
(5), granulate: the granule made is passed through the fluid bed granulate of built-in 14 eye mesh screens;
(6) semi-finished product, it are mixed and made into: added in mixer by the essence of the granule after granulate and 1g ~ 3g and mix 5 minutes, must become
Product granule, subpackage.
The production method for the treatment of children's cold granule the most according to claim 1, is characterized in that: comprise the following steps:
(1), preparation raw material: its raw material is following weight meter: acetaminophen 125g, sucrose 2705g, chlorphenamine maleate
Quick 0.5g, corn starch 150g, artificial Calculus Bovis 5g, binding agent 156.25g and essence 2g;
(2), pulverize: sucrose is pulverized, cross 60 mesh sieves, obtain Icing Sugar;
(3), mixing: chlorphenamine maleate is mixed homogeneously with the corn starch of 0.5g, obtains the first mixture, by the jade of 1.0g
Rice starch and the first mixture mix homogeneously, obtain the second mixture, artificial Calculus Bovis mixed homogeneously with the second mixture, obtain the 3rd
Mixture;
(4), pelletize, be dried: remaining corn starch, acetaminophen are added boiling granulating with sucrose, the 3rd mixture
Machine, is simultaneously introduced binding agent and pelletizes, and at 60-70 DEG C, system is dry;
(5), granulate: the granule made is passed through the fluid bed granulate of built-in 14 eye mesh screens;
(6) semi-finished product, it are mixed and made into: added in mixer by the essence of the granule after granulate and 2g and mix 5 minutes, obtain finished product
Grain, subpackage.
The production method for the treatment of children's cold granule the most according to claim 1, is characterized in that: comprise the following steps:
(1), preparation raw material: its raw material is following weight meter: acetaminophen 375g, sucrose 2705, chlorphenamine maleate
Quick 1.5g, corn starch 150g, artificial Calculus Bovis 15g, binding agent 225g and essence 2g;
(2), pulverize: sucrose is pulverized, cross 60 mesh sieves, obtain Icing Sugar;
(3), mixing: chlorphenamine maleate is mixed homogeneously with the corn starch of 1.5g, obtains the first mixture, by the jade of 3.0g
Rice starch and the first mixture mix homogeneously, obtain the second mixture, artificial Calculus Bovis mixed homogeneously with the second mixture, obtain the 3rd
Mixture;
(4), pelletize, be dried: remaining corn starch, acetaminophen are added boiling granulating with sucrose, the 3rd mixture
Machine, is simultaneously introduced binding agent and pelletizes, and at 60-70 DEG C, system is dry;
(5), granulate: the granule made is passed through the fluid bed granulate of built-in 14 eye mesh screens;
(6) semi-finished product, it are mixed and made into: added in mixer by the essence of the granule after granulate and 2g and mix 5 minutes, obtain finished product
Grain, subpackage.
The production method for the treatment of children's cold granule the most according to claim 1, is characterized in that: comprise the following steps:
(1), preparation raw material: its raw material is following weight meter: acetaminophen 250g, sucrose 2705g, chlorphenamine maleate
Quick 1.0g, corn starch 150g, artificial Calculus Bovis 10g, binding agent 190.5g and essence 2g;
(2), pulverize: sucrose is pulverized, cross 60 mesh sieves, obtain Icing Sugar;
(3), mixing: chlorphenamine maleate is mixed homogeneously with the corn starch of 1.0g, obtains the first mixture, by the jade of 2.0g
Rice starch and the first mixture mix homogeneously, obtain the second mixture, artificial Calculus Bovis mixed homogeneously with the second mixture, obtain the 3rd
Mixture;
(4), pelletize, be dried: remaining corn starch, acetaminophen are added boiling granulating with sucrose, the 3rd mixture
Machine, is simultaneously introduced binding agent and pelletizes, and at 60-70 DEG C, system is dry;
(5), granulate: the granule made is passed through the fluid bed granulate of built-in 14 eye mesh screens;
(6) semi-finished product, it are mixed and made into: added in mixer by the essence of the granule after granulate and 2g and mix 5 minutes, obtain finished product
Grain, subpackage.
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108186579A (en) * | 2018-02-01 | 2018-06-22 | 重庆希尔安药业有限公司 | Xiao ' er Anfen Huangnamin composition grain and preparation method thereof |
CN108904452A (en) * | 2018-08-15 | 2018-11-30 | 康美保宁(四川)制药有限公司 | A kind of preparation method of pediatric paracetamol granule |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101991603A (en) * | 2009-08-11 | 2011-03-30 | 汤明昌 | Preparation for treating cold in children and preparation method |
CN104189011A (en) * | 2014-09-29 | 2014-12-10 | 安徽安科恒益药业有限公司 | Preparation method for pediatric paracetamol |
-
2016
- 2016-08-30 CN CN201610763286.8A patent/CN106074609A/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101991603A (en) * | 2009-08-11 | 2011-03-30 | 汤明昌 | Preparation for treating cold in children and preparation method |
CN104189011A (en) * | 2014-09-29 | 2014-12-10 | 安徽安科恒益药业有限公司 | Preparation method for pediatric paracetamol |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108186579A (en) * | 2018-02-01 | 2018-06-22 | 重庆希尔安药业有限公司 | Xiao ' er Anfen Huangnamin composition grain and preparation method thereof |
CN108904452A (en) * | 2018-08-15 | 2018-11-30 | 康美保宁(四川)制药有限公司 | A kind of preparation method of pediatric paracetamol granule |
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Address after: 465550 No. 666 General Road, Xinxian County, Henan Province Applicant after: Henan Lingrui Pharmaceutical Co., Ltd. Address before: 464000 No. 9 North Ring Road, Xinyang City, Henan Province Applicant before: Henan Lingrui Pharmaceutical Co., Ltd. |
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Application publication date: 20161109 |