CN109044961A - A kind of compound antifebrile suppository for children and preparation method thereof - Google Patents

A kind of compound antifebrile suppository for children and preparation method thereof Download PDF

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CN109044961A
CN109044961A CN201811143928.XA CN201811143928A CN109044961A CN 109044961 A CN109044961 A CN 109044961A CN 201811143928 A CN201811143928 A CN 201811143928A CN 109044961 A CN109044961 A CN 109044961A
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preparation
compound
suppository
powder
children
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宋九红
许焰辉
雷迅
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JIANGXI JIUHUA PHARMACEUTICAL CO Ltd
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JIANGXI JIUHUA PHARMACEUTICAL CO Ltd
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    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/02Suppositories; Bougies; Bases therefor; Ovules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, 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
    • AHUMAN NECESSITIES
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    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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Abstract

The invention discloses a kind of compound antifebrile suppository for children and preparation method thereof, a kind of superfine communication technique and grinding technique are united and applied in the preparation method of compound antifebrile suppository for children by the present invention, compound antifebrile suppository for children raw material can sufficiently be crushed, and it is fully ground compound antifebrile suppository for children bolt liquid uniformly, it solves the problems, such as body layering in suppository forming process, have bubble empty among body, to improve the quality of compound antifebrile suppository for children.Preparation process of the present invention is convenient and practical, and easily controllable product quality.

Description

A kind of compound antifebrile suppository for children and preparation method thereof
Technical field
The invention belongs to pharmaceutical fields, and in particular to a kind of compound antifebrile suppository for children and preparation method thereof.
Background technique
Compound antifebrile suppository for children is that mixing is added by calculus bovis factitius, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder, three taste medicine of paracetamol The torpedo suppository that a weight is 1.0g is made in fatty glyceride (38 type).Administration mode is rectally.With antipyretic town Bitterly, the effect of liyan jiedu, eliminating the phlegm is calmed the frightened.For treating fever in children, palpitation with fear is uneasy, abscess of throat and lung heat many coughs of phlegm.
Existing compound antifebrile suppository for children preparation method: calculus bovis factitius, rhizoma et Radix Baphicacanthis Cusiae dried cream powder, three taste of paracetamol point Polyoxyethylene sorbitan monoleate and and ethyl hydroxy benzoate is added dropwise in 50 DEG C or so of semi-synthetic fatty glyceride in secondary a small amount of addition heat preservation Ethanol solution, it is stirring while adding, continue stirring 30 minutes after adding, pour into mold, be made 20000, demoulded after cooling, Packaging to get.
After testing verifying repeatedly, it has been found that existing method is mainly using the mode of heating fusing, mixing It is processed, there is a problem of body layering in suppository forming process, has bubble cavity among body, severely impact drug Quality and safety.
Chinese patent (application number: CN201410386715.5) discloses a kind of compound antifebrile suppository for children, each kilogram The compound antifebrile suppository for children includes calculus bovis factitius 5g, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 50g, paracetamol 150g, 7g polysorbate The 80 and ethyl alcohol 10g containing 0.105g ethyl hydroxy benzoate, surplus are semi-synthetic fatty glyceride.It is multiple that the invention also discloses this The preparation method of square antifebrile suppository for children.Compound antifebrile suppository for children of the invention with calculus bovis factitius, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder, to acetyl Amino phenols is compound, is equipped with special auxiliary material and is made, and has the advantages that absorb fast, good effect, brings down a fever fast, to fever in children, above exhales Road infection is inhaled, bronchitis, palpitation with fear is uneasy, and children's symptom such as abscess of throat and lung heat, abundant expectoration, cough has good curative effect.Its It is disadvantageous in that and is mainly processed using heating fusing, the mode mixed, there are bodies in suppository forming process point There is the problem in bubble cavity among layer, body, severely impacts the quality and safety of drug.
Summary of the invention
In view of the deficienciess of the prior art, superfine communication technique joint grinding technique is applied to the system of suppository by the present invention During standby, the above problem has been well solved.
In order to solve the above technical problems, the technical solution used in the present invention is:
A kind of compound antifebrile suppository for children and preparation method thereof, the compound antifebrile suppository for children is made of following Raw material processing: Calculus bovis factitius 100g, paracetamol 3kg, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 1kg, polyoxyethylene sorbitan monoleate 140g, ethyl hydroxy benzoate 2.1g, 38 type mixed fatty glycerides 15.67kg, 95% ethyl alcohol 197.93g.
A kind of compound antifebrile suppository for children and preparation method thereof, comprising the following steps:
(1) preparation of Rhizoma Et Radix Baphicacanthis Cusiae extractum powder powder:
The purified water that weight is 1 times of crude drug amount is added in rhizoma et Radix Baphicacanthis Cusiae medicine materical crude slice, impregnates 30 minutes, decocts twice;It mentions every time During taking, 2 forced circulations are carried out, each forced circulation time is 15 minutes, and combined extract filters, and concentration is let cool; It is transferred in Alcohol-settling tank, ethyl alcohol is added under stirring, make alcohol content 60%, static 24 is small after continuing stirring 30 minutes When;Supernatant is taken, filters, takes filtrate, ethyl alcohol is recovered under reduced pressure to no alcohol taste, is concentrated, vacuum drying obtains rhizoma et Radix Baphicacanthis Cusiae dry cream.It will Rhizoma et Radix Baphicacanthis Cusiae dry cream through micronizer be ground into impalpable powder to get.
(2) preparation of paracetamol impalpable powder:
Paracetamol is ground into impalpable powder with superfine communication technique, it is spare.
(3) preparation of calculus bovis factitius fine powder:
Calculus bovis factitius is ground into fine powder, it is spare.
(4) polysorbate, ethyl hydroxy benzoate ethanol preparation:
140g polyoxyethylene sorbitan monoleate is taken, 2.1g ethyl hydroxy benzoate is spare after being completely dissolved with 197.93g95% ethyl alcohol.
(5) preparation of bolt liquid:
Suppository material-compound tank heater switch is opened, set temperature delays 38 type mixed fatty glycerides at 65 DEG C~70 DEG C In slow investment material-compound tank;After matrix melting, agitating paddle is opened, setting frequency is 28 ± 5Hz, and stirring after forty minutes, sets base Matter liquid temperature is 45 DEG C~50 DEG C, and constant temperature is simultaneously kept stirring spare;The stirring frequency of material-compound tank is adjusted to 25 ± 5Hz, by finger Odd number amount is enabled to be slowly added to calculus bovis factitius fine powder, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder powder, paracetamol impalpable powder by several times, while at a slow speed Polyoxyethylene sorbitan monoleate and ethyl hydroxy benzoate ethanol solution is added dropwise, it is 45 ± 5Hz that frequency is arranged after adding, and keeping temperature is 50 DEG C or so, Persistently stir 60 minutes.
(6) bolt liquid crosses colloid mill and bolt processed:
Colloid mill is modulated into most fineness, material obtained in step (5) is ground with colloid mill, temperature is kept after grinding Degree 50 DEG C or so, persistently stir 4 hours it is spare to being uniformly mixed, agitating paddle continues stirring until bolt process processed and takes medical fluid, passes through Suppository shaping mechanism at torpedo bolt, packaging to get.
Further, it is decocted for the first time in the step (1) and the drinking water that weight is 5 times of crude drug amount is added, decocted 2 liang small When;The drinking water that weight is 4 times of crude drug amount is added in second of decoction, decocts 1.5 hours.
Further, the clear cream that relative density is 1.15-1.25 is concentrated into the step (1), thickening temperature is 60 DEG C.
Further, the grinding rate of colloid mill described in the step (6) is 2890r/min.
Further, the milling time of colloid mill is 30 minutes in the step (6).
Compared with prior art, the present invention have it is following the utility model has the advantages that
Method of the invention can sufficiently crush compound antifebrile suppository for children raw material, and fill compound antifebrile suppository for children bolt liquid Divide grinding uniformly, can solve body layering in suppository forming process, has the problem in bubble cavity among body, to improve compound The quality of antifebrile suppository for children.
Specific embodiment
Form by the following examples is described in further detail above content of the invention again, but should not be by this The range for being interpreted as the above-mentioned theme of the present invention is only limitted to following embodiment, all technologies based on realization belonging to above content of the present invention It all belongs to the scope of the present invention.
Embodiment 1
Prescription:
Calculus bovis factitius 100g paracetamol 3kg Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 1kg polyoxyethylene sorbitan monoleate 140g
95% ethyl alcohol 197.93g of ethyl hydroxy benzoate 2.1g mixed fatty glycerides (38 type) 15.67kg
Preparation method:
(1) preparation of Rhizoma Et Radix Baphicacanthis Cusiae extractum powder powder:
Rhizoma et Radix Baphicacanthis Cusiae medicine materical crude slice adds 1 times of crude drug amount of drinking water, impregnates 30 minutes.It decocts twice.It decocts for the first time and life is added The drinking water that 5 times of dose decocts 2 two hours.4 times of crude drug amount of drinking water is added in second of decoction, decocts 1.5 hours.Every time In extraction process, 2 forced circulations are carried out, each forced circulation time is 15 minutes.Combined extract, filtration.It is concentrated into phase It is the clear cream of 1.15-1.25 (60 DEG C) to density, lets cool.It is transferred in Alcohol-settling tank and ethyl alcohol is added under stirring, make alcohol-containing Amount is 60%.Static 24 hours after continuing stirring 30 minutes.Supernatant is taken, is filtered, is taken filtrate, ethyl alcohol is recovered under reduced pressure to no alcohol Taste.Concentration, vacuum drying, obtains rhizoma et Radix Baphicacanthis Cusiae dry cream.By rhizoma et Radix Baphicacanthis Cusiae dry cream through micronizer be ground into impalpable powder to get.
(2) preparation of paracetamol impalpable powder:
Paracetamol is ground into impalpable powder with superfine communication technique, it is spare.
(3) preparation of calculus bovis factitius fine powder:
Calculus bovis factitius is ground into fine powder, it is spare.
(4) polysorbate, ethyl hydroxy benzoate ethanol preparation:
After taking 140g polyoxyethylene sorbitan monoleate and 2.1g ethyl hydroxy benzoate to be completely dissolved with 197.93g95% ethyl alcohol, deposited between weighing It puts spare.
(5) preparation of bolt liquid:
Suppository material-compound tank heater switch is opened, set temperature is at 65 DEG C~70 DEG C, by mixed fatty glycerides (38 type) Slowly put into material-compound tank.After matrix melting, agitating paddle is opened, setting frequency is 28 ± 5Hz, and stirring after forty minutes, is set Matrix liquid temperature is 45 DEG C~50 DEG C, and constant temperature is simultaneously kept stirring spare.The stirring frequency of material-compound tank is adjusted to 25 ± 5Hz, is pressed Instruction sheet quantity is slowly added into calculus bovis factitius fine powder, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder powder, paracetamol impalpable powder by several times, while slow Polyoxyethylene sorbitan monoleate and ethyl hydroxy benzoate ethanol solution is added dropwise in speed, and it is 45 ± 5Hz that frequency is arranged after adding, and holding temperature is 50 DEG C of left sides The right side is persistently stirred 60 minutes.
(6) bolt liquid crosses colloid mill and bolt processed:
Colloid mill is modulated into most fineness, material obtained in step (5) is ground with colloid mill, milling time 30 is divided Clock keeps temperature 50 C or so after grinding, persistently stir 4 hours it is spare to being uniformly mixed, agitating paddle continues stirring until bolt work processed Sequence takes medical fluid.By suppository shaping mechanism at 20000 (every weight 1.0g) torpedo bolts, packaging to get.
Embodiment 2
Prescription:
Calculus bovis factitius 100g paracetamol 3kg Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 1kg polyoxyethylene sorbitan monoleate 140g
95% ethyl alcohol 197.93g of ethyl hydroxy benzoate 2.1g mixed fatty glycerides (38 type) 15.67kg
Preparation method:
(1) preparation of Rhizoma Et Radix Baphicacanthis Cusiae extractum powder powder:
Rhizoma et Radix Baphicacanthis Cusiae medicine materical crude slice adds 1 times of crude drug amount of drinking water, impregnates 30 minutes.It decocts twice.It decocts for the first time and life is added The drinking water that 5 times of dose decocts 2 two hours.4 times of crude drug amount of drinking water is added in second of decoction, decocts 1.5 hours.Every time In extraction process, 2 forced circulations are carried out, each forced circulation time is 15 minutes.Combined extract, filtration.It is concentrated into phase It is the clear cream of 1.15-1.25 (60 DEG C) to density, lets cool.It is transferred in Alcohol-settling tank and ethyl alcohol is added under stirring, make alcohol-containing Amount is 60%.Static 24 hours after continuing stirring 30 minutes.Supernatant is taken, is filtered, is taken filtrate, ethyl alcohol is recovered under reduced pressure to no alcohol Taste.Concentration, vacuum drying, obtains rhizoma et Radix Baphicacanthis Cusiae dry cream.By rhizoma et Radix Baphicacanthis Cusiae dry cream through micronizer be ground into impalpable powder to get.
(2) preparation of paracetamol impalpable powder:
Paracetamol is ground into impalpable powder with superfine communication technique, it is spare.
(3) preparation of calculus bovis factitius fine powder:
Calculus bovis factitius is ground into fine powder, it is spare.
(4) polysorbate, ethyl hydroxy benzoate ethanol preparation:
After taking 140g polyoxyethylene sorbitan monoleate and 2.1g ethyl hydroxy benzoate to be completely dissolved with 197.93g95% ethyl alcohol, deposited between weighing It puts spare.
(5) preparation of bolt liquid and bolt processed:
Suppository material-compound tank heater switch is opened, set temperature is at 65 DEG C~70 DEG C, by mixed fatty glycerides (38 type) Slowly put into material-compound tank.After matrix melting, agitating paddle is opened, setting frequency is 28 ± 5Hz, and stirring after forty minutes, is set Matrix liquid temperature is 45 DEG C~50 DEG C, and constant temperature is simultaneously kept stirring spare.The stirring frequency of material-compound tank is adjusted to 25 ± 5Hz, is pressed Instruction sheet quantity is slowly added into calculus bovis factitius fine powder, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder powder, paracetamol impalpable powder by several times, while slow Polyoxyethylene sorbitan monoleate and ethyl hydroxy benzoate ethanol solution is added dropwise in speed, and it is 45 ± 5Hz that frequency is arranged after adding, and holding temperature is 50 DEG C of left sides The right side is persistently stirred 60 minutes.By suppository shaping mechanism at 20000 (every weight 1.0g) torpedo bolts, packaging to get.
Embodiment 3
Prescription:
Calculus bovis factitius 100g paracetamol 3kg Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 1kg polyoxyethylene sorbitan monoleate 140g
95% ethyl alcohol 197.93g of ethyl hydroxy benzoate 2.1g mixed fatty glycerides (38 type) 15.67kg
Preparation method:
(1) preparation of rhizoma et Radix Baphicacanthis Cusiae dried cream powder:
Rhizoma et Radix Baphicacanthis Cusiae medicine materical crude slice adds 1 times of crude drug amount of drinking water, impregnates 30 minutes.It decocts twice.It decocts for the first time and life is added The drinking water that 5 times of dose decocts 2 two hours.4 times of crude drug amount of drinking water is added in second of decoction, decocts 1.5 hours.Every time In extraction process, 2 forced circulations are carried out, each forced circulation time is 15 minutes.Combined extract, filtration.It is concentrated into phase It is the clear cream of 1.15-1.25 (60 DEG C) to density, lets cool.It is transferred in Alcohol-settling tank and ethyl alcohol is added under stirring, make alcohol-containing Amount is 60%.Static 24 hours after continuing stirring 30 minutes.Supernatant is taken, is filtered, is taken filtrate, ethyl alcohol is recovered under reduced pressure to no alcohol Taste.Concentration, vacuum drying, obtains rhizoma et Radix Baphicacanthis Cusiae dry cream.Fine powder, which is broken to complete 95%, can pass through 120 meshes and can all pass through 100 mesh The fine powder of sieve to get.
(2) preparation of paracetamol fine powder:
Paracetamol is ground into 95% can be spare by that 120 meshes and all can lead to the fine powder sieved with 100 mesh sieve.
(3) preparation of calculus bovis factitius fine powder:
Calculus bovis factitius is ground into fine powder, it is spare.
(4) polysorbate, ethyl hydroxy benzoate ethanol preparation:
After taking 140g polyoxyethylene sorbitan monoleate and 2.1g ethyl hydroxy benzoate to be completely dissolved with 197.93g95% ethyl alcohol, deposited between weighing It puts spare.
(5) preparation of bolt liquid:
Suppository material-compound tank heater switch is opened, set temperature is at 65 DEG C~70 DEG C, by mixed fatty glycerides (38 type) Slowly put into material-compound tank.After matrix melting, agitating paddle is opened, setting frequency is 28 ± 5Hz, and stirring after forty minutes, is set Matrix liquid temperature is 45 DEG C~50 DEG C, and constant temperature is simultaneously kept stirring spare.The stirring frequency of material-compound tank is adjusted to 25 ± 5Hz, is pressed Instruction sheet quantity is slowly added into calculus bovis factitius fine powder, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder powder, paracetamol impalpable powder by several times, while slow Polyoxyethylene sorbitan monoleate and ethyl hydroxy benzoate ethanol solution is added dropwise in speed, and it is 45 ± 5Hz that frequency is arranged after adding, and holding temperature is 50 DEG C of left sides The right side is persistently stirred 60 minutes.
(6) bolt liquid crosses colloid mill and bolt processed:
Colloid mill is modulated into most fineness, material obtained in step (5) is ground with colloid mill, milling time 30 is divided Clock keeps temperature 50 C or so after grinding, persistently stir 4 hours it is spare to being uniformly mixed, agitating paddle continues stirring until bolt work processed Sequence takes medical fluid.By suppository shaping mechanism at 20000 (every weight 1.0g) torpedo bolts, packaging to get.
Comparative example 1
Prescription:
Calculus bovis factitius 100g paracetamol 3kg Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 1kg polyoxyethylene sorbitan monoleate 140g
95% ethyl alcohol 197.93g of ethyl hydroxy benzoate 2.1g mixed fatty glycerides (38 type) 15.67kg
Preparation method:
(1) preparation of rhizoma et Radix Baphicacanthis Cusiae dried cream powder:
Rhizoma et Radix Baphicacanthis Cusiae medicine materical crude slice adds 1 times of crude drug amount of drinking water, impregnates 30 minutes.It decocts twice.It decocts for the first time and life is added The drinking water that 5 times of dose decocts 2 two hours.4 times of crude drug amount of drinking water is added in second of decoction, decocts 1.5 hours.Every time In extraction process, 2 forced circulations are carried out, each forced circulation time is 15 minutes.Combined extract, filtration.It is concentrated into phase It is the clear cream of 1.15-1.25 (60 DEG C) to density, lets cool.It is transferred in Alcohol-settling tank and ethyl alcohol is added under stirring, make alcohol-containing Amount is 60%.Static 24 hours after continuing stirring 30 minutes.Supernatant is taken, is filtered, is taken filtrate, ethyl alcohol is recovered under reduced pressure to no alcohol Taste.Concentration, vacuum drying, obtains rhizoma et Radix Baphicacanthis Cusiae dry cream.Fine powder, which is broken to complete 95%, can pass through 120 meshes and can all pass through 100 mesh The fine powder of sieve to get.
(2) preparation of paracetamol fine powder:
Paracetamol is ground into 95% can be spare by that 120 meshes and all can lead to the fine powder sieved with 100 mesh sieve.
(3) preparation of calculus bovis factitius fine powder:
Calculus bovis factitius is ground into fine powder, it is spare.
(4) polysorbate, ethyl hydroxy benzoate ethanol preparation:
After taking 140g polyoxyethylene sorbitan monoleate and 2.1g ethyl hydroxy benzoate to be completely dissolved with 197.93g95% ethyl alcohol, deposited between weighing It puts spare.
(5) preparation of bolt liquid and bolt processed:
Suppository material-compound tank heater switch is opened, set temperature is at 65 DEG C~70 DEG C, by mixed fatty glycerides (38 type) Slowly put into material-compound tank.After matrix melting, agitating paddle is opened, setting frequency is 28 ± 5Hz, and stirring after forty minutes, is set Matrix liquid temperature is 45 DEG C~50 DEG C, and constant temperature is simultaneously kept stirring spare.The stirring frequency of material-compound tank is adjusted to 25 ± 5Hz, is pressed Instruction sheet quantity is slowly added into calculus bovis factitius fine powder, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder powder, paracetamol impalpable powder by several times, while slow Polyoxyethylene sorbitan monoleate and ethyl hydroxy benzoate ethanol solution is added dropwise in speed, and it is 45 ± 5Hz that frequency is arranged after adding, and holding temperature is 50 DEG C of left sides The right side is persistently stirred 60 minutes.By suppository shaping mechanism at 20000 (every weight 1.0g) torpedo bolts, packaging to get.
Experimental example 1
Table 1: compound antifebrile suppository for children accelerates speed with original process comparison using superfine communication technique joint grinding technique preparation Stability test result:
It can be concluded that, answered from 1 accelerated stability test result of table using prepared by superfine communication technique joint grinding technique Square antifebrile suppository for children content of bilirubin and red Determination Paracetamol in Paracetamol are more more stable than original process.
Experimental example 2
Table 2: compound antifebrile suppository for children is using superfine communication technique joint grinding technique preparation and original process comparative test knot Fruit:
As can be drawn from Table 2, the compound antifebrile suppository for children quality using superfine communication technique joint grinding technique preparation is bright It is aobvious to be better than original process.
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, although referring to aforementioned reality Applying example, invention is explained in detail, for those skilled in the art, still can be to aforementioned each implementation Technical solution documented by example is modified or equivalent replacement of some of the technical features.It is all in essence of the invention Within mind and principle, any modification, equivalent replacement, improvement and so on be should all be included in the protection scope of the present invention.

Claims (6)

1. a kind of compound antifebrile suppository for children and preparation method thereof, which is characterized in that the compound antifebrile suppository for children is by following raw material It is processed into: calculus bovis factitius 100g, paracetamol 3kg, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder 1kg, polyoxyethylene sorbitan monoleate 140g, oxybenzene Ethyl ester 2.1g, 38 type mixed fatty glycerides 15.67kg, 95% ethyl alcohol 197.93g.
2. a kind of compound antifebrile suppository for children according to claim 1 and preparation method thereof, which is characterized in that including following step It is rapid:
(1) preparation of Rhizoma Et Radix Baphicacanthis Cusiae extractum powder powder:
The purified water that weight is 1 times of crude drug amount is added in rhizoma et Radix Baphicacanthis Cusiae medicine materical crude slice, impregnates 30 minutes, decocts twice;It extracted every time Cheng Zhong carries out 2 forced circulations, and each forced circulation time is 15 minutes, and combined extract filters, and concentration is let cool;Transfer Into Alcohol-settling tank, ethyl alcohol is added under stirring, makes alcohol content 60%, continues after stirring 30 minutes static 24 hours;It takes Supernatant, filtering, takes filtrate, and ethyl alcohol is recovered under reduced pressure to no alcohol taste, is concentrated, vacuum drying obtains rhizoma et Radix Baphicacanthis Cusiae dry cream.By Baphicanthus cusia Root dry cream through micronizer be ground into impalpable powder to get.
(2) preparation of paracetamol impalpable powder:
Paracetamol is ground into impalpable powder with superfine communication technique, it is spare.
(3) preparation of calculus bovis factitius fine powder:
Calculus bovis factitius is ground into fine powder, it is spare.
(4) polysorbate, ethyl hydroxy benzoate ethanol preparation:
140g polyoxyethylene sorbitan monoleate is taken, 2.1g ethyl hydroxy benzoate is spare after being completely dissolved with 197.93g95% ethyl alcohol.
(5) preparation of bolt liquid:
Suppository material-compound tank heater switch is opened, set temperature slowly throws 38 type mixed fatty glycerides at 65 DEG C~70 DEG C Enter in material-compound tank;After matrix melting, agitating paddle is opened, setting frequency is 28 ± 5Hz, and stirring after forty minutes, sets matrix liquid Temperature is 45 DEG C~50 DEG C, and constant temperature is simultaneously kept stirring spare;The stirring frequency of material-compound tank is adjusted to 25 ± 5Hz, by instruction sheet Quantity is slowly added to calculus bovis factitius fine powder, Rhizoma Et Radix Baphicacanthis Cusiae extractum powder powder, paracetamol impalpable powder by several times, while being added dropwise at a slow speed Polyoxyethylene sorbitan monoleate and ethyl hydroxy benzoate ethanol solution, it is 45 ± 5Hz that frequency is arranged after adding, and keeping temperature is 50 DEG C or so, is continued Stirring 60 minutes.
(6) bolt liquid crosses colloid mill and bolt processed:
Colloid mill is modulated into most fineness, material obtained in step (5) is ground with colloid mill, temperature 50 is kept after grinding DEG C or so, persistently stir 4 hours it is spare to being uniformly mixed, agitating paddle continues stirring until bolt process processed and takes medical fluid, passes through suppository Shaping mechanism at torpedo bolt, packaging to get.
3. a kind of compound antifebrile suppository for children according to claim 2 and preparation method thereof, which is characterized in that the step (1) it is decocted for the first time in and the drinking water that weight is 5 times of crude drug amount is added, decocted 2 two hours;Second of decoction is added weight and makes a living The drinking water that 4 times of dose decocts 1.5 hours.
4. a kind of compound antifebrile suppository for children according to claim 2 and preparation method thereof, which is characterized in that the step (1) clear cream that relative density is 1.15-1.25 is concentrated into, thickening temperature is 60 DEG C.
5. a kind of compound antifebrile suppository for children according to claim 2 and preparation method thereof, which is characterized in that the step (6) grinding rate of colloid mill described in is 2890r/min.
6. a kind of compound antifebrile suppository for children according to claim 2 and preparation method thereof, which is characterized in that the step (6) milling time of colloid mill is 30 minutes in.
CN201811143928.XA 2018-09-29 2018-09-29 A kind of compound antifebrile suppository for children and preparation method thereof Pending CN109044961A (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1679755A (en) * 2005-02-02 2005-10-12 广西康华药业有限责任公司 Preparation of Chinese medicinal suppository for treating female chronic cervicitis
CN101518562A (en) * 2008-02-27 2009-09-02 北京凯瑞创新医药科技有限公司 Non-oral preparation of kudzuvine root total aglycon, preparation method and application thereof
CN104147063A (en) * 2014-08-07 2014-11-19 江西九华药业有限公司 Compound pediatric antipyretic suppository and preparation method thereof
CN108553554A (en) * 2018-06-12 2018-09-21 江西九华药业有限公司 A kind of suppository and preparation method thereof for treating fever in children, palpitation with fear uneasiness, lung heat many coughs of phlegm

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1679755A (en) * 2005-02-02 2005-10-12 广西康华药业有限责任公司 Preparation of Chinese medicinal suppository for treating female chronic cervicitis
CN101518562A (en) * 2008-02-27 2009-09-02 北京凯瑞创新医药科技有限公司 Non-oral preparation of kudzuvine root total aglycon, preparation method and application thereof
CN104147063A (en) * 2014-08-07 2014-11-19 江西九华药业有限公司 Compound pediatric antipyretic suppository and preparation method thereof
CN108553554A (en) * 2018-06-12 2018-09-21 江西九华药业有限公司 A kind of suppository and preparation method thereof for treating fever in children, palpitation with fear uneasiness, lung heat many coughs of phlegm

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