CN101744852B - Preparation method of acanthopanax effervescent tablet and products thereof - Google Patents
Preparation method of acanthopanax effervescent tablet and products thereof Download PDFInfo
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- CN101744852B CN101744852B CN201010119840A CN201010119840A CN101744852B CN 101744852 B CN101744852 B CN 101744852B CN 201010119840 A CN201010119840 A CN 201010119840A CN 201010119840 A CN201010119840 A CN 201010119840A CN 101744852 B CN101744852 B CN 101744852B
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Abstract
The invention discloses a preparation method of acanthopanax effervescent tablet, which comprises the following steps of: (1) evenly mixing the acanthopanax extract with the lactose, drying and crashing to fine powder for later use; (2) wrapping the sodium bicarbonate with the polyethyleneglycol 4000 to obtain a mixed solution containing the inclusion; (3) spraying the mixed solution containing the inclusion in a rotation coating pan filled with the powder obtained in the step (1), screening and granulating to obtain the grains; and (4) screening the citric acid and the sodium cyclamate to obtain the grains, mixing with the grains prepared in the step (3) and the boletic acid powder and tabletting to prepare the finished product. In the preparation method, the sodium bicarbonate is wrapped by the polyethyleneglycol 4000 to avoid the direct contact of the sodium bicarbonate with the acid, thereby the stability of the preparation is enhanced, and the sticking problem when tabletting is solved. In addition, in the method of the invention, the lactose and the sodium cyclamate are utilized to replace the cane sugar for filling so that the moisture absorption is reduced. The preparation method has the advantages of simpleness, security, stability and high operability.
Description
Technical field
The present invention relates to a kind of method for preparing of effervescent tablet, relate in particular to a kind of method for preparing of acanthopanax effervescent tablet and, belong to the Radix Et Caulis Acanthopanacis Senticosi field of pharmaceutical preparations by the acanthopanax effervescent tablet product that this method prepares.
Background technology
Prove that through vast amount of clinical Radix Et Caulis Acanthopanacis Senticosi has the nervus centralis of adjusting, improves sleep quality, improves heart and brain blood circulation and endocrine regulation system, improves the effect of body immunity.Its widely medical value and health care be worth and determined its important clinical application value and economic worth, the Radix Et Caulis Acanthopanacis Senticosi preparation of therefore developing good effect, taking convenience, process stabilizing meets the industry development requirement.
Existing acanthopanax effervescent tablet (acanthopanax nutrient effervescence decoction piece) is directly to mix film-making through acid particles (Radix Et Caulis Acanthopanacis Senticosi extract, lactose, citric acid, glucose) and alkali grain (Radix Et Caulis Acanthopanacis Senticosi extract, lactose, glucose, sodium carbonate, sweeting agent) to form.Its main preparation technology is following:
(1) alkali grain: Radix Et Caulis Acanthopanacis Senticosi extract, lactose, glucose, sodium carbonate, sweeting agent take by weighing by formula ratio, and mixer mix homogeneously (20min) is with 70% ethanol system soft material.
(2) acid particles: Radix Et Caulis Acanthopanacis Senticosi extract, lactose, citric acid, glucose take by weighing by formula ratio, and mixer mix homogeneously (20min) adds 70% ethanol system soft material.
(3) above two soft materials are granulated respectively, dried granulate 3 hours for 75 ℃.
Two kinds of granule mixing 20min that (4) will put in order, tabletting promptly gets.
Alkalescence foaming thing sodium carbonate during the preparation major defect that carries out acanthopanax effervescent tablet according to this technology is to fill a prescription directly contacts with the acidic materials in the prescription, makes stability of formulation poor, and foaming effect is poor, easy sticking during tabletting.
Summary of the invention
Technical problem to be solved by this invention is the deficiency that overcomes prior art, provides that a kind of good effect, taking convenience, foaming effect are good, the method for preparing of the acanthopanax effervescent tablet of process stabilizing;
Technical problem to be solved by this invention realizes through following technical scheme:
A kind of method for preparing acanthopanax effervescent tablet, the constituent of this acanthopanax effervescent tablet comprises: Radix Et Caulis Acanthopanacis Senticosi extractum, lactose, citric acid, sodium bicarbonate, Macrogol 4000, fumaric acid and cyclamate; Its preparation method comprises:
(1) with Radix Et Caulis Acanthopanacis Senticosi extractum and lactose mix homogeneously, drying is ground into fine powder, and is subsequent use;
(2) adopt the microcapsule packaging method sodium bicarbonate to be wrapped up, obtain containing the mixed solution of inclusion enclave with Macrogol 4000, subsequent use;
(3) the biological mixed solution of inclusion enclave that contains with step (2) is sprayed in the rotation coating pan that fills step (1) gained fine powder through the mode of spraying, and sieves, and it is subsequent use that granulate gets granule;
(4) citric acid, cyclamate are sieved process granule with step (3) prepared granule and fumaric acid fine powder mixing, tabletting promptly gets.
Wherein, the packaging method described in the step (2) may further comprise the steps: Macrogol 4000 is used dissolve with ethanol, add sodium bicarbonate, obtain containing the inclusion enclave mixed solution after the dissolving;
Wherein, when tabletting, adopt the infrared lamp irradiation at the feeding port place, can control particulate preference temperature, increase particulate soft lubricant nature, not glutinous dashing when further guaranteeing tabletting.
Additive of tablet generally comprises diluent, binding agent, disintegrating agent and lubricant.Preparation of the present invention is an effervescent tablet, should select gas-producing disintegrant.The most frequently used gas-producing disintegrant is made up of sodium bicarbonate and citric acid or tartaric acid, meets the water generates carbon dioxide, makes the rapid disintegrate of tablet.Citric acid conveniently is easy to get, so selection sodium bicarbonate and citric acid are as the gas-producing disintegrant of these article.Diluent is commonly used has starch, Icing Sugar, lactose etc., and the starch poor compressibility is prone to produce loose sheet, should not select for use.Icing Sugar is prone to moisture absorption, influences effervescent effect, should not select for use.The lactose no hygroscopicity has good compressibility, and the tablet of processing is bright and clean attractive in appearance, does not influence the stripping of medicine, is good tablet diluent, so select the diluent of lactose as these article.Select for use fumaric acid, cyclamate respectively as correctives.
Because of ethanol volatile; In the preparation technology of acanthopanax effervescent tablet as the dissolution solvent of Macrogol 4000; And with the solution of Macrogol 4000, sodium bicarbonate co-formulated as binding agent; Its addition is hard and fast rule not, can dissolve fully with Macrogol 4000, and suitably be advisable as binder dosage.
The present invention finds through lot of test, and when the weight proportion of sodium bicarbonate and citric acid is 3: 2, the prepared effervescent tablet that obtains has the technique effect of optimum;
Preferred, the weight portion of each component is: 300 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 150 parts of lactose, 485 parts of citric acid, 730 parts of sodium bicarbonate, 65 parts of Macrogol 4000s, 100 parts of fumaric acid, 60 parts of cyclamates.
The spraying absorption dehydration method that has adopted the microencapsulation method for preparing to be adopted in the method for preparing of acanthopanax effervescent tablet of the present invention; Sodium bicarbonate is wrapped up through the microcapsule packaging method with Macrogol 4000; Avoid sodium bicarbonate and sour direct the contact; Increased stability of formulation, sticking when having solved tabletting simultaneously towards problem; In addition, the inventive method is filled with lactose and cyclamate and has been replaced sucrose, has reduced its hygroscopicity; Used fumaric acid not only can play the foaming agent effect but also can play the water-soluble lubricating effect.The method for preparing of acanthopanax effervescent tablet of the present invention is simple, safety, stable, workable.
The specific embodiment
Further describe the present invention below in conjunction with specific embodiment, advantage of the present invention and characteristics will be more clear along with description.But these embodiment only are exemplary, scope of the present invention are not constituted any restriction.It will be understood by those skilled in the art that and down can make amendment with form or replace without departing from the spirit and scope of the present invention, but these modifications and replacing all fall in protection scope of the present invention the details of technical scheme of the present invention.
Test Example 1 acanthopanax effervescent tablet adopts the test of Macrogol 4000 parcel effect expedition.
It is subsequent use to take by weighing each two parts of citric acid 450g, sodium bicarbonate 675g, sweetener 50g, fumaric acid 100g and Radix Et Caulis Acanthopanacis Senticosi extractum 300g and lactose 315g respectively; Taking polyethylene glycol 4000 90g are subsequent use in addition.
Technology 1: Polyethylene Glycol pack technology: Macrogol 4000 is used dissolve with ethanol, add sodium bicarbonate. stir, as binding agent Radix Et Caulis Acanthopanacis Senticosi extractum and lactose combination drying fine powder are granulated with this; In addition with granulations of sieving of citric acid, cyclamate, above granule and fumaric acid fine powder are suppressed jointly and are promptly got in flakes.
Technology 2: conventional preparation technology: with sodium bicarbonate, citric acid, cyclamate pulverize separately, cross 80 mesh sieves, by the effervescent tablet method for preparing operation that traditional acid, alkali are granulated respectively, compacting promptly gets in flakes.
The pH value of the effervescent tablet that integrated survey is processed by above two technologies, disintegration, hardness, stability, index such as sticking whether, result of the test is seen table 1.
Table 1 adopts Macrogol 4000 parcel effect expedition result of the test
Can be known by last watch test result: the effervescent tablet that adopts two kinds of technologies to process is little to the pH value influence; But to other technical specification; The effervescent tablet that adopts the Macrogol 4000 technique for packing to process all obviously is superior to the effervescent tablet that direct compression process makes, so the present invention selects for use the microcapsule packaging method promptly to carry out the acanthopanax effervescent tablet preparation with the method for Macrogol 4000 encapsulated sodium bicarbonate.
The best proportioning screening test of each component in Test Example 2 acanthopanax effervescent tablets
Different proportioning tests through main adjuvant come optimizing technology parameters with indexs such as surface color, disintegration, hardness, flowability, gas release, tastes.The supplementary material addition is seen table 2, and experimental result is seen table 3.
Table 2 is former, the test of adjuvant addition
Table 3 different proportion is former, ratio of adjuvant physical and chemical index table
Result of the test shows that the adjuvant addition does not influence the surface color of slice, thin piece, is any surface finish, and hardness is all moderate except that No. 1 adjuvant.The consumption of adjuvant gas-producing disintegrant directly influences the disintegration and the gas release of slice, thin piece; Except that 1, No. 2 adjuvant; All the other adjuvant additions all cause the slice, thin piece disintegrate to be transfinited; Integrated survey, the best proportioning of each component was during finally definite No. 2 prescriptions were promptly square: 300 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 150 parts of lactose, 485 parts of citric acid, 730 parts of sodium bicarbonate, 65 parts of Macrogol 4000s, 100 parts of fumaric acid, 60 parts of cyclamates.
Embodiment 1
Take by weighing Radix Et Caulis Acanthopanacis Senticosi extractum 300g, lactose 150g, citric acid 485g, sodium bicarbonate 730g, Macrogol 4000 65g, fumaric acid 100g, cyclamate 60g respectively;
With Radix Et Caulis Acanthopanacis Senticosi extractum and lactose mix homogeneously, drying is ground into fine powder, and is subsequent use according to Test Example 1 described technology; Measure alcoholic solution 500ml Macrogol 4000 is dissolved, sodium bicarbonate is added in the polyglycol solution, it is wrapped up; Obtain containing the mixed solution of inclusion enclave; It in sparging the rotation coating pan that fills Radix Et Caulis Acanthopanacis Senticosi extractum and lactose mixing fine powders, is sieved, and it is subsequent use that granulate gets granule; In addition citric acid, cyclamate are sieved and process granule, suppress 1000 (1.8g/ sheets), promptly get with above-mentioned granule and fumaric acid fine powder mixing.Prepared granule each item test rating is all up to specification, and accelerated test is investigated 3 months, and each index does not have significant change.
Embodiment 2
Take by weighing Radix Et Caulis Acanthopanacis Senticosi extractum 300g, lactose 175g, citric acid 370g, sodium bicarbonate 555g, Macrogol 4000 60g, fumaric acid 80g, cyclamate 50g respectively;
With Radix Et Caulis Acanthopanacis Senticosi extractum and lactose mix homogeneously, drying is ground into fine powder, and is subsequent use according to Test Example 1 said technology; Measure alcoholic solution 400ml Macrogol 4000 is dissolved, sodium bicarbonate is added in the polyglycol solution, it is wrapped up; Obtain containing the mixed solution of inclusion enclave; It in sparging the rotation coating pan that fills Radix Et Caulis Acanthopanacis Senticosi extractum and lactose mixing fine powders, is sieved, and it is subsequent use that granulate gets granule; In addition citric acid, cyclamate are sieved and process granule, suppress 1000 (1.5g/ sheets), promptly get with above-mentioned granule and fumaric acid fine powder mixing.Prepared granule each item test rating is all up to specification, and accelerated test is investigated 3 months, and each index does not have significant change.
Claims (2)
1. the method for preparing of an acanthopanax effervescent tablet, this acanthopanax effervescent tablet is processed by following raw material: 60 parts of 300 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 150 parts of lactose, 485 parts of citric acid, 730 parts of sodium bicarbonate, 65 parts of Macrogol 4000s, 100 parts of fumaric acid fine powders and cyclamates; Its preparation method comprises:
(1) with Radix Et Caulis Acanthopanacis Senticosi extractum and lactose mix homogeneously, drying is ground into fine powder, and is subsequent use;
(2) adopt the microcapsule packaging method sodium bicarbonate to be wrapped up with Macrogol 4000; Obtain containing the mixed solution of inclusion enclave; Subsequent use; Described packaging method may further comprise the steps: Macrogol 4000 is used dissolve with ethanol, add sodium bicarbonate, with obtaining containing the inclusion enclave mixed solution after the sodium bicarbonate dissolving;
(3) mixed solution that contains inclusion enclave with step (2) is sprayed in the rotation coating pan that fills step (1) gained fine powder through the mode of spraying, and sieves, and it is subsequent use that granulate gets granule;
(4) citric acid, cyclamate are sieved process granule with step (3) prepared granule and fumaric acid fine powder mixing, tabletting, during tabletting, the feeding port place adopts the infrared lamp irradiation, promptly gets.
2. the acanthopanax effervescent tablet that obtains by the said method for preparing of claim 1.
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| CN201010119840A CN101744852B (en) | 2010-02-24 | 2010-02-24 | Preparation method of acanthopanax effervescent tablet and products thereof |
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| CN201010119840A CN101744852B (en) | 2010-02-24 | 2010-02-24 | Preparation method of acanthopanax effervescent tablet and products thereof |
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102396763A (en) * | 2010-09-08 | 2012-04-04 | 廖思淳 | Foaming ingot structure containing acanthopanax extract and its preparation method |
| CN104473900A (en) * | 2014-11-19 | 2015-04-01 | 峨眉山通惠制药有限公司 | Fudosteine preparation and preparation method thereof |
| CN105767836A (en) * | 2014-12-22 | 2016-07-20 | 重庆雪瑞盛泉农业开发有限公司 | Herba dendrobii effervescent drink tablet and preparation method thereof |
| CN104738450B (en) * | 2015-03-09 | 2017-12-01 | 沈阳农业大学 | The method that effervescent tablet is prepared with Panax sessiliflorus fruit powder |
| CN105412027B (en) * | 2015-11-13 | 2018-10-26 | 青岛市海慈医疗集团 | A kind of preparation method of Dronedarone hydrochloride tablet |
| CN106578824A (en) * | 2016-11-25 | 2017-04-26 | 成都大学 | Lucid ganoderma effervescent tablets and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101455346A (en) * | 2007-11-16 | 2009-06-17 | 刘洪生 | Acanthopanax nutrient effervescence tablet and manufacture method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101455346A (en) * | 2007-11-16 | 2009-06-17 | 刘洪生 | Acanthopanax nutrient effervescence tablet and manufacture method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 温文清，陈斌.中药泡腾片的工艺研究.《中成药》.1992,(第5期),第6页. * |
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Granted publication date: 20121024 Termination date: 20140224 |