CN104013841A - Preparation method of vitamin C fructus forsythiae capsule - Google Patents
Preparation method of vitamin C fructus forsythiae capsule Download PDFInfo
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- CN104013841A CN104013841A CN201410234396.6A CN201410234396A CN104013841A CN 104013841 A CN104013841 A CN 104013841A CN 201410234396 A CN201410234396 A CN 201410234396A CN 104013841 A CN104013841 A CN 104013841A
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Abstract
The invention discloses a preparation method of a vitamin C fructus forsythiae capsule, and the main feature is as follows: polyacrylic acid resin is used for coating vitamin C, betadex is used for coating volatile oil and peppermint oil in the prescription, volatile oil and peppermint oil loss in the production and placing process can be reduced by the method, the curative effect is guaranteed, the production process is reduced. The product produced by the method is good in stability and low in production cost.
Description
Technical field
The present invention relates to a kind of preparation method of pharmaceutical preparation, belong to the technical field of medicine.
Background technology
Vitaminc lonicera and forsythia capsule prescription derives from the WEI C YINQIAO PIAN of the 20 324 pages of national drug standards Traditional Chinese medicine historical preparations, for Chinese medicine and western medicine compound preparation, be mainly used in fever and headache, cough, xerostomia that influenza causes, have sore throat, its clinical practice determined curative effect, is welcome by patient deeply.In its prescription, contain plurality of active ingredients, the compositions such as volatile oil wherein, vitamin C volatile or oxidation, cause product stability bad, in recent years the improved technique formulation method that had bibliographical information, but still there is the problems such as preparation stability is good not, production cost is high, be necessary to continue it to be optimized.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of preparation method of Vitaminc lonicera and forsythia capsule, thereby makes product stability better, and cost is lower.
For solving the problems of the technologies described above, the present invention is achieved by the following technical solutions:
Prescription: Flos Lonicerae 180g, Fructus Forsythiae 180g, Herba Schizonepetae 72g, Fructus Arctii 108g, Semen Sojae Preparatum 90g, Herba Lophatheri 72g, Rhizoma Phragmitis 108g, Radix Platycodonis 108g, Radix Glycyrrhizae 90g, Oleum menthae 1.08ml, acetaminophen 105g, vitamin C 49.5g, chlorphenamine maleate 1.05g, make 1000 altogether;
Method for making: above 13 tastes, Fructus Forsythiae, Herba Schizonepetae, Flos Lonicerae are extracted volatile oil, and medicinal residues and Herba Lophatheri, Semen Sojae Preparatum, Rhizoma Phragmitis, Radix Platycodonis, Radix Glycyrrhizae decoct with water secondary, and each 2 hours, filter, merging filtrate, obtains solution A; 60% alcohol reflux secondary for Fructus Arctii, each 4 hours, filter, merging filtrate, reclaims ethanol, adds paraffin to make to dissolve, and is cooled to paraffin and floats on liquid level, removes paraffin layer, obtains solution B; Merge solution A and B, be condensed into thick paste, be dried to dry cream, pulverize, obtain C; Get vitamin C, adopt polyacrylic resin to carry out peplos, obtain D; Get above-mentioned volatile oil and mix with Oleum menthae, use betacyclodextrin inclusion, obtain E; Get C, D, E, chlorphenamine maleate and acetaminophen, add appropriate amount of starch, mix, incapsulate, make 1000, obtain.
As the preparation method of above-mentioned Vitaminc lonicera and forsythia capsule, described polyacrylic resin comprises: polyacrylic resin Ⅳ, polyacrylic resin Ⅲ, polyacrylic resin Ⅱ etc., most preferably be polyacrylic resin Ⅳ.
As the preparation method of above-mentioned Vitaminc lonicera and forsythia capsule, ascorbic peplos operational approach is: get polyacrylic resin appropriate, add 95% ethanol 4000ml, soak, make to dissolve completely, obtain film coating liquid; Vitamin C is put in coating pan, be preheated to 40～50 ℃.Under the condition of continuous blowing hot-air, on the vitamin C of continuous rolling, with spray gun, spray into above-mentioned film coating liquid, after hydrojet, dry appropriate time, changing blows a cold wind over makes coated vitamin C cooling, takes the dish out of the pot, and puts in 35～45 ℃ of drying baker and is dried, and obtains.
As the preparation method of above-mentioned Vitaminc lonicera and forsythia capsule, more excellent ascorbic peplos operational approach is: get polyacrylic resin Ⅳ 100～300g, add 95% ethanol 4000ml, soak 24 hours, make to dissolve completely, obtain film coating liquid; Vitamin C is put in coating pan, be preheated to 45 ℃; Constantly blowing under the condition of 50 ℃ of hot blasts, on the vitamin C of continuous rolling, with spray gun, spray into above-mentioned film coating liquid, film coating liquid 2000ml for per kilogram vitamin C, after hydrojet, dry 15 minutes, changing blows a cold wind over made coated vitamin C be cooled to 30 ℃, takes the dish out of the pot, put in 40 ℃ of cold drying casees and be dried, obtain.
As the preparation method of above-mentioned Vitaminc lonicera and forsythia capsule, the preparation method of volatile oil and Oleum menthae mixing inclusion complex is: get 6～10 times of amount betacyclodextrins, add water heating for dissolving, make saturated solution, cool to inclusion temperature be 30～50 ℃, add volatile oil and Oleum menthae mixed solution, constant temperature stirs 1～2 hour, takes out, cooling, put refrigerator cold-storage 12 hours, take out, sucking filtration, inclusion complex is put 40 ℃ of drying under reduced pressure 4h, porphyrize, obtains Powdered volatile oil inclusion complex.
As the preparation method of above-mentioned Vitaminc lonicera and forsythia capsule, the preparation method of described volatile oil and Oleum menthae mixing inclusion complex, the amount optimum of inclusion volatile oil and betacyclodextrin that Oleum menthae is used is 8 times of amounts.
As the preparation method of above-mentioned Vitaminc lonicera and forsythia capsule, the preparation method of described volatile oil and Oleum menthae mixing inclusion complex, constant temperature mixing time optimum is 1 hour.
As the preparation method of above-mentioned Vitaminc lonicera and forsythia capsule, the preparation method of described volatile oil and Oleum menthae mixing inclusion complex, inclusion temperature optimum is 40 ℃.
The preparation method of Vitaminc lonicera and forsythia capsule of the present invention, its maximum advantage is:
1, adopt polyacrylic resin to carry out peplos to vitamin C, its peplos efficiency is high, and good with other supplementary material compatibilitys of prescription, finished product stability obviously extends.
2, adopt volatile oil and the Oleum menthae in betacyclodextrin while inclusion prescription, reduced the loss in production and put procedure, guaranteed curative effect; Reduce production process, saved production cost.
By reading description and appending claims below, can understand better these and other feature, aspect and advantage of the present invention.
The specific embodiment
Although this description by particularly pointing out and knowing that claimed claims of the present invention draw a conclusion, should be believed following explanation and will understand better the present invention.
The percentage ratio of ethanol as herein described is volume ratio.Except as otherwise noted, the equal actual content based on this composition of all percentage ratios, ratio and the content of related composition herein, and be not included in solvent, filler or other material that can combine with these compositions in commercially available prod.
As used herein, word " preferably " and variant refer to embodiment of the present invention that specific beneficial effect can be provided under specific environment.Yet other embodiment can be also preferred under identical or other environment.In addition, the detailed description of one or more preferred embodiments does not represent that other embodiment is useless, and is not intended to get rid of from category of the present invention other embodiment.
The ascorbic peplos research experiment of experimental example 1
Vitamin C is unstable, oxidizable under water, light and heat condition, affects product quality and curative effect.Especially more easily oxidation under water and heat condition, for improving its stability, can gelatin, betacyclodextrin etc. for vitamin C is material coated, so that with the moisture isolation in extractum, though stability is improved like this, but after placing a period of time, Vitamin C content still declines obviously, and this is poor relevant with coated vitamin C adjuvant used and the extractum compatibility, and the present invention adopts polyacrylic resin to solve well this problem.Experimental study is as follows:
Get polyacrylic resin Ⅳ 200g, add 95% ethanol 4000ml, soak 24 hours, make to dissolve completely, obtain film coating liquid.
Peplos operational approach: vitamin C is put in coating pan, be preheated to 45 ℃ of left and right.Constantly blowing under the condition of 50 ℃ of left and right hot blasts, on the vitamin C of continuous rolling, with spray gun, spray into above-mentioned film liquid, per kilogram vitamin C is approximately used film coating liquid 2000ml, after hydrojet, dry approximately 15 minutes, changing blows a cold wind over made coated vitamin C be cooled to 30 ℃ of left and right, takes the dish out of the pot, to 40 ℃ of cold drying casees, be dried, obtain.
Investigate the Vitaminc lonicera and forsythia capsule steadiness that different materials coated vitamin C is made, the results are shown in Table 1.
Table 1 different materials coated vitamin C is made product stability and is investigated result
Note: 2, the method for making of No. 3 products is the preparation method with reference to No. 1 product, difference is, in the operation of vitamin C peplos, has changed corresponding coated fertilizer.
The product stability that result shows to carry out vitamin C peplos with polyacrylic resin Ⅳ is obviously made the good stability of product than gelatin and betacyclodextrin coated vitamin C, other supplementary material compatibilitys in the present invention's adjuvant polyacrylic resin Ⅳ used and product are better.
The inclusion of experimental example 2 volatile oil and mint oil mixtures
Flos Lonicerae, Fructus Forsythiae, Herba Schizonepetae volatile oil composition and Oleum menthae are Vitaminc lonicera and forsythia capsule main active, for increasing its stability, reduce volatilization, the present invention adopts betacyclodextrin to carry out inclusion to it, makes volatile oil betacyclodextrin inclusion complex and guarantees its stability.The method that adopts volatile oil and Oleum menthae simultaneously to protect knot also makes product cost obviously reduce.
Adopt saturated water solution method inclusion volatile oil.The inclusion of take volatilization oil mass, as investigating index, adopts L
9(3
4) orthogonal table arrangement test, betacyclodextrin consumption, inclusion time, three factors of inclusion temperature to be investigated, factor level table, in Table 2, the results are shown in Table 3, and variance analysis is in Table 4.
Operational approach: get a certain amount of betacyclodextrin, add 6 times of amount distilled water heating for dissolving, make saturated solution, cool to required inclusion temperature, add 1ml volatile oil solution and mix (the first mix homogeneously of Flos Lonicerae, Fructus Forsythiae, Herba Schizonepetae volatile oil and Oleum menthae), constant temperature stirs after certain hour, take out, cooling, put refrigerator cold-storage 12 hours, take out, sucking filtration, inclusion complex is put drying under reduced pressure 4h at 40 ℃, and porphyrize obtains Powdered volatile oil inclusion complex.Volatile oil inclusion complex is put in round-bottomed flask, and adding distil water 200ml, connects volatile oil determination apparatus, and boiling 1 ~ 2h stops heating when oil mass no longer increases, and places 1 hour, and reading, calculates volatile oil yield.
Table 2 volatile oil inclusion factor level table
Table 3 volatile oil inclusion orthogonal test table
Table 4 volatile oil inclusion analysis of variance table
F
1-0.05 (2,2)=19.0 F
1-0.10 (2,2)=9.0 * * represent P<0.10
Experimental result shows, the factor that affects inclusion yield is followed successively by A > C > B, and best of breed is A
2b
1c
2, that is: betacyclodextrin and water ratio are 1:6(g:ml), volatilization oil mass: betacyclodextrin amount=1:8(ml:g), mixing time 1h, 40 ℃ of temperature.The results of analysis of variance shows, betacyclodextrin consumption has appreciable impact (P<0.10) to volatile oil inclusion amount, and inclusion time and inclusion temperature have certain influence trend.
By experimental result, can be seen, when betacyclodextrin consumption is increased to a certain degree (1:8), then increases consumption (1:10) yield and no longer improve, mixing time is also like this, the too high inclusion that is also unfavorable for volatile oil of temperature, this and temperature is high, mixing time is long, how relevant volatile oils loss is.
Embodiment
The following example has further described and has proved the embodiment in the scope of the invention.These embodiment are only illustrative, but not limit the scope of the invention, because its many modification are possible in the situation that not deviating from the spirit and scope of the invention.
embodiment 1
Prescription: Flos Lonicerae 180g, Fructus Forsythiae 180g, Herba Schizonepetae 72g, Fructus Arctii 108g, Semen Sojae Preparatum 90g, Herba Lophatheri 72g, Rhizoma Phragmitis 108g, Radix Platycodonis 108g, Radix Glycyrrhizae 90g, Oleum menthae 1.08ml, acetaminophen 105g, vitamin C 49.5g, chlorphenamine maleate 1.05g, make 1000 altogether;
Method for making: above 13 tastes, Fructus Forsythiae, Herba Schizonepetae, Flos Lonicerae are extracted volatile oil, and medicinal residues and Herba Lophatheri, Semen Sojae Preparatum, Rhizoma Phragmitis, Radix Platycodonis, Radix Glycyrrhizae decoct with water secondary, and each 2 hours, filter, merging filtrate, obtains solution A; 60% alcohol reflux secondary for Fructus Arctii, each 4 hours, filter, merging filtrate, reclaims ethanol, adds paraffin to make to dissolve, and is cooled to paraffin and floats on liquid level, removes paraffin layer, obtains solution B; Merge solution A and B, be condensed into thick paste, be dried to dry cream, pulverize, obtain C; Get vitamin C, adopt polyacrylic resin Ⅳ to carry out peplos, obtain D; Get above-mentioned volatile oil and mix with Oleum menthae, use betacyclodextrin inclusion, obtain E; Get C, D, E, chlorphenamine maleate and acetaminophen, add appropriate amount of starch, mix, incapsulate, make 1000, obtain.
Ascorbic peplos operational approach is: get polyacrylic resin Ⅳ 200g, add 95% ethanol 4000ml, soak 24 hours, make to dissolve completely, obtain film coating liquid; Vitamin C is put in coating pan, be preheated to 45 ℃ of left and right.Constantly blowing under the condition of 50 ℃ of left and right hot blasts, on the vitamin C of continuous rolling, with spray gun, spray into above-mentioned film coating liquid, per kilogram vitamin C is approximately used film coating liquid 2000ml, after hydrojet, dry approximately 15 minutes, changing blows a cold wind over made coated vitamin C be cooled to 30 ℃ of left and right, takes the dish out of the pot, to 40 ℃ of cold drying casees, be dried, obtain.
The preparation method of volatile oil and Oleum menthae mixing inclusion complex is: get 8 times of amount betacyclodextrins, adding distil water heating for dissolving, makes saturated solution, cool to inclusion temperature be 40 ℃, add volatile oil and Oleum menthae mixed solution, constant temperature stirs 1 hour, take out, cooling, put refrigerator cold-storage 12 hours, take out, sucking filtration, inclusion complex is put drying under reduced pressure 4h at 40 ℃, and porphyrize obtains Powdered volatile oil inclusion complex.
Claims (7)
1. a preparation method for Vitaminc lonicera and forsythia capsule, is characterized in that, the method is:
Prescription: Flos Lonicerae 180g, Fructus Forsythiae 180g, Herba Schizonepetae 72g, Fructus Arctii 108g, Semen Sojae Preparatum 90g, Herba Lophatheri 72g, Rhizoma Phragmitis 108g, Radix Platycodonis 108g, Radix Glycyrrhizae 90g, Oleum menthae 1.08ml, acetaminophen 105g, vitamin C 49.5g, chlorphenamine maleate 1.05g, make 1000 altogether;
Method for making: above 13 tastes, Fructus Forsythiae, Herba Schizonepetae, Flos Lonicerae are extracted volatile oil, and medicinal residues and Herba Lophatheri, Semen Sojae Preparatum, Rhizoma Phragmitis, Radix Platycodonis, Radix Glycyrrhizae decoct with water secondary, and each 2 hours, filter, merging filtrate, obtains solution A; 60% alcohol reflux secondary for Fructus Arctii, each 4 hours, filter, merging filtrate, reclaims ethanol, adds paraffin to make to dissolve, and is cooled to paraffin and floats on liquid level, removes paraffin layer, obtains solution B; Merge solution A and B, be condensed into thick paste, be dried to dry cream, pulverize, obtain C; Get vitamin C, adopt polyacrylic resin to carry out peplos, obtain D; Get above-mentioned volatile oil and mix with Oleum menthae, use betacyclodextrin inclusion, obtain E; Get C, D, E, chlorphenamine maleate and acetaminophen, add appropriate amount of starch, mix, incapsulate, make 1000, obtain.
2. the preparation method of Vitaminc lonicera and forsythia capsule as claimed in claim 1, is characterized in that, described polyacrylic resin comprises: polyacrylic resin Ⅳ, polyacrylic resin Ⅲ, polyacrylic resin Ⅱ.
3. the preparation method of Vitaminc lonicera and forsythia capsule as claimed in claim 1, is characterized in that, describedly by the operational approach that polyacrylic resin carries out coated vitamin C, is: get polyacrylic resin appropriate, add 95% ethanol 4000ml, soak, make to dissolve completely, obtain film coating liquid; Vitamin C is put in coating pan, be preheated to 40～50 ℃; Under the condition of continuous blowing hot-air, on the vitamin C of continuous rolling, with spray gun, spray into above-mentioned film coating liquid, after hydrojet, dry appropriate time, changing blows a cold wind over makes coated vitamin C cooling, takes the dish out of the pot, and puts in 35～45 ℃ of drying baker and is dried, and obtains.
4. the preparation method of Vitaminc lonicera and forsythia capsule as claimed in claim 1, it is characterized in that, the preparation method of described volatile oil and Oleum menthae mixing inclusion complex is: get 6～10 times of amount betacyclodextrins, add water heating for dissolving, make saturated solution, cool to inclusion temperature be 30～50 ℃, add volatile oil and Oleum menthae mixed solution, constant temperature stirs 1～2 hour, take out, cooling, put refrigerator cold-storage 12 hours, take out, sucking filtration, inclusion complex is put 40 ℃ of drying under reduced pressure 4 hours, and porphyrize obtains Powdered volatile oil inclusion complex.
5. the preparation method of Vitaminc lonicera and forsythia capsule as claimed in claim 4, is characterized in that, the consumption of described betacyclodextrin is 8 times of amounts.
6. the preparation method of Vitaminc lonicera and forsythia capsule as claimed in claim 4, is characterized in that, described constant temperature mixing time is 1 hour.
7. the preparation method of Vitaminc lonicera and forsythia capsule as claimed in claim 4, is characterized in that, described inclusion temperature is 40 ℃.
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Cited By (3)
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| CN115381787A (en) * | 2022-08-24 | 2022-11-25 | 广西纯正堂制药有限公司 | New vitamin C enteric-coated pellet Yinqiao tablet and preparation method thereof |
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