CN101919960A - Inflammation and heat clearing tablets and preparation method thereof - Google Patents
Inflammation and heat clearing tablets and preparation method thereof Download PDFInfo
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Abstract
The invention discloses inflammation and heat clearing tablets. 1,000 inflammation and heat clearing tablets are prepared from raw materials of 160 to 180g of inflammation and heat clearing extract powder, 150 to 170g of filler, 13 to 15g of disintegrating agent, 0.8 to 2.0g of lubricating agent, 10 to 20g of silicon dioxide, 1.5 to 3.5g of menthol, 136 to 138g of baical skullcap root, a proper amount of povidone and a proper amount of ethanol by wet-process granulation and tabletting, wherein the inflammation and heat clearing extract powder is prepared by spray drying of inflammation and heat clearing extract. The invention also discloses a method for preparing the inflammation and heat clearing tablets. The tablets prepared by dissolving the menthol and the proper amount of ethanol, adding the silicon dioxide, mixing with the dry extract powder and tabletting have the stability effectively improved, and solve the problems of unqualified menthol identification, non-uniform content and unqualified hardness so as to improve product quality; and the method has the advantages of simple process flow, energy conservation, cost conservation and suitability for industrial production.
Description
Technical field
The present invention relates to a kind of Chinese patent medicine tablet and preparation field thereof, be specifically related to a kind of inflammation and heat clearing tablets and preparation method thereof.
Background technology
Inflammation and heat clearing tablets is that the hot clearing capsule by domestic list marketing changes dosage form and forms, belong to Chinese medicine and register 9 classes, function with expelling pathogen from the exterior and clearing up internal heat, heat-clearing and toxic substances removing, clinical respiratory tract infection, bronchitis, pneumonia, the acute tonsillitis of being used for also can be used for urinary system infection, biliary tract infection; This drug effect fruit is good, taking convenience, and side effect is very little, and is cheap, and the heat-clearing formula for clearing heat in QI system belongs to national essential drugs, favored by extensive patients.
The prescription and the hot clearing capsule of existing inflammation and heat clearing tablets are identical, generally be prescription according to the hot clearing capsule of the 8th record of " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation: Radix Scutellariae 137g, Mentholum 2g and hot clear extractum 161g, make 1000; Wherein used hot clear extractum generally is prepared as follows: get Radix Scrophulariae 154.36g, Radix Gentianae 102.60g, Gypsum Fibrosum 308.73g, Radix Scutellariae 210.90g, Radix Bupleuri 102.60g, Fructus Gardeniae 102.60g and Rhizoma Anemarrhenae 102.60g, 137g is ground into fine powder with Radix Scutellariae; Six-elements such as remaining Radix Scutellariae and all the other Radix Scrophulariaes decoct with water secondary, and each 1.5 hours, collecting decoction filtered, and filtrate is condensed into thick paste, make hot clear extractum.
Hot clearing capsule adds the Radix Scutellariae fecula by the clear extractum of sweltering heat and the Mentholum fecula is formed, and content is a loose powder, has certain moisture, easily deliquescence; The Mentholum that capsule includes has certain volatility, and under high temperature or the situation of storage long period, Mentholum can be overflowed gradually.
Application number is to disclose oral formulations such as a kind of hot Yiqing dispersing tablets and preparation method thereof in the Chinese patent application of CN200510088658.3: Radix Scrophulariae, Radix Gentianae, Gypsum Fibrosum, Radix Bupleuri, Fructus Gardeniae, the Rhizoma Anemarrhenae and Radix Scutellariae mixing and water adding are decocted secondary, each 1.5 hours, collecting decoction filtered, filtrate is concentrated into thick paste, oven dry adds Mentholum, mixing, pulverize, get dry extract, add the proper auxiliary materials mixing, make dispersible tablet or other oral formulations.
Application number is to disclose a kind of hot Yiqing dispersing tablets and preparation method in 200610032658.6 the Chinese patent application: Radix Scrophulariae, Radix Gentianae, Gypsum Fibrosum, Radix Bupleuri, Fructus Gardeniae, the Rhizoma Anemarrhenae and Radix Scutellariae seven flavor medicine are decocted with water secondary, and each 1.5 hours, collecting decoction, filter, filtrate is concentrated into thick paste, adds Radix Scutellariae powder, mixing, drying under reduced pressure is ground into fine powder, adds Mentholum and appropriate amount of auxiliary materials, mixing, full powder compaction dispersible tablet is made 1000, promptly.
More than two kinds of methods, all have following shortcoming: 1, Mentholum is that form with pressed powder directly adds, and is not easy mix homogeneously; Problems such as easy volatilization loss causes the discriminating item of Mentholum in the finished product defective in mixed process and coating temperature-rise period, and character is defective.2 moreover, there is hydrophilic and hydrophobic structure in Mentholum, and directly the form with pressed powder adds, and exists medicated powder and adjuvant to be difficult for the problem of mixing in the pelletization, during tabletting, difficult adjuvant with other is bonding, causes finished product content inhomogeneous, and tablet hardness is defective, friability is defective, the appearance of problems such as pine sheet, quality is uncontrollable and man-hour is longer, and cost is higher.
If can develop a kind of composition and appropriate preparation method that can overcome the 'Yanreqing ' of above-mentioned defective, will have vast market prospect.
Summary of the invention
The invention provides that a kind of cost is low, the measured inflammation and heat clearing tablets of matter.
The present invention also provides a kind of operation simple, quality controllable and be suitable for the preparation method of the inflammation and heat clearing tablets of suitability for industrialized production, the inflammation and heat clearing tablets of fundamentally having avoided the preparation of existing preparation method hardness, friability and Mentholum differentiate the phenomenon defective, that content is inhomogeneous and cost is high, improved the qualification rate of product greatly.
A kind of inflammation and heat clearing tablets, in 1000, make by wet granule compression tablet by following raw material:
Hot clear extract powder 160～180g filler 150～170g disintegrating agent 13～15g
Lubricant 0.8～2.0g silica 1 0～20g Mentholum 1.5～3.5g
An amount of ethanol of Radix Scutellariae 136～138g polyvidone (PVP) is an amount of;
The clear extract powder of described sweltering heat is prepared from by spray drying by the clear extractum of sweltering heat.
The clear extractum of described sweltering heat is that feedstock production forms with Radix Scrophulariae, Radix Gentianae, Gypsum Fibrosum, Radix Scutellariae, Radix Bupleuri, Fructus Gardeniae and the Rhizoma Anemarrhenae.Can prepare according to existing hot clear extract making method.
The character of a few flavor medical materials of Radix Scrophulariae, Radix Gentianae, Gypsum Fibrosum, Radix Scutellariae, Radix Bupleuri, Fructus Gardeniae, the Rhizoma Anemarrhenae and Mentholum that the present invention is used all meets the version " record in Chinese pharmacopoeia and " the Chinese medicine pandect " in 2005.
In the preferred dextrin of described filler, pregelatinized Starch, cane sugar powder, lactose, mannitol, the microcrystalline Cellulose any one.
In the preferred carboxymethyl starch sodium of described disintegrating agent, the low-substituted hydroxypropyl cellulose (L-HPC) any one.
In the preferred magnesium stearate of described lubricant, the micropowder silica gel any one.
The preparation method of described inflammation and heat clearing tablets comprises step:
(1) Mentholum is made the Mentholum powder, Radix Scutellariae is made Radix Scutellariae powder, and is standby;
(2) with the clear extract powder of sweltering heat and Radix Scutellariae powder, filler and disintegrating agent mixing, the alcoholic solution that adds polyvidone is an amount of, through granulation, drying and granulate, makes granule;
(3) the Mentholum powder is dissolved in ethanol, preparation Mentholum alcoholic solution adds an amount of silicon dioxide earlier in the Mentholum alcoholic solution, add remaining silica again, carry out always mixing with above-mentioned granule and lubricant behind the mixing, through tabletting, the bag film-coat makes inflammation and heat clearing tablets.
The inventive method is mixed with the form of Mentholum alcoholic solution Mentholum with silicon dioxide, and after silicon dioxide mixes at twice, adds in the granule again, can further reach mix homogeneously, is beneficial to tabletting, and obtains up-to-standard tablet.Simultaneously, add an amount of silicon dioxide in the Mentholum alcoholic solution, add remaining silica again, can make Mentholum be absorbed, wrap up by silicon dioxide fully, further make the Mentholum mixing of final products even, Mentholum differentiates that item is qualified.
In order to guarantee extract dry fully and shorten drying time, so that mixing of materials is more even during follow-up wet granule compression tablet, further improve the hardness and the stability of tablet, the preparation method of the clear extract powder of described sweltering heat comprises:
The clear extractum of sweltering heat is carried out spray drying under the condition of 130～160 ℃ of intake air temperatures, make moisture content smaller or equal to the clear extract powder of 7% sweltering heat.Moisture content of the present invention is meant the percentage ratio of quality with the quality of hot clear extract powder of moisture in the hot clear extract powder.
The clear extract making method of described sweltering heat comprises:
Radix Scrophulariae, Radix Gentianae, Gypsum Fibrosum, Radix Scutellariae, Radix Bupleuri, Fructus Gardeniae and Rhizoma Anemarrhenae seven flavor medicine material are decocted with water secondary, the water that adds for the first time 12 times of amounts of seven flavor medicine material gross weight, the water that adds for the second time 10 times of amounts of seven flavor medicine material gross weight, each 1.5 hours, collecting decoction, filter, it is 1.08～1.15 hot clear extractum that filtrate is concentrated into 80 ℃ of relative densities.
The order number of the clear extract powder of described sweltering heat, filler, disintegrating agent, lubricant, Mentholum powder, silicon dioxide, Radix Scutellariae powder is at least 100 orders; Select for use the less raw material of granularity to be more conducive to the uniform mixing of material,, further improve the stability and the compressibility of the mixture of particulate matter and magnesium stearate and silicon dioxide so that can access the better particulate matter of uniformity when granulating.
In the step (3), add after an amount of silicon dioxide earlier in the Mentholum alcoholic solution, the most well 60 orders～100 mesh sieves add remaining silica again, can remove the bigger impurity of particle diameter, further improve the quality of finished product.
The mass percentage concentration of polyvidone is preferably 20%～30% in the alcoholic solution of described polyvidone, and used etoh solvent is that mass percentage concentration is preferably 90%～96% ethanol water.Adopt the alcoholic solution of polyvidone can further increase the adhesion of hot clear extract powder and Radix Scutellariae powder, other adjuvant, be easy to granulate, and reduce the phenomenon of the loose sheet of appearance behind the tabletting.
Mentholum and alcoholic acid mass ratio are preferably 1: 1 in the described Mentholum alcoholic solution.The dissolve with ethanol of Mentholum powder with equivalent weight can be obtained being transparent clear solutions during concrete the preparation, standby.
The usage and dosage of inflammation and heat clearing tablets of the present invention: oral, one time 3,3 times on the one, serious symptom person's dosage doubles; The child is cut down according to the circumstance, or follows the doctor's advice.
The invention has the advantages that: because of Mentholum consumption in prescription few, if directly add in hot clear extractum and the Radix Scutellariae powder, be not easy evenly mixed, and Mentholum has volatility, all easy volatilization loss in the temperature-rise period when granulation dry run and coating, and the present invention is by the processing to Mentholum, the discriminating item that reaches Mentholum is qualified, guaranteed the quality of final products, and tablet is after preserving certain hour, underproof phenomenon does not appear in the content of Mentholum.
Inflammation and heat clearing tablets Mentholum of the present invention differentiates that quality index such as item, uniformity of dosage units, hardness, stability, friability all meet the requirements, and constant product quality is controlled.
Preparation method of the present invention is simple to operate, is easy to control, and cost is low, is suitable for suitability for industrialized production.
The specific embodiment
Further explain by the following examples or explanation content of the present invention, but the embodiment that is provided should not be understood that protection domain of the present invention is construed as limiting.
Embodiment 1
Get Radix Scrophulariae 154.36g, Radix Gentianae 102.60g, Gypsum Fibrosum 308.73g, Radix Scutellariae 210.90g, Radix Bupleuri 102.60g, Fructus Gardeniae 102.60g and Rhizoma Anemarrhenae 102.60g; Six-elements such as Radix Scutellariae 73.9g and all the other Radix Scrophulariaes are decocted with water secondary, add the water of 12 times of amounts of seven flavor medicine material gross weight for the first time, add the water of 10 times of amounts of seven flavor medicine material gross weight for the second time, each 1.5 hours, collecting decoction filters, and it is 1.10 hot clear extractum that filtrate is concentrated into 80 ℃ of relative densities.
The clear extractum of above-mentioned sweltering heat is carried out spray drying with GLZ-150 type spray dryer under the condition of 130 ℃ of shower nozzle feed liquor speed 2L/h, intake air temperature, make the hot clear extract powder of 168g, its moisture content is 2.42%.
Prescription:
Hot clear extract powder 168g cane sugar powder 160g carboxymethyl starch sodium 14g
Magnesium stearate 1.0g silica 1 5g Mentholum 2g
An amount of ethanol of Radix Scutellariae 137g polyvidone is an amount of;
Preparation method:
(1) the 2g Mentholum is ground into 100 purpose Mentholum powder, the 137g Radix Scutellariae powder is broken into 120 purpose Radix Scutellariae powder, and is standby;
(2) with the hot clear extract powder of 168g and above-mentioned Radix Scutellariae powder, 160g cane sugar powder and 14g carboxymethyl starch sodium mixing, the alcoholic solution that adds polyvidone is an amount of, through granulation, drying and granulate, makes granule; The mass percentage concentration of polyvidone is 25% in the alcoholic solution of polyvidone, and used etoh solvent is that mass percentage concentration is 95% ethanol water.
(3) above-mentioned Mentholum powder is dissolved in 2g ethanol, preparation Mentholum alcoholic solution, in the Mentholum alcoholic solution, add 5g silicon dioxide, cross 60 mesh sieves, add 10g silicon dioxide again, carry out always mixing with above-mentioned granule and 1.0g magnesium stearate behind the mixing, through tabletting, the bag film-coat makes 1000 inflammation and heat clearing tablets.
Embodiment 2
Get Radix Scrophulariae 154.36g, Radix Gentianae 102.60g, Gypsum Fibrosum 308.73g, Radix Scutellariae 210.90g, Radix Bupleuri 102.60g, Fructus Gardeniae 102.60g and Rhizoma Anemarrhenae 102.60g; Six-elements such as Radix Scutellariae 73.9g and all the other Radix Scrophulariaes are decocted with water secondary, add the water of 12 times of amounts of seven flavor medicine material gross weight for the first time, add the water of 10 times of amounts of seven flavor medicine material gross weight for the second time, each 1.5 hours, collecting decoction filters, and it is 1.08 hot clear extractum that filtrate is concentrated into 80 ℃ of relative densities.
The clear extractum of above-mentioned sweltering heat is carried out spray drying with GLZ-150 type spray dryer under the condition of 150 ℃ of shower nozzle feed liquor speed 2.5L/h, intake air temperature, make the hot clear extract powder of 180g, its moisture content is 2.48%.
Prescription:
Hot clear extract powder 180g pregelatinized Starch 150g L-HPC13g
Magnesium stearate 0.8g silica 1 0g Mentholum 1.5g
An amount of ethanol of Radix Scutellariae 136g polyvidone is an amount of;
Preparation method:
(1) the 1.5g Mentholum is ground into 100 purpose Mentholum powder, the 136g Radix Scutellariae powder is broken into 100 purpose Radix Scutellariae powder, and is standby;
(2) with the hot clear extract powder of 180g and above-mentioned Radix Scutellariae powder, 150g pregelatinized Starch and 13gL-HPC mixing, the alcoholic solution that adds polyvidone is an amount of, through granulation, drying and granulate, makes granule; The mass percentage concentration of polyvidone is 25% in the alcoholic solution of polyvidone, and used etoh solvent is that mass percentage concentration is 95% ethanol water.
(3) above-mentioned Mentholum powder is dissolved in 1.5g ethanol, preparation Mentholum alcoholic solution, in the Mentholum alcoholic solution, add 4g silicon dioxide, cross 60 mesh sieves, add 6g silicon dioxide again, carry out always mixing with above-mentioned granule and 0.8g magnesium stearate behind the mixing, through tabletting, the bag film-coat makes 1000 inflammation and heat clearing tablets.
Embodiment 3
Get Radix Scrophulariae 154.36g, Radix Gentianae 102.60g, Gypsum Fibrosum 308.73g, Radix Scutellariae 210.90g, Radix Bupleuri 102.60g, Fructus Gardeniae 102.60g and Rhizoma Anemarrhenae 102.60g; Six-elements such as Radix Scutellariae 73.9g and all the other Radix Scrophulariaes are decocted with water secondary, add the water of 12 times of amounts of seven flavor medicine material gross weight for the first time, add the water of 10 times of amounts of seven flavor medicine material gross weight for the second time, each 1.5 hours, collecting decoction filters, and it is 1.15 hot clear extractum that filtrate is concentrated into 80 ℃ of relative densities.
The clear extractum of above-mentioned sweltering heat is carried out spray drying with GLZ-150 type spray dryer under the condition of 160 ℃ of shower nozzle feed liquor speed 3L/h, intake air temperature, make the hot clear extract powder of 160g, its moisture content is 2.52%.
Prescription:
Hot clear extract powder 160g lactose powder 170g carboxymethyl starch sodium 15g
Magnesium stearate 1g silicon dioxide 20g Mentholum 2g
An amount of ethanol of Radix Scutellariae 138g polyvidone is an amount of;
Preparation method:
(1) the 2g Mentholum is ground into 100 purpose Mentholum powder, the 138g Radix Scutellariae powder is broken into 140 purpose Radix Scutellariae powder, and is standby;
(2) with the hot clear extract powder of 160g and above-mentioned Radix Scutellariae powder, 170g lactose powder and 15g carboxymethyl starch sodium mixing, the alcoholic solution that adds polyvidone is an amount of, through granulation, drying and granulate, makes granule; The mass percentage concentration of polyvidone is 25% in the alcoholic solution of polyvidone, and used etoh solvent is that mass percentage concentration is 95% ethanol water.
(3) above-mentioned Mentholum powder is dissolved in 2g ethanol, preparation Mentholum alcoholic solution, in the Mentholum alcoholic solution, add 8g silicon dioxide, cross 60 mesh sieves, add 12g silicon dioxide again, carry out always mixing with above-mentioned granule and 1g magnesium stearate behind the mixing, through tabletting, the bag film-coat makes 1000 inflammation and heat clearing tablets.
Comparative Examples 1
Radix Scrophulariae 208.73g, Radix Gentianae 102.60g, Gypsum Fibrosum 614.46g, Radix Bupleuri 205.20g, Fructus Gardeniae 205.2g, Rhizoma Anemarrhenae 205.2g, Radix Scutellariae 284.79g mixing and water adding are decocted secondary, each 1.5 hours, collecting decoction, filter, filtrate is concentrated into thick paste, oven dry, add Mentholum, mixing is pulverized, get dry extract, add proper auxiliary materials cross-linking sodium carboxymethyl cellulose mixing, granulate, be pressed into dispersible tablet, check, packing.
" two appendix I of Chinese pharmacopoeia A method was carried out quality inspection to the inflammation and heat clearing tablets of embodiment 1～3 preparation and the inflammation and heat clearing tablets of Comparative Examples 1 preparation, detects the testing result such as the table 1 of projects according to version in 2005.
The related check data of table 1 inflammation and heat clearing tablets
| Sample | Appearance character | Mentholum is differentiated item | Friability (%) | Hardness (N) |
| Embodiment 1 | Appearance is bright and clean | Up to specification | 0.2 | 21.4 |
| Embodiment 2 | Appearance is bright and clean | Up to specification | 0.12 | 21 |
| Embodiment 3 | Appearance is bright and clean | Up to specification | 0.1 | 22.6 |
| Comparative Examples 1 | Appearance is bright and clean | Against regulation | 1.2 | 42 |
By the testing result in the table 1 as can be known, tablet content of the present invention and Mentholum differentiate that item, friability, hardness all are better than the tablet of Comparative Examples 1 (being that publication number is 200510088658.3 Chinese patent application) preparation.
The inflammation and heat clearing tablets of embodiment 1～3 preparation and the dispersible tablet of Comparative Examples 1 preparation are carried out the Mentholum discriminating respectively, and the inflammation and heat clearing tablets of each embodiment and Comparative Examples preparation is got three parts respectively, and 8 every part, do parallel test, method is as follows:
Get 8 of this product, porphyrize, the 35ml that adds diethyl ether flooded 1 hour, filtered, and filtrate is put in 60 ℃ of water-baths and is volatilized, and takes off immediately, and residue adds ethyl acetate 2ml makes dissolving, as need testing solution.Other gets the Mentholum reference substance, adds ethyl acetate and makes the solution that every 1ml contains 2mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetate (volume ratio is 19: 1) is developing solvent, launch, take out, dry, spray is with mass percentage concentration 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
The result is as follows: the inflammation and heat clearing tablets Mentholum of embodiment 1～3 preparation differentiate be with the corresponding position of reference substance chromatograph on show the speckle of same color; Show: the inflammation and heat clearing tablets Mentholum of the embodiment of the invention 1～3 preparation differentiates that item meets the requirements.
The Mentholum of the dispersible tablet of Comparative Examples 1 preparation differentiate all not with the corresponding position of reference substance chromatograph on the speckle of apparent same color; Show: the hot Yiqing dispersing tablets Mentholum of Comparative Examples 1 preparation differentiates that item is undesirable.
The inflammation and heat clearing tablets of embodiment 1～3 preparation and the dispersible tablet of Comparative Examples 1 preparation are measured content of baicalin respectively, and the inflammation and heat clearing tablets of each embodiment and Comparative Examples preparation all detects three times, does parallel test, and assay method is as follows:
Measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 D).
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler, and methanol-water-phosphoric acid (volume ratio is 45: 55: 0.2) is a mobile phase; The detection wavelength is 316nm.Number of theoretical plate calculates by the baicalin peak should be not less than 3000, and the separating degree of baicalin peak and adjacent chromatographic peak should be greater than 1.5.
The preparation of reference substance solution: precision takes by weighing at 4 hours baicalin reference substance of 60 ℃ of drying under reduced pressure an amount of, adds mass percentage concentration 50% methanol aqueous solution and makes the solution that every 1ml contains 30 μ g, promptly.
The preparation of need testing solution: get the tablet under this product weight differential item, porphyrize, mixing, get about 0.4g, the accurate title, decide, and puts in the tool plug conical flask, the accurate mass percentage concentration 50% methanol aqueous solution 50ml that adds claims to decide weight, supersound process 20 minutes, put coldly, claim again to decide weight, supply the weight that subtracts mistake with mass percentage concentration 50% methanol aqueous solution, filter, precision is measured subsequent filtrate 2ml, puts in the 20ml volumetric flask, be diluted to scale with mass percentage concentration 50% methanol aqueous solution, shake up, promptly.
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.
The result is as follows: the inflammation and heat clearing tablets of embodiment 1 preparation, and in a slice tablet, content of baicalin is respectively 16.2mg, 16.4mg, 16.7mg; The inflammation and heat clearing tablets of embodiment 2 preparations, in a slice tablet, content of baicalin is respectively 16.2mg, 16.4mg, 16.5mg; The inflammation and heat clearing tablets of embodiment 3 preparations, in a slice tablet, content of baicalin is respectively 16.8mg, 16.8mg, 17.01mg.
Measurement result shows: the inflammation and heat clearing tablets of the present invention's preparation meets every and contains Radix Scutellariae with baicalin (C
21H
18O
11) count, must not be less than the standard of 10.0mg, meet the requirements.
The content of baicalin of the dispersible tablet of Comparative Examples 1 preparation is respectively 9.2mg, 18.4mg, 16.7mg; Measurement result shows: the content of baicalin of the inflammation and heat clearing tablets of the method preparation of Comparative Examples 1 is inhomogeneous, underproof phenomenon occurs, and product quality is uncontrollable.
Claims (10)
1. inflammation and heat clearing tablets, in 1000, make by wet granule compression tablet by following raw material:
Hot clear extract powder 160～180g filler 150～170g disintegrating agent 13～15g
Lubricant 0.8～2.0g silica 1 0～20g Mentholum 1.5～3.5g
An amount of ethanol of Radix Scutellariae 136～138g polyvidone is an amount of;
The clear extract powder of described sweltering heat is prepared from by spray drying by the clear extractum of sweltering heat.
2. inflammation and heat clearing tablets according to claim 1 is characterized in that, the clear extractum of described sweltering heat is that feedstock production forms with Radix Scrophulariae, Radix Gentianae, Gypsum Fibrosum, Radix Scutellariae, Radix Bupleuri, Fructus Gardeniae and the Rhizoma Anemarrhenae.
3. inflammation and heat clearing tablets according to claim 1 is characterized in that, described filler is any one in dextrin, pregelatinized Starch, cane sugar powder, lactose, mannitol, the microcrystalline Cellulose.
4. inflammation and heat clearing tablets according to claim 1 is characterized in that, described disintegrating agent is any one in carboxymethyl starch sodium, the low-substituted hydroxypropyl cellulose.
5. inflammation and heat clearing tablets according to claim 1 is characterized in that, described lubricant is any one in magnesium stearate, the micropowder silica gel.
6. according to the preparation method of each described inflammation and heat clearing tablets of claim 1～5, it is characterized in that, comprise step:
(1) Mentholum is made the Mentholum powder, Radix Scutellariae is made Radix Scutellariae powder, and is standby;
(2) with the clear extract powder of sweltering heat and Radix Scutellariae powder, filler and disintegrating agent mixing, the alcoholic solution that adds polyvidone is an amount of, through granulation, drying and granulate, makes granule;
(3) the Mentholum powder is dissolved in ethanol, preparation Mentholum alcoholic solution adds an amount of silicon dioxide earlier in the Mentholum alcoholic solution, add remaining silica again, carry out always mixing with above-mentioned granule and lubricant behind the mixing, through tabletting, the bag film-coat makes inflammation and heat clearing tablets.
7. the preparation method of inflammation and heat clearing tablets according to claim 6 is characterized in that, the preparation method of the clear extract powder of described sweltering heat comprises:
The clear extractum of sweltering heat is carried out spray drying under the condition of 130～160 ℃ of intake air temperatures, make moisture content smaller or equal to the clear extract powder of 7% sweltering heat.
8. the preparation method of inflammation and heat clearing tablets according to claim 7 is characterized in that, the clear extract making method of described sweltering heat comprises:
Radix Scrophulariae, Radix Gentianae, Gypsum Fibrosum, Radix Scutellariae, Radix Bupleuri, Fructus Gardeniae and Rhizoma Anemarrhenae seven flavor medicine material are decocted with water secondary, the water that adds for the first time 12 times of amounts of seven flavor medicine material gross weight, the water that adds for the second time 10 times of amounts of seven flavor medicine material gross weight, each 1.5 hours, collecting decoction, filter, it is 1.08～1.15 hot clear extractum that filtrate is concentrated into 80 ℃ of relative densities.
9. the preparation method of inflammation and heat clearing tablets according to claim 6 is characterized in that, the order number of the clear extract powder of described sweltering heat, filler, disintegrating agent, lubricant, Mentholum powder, silicon dioxide, Radix Scutellariae powder is at least 100 orders;
Perhaps, in the step (3), in the Mentholum alcoholic solution, add an amount of silicon dioxide earlier, cross 60 orders～100 mesh sieves, add remaining silica again.
10. the preparation method of inflammation and heat clearing tablets according to claim 6, it is characterized in that, the mass percentage concentration of polyvidone is 20%～30% in the alcoholic solution of described polyvidone, and used etoh solvent is that mass percentage concentration is 90%～96% ethanol water;
Perhaps, Mentholum and alcoholic acid mass ratio are 1: 1 in the described Mentholum alcoholic solution.
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| CN106579331A (en) * | 2016-12-20 | 2017-04-26 | 安徽爱迪香料股份有限公司 | Low-bitterness L-menthol, preparation method and application |
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| CN1840065A (en) * | 2006-01-05 | 2006-10-04 | 李瑞庆 | Dispersible tablet for eliminating inflammation and preparation method thereof |
| US20080279947A1 (en) * | 2005-03-16 | 2008-11-13 | Symrise Gmbh & Co. Kg | Menthol-Containing Solids Composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080279947A1 (en) * | 2005-03-16 | 2008-11-13 | Symrise Gmbh & Co. Kg | Menthol-Containing Solids Composition |
| CN1840065A (en) * | 2006-01-05 | 2006-10-04 | 李瑞庆 | Dispersible tablet for eliminating inflammation and preparation method thereof |
Non-Patent Citations (1)
| Title |
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| 《http:/bbs.sdatc.com/read.php?tid=32979》 20070329 fengzhige 薄荷脑 6-10 , 2 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106579331A (en) * | 2016-12-20 | 2017-04-26 | 安徽爱迪香料股份有限公司 | Low-bitterness L-menthol, preparation method and application |
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| CN101919960B (en) | 2012-06-27 |
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