CN1267147C - Effervescence tablet of antiviral medicine and its preparation process - Google Patents
Effervescence tablet of antiviral medicine and its preparation process Download PDFInfo
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- CN1267147C CN1267147C CN 200310120001 CN200310120001A CN1267147C CN 1267147 C CN1267147 C CN 1267147C CN 200310120001 CN200310120001 CN 200310120001 CN 200310120001 A CN200310120001 A CN 200310120001A CN 1267147 C CN1267147 C CN 1267147C
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Abstract
The present invention relates to a preparation process of an antivirus effervescent tablet. The volatile oil of grassleaf sweetflag rhizome, curcuma root, cablin patchouli herb and forsythia fruit is covered by beta-cyclodextrin so that the loss of the volatile oil is avoided in the process of preparation and a storage period and the stability of the antivirus effervescent tablet is increased so as to guarantee the clinical curative effect of the antivirus effervescent tablet. When the effervescent tablet comes into contact with water, acid and base reacts to generate carbon dioxide so that the whole tablet is dissolved in a short time. The antivirus effervescent tablet prepared in the process of the present invention uses polyethyleneglycol to wrap sodium bicarbonate and/or potassium so that acid sources are isolated from alkali sources and the effect of the effervescent tablet can not be lost in placing to guarantee the stability of the effervescent tablet. As indicated by experiments, the antivirus effervescent tablet of the present invention has a stronger inhibiting effect on influenza a virus and influenza b virus than that of an antivirus oral liquid and the antivirus effervescence tablet prepared by the process of the present invention has the advantages of stable quality, good taste, convenient oral application and easy acceptance for patients.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, relate to a kind of antivirus effervescence tablet agent and preparation method thereof.
Background technology
The viral influenza particularly of catching a cold is clinically commonly encountered diseases, frequently-occurring disease, mainly show as acute upper respiratory tract infection, this disease onset is anxious, body temperature can rise sharply to more than 39 ℃ even 40 ℃, and at present to the also not effective especially medicine of the treatment Western medicine of viral influenza, Chinese medicine then has clinical effectiveness preferably in this respect.Antivirus oral liquid is by Radix Isatidis, Gypsum Fibrosum, Rhizoma Phragmitis, the Radix Rehmanniae, Radix Curcumae, the Rhizoma Anemarrhenae, Rhizoma Acori Graminei, Herba Pogostemonis, totally nine flavor medicines such as Fructus Forsythiaes etc. are formed, has clearing heat and expelling damp, the function of removing pathogenic heat from blood and toxic substance from the body, be used for anemopyretic cold clinically, the upper respiratory tract infection of epidemic febrile disease heating, virus infectious disease such as influenza and parotitis, has curative effect preferably, but oral liquid is a liquid preparation, less stable, place the back and occur muddy or precipitation easily, and after making solid preparation into, then can overcome above-mentioned shortcoming, but the absorption of conventional solid preparation is slower, therefore the drug effect of medicine can not obtain very fast performance, plans it and makes solid preparation into and drug effect is brought into play effervescent tablet faster.Effervescent tablet is taken with the solution form, and drug effect is rapid, and the bioavailability height is compared with liquid preparation, carries more convenient.Therefore, make antivirus oral liquid into effervescent tablet and both kept oral liquid onset characteristics rapidly, have tablet advantage easy to carry again, have vast market prospect.
Effervescent tablet is to be a kind of tablet that disintegrating agent is made with the effervescent material, in water, can produce a large amount of bubbles, and can dissolve in the short period of time, have that drug effect is rapid, bioavailability is high, convenient carrying, the patient who is specially adapted to child, old man and can not swallows solid preparation is so effervescent tablet has the dosage form novelty, the characteristics that market prospect is wide, but also there is certain shortcoming in it simultaneously, and as its poor stability, the production environment and the condition of requirement are more high.
The part medical material contains volatile oil component in the antivirus oral liquid, volatile oil contents is also than higher in the medical material that wherein has, and volatile oil contents is more than 2% in the Rhizoma Acori Graminei, and the volatile oil content in the Radix Curcumae is about 1%, in addition, all contain volatile oil in Herba Pogostemonis, the Fructus Forsythiae, its preparation technology adopts the decocting in water alcohol precipitation process at present, though volatile oil is through extracting, but after directly joining in the oral liquid, almost insoluble in water because of it, poor stability, thus influence the clarity and the clinical efficacy of oral liquid.For overcoming above-mentioned shortcoming, the present invention adopts beta-schardinger dextrin-, and (β-CD) with inclusion essential oil, be pressed in the effervescent tablet can effectively prevent scattering and disappearing of volatile oil, has the curative effect height, the characteristics of good stability.
Summary of the invention
The object of the present invention is to provide a kind of efficient, stablize, take, antivirus effervescence tablet agent easy to carry and preparation method thereof.To difference extracting in water (device is collected volatile oil in addition simultaneously) after the pulverizing medicinal materials in the prescription, the extracting solution precipitate with ethanol concentrates, drying, and porphyrize gets antivirus extract extractum fine powder; Get volatile oil, use anhydrous sodium sulfate drying, use beta-cyclodextrin inclusion compound, filter, drying, standby; After taking polyethylene glycol 6000 fusions, add sodium bicarbonate fine powder, stir, pulverize the cooling back, sieves; In addition citric acid, sweeting agent crushed after being dried are sieved,, granulate with the sodium bicarbonate fine powder mixing behind above-mentioned extractum fine powder, Benexate Hydrochloride and the parcel Polyethylene Glycol, drying, tabletting, promptly.The antivirus effervescence tablet good stability that adopts the inventive method to make, active constituent content height, volatile oil component are difficult for scattering and disappearing, going bad determined curative effect.
A kind of antivirus effervescence tablet agent of the present invention is achieved through the following technical solutions:
(1) medicine of the present invention is made by following bulk drugs: (consumption is a weight portion)
12～24 parts of 10～20 parts of Rhizoma Phragmitiss of 30～45 parts of Gypsum Fibrosum of Radix Isatidis
4～10 parts of 4～10 parts of Rhizoma Anemarrhenaes of 6～14 portions of Radix Curcumaes of the Radix Rehmanniae
4～12 parts of 9～17 parts of Herba Pogostemonis of 4～10 parts of Fructus Forsythiaes of Rhizoma Acori Graminei
The optimum weight proportioning of medicine of the present invention is:
9 parts in 17 parts of Radix Rehmanniae of 16 parts of Rhizoma Phragmitiss of 36 parts of Gypsum Fibrosum of Radix Isatidis
8 parts of 7 parts of Herba Pogostemonis of 7 parts of Rhizoma Acori Graminei of 7 parts of Rhizoma Anemarrhenaes of Radix Curcumae
13 parts of Fructus Forsythiaes
Effervescent tablet of the present invention is raw material with the said medicine, adopts β-CD to seal processing to wherein Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, Forsythia volatile oil, the preparation effervescent tablet, and its Chinese medicine powder and effervescent weight ratio are 0.5～1: 1～2; Effervescent is organic acid, sodium bicarbonate and/or potassium bicarbonate, wherein organic acid: the ratio of sodium bicarbonate and/or potassium bicarbonate is 0.5～1: 1; Adopt the polyethylene glycol 6000 parcel to handle to sodium bicarbonate and/or potassium bicarbonate.
(2) preparation method:
A. the preparation of the beta-CD inclusion of Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, Forsythia volatile oil adopt saturated water solution method or-the liquid envelope.
A. saturated water solution method:
Get Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, the Fructus Forsythiae medical material of said ratio,, extract volatile oil, collect volatile oil, use anhydrous sodium sulfate dehydration, get volatile oil with steam distillation with the suitable quantity of water moistening.
With an amount of dissolved in distilled water β-CD, after making saturated solution, mix (weight ratio of volatile oil and β-CD is 1: 4～1: 12) with Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, Forsythia volatile oil, preferred weight ratio is 1: 6～1: 9), constant temperature stirs certain hour, puts refrigerator cold-storage and spends the night; Sucking filtration, cold drying promptly gets white loose shape beta-CD inclusion powder.
B. liquid-liquid envelope:
Get Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, the Fructus Forsythiae medical material of said ratio, immersion, heating, steam directly is passed in the airtight saturated solution that contains β-CD after condensing tube condensation becomes to drip, and constant temperature stirs certain hour, and the gained suspension is put the refrigerator and cooled Tibetan and is spent the night; Sucking filtration, cold drying promptly gets white loose shape beta-CD inclusion powder.
B, Rhizoma Acori Graminei behind the vapor distillation, Radix Curcumae, Herba Pogostemonis, the Fructus Forsythiae medicinal liquid, all the other five tastes such as medicinal residues and Radix Isatidis decoct with water secondary, each 2h, collecting decoction, be condensed into every 1ml and contain the concentrated solution of 1g crude drug, add ethanol and make and contain the alcohol amount and reach 60%～70%, fully stir, leave standstill, filter, filtrate decompression is concentrated into the concentrated solution that every 1ml contains the 2g crude drug, adds ethanol and makes and contain the alcohol amount and reach 70%～80%, fully stir, leave standstill, filter, decompression filtrate recycling ethanol to relative density is 1.08～1.10 medicinal liquid (55 ℃), spray drying, be ground into fine powder, mix, get medicated powder with beta-CD inclusion.
After C, taking polyethylene glycol 6000 fusions, add sodium bicarbonate and/or potassium bicarbonate fine powder, stir, cooling is pulverized, and crosses 80 mesh sieves.With organic acid, sweeting agent and correctives drying, pulverize in addition, cross 80 mesh sieves,, granulate with medicated powder, Polyethylene Glycol wrappage fine powder mixing, drying, compacting is in flakes promptly.
The present invention is further illustrated below by embodiment
One, the comparison of antivirus effervescence tablet and the susceptible toxic action of antivirus oral liquid convection current
1, experimental technique: adopt half intracorporal method to do the antivirus action test
Antivirus effervescence tablet (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides), every is equivalent to crude drug 4.285g; Antivirus oral liquid (Benxi, Liaoning pharmaceutical factory), every 10ml is equivalent to crude drug 4.285g; Influenza A virus (A/ capital anti-/ 44/89), Influenza B virus (second/capital anti-/ 3/91) derive from health and epidemic prevention station Viral Laboratory, Guangdong Province.
(1) to the influence of influenza A virus:
Half intracorporal method is adopted in experiment, four dosage groups of antivirus effervescence tablet 3.0,1.0,0.1,0.05g/L, positive controls antivirus oral liquid 3.0,1.0,0.1,0.05g/L, normal control group and virus control group, the medicine of variable concentrations is directly acted on virus respectively, be inoculated in immediately in the chick embryo allantoic cavity,, put 37 ℃ of incubators and cultivate 48h with paraffin sealing-in kind hole, collect the urine of every embryo, with the test of 0.5% chicken erythrocyte agglutination, judge the antiviral activity of medicine, the results are shown in Table 1.
(2) to the influence of Influenza B virus: inoculation method, drug dose are tested with influenza A virus, the results are shown in following table 1.
Table 1 antivirus effervescence tablet and antivirus oral liquid are to the effect of influenza virus
| Group | Dosage (g/L) | Influenza A virus | Influenza B virus |
| Antivirus effervescence tablet | 3.0 1.0 0.4 0.1 | - - - + | + + + ++ |
| Antivirus oral liquid | 3.0 1.0 0.4 0.1 | - - + ++ | + + ++ +++ |
| Virus control | - | +++ | +++ |
| Normal control | - | - | - |
Annotate :-represent virus-free growth ,+represent a small amount of viral growth, ++ represent more viral growth, +++represent a large amount of viral growths
The result shows that antivirus effervescence tablet and antivirus oral liquid all have certain antivirus action to first, Influenza B virus, and the former antivirus action is better than the latter.
The specific embodiment
Embodiment 1:
Prescription Radix Isatidis 128.6g Gypsum Fibrosum 57.1g Rhizoma Phragmitis 60.7g
Radix Rehmanniae 32.1g Radix Curcumae 25.0g Rhizoma Anemarrhenae 25.0g
Rhizoma Acori Graminei 25.0 Herba Pogostemonis 28.6g Fructus Forsythiae 46.4g
Get above-mentioned Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, Fructus Forsythiae medical material and soak with 10 times of water gagings, vapor distillation 4h collects volatile oil, use anhydrous sodium sulfate dehydration, must volatile oil.The volatile oil anhydrous alcohol solution is made into 50% (V/V) ethanol solution.
With the ratio adding distil water of β-CD with 27.5ml/g, heating for dissolving is chilled to room temperature, makes saturated solution.Under the mixing speed of 100r/min, slowly (weight ratio of volatile oil and β-CD is 1 to the volatile oil solution of adding dissolve with ethanol: 6-1: 9), stir 1h, put cold preservation 24h in the refrigerator then, sucking filtration, to tasteless, 40 ℃ of vacuum drying 4h promptly get the white loose sprills to clathrate with a small amount of petroleum ether.
Medicinal liquid and all the other five tastes such as medicinal residues and Radix Isatidis behind Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, the Fructus Forsythiae vapor distillation decoct with water secondary, each 2h, collecting decoction, be condensed into every 1ml and contain the concentrated solution of 1g crude drug, add 2 times of amount ethanol, fully stir, standing over night, filter, filtrate decompression is concentrated into the concentrated solution that every 1ml contains the 2g crude drug, adds 3 times of amount ethanol, fully stir, standing over night filters, and decompression filtrate recycling ethanol to relative density is 1.08～1.10 medicinal liquid (55 ℃), spray drying, be ground into fine powder, mix, get medicated powder with beta-CD inclusion.
After the fusion of 60g polyethylene glycol 6000, add potassium bicarbonate 60g, sodium bicarbonate fine powder 140g, stir, cooling is pulverized, and crosses 80 mesh sieves.With tartaric acid 150g, aspartame 10g, fragrant citrus essence 3g pulverizes, and crosses 80 mesh sieves, with medicated powder, Polyethylene Glycol wrappage fine powder mixing, granulate, and drying, compacting is in blocks, promptly.
Embodiment 2
Prescription Radix Isatidis 128.6g Gypsum Fibrosum 57.1g Rhizoma Phragmitis 60.7g
Radix Rehmanniae 32.1g Radix Curcumae 25.0g Rhizoma Anemarrhenae 25.0g
Rhizoma Acori Graminei 25.0 Herba Pogostemonis 28.6g Fructus Forsythiae 46.4g
Get above-mentioned Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, Fructus Forsythiae medical material and soak a few hours with 10 times of water gagings, vapor distillation 4h collects volatile oil, use anhydrous sodium sulfate dehydration, must volatile oil.The volatile oil anhydrous alcohol solution is made into 50% (V/V) ethanol solution.
With the ratio adding distil water of β-CD with 27.5ml/g, heating for dissolving is chilled to room temperature, makes saturated solution.Under the mixing speed of 100r/min, slowly (weight ratio of volatile oil and β-CD is 1 to the volatile oil solution of adding dissolve with ethanol: 6-1: 9), stir 1h, put cold preservation 24h in the refrigerator then, sucking filtration, to tasteless, 40 ℃ of vacuum drying 4h promptly get the white loose sprills to clathrate with a small amount of petroleum ether.
Medicinal liquid and all the other five tastes such as medicinal residues and Radix Isatidis behind Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, the Fructus Forsythiae vapor distillation decoct with water secondary, each 2h, collecting decoction, be condensed into every 1ml and contain the concentrated solution of 1g crude drug, add 2 times of amount ethanol, fully stir, standing over night, filter, filtrate decompression is concentrated into the concentrated solution that every 1ml contains the 2g crude drug, adds 3 times of amount ethanol, fully stir, standing over night filters, and decompression filtrate recycling ethanol to relative density is 1.08～1.10 medicinal liquid (55 ℃), spray drying, be ground into fine powder, mix, get medicated powder with beta-CD inclusion.
After the fusion of 60g polyethylene glycol 6000, add potassium bicarbonate fine powder 60g, sodium bicarbonate fine powder 140g stirs, and cooling is pulverized, and crosses 80 mesh sieves.With citric acid 150g, aspartame 10g, strawberry essence 3g pulverizes, and crosses 80 mesh sieves, with medicated powder, Polyethylene Glycol wrappage fine powder mixing, granulate, and drying, compacting is in blocks, promptly.
Embodiment 3
Prescription Radix Isatidis 128.6g Gypsum Fibrosum 57.1g Rhizoma Phragmitis 60.7g
Radix Rehmanniae 32.1g Radix Curcumae 25.0g Rhizoma Anemarrhenae 25.0g
Rhizoma Acori Graminei 25.0 Herba Pogostemonis 28.6g Fructus Forsythiae 46.4g
Get above-mentioned Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, Fructus Forsythiae medical material, soak with 10 times of water gagings, vapor distillation 5 hours, steam directly is passed in the saturated solution of airtight β-CD after condensing tube condensation becomes to drip, and control enclose temperature is 40 ℃, stir, till not having volatile oil and splashing into, continue to stir 30 minutes, the gained suspension is put refrigerator cold-storage and is spent the night; Sucking filtration, to tasteless, 40 ℃ of vacuum drying 4h promptly get the white loose sprills to clathrate with a small amount of petroleum ether; Get all the other five tastes medical materials such as Radix Isatidis, be ground into coarse powder, together with the four Chinese medicine materials such as Rhizoma Acori Graminei behind the above-mentioned extraction volatile oil, decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate is concentrated in right amount, stirs when being chilled to 40 ℃ slowly to add ethanol down, makes to contain the alcohol amount and reach 70%, left standstill 12 hours, the leaching supernatant reclaims ethanol, and concentrated solution adds ethanol again to be made and contain the alcohol amount and reach 80%, fully stir, left standstill 12 hours, the leaching supernatant, decompression recycling ethanol is to there not being the alcohol flavor, further concentrating under reduced pressure becomes thick paste, cold drying is pulverized, and gets the antiviral extract powder; Get citric acid 140g, tartaric acid 40g, sodium bicarbonate 140g, potassium bicarbonate 60g, 60-80 ℃ dry 2-4 hour, pulverize, cross the 100-120 mesh sieve.Get lactose 80g, sweetleaf centautin 10g, fragrant citrus essence 5g, drying was pulverized the 100-120 mesh sieve, and was standby.Taking polyethylene glycol (polyethylene glycol 6000) 50g behind the heating and melting, adds above-mentioned sodium bicarbonate, potassium bicarbonate fine powder, stirs, cooling is pulverized, and crosses the 100-120 mesh sieve, with above-mentioned fine powder mix homogeneously, tabletting, promptly get (the filler place is moistureproof with the infrared lamp irradiation during tabletting).
Claims (1)
1. antivirus effervescence tablet is characterized in that by following method preparation:
(1) crude drug is: Radix Isatidis 128.6 grams, Gypsum Fibrosum 57.1 grams, Rhizoma Phragmitis 60.7 grams, the Radix Rehmanniae 32.1 grams, Radix Curcumae 25.0 grams, the Rhizoma Anemarrhenae 25.0 grams, Rhizoma Acori Graminei 25.0 grams, Herba Pogostemonis 28.6 grams, Fructus Forsythiae 46.4 grams;
(2) get Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, Fructus Forsythiae medical material and steep with 10 times of water loggings, vapor distillation 4 hours is collected volatile oil, use anhydrous sodium sulfate dehydration, must volatile oil, and the volatile oil anhydrous alcohol solution is made into 50% ethanol solution of volume by volume; With the ratio adding distil water of beta-schardinger dextrin-with 27.5 milliliters/gram, heating for dissolving is chilled to room temperature, make saturated solution, under 100 rev/mins mixing speed, slowly add the volatile oil solution of dissolve with ethanol, the weight ratio of volatile oil and beta-schardinger dextrin-is 1: 6-1: 9, stirred 1 hour, put the interior cold preservation of refrigerator 24 hours then, sucking filtration, clathrate is extremely tasteless with a small amount of petroleum ether, 40 ℃ of vacuum dryings 4 hours promptly get the white loose sprills;
(3) medicinal liquid behind Rhizoma Acori Graminei, Radix Curcumae, Herba Pogostemonis, the Fructus Forsythiae vapor distillation and medicinal residues and all the other five kinds of Chinese medicine decoct with water secondary, each 2 hours, collecting decoction, be condensed into per 1 milliliter of concentrated solution that contains 1 gram crude drug, add 2 times of amount ethanol, fully stir, standing over night, filter, filtrate decompression is concentrated into per 1 milliliter of concentrated solution that contains 2 gram crude drugs, adds 3 times of amount ethanol, fully stir, standing over night filters, and decompression filtrate recycling ethanol to 55 ℃ relative density is the medicinal liquid of 1.08-1.10, spray drying, be ground into fine powder, mix, get medicated powder with Benexate Hydrochloride;
(4) with after the 60 gram polyethylene glycol 6000 fusions, add potassium bicarbonate 60 grams, sodium bicarbonate fine powder 140 grams, stir, cooling is pulverized, and crosses 80 mesh sieves, with tartaric acid 150 grams, aspartame 10 grams, fragrant citrus essence 3 grams, pulverize, cross 80 mesh sieves, with medicated powder, Polyethylene Glycol wrappage fine powder mixing, granulate, drying, compacting is in blocks, promptly.
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| CN 200310120001 CN1267147C (en) | 2003-11-28 | 2003-11-28 | Effervescence tablet of antiviral medicine and its preparation process |
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1315511C (en) * | 2005-09-07 | 2007-05-16 | 北京因科瑞斯生物制品研究所 | Effervescence tablet of antiviral medicine and its preparation process |
| CN101002909B (en) * | 2005-12-05 | 2010-05-19 | 北京奇源益德药物研究所 | Antiviral traditional Chinese medicine, its preparing method and quality control method |
| CN100431596C (en) * | 2006-01-20 | 2008-11-12 | 丽珠医药集团股份有限公司 | Medicine composition for treating bird flu, its preparation method and use |
| CN1879814B (en) * | 2006-05-16 | 2010-09-08 | 天津生机集团有限公司 | Antivirus medicine for birds and method for preparing same |
| CN109221276A (en) * | 2018-11-02 | 2019-01-18 | 广东食品药品职业学院 | A kind of Pogostemon cablin essential inclusion compound and its preparation method and application |
| CN109999162A (en) * | 2019-05-15 | 2019-07-12 | 安徽东盛友邦制药有限公司 | A kind of preparation method of the means of supercritical extraction effective component of antiviral oral liquor |
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