CN115645490A - Tablet for pharyngitis and preparation method thereof - Google Patents
Tablet for pharyngitis and preparation method thereof Download PDFInfo
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Abstract
The invention provides a tablet for pharyngitis and a preparation method thereof, and relates to a pharmaceutical preparation, wherein the tablet comprises the following raw materials: traditional Chinese medicine composition and auxiliary materials; the traditional Chinese medicine composition comprises honeysuckle, chrysanthemum, wild chrysanthemum, blackberry lily, scutellaria, akebiaquinata, radix ophiopogonis, asparagus cochinchinensis, platycodon grandiflorum, honeysuckle stem, liquorice and menthol; the adjuvants comprise filler, wetting agent, croscarmellose sodium, mannitol, arabinogalactan, corn oil, methionine, and tartaric acid. The tablet has excellent solubility while maintaining good pharyngitis treatment effect by matching the traditional Chinese medicine composition and the auxiliary materials.
Description
Technical Field
The invention relates to a pharmaceutical preparation, in particular to a tablet for pharyngitis and a preparation method thereof.
Background
Pharyngitis is nonspecific inflammation of pharynx, is a general name of inflammation caused by infection of pharynx with various microorganisms, and has the characteristics of long course of disease, easy recurrence and difficult cure. For pharyngitis, the existing treatment methods comprise anti-inflammatory treatment, local treatment, traditional Chinese medicine treatment and the like, wherein the traditional Chinese medicine treatment is common, related medicines such as honeysuckle flower and scutellaria baicalensis lozenge, sarcandra glabra lozenge, huangshi sounding pills and the like are widely used in various pharmaceutical preparations, and tablets have the characteristics of accurate dosage, stable quality and convenience in taking and carrying. Relevant tablet researches for treating pharyngitis are disclosed in the following documents: yu Jiaojiao, xuanzhen Yu, zhang Huiyong, etc. the dosage of the buccal tablet for clearing throat and treating acute pharyngitis and tonsillitis is explored [ J ] Chinese patent medicine, 2015 (3): 505-507, and the optimal administration dosage of the buccal tablet for clearing throat and treating acute pharyngitis and tonsillitis (lung heat and yin deficiency syndrome) is explored.
In addition, the prior common tablets are pharyngitis lozenges, the main components of the lozenges comprise 12 medicines of honeysuckle, blackberrylily rhizome, dwarf lilyturf tuber, honeysuckle stem, baical skullcap root, cochinchinese asparagus root, wild chrysanthemum, platycodon root, liquoric root, menthol, akebia stem and the like, the lozenges have the effects of clearing away heat and toxic materials, diminishing inflammation and relieving pain, and are usually used for relieving symptoms of dry mouth and throat, sore throat, dysphagia and the like caused by acute and chronic pharyngitis. Patent CN110101791A discloses a pharyngitis buccal tablet and a preparation method thereof, and the raw materials are as follows: 100-130g of honeysuckle, 65-80g of chrysanthemum, 65-82g of wild chrysanthemum flower, 90-110g of blackberry lily, 90-110g of scutellaria baicalensis, 90-110g of akebiaquinata, 950-1050g of radix ophiopogonis, 90-110g of radix asparagi, 70-90g of platycodon grandiflorum, 100-130g of honeysuckle stem, 70-90g of liquorice and 0.110-0.140g of menthol.
However, compared with powder or capsule, the tablet has slower dissolution speed, thus affecting the bioavailability, and meanwhile, the tablet usually contains volatile components, and the content of the volatile components is reduced after long-term storage, and in order to solve the problem, the patent CN106963813A discloses a quick-dissolving Chinese patent medicine tablet for treating pharyngitis and a preparation method thereof, and the invention focuses on the research on the dissolution efficiency of the effective components of the medicine.
Aiming at the problem of low dissolution rate of tablets for treating pharyngitis in the prior art, the search for a tablet with excellent dissolution rate and better curative effect is necessary.
Disclosure of Invention
The invention provides a tablet for pharyngitis and a preparation method thereof aiming at the problems in the prior art, and the tablet has excellent dissolubility while keeping good pharyngitis treatment effect by matching the traditional Chinese medicine composition and auxiliary materials.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
the invention provides a tablet, which comprises the following raw materials: traditional Chinese medicine composition and auxiliary materials;
the traditional Chinese medicine composition comprises honeysuckle, chrysanthemum, wild chrysanthemum, blackberry lily, scutellaria baicalensis, akebiaquinata, radix ophiopogonis, asparagus cochinchinensis, platycodon grandiflorum, honeysuckle stem, liquorice and menthol; the adjuvants include filler, wetting agent, croscarmellose sodium, mannitol, arabinogalactan, corn oil, methionine, tartaric acid and sugar powder.
Further, the tablet comprises the following auxiliary materials in parts by weight: 12-18 parts of filler, 2-8 parts of wetting agent, 6-9 parts of croscarmellose sodium, 4-6 parts of mannitol, 4-6 parts of arabinogalactan, 4-6 parts of corn oil, 3-7 parts of methionine, 5-8 parts of tartaric acid and 3-5 parts of powdered sugar.
Preferably, the tablet comprises the following auxiliary materials in parts by weight: 14 parts of filler, 6 parts of wetting agent, 8 parts of croscarmellose sodium, 5 parts of mannitol, 5 parts of arabinogalactan, 5 parts of corn oil, 4 parts of methionine, 6 parts of tartaric acid and 4 parts of powdered sugar.
Further, the weight ratio of the traditional Chinese medicine composition to the auxiliary materials is 2-3:1.
Further, the traditional Chinese medicine composition comprises the following components in parts by weight: 280-330 parts of honeysuckle, 150-200 parts of chrysanthemum, 150-200 parts of wild chrysanthemum flower, 240-270 parts of blackberry lily, 240-270 parts of scutellaria baicalensis, 240-270 parts of akebiaquinata, 240-270 parts of radix ophiopogonis, 240-270 parts of asparagus, 180-220 parts of platycodon grandiflorum, 280-320 parts of honeysuckle stem, 180-220 parts of liquorice and 0.3-0.4 part of menthol.
Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 300 parts of honeysuckle, 180 parts of chrysanthemum, 180 parts of wild chrysanthemum flower, 250 parts of blackberrylily rhizome, 250 parts of baical skullcap root, 250 parts of akebia stem, 250 parts of dwarf lilyturf tuber, 250 parts of cochinchnese asparagus root, 200 parts of platycodon root, 300 parts of honeysuckle stem, 200 parts of liquoric root and 0.33 part of menthol.
Further, the weight ratio of the arabinogalactan, the corn oil and the methionine is 4-6:4-6:3-7; preferably 1.
Further, the wetting agent comprises water and/or ethanol; ethanol is preferred.
Further, the filler includes one or more of lactose, starch, microcrystalline cellulose, sucrose, and pregelatinized starch.
The invention also provides a preparation method of the tablet, which comprises the following steps:
(1) Extracting flos Chrysanthemi and flos Chrysanthemi Indici with water to obtain volatile oil and residue;
(2) Decocting the residue obtained in the step (1) and honeysuckle, blackberrylily rhizome, scutellaria baicalensis, akebiaquinata, radix ophiopogonis, asparagus cochinchinensis, platycodon grandiflorum, honeysuckle stem and liquorice with water, mixing decoctions, filtering, concentrating, adding sugar powder, granulating and drying to obtain granules;
(3) Adding menthol into ethanol, adsorbing, sieving, mixing with the granules obtained in step (2) and adjuvants, adding the volatile oil obtained in step (1), and tabletting.
In some embodiments, the process for preparing the tablet comprises the steps of:
(1) Adding water in an amount which is 10 times that of the chrysanthemum and the wild chrysanthemum, extracting volatile oil for 6 hours by a distillation method to obtain dregs and the volatile oil, and collecting the volatile oil for later use;
(2) Decocting the medicine residues and nine ingredients (except menthol) such as the rest blackberry lily and the like twice by adding water, adding 10 times of water for the first time, soaking for l hour, decocting for 2 hours, adding 8 times of water for the second time, decocting for 1.5 hours, merging decoction, filtering, concentrating the filtrate to the relative density of 1.29-1.31, adding sugar powder, granulating and drying;
(3) Dissolving Mentholum in small amount of ethanol, adsorbing with aluminum hydroxide, sieving, mixing with above granules, filler, wetting agent, croscarmellose sodium, mannitol, arabinogalactan, corn oil, methionine, and tartaric acid, spraying volatile oil of flos Chrysanthemi, sealing for 1 hr, and tabletting.
The invention comprises the following medicaments:
honeysuckle flower: sweet and cold in nature. It enters lung, heart and stomach meridians. Clear heat and remove toxicity, disperse wind-heat.
Chrysanthemum: sweet, bitter and slightly cold. It enters lung and liver meridians. Disperse wind-heat, calm liver yang, clear liver heat and improve vision, clear heat and remove toxicity.
Wild chrysanthemum flower: bitter, pungent and slightly cold. It enters liver and heart meridians. Clear heat and remove toxicity, purge fire and pacify liver.
Shooting: bitter and cold. It enters lung meridian. Clear heat and remove toxicity, dissolve phlegm and relieve sore throat.
Scutellaria baicalensis: bitter and cold. It enters lung, gallbladder, spleen, large intestine and small intestine meridians. Clear heat and dry dampness, purge fire and remove toxicity, stop bleeding, prevent abortion.
B, wood through: bitter and cold. It enters heart, small intestine and bladder meridians. Induce diuresis to treat stranguria, clear heart fire and relieve restlessness, dredge meridians and promote lactation.
Radix ophiopogonis: sweet, slightly bitter and slightly cold. It enters heart, lung and stomach meridians. Nourish yin and moisten lung, nourish stomach and promote fluid production, clear heart and relieve restlessness.
Asparagus: sweet, bitter and cold. It enters lung and kidney meridians. To nourish yin, moisten dryness, clear lung and promote fluid production.
Balloon flower: bitter, pungent and mild. It enters lung meridian. Disperse lung qi, dispel phlegm, relieve sore throat and expel pus.
Licorice root: sweet and neutral. It enters heart, lung, spleen and stomach meridians. Invigorating spleen and replenishing qi, clearing away heat and toxic material, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the drugs.
Honeysuckle stem: sweet in nature and taste and cold in nature; it enters lung and stomach meridians. Clearing away heat and toxic material, and also has the effects of clearing away heat, dispelling wind, dredging collaterals and relieving pain.
Menthol: has effects of dispelling pathogenic wind, clearing away heat, and removing toxic substances. Is mainly used for treating headache, conjunctival congestion, wind-heat common cold, sore throat and teeth, skin pruritus, etc.
The technical effects obtained by the invention are as follows:
the product has the effects of clearing away heat and toxic materials, diminishing inflammation and relieving pain, and is used for treating acute and chronic pharyngitis, wherein honeysuckle, chrysanthemum, wild chrysanthemum and blackberry lily are monarch drugs, scutellaria and akebiaquinata are ministerial drugs, radix ophiopogonis, asparagus cochinchinensis and platycodon grandiflorum are adjuvant drugs, honeysuckle stem and liquorice are conductant drugs, and menthol is added for clearing away heat and dispelling wind and detoxifying, so that the product is helpful for relieving headache and conjunctival congestion, wind heat caused by external infection and sore throat and teeth. Through compatibility research of various raw materials and by combining auxiliary materials for matching use and optimization, the finally prepared tablet has a more excellent dissolving effect compared with a common pharyngitis tablet, and meanwhile, research shows that due to the matching effect of related auxiliary materials, the tablet has a more excellent treatment effect on pharyngitis.
Detailed Description
The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention.
Before the present embodiments are further described, it is to be understood that the scope of the invention is not limited to the particular embodiments described below; it is also to be understood that the terminology used in the examples is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention.
When numerical ranges are given in the examples, it is understood that both endpoints of each of the numerical ranges and any value therebetween can be selected unless the invention otherwise indicated. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
It should be noted that the raw materials used in the present invention are all common commercial products, and thus the sources thereof are not particularly limited.
Examples 1 to 3
TABLE 1 formulation and dosage of tablets in examples 1-3
The preparation method of the tablets in examples 1-3 comprises the following steps:
(1) Adding water in an amount which is 10 times that of the chrysanthemum and the wild chrysanthemum, extracting volatile oil for 6 hours by a distillation method to obtain dregs and the volatile oil, and collecting the volatile oil for later use;
(2) Decocting the dregs and the nine medicinal materials (except menthol) such as the rest blackberry lily and the like twice by adding water, adding 10 times of water for the first time, soaking for l hours, decocting for 2 hours, adding 8 times of water for the second time, decocting for 1.5 hours, merging decoction, filtering, concentrating the filtrate to the relative density of 1.29-1.31, adding sugar powder, granulating and drying;
(3) Dissolving Mentholum in small amount of ethanol, adsorbing with aluminum hydroxide, sieving, mixing with above granules, filler, wetting agent, croscarmellose sodium, mannitol, arabinogalactan, corn oil, methionine, and tartaric acid, spraying volatile oil of flos Chrysanthemi, sealing for 1 hr, and tabletting.
TABLE 2 formulation and dosage of tablets in comparative examples 1-4
Comparative examples 1 to 4 were prepared in the same manner as in examples 1 to 3 (the material replacement was changed depending on the specific material and the order of addition was the same).
Comparative example 5
The pharyngitis buccal tablet corresponding to example 1 in patent CN 110101791A.
1. Dissolution test of active ingredient in tablet of the present invention
And (3) testing: determining in vitro solubility of glycyrrhizin in tablet by Paddle method of United states pharmacopoeia, wherein the dissolving medium is distilled water containing 1% sodium dodecyl sulfate, the test temperature is 37 deg.C, rotation speed is 100r/min, determining glycyrrhizin and isoliquiritigenin content under 260nm condition by HPLC, and counting and calculating MDT (time required for dissolving 50% glycyrrhizin) and DE 120 (the region under the dissolution curve in t-time, calculated as DE 120 =(ii) a Where y is the percent dissolved in a particular time) and the results are shown in the table below.
TABLE 3 dissolution test results
The tests above investigate the dissolution of the effective components in the licorice in the tablet of the present invention, the licorice contains glycyrrhizic acid, liquiritin, liquiritigenin, isoliquiritigenin, glycyrol and other active components, except glycyrrhizic acid, liquiritigenin and isoliquiritigenin have good anti-inflammatory and cough relieving effects, both of which are lipophilic molecules with poor water solubility, and have a critical effect on the dissolution and release conditions in the tablet, and here, the related dissolution conditions of liquiritigenin are mainly investigated. As a result, the tablets of examples 1 to 3 had lower MDT values and DE 120 The higher value indicates that the dissolution of glycyrrhizin in the tablet of the present invention is superior to that in the comparative example.
2. Cough relieving effect test of tablets on mice with cough induced by ammonia water
Test animals: kunming mouse, weight 18-22g;
the test method comprises the following steps: the mice were randomly divided into 9 groups of 6 mice each, the control group was perfused with 10mL/kg of normal saline, and each of the example groups and the comparative example groups was separately perfused with a mixture of the same amount of the test substance and normal saline (crude drug amount about 15 g) corresponding to each of the examples and comparative examples 1 time per day for a total of 5 days. The mice with cough were elicited using 12.5% ammonia, the time required for the mice to spend was recorded, and the results were counted in table 4.
TABLE 4 cough test results
(Note: p < 0.01 compared to control; p < 0.05 compared to control).
As can be seen from the above table, the tablet of the present invention takes longer to induce cough than other tablets.
Finally, it should be noted that the above-mentioned contents are only used for illustrating the technical solutions of the present invention, and not for limiting the protection scope of the present invention, and that the simple modifications or equivalent substitutions of the technical solutions of the present invention by those of ordinary skill in the art can be made without departing from the spirit and scope of the technical solutions of the present invention.
Claims (8)
1. A tablet characterized by: the raw materials comprise: traditional Chinese medicine composition and auxiliary materials;
the traditional Chinese medicine composition comprises the following components in parts by weight: 280-330 parts of honeysuckle, 150-200 parts of chrysanthemum, 150-200 parts of wild chrysanthemum flower, 240-270 parts of blackberry lily, 240-270 parts of scutellaria baicalensis, 240-270 parts of akebiaquinata, 240-270 parts of radix ophiopogonis, 240-270 parts of asparagus, 180-220 parts of platycodon grandiflorum, 280-320 parts of honeysuckle stem, 180-220 parts of liquorice and 0.3-0.4 part of menthol; the auxiliary materials comprise the following components in parts by weight: 12-18 parts of filler, 2-8 parts of wetting agent, 6-9 parts of croscarmellose sodium, 4-6 parts of mannitol, 4-6 parts of arabinogalactan, 4-6 parts of corn oil, 3-7 parts of methionine, 5-8 parts of tartaric acid and 3-5 parts of powdered sugar.
2. The tablet of claim 1, wherein: the auxiliary materials comprise the following components in parts by weight: 14 parts of filler, 6 parts of wetting agent, 8 parts of croscarmellose sodium, 5 parts of mannitol, 5 parts of arabinogalactan, 5 parts of corn oil, 4 parts of methionine, 6 parts of tartaric acid and 4 parts of powdered sugar.
3. The tablet of claim 1, wherein: the weight ratio of the traditional Chinese medicine composition to the auxiliary materials is 2-3:1.
4. The tablet of claim 1, wherein: the traditional Chinese medicine composition comprises the following components in parts by weight: 300 parts of honeysuckle, 180 parts of chrysanthemum, 180 parts of wild chrysanthemum flower, 250 parts of blackberrylily rhizome, 250 parts of baical skullcap root, 250 parts of akebia stem, 250 parts of dwarf lilyturf tuber, 250 parts of cochinchnese asparagus root, 200 parts of platycodon root, 300 parts of honeysuckle stem, 200 parts of liquoric root and 0.33 part of menthol.
5. The tablet of claim 1, wherein: the weight ratio of the arabinogalactan, the corn oil and the methionine is 4-6:4-6:3-7.
6. The tablet of claim 1, wherein: the wetting agent comprises water and/or ethanol.
7. The tablet of claim 1, wherein: the filler comprises one or more of lactose, starch, microcrystalline cellulose, sucrose and pregelatinized starch.
8. A process for the preparation of a tablet according to any one of claims 1 to 7, characterized in that: the method comprises the following steps:
(1) Extracting flos Chrysanthemi and flos Chrysanthemi Indici with water to obtain volatile oil and residue;
(2) Decocting the dregs of the decoction obtained in the step (1) with honeysuckle, blackberrylily rhizome, scutellaria baicalensis, akebiaquinata, radix ophiopogonis, asparagus cochinchinensis, platycodon grandiflorum, honeysuckle stem and liquorice in water, mixing decoctions, filtering, concentrating, adding sugar powder, granulating and drying to obtain granules;
(3) Adding menthol into ethanol, adsorbing, sieving, mixing with the granules obtained in step (2), filler, wetting agent, croscarmellose sodium, mannitol, arabinogalactan, corn oil, methionine and tartaric acid, adding the volatile oil obtained in step (1), and tabletting.
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CN102302672A (en) * | 2011-09-26 | 2012-01-04 | 广东太阳神集团有限公司 | Honeysuckle flower buccal tablets and preparation method thereof |
CN103127009A (en) * | 2011-12-02 | 2013-06-05 | 浙江永宁药业股份有限公司 | Carthamin yellow sublingual tablet and preparation method and application thereof |
CN105535439A (en) * | 2016-01-19 | 2016-05-04 | 宁夏金太阳药业有限公司 | Traditional Chinese medicinal composition for treating pharyngitis and preparation method thereof |
CN105663649A (en) * | 2016-01-19 | 2016-06-15 | 宁夏金太阳药业有限公司 | Traditional Chinese medicine composition for treating pharyngitis and preparation method thereof |
CN110101791A (en) * | 2019-06-14 | 2019-08-09 | 西安博爱制药有限责任公司 | A kind of pharyngitis mouth-sucking tablet and preparation method thereof |
CN110433142A (en) * | 2019-09-06 | 2019-11-12 | 杭州百诚医药科技股份有限公司 | A kind of ramelteon sublingual tablet and preparation method thereof |
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2022
- 2022-12-12 CN CN202211590285.XA patent/CN115645490B/en active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102302672A (en) * | 2011-09-26 | 2012-01-04 | 广东太阳神集团有限公司 | Honeysuckle flower buccal tablets and preparation method thereof |
CN103127009A (en) * | 2011-12-02 | 2013-06-05 | 浙江永宁药业股份有限公司 | Carthamin yellow sublingual tablet and preparation method and application thereof |
CN105535439A (en) * | 2016-01-19 | 2016-05-04 | 宁夏金太阳药业有限公司 | Traditional Chinese medicinal composition for treating pharyngitis and preparation method thereof |
CN105663649A (en) * | 2016-01-19 | 2016-06-15 | 宁夏金太阳药业有限公司 | Traditional Chinese medicine composition for treating pharyngitis and preparation method thereof |
CN110101791A (en) * | 2019-06-14 | 2019-08-09 | 西安博爱制药有限责任公司 | A kind of pharyngitis mouth-sucking tablet and preparation method thereof |
CN110433142A (en) * | 2019-09-06 | 2019-11-12 | 杭州百诚医药科技股份有限公司 | A kind of ramelteon sublingual tablet and preparation method thereof |
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