CN115645490B - 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: a traditional Chinese medicine composition and auxiliary materials; the traditional Chinese medicine composition comprises honeysuckle, chrysanthemum, wild chrysanthemum, blackberry lily, radix scutellariae, akebia stem, dwarf lilyturf tuber, radix asparagi, platycodon grandiflorum, honeysuckle stem, liquorice and menthol; the auxiliary materials 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 through the matching use of the traditional Chinese medicine composition and 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 common name for inflammation caused by infection of pharynx by various microorganisms, and has the characteristics of long course of disease, easy recurrence and difficult cure. For pharyngitis, the current treatment method comprises anti-inflammatory treatment, local treatment, traditional Chinese medicine treatment and the like, wherein the traditional Chinese medicine treatment is common, related medicines such as Yinhuang lozenge, caoshanhu lozenge, huangshi jingsheng pill and the like are widely used in various medicinal preparations due to the characteristics of accurate dosage, stable quality and convenience in taking and carrying. Related studies on tablets for treating pharyngitis are as follows: jiaojiao Xuanzhen Yu, zhang Huiyong, etc. A Chinese patent medicine for treating acute pharyngitis and tonsillitis is prepared by exploring the dosage of the throat-clearing lozenge (505-507) (2015 (3)), and the optimal dosage of the throat-clearing lozenge (radix scrophulariae, dried rehmannia root, dwarf lilyturf tuber, baical skullcap root and weeping forsythiae) for treating acute pharyngitis and tonsillitis (lung heat yin deficiency syndrome) is explored.
In addition, the existing common tablet has 12 medicines of honeysuckle, blackberry lily, dwarf lilyturf tuber, honeysuckle stem, baical skullcap root, radix asparagi, wild chrysanthemum flower, platycodon root, liquoric root, menthol, akebia stem and the like as main components, has the effects of clearing heat and detoxicating, diminishing inflammation and relieving pain, and is generally 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 lozenge and a preparation method thereof, wherein the raw materials are as follows: 100-130g of honeysuckle, 65-80g of chrysanthemum, 65-82g of wild chrysanthemum, 90-110g of blackberry lily, 90-110g of radix scutellariae, 90-110g of akebia stem, 950-1050g of dwarf lilyturf tuber, 90-110g of asparagus, 70-90g of platycodon root, 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 is reduced after long-term storage, aiming at the problems, the patent CN106963813A discloses an instant Chinese patent medicine tablet for treating pharyngitis and a preparation method thereof.
Aiming at the problem of low dissolution rate of tablets for treating pharyngitis in the prior art, it is necessary to find a tablet with excellent dissolution rate and better curative effect.
Disclosure of Invention
Aiming at the problems existing in the prior art, the invention provides a tablet for treating pharyngitis and a preparation method thereof, and the tablet has excellent solubility while maintaining good effect of treating pharyngitis through the matched use of a traditional Chinese medicine composition and auxiliary materials.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
the invention provides a tablet, which comprises the following raw materials: a traditional Chinese medicine composition and auxiliary materials;
the traditional Chinese medicine composition comprises honeysuckle, chrysanthemum, wild chrysanthemum, blackberry lily, radix scutellariae, akebia stem, dwarf lilyturf tuber, radix asparagi, platycodon grandiflorum, honeysuckle stem, liquorice and menthol; the auxiliary materials comprise 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 cross-linked sodium carboxymethyl cellulose, 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 sugar powder.
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 sugar powder.
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, 240-270 parts of blackberry lily, 240-270 parts of radix scutellariae, 240-270 parts of akebia stem, 240-270 parts of dwarf lilyturf tuber, 240-270 parts of radix asparagi, 180-220 parts of platycodon root, 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, 250 parts of blackberry lily, 250 parts of baical skullcap root, 250 parts of akebia stem, 250 parts of dwarf lilyturf tuber, 250 parts of radix asparagi, 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 to the corn oil to the methionine is 4-6:4-6:3-7; preferably 1:1:1.
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 residues obtained in the step (1) and honeysuckle, blackberry lily, radix scutellariae, akebia stem, dwarf lilyturf tuber, radix asparagi, 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 granule obtained in step (2) and adjuvants, adding the volatile oil obtained in step (1), and tabletting.
In some embodiments, the method of making the tablet comprises the steps of:
(1) Adding 10 times of water into chrysanthemum and wild chrysanthemum, extracting volatile oil by a distillation method for 6 hours to obtain dregs and volatile oil, and collecting the volatile oil for later use;
(2) Decocting the residue and the rest nine ingredients (excluding menthol) with water twice, adding 10 times of water for soaking for 1 hr, decocting for 2 hr, adding 8 times of water for decocting for 1.5 hr, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.29-1.31, adding sugar powder, granulating, and oven drying;
(3) Dissolving Mentholum in small amount of ethanol, adsorbing with aluminum hydroxide, sieving, mixing with above granule, 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 steps:
honeysuckle flower: sweet and cold. Enter lung, heart and stomach meridians. Clear away heat and toxic materials, disperse wind-heat.
And (3) chrysanthemum: sweet, bitter and slightly cold. It enters lung and liver meridians. Dispelling wind-heat, suppressing liver-yang, clearing liver-fire, improving vision, and clearing away heat and toxic materials.
Wild chrysanthemum flower: bitter and pungent, and slightly cold. Enter liver and heart meridians. Clear away heat and toxic materials, purge fire and calm liver.
Blackberry lily: bitter and cold. Enter lung meridian. Clear away heat and toxic materials, remove phlegm, and relieve sore throat.
Radix Scutellariae Baicalensis: bitter and cold. It enters lung, gallbladder, spleen, large intestine and small intestine meridians. Clear heat and dry dampness, purge fire and detoxify, stop bleeding and prevent abortion.
Akebia stem: bitter and cold. It enters heart, small intestine and bladder meridians. Induce diuresis to treat stranguria, clear heart and relieve restlessness, and promote menstruation and promote lactation.
Radix Ophiopogonis: sweet, slightly bitter and slightly cold. It enters heart, lung and stomach meridians. Nourishing yin, moistening lung, benefiting stomach, promoting fluid production, clearing heart fire and relieving restlessness.
Radix asparagi: sweet, bitter and cold. Enter lung and kidney meridians. Nourish yin, moisten dryness, clear lung-heat and promote salivation.
Radix Platycodi: bitter and pungent. Enter lung meridian. Dispersing lung qi, eliminating phlegm, relieving sore throat, and expelling pus.
Licorice root: sweet and flat. It enters heart, lung, spleen and stomach meridians. Spleen invigorating, qi replenishing, heat and toxic materials clearing away, phlegm eliminating, cough relieving, pain relieving, and medicines regulating.
Caulis Lonicerae: sweet and cold in nature; enter lung and stomach meridians. Has the effects of clearing heat and expelling wind, dredging collaterals and relieving pain.
Menthol: has effects of dispelling pathogenic wind, clearing heat, and removing toxic substances. Is mainly used for treating headache, conjunctival congestion, exogenous wind-heat, sore throat, odontopathy, skin wind itch and the like.
The invention has the technical effects that:
the product of the invention has the effects of clearing heat and detoxicating, diminishing inflammation and relieving pain, is used for acute and chronic pharyngitis, wherein honeysuckle, chrysanthemum, wild chrysanthemum and blackberry lily are used as monarch drugs, baical skullcap root and akebia stem are used as ministerial drugs, dwarf lilyturf tuber, radix asparagi and platycodon root are used as adjuvant drugs, honeysuckle stem and liquoric root are used as conductant drugs, menthol is used for clearing heat and dispelling wind and detoxifying, and the product is beneficial to relieving headache and conjunctival congestion, exogenous wind-heat and sore throat and tooth pain. Through compatibility research of various raw materials and matching and using and optimizing of auxiliary materials, compared with a common pharyngitis tablet, the finally prepared tablet has more excellent dissolution effect, and meanwhile, the research shows that the tablet has more excellent treatment effect on pharyngitis due to the matching effect of relevant auxiliary materials.
Detailed Description
Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention.
Before the embodiments of the invention are explained in further detail, it is to be understood that the invention is not limited in its scope to the particular embodiments described below; it is also to be understood that the terminology used in the examples of the invention is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the invention.
Where numerical ranges are provided in the examples, it is understood that unless otherwise stated herein, both endpoints of each numerical range and any number between the two endpoints are significant both in the numerical range. 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 therefore the sources thereof are not particularly limited.
Examples 1 to 3
Table 1 formulations and amounts of tablets in examples 1-3
The preparation method of the tablets in examples 1-3 comprises the following steps:
(1) Adding 10 times of water into chrysanthemum and wild chrysanthemum, extracting volatile oil by a distillation method for 6 hours to obtain dregs and volatile oil, and collecting the volatile oil for later use;
(2) Decocting the residue and the rest nine medicinal materials (excluding menthol) with water twice, adding 10 times of water for soaking for 1 hr, decocting for 2 hr, adding 8 times of water for decocting for 1.5 hr, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.29-1.31, adding sugar powder, granulating, and oven drying;
(3) Dissolving Mentholum in small amount of ethanol, adsorbing with aluminum hydroxide, sieving, mixing with above granule, 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 formulations and amounts of tablets in comparative examples 1-4
The preparation method of comparative examples 1 to 4 was the same as examples 1 to 3 (the material replacement condition was changed depending on the specific material, and the addition order was the same).
Comparative example 5
The pharyngitis tablet corresponding to the example 1 in the patent CN 110101791A.
1. Dissolution test of the active ingredient in the tablet of the present invention
And (3) testing: measuring in vitro solubility of glycyrrhizin in tablet by paddle method of United states pharmacopoeia, wherein dissolution medium is distilled water containing 1% sodium dodecyl sulfate, test temperature is 37deg.C, rotation speed is 100r/min, measuring content of glycyrrhizin and isoliquiritigenin under 260nm condition by HPLC, and counting and calculating MDT (time required for dissolving 50% glycyrrhizin) and DE 120 (the area under the dissolution curve in t time has the calculation formula of DE 120 =
The method comprises the steps of carrying out a first treatment on the surface of the Where y is the percentage of dissolution over a particular time) and the results are shown in the table below.
TABLE 3 dissolution test results
The above experiments examine the dissolution of the effective components in the liquorice in the tablets of the invention, the liquorice contains various active components such as glycyrrhizic acid, glycyrrhizin, isoliquiritigenin, glycyrrhizin and the like, and besides glycyrrhizic acid, the glycyrrhizin and isoliquiritigenin have good anti-inflammatory and cough relieving effects, and the glycyrrhizin and isoliquiritigenin are taken as lipophilic molecules with poor water solubility, have critical effects on dissolution and release conditions in the tablets, and the related dissolution conditions of the glycyrrhizin are mainly examined. As a result of the invention, the tablets of examples 1-3 have lower MDT and DE 120 The higher values indicate that the dissolution of glycyrrhizin in the tablets of the invention is more effective than the comparative examples.
2. Cough test of the tablet in the invention on mice with ammonia water induced cough
Test animals: kunming mice weighing 18-22g;
the test method comprises the following steps: the mice were randomly divided into 9 groups of 6 mice, and the control group was filled with 10mL/kg of physiological saline, and each of the example groups and the comparative example groups was filled with the mixture of the same amount of the test substance and physiological saline (crude drug amount: about 15 g) corresponding to each example and comparative example, 1 time a day for a total of 5 days. The mice were challenged with 12.5% ammonia, the time spent for the mice were recorded, and the results were counted in table 4.
TABLE 4 cough test results
(note: p < 0.01 compared to control group; p < 0.05 compared to control group).
As can be seen from the above table, the tablets of the present invention require longer time to initiate cough than other tablets.
Finally, it should be noted that the above description is only for illustrating the technical solution of the present invention, and not for limiting the scope of the present invention, and that the simple modification and equivalent substitution of the technical solution of the present invention can be made by those skilled in the art without departing from the spirit and scope of the technical solution of the present invention.
Claims (3)
1. A tablet, characterized in that: the raw materials comprise: a traditional Chinese medicine composition and auxiliary materials;
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, 250 parts of blackberry lily, 250 parts of baical skullcap root, 250 parts of akebia stem, 250 parts of dwarf lilyturf tuber, 250 parts of radix asparagi, 200 parts of platycodon root, 300 parts of honeysuckle stem, 200 parts of liquoric root and 0.33 part of menthol;
the auxiliary materials comprise, 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 sugar powder;
the filler is microcrystalline cellulose and starch in a weight ratio of 1:2; the wetting agent is ethanol.
2. The tablet according to claim 1, wherein: the weight ratio of the traditional Chinese medicine composition to the auxiliary materials is 2-3:1.
3. A process for the preparation of a tablet according to claim 1 or 2, 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 residues obtained in the step (1) and honeysuckle, blackberry lily, radix scutellariae, akebia stem, dwarf lilyturf tuber, radix asparagi, platycodon grandiflorum, honeysuckle stem and liquorice with water, mixing decoctions, filtering, concentrating, adding sugar powder, granulating and drying to obtain granules;
(3) And (3) adding menthol into ethanol, adsorbing, sieving, uniformly mixing with the particles obtained in the step (2), the filler, the wetting agent, the croscarmellose sodium, mannitol, the arabinogalactan, the corn oil, the methionine and the tartaric acid, adding the volatile oil obtained in the step (1), and tabletting.
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| CN115645490B true CN115645490B (en) | 2023-05-16 |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
-
2022
- 2022-12-12 CN CN202211590285.XA patent/CN115645490B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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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