CN109453141B - Preparation method of film agent for treating chronic pharyngitis - Google Patents

Preparation method of film agent for treating chronic pharyngitis Download PDF

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CN109453141B
CN109453141B CN201811410239.0A CN201811410239A CN109453141B CN 109453141 B CN109453141 B CN 109453141B CN 201811410239 A CN201811410239 A CN 201811410239A CN 109453141 B CN109453141 B CN 109453141B
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parts
stirring
pva
mucilage
medicine film
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CN109453141A (en
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王丹丹
於江华
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Wuxi Jiyu Shanhe Pharmaceutical Co ltd
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Wuxi Jiyu Shanhe Pharmaceutical Co ltd
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Abstract

The invention relates to a Huangshi Xiang oral film agent for treating chronic pharyngitis, which is prepared by mixing a medicinal extract prepared from boat-fruited sterculia seed, platycodon root, periostracum cicadae, liquorice, fructus forsythiae, rhubarb, ligusticum wallichii, myrobalan pulp, thunberg fritillary bulb, mint, catechu and menthol crystal and a medicinal auxiliary material for preparing a film forming agent, wherein the medicinal auxiliary material comprises a film forming material, a plasticizer, a disintegrating agent and a coloring agent in a mass ratio of 1: 1-1.5: 0.3-0.6: 0.06-0.12: 0.02-0.05.

Description

Preparation method of film agent for treating chronic pharyngitis
Technical Field
The invention relates to the field of traditional Chinese medicine preparations, in particular to a film agent for treating chronic pharyngitis.
Background
Chronic pharyngitis is a chronic inflammation of the pharyngeal mucosa, submucosa and lymphoid tissues. Chronic pharyngitis is common in adults and also in children. The general symptoms are not obvious, and the local symptoms are the main symptoms. The symptoms of various types of chronic pharyngitis are similar and various, such as pharyngeal discomfort, foreign body sensation, pharyngeal secretion difficult to be expelled, pharyngeal itching, burning sensation, dryness or irritation, and slight pain. The back wall of pharynx usually causes the adhesion of relatively viscous secretions due to chronic inflammation of the pharynx, and the mouth-opening breath at night due to lesions of the nose, sinuses and nasopharynx, which often causes irritable cough and nausea in the morning. Frequent swallowing can be manifested by a foreign body sensation in the pharynx. The patients with little pharyngeal secretion and difficult cough are usually manifested as habitual dry cough and phlegm-clearing action of throat, and bleeding of pharyngeal mucosa can be caused if cough is done forcefully or throat-clearing action is done forcefully, resulting in blood in the secretion. The disease is common in clinic, the course of disease is long, and the symptoms are easy to recur.
Huangshi Xiang Sheng Wan (Huangshi Sound pill) is disclosed in 2015 edition of Chinese pharmacopoeia and is prepared from boat-fruited sterculia seed, platycodon root, periostracum cicadae, liquorice, fructus forsythiae, rhubarb, rhizoma ligustici wallichii, myrobalan meat, thunberg fritillary bulb, mint, catechu and menthol, and has the effects of dispelling wind and clearing heat, reducing phlegm and resolving masses, relieving sore throat and easing voice. At present, Huangshi rattle medicines in the market are mainly pills, but can also be prepared into buccal tablets and tea. The pill is easy to swallow and is not easy to take for children and old people, and the buccal tablet and the tea are not easy to take due to the influence of the smell of the traditional Chinese medicine. There is therefore a need to add dosage forms to meet the needs of different patients.
The medicine and proper film forming material are processed into film preparation for oral administration or mucous membrane, and the oral film preparation comprises: oral cavity dispersing membrane agent, oral cavity medicinal membrane, sublingual membrane, oral instant membrane, oral cavity membrane, and oral dissolving membrane,
however, the traditional Chinese medicine is difficult to prepare the film-forming agent, and especially the traditional Chinese medicine containing bitter components or fiber components in the extract causes inconvenience for taking the film-forming agent.
Disclosure of Invention
The invention aims to provide a preparation method of a film agent for a Huangshi soundness prescription.
The invention provides a Huangshi sonorous membrane agent, which is prepared by extracting medicinal materials in a Huangshi sonorous prescription to obtain a traditional Chinese medicine extract and using the extract as a medicinal component and a film-forming material together.
In order to avoid bitter taste in the traditional Chinese medicine extract and difficulty in taking medicine due to fiber components contained in the traditional Chinese medicine extract, the invention finds a suitable preparation method through research and solves the problems in the prior art.
The invention provides a Huangshi Xiang pellicle, which is prepared by preparing medicinal active ingredients from traditional Chinese medicines such as boat-fruited sterculia seed, platycodon grandiflorum, cicada slough, liquorice, fructus forsythiae, rheum officinale, ligusticum wallichii, myrobalan pulp, thunberg fritillary bulb, mint, catechu, menthol and the like, and further mixing the medicinal active ingredients with a film-forming material plasticizer, a disintegrating agent, a coloring agent and the like, wherein the film-forming material is polyvinyl alcohol (PVA), and the coloring agent is titanium dioxide (TiO)2) The mass ratio of the medicinal material extracting solution to the film forming material to the plasticizer to the disintegrant to the colorant is 1: 1-1.5: 0.3-0.6: 0.06-0.12：0.02-0.05.
wherein the plasticizer is one or more of sorbitol, polyethylene glycol (PEG) and glycerol.
Wherein the disintegrant is one or more of sodium carboxymethylcellulose (CMC), pregelatinized starch, and crospovidone.
The preparation method of the active pharmaceutical ingredient is improved, and avoids bitter taste and cellulose, and the preparation method comprises the following steps:
(1) decocting 11 medicinal materials except Mentholum in Huangshi rattle prescription twice with appropriate amount of water for a certain time each time, mixing decoctions, standing for precipitation, filtering, and concentrating the filtrate to appropriate amount;
(2) mixing PVA with water, heating and stirring until the PVA is completely dissolved, sequentially adding a plasticizer, a disintegrating agent, the concentrated solution in the step (1) and a coloring agent, and uniformly stirring to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
Further, the heating temperature in the step (1) is 40 ℃ to 60 ℃.
Further, in the step (2), the alcohol solvent is 20-80% of ethanol water solution by mass fraction.
The preferred formulation and preparation method of the present invention is as follows:
(1) decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6-10 times of water twice, decocting for 1-2 hours each time, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 12-15g PVA with water, heating and stirring until completely dissolving, and sequentially addingAdding PEG0.6-1.0g, CMC3-5g, the concentrated solution of (1) above, and TIO20.2-0.5 g. Uniformly stirring the mixture by magnetic force at 40-60 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
The most preferred formulation and preparation method of the present invention is as follows:
(1) decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 15g of PVA with water, heating and stirring until the PVA is completely dissolved, and sequentially adding PEG0.8g, CMC5g, 10g of the concentrated solution in the step (1) and TIO20.3 g. Uniformly stirring by magnetic force at 60 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
The formula and the preparation method are obtained by screening, and the screening process is as follows:
preparation and screening of active ingredients of the medicine:
decocting 11 medicinal materials except Mentholum in the prescription of HUANGSHIBINGSONG with 6 times of water twice, each for 1 hr, mixing decoctions, standing for precipitation, filtering, concentrating the filtrate to appropriate amount (relative density of 1.35-1.40) to obtain concentrated solution as active ingredient 1;
decocting 11 medicinal materials except Mentholum in the prescription of HUANGSHI Sound with 8 times of water twice, each for 1.5 hr, mixing decoctions, standing for precipitation, filtering, concentrating the filtrate to appropriate amount (relative density of 1.35-1.40) to obtain concentrated solution as active ingredient 2;
decocting 11 medicinal materials except Mentholum in the prescription of HUANGSHI Sound with 10 times of water twice, each for 2 hr, mixing decoctions, standing for precipitation, filtering, concentrating the filtrate to appropriate amount (relative density of 1.35-1.40) to obtain concentrated solution as active ingredient 3;
decocting 11 medicinal materials except Mentholum in the prescription of HUANGSHISONG twice with 6 times of water for 1.5 hr each time, mixing decoctions, standing for precipitation, filtering, concentrating the filtrate to appropriate amount (relative density of 1.35-1.40) to obtain concentrated solution as active ingredient 4;
the concentrated solution is subjected to content measurement of peimine and peiminine to determine the preparation method of the active ingredients of the medicine, and the content measurement results are shown in table 1.
Screening of film-forming materials:
dissolving the film forming material in ethanol with a certain mass fraction, magnetically stirring and dissolving at a certain temperature, standing and degassing the solution, coating the solution on a base material according to a certain specification, drying, cooling, demoulding, and performing disintegration time test, wherein the test results are shown in Table 2.
Screening of the plasticizer:
dissolving the film forming material in ethanol with a certain mass fraction, dissolving the film forming material by magnetic stirring at a certain temperature, adding a plasticizer into the solution dissolved by stirring, continuously performing magnetic stirring dissolution, standing and degassing, coating the film on a base material according to a certain specification, drying, cooling, demolding, and performing disintegration time and elastic modulus tests, wherein the test results are shown in Table 3.
Screening of disintegrating agent:
dissolving a film forming material in ethanol with a certain mass fraction, dissolving the film forming material by magnetic stirring at a certain temperature, adding a plasticizer into the solution dissolved by stirring, continuously dissolving the film forming material by magnetic stirring, adding a disintegrating agent, continuously dissolving the film forming material by magnetic stirring, standing, degassing, coating the film on a base material according to a certain specification, drying, cooling, demoulding, and performing disintegration time test, wherein the test results are shown in table 4.
Screening of the coloring agent:
the effective component extract in the formula has dark color, and TIO2The colorant of the present preparation is preferred because of its high hiding power, stability and good weatherability.
The invention has the advantages that:
the menthol layer is arranged outside the rest Chinese medicinal material film layers, so that the unpleasant smell of the Chinese medicinal extract can be covered, the mint fragrance is provided, the taste is improved, the comfort of a patient in taking the medicine can be improved, and the Chinese medicinal extract is prepared by decocting the Chinese medicinal extract with water, so that the medicinal components are all water-soluble components and can be quickly dissolved after entering the mouth of the patient.
The film agent of the invention is easy to take, is especially suitable for children and old people, and has fast dissolution and absorption.
The preparation method of the invention has simple process and is beneficial to large-scale industrial production.
Detailed Description
Example 1
(1) Decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 12g PVA with water, heating and stirring to dissolve completely, sequentially adding sorbitol 0.6g, CMC4g, the concentrated solution 10g in (1), and TIO20.3 g. Uniformly stirring by magnetic force at 60 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
Example 2
(1) Decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 13g of PVA with water, heating and stirring until the PVA is completely dissolved, and sequentially adding 0.8g of PEG0, 5g of pre-crosslinked starch, 10g of the concentrated solution in the step (1) and TIO20.4 g. Uniformly stirring by magnetic force at 60 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
Example 3
(1) Decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 14g of PVA with water, heating and stirring until the PVA is completely dissolved, and sequentially adding 1.0g of glycerol, 6g of crospovidone, 10g of the concentrated solution in the step (1) and TIO20.2 g. Uniformly stirring by magnetic force at 60 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
Example 4
(1) Decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 15g PVA with water, heating and stirring for dissolving completely, sequentially adding PEG0.7g, CMC3g, the concentrated solution of (1) above, and TIO20.5 g. Uniformly stirring by magnetic force at 60 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
Example 5
(1) Decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 12g of PVA with water, heating and stirring until the PVA is completely dissolved, and sequentially adding 0.9g of sorbitol, 4g of pre-crosslinked starch, 10g of the concentrated solution in the step (1) and TIO20.3 g. Uniformly stirring by magnetic force at 60 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
Example 6
(1) Decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 14g of PVA with water, heating and stirring until the PVA is completely dissolved, and sequentially adding 1.1g of glycerol, 5g of crospovidone, 10g of the concentrated solution in the step (1) and TIO20.4 g. Uniformly stirring by magnetic force at 60 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
Example 7
(1) Decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 15g of PVA with water, heating and stirring until the PVA is completely dissolved, and sequentially adding PEG0.8g, CMC5g, 10g of the concentrated solution in the step (1) and TIO20.3 g. Uniformly stirring by magnetic force at 60 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
Example 8
(1) Decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 15g of PVA with water, heating and stirring until the PVA is completely dissolved, and sequentially adding PEG0.8g, CMC5g, 10g of the concentrated solution in the step (1) and TIO20.3 g. Uniformly stirring by magnetic force at 50 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
Example 9
(1) Decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to a proper amount (the relative density is 1.35-1.40);
(2) mixing 15g of PVA with water, heating and stirring until the PVA is completely dissolved, and sequentially adding PEG0.8g, CMC5g, 10g of the concentrated solution in the step (1) and TIO20.3 g. Uniformly stirring by magnetic force at 40 ℃ to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film;
cutting the obtained medicinal membrane, and sterilizing.
Comparative example
Is treated by Huangshi Xiang Wan.
Blank group
Without any treatment
The beneficial effects of the present invention are further illustrated by the following tests:
the test method comprises the following steps: in each example, 30 patients with chronic pharyngitis of 7-50 years old are selected for experiment, half of the patients are selected
Huangshi Sound film agent (area 1.0 cm) obtained in examples 1 to 92) And the Huangshi Xiangsheng pills in the comparison example are used once in the morning, at noon and at night every day, and 2 tablets are used as the film agent each time. The blank group was not given any medication.
The examination is carried out 7 days after the test, the number of the patients with obvious effect, improvement and ineffectiveness is counted, and the total effective rate is calculated. The therapeutic effect judgment standard is as follows: the method has the following advantages: no obvious pharyngitis symptom exists, and the pharynx is comfortable; improvement: the pharyngitis symptom is still remained, but the pharyngitis symptom is relieved compared with that before the medicine is taken; ③ invalid: the symptoms are not obviously improved.
The test results are shown in Table 5.
Table 1: results of different preparation methods of active ingredients
Figure BDA0001878309500000071
Table 2: disintegration time results for film-forming materials of different mass fractions
PVA quality (g) 12 13 14 15
Disintegration time limit (sec) 36 38 39 39
Table 3: disintegration time and elastic modulus results for different plasticizers
Plasticizer Sorbitol PEG Glycerol
Disintegration time limit (sec) 46 43 45
Modulus of elasticity (MPa) 36 40 35
Table 4: disintegration time results for different disintegrants
Disintegrating agent Pre-crosslinked starch Cross-linked polyvidone CMC
Disintegration time limit (sec) 38 35 30
Table 5: clinical contrast test result of sample on chronic pharyngitis
Patient (example) Show effect Improvement of life Invalidation Total effective rate
Example 1 30 22 7 1 96.7％
Example 2 30 23 6 1 96.7％
Example 3 30 21 8 1 96.7％
Example 4 30 24 5 1 96.7％
Example 5 30 22 7 1 96.7％
Example 6 30 21 8 1 96.7％
Example 7 30 26 4 0 100％
Example 8 30 25 5 0 100％
Example 9 30 24 6 0 100％
Control group 30 25 5 1 96.7％
Blank group 30 0 0 30 0％
As can be seen from the test results of examples 1-9, the Huangshi Sound film agent of the present invention has very significant effect on the treatment of chronic pharyngitis.
The above embodiments are preferred embodiments of the present invention, but the scope of the present invention is not limited thereto, and a person skilled in the art should consider several modifications and variations according to the technical solution of the present invention.

Claims (1)

1. The preparation method of the film agent for treating chronic pharyngitis is characterized by comprising the following steps:
(1) decocting 11 kinds of medicinal materials including 5 parts of boat-fruited sterculia seed, 50 parts of platycodon grandiflorum, 20 parts of periostracum cicadae, 50 parts of liquorice, 50 parts of fructus forsythiae, 20 parts of rheum officinale, 20 parts of ligusticum wallichii, 20 parts of myrobalan pulp, 60 parts of thunberg fritillary bulb, 40 parts of mint and 40 parts of catechu with 6 times of water twice, each time for 1.5 hours, combining decoctions, standing for precipitation, filtering, and concentrating the filtrate to the relative density of 1.35-1.40;
(2) mixing 15g of PVA with water, heating and stirring until the PVA is completely dissolved, and sequentially adding PEG0.8g, CMC5g, 10g of the concentrated solution in the step (1) and TIO20.3g, and uniformly stirring the mixture at 60 ℃ by magnetic force to prepare a mucilage solution;
(3) adding PVA into alcohol solvent, adding menthol while stirring, and stirring to obtain colloidal solution;
(4) and (3) taking the mucilage obtained in the step (2) to prepare a medicine film layer by a tape casting method, adding the mucilage solution obtained in the step (3) on the medicine film layer, continuously preparing the medicine film by the tape casting method, and naturally drying to obtain the medicine film.
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