CN117599012A - Preparation method of nose comfort tablet - Google Patents

Preparation method of nose comfort tablet Download PDF

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Publication number
CN117599012A
CN117599012A CN202311682556.9A CN202311682556A CN117599012A CN 117599012 A CN117599012 A CN 117599012A CN 202311682556 A CN202311682556 A CN 202311682556A CN 117599012 A CN117599012 A CN 117599012A
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powder
cum bile
arisaema cum
mixing
tablet
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李治尧
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Guangxi Ditai Pharmaceutical Co ltd
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Guangxi Ditai Pharmaceutical Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • A61K9/2826Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4402Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
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    • A61K36/238Saposhnikovia
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Abstract

The invention provides a preparation method of a nose comfort tablet, which comprises the following steps: mixing fructus Xanthii, flos Chrysanthemi Indici, herba Centipedae, radix Angelicae Dahuricae, radix Saposhnikoviae, herba Ecliptae, radix Paeoniae alba, glycyrrhrizae radix and fructus Tribuli, pulverizing, micronizing to obtain second powder, mixing with water, extracting in a microwave and ultrasonic synergistic extraction tank, filtering, and concentrating to obtain soft extract; adding Arisaema cum bile fine powder and medicinal starch, granulating, drying, adding chlorpheniramine maleate, magnesium stearate, oleum herba Pogostemonis, and oleum Menthae Dementholatum, tabletting, and sugar coating. The preparation method adopts superfine grinding to treat the raw materials, and combines microwave-ultrasonic synergistic extraction to facilitate the full dissolution of active ingredients, avoid the damage of high temperature to the active ingredients, and the prepared nasal comfort tablet has high curative effect. Moreover, the method is simple to operate, is suitable for quality control, is convenient for industrial production, and has good application prospect.

Description

Preparation method of nose comfort tablet
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a preparation method of a nose comfort tablet.
Background
It is reported that one sixth of people worldwide suffer from various rhinitis, and domestic rhinitis incidence is far higher than this data. Rhinitis is a common disease, namely, nasal inflammatory disease, is inflammation of nasal mucosa caused by viruses, bacteria, allergens, various physical and chemical factors and certain systemic diseases, the main pathological changes of rhinitis are congestion, swelling, exudation, hyperplasia, atrophy or necrosis of nasal mucosa, and the like, especially in the days of increasingly serious environmental pollution and increasingly severe extreme weather with ever-changing changes, rhinitis patients are more and less aged, the rhinitis looks like small diseases and is very harmful, the five sense organs of a human body are greatly influenced in the onset period, great pain is brought to the work and life of the rhinitis patients, and a plurality of serious diseases are induced even endangered by the fact that effective treatment is not available for a long time.
And the nose comfort tablet is stored in a seventh book of standard Chinese medicine prescription preparation of the ministry of health. Is prepared from fructus Xanthii, flos Chrysanthemi Indici, herba Centipedae, radix Angelicae Dahuricae, radix Saposhnikoviae, herba Ecliptae, radix Paeoniae alba, rhizoma arisaematis cum bile, glycyrrhrizae radix, fructus Tribuli, and chlorpheniramine maleate. The nasal comforting tablet has effects of clearing heat, relieving inflammation, and inducing resuscitation, and can be used for treating sneeze, watery nasal discharge, nasal obstruction, headache, allergic rhinitis, and chronic sinusitis caused by chronic rhinitis. And the use is convenient, and the market prospect is extremely wide.
However, the existing production process of the nose comfort tablet is quite a lot, so that the quality of the nose comfort tablet is uneven, and in addition, the nose comfort tablet is prepared by adopting the traditional process, and has the defects of low curative effect and the like. Thus, there is a need for an improved process for preparing nasal comfort tablets.
Disclosure of Invention
In view of the defects of the prior art, the technical problem to be solved by the invention is to provide a preparation method of the nose comfort tablet, which adopts superfine grinding to treat raw materials, combines microwave-ultrasonic synergistic extraction, is beneficial to fully dissolving out active ingredients, avoids damaging the active ingredients at high temperature, and has high curative effect.
In order to achieve the purpose of the invention, the invention adopts the following technical scheme:
the invention provides a preparation method of a nose comfort tablet, which comprises the following steps:
(1) Weighing 364g of fructus xanthil, 145g of wild chrysanthemum, 218g of centipeda minima, 109g of angelica dahurica, 109g of radix sileris, 218g of eclipta alba, 145g of white peony root, 70g of arisaema cum bile, 73g of liquorice, 218g of caltrop and 0.3g of chlorpheniramine maleate for later use;
(2) Crushing the arisaema cum bile weighed in the step (1), and sieving the crushed arisaema cum bile by a 80-100-mesh sieve to obtain arisaema cum bile fine powder;
(3) Mixing the cocklebur fruit, the wild chrysanthemum flower, the centipeda minima, the angelica dahurica, the radix sileris, the eclipta alba, the liquorice and the caltrop which are weighed in the step (1), crushing for 1-2 hours by adopting a crusher to obtain first powder, and then putting the first powder into an ultrafine crusher to crush for 0.5-1 hour to obtain second powder;
(4) Adding water into the second powder prepared in the step (3) for mixing, then adding the mixture into a microwave and ultrasonic synergistic extraction tank for extraction, and filtering and concentrating the extract to obtain thick paste;
(5) Adding the arisaema cum bile fine powder obtained in the step (4) into the thick paste obtained in the step (2), adding a proper amount of auxiliary material medical starch, uniformly mixing, granulating, drying, adding chlorpheniramine maleate and a proper amount of magnesium stearate, patchouli oil and peppermint oil which are weighed in the step (1), uniformly mixing, tabletting, and coating with sugar to obtain the nasal comfort tablet.
Preferably, in step (4):
the volume ratio of the second powder to the water is 1:4-6.
The ultrasonic frequency is 30-40KHz, and the power is 0.8-1KW; the microwave frequency is 1500-1600MHz, and the power is 2-2.5KW; the synergistic extraction temperature is 55-65deg.C, and the extraction time is 1.5-2.5 hr.
The concentration adopts a vacuum concentration tank, and the vacuum degree is controlled to be 0.04-0.06 Mpa in the concentration process.
Preferably, in step (5):
adding Arisaema cum bile fine powder obtained in the step (4) into the thick paste obtained in the step (2), adding a proper amount of medicinal starch serving as an auxiliary material, uniformly mixing in a groove type mixer, adding a swing type granulator, sieving with a 12-mesh sieve to prepare wet granules, then adding a one-step granulator, drying for 30-45 minutes, controlling the temperature at 50-60 ℃ to enable the moisture of the granules to be within 5%, stopping drying, pouring out, adding a swing type granulator, sieving with a 14-mesh sieve to prepare granules, finally adding the prepared granules into a total mixing device, adding chlorpheniramine maleate weighed in the step (1) and a proper amount of magnesium stearate, patchouli oil and peppermint oil, uniformly mixing, tabletting, and coating sugar to obtain the nasal comfort tablet.
Compared with the prior art, the invention has the following beneficial effects:
the invention provides a preparation method of a nose comfort tablet, which adopts superfine grinding to treat raw materials, combines microwave-ultrasonic synergistic extraction to be beneficial to the full dissolution of active ingredients, avoids the damage of high temperature to the active ingredients, and has high curative effect, thereby reducing the dosage of oral administration and reducing the side effect of oral administration medicine to human liver. Moreover, the method is simple to operate, is suitable for quality control, is convenient for industrial production, and has good application prospect.
Detailed Description
The following detailed description of the embodiments of the present invention is provided for better illustration of the present invention, but is not to be construed as limiting the invention.
The specific techniques or conditions are not identified in the examples and are described in the literature in this field or are carried out in accordance with the product specifications. The reagents or equipment used were conventional products available for purchase through regular channels, with no manufacturer noted.
Example 1: a method of preparing a nasal comfort tablet comprising:
(1) Weighing 364g of fructus xanthil, 145g of wild chrysanthemum flower, 218g of centipeda minima, 109g of angelica dahurica, 109g of radix sileris, 218g of eclipta alba, 145g of white peony root, 70g of arisaema cum bile, 73g of liquorice, 218g of caltrop and 0.3g of chlorpheniramine maleate;
(2) Crushing the arisaema cum bile weighed in the step (1), and sieving the crushed arisaema cum bile with a 80-mesh sieve to obtain arisaema cum bile fine powder;
(3) Mixing the cocklebur fruit, the wild chrysanthemum flower, the centipeda minima, the angelica dahurica, the radix sileris, the eclipta alba, the liquorice and the caltrop which are weighed in the step (1), crushing for 1h by adopting a crusher to obtain first powder, and then placing the first powder into a superfine crusher to crush for 0.5h to obtain second powder;
(4) Adding water with the volume being 4 times that of the second powder prepared in the step (3), stirring and mixing, then adding the second powder into a microwave and ultrasonic wave synergistic extraction tank for extraction, wherein the ultrasonic frequency is 30KHz, and the power is 0.8KW; the microwave frequency is 1500MHz, and the power is 2KW; the synergic extraction temperature is 55 ℃, and the extraction time is 1.5h; filtering the obtained extracting solution, concentrating the filtrate by adopting a vacuum concentration tank, controlling the vacuum degree to be 0.04Mpa, and preparing thick paste when the extracting solution is concentrated to the density of 1.30-1.35;
(5) Adding Arisaema cum bile fine powder obtained in the step (4) into the thick paste obtained in the step (2), adding a proper amount of auxiliary material medicinal starch, uniformly mixing in a groove type mixer, adding a swing type granulator, sieving with a 12-mesh sieve to prepare wet granules, then placing into a one-step granulator for drying for 30 minutes, controlling the temperature at 50 ℃ to control the water content of the granules to be within 5%, stopping drying, pouring out, placing into a swing type granulator, sieving with a 14-mesh sieve to obtain granules, finally putting the prepared granules into a total mixing device, adding chlorpheniramine maleate weighed in the step (1) and a proper amount of magnesium stearate, 0.5ml of patchouli oil and 0.5ml of peppermint oil, uniformly mixing, tabletting, and coating sugar to obtain 1000 nasal comfort tablets (0.2 g each tablet).
Example 2: a method of preparing a nasal comfort tablet comprising:
(1) Weighing 364g of fructus xanthil, 145g of wild chrysanthemum flower, 218g of centipeda minima, 109g of angelica dahurica, 109g of radix sileris, 218g of eclipta alba, 145g of white peony root, 70g of arisaema cum bile, 73g of liquorice, 218g of caltrop and 0.3g of chlorpheniramine maleate;
(2) Crushing the arisaema cum bile weighed in the step (1), and sieving the crushed arisaema cum bile by a 100-mesh sieve to obtain arisaema cum bile fine powder;
(3) Mixing the cocklebur fruit, the wild chrysanthemum flower, the centipeda minima, the angelica dahurica, the radix sileris, the eclipta alba, the liquorice and the caltrop which are weighed in the step (1), crushing the mixture for 2 hours by a crusher to obtain first powder, and then placing the first powder into a superfine crusher to crush for 1 hour to obtain second powder;
(4) Adding water with the volume being 4 times that of the second powder prepared in the step (3), stirring and mixing, and then adding the second powder into a microwave and ultrasonic wave synergistic extraction tank for extraction, wherein the ultrasonic wave frequency is 40KHz, and the power is 1KW; the microwave frequency is 1600MHz, and the power is 2.5KW; the synergistic extraction temperature is 65 ℃ and the extraction time is 2.5h; filtering the obtained extracting solution, concentrating the filtrate by adopting a vacuum concentration tank, controlling the vacuum degree to be 0.06Mpa, and preparing thick paste when the extracting solution is concentrated to the density of 1.30-1.35;
(5) Adding Arisaema cum bile fine powder obtained in the step (4) into the thick paste obtained in the step (2), adding a proper amount of auxiliary material medicinal starch, uniformly mixing in a groove type mixer, adding a swing type granulator, sieving with a 12-mesh sieve to prepare wet granules, then placing into a one-step granulator for drying for 45 minutes, controlling the temperature to be 60 ℃ so that the water content of the granules is controlled to be within 5%, stopping drying, pouring out, placing into a swing type granulator, sieving with a 14-mesh sieve to prepare granules, finally putting the prepared granules into a total mixing device, adding chlorpheniramine maleate weighed in the step (1) and a proper amount of magnesium stearate, 0.5ml of patchouli oil and 0.5ml of peppermint oil, uniformly mixing, tabletting, and coating sugar to obtain 1000 nasal comfort tablets (0.2 g each tablet).
Clinical trials
1. Diagnostic criteria for traditional Chinese medicine
The traditional Chinese medicine diagnosis and treatment standard of the traditional Chinese medicine disease is referred to the traditional Chinese medicine industry standard of the people's republic of China issued by the national traditional Chinese medicine administration.
2. Study object
The experimental cases are selected from 90 cases of chronic rhinitis patients which are diagnosed at the clinic of otorhinolaryngology department, are 20-60 years old and meet the diagnosis standard, and are randomly divided into 3 groups.
3. Research method
Treatment group 1: the nasal comforting tablet prepared in example 1 was orally taken 3 times a day, 4 tablets at a time, and 7 days as a course of treatment, followed by 2 courses of treatment.
Treatment group 2: the nasal comforting tablet prepared in example 2 was orally taken 3 times a day, 4 tablets at a time, and 7 days as a course of treatment, followed by 2 courses of treatment.
Control group: the nasal comfort tablet of the new peak pharmaceutical industry is orally taken 3 times a day, 4 tablets at a time, 7 days is a treatment course, and 2 treatment courses are continuously taken.
No other therapeutic agents or methods were used throughout the treatment, and observations and evaluations were made on days 1, 7, 9, 12, 14 of the treatment. The results are shown in Table 1.
The symptoms were observed: sneeze, nasal discharge, nasal obstruction, headache, turbinate swelling, mucous membrane and nasal secretion, tongue and pulse.
Clinical efficacy assessment criteria
(1) And (3) curing: symptoms such as sneeze, nasal obstruction, watery nasal discharge, headache and the like disappear, and the nasal cavity is checked to be normal, and the score is 0.
(2) The effect is shown: the sign of the main symptoms is obviously improved (50-70%), and the integral is reduced by 2/3.
(3) The method is effective: the symptoms of sneeze, nasal obstruction, nasal discharge, headache and the like are reduced, the local physical signs are obviously improved, and the integral is reduced by 1/3.
(4) Invalidation: no significant improvement in symptoms and signs, no change in integration.
Table 1: therapeutic effect of nasal comfort tablets
As can be seen from Table 1, the nasal comfort tablet prepared by the preparation method has obvious treatment effect on chronic rhinitis, and the treatment effect is obviously higher than that of the existing commercial nasal comfort tablet. The preparation method is simple to operate, is suitable for quality control, is convenient for industrial production, and has good application prospect.
It is apparent that the above examples are only illustrative of the present invention and are not limiting of the embodiments of the present invention. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims (5)

1. A method of preparing a nasal comfort tablet, the method comprising:
(1) Weighing 364g of fructus xanthil, 145g of wild chrysanthemum, 218g of centipeda minima, 109g of angelica dahurica, 109g of radix sileris, 218g of eclipta alba, 145g of white peony root, 70g of arisaema cum bile, 73g of liquorice, 218g of caltrop and 0.3g of chlorpheniramine maleate for later use;
(2) Crushing the arisaema cum bile weighed in the step (1), and sieving the crushed arisaema cum bile by a 80-100-mesh sieve to obtain arisaema cum bile fine powder;
(3) Mixing the cocklebur fruit, the wild chrysanthemum flower, the centipeda minima, the angelica dahurica, the radix sileris, the eclipta alba, the liquorice and the caltrop which are weighed in the step (1), crushing for 1-2 hours by adopting a crusher to obtain first powder, and then putting the first powder into an ultrafine crusher to crush for 0.5-1 hour to obtain second powder;
(4) Adding water into the second powder prepared in the step (3) for mixing, then adding the mixture into a microwave and ultrasonic synergistic extraction tank for extraction, and filtering and concentrating the extract to obtain thick paste;
(5) Adding the arisaema cum bile fine powder obtained in the step (4) into the thick paste obtained in the step (2), adding a proper amount of auxiliary material medical starch, uniformly mixing, granulating, drying, adding chlorpheniramine maleate and a proper amount of magnesium stearate, patchouli oil and peppermint oil which are weighed in the step (1), uniformly mixing, tabletting, and coating with sugar to obtain the nasal comfort tablet.
2. The method according to claim 1, wherein in the step (4), the volume ratio of the second powder to water is 1:4-6.
3. The method according to claim 1, wherein in the step (4), the ultrasonic frequency is 30-40KHz and the power is 0.8-1KW; the microwave frequency is 1500-1600MHz, and the power is 2-2.5KW; the synergistic extraction temperature is 55-65 ℃; the extraction time is 1.5-2.5h.
4. The method according to claim 1, wherein in the step (4), the concentration is performed in a vacuum concentration tank, and the vacuum degree is controlled to be 0.04-0.06 Mpa during the concentration.
5. The preparation method of claim 1, wherein in the step (5), the arisaema cum bile fine powder of the step (2) is added into the thick paste prepared in the step (4), then a proper amount of auxiliary material medical starch is added, the mixture is uniformly mixed in a groove type mixer, then the mixture is put into a swing type granulator to be wet through a 12-mesh sieve, the mixture is put into a one-step granulator to be dried for 30 to 45 minutes, the temperature is controlled to be 50 to 60 ℃ to ensure that the water content of the particles is controlled to be within 5 percent, the mixture is stopped to be dried, poured out, put into a swing type granulator to be sieved through a 14-mesh sieve for finishing, and finally the prepared particles are put into a total mixing device, and then the chlorpheniramine maleate weighed in the step (1) and a proper amount of magnesium stearate, the sesame oil and the peppermint oil are added, uniformly mixed, pressed into tablets and sugar-coated to obtain the nose comfort tablet.
CN202311682556.9A 2023-12-08 2023-12-08 Preparation method of nose comfort tablet Pending CN117599012A (en)

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Publication number Priority date Publication date Assignee Title
CN102988480A (en) * 2012-10-08 2013-03-27 卞毓平 Method for preparing bile and patchouli rhinitis tablets and application
CN104983967A (en) * 2015-06-18 2015-10-21 南京华宽信息咨询中心 Preparation method and application of nasal comforting tablets
CN113940957A (en) * 2021-12-02 2022-01-18 张鹏 Formula for treating rhinitis disease

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CN102988480A (en) * 2012-10-08 2013-03-27 卞毓平 Method for preparing bile and patchouli rhinitis tablets and application
CN104983967A (en) * 2015-06-18 2015-10-21 南京华宽信息咨询中心 Preparation method and application of nasal comforting tablets
CN113940957A (en) * 2021-12-02 2022-01-18 张鹏 Formula for treating rhinitis disease

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