A preparation method of nasal comfort sheet

Abstract

The present invention provides a method for preparing a nasal comfort tablet, the method comprising: mixing Xanthium sibiricum, Chrysanthemum indica, Herba Capillaris, Angelicae Dahuricae, Saposhnikovia divaricata, Herba Lycopodii, Radix Paeoniae Alba, Radix Glycyrrhizae, and Herba Tribulae, then crushing and ultrafine grinding to obtain a second powder, adding water to mix, then adding microwave and ultrasonic synergistic extraction tank to extract, filtering and concentrating to obtain a thick paste; then adding gallbladder arisaema fine powder and medicinal starch to make granules, adding chlorpheniramine maleate and magnesium stearate, Patchouli oil, and peppermint oil after drying, tableting, sugar coating, and obtaining a nasal comfort tablet. The preparation method of the present invention uses ultrafine grinding to process raw materials, and then combines microwave-ultrasound synergistic extraction, which is conducive to the full dissolution of active ingredients, and avoids the destruction of active ingredients by high temperature, and the prepared nasal comfort tablet has high curative effect. Moreover, the method is simple to operate, suitable for quality control, convenient for industrial production, and has a good application prospect.

Description

Technical Field

[0001] The invention belongs to the technical field of medicine, and particularly relates to a method for preparing a nasal comfort sheet. Background Art

[0002] According to reports, one in six people in the world suffers from various types of rhinitis, and the incidence of rhinitis in China is much higher than this figure. Rhinitis is a common disease. Rhinitis is an inflammatory disease of the nasal cavity. It is an inflammation of the 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 the nasal mucosa. Especially today, when environmental pollution is becoming more and more serious and extreme weather is becoming more and more unpredictable, there are more and more patients with rhinitis, and they tend to be younger. Rhinitis seems to be a minor disease, but it is actually very harmful. It greatly affects the human body's five senses during the onset period, and brings great pain to the work and life of patients with rhinitis. If it is not effectively treated for a long time, it will induce a variety of serious diseases and even endanger life.

[0003] The nose comfort tablets are collected in the seventh volume of the Ministry of Health's drug standard Chinese medicine formula preparations. It is made of Xanthium sibiricum, wild chrysanthemum, goose grass, angelica dahurica, saposhnikovia divaricata, black lotus, white peony root, gall bladder arisaema, liquorice, tribulus terrestris, and chlorpheniramine maleate as raw materials. The nose comfort tablets have the effects of clearing heat and anti-inflammation, and opening the orifices. It is used to treat sneezing, runny nose, nasal congestion, headache caused by chronic rhinitis, allergic rhinitis, and chronic sinusitis. It is easy to use and has a very broad market sales prospect.

[0004] However, there are many production processes for nasal comfort sheets, resulting in uneven quality of nasal comfort sheets. In addition, the traditional process has the disadvantages of low efficacy. Therefore, it is necessary to improve the preparation method of nasal comfort sheets. Summary of the invention

[0005] In view of the deficiencies in the prior art, the technical problem to be solved by the present invention is to provide a method for preparing a nasal comfort sheet. The method uses ultrafine grinding to process the raw materials and combines microwave-ultrasonic synergistic extraction to facilitate the full dissolution of the active ingredients and avoid the destruction of the active ingredients by high temperature. The prepared nasal comfort sheet has high therapeutic effect.

[0006] To achieve the purpose of the present invention, the present invention adopts the following technical solutions:

[0007] The present invention provides a method for preparing a nasal comfort sheet, the method comprising:

[0008] (1) Weigh 364 g of Xanthium sibiricum, 145 g of Chrysanthemum indica, 218 g of Herba Capillaris, 109 g of Angelica dahurica, 109 g of Saposhnikovia divaricata, 218 g of Herba Polygoni Multiflori, 145 g of Paeonia lactiflora, 70 g of Arisaema cinerea, 73 g of Licorice, 218 g of Tribulus terrestris, and 0.3 g of Chlorphenamine maleate, and set aside;

[0009] (2) crushing the Arisaema ciliata weighed in step (1) and passing it through an 80-100 mesh sieve to obtain Arisaema ciliata fine powder;

[0010] (3) mixing the Xanthium sibiricum, Chrysanthemum indica, Herba Capillaris, Angelica dahurica, Saposhnikovia divaricata, Herba Lycopodii, Paeonia lactiflora, Glycyrrhiza uralensis, and Tribulus terrestris weighed in step (1), and then grinding the mixture in a grinder for 1 h to 2 h to obtain a first powder, and then grinding the first powder in an ultrafine grinder for 0.5 h to 1 h to obtain a second powder;

[0011] (4) adding water to the second powder obtained in step (3) and mixing, and then adding the mixture to a microwave and ultrasonic synergistic extraction tank for extraction, filtering and concentrating the extract to obtain a thick paste;

[0012] (5) Adding the fine powder of Arisaema consanguineum obtained in step (2) to the thick paste obtained in step (4), and then adding an appropriate amount of auxiliary material medicinal starch, mixing well, making granules, and then adding the chlorpheniramine maleate weighed in step (1) and an appropriate amount of magnesium stearate, patchouli oil, and peppermint oil after drying, mixing well, tableting, and coating with sugar to obtain nasal comfort tablets.

[0013] Preferably, in step (4):

[0014] The volume ratio of the second powder to water is 1:4-6.

[0015] 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°C, and the extraction time is 1.5-2.5h.

[0016] The concentration is carried out using a vacuum concentration tank, and during the concentration process, the vacuum degree is controlled at 0.04-0.06Mpa.

[0017] Preferably, in step (5):

[0018] The fine powder of Arisaema consanguineum obtained in step (2) is added to the thick paste obtained in step (4), and then an appropriate amount of auxiliary material medicinal starch is added, and the mixture is mixed in a trough mixer, and then the mixture is put into a swing granulator and passed through a 12-mesh sieve to prepare wet granules, and then the mixture is put into a one-step granulator and dried for 30 to 45 minutes. The temperature is controlled at 50 to 60° C. to control the moisture content of the granules to less than 5%, and the drying is stopped. The mixture is poured out, and the mixture is put into a swing granulator and passed through a 14-mesh sieve to prepare granules. Finally, the prepared granules are put into a total mixing device, and the chlorpheniramine maleate weighed in step (1) and an appropriate amount of magnesium stearate, patchouli oil, and peppermint oil are added, and the mixture is mixed, tableted, and coated with sugar to obtain nasal comfort tablets.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] The present invention provides a method for preparing a nasal comfort tablet, which uses ultrafine grinding to process raw materials, and then combines microwave-ultrasound synergistic extraction, which is conducive to the full dissolution of active ingredients and avoids the destruction of active ingredients by high temperature. The prepared nasal comfort tablet has high therapeutic effect, thereby reducing the oral dosage and reducing the side effects of oral drugs on human liver. Moreover, the method is simple to operate, suitable for quality control, convenient for industrial production, and has good application prospects. DETAILED DESCRIPTION

[0021] The embodiments of the present invention are described in detail below. The embodiments are given to better illustrate the contents of the present invention and are only used to explain the present invention, but should not be understood as limiting the present invention.

[0022] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0023] Embodiment 1: A method for preparing a nasal comfort sheet, comprising:

[0024] (1) Weigh 364 g of Xanthium sibiricum, 145 g of Chrysanthemum indica, 218 g of Herba Capillaris, 109 g of Angelica dahurica, 109 g of Saposhnikovia divaricata, 218 g of Polygonum multiflorum, 145 g of Paeonia lactiflora, 70 g of Arisaema cinerea, 73 g of Licorice, 218 g of Tribulus terrestris, and 0.3 g of Chlorphenamine maleate;

[0025] (2) crushing the Arisaema ciliata weighed in step (1) and passing it through an 80-mesh sieve to obtain Arisaema ciliata fine powder;

[0026] (3) mixing the Xanthium sibiricum, Chrysanthemum indica, Herba Capillaris, Angelica dahurica, Saposhnikovia divaricata, Herba Lycopodii, Paeonia lactiflora, Glycyrrhiza uralensis, and Tribulus terrestris weighed in step (1), and then grinding the mixture in a grinder for 1 hour to obtain a first powder, and then grinding the first powder in an ultrafine grinder for 0.5 hour to obtain a second powder;

[0027] (4) adding 4 times the volume of water to the second powder obtained in step (3), stirring and mixing, and then adding the powder to a microwave and ultrasonic synergistic extraction tank for extraction, wherein the ultrasonic frequency is 30 kHz and the power is 0.8 kW; the microwave frequency is 1500 MHz and the power is 2 kW; the synergistic extraction temperature is 55° C. and the extraction time is 1.5 h; the obtained extract is filtered, and the filtrate is concentrated in a vacuum concentrator with the vacuum degree controlled at 0.04 MPa. When the extract is concentrated to a density of 1.30 to 1.35, a thick paste is obtained;

[0028] (5) Add the fine powder of Arisaema consanguineum obtained in step (2) to the thick paste obtained in step (4), and then add an appropriate amount of auxiliary material medicinal starch, mix well in a trough mixer, put into a swing granulator and pass through a 12-mesh sieve to prepare wet granules, then put into a one-step granulator and dry for 30 minutes, control the temperature at 50°C to control the moisture content of the granules to less than 5%, stop drying, pour out, put into a swing granulator and pass through a 14-mesh sieve to granulate, finally put the prepared granules into a total mixing device, add the chlorpheniramine maleate weighed in step (1) and an appropriate amount of magnesium stearate, 0.5 ml of patchouli oil, and 0.5 ml of peppermint oil, mix well, press into tablets, and coat with sugar to obtain 1000 nose comfort tablets (0.2 g per tablet).

[0029] Embodiment 2: The preparation method of the nasal comfort sheet comprises:

[0030] (1) Weigh 364 g of Xanthium sibiricum, 145 g of Chrysanthemum indica, 218 g of Herba Capillaris, 109 g of Angelica dahurica, 109 g of Saposhnikovia divaricata, 218 g of Polygonum multiflorum, 145 g of Paeonia lactiflora, 70 g of Arisaema cinerea, 73 g of Licorice, 218 g of Tribulus terrestris, and 0.3 g of Chlorphenamine maleate;

[0031] (2) crushing the Arisaema ciliata weighed in step (1) and passing it through a 100-mesh sieve to obtain Arisaema ciliata fine powder;

[0032] (3) mixing the Xanthium sibiricum, Chrysanthemum indica, Herba Capillaris, Angelica dahurica, Saposhnikovia divaricata, Herba Lycopodii, Paeonia lactiflora, Glycyrrhiza uralensis, and Tribulus terrestris weighed in step (1), and then grinding the mixture in a grinder for 2 h to obtain a first powder, and then grinding the first powder in an ultrafine grinder for 1 h to obtain a second powder;

[0033] (4) adding 4 times the volume of water to the second powder obtained in step (3), stirring and mixing, and then adding the powder to a microwave and ultrasonic synergistic extraction tank for extraction, wherein the ultrasonic frequency is 40 kHz and the power is 1 kW; the microwave frequency is 1600 MHz and the power is 2.5 kW; the synergistic extraction temperature is 65° C. and the extraction time is 2.5 h; the obtained extract is filtered, and the filtrate is concentrated in a vacuum concentrator with the vacuum degree controlled at 0.06 MPa. When the extract is concentrated to a density of 1.30 to 1.35, a thick paste is obtained;

[0034] (5) Add the fine powder of Arisaema consanguineum obtained in step (2) to the thick paste obtained in step (4), and then add an appropriate amount of auxiliary material medicinal starch, mix well in a trough mixer, put into a swing granulator to pass through a 12-mesh sieve to prepare wet granules, and then put into a one-step granulator to dry for 45 minutes, control the temperature at 60°C so that the moisture content of the granules is controlled within 5%, stop drying, pour out, put into a swing granulator to pass through a 14-mesh sieve to granulate, and finally put the prepared granules into a total mixing device, add the chlorpheniramine maleate weighed in step (1) and an appropriate amount of magnesium stearate, 0.5 ml of patchouli oil, and 0.5 ml of peppermint oil, mix well, press into tablets, and coat with sugar to obtain 1000 nose comfort tablets (0.2 g per tablet).

[0035] Clinical Trials

[0036] 1. TCM diagnostic criteria

[0037] Refer to the Traditional Chinese Medicine Industry Standard of the People's Republic of China issued by the State Administration of Traditional Chinese Medicine, "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes".

[0038] 2. Research subjects

[0039] A total of 90 patients with chronic rhinitis aged 20-60 years who visited the otorhinolaryngology clinic and met the diagnostic criteria were randomly divided into three groups.

[0040] 3. Research Methods

[0041] Treatment group 1: Orally take the nasal comfort tablets prepared in Example 1, 3 times a day, 4 tablets each time, 7 days as a course of treatment, and take it continuously for 2 courses of treatment.

[0042] Treatment group 2: Orally take the nasal comfort tablets prepared in Example 2, 3 times a day, 4 tablets each time, 7 days as a course of treatment, and take it continuously for 2 courses of treatment.

[0043] Control group: Orally take Xinfeng Pharmaceutical's nasal comfort tablets, 3 times a day, 4 tablets each time, 7 days as a course of treatment, and take it continuously for 2 courses.

[0044] No other drugs or methods were used during the entire treatment process, and observation and evaluation were performed on the 1st, 7th, 9th, 12th, and 14th days of treatment. The results are shown in Table 1.

[0045] Observe the symptoms: sneezing, runny nose, nasal congestion, headache, swollen nasal concha, mucosal and nasal secretions, tongue and pulse.

[0046] Clinical efficacy evaluation criteria

[0047] (1) Cured: Symptoms such as sneezing, nasal congestion, runny nose, and headache disappear, and nasal examination is normal, with a score of 0.

[0048] (2) Markedly effective: The main symptoms and signs were significantly improved (50-70%), and the score was reduced by 2 / 3.

[0049] (3) Effective: Symptoms such as sneezing, nasal congestion, runny nose, and headache are alleviated, local signs are significantly improved, and the score is reduced by 1 / 3.

[0050] (4) Ineffective: There is no significant improvement in symptoms and signs, and no change in the score.

[0051] Table 1: The therapeutic effect of nasal comfort tablets

[0052]

[0053]

[0054] As can be seen from Table 1, the nasal comfort sheet prepared by the preparation method of the present invention has an obvious therapeutic effect on chronic rhinitis, and its therapeutic effect is significantly higher than the existing commercially available nasal comfort sheet. In addition, the preparation method of the present invention is simple to operate, suitable for quality control, convenient for industrial production, and has good application prospects.

[0055] Obviously, the above embodiments are only examples for clearly explaining the present invention, and are not intended to limit the implementation methods of the present invention. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A method for preparing a nasal comfort sheet, characterized in that: The method comprises: (1) Weigh 364 g of Xanthium sibiricum, 145 g of Chrysanthemum indica, 218 g of Herba Capillaris, 109 g of Angelica dahurica, 109 g of Saposhnikovia divaricata, 218 g of Polygonum multiflorum, 145 g of Paeonia lactiflora, 70 g of Arisaema cinerea, 73 g of Licorice, 218 g of Tribulus terrestris, and 0.3 g of Chlorphenamine maleate, and set aside; (2) crushing the Arisaema ciliata weighed in step (1) and passing it through a 80-100 mesh sieve to obtain Arisaema ciliata fine powder; (3) Mix the Xanthium sibiricum, Chrysanthemum indica, Herba Capillaris, Angelica dahurica, Saposhnikovia divaricata, Polygonum multiflorum, Paeonia lactiflora, Glycyrrhiza uralensis, and Tribulus terrestris weighed in step (1), and then grind them in a grinder for 1 h to 2 h to obtain a first powder, and then grind the first powder in an ultrafine grinder for 0.5 h to 1 h to obtain a second powder; (4) adding water to the second powder obtained in step (3) and mixing, and then adding the mixture to a microwave and ultrasonic synergistic extraction tank for extraction, filtering and concentrating the extract to obtain a thick paste; (5) Adding the fine powder of Arisaema consanguineum obtained in step (2) to the thick paste obtained in step (4), and then adding an appropriate amount of auxiliary material medicinal starch, mixing well, making granules, and then adding the chlorpheniramine maleate weighed in step (1) and an appropriate amount of magnesium stearate, patchouli oil, and peppermint oil after drying, mixing well, tableting, and coating with sugar to obtain nasal comfort tablets; Wherein, in step (4), the volume ratio of the second powder to water is 1:4-6; In step (4), the ultrasonic frequency is 30-40KHz, the power is 0.8-1KW; the microwave frequency is 1500-1600MHz, the power is 2-2.5KW; the synergistic extraction temperature is 55-65°C; the extraction time is 1.5-2.5h; In step (4), the concentration is carried out using a vacuum concentration tank, and during the concentration process, the vacuum degree is controlled at 0.04-0.06 MPa.

2. The preparation method according to claim 1, characterized in that: In step (5), the fine powder of Arisaema consanguineum obtained in step (2) is added to the thick paste obtained in step (4), and then an appropriate amount of auxiliary material medicinal starch is added, and the mixture is mixed in a trough mixer, and then placed in a swing granulator to pass through a 12-mesh sieve to prepare wet granules, and then placed in a one-step granulator for drying for 30 to 45 minutes, and the temperature is controlled at 50 to 60° C. to control the moisture content of the granules to less than 5%. The drying is stopped, the granules are poured out, and placed in a swing granulator to pass through a 14-mesh sieve to granulate the granules. Finally, the prepared granules are placed in a total mixing device, and the chlorpheniramine maleate weighed in step (1) and an appropriate amount of magnesium stearate, patchouli oil, and peppermint oil are added, mixed, tableted, and coated with sugar to obtain nasal comfort tablets.

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