Nasal cavity hot compress patch and preparation method thereof
The nasal hot compress prepared by using raw materials such as Xanthium, Cyclotrium, Red Astragalus polysaccharide, Ginkgo, Half Lotus and Bitter Almond Oil, combined with composite enzyme extraction and weak alkaline buffer solution extraction technology, the traditional treatment of rhinitis is not effective. The problem of good and major side effects has achieved effective nasal redness, itching and anti-inflammatory effects, significantly improving the efficacy of treating rhinitis and reducing side effects.
Patent Information
- Application Number
- CN202411074542.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-08-07
- Publication Date
- 2024-12-13
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
The existing treatment methods for rhinitis have problems such as poor efficacy, high side effects and high cost. Especially for patients with stubborn rhinitis, traditional external paste can easily cause adverse skin reactions, and oral medications can be slow to take effect.
Prepare the nasal hot compress patch by using raw materials such as Xanthium, Pineapple, Red Astragalus polysaccharide, Ginkgo, Half Lotus and Bitter Almond Oil. Combined with the steps of vacuum drying, sieving, mixing, adding beeswax and Bitter Almond Oil, sterilizing, etc. Extraction and weakly alkaline buffer solution leaching technology improves the purity and active ingredients of red astragalus polysaccharide and bitter almond oil, and enhances the therapeutic effect of nasal hot compress.
Effectively treat nasal redness, control nasal bleeding, nasal itching and sneezing, it has anti-inflammatory effects in nasal cavity, significantly reduces the levels of nasal inflammatory factors and histamine in rats, improves the efficacy of treating rhinitis and reduces side effects.
Smart Images
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Abstract
Description
Technical Field
[0001] The invention relates to a nasal medicine preparation, in particular to a preparation method of a nasal hot compress patch. Background Art
[0002] Allergic rhinitis (AR) is an immune system type I allergic disease induced by inflammation mediated by immunoglobulin E. Its clinical manifestations include intermittent and alternating nasal congestion, headache, increased nasal secretions, sneezing, and a small amount of bleeding. It can occur all year round, especially in the northwest region of my country where the climate is cold and dry in winter, and the chance of suffering from rhinitis increases. Other complications caused by rhinitis include: emphysema, cor pulmonale, asthma, otitis media, meningitis, etc. Long-term nasal congestion and difficulty breathing can cause sleep apnea syndrome, insufficient oxygen during sleep, and in severe cases, cerebral infarction, hypertension, sudden heart attack, etc., and some patients may even die suddenly at night. At present, the commonly used Western medicines for the treatment of rhinitis include corticosteroids, mast cell stabilizers, anticholinergics, antihistamines, leukotriene receptor antagonists, etc., but the therapeutic effect of Western medicines is limited, and the price is expensive and the cost is high. Traditional Chinese medicine for the treatment of rhinitis advocates the external treatment method of "exorcising evil spirits nearby", but oral medicine has the disadvantages of long conditioning time and slow effect. Therefore, external application of plasters to treat or alleviate symptoms is a good choice, but external application of plasters can easily cause adverse reactions such as skin redness, swelling, and blistering at the contact site of the patient. There are many ways to treat rhinitis, such as taking medicine, nasal drops, and nasal puncture, but for many patients with stubborn rhinitis, the effect is minimal or the disease often recurs, so that the pain of rhinitis patients cannot be fundamentally relieved, and the cost of treatment is also high. Therefore, a plaster for the treatment of rhinitis that is easy to carry, has good efficacy, low cost, and few side effects has become an important demand for rhinitis patients. Summary of the invention
[0003] In view of this, the present invention develops a method for preparing a nasal hot compress patch.
[0004] The technical solution of the present invention is achieved in this way:
[0005] A method for preparing a nasal hot compress patch comprises the following steps:
[0006] A method for preparing a nasal hot compress patch comprises the following raw materials in parts by weight: 60-65 parts of Xanthium sibiricum, 50-55 parts of Cynanchum paniculatum, 20-25 parts of Hedysari polysaccharide, 10-15 parts of Ginkgo biloba, 5-10 parts of Lobelia chinensis, and 5-10 parts of bitter almond oil; the method comprises the following preparation steps: vacuum drying Xanthium sibiricum, Cynanchum paniculatum, Hedysari polysaccharide, Ginkgo biloba, and Lobelia chinensis, sieving, adding bitter almond oil and beeswax after mixing, stirring, immersing slices, and sterilizing to obtain a finished product.
[0007] The preparation of Heshen polysaccharide comprises the following steps: adding Heshen to complex enzyme, stirring, ultrasonic extraction, adding ethanol solution, leaching, and obtaining Heshen polysaccharide.
[0008] Furthermore, the complex enzyme is cellulase and ficin, and the mass ratio of cellulase to ficin is 1:(1.2-1.5).
[0009] Furthermore, the pH of the complex enzyme extraction is 5-5.7, the temperature is 45-50° C., and the extraction time is 2.5-3.0 h; the concentration of the ethanol solution is 90-95% vol.
[0010] The preparation of bitter almond oil comprises the following steps: frying bitter almonds with salt over a warm fire, crushing them to a particle size of 20-40 meshes, placing them in a weak alkaline buffer solution for leaching, and taking the upper layer of liquid after leaching to obtain bitter almond oil.
[0011] Furthermore, the salt is fried over a warm fire at a temperature of 55-60° C. for 3-3.5 hours, and the particle size of the salt during the salt frying is 3-10 mm.
[0012] Furthermore, the weakly alkaline buffer solution is a sodium carbonate-sodium bicarbonate buffer solution with a pH value of 7.5-8.0, and the mass volume ratio of bitter almonds to the buffer solution is (0.2-0.5) mg / mL:1.
[0013] Furthermore, the vacuum drying has a vacuum degree of 75-80 kPa, a time of 90-120 min, a temperature of 50-60° C., and the sieving is through a 160-200 mesh sieve.
[0014] Compared with the prior art, the present invention has the following beneficial effects:
[0015] The present invention uses Xanthium sibiricum, Herba Aspergillus, Herba Aspergillus polysaccharides, Ginkgo biloba, Herba Lobelia and bitter almond oil raw materials for compounding, adds Herba Aspergillus polysaccharides to complex enzymes, stirs, adds ethanol ultrasonic extraction twice to prepare Herba Aspergillus polysaccharides, stirs bitter almond salt, extracts with weak alkaline buffer solution, and prepares bitter almond oil. The preparation methods of Herba Aspergillus polysaccharides and bitter almond oil are combined to improve the purity and quality of effective ingredients in Herba Aspergillus polysaccharides and bitter almond oil, and improve the effectiveness of nasal hot compress. Xanthium sibiricum and Herba Aspergillus polysaccharides in the nasal hot compress of the present invention have the effects of dispelling rheumatism, dispersing wind and cold, and clearing the nasal passages, Herba Aspergillus polysaccharides can inhibit the levels of histamine and IgE in serum, and bitter almond oil can soften the stratum corneum of the skin, moisturize and protect the skin, and Ginkgo biloba and Herba Lobelia clear away heat and detoxify, promote diuresis and reduce swelling, and after compounding, nasal redness and swelling can be effectively treated, nasal bleeding, nasal itching and sneezing can be controlled, and the nasal anti-inflammatory effect is achieved. DETAILED DESCRIPTION
[0016] In order to better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention. The experimental methods used in the examples of the present invention are all conventional methods unless otherwise specified.
[0017] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.
[0018] Cellulase: purity 99%, Hubei Zhenfu Pharmaceutical Co., Ltd.
[0019] Fig enzyme: purity 96%, Wuhan Lanabai Pharmaceutical Chemical Co., Ltd.
[0020] Example 1
[0021] A method for preparing a nasal hot compress patch comprises the following raw materials in parts by weight: 60 parts of Xanthium sibiricum, 50 parts of Cynanchum wilfordii, 20 parts of Astragalus polysaccharide, 10 parts of Ginkgo biloba, 5 parts of Lobelia chinensis, and 5 parts of bitter almond oil.
[0022] The preparation of Hessalis polysaccharide includes the following steps: adding cellulase and ficin in a mass ratio of 1:1.2 to Hessalis, adjusting the pH value to 5.3, stirring, ultrasonic extraction, the extraction temperature is 45°C, the extraction time is 2.5h, and then adding 90% vol ethanol solution, stirring, and leaching to obtain Hessalis polysaccharide.
[0023] The preparation of bitter almond oil comprises the following steps: frying bitter almonds with salt at a low heat, the frying temperature is 55°C, the time is 3 hours, the particle size of the salt in the frying is 3 mm, crushing to a particle size of 20 mesh, placing in a weak alkaline buffer solution, i.e., sodium carbonate-sodium bicarbonate buffer solution for leaching, the pH value during leaching is 7.5, the mass volume ratio of bitter almonds to the buffer solution is mg / mL 0.2:1, and after leaching, taking the upper liquid to obtain bitter almond oil.
[0024] The above-mentioned nasal hot compress patch includes the following preparation steps: vacuum drying Xanthium sibiricum, Scutellaria baicalensis, Astragalus polysaccharide, Ginkgo biloba, and Lobelia chinensis, with a vacuum degree of 75kPa, a time of 90 minutes, and a temperature of 50°C, after drying, passing through a 160-mesh sieve, mixing, adding bitter almond oil and beeswax, stirring, soaking, sterilizing, and obtaining a finished product.
[0025] Example 2
[0026] A method for preparing a nasal hot compress patch comprises the following raw materials in parts by weight: 65 parts of Xanthium sibiricum, 55 parts of Cynanchum wilfordii, 25 parts of Astragalus polysaccharide, 15 parts of Ginkgo biloba, 10 parts of Lobelia chinensis, and 10 parts of bitter almond oil.
[0027] The preparation of Hessalis polysaccharide includes the following steps: adding cellulase and fig enzyme in a mass ratio of 1:1.5 to Hessalis, adjusting the pH value to 5.7, stirring, ultrasonic extraction, the extraction temperature is 50°C, the extraction time is 3.0h, and then adding 95%vol ethanol solution, stirring, and leaching to obtain Hessalis polysaccharide.
[0028] The preparation of bitter almond oil comprises the following steps: frying bitter almonds with salt at a low heat, the frying temperature is 60°C, the time is 3.5 hours, the particle size of the salt in the frying is 10 mm, crushing to a particle size of 40 mesh, placing in a weak alkaline buffer solution, i.e., sodium carbonate-sodium bicarbonate buffer solution for leaching, the pH value during leaching is 8.0, the mass volume ratio of bitter almonds to the buffer solution is mg / mL 0.5:1, and after leaching, taking the upper liquid to obtain bitter almond oil.
[0029] The above-mentioned nasal hot compress patch includes the following preparation steps: vacuum drying Xanthium sibiricum, Scutellaria baicalensis, Astragalus polysaccharide, Ginkgo biloba, and Lobelia chinensis, with a vacuum degree of 80 kPa, a time of 120 minutes, and a temperature of 60°C, after drying, passing through a 200-mesh sieve, mixing, adding bitter almond oil and beeswax, stirring, soaking, sterilizing, and obtaining a finished product.
[0030] Example 3
[0031] A method for preparing a nasal hot compress comprises the following raw materials in parts by weight: 62 parts of Xanthium sibiricum, 52 parts of Cynanchum wilfordii, 23 parts of Astragalus polysaccharide, 13 parts of Ginkgo biloba, 7 parts of Lobelia chinensis and 8 parts of bitter almond oil.
[0032] The preparation of Hessalis polysaccharide includes the following steps: adding cellulase and ficin in a mass ratio of 1:1.3 to Hessalis, adjusting the pH value to 5.5, stirring, ultrasonic extraction, the extraction temperature is 45°C, the extraction time is 2.5h, and then adding 90% vol ethanol solution, stirring, and leaching to obtain Hessalis polysaccharide.
[0033] The preparation of bitter almond oil comprises the following steps: frying bitter almonds with salt at a low heat, the frying temperature is 60°C, the time is 3 hours, the particle size of the salt in the frying is 5 mm, crushing to a particle size of 30 mesh, placing in a weak alkaline buffer solution, i.e., sodium carbonate-sodium bicarbonate buffer solution for leaching, the pH value during leaching is 7.5, the mass volume ratio of bitter almonds to the buffer solution is mg / mL 0.3:1, and after leaching, taking the upper liquid to obtain bitter almond oil.
[0034] The above-mentioned nasal hot compress patch includes the following preparation steps: vacuum drying Xanthium sibiricum, Scutellaria baicalensis, Astragalus polysaccharide, Ginkgo biloba, and Lobelia chinensis, with a vacuum degree of 80 kPa, a time of 100 minutes, and a temperature of 55°C. After drying, the dried products are sieved with a 180-mesh sieve, mixed, bitter almond oil and beeswax are added, stirred, soaked, and sterilized to obtain the finished product.
[0035] Comparative Example 1
[0036] The main difference between Comparative Example 1 and Example 3 is that the enzymatic hydrolysis step is removed from the preparation of Hedysari polysaccharide, and ethanol extraction is directly used. All raw material contents and other preparation steps are the same as those in Example 3.
[0037] The preparation of red stilbene polysaccharide comprises the following steps: adding red stilbene to 90% vol ethanol solution, stirring, and extracting to obtain red stilbene polysaccharide.
[0038] Comparative Example 2
[0039] The main difference between Comparative Example 2 and Example 3 is that the ethanol extraction is removed in the preparation step of Hedysari polysaccharide. All raw material contents and other preparation steps are the same as those in Example 3.
[0040] The preparation of Hessalis polysaccharide includes the following steps: adding Hessalis to cellulase and ficin in a mass ratio of 1:1.3, adjusting the pH value to 5.5, stirring, ultrasonic extraction, the extraction temperature is 45°C, the extraction time is 2.5h, and Hessalis polysaccharide is obtained.
[0041] Comparative Example 3
[0042] The main difference between Comparative Example 3 and Example 3 is that the salt frying is removed in the preparation step of bitter almond oil, and the buffer solution is replaced with purified water. All raw material contents and other preparation steps are the same as those in Example 3.
[0043] The preparation of bitter almond oil comprises the following steps: crushing bitter almonds to a particle size of 30 meshes, placing them in a pure water solution for leaching, wherein the mass volume ratio of bitter almonds to the water solution is 0.3:1, and after leaching, taking the upper layer liquid to obtain bitter almond oil.
[0044] Comparative Example 4
[0045] The main difference between Comparative Example 4 and Example 3 is that ginkgo and lobelia are removed from the ingredients, and the contents of all raw materials and other preparation steps are the same as those in Example 3.
[0046] A method for preparing a nasal hot compress comprises the following raw materials in parts by weight: 62 parts of Xanthium sibiricum, 52 parts of Cynanchum cyrtonema, 23 parts of Rubus polysaccharide and 8 parts of bitter almond oil; the method comprises the following preparation steps: vacuum drying the Xanthium sibiricum, Cynanchum cyrtonema and Rubus polysaccharide at a vacuum degree of 80 kPa for 100 min at a temperature of 55 DEG C, passing through a 180-mesh sieve after drying, mixing, adding bitter almond oil and beeswax, stirring, immersing slices, sterilizing and obtaining a finished product.
[0047] Positive control: Naphazoline hydrochloride nasal drops, manufacturer: Tianjin Jinhong Shengli Pharmaceutical Co., Ltd. Blank control: A blank test was used as a control, and the reagent was an equal mass of normal saline.
[0048] test
[0049] Rats of mass (230g ± 20g) were selected, and 45 rats were randomly divided into 9 groups, 5 rats in each group, including Example 1-3 groups, Comparative Example 1-4 groups, positive control group and blank control group. A rat rhinitis model was established, and an improved AR modeling method was adopted to prepare a suspension with 1g of ovalbumin (OVA) plus 3g of Al(OH)3 powder and 100mL of normal saline as an antigen. The modeling rats were intraperitoneally injected with 1mL of OVA suspension, once every other day, for a total of 7 times, and then the bilateral nasal cavities were attacked with 5% OVA, 50μL on each side, once a day, for a total of 14 times. Rat animal experiments strictly abide by the Guidelines for the Care and Use of Laboratory Animals.
[0050] The test period was 21 days. The embodiment group and the comparative example group were treated with the nasal hot compress prepared according to the embodiment and the comparative example. The positive control used naphazoline hydrochloride nasal drops, which were dripped into the nasal cavity once a day, with a drop of 0.03-0.05 mL each time. The blank test used an equal amount of normal saline nasal drops, which were dripped into the nasal cavity once a day, with a drop of 0.03-0.05 mL each time. The steamer was used for hot steaming, and the steaming time was 200 minutes at a temperature of 45°C.
[0051] Test Example 1: Allergy Treatment Test
[0052] The model evaluation mainly observed nasal symptoms and signs. From the time of administration of the sensitizer, the scores were based on the degree and frequency of nasal itching, sneezing, and runny nose. The total score of each symptom was added up, and the model was successfully replicated if the total score was ≥5 points. The observation time was within 3 minutes after each sensitization (see Table 1). The total number of sneezes and nose scratches of the rats within 21 days was counted, and the symptoms of nasal redness and swelling and nasal bloodshot were observed from the 18th to the 21st day, as shown in Table 2.
[0053] Table 1
[0054]
[0055] The number of sneezing and scratching of the rats using the nose patch of the comparative example 1-4 formula was higher than that of the example 1-3, indicating that the change of raw materials and preparation method reduced the therapeutic effect of the nasal hot compress patch. At the same time, the therapeutic effect of the rats of the example 1-3 was higher than that of the positive control, indicating that the nose patch prepared by the raw material compounding method has a better effect.
[0056] Table 2
[0057]
[0058] Test Example 2: Enzyme-linked immunosorbent assay (ELISA)
[0059] The inflammatory factors OVA-sige and histamine in the serum of each group of rats were detected using an ELISA kit. The collected nasal lavage fluid was used to determine the OVA-sige and histamine content in the serum according to the ELISA kit instructions. Compared with the blank control group, the levels of OVA-sige and histamine in the serum of the rats in the example were significantly reduced (P < 0.05), and the reduction amounts were significantly higher than those in comparative examples 1-4. This shows that the nasal hot compress prepared by the raw materials, proportions and methods of the present invention can effectively improve nasal inflammation (Table 3). At the same time, the reduction in the inflammatory factors in Examples 1-3 was higher than that in the positive control, indicating that the nasal patch prepared by the raw material compounding method has a significant anti-inflammatory effect.
[0060] Table 3
[0061]
[0062] Note: a / b / c / d indicate significant difference with P < 0.05
[0063] Test results: The present invention uses Xanthium sibiricum, Scutellaria baicalensis, Astragalus polysaccharide, Ginkgo biloba, Lobelia chinensis and bitter almond oil in combination, and the resulting nasal hot compress can effectively treat nasal redness and swelling, nasal itching and sneezing, and has the effect of nasal anti-inflammatory. The acute itching scratching frequency test shows (Table 2) that the nasal hot compress prepared by the method of Examples 1-3 of the present invention significantly reduces the number of scratching times of rats, and the effect is significantly reduced when the preparation method is changed in Comparative Examples 1-4, indicating that the nasal hot compress prepared by the raw materials and methods of the present invention can effectively control nasal adverse reactions. The results of ELISA detection of the content of inflammatory factors OVA-sige and histamine in rat serum show (Table 3) that the nasal hot compress controls nasal inflammation. Therefore, the nasal hot compress prepared by the raw materials, raw material ratios and preparation methods of the present invention has the effect of controlling and treating nasal redness and swelling, itching and sneezing, and reducing nasal inflammation.
[0064] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims
1. A nasal hot compress, characterized in that: The invention comprises the following raw materials in parts by weight: 60-65 parts of Xanthium sibiricum, 50-55 parts of Cynanchum wilfordii, 20-25 parts of Astragalus polysaccharide, 10-15 parts of Ginkgo biloba, 5-10 parts of Lobelia chinensis and 5-10 parts of bitter almond oil.
2. A nasal hot compress according to claim 1, characterized in that: The preparation of the red stilbene polysaccharide comprises the following steps: adding the red stilbene to the complex enzyme, adjusting the pH value, stirring, ultrasonic extraction, adding the ethanol solution, leaching, and obtaining the red stilbene polysaccharide.
3. A nasal hot compress according to claim 2, characterized in that: The complex enzyme is cellulase and ficin, and the mass ratio of cellulase to ficin is 1:(1.2-1.5).
4. A nasal hot compress according to claim 2, characterized in that: The pH value is adjusted to 5-5.7, the temperature is 45-50° C., and the extraction time is 2.5-3.0 h.
5. A nasal hot compress according to claim 2, characterized in that: The concentration of the ethanol solution is 90-95% vol.
6. A nasal hot compress according to claim 1, characterized in that: The preparation of bitter almond oil comprises the following steps: frying bitter almonds with salt over a low heat, crushing them to a particle size of 20-40 meshes, placing them in a weak alkaline buffer solution for leaching, and taking the upper layer of liquid after leaching to obtain bitter almond oil.
7. A nasal hot compress according to claim 6, characterized in that: The salt is frying over a warm fire at a temperature of 55-60° C. for 3-3.5 hours, and the particle size of the salt in the frying is 3-10 mm.
8. A nasal hot compress according to claim 6, characterized in that: The weakly alkaline buffer solution is a sodium carbonate-sodium bicarbonate buffer solution with a pH value of 7.5-8.0, and the mass volume ratio of bitter almonds to the buffer solution is (0.2-0.5) mg / mL:
1.
9. A method for preparing a nasal hot compress, characterized in that: The preparation method comprises the following steps: vacuum drying, crushing and sieving Xanthium sibiricum, Scutellaria baicalensis, Hedysari polysaccharide, Ginkgo biloba and Lobelia chinensis, mixing, adding bitter almond oil and beeswax, stirring, soaking slices, sterilizing and obtaining the finished product.
10. The method for preparing a nasal hot compress according to claim 9, characterized in that: The vacuum drying has a vacuum degree of 75-80 kPa, a time of 90-120 min, a temperature of 50-60° C., and the sieving is through a 160-200 mesh sieve.