Traditional Chinese medicine compound preparation for treating snoring syndrome and preparation method of traditional Chinese medicine compound preparation

Abstract

The invention relates to the technical field of medicine for treating snoring, in particular to a traditional Chinese medicine compound preparation for treating snoring and a preparation method thereof, and the traditional Chinese medicine compound preparation is prepared from the following raw materials: 8-40 parts of astragalus membranaceus, 4-20 parts of rhizoma anemarrhenae, 2-10 parts of platycodon grandiflorum, 2-10 parts of radix bupleuri, 2-10 parts of rhizoma cimicifugae, 3-20 parts of rhizoma acori graminei, 3-15 parts of arisaema cum bile, 3-15 parts of bamboo shavings, 3-15 parts of rhodiola rosea and 2-10 parts of cassia twig. The traditional Chinese medicine compound preparation for treating the snoring syndrome is simple in preparation method, easy and convenient to take, capable of improving clinical symptoms and indexes of the snoring syndrome, capable of achieving the effects of tonifying qi, ascending sinking, eliminating phlegm and dispersing blood stasis, remarkable in effect on treating the snoring syndrome and capable of solving the problem that in the prior art, the effect of improving the clinical symptoms and indexes is poor.

Description

Technical Field

[0001] The invention relates to the technical field of drugs for treating snoring, and in particular to a Chinese medicinal compound preparation for treating snoring and a preparation method thereof. Background Art

[0002] Snoring (Western medical name: obstructive sleep apnea hypopnea syndrome OSAHS) can not only lead to daytime fatigue and sleepiness, traffic accidents, cognitive impairment, but also cause complications such as hypertension, diabetes, coronary heart disease, stroke, and even sudden death. The high prevalence of OSAHS and its damage to multiple organs and systems seriously endanger human health.

[0003] However, the current treatment methods include: mainly continuous positive airway pressure (CPAP), oral appliances, and surgical treatment. The CPAP ventilator has a definite effect, but due to poor tolerance, compliance is poor. At least 40% of patients stop using CPAP treatment within 1 year of treatment, and less than 50% of patients insist on long-term treatment. Oral appliances and surgical treatments have poor long-term efficacy, and Western medicine is not used due to uncertain efficacy and large side effects. Therefore, there are bottlenecks in treatment selection. Traditional Chinese medicine has become an important treatment method due to its few side effects and high compliance. Due to different understandings of etiology and pathogenesis, traditional Chinese medicine has different formulations, and is not ideal in improving clinical symptoms and objective indicators. Clinically, there is a lack of traditional Chinese medicine compound preparations with definite efficacy.

[0004] Therefore, there is an urgent need in the art to develop a Chinese medicine compound preparation that is good in efficacy and easy to use. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicinal compound preparation for treating snoring which has good efficacy and is convenient to use and a preparation method thereof.

[0006] To achieve the above object, the present invention provides the following technical solutions:

[0007] The invention provides a traditional Chinese medicine compound preparation for treating snoring. The traditional Chinese medicine compound preparation is prepared with 8-40 parts of astragalus, 4-20 parts of rhizoma anemarrhenae, 2-10 parts of platycodon, 2-10 parts of radix bupleuri, 2-10 parts of cimicifuga, 3-20 parts of calamus, 3-15 parts of arisaema ciliata, 3-15 parts of bamboo shavings, 3-15 parts of rhodiola rosea and 2-10 parts of cassia twig as raw materials.

[0008] Furthermore, the astragalus is 8-30 parts, the rhizome of anemarrhena is 4-15 parts, the platycodon is 2-8 parts, the bupleurum is 2-8 parts, the cimicifuga is 2-8 parts, the calamus is 3-15 parts, the arisaema is 3-12 parts, the bamboo shavings is 3-12 parts, the rhodiola rosea is 3-12 parts, and the cassia twig is 2-8 parts.

[0009] Furthermore, the astragalus is 8-24 parts, the rhizome of anemarrhena is 4-12 parts, the platycodon is 2-6 parts, the bupleurum is 2-6 parts, the cimicifuga is 2-6 parts, the calamus is 3-10 parts, the arisaema is 3-9 parts, the bamboo shavings is 3-9 parts, the rhodiola rosea is 3-9 parts, and the cassia twig is 2-6 parts.

[0010] Furthermore, the dosage form of the Chinese medicine compound preparation includes one or more of oral liquid, tablets, capsules and granules.

[0011] Furthermore, it contains auxiliary materials as pharmaceutical carriers, and the auxiliary materials include one or more of water, flavoring agents, sweeteners, glycerin, disintegrants and lubricants.

[0012] The present invention also includes a method for preparing the above-mentioned Chinese medicine compound preparation, characterized in that the method for preparing the granules comprises the following steps:

[0013] S1, grinding the Rhodiola rosea to obtain Rhodiola rosea powder;

[0014] S2, extracting the astragalus, rhizoma anemarrhenae, platycodon grandiflorum, radix bupleuri, rhizoma cimicifugae, calamus calamus, rhizoma arisaemae, rhizoma anemarrhenae, and cassia twig twice, combining the obtained extracts, concentrating them, and obtaining a clear paste;

[0015] S3, mixing the Rhodiola rosea powder, the clear paste, dextrin and stevioside, spraying 60% ethanol after mixing to make a soft material, granulating the soft material with a granulator, placing the prepared wet granules in a drying oven to dry, and then sieving to obtain granules.

[0016] The present invention also includes a method for preparing the above-mentioned compound medicine, characterized in that the granules are filled into gelatin capsules, each capsule containing 0.5 g of granules, to obtain capsules.

[0017] The present invention also includes a method for preparing the above-mentioned Chinese medicine compound preparation, characterized in that the method for preparing the tablets comprises the following steps:

[0018] A1, grinding the Rhodiola rosea to obtain Rhodiola rosea powder;

[0019] A2, extracting the astragalus, rhizoma anemarrhenae, platycodon grandiflorum, radix bupleuri, rhizoma cimicifugae, calamus calamus, rhizoma aconiti scopariae, rhizoma anemarrhenae, and cassia twig twice, combining the obtained extracts, concentrating, and obtaining a clear paste;

[0020] A3, mix the Rhodiola rosea powder and the clear paste, add microcrystalline cellulose and magnesium stearate, granulate and tablet, and obtain tablets.

[0021] The present invention also includes a method for preparing the above-mentioned Chinese medicine compound preparation, characterized in that the method for preparing the oral liquid comprises the following steps:

[0022] T1, grinding the Rhodiola rosea to obtain Rhodiola rosea powder;

[0023] T2, extracting the astragalus, rhizoma anemarrhenae, platycodon grandiflorum, radix bupleuri, rhizoma cimicifugae, calamus calamus, rhizoma arisaemae, rhizoma anemarrhenae, and cassia twig twice, combining the obtained extracts, concentrating them, and obtaining a clear paste;

[0024] T3, mixing the Rhodiola rosea powder and the clear paste, adding purified water, stevioside, and glycerin, adjusting the pH to 6.0, filtering and filling, and obtaining an oral solution.

[0025] Compared with the prior art, the Chinese medicine compound preparation for treating snoring disclosed in the present invention is simple to make and easy to take, can improve the clinical symptoms and indicators of snoring, can achieve the effects of invigorating Qi and lifting the sunken qi, removing phlegm and removing blood stasis, and is significantly effective in treating snoring, solving the problem that the prior art is not effective in improving clinical symptoms and indicators. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 The graphs show the data results of sleep apnea index (AHI), lowest blood oxygen saturation at night (LSaO2), and nocturnal hypoxia time (T-SP90%) of the two groups before and after treatment.

[0028] Figure 2 The graphs show the Epworeh Sleepiness Scale (ESS) scores, Pittsburgh Sleepiness Index (PSQI) scores, and Traditional Chinese Medicine Symptom Score data of the two groups before and after treatment.

[0029] Figure 3 The graph shows the data results of platelet / lymphocyte ratio (PLR), neutrophil / lymphocyte ratio (NLR), and C-reactive protein (CRP) in the two groups before and after treatment.

[0030] Figure 4 This is a graph showing the clinical efficacy data results for the two groups. DETAILED DESCRIPTION

[0031] The technical scheme of the present invention is further described below in conjunction with specific examples. It should be understood that the following examples are only exemplary descriptions and explanations of the present invention, and should not be construed as limiting the scope of protection of the present invention. All technologies implemented based on the above content of the present invention are included in the scope that the present invention is intended to protect.

[0032] Example 1

[0033] G1, Rhodiola rosea pretreatment: 9 portions of Rhodiola rosea were crushed by an ultrafine grinder to a particle size of ≤50 μm, and passed through a 200-mesh sieve to obtain Rhodiola rosea powder; the cell wall barrier was broken and the solubility of Rhodiola rosea was improved (35% higher than the traditional method);

[0034] G2A, water extraction: 24 parts of Astragalus, 12 parts of Anemarrhena, 6 parts of Platycodon, 6 parts of Bupleurum, 6 parts of Cimicifuga, 10 parts of Acorus calamus, 9 parts of Arisaema consanguineum, 9 parts of Rhizoma Anemarrhenae, 6 parts of Cinnamomum cassiae, boiled twice with water (8 cups of water each time, boiled for 1 hour each time), combined the filtrates and concentrated to a clear paste with a relative density of 1.10-1.15;

[0035] G2B, alcohol extraction: 24 parts of Astragalus, 12 parts of Anemarrhena, 6 parts of Platycodon, 6 parts of Bupleurum, 6 parts of Cimicifuga, 10 parts of Acorus calamus, 9 parts of Arisaema consanguineum, 9 parts of Rhizoma Anemarrhenae, 6 parts of Cinnamomum cassiae were extracted twice with 60% ethanol under reflux (6 times of alcohol was added each time, each time for 1.5 hours), and the ethanol from the two extractions was combined and concentrated into a clear paste;

[0036] G3A, mix the Rhodiola rosea powder prepared in G1 with the clear paste prepared in G2A or G2B, add purified water, stevioside (0.1%), glycerol (5%), adjust the pH to 6.0, filter and fill to obtain the oral solution.

[0037] G3B, the Rhodiola rosea powder prepared in G1 is mixed with the clear paste prepared in G2A or G2B, microcrystalline cellulose (20%) and magnesium stearate (0.5%) are added, and the mixture is granulated and compressed to obtain tablets.

[0038] Example 2

[0039] W1, Rhodiola rosea pretreatment: 9 portions of Rhodiola rosea were placed in an oven at 60°C for drying, the moisture content was controlled to be ≤8%, and the particles were crushed to a particle size of ≤50 μm using an ultrafine grinder, and passed through a 200-mesh sieve to obtain Rhodiola rosea powder; the cell wall barrier was broken and the solubility of Rhodiola rosea was improved (35% higher than the traditional method);

[0040] W2, water extraction: add 8 times the amount of water to 24 parts of Astragalus, 12 parts of Anemarrhena, 6 parts of Platycodon, 6 parts of Bupleurum, 6 parts of Cimicifuga, 10 parts of Acorus calamus, 9 parts of Arisaema consanguineum, 9 parts of Rhizoma Anemarrhenae, and 6 parts of Cinnamomum cassiae, decoct for 1.5 hours, and filter to obtain filtrate A; add 6 times the amount of water to the residue, decoct for 1 hour, and filter to obtain filtrate B; combine filtrate A and filtrate B, and concentrate to a clear paste with a relative density of 1.20 by a double-effect concentrator (vacuum degree -0.08MPa, temperature 60°C); double-stage water extraction process, the first decoction focuses on dissolving saponin components, and the second decoction strengthens the extraction of flavonoids to improve the utilization rate of active substances;

[0041] W3, granulation and drying: the prepared rhodiola rosea powder, clear paste, dextrin (20% of the total material amount) and stevioside (0.5%) are put into a trough mixer and mixed for 15 minutes; 60% ethanol solution (the amount used is 12% of the total material amount) is slowly sprayed to make a soft material (it forms a ball when held and falls apart when touched); a swing granulator (14 mesh screen) is used for granulation, the wet granules are spread on a tray, and placed in a hot air drying oven at 55°C for drying, and the moisture content is controlled to be ≤6.0%; after drying, the granules are sieved through a 12-mesh screen to remove fine powder and lumps; low-temperature drying at 55°C avoids the decomposition of heat-sensitive components (such as saposides), and vacuum decompression can shorten the drying time;

[0042] W4A, granules are mixed with glycerol (3%), mixed for 20 minutes using a three-dimensional motion mixer, and packaged into aluminum foil bags using an automatic granule packaging machine, with 10g per bag. Stevioside is used in combination with glycerol to mask the bitter taste while maintaining low sugar properties, and is suitable for diabetic patients.

[0043] How to take W400: Take 1 bag twice a day with warm water for four weeks. Clinical observations show that the granules are 83% effective in improving sleep apnea, and have a sweet taste without gastrointestinal irritation.

[0044] W4B, the granules are filled into gelatin capsules, each capsule containing 0.5 g of granules, to prepare capsules.

[0045] Example 3

[0046] Application of the Chinese medicine composition of the present invention

[0047] A total of 64 patients with snoring syndrome (OSAHS) were divided into two groups (control group and treatment group), with 32 cases in each group, taking into account factors that may affect the results, such as body mass index, and balanced distribution to ensure comparability between groups.

[0048] The control group was given behavioral intervention; the treatment group took the Chinese medicine compound preparation of the present invention while taking behavioral intervention, and the course of treatment was 8 weeks. (Behavioral intervention refers to the behavioral intervention treatment recommended in the "Guidelines for the Diagnosis and Treatment of Obstructive Sleep Apnea-Hypopnea Syndrome (2011 Revised Edition)")

[0049] The changes of polysomnography parameters [sleep apnea index (AHI), lowest blood oxygen saturation at night (LSaO2), time of hypoxia at night (T-SP90%)], Epworeh sleepiness scale (ESS) score, Pittsburgh sleepiness index (PSQI) score, traditional Chinese medicine symptom score, and related serological indexes [platelet / lymphocyte ratio (PLR), neutrophil / lymphocyte ratio (NLR), C-reactive protein (CRP)] levels were observed in the two groups before and after treatment.

[0050] Results Figure 1-Figure 4 Compared with before treatment, the AHI, T-SP90%, LSaO2, ESS score, PSQI score, BMI, TCM syndrome score and serum PLR, NLR, CRP levels of the two groups were significantly improved after treatment (P < 0.05), and the improvement in the treatment group was more significant than that in the control group (P < 0.05). The clinical efficacy of the treatment group was 84.4% (27 / 32), which was much higher than 37.5% (12 / 32) in the control group (P < 0.05).

[0051] The above further proves that Shengxian Zhihan Decoction can effectively improve sleep breathing disorders in patients with OSAHS, and can also improve the excessive inflammatory response caused by hypoxia.

[0052] Although the specific implementation modes of the present invention are described above, those skilled in the art should understand that the specific implementation modes described are only illustrative and are not intended to limit the scope of the present invention. Equivalent modifications and changes made by those skilled in the art in accordance with the scope of the patent application of the present invention should be included in the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicinal compound preparation for treating snoring, characterized in that: The medicine is prepared with 8-40 parts of astragalus, 4-20 parts of anemarrhena, 2-10 parts of platycodon, 2-10 parts of bupleurum, 2-10 parts of cimicifuga, 3-20 parts of calamus, 3-15 parts of arisaema, 3-15 parts of bamboo shavings, 3-15 parts of rhodiola and 2-10 parts of cassia twig as raw materials.

2. A Chinese medicinal compound preparation for treating snoring according to claim 1, characterized in that: The ingredients include 8-30 parts of Astragalus, 4-15 parts of Anemarrhena, 2-8 parts of Platycodon, 2-8 parts of Bupleurum, 2-8 parts of Cimicifuga, 3-15 parts of Acorus calamus, 3-12 parts of Arisaema cinerea, 3-12 parts of Rhodiola rosea, and 2-8 parts of Cinnamomum cassia.

3. A Chinese medicinal compound preparation for treating snoring according to claim 1, characterized in that: The ingredients include 8-24 parts of Astragalus, 4-12 parts of Anemarrhena, 2-6 parts of Platycodon, 2-6 parts of Bupleurum, 2-6 parts of Cimicifuga, 3-10 parts of Acorus calamus, 3-9 parts of Arisaema cinerea, 3-9 parts of Rhodiola rosea, and 2-6 parts of Cinnamomum cassia.

4. A Chinese medicinal compound preparation for treating snoring according to any one of claims 1 to 3, characterized in that: The dosage form of the Chinese medicine compound preparation includes one or more of oral liquid, tablet, capsule and granule.

5. A Chinese medicinal compound preparation for treating snoring according to claim 4, characterized in that: The invention comprises auxiliary materials as pharmaceutical carriers, wherein the auxiliary materials include one or more of water, flavoring agents, sweeteners, glycerin, disintegrants and lubricants.

6. The method for preparing the Chinese medicinal compound preparation according to claim 4, characterized in that: The preparation method of the granules comprises the following steps: S1, grinding the Rhodiola rosea to obtain Rhodiola rosea powder; S2, extracting the astragalus, rhizoma anemarrhenae, platycodon grandiflorum, radix bupleuri, rhizoma cimicifugae, calamus calamus, rhizoma arisaemae, rhizoma anemarrhenae, and cassia twig twice, combining the obtained extracts, concentrating them, and obtaining a clear paste; S3, mixing the Rhodiola rosea powder, the clear paste, dextrin and stevioside, spraying 60% ethanol after mixing to make a soft material, granulating the soft material with a granulator, placing the prepared wet granules in a drying oven to dry, and then sieving to obtain granules.

7. The method for preparing the Chinese medicinal compound preparation according to claim 4, characterized in that: The granules are filled into gelatin capsules, with each capsule containing 0.5 g of granules, to prepare capsules.

8. The method for preparing the Chinese medicinal compound preparation according to claim 4, characterized in that: The preparation method of the tablet comprises the following steps: A1, grinding the Rhodiola rosea to obtain Rhodiola rosea powder; A2, extracting the astragalus, rhizoma anemarrhenae, platycodon grandiflorum, radix bupleuri, rhizoma cimicifugae, calamus calamus, rhizoma aconiti scopariae, rhizoma anemarrhenae, and cassia twig twice, combining the obtained extracts, concentrating, and obtaining a clear paste; A3, mix the Rhodiola rosea powder and the clear paste, add microcrystalline cellulose and magnesium stearate, granulate and tablet, and obtain tablets.

9. The method for preparing the Chinese medicinal compound preparation according to claim 4, characterized in that: Preparation method of the oral liquid The following steps are involved: T1, grinding the Rhodiola rosea to obtain Rhodiola rosea powder; T2, extracting the astragalus, rhizoma anemarrhenae, platycodon grandiflorum, radix bupleuri, rhizoma cimicifugae, calamus calamus, rhizoma arisaemae, rhizoma anemarrhenae, and cassia twig twice, combining the obtained extracts, concentrating them, and obtaining a clear paste; T3, mixing the Rhodiola rosea powder and the clear paste, adding purified water, stevioside, and glycerin, and adjusting the pH to 6.0, filtering and filling to obtain an oral solution.

Images