A traditional Chinese medicine compound gel plaster for preventing and treating high altitude sleep disorder

Abstract

The present application relates to the medical technology field, specifically to a traditional Chinese medicine external preparation developed for the special environment of high altitude, which is used for preventing and treating sleep disorders caused by the low oxygen environment of high altitude. The main drugs are Coptis chinensis and Cinnamomum cassia, which are mixed in a certain proportion, extracted, freeze-dried and prepared into a gel plaster, and then the plaster can play the effect of improving sleep disorders through transdermal administration.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology. Specifically, it relates to a topical preparation of traditional Chinese medicine developed for the special environment of high-altitude areas, used to prevent and treat sleep disorders caused by the low oxygen environment of high altitudes. Background Technology

[0002] High-altitude sleep disorders are a common health problem faced by people rapidly ascending to high altitudes, with an incidence rate of 50%-80%. They are mainly caused by hyperventilation, sympathetic nerve excitation, and sleep-disordered breathing due to the hypoxic environment, severely affecting the body's ability to adapt to high altitudes and cognitive function. Under hypoxic stress, the body produces a large number of reactive oxygen species, triggering an oxidative stress cascade that leads to lipid peroxidation of neuronal cell membranes and the release of large amounts of inflammatory factors. This, in turn, disrupts the integrity of the blood-brain barrier, causing apoptosis of neurons in key brain regions such as the hippocampus and cortex. This is the core pathological mechanism behind high-altitude sleep disorders and the accompanying decline in cognitive function. Existing treatments have significant limitations. Western sedative-hypnotic drugs may worsen respiratory depression and are unsuitable for the hypoxic environment of high altitudes. Preventive drugs such as acetazolamide need to be taken in advance and have many side effects. Oxygen therapy and hyperbaric oxygen chambers suffer from insufficient portability and accessibility. Furthermore, oral administration methods have reduced absorption efficiency under conditions of weakened gastrointestinal function at high altitudes and are difficult to target for specific brain lesions.

[0003] The main component of this invention, the traditional Chinese medicine Coptis chinensis, possesses the traditional effects of clearing heat and drying dampness, purging fire and detoxifying, and calming the mind and soothing the nerves. Modern pharmacological studies have shown that its main active components, berberine and other alkaloids, have significant anti-inflammatory, antioxidant stress, and neuroprotective effects. Simultaneously, it reduces hypoxia-induced neuronal oxidative damage; it also inhibits the activation of inflammatory pathways, reduces the expression of pro-inflammatory factors such as tumor necrosis factor-α and interleukin-6, blocks the vicious cycle of neuroinflammation, and protects the blood-brain barrier function. Furthermore, berberine can regulate the levels of neurotransmitters such as γ-aminobutyric acid and serotonin in the brain, improve sleep-wake cycle disorders, and enhance synaptic plasticity by inhibiting acetylcholinesterase activity and promoting the expression of brain-derived neurotrophic factor, thereby improving hypoxia-related memory consolidation impairment and cognitive decline. Cinnamon, a warming herb, mainly contains volatile components such as cinnamaldehyde and cinnamic acid. It has the effects of warming and unblocking the meridians and guiding fire back to its source. Its antioxidant activity, in synergy with Coptis chinensis, can significantly enhance the ability to scavenge free radicals. At the same time, cinnamaldehyde can cross the blood-brain barrier and act directly on the central nervous system, regulating the function of the hypothalamus-pituitary-adrenal axis, relieving excessive arousal caused by hypoxia stress, and improving sleep structure. More importantly, the volatile oil contained in cinnamon can act as a natural transdermal absorption promoter, dilating skin capillaries, increasing local blood flow, and significantly improving the transdermal penetration rate and cumulative permeation of Coptis chinensis alkaloids, achieving the combined advantages of "medicine and adjuvant".

[0004] The 10:1 ratio of Coptis chinensis and cinnamon embodies the traditional Chinese medicine principle of "using both cold and hot herbs to harmonize the heart and kidneys," aligning with the pathogenesis of high-altitude sleep disorders characterized by "excessive heart fire, insufficient kidney yang, and disharmony between the heart and kidneys." In this ratio, Coptis chinensis, with its bitter and cold properties, clears and descends to purge heart fire, relieve irritability, and calm the mind, while cinnamon, with its pungent and warm properties, guides fire back to its source and warms the kidneys to assist yang. The two complement each other, both mitigating the potential harm of excessive bitterness and coldness from Coptis chinensis and avoiding the excessive heat from cinnamon, thus achieving the combined effects of clearing the heart and warming the kidneys, calming the mind, and soothing the nerves. From a modern pharmacological perspective, this ratio addresses multiple mechanisms, including anti-inflammatory and antioxidant stress damage, regulation of neurotransmitter balance, and improvement of cognitive function: by effectively blocking the hypoxia-induced oxidative stress-inflammatory cascade, it protects neuronal structure and function; it restores the neuromodulation homeostasis of the sleep-wake cycle; and by inhibiting neuronal apoptosis, it improves hippocampus-dependent spatial and episodic memory abilities, thereby comprehensively addressing the pathophysiological needs of high-altitude sleep disorders.

[0005] As a transdermal drug delivery system, gel patches utilize a hydrophilic polymer matrix as a carrier to penetrate the skin's stratum corneum into the systemic circulation, offering significant advantages such as avoiding the first-pass effect of the liver, maintaining stable blood drug concentrations, reducing gastrointestinal irritation, and ease of use. This makes them particularly suitable for high-altitude gastrointestinal disorders and fieldwork scenarios. The sustained-release and controlled-release properties allow the drug to act continuously during the sleep cycle, avoiding the peak-trough fluctuations associated with oral administration. Currently, gel patch technology is mainly used in the field of analgesia, and there are no reports of formulations specifically targeting the prevention and treatment of sleep disorders at high altitudes that combine the Coptis chinensis-Cinnamomum cassia compound with gel patch technology. Therefore, developing a compound formulation based on a 10:1 Coptis chinensis-Cinnamomum cassia ratio, utilizing multiple mechanisms including anti-inflammatory and antioxidant stress damage, neuromodulation, and cognitive improvement, and delivered via a gel patch, has significant clinical application value and market potential in filling the gap in safe and effective treatments for sleep disorders at high altitudes and ensuring the health and work capacity of people rapidly venturing to high altitudes. Summary of the Invention

[0006] This invention discloses a Compound Coptis Gel Patch (CCGP) for transdermal abdominal administration, aiming to prevent and treat altitude sickness. When applied 7 days before rapid ascent to high altitudes, this formula can significantly improve blood oxygen saturation, alleviate inflammatory responses, and thus improve altitude sickness.

[0007] The gel patch prepared according to this invention is made from the following raw materials:

[0008] Accurately weigh the prescribed amounts of Coptis chinensis and Cinnamomum cassia and place them in a heating device. Add ten times the amount of water and soak for 1 hour. Then bring to a boil over high heat, reduce to low heat, and simmer for 2 hours. Extract twice (the second time using eight times the amount of water). Combine the decoctions. Centrifuge at 2000 rpm for 10 minutes, vacuum filter, combine the filtrates, and heat to concentrate to an appropriate amount. Then dry in a vacuum dryer to obtain a lyophilized powder. Prepare a gel patch with the above-mentioned compound lyophilized powder of traditional Chinese medicine and the remaining excipients according to the process in the examples.

[0009] Phase A: NP-700, aluminum hydroxyl, EDTA-2Na, kaolin, glycerin, and lyophilized compound powder of Coptis chinensis and cinnamon.

[0010] Phase B: Carbomer, Triethanolamine, Tartaric Acid

[0011] Prescription ratio: NP-700∶Carbomer∶Glycerin∶Aluminum Hydroxyhydroxyacetic Acid∶Kaolin∶Drug∶EDTA-2Na∶Tartaric Acid∶Deionized Water=6∶0.2∶30∶0.3∶5∶1∶0.1∶0.2∶57.2.

[0012] Other advantages, objectives and features of the present invention will become apparent in part from the following description, and in part from those skilled in the art through study and practice of the invention. Attached Figure Description

[0013] Figure 1 .Diagram of gel patch

[0014] Figure 2 .CCGP fingerprint identification. Berberine hydrochloride (A), Coptis chinensis reference material (B), CCGP (C);

[0015] Blank gel patch (D)

[0016] Figure 3 TLC detection of berberine hydrochloride. (A): Spotting; (B): Daylight examination; (C): 254nm UV examination; (D): 365nm UV examination. Samples: 1, 2: Berberine reference standard; 3, 4: Coptis chinensis reference herb; 5, 6: CCGP; 7, 8: Blank gel.

[0017] Figure 4 CCGP rheological parameters: (A) Shear stress scan curve, (B) Frequency scan curve

[0018] Figure 5 CCGP's anti-inflammatory and anti-hypoxia indicators. Mouse blood cell analysis (AD): experimentally measured white blood cell count (A), red blood cell count (B), hemoglobin concentration (C), and hematocrit (D); Effects of CCGP on mouse HASD biochemical indicators (E, F): TNF-α level (E), IL-6 level (F); Mouse spleen (G) and spleen weight (H).

[0019] Figure 6 CCGP improves sleep and cognitive abilities (AG). Sleep righting test (AB): sleep latency (A) and total sleep duration (B); open field test (CE): number of times entering the central area (C), total distance traveled in the central area (D), and trajectory (E); new object recognition test (FG): trajectory (F) and recognition index (DI) (G). Detailed Implementation

[0020] Example 1. Preparation of CCGP

[0021] After the carbomer in phase B has completely swollen overnight, its pH is adjusted to 7.0 with triethanolamine, then tartaric acid is added and completely dissolved. This solution is then slowly added to phase A, stirred for about ten minutes, allowed to stand for 20 minutes to defoam, and poured into a small experimental coating machine for coating. After coating, it is placed in a 45°C electric heating drying oven for 2 hours to mature. After removal, it is allowed to stand at room temperature to solidify. Its appearance is a brown, elastic, paste-like substance. Figure 1 ).

[0022] Experimental Example 1. CCGP fingerprint identification

[0023] Methods: Preparation of standard solution: Accurately weigh 12.08 mg of berberine hydrochloride reference standard (98% purity) and place it in a 20 mL volumetric flask. Add methanol to prepare a solution with a concentration of 604 μg / mL. Store at 4℃ in a sealed container, protected from light.

[0024] Preparation of test solution: Take one compound Coptis chinensis gel patch and precisely cut a 1cm piece of the patch. 2 Remove the cap, place in a beaker, add an appropriate amount of methanol solution, sonicate for 30 minutes, cool to room temperature, shake well, centrifuge, take the upper clear solution, add to a 10 mL volumetric flask and dilute to volume with methanol, filter through a 0.22 μm filter membrane, and take the filtrate as the test solution.

[0025] Preparation of control medicinal material: Take 0.2607g of Coptis chinensis sample, put it into a 50mL centrifuge tube, add 15mL of methanol, seal, sonicate for 30min, cool, centrifuge, take the upper clear solution, put it into a 20mL volumetric flask, add methanol to the mark, shake well, filter through a 0.22μm filter membrane, and take the filtrate as the control medicinal material solution.

[0026] Preparation of blank gel patch extract: The steps are the same as those for preparing the test sample solution.

[0027] Chromatographic column conditions: CAPCELLPAK ADME C18 column (250 mm × 4.6 mm, 5 μm), mobile phase: acetonitrile-0.05 mol / L potassium dihydrogen phosphate solution (v / v) = 60:40 (v / v, add 0.4 g sodium dodecyl sulfate per 100 mL, then adjust the pH to 4.0 with phosphoric acid); flow rate: 1.0 mL / min; column temperature: 35 ℃; detection wavelength: 345 nm; injection volume: 10 μL.

[0028] Results: According to the HPLC fingerprint results, the peak shape was good, there were no interfering peaks, and the retention time was consistent with that of the standard. Figure 2 (A, B, C). Furthermore, according to the HPLC results, the retention time of berberine hydrochloride was 8.467 min, with a good peak shape and no interfering peaks.

[0029] Experimental Example 2. TLC Detection of Berberine Hydrochloride

[0030] Method: Prepare the developing solvent (freshly prepared): toluene: methanol: isopropanol: ethyl acetate: concentrated ammonia = 6:1.5:1.5:3:0.5

[0031] Measure 12 mL of toluene, 3 mL of methanol, 3 mL of isopropanol, 6 mL of ethyl acetate, and 1 mL of concentrated ammonia into a 50 mL centrifuge tube and mix well. First, take 15 mL of ammonia solution and place it in one side of the thin-layer chromatography tank for pre-saturation for 1 hour. Then, add the prepared developing solvent solution in two portions to the other side and saturate for half an hour each time.

[0032] Test sample: Take 1.303g of compound Coptis chinensis gel plaster, add 20mL of methanol, sonicate for 30 minutes, let stand overnight, filter, evaporate the filtrate to dryness, and dissolve the residue in 1mL of methanol.

[0033] Negative blank gel: Take 1.227g of blank gel patch, add 20mL of methanol, sonicate for 30 minutes, let stand overnight, filter, evaporate the filtrate to dryness, and dissolve the residue in 1mL of methanol.

[0034] Reference material for Coptis chinensis: Take 0.134g of the herb, add 20mL of methanol, sonicate for 30 minutes, let stand overnight, filter, evaporate the filter residue to dryness, and dissolve the residue in 1mL of methanol.

[0035] Berberine reference standard: Add 5.02 mg of berberine powder to 10 mL of methanol solution and sonicate for 30 minutes to mix.

[0036] Spotting: Take a thin-layer chromatography plate (10×15cm) and draw a horizontal line 1.5cm from the bottom with a pencil. Mark eight spotting points on the line. Use a 0.3µL spotting capillary to draw a certain amount of sample and spot it onto the marked points, from left to right: standard group, reference herb group, test sample group, and blank gel group (two samples per group). After each spotting, immediately dry the sample with a syringe wash before proceeding to the next spotting. After all spots are completed and dried, place the plate in the chromatography tank for development.

[0037] After the samples were displayed, they were dried with hot air using a hair dryer, cooled to room temperature, and then placed in a UV analyzer for observation.

[0038] CCGP(5, 6) at the same R f The presence of a visible yellow spot (D) and a dark spot (C) at 254 nm, completely overlapping with the control / reference herb, and exhibiting weak fluorescence at 365 nm consistent with the control, confirms that Coptis chinensis in the prescription was completely preserved and released into the gel in the form of berberine hydrochloride, without any "false negatives" caused by adsorption or matrix interference. Blank gels (7, 8) showed fluorescence at the corresponding R... f The absence of any visible or ultraviolet absorption / fluorescence spots in the area indicates that the excipients such as NP-700-carbomer-glycerol and cross-linking residues do not have background interference on the detection of berberine, and the method specificity meets the requirements of General Chapter 0502 (TLC identification) of Part IV of the 2020 edition of the Chinese Pharmacopoeia.

[0039] Experimental Example 3. Rheological Properties of CCGP

[0040] Methods: Rheological studies of the samples were conducted using a dynamic oscillation mode with a flat plate fixture. The flat plate diameter was 25 mm, the distance between the upper and lower plates was 2000 μm, and the temperature was kept constant at 25 °C.

[0041] Frequency scanning: The constant strain (stress) is 1%, and the frequency variation range is 0.1-100Hz.

[0042] Amplitude scanning: constant frequency: 1Hz, strain (stress) variation range: 0.1-100%.

[0043] The parameters measured include:

[0044] The elastic modulus (G′): also known as the storage modulus, describes the elastic characteristics of the gel patch matrix and reflects the material's resistance to elastic deformation. The larger the G′, the stronger the cohesion of the matrix.

[0045] Viscous modulus (G″): also known as loss modulus, it can characterize the viscous properties of gel patch matrix. The larger G″ is, the tighter the matrix adheres to the skin.

[0046] Complex modulus (G*) = (G′2 + G″2)1 / 2, characterizes the ability of a rubber compound to resist shear strain, and can reflect the degree of crosslinking, hardness and flexibility of the rubber compound.

[0047] Results: Within the angular frequency range of 0–100 rad / s, the storage modulus of CCGP was consistently higher than its loss modulus, indicating that CCGP exhibited good elasticity, cohesion, and moldability within this range. In the shear stress range of 1–1000 Pa, the storage modulus was greater than the loss modulus. However, as the shear stress increased to a certain extent, both the storage modulus and loss modulus began to decrease, and the gel transitioned from a solid-like state to a liquid-like state.

[0048] Experimental Example 4. Anti-inflammatory and anti-hypoxia activities of CCGP

[0049] Methods: Modeling and grouping: Male C57BL / 6J mice were acclimatized for 3 days, and 32 mice were randomly divided into 4 groups of 8 mice each: a healthy group, a model group, an acetazolamide positive control group (50 mg / kg), and a CCGP group (1.2 × 1.2 cm). 2 (54 mg / mouse). Mice were given preventative medication every morning for 7 days prior to entering the chamber (except for the model group and healthy group). On the 7th day, mice were prepared for chamber entry after administration of the medication. An animal model was established using a small animal hypobaric chamber. The chamber was set at an altitude of 7000 m and a temperature of 25 °C. The machine was adjusted to rise to an altitude of 7000 m within half an hour and maintain it for 71 hours, then descend to the normal altitude at the same rate. Mice lived freely in the chamber for 3 days (72 hours), with alternating light and dark periods of 12 hours each day.

[0050] Blood cell analysis: After the mice were removed from the chamber, a scalpel blade was disinfected with alcohol and the tail vein was quickly punctured. The entire tail was then stroked from top to bottom with a finger to facilitate bleeding. Once the blood droplet formed a spherical shape without dripping, 20 microliters of blood were collected using a capillary tube and simultaneously injected into a pre-diluent taken from an automated hematology analyzer. The blood was agitated to ensure even distribution and to prevent clotting. The blood was then analyzed using an automated hematology analyzer.

[0051] Results: The numerical results show that... Figure 5 In group A, the white blood cell (WBC) count in the model group mice was approximately 1.9 times that of the healthy group, suggesting acute inflammation or stress response; and the red blood cell (RBC) count was significantly elevated, suggesting polycythemia. Figure 5 B); The hemoglobin (HGB) level in the model group was 196 g / L, exceeding the upper limit of normal for mice (140-170 g / L), further supporting the finding of increased red blood cells. Figure 5C); The hematocrit (HCT) index model group showed an increase of 33% (50.7% compared to the healthy group of 38.2%), confirming hemoconcentration or polycythemia vera. Figure 5 D). Acetazolamide primarily reduces WBC and HGB, but has only a moderate effect on RBC / HCT, suggesting that its anti-inflammatory effect is superior to its inhibition of erythrocyte proliferation. CCGP is more effective in restoring RBC and HCT to normal, suggesting that it may improve microcirculation or reduce blood viscosity.

[0052] Serum biomarkers were detected using ELISA. One eye was quickly enucleated with curved forceps, and blood was dripped into a 1.5 mL sterile centrifuge tube (without anticoagulant); 0.6–1.0 mL of whole blood was collected from each mouse. The blood was allowed to stand at room temperature for 2 hours or refrigerated overnight at 4°C, at which point clot retraction was observed. The blood was centrifuged at 3000 rpm (≈1000 × g) for 15 minutes at 4°C. The supernatant pale yellow serum was carefully aspirated using a micropipette and aliquoted into 0.5 mL cryovials. Serum TNF-α and IL-6 levels (pg·mL) were measured strictly according to the detailed kit instructions. -1 ) to conduct testing.

[0053] : Figure 5 The biochemical data from mice E and F showed that the Model group successfully induced a significant inflammatory response, with both TNF-α and IL-6 levels significantly elevated. Acetazolamide showed some inhibitory effect on TNF-α and IL-6, suggesting that acetazolamide has a good anti-inflammatory effect. CCGP showed some inhibitory effect on both TNF-α and IL-6, but failed to completely restore them to normal levels, suggesting that CCGP has some anti-inflammatory activity.

[0054] Spleen organ parameters: The mouse's fur and muscles were cut along the midline of the abdomen to expose the abdominal viscera. The liver tissue was gently grasped with forceps, and the surrounding tissue was carefully separated to remove the liver tissue intact. The size was observed and the weight was measured under a shadowless lamp.

[0055] The Model group successfully induced splenomegaly, indicating successful model establishment and reflecting the significant immune activation or inflammatory response induced by the high-altitude hypoxic environment. CCGP showed the best alleviating effect on splenomegaly, approaching normal levels, suggesting that CCGP may have good immunomodulatory or anti-inflammatory effects. Acetazolamide also had some alleviating effect on splenomegaly, but the effect was not as significant as CCGP, suggesting that its mechanism of action or effect may be limited. The Healthy group had the lowest spleen weight, serving as a normal control group and reflecting the spleen weight under normal physiological conditions. Figure 5 G, H).

[0056] Experimental Example 5. CCGP Improves Sleep and Cognitive Ability

[0057] Sleep righting test: Mice were injected intraperitoneally with 50 mg / kg sodium pentobarbital solution, and the occurrence of sleep phenomena was observed. Sleep duration was measured by the disappearance of the righting reflex, and the time from the disappearance of the righting reflex to its recovery was defined as sleep time. The sleep latency and sleep duration of mice in the healthy group, model group, and each drug-treated group were recorded, and the differences between the groups were compared.

[0058] The mean sleep duration of the Model was approximately 90% longer than that of the Healthy model, consistent with the expectations of the "insomnia" model; both interventions shortened the latency period, with Acetazolamide showing a more similar effect to the Healthy model. The Model reduced sleep duration by >50%, confirming the success of the insomnia model; both Acetazolamide and CCGP showed significant reversal, with CCGP showing slightly better recovery than Acetazolamide. Figure 6 A, B).

[0059] Open Field Test: This invention employs the Open Field Test (OFT) to assess the spontaneous activity and emotional behavior of mice in an open environment. The open field test setup consists of an open area divided into a central region. At the start of the experiment, mice are placed in the central region and allowed to move freely within the open field. After a 5-minute adaptation period, video tracking software is activated to record the mice's movement trajectory. During the experiment, the total distance traveled by the mice within the central region and the number of times they entered the central region are recorded. To ensure the reliability of the experimental results, the open field is wiped and cleaned with diluted 84 disinfectant after each experiment to eliminate odor residue and avoid interfering with the behavior of mice in subsequent experiments.

[0060] Open field experiments showed that the high-altitude hypoxia model group exhibited typical anxiety-like behaviors (central avoidance, reduced activity), indicating successful modeling of anxiety states associated with high-altitude sleep disorders. The Acetazolamide group showed increased central area activity, but it remained relatively limited. The CCGP group's trajectory distribution was similar to the Healthy group, with a significant recovery in central area exploration behavior. CCGP intervention almost completely restored central exploration behavior, significantly better than Acetazolamide. These results indicate that CCGP can effectively alleviate anxiety-like behaviors induced by high-altitude hypoxia (central avoidance, reduced activity). Figure 6 CE).

[0061] New Object Recognition Experiment: Adaptation Phase: The animal is placed in an open space box and allowed to explore freely for 10 minutes to familiarize itself with the environment. Familiarization Phase: Two identical objects are placed symmetrically in the open space. The animal is placed in the box with its back to the objects, and its exploration time is recorded for 5 minutes (nose touching or approaching the object ≤2cm is considered exploration). After the exploration, the animal is removed, and the objects and the box are cleaned. Testing Phase: A familiar object (A) is replaced with a new object (B) in a randomized location. The animal is placed in the box, and its exploration behavior is recorded for 5 minutes. Evaluation is based on this standard:

[0062] T novel Total time mice spend exploring new objects

[0063] T familiar Total time mice spend exploring and becoming familiar with objects

[0064] DI > 0; Preference for new objects (normal memory)

[0065] DI≈0: No preference (memory gap)

[0066] DI < 0: Preference for old objects (abnormal behavior)

[0067]

[0068] Formula recognition index formula

[0069] The results of the novel object recognition experiment showed that the recognition index (DI) of the healthy group was positive, indicating normal novel object preference; the DI of the model group was significantly negative, indicating severe impairment of recognition memory (**P<0.01). After acetazolamide intervention, although the DI rebounded, it remained at a low level, with limited improvement; while the DI of the CCGP group recovered to a positive value similar to that of the healthy group, significantly reversing the memory deficit of the model group (**P<0.05). The recognition trajectory map also demonstrated that the animals in the healthy and CCGP groups explored novel objects (green) more frequently, while there was no significant difference in the exploration of old and new objects in the model group. In conclusion, CCGP has a significant improving effect on the recognition memory impairment of the model group, and its effect is better than that of acetazolamide. Figure 6 F, G).

Claims

1. The traditional Chinese medicine compound gel patch for preventing and treating sleep disorders at high altitudes, included in this invention, comprises the following ingredients: Phase A: Sodium polyacrylate NP-700, aluminum hydroxyl, EDTA-2Na, kaolin, glycerin, freeze-dried Coptis chinensis / cinnamon powder Phase B: Carbomer, triethanolamine, tartaric acid.

2. The weight ratio of each component in claim 1 is as follows: NP-700: Carbomer: Glycerin: Aluminum Hydroxyhydroxy: Kaolin: Drug: EDTA-2Na: Tartaric Acid: Deionized Water = 6:0.2:30:0.3:5:1:0.1:0.2:57.

2.

3. The preparation process of the traditional Chinese medicine compound gel plaster for preventing and treating sleep disorders at high altitudes included in this invention is as follows: Accurately weigh the prescribed amounts of Coptis chinensis and Cinnamomum cassia, place them in a heating device, add ten times the amount of water, soak for 1 hour, then bring to a boil over high heat and simmer over low heat for 2 hours. Extract twice (the second extraction uses eight times the amount of water), and combine the decoctions. Centrifuge at 2000 rpm for 10 minutes, vacuum filter, combine the filtrates, and heat to concentrate to an appropriate amount. Then dry in a vacuum dryer to obtain freeze-dried Coptis chinensis / Cinnamomum cassia powder. In claim 1, after the carbomer in phase B has completely swelled overnight, adjust its pH to 7.0 with triethanolamine, then add tartaric acid. After complete dissolution, slowly add it to phase A, stir for about ten minutes, let stand for 20 minutes to defoam, pour into a small experimental coating machine for coating, and after coating, place in a 45℃ electric heating oven for 2 hours to mature. After removal, let stand at room temperature to solidify. Its appearance is a brown, elastic plaster.

4. The optimal weight ratio of Coptis chinensis and cinnamon in the traditional Chinese medicine compound for treating sleep disorders at high altitudes is 10:1.

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