Damp-clearing sleep-aiding Tibetan foot bath tablet and preparation method thereof

Abstract

The invention discloses a dampness-clearing sleep-aiding Tibetan foot bathing tablet and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparations, the dampness-clearing sleep-aiding Tibetan foot bathing tablet is composed of a monarch drug group, a ministerial drug group, an adjuvant drug group, a conductant drug group and an auxiliary material group, and the preparation method comprises the following steps: step 1, crushing; step 2, weighing; step 3, extracting active ingredients; step 4, drying and powdering; step 5, total mixing; step 6, tabletting; step 7, inner packaging; and step 8, external packaging. Through the compatibility of monarch, minister, assistant and guide, the synergistic effect of dampness clearing and sleep aiding is realized, the monarch drug group and the adjuvant drug group synergistically regulate a dampness clearing pathway (AQP4 aquaporin + TRPV1 ion channel), the minister drug group and the guide drug group synergistically enhance the sleep aiding effect (GABA receptor activation + glutamic acid inhibition), and clinical experiments show that after the traditional Chinese medicine composition is used for 4 weeks, the effective rate of improving the dampness symptom reaches 80%, and the curative effect is good. And the sleep quality improvement rate reaches 82%.

Description

TECHNICAL FIELD

[0001] The application relates to the technical field of traditional Chinese medicine preparations, and particularly relates to a Tibetan bath foot piece for removing dampness and assisting sleep and a preparation method thereof. BACKGROUND

[0002] Traditional Chinese medicine foot bath has a history of thousands of years in China, and its core principle is to open the pores of the feet, dredge the meridians, and make the active ingredients of the medicine penetrate into the body through the skin to regulate the blood circulation and relieve fatigue, thereby improving the metabolism. The Tibetan medicine bath method (known as “Tashi Mub” in Tibetan) is an important part of traditional Tibetan medicine and a national intangible cultural heritage. The Tibetan medicine bath method is guided by the five-source life concept of “earth, water, fire, wind and space” and the three-cause health concept of “lung, chiba and peigen”, and has a unique advantage in removing dampness, dredging collaterals and soothing the nerves, that is, according to the Tibetan medicine, imbalance of “peigen” can easily lead to accumulation of dampness in the body, and imbalance of “lung” can easily cause nerve disorders and lead to insomnia, and the imbalance needs to be adjusted by the warm medicine bath liquid.

[0003] With the change of modern lifestyle, factors such as long-term stay in air-conditioned environment, lack of exercise, spicy and greasy diet or cold food, irregular work and rest, etc. lead to the generalization of the problem of excessive dampness in the body of the population, and the clinical manifestations are heavy and weak body, sore limbs, greasy and itchy skin, sticky and uncomfortable stool, etc. At the same time, factors such as high work pressure, mental stress, use of electronic products before sleep, etc. further cause sleep disorders such as insomnia, dreaminess, increased number of night awakenings and decreased sleep efficiency. Dampness and sleep problems influence each other to form a vicious cycle: excessive dampness leads to physical discomfort and affects sleep quality, and sleep deficiency weakens the body's metabolic function and aggravates the accumulation of dampness, which causes significant disturbance to the physical and mental health and the quality of life of the population, and the market urgently needs safe, efficient and convenient products for removing dampness and assisting sleep.

[0004] The current market products for removing dampness and assisting sleep are mainly divided into oral and external foot bath types, and the external foot bath type is more popular due to its high safety and no gastrointestinal stimulation, but still has many technical defects: Most of the oral products for removing dampness and assisting sleep (such as dampness-removing capsules and soothing oral liquid) need to be absorbed by the gastrointestinal tract, which may cause irritation to the gastrointestinal mucosa; some products contain sedative ingredients, and long-term use may cause dependence and drug resistance; and the products are not suitable for the elderly, children, pregnant women and people with weak gastrointestinal function, and the scope of application is limited.

[0005] Most of the existing external foot bath products are powders, crude extracts or ordinary tablets, and have three key problems: Slow release of active ingredients, late effect: The powder and crude extract product need to be boiled in boiling water for more than 30 minutes or soaked in warm water for 1 hour to make the active ingredients fully dissolved, which does not meet the needs of modern people's fast-paced life; the ordinary tablet has a slow disintegration speed, and it takes 15-20 minutes to completely dissolve in 40-45℃ foot bath water, which is too long to wait.

[0006] Serious residue problem, poor user experience: The powder product is easy to produce drug residue after dissolution, which adheres to the skin of the foot and the inner wall of the foot bath basin, and is difficult to clean; some tablets are not completely disintegrated, and the residual particles can easily scratch the skin of the foot, reducing the safety and comfort of use.

[0007] Single efficacy, poor synergy: Most of them use single herbs (such as mugwort and ginger) or simple compound, which can only achieve the basic dampness or weak sleep aid effect, and cannot meet the dual needs of "dampness + sleep aid"; and the ingredients have poor permeability, which is difficult to be absorbed effectively through the skin of the foot, and the conditioning effect is limited.

[0008] The existing Tibetan medicine bath products (such as Tibetan medicine bath powder and Tibetan medicine foot bath bag) mostly follow the traditional decoction process, and the damage rate of heat-sensitive active ingredients (such as rhodioloside, schisantherin A, and gastrodin) is more than 35%, which reduces the efficacy; At the same time, the formula does not follow the scientific "monarch, minister, assistant and envoy" compatibility principle, and only simply mixes multiple Tibetan medicines, which cannot form a synergistic effect of dampness and sleep aid, and the product quality stability and efficacy repeatability are poor, and there are also problems such as slow dissolution, residue, etc. SUMMARY

[0009] The purpose of the present application is to provide a dampness-removing and sleep-aiding Tibetan bath foot tablet and a preparation method thereof, to solve the problems of poor oral safety of existing products, slow release / residue / single efficacy of traditional external use foot bath products, and imperfect process and formula of Tibetan medicine bath products.

[0010] To achieve the above-mentioned purpose, the present application provides the following technical scheme: the foot bath tablet consists of a monarch group (15-30wt%), a minister group (25-40wt%), an assistant group (10-20wt%), an envoy group (5-10wt%), and an auxiliary group (15-25wt%) by weight percentage, and the functional synergy mechanism of each component is as follows: Monarch group: Rhodioloside extract regulates AQP4 water channel protein and accelerates body fluid metabolism; Tibetan red salt opens foot pores and promotes ingredient penetration; safflower extract, Chinese ganoderma extract, and sea buckthorn assist blood circulation, network dredging, and immune enhancement, together laying the foundation for dampness removal.

[0011] Minister group: Schisandra extract and lavender synergistically enhance GABA receptor activity and inhibit nerve excitement; chebulic myrobalan extract and Terminalia chebula extract astringe and astringe, balance the warm nature of the monarch; the rest of the ingredients assist blood circulation, water, and heat, and enhance the effects of dampness removal and sleep aid.

[0012] Adjuvant group: The extract of Lycopus lucidus and Rheum palmatum activate TRPV1 ion channel, promote perspiration and remove dampness; The extract of Gentiana macrophylla and the extract of Gentiana scabra assist in removing dampness and relieving pain, and improving joint discomfort caused by dampness; meanwhile, the medicinal properties of monarch and minister are adjusted to reduce the risk of stimulation.

[0013] Medicine group: Gastrodia elata inhibits excessive release of glutamate, and enhances the effect of calming nerves; the calamus opens the orifices and removes phlegm, and guides the target action of each component to the dampness accumulation site and the nervous system, and improves the overall synergistic effect.

[0014] Auxiliary material group: The effervescent agent produces CO2 when meeting water, accelerates the disintegration of the tablet; the disintegrating agent further promotes the dissolution of the tablet to ensure no residue; the binder ensures the hardness of the tablet to prevent breakage during transportation.

[0015] The preparation method of the Qushi Zhenshen Zangmu Bathing Foot Tablet includes five steps of raw material pretreatment, active ingredient extraction, drying and powdering, total mixing and tablet pressing, and packaging and inspection, and the specific steps are as follows: Raw material pretreatment: remove impurities (impurity content ≤0.5%) from each medicinal material, and crush and sieve, wherein the Tibetan red salt is separately crushed to 80-120 meshes to ensure uniform dissolution in the subsequent process.

[0016] Active ingredient extraction: select the extraction method according to the characteristics of different medicinal materials - use water extraction and alcohol precipitation method for medicinal materials mainly containing water-soluble components to ensure that polysaccharides, alkaloids and other components are fully dissolved; use supercritical CO2 extraction for medicinal materials mainly containing fat-soluble components to reduce the damage to heat-sensitive components, such as the retention rate of rhodioloside ≥92%.

[0017] Drying and powdering: use spray drying technology to quickly remove water in the concentrated extract, obtain dry paste powder with uniform particle size, and avoid the influence of component aggregation on subsequent uniform mixing.

[0018] Total mixing and tablet pressing: realize uniform mixing of materials through a three-dimensional mixer, and ensure uniform mixing through near-infrared spectrum online monitoring; accurately control the pressure and tablet weight during tablet pressing to balance the hardness and disintegration performance of the tablet.

[0019] Packaging and inspection: use composite film single tablet packaging to ensure product sealing and shelf life; product inspection covers key indicators such as appearance, dissolution performance and microbial limit to ensure stable product quality.

[0020] Compared with the prior art, the beneficial effects of the present application are: 1. By the combination of "jun, chen, zhuo and shi", the synergistic effect of removing dampness and promoting sleep is realized - the jun and zhuo groups synergistically regulate the dampness pathway (AQP4 water channel protein + TRPV1 ion channel), the chen and shi groups synergistically enhance the sleep-promoting effect (GABA receptor activation + glutamate inhibition), and the clinical experiment shows that after 4 weeks of use, the effective rate of improving dampness symptoms is 80%, and the sleep quality improvement rate is 82%.

[0021] 2. The effervescent tablet design makes the tablet dissolve in 40-45℃ hot water in ≤3 minutes without needing to decoct; and after dissolving, there is no residue, which is easy to clean, solves the residue problem of traditional powder, and improves the use experience.

[0022] 3. The use of supercritical CO2 extraction and spray drying process, the retention rate of active ingredients is ≥85%, far exceeding the traditional decoction process (retention rate ≤65%); and the tablet dosage form is easy to store (shelf life 18 months at 25℃ in the dark) and carry, suitable for modern fast-paced life.

[0023] 4. Natural Tibetan medicinal materials and food-grade auxiliary materials are used, and there is no chemical synthetic component; the skin irritation experiment verifies that there is no adverse reaction such as skin swelling and itching after continuous use for 8 weeks, and it is suitable for a wide range of people (including people over 60 years old and sub-health people). BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 It is a preparation flow chart of a Tibetan foot bath tablet for removing dampness and promoting sleep. DETAILED DESCRIPTION

[0025] The technical solutions in the embodiments of the present application will be described clearly and completely below in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0026] The present application provides a technical solution of a Tibetan foot bath tablet for removing dampness and promoting sleep and a preparation method thereof.

[0027] Example 1

[0028] Formula: monarch drug group (20wt%): rhodiola extract, safflower extract, ganoderma lucidum extract, sea buckthorn, Tibetan red salt; minister drug group (40wt%): chebula extract, chebula extract, emblic extract, schisandra extract, radix codonopsis, danshen, motherwort, sanchi, cypress, kaempferia extract, radix astragali, water willow, chuanxiong, sea salt, artemisia, lavender, purple jasmine extract; auxiliary drug group (20wt%): gentiana extract, gentiana extract, earth turtle extract, wind-preventing plant, citrus peel, red sandalwood, perilla leaf, mint extract, cowslip extract, tribulus terrestris, rhododendron, rhubarb; making medicine group (5wt%): gastrodia elata, calamus; auxiliary material group (15wt%): effervescent agent (citric acid + sodium bicarbonate), disintegrating agent (cross-linked sodium carboxymethyl cellulose), adhesive (hydroxypropyl methyl cellulose); Preparation steps: according to the above preparation process, the medicinal materials are pretreated, mixed, dried, granulated, and tableted in sequence to obtain the dampness-removing and sleep-aiding Tibetan bath foot tablets. Application effect: 50 volunteers with heavy dampness and poor sleep quality were selected to use the foot tablets prepared in the embodiment according to the above application method. After 4 weeks of use, 40 volunteers indicated that the body dampness symptoms were obviously reduced, the sleep quality was significantly improved, the sleep time was shortened, the number of night awakenings was reduced, and the sleep depth was increased.

[0029] Example two

[0030] Formula: monarch drug group (30wt%): rhodiola extract, safflower extract, ganoderma lucidum extract, sea buckthorn, Tibetan red salt; minister drug group (30wt%): chebula extract, chebula extract, emblic extract, schisandra extract, radix codonopsis, danshen, motherwort, sanchi, cypress, kaempferia extract, radix astragali, water willow, chuanxiong, sea salt, artemisia, lavender, purple jasmine extract; auxiliary drug group (10wt%): gentiana extract, gentiana extract, earth turtle extract, wind-preventing plant, citrus peel, red sandalwood, perilla leaf, mint extract, cowslip extract, tribulus terrestris, rhododendron, rhubarb; making medicine group (10wt%): gastrodia elata, calamus; auxiliary material group (20wt%): effervescent agent (citric acid + sodium bicarbonate), disintegrating agent (cross-linked sodium carboxymethyl cellulose), adhesive (hydroxypropyl methyl cellulose) Preparation steps: same as the preparation process of example one. Application effect: another 50 volunteers were selected for trial use, and after 8 weeks of use, 45 volunteers fed back that the body condition was obviously improved, the dampness-related symptoms basically disappeared, and the sleep quality returned to normal. In summary, the preparation method of the dampness-removing and sleep-aiding Tibetan bath foot tablets is simple and feasible, the product has significant dampness-removing and sleep-aiding effect, and is convenient, safe and reliable to use, and has broad market application prospect.

[0031] It will be apparent to those skilled in the art that the application is not limited to the details of the above-exemplified embodiments and that the present application can be implemented in other particular forms without departing from the spirit or essential characteristics of the present application. The embodiments should therefore be considered in all respects as illustrative and not restrictive, the scope of the application being indicated by the appended claims rather than by the above description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. No reference signs in the claims should be considered as limiting the scope of the claims with respect to the figures of the patent document.

Claims

1. A Tibetan-style foot bath for removing dampness and aiding sleep, characterized in that, By weight percentage, it consists of a principal drug group (15-30 wt%), an assistant drug group (25-40 wt%), an adjuvant drug group (10-20 wt%), a guide drug group (5-10 wt%), and an excipient group (15-25 wt%). The principal drug group includes Rhodiola rosea extract, safflower extract, Ganoderma lucidum extract, sea buckthorn, and saffron salt. The saffron salt is a natural crystalline salt from Zabuye Salt Lake in Tibet, with a particle size of 80-120 mesh, a NaCl content of ≤60%, and is rich in trace elements such as lithium and boron. The herbal ingredients include Terminalia chebula extract, Terminalia chebula extract, Phyllanthus emblica extract, Schisandra chinensis extract, Codonopsis pilosula, Salvia miltiorrhiza, Leonurus japonicus, Panax notoginseng, Juniperus chinensis, Kaempferia galanga extract, Astragalus membranaceus, Myrica rubra, Ligusticum chuanxiong, sea salt, Artemisia annua, lavender, and Mirabilis jalapa extract; The adjuvant group includes extracts of Gentiana macrophylla, Gentiana scabra, Fritillaria cirrhosa, Saposhnikovia divaricata, Citrus reticulata peel, Caesalpinia sappan, Perilla frutescens leaf, Lycopus lucidus extract, Vaccaria segetalis extract, Tribulus terrestris, Rhododendron molle, and Rheum palmatum. The herbal ingredients include Gastrodia elata and Acorus tatarinowii; The excipient group includes an effervescent agent, a disintegrant, and a binder, wherein the effervescent agent is a mixture of citric acid and sodium bicarbonate, the disintegrant is croscarmellose sodium, and the binder is hydroxypropyl methylcellulose.

2. The Tibetan bath foot patch for removing dampness and aiding sleep according to claim 1, characterized in that, The mass ratio of citric acid to sodium bicarbonate in the effervescent agent is 1:1.

2.

3. A method for preparing the Tibetan bath foot tablets for removing dampness and aiding sleep as described in any one of claims 1-2, characterized in that, Includes the following steps: Step 1, Grinding: After removing impurities from all the medicinal materials in the principal drug group, assistant drug group, adjuvant drug group, and guide drug group, grind them using a universal grinder. After grinding, pass them through a 20-40 mesh sieve and set aside. Saffron salt is ground separately and passed through an 80-120 mesh sieve. Step 2, Weighing: According to the weight percentages described in claim 1, accurately weigh each powdered medicinal material and excipient component after pulverization using an electronic analytical balance (accuracy 0.0001g), with the weighing error controlled within ±0.1%, and set aside for later use; Step 3, Active ingredient extraction: Weigh out Rhodiola rosea and Ganoderma lucidum from the principal herb group, Terminalia chebula, Terminalia chebula var. pubescens, Phyllanthus emblica, Kaempferia galanga, Mirabilis jalapa, and Schisandra chinensis from the assistant herb group, and Gentiana macrophylla, Gentiana scabra, Fritillaria cirrhosa, Lycopus lucidus, and Vaccaria segetalis from the adjuvant herb group. Extract the active ingredients using water extraction and alcohol precipitation or supercritical CO2 extraction to obtain concentrated extracts. When using supercritical CO2 extraction, control the extraction pressure at 25-35 MPa, the extraction temperature at 40-50℃, and the extraction time at 2-3 hours. Step 4, Drying and Powdering: The concentrated extract obtained in Step 3 is fed into a spray dryer, with the inlet air temperature set to 180-200℃, the outlet air temperature to 80-90℃, and the atomization pressure to 0.3-0.4MPa, to perform spray drying and obtain a dry powder. The moisture content of the dry powder is controlled to be ≤3%. Step 5, Total Mixing: Add the dry extract powder obtained in Step 4, the remaining medicinal powders (unextracted medicinal materials such as sea buckthorn, saffron salt, codonopsis, salvia miltiorrhiza, etc.) and excipients from Step 1 to a three-dimensional mixer and mix at 25-35 rpm for 25-30 minutes. Take samples every 10 minutes during the mixing process and determine the rhodioloside content using high performance liquid chromatography to ensure that the coefficient of variation (CV) is ≤3% to obtain the total mixture. Step 6, Tableting: The total mixture obtained in Step 5 is fed into a rotary tablet press. The tableting pressure is set to 15-20kN to compress the tablets into tablets with a weight of 9.0g / tablet. During the tableting process, samples are taken every 100 tablets produced to check the weight difference. The weight difference is controlled within ±7%. At the same time, the tablet hardness is checked to be 4-6kg and the friability is ≤0.5%. Step 7, Inner Packaging: Obtain PET / AL / PE composite film, adjust the horizontal sealing temperature of the packaging machine to 120-130℃ and the vertical sealing temperature to 110-120℃, and package the tablets individually, one tablet per bag. After packaging, use a sealing tester to ensure that the leakage rate is ≤0.1%. Step 8, Outer Packaging: Pack the qualified tablets in boxes of 10 tablets each, label them, and put them into storage. After the outer packaging is completed, inspect the finished product according to the standard. The inspection items include appearance, identification, dissolution time, and microbial limits. The dissolution time is ≤3 minutes (in 250mL of 45℃ water), and the microbial limits meet the requirements of bacterial count ≤1000cfu / g, mold and yeast count ≤100cfu / g, and no pathogenic bacteria should be detected.

4. The preparation method according to claim 3, characterized in that, The water extraction and alcohol precipitation method described in step three specifically includes: adding 10 times the amount of deionized water to the medicinal material, heating to 90-95℃ and extracting twice, each time for 1.5-2 hours, and combining the two extracts; adding 95% ethanol to the extract to adjust the alcohol concentration of the system to 60-70%, letting it stand at 4℃ for 12-16 hours, filtering to remove the precipitate, and taking the supernatant; transferring the supernatant to a rotary evaporator and concentrating it under a vacuum of -0.08 to -0.09 MPa and a temperature of 55-65℃ to obtain a concentrated extract with a relative density of 1.20-1.25 (25℃).

Images