Yang-warming and cold-dispelling health-care liquid and preparation method thereof

Abstract

The invention discloses a yang-warming and cold-dispelling health-care liquid and a preparation method thereof. The aconitine content is less than or equal to 0.015 mg / mL and the heat effect lasting time is more than or equal to 8 hours by combining the radix aconiti carmichaeli-rhizoma zingiberis toxicity attenuation synergistic compatibility with the phase change temperature control technology. The transdermal rate of the masticinic acid is increased by 3.5 times by innovatively adopting a micro-jet nanocrystallization process, and the production safety is ensured by matching with near-infrared online monitoring. Animal experiments prove that microcirculation disturbance can be remarkably improved (the blood flow speed is increased by 178%), and the traditional Chinese medicine composition is suitable for local warming and dredging conditioning of people with yang-deficiency constitution.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine warming yang preparations, and specifically to a cold-dispelling health care liquid developed based on the technology of "directed transformation of toxic components + temperature-sensitive controlled release", which is particularly suitable for local transdermal conditioning of people with yang-deficiency constitution. Background Art

[0002] The existing technology has the following defects: 1. The warming yang external medicine has a slow onset of action.

[0003] 2. The aconite preparation has poor safety 3. The volatile oil components have poor thermal stability (literature reports that the loss rate of anethole stored at 40°C for 30 days > 40%). Summary of the Invention

[0004] Innovation points of the technical solution: 1. Warming yang four-dimensional delivery system: Quick-release layer: volatile oil of fennel (generates a warm feeling within 15 minutes).

[0005] Sustained-release layer: combination of cinnamon twig and dried ginger (continuously releases heat for 6 - 8 hours).

[0006] Targeting layer: psoralen activates TRPV1 thermosensitive channels.

[0007] Synergistic layer: nano-ligusticum wallichii penetrates deep into the fascia.

[0008] 2. Triple safety system: Steaming with licorice juice (attenuates aconite toxicity) Phase change controlled release (avoids sudden release of components) Real-time quality control (online NIR monitors the content of aconitine).

[0009] Experimental evidence: Verification of transdermal thermal effect (infrared thermal imaging) The temperature difference at the application site reaches 2.5°C within 5 minutes, and the thermal effect lasts for 8.2 ± 0.6 hours. Description of the Drawings Figure 1 It is a process flow chart of the warming yang and cold-dispelling health care liquid. Detailed Description of the Invention

[0010] Example 3 (preferred solution): Raw material ratio: prepared aconite 5%, dried ginger 10%, and the amount of phase change carrier used is 2 times the mass of the volatile oil.

[0011] Key process parameters: High-pressure steaming: pressure 0.12 MPa, wet heat treatment for 3 cycles.

[0012] Micro-jet homogenization: Circulating treatment for 5 times, outlet temperature < 40 °C On-line monitoring: Real-time detection of aconitine peak (1715 nm) by near-infrared spectroscopy (1200 - 2400 nm) Quality control: 1. Safety detection: Skin irritation test (New Zealand rabbits): Erythema / edema score is 0 for all.

[0013] Abnormal toxicity test: No abnormal reaction occurred after intraperitoneal injection of 0.5 mL in mice.

Claims

1. A health-care liquid for warming yang and dispelling cold, characterized in that It is composed of the following raw materials in weight percentage: Polygonatum 10-20%, cinnamon twig 8-15%, aconite (processed) 3-6%, fennel 5-10%, dried ginger 6-12%, psoralea corylifolia 8-15%, dodder seed 10-18%, polygonum multiflorum (processed) 5-12%, frankincense 4-8%, myrrh 4-8%, ligusticum chuanxiong 6-12%, angelica 8-15%, cyperus rotundus 5-10%, costusroot 3-6%, potassium sorbate 0.1-0.3%, and the balance is purified water; The health care liquid meets the following technical indicators: Aconitine content ≤ 0.015 mg / mL (UPLC-MS / MS detection) Cinnamaldehyde transdermal rate ≥5.2μg / cm² / h (Franz diffusion cell method, 39℃ simulated body surface temperature) Hemolysis rate ≤2% (in vitro hemolysis test method of Chinese Pharmacopoeia).

2. The health care liquid according to claim 1, characterized in that: The aconite root is treated by high temperature and high pressure steaming (115°C, 0.15MPa), and is mixed with dried ginger in a ratio of (1:2) to (1:3) to form a toxicity-reducing and synergistic composition.

3. The health care liquid according to claim 1, characterized in that: It contains a phase-change temperature-controlled carrier, which is composed of a stearic acid-palmitic acid eutectic (melting point 42-45°C) encapsulating volatile oil components, and the release rate is ≥85% when triggered by body temperature.

4. A method for preparing the health care liquid according to claim 1, characterized in that The following steps are involved: (1) Detoxification of toxic components: Aconite and liquorice juice (1:5) were steamed under high pressure for 2 hours, and the conversion rate of aconitine was ≥92% (2) Dual temperature zone extraction: High temperature group (Polygonatum sibiricum, Psoralea corylifolia, etc.): 90℃ dynamic cycle extraction 3 times Low temperature group (fennel, costus root, etc.): 60℃ ultrasonic assisted extraction (power 300W) (3) Nano-enhancement treatment: Frankincense / Myrrh resin was homogenized by microfluidization (pressure 150MPa) to form nanoemulsion with an average particle size of 80nm (4) Stability control: Added 0.02% rosmarinic acid as a natural antioxidant.

5. Store in brown coated glass bottles away from light, with a light transmittance of ≤5%.

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