Health-care liquid for promoting lactation and removing stasis and preparation method of health-care liquid

Abstract

The invention discloses a lactation dredging and stasis removing health-care liquid and a preparation method thereof. According to the preparation, through triple anti-hyperplasia core compatibility of selfheal, paris polyphylla and stigma croci and in combination with supercritical extraction and liposome encapsulation technologies, the concentration of crocin mammary tissue reaches 35.6 mu g / g. A vinegar-fried frankincense / myrrh nanocrystallization dispersion process is innovatively adopted, the problem of crystallization of resin components is solved, and no precipitate is generated in a 12-month accelerated test. Animal experiments prove that the volume of breast nodules can be reduced by 68.3%, and the traditional Chinese medicine composition is suitable for conditioning the sub-health state of female mammary glands.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine compound preparations, and in particular relates to a knot-dispersing health-care liquid achieved through mammary gland targeted penetration technology and component stabilization technology. Background Art

[0002] The prior art has the following defects: 1. Low drug penetration rate in breast tissue (literature reports that the breast tissue concentration of ordinary tinctures is only 12% of the blood drug concentration) 2. Resin ingredients such as frankincense and myrrh are prone to crystallization.

[0003] 3. Crocin has poor light and heat stability (experiments show that the degradation rate is >40% after 4 hours of direct sunlight) Summary of the invention

[0004] Technical solution innovations: 1. Breast Targeting System: Trans-anethole in fennel essential oil can specifically bind to breast tissue fatty acid binding protein (FABP4).

[0005] The liposome particle size is controlled at 120±20nm and penetrates through the gaps in the mammary ducts.

[0006] 2. Three-dimensional stabilization system: CD inclusion (volatile components) + phospholipid complex (fat-soluble components) + EDTA chelation (metal ions). BRIEF DESCRIPTION OF THE DRAWINGS Figure 1. Diagram of the mechanism of breast targeted penetration [Breast tissue anatomical model] Mammary duct: liposomes (120±20nm particle size marked) dynamically penetrate through the ductal gap. Schematic diagram of trans-anethole binding to FABP4 (marked Kd=8.3nM) Acinar region: vinegar-roasted frankincense-myrrh complex targeting fibrosis area (collagen fiber decomposition arrow) Side annotation: drug concentration comparison bar graph (breast tissue vs blood = 5:1) DETAILED DESCRIPTION

[0007] Embodiment 2 (optimization scheme): Raw material ratio: Prunella vulgaris 12%, saffron 0.8%, frankincense 6% (fried with vinegar), myrrh 6.5% (fried with vinegar), HP-β-CD dosage is 3 times the weight of volatile oil Key process parameters: Supercritical CO 2 Extraction: The entrainer is 5% anhydrous ethanol, and the dynamic extraction time is 2h.

[0008] Microwave sterilization power density is 3W / g, and temperature control accuracy is ±1℃.

[0009] Quality control: 1. Characteristic chromatogram (UPLC fingerprint): 12 common peaks are established, similarity ≥ 0.95 Crocin-I (tR = 8.2 min) and ferulic acid (tR = 11.5 min) are the quantitative peaks.

Claims

1. A Rutong Sanjie health care liquid, characterized in that It is composed of the following raw materials in weight percentage: Prunella Vulgaris 8-15%, fennel 3-6%, saffron 0.5-1.2%, Panax notoginseng 5-10%, Chuanxiong 6-12%, Angelica 8-15%, Cyperus rotundus 4-8%, costusroot 2-5%, agarwood 1-3%, frankincense 4-8%, myrrh 4-8%, Paris polyphylla 2-5%, dried orange peel 5-10%, peony bark 6-12%, potassium sorbate 0.1-0.3%, and the balance is purified water; The health care liquid meets the following technical indicators: Crocin-I content ≥ 0.8 mg / mL (HPLC detection) Boswellic acid transdermal rate ≥4.5μg / cm² / h (Franz diffusion cell method, 37℃) The residual amount of dibutyl terephthalate (plasticizer) is less than 0.01ppm.

2. The health care liquid according to claim 1, characterized in that: The frankincense and myrrh are mixed in a ratio of (1:1)-(1:1.2) after being roasted with vinegar to form a nano-micelle dispersion system with an average particle size of 80-150nm.

3. The health care liquid according to claim 1, characterized in that: It contains a transdermal enhancement system, which is composed of fennel volatile oil and azone in a ratio of (3:1)-(5:1), and the penetration enhancement factor PE value is ≥4.

8.

4. A method for preparing the health care liquid according to claim 1, characterized in that The following steps are involved: (1) Biphasic extraction: Lipid-soluble phase: Frankincense, myrrh, and agarwood are extracted with supercritical CO2 (pressure 25MPa, temperature 45°C) Water-soluble phase: Prunella vulgaris, Paris polyphylla, Angelica sinensis, etc. are decocted in water for 3 times (gradient temperature: 100℃→90℃→80℃) (2) Targeted modification: Crocin and phospholipid complex (drug-lipid ratio 1:2) are made into liposomes; (3) Stability control: Volatile oil components (fennel, costusroot) are included with HP-β-CD (inclusion rate ≥ 90%) 0.05% EDTA-2Na was added as a metal ion chelator; (4) Terminal sterilization: Use microwave low-temperature sterilization (65°C, 8 minutes) and fill in amber light-proof bottles.

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