Health-care cream for expelling cold and clearing damp and preparation method of health-care cream

Abstract

The invention relates to a cold-expelling and dampness-eliminating health-care cream and a preparation method thereof, and belongs to the field of external traditional Chinese medicine preparations. The health-care cream is prepared from traditional Chinese medicine extracts such as radix aconiti preparata, pseudo-ginseng and ligusticum wallichii and auxiliary materials such as glyceryl monostearate and glyceryl distearate according to a scientific ratio and a special process. The product has the health-care effects of warming interior to dispel cold, promoting blood circulation to remove meridian obstruction and relieving swelling and pain, and is suitable for sub-health symptoms such as local pain, swelling and numbness caused by wind-cold damp evil. Water extraction, alcohol precipitation and emulsification processes are creatively combined, and the transdermal absorption rate and stability of the medicine are remarkably improved through a specific matrix formula. Clinical verifications show that the total effective rate on the cold-dampness type arthralgia reaches 94.3%, and skin irritation reaction is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of external traditional Chinese medicine preparations, and specifically to a health cream with the functions of expelling cold and removing dampness, promoting blood circulation and dredging collaterals, and a preparation method thereof. Background Art

[0002] Existing external preparations for removing dampness mostly have problems such as low transdermal absorption rate (generally <15%), greasy paste or strong irritation. Due to problems such as water-oil phase separation and degradation of active ingredients in traditional Chinese medicine creams, it is difficult to ensure the stability of curative effects. The present invention optimizes the combination of traditional Chinese medicines (such as the synergistic enhancement of anti-inflammatory effect by Radix Aconiti Preparata and Cortex Phellodendri), improves the extraction process (segmented treatment of volatile oil and water extract), and combines with emulsification technology to increase the transdermal absorption rate to 26.5%, and the paste stability reaches more than 12 months. Summary of the Invention

[0003] 1. Formula design: King drug: Radix Aconiti Preparata (expelling cold and relieving pain), Radix Notoginseng (promoting blood circulation to remove stasis) Ministerial drug: Rhizoma Chuanxiong, Flos Carthami (enhancing collateral dredging), Folium Artemisiae Argyi (warming meridians and dispelling cold) Assistant and guiding drug: Cortex Phellodendri, Radix Et Rhizoma Rhei (clearing heat and drying dampness, balancing warmth) The optimal ratio is determined by orthogonal experiment as Radix Aconiti Preparata: Radix Notoginseng: Rhizoma Chuanxiong = 15:10:15 (parts by weight).

[0004] 2. Innovation in preparation process: Segmented extraction: Ethanol is used to extract fat-soluble components (such as curcumin), and water extraction is used to retain polysaccharide substances (such as Angelica polysaccharide) Emulsification process: Monoglyceride and diglyceride stearate are used to form an O / W type emulsion, and the particle size is controlled below 50μm Brief Description of the Drawings Figure 1 It is a process flow chart of a health cream for expelling cold and removing dampness Detailed Description of the Invention Embodiment

[0005] 1. Raw material ratio: Traditional Chinese medicine extract composition (15 parts of Radix Aconiti Preparata, 10 parts of Radix Notoginseng, 15 parts of Rhizoma Chuanxiong, 12 parts of Semen Vaccariae, 10 parts of Curcuma longa, 8 parts of Folium Artemisiae Argyi, 9 parts of Cortex Phellodendri, 15 parts of Radix Salviae Miltiorrhizae, 10 parts of Flos Carthami, 12 parts of Angelica sinensis, 8 parts of Radix Et Rhizoma Rhei, 8 parts of Cortex Moutan) 2. Preparation steps: (1) Preparation of traditional Chinese medicine extract: After Radix Aconiti Preparata, Folium Artemisiae Argyi, and Curcuma longa are pulverized, they are refluxed and extracted with 75% ethanol (material-liquid ratio 1:10) at 80°C for 2 times, 2 hours each time. The extraction liquids are combined, ethanol is recovered to obtain an ethanol extract paste, and the volatile oil is collected for standby; The remaining medicinal materials are decocted with water twice (material-liquid ratio 1:12, 1:10), each time for 1.5 hours, and the decoction liquids are combined and concentrated to a relative density of 1.12 (60 °C); The ethanol extract paste and the water decoction paste are mixed, volatile oil is added, and spray drying is carried out (inlet air temperature 160 °C, outlet air temperature 85 °C) to obtain the powder of the traditional Chinese medicine extract.

[0006] (2) Preparation of the emulsifying matrix: Heat glyceryl monostearate and distearate (12%) to 72 °C until melted, add purified water (68%), and stir and emulsify for 10 minutes; Add the powder of the traditional Chinese medicine extract (15%), and process with a homogenizer at 4000 rpm for 15 minutes; Cool down to 35 °C for filling to obtain a milky white paste with a pH value of 6.0.

[0007] V. Supplementary experimental data 1. Quality detection method Total alkaloid content: Acid-base titration method (calculated as aconitine), and it is required that each gram of paste ≥ 0.8 mg Detection of tanshinone IIA: HPLC method (C18 column, methanol-water = 75:25, detection wavelength 270 nm), each gram of paste ≥ 0.5 mg Stability test (40 °C / RH75%, 6 months): The paste has no delamination, and the retention rate of the active ingredients > 95% 2. Transdermal absorption comparison (Franz diffusion cell, ex vivo porcine skin) 3. Clinical effect statistics (60 patients with cold-dampness arthralgia, treatment course 14 days) Index Experimental group (n = 30) Control group (n = 30) Total effective rate 94.3% 76.7% Onset time 2.4 ± 0.6 h 4.1 ± 1.2 h Skin allergy rate 0% 13.3%.

Claims

1. A health cream for expelling cold and dampness, characterized in that Made from the following raw materials in weight percentage: 10-20% of Chinese herbal medicine extract composition, 8-15% of mono- and distearic glyceryl, and the balance is purified water; The Chinese medicine extract composition is prepared from the following raw materials by weight: 10-20 parts of processed Chuanwu, 8-15 parts of Panax notoginseng, 12-18 parts of Chuanxiong, 10-15 parts of Vaccaria segetalis, 8-12 parts of Curcuma longa, 5-10 parts of Artemisia argyi, 6-12 parts of Phellodendron amurense, 10-20 parts of Salvia miltiorrhiza, 8-15 parts of Carthamus tinctorius, 10-18 parts of Angelica sinensis, 5-12 parts of Rhubarb, and 6-10 parts of Paeonia suffruticosa.

2. The health cream as claimed in claim 1, characterized in that The preparation method of the Chinese medicine extract composition comprises the following steps: (1) Extracting the processed Chuanwu, Artemisia argyi and Curcuma longa with 70-80% ethanol twice by reflux, and collecting the volatile oil and alcohol extract; (2) The remaining medicinal materials were decocted twice with water, and the combined decoctions were concentrated to an extract with a relative density of 1.10-1.15; (3) Mix the alcohol extract with the water decoction, add volatile oil, and spray dry to obtain the Chinese medicine extract powder.

3. The preparation method according to claim 1, characterized in that The following steps are involved: (1) heating mono- and distearic acid glyceryl to 70-75° C. to melt, adding purified water and stirring to form colostrum; (2) dispersing the Chinese herbal extract composition in colostrum and homogenizing it to a particle size of ≤50 μm; (3) Cooling to below 40°C and filling to obtain a health cream with a fine paste and a pH value of 5.5-6.5.

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