Pseudo-ginseng oral liquid as well as preparation method and application thereof

Abstract

The invention relates to the technical field of health-care food, in particular to a pseudo-ginseng oral liquid and a preparation method and application thereof, and the pseudo-ginseng oral liquid comprises the following components in percentage by weight: 20-40% of pseudo-ginseng root extract, 3-8% of pseudo-ginseng stem and leaf extract, 0.5-2% of pseudo-ginseng flower extract and the balance of purified water. The total saponin is not less than 1200 mg / 100 mL in terms of ginsenoside Re, the ginsenoside Rb1 is not less than 30 wt%, the ginsenoside Rg1 is not less than 25 wt%, and the notoginsenoside R1 is not less than 5 wt%. The pH value of the product is 4.5-7.5, the product meets strict physicochemical and microbial standards, the product is packaged by a sodium-calcium glass bottle, and the shelf life is 24 months. The preparation method comprises the following steps: exclusively extracting, purifying, preparing, sterilizing and the like, and realizing quality controllability through an HPLC (High Performance Liquid Chromatography) characteristic chromatogram. The preparation is reasonable in dosage form, the problems of moisture absorption, low bioavailability and the like of a solid preparation are solved, and the active components are easy to absorb and convenient to take. Through research, the health-care tea has the health-care functions of improving hypoxia tolerance and relieving physical fatigue, and is suitable for people with related requirements.

Description

Technical Field

[0001] This invention relates to the field of health food technology, specifically to a Panax notoginseng oral liquid, its preparation method, and its application. Background Technology

[0002] The medicinal parts and active ingredients of Panax notoginseng: Panax notoginseng (Burk.) FHChen is a plant belonging to the genus Panax in the family Araliaceae. The 2020 edition of the Chinese Pharmacopoeia lists its dried roots and rhizomes as the legally permitted medicinal parts. Traditional and local standards also list the stems, leaves, and flowers for edible or health-promoting purposes. Modern research shows that the roots, rhizomes, stems, leaves, and flowers of Panax notoginseng contain various active ingredients such as saponins (ginsenosides Rg1, Rb1, Re, Rd, and notoginsenoside R1), flavonoids, polysaccharides, and amino acids. These ingredients possess pharmacological effects such as vasodilation, improved microcirculation, anti-platelet aggregation, and antioxidant properties, thus offering potential benefits for maintaining healthy blood pressure levels.

[0003] Existing Formulations and Defects: Currently, commercially available Panax notoginseng health foods and traditional Chinese medicines are mainly solid dosage forms such as tablets, hard capsules, granules, pills, and powders. Their preparation process typically involves water or ethanol extraction of Panax notoginseng roots / rhizomes or stems, leaves, and flowers → concentration → drying → pulverization → granulation / tableting / capsule filling. The above processes share the following common problems:

[0004] (1) High hygroscopicity: Panax notoginseng extract is rich in polar saponins and polysaccharides, which are extremely hygroscopic, leading to prolonged disintegration time of tablets or even failure to disintegrate, particle adhesion, and brittle or softened capsule shells.

[0005] (2) Low bioavailability: Solid dosage forms need to disintegrate and dissolve before they can be absorbed by the gastrointestinal tract, resulting in slow onset of action; and the dissolution rate of the hygroscopic dosage form further decreases after absorbing moisture, and the active ingredients are not sufficiently dispersed in the stomach, thus reducing bioavailability.

[0006] (3) Inconvenient to take: Elderly people or people with difficulty swallowing have poor compliance with taking tablets / capsules.

[0007] (4) Limitations of the formula: Most existing products use only Panax notoginseng root or rhizome as raw material, which does not make full use of Panax notoginseng stem, leaf and flower resources, and it is difficult to achieve the comprehensive effect of "whole plant utilization".

[0008] Yunnan Province has issued local food safety standards such as DBS53 / 023-2017 "Dried Panax notoginseng Flowers" and DBS53 / 024-2017 "Dried Panax notoginseng Stems and Leaves," which clarify the quality requirements and consumption limits for stems, leaves, and flowers, providing a legal basis for the development of the whole Panax notoginseng plant. However, there are currently no health food products on the market that combine Panax notoginseng roots, rhizomes, stems, leaves, and flowers in a specific ratio and formulate them into a solution.

[0009] To address the aforementioned shortcomings and achieve comprehensive utilization of the entire Panax notoginseng plant, it is urgently necessary to develop a:

[0010] (1) Reasonable dosage form: avoid moisture absorption and delayed disintegration, and ensure rapid dissolution and absorption of active ingredients;

[0011] (2) Scientific formulation: Within the permitted dosage range, Panax notoginseng roots, rhizomes, stems, leaves and flowers are combined according to the principle of complementary efficacy;

[0012] (3) The process is feasible: it is suitable for the integrated process of extraction, purification, formulation, sterilization and packaging in large-scale industrial production;

[0013] (4) Quality controllable: oral liquid preparations with exclusive identification, content determination, stability study and safety evaluation system. Summary of the Invention

[0014] In response to the technical problems pointed out in the background art, the present invention provides an oral liquid with synergistic effects of Panax notoginseng root, stem, leaves and flowers, significant efficacy, controllable quality and excellent stability, and its preparation method, as well as a health care oral liquid with Panax notoginseng whole plant (root / root and stem, stem and leaves and flowers) extract as the main active ingredient, its preparation method and uses.

[0015] The technical solution adopted in this invention is

[0016] A whole-plant oral liquid composition of Panax notoginseng, comprising by weight percentage: 20-40% Panax notoginseng root extract; 3-8% Panax notoginseng stem and leaf extract; 0.5-2% Panax notoginseng flower extract; purified water to 100%; and the total saponins of the oral liquid, calculated as ginsenoside Re, are not less than 1200 mg / 100 mL.

[0017] Preferably, the total saponins contain not less than 30 wt% ginsenoside Rb1, not less than 25 wt% ginsenoside Rg1, and not less than 5 wt% notoginsenoside R1.

[0018] Preferably, the pH value is 4.5-7.5, the soluble solids content is not less than 1.5%, the lead content is not greater than 0.5 mg / L, the total arsenic content is not greater than 0.3 mg / L, and the hexachlorocyclohexane (HCH) and dichlorodiphenyltrichloroethane (DDT) content are both not greater than 0.2 mg / L.

[0019] Preferably, the total bacterial count is no more than 1000 CFU / mL, the coliform count is no more than 0.43 MPN / mL, the mold and yeast count is no more than 50 CFU / mL, and pathogenic bacteria are not detected.

[0020] The present invention also provides a method for preparing the composition, comprising:

[0021] a) Panax notoginseng roots were extracted by hot reflux with 70% ethanol, concentrated, water-precipitated, purified by macroporous resin, and dried under reduced pressure.

[0022] b) Panax notoginseng stems and leaves were extracted with water, precipitated with alcohol, purified with macroporous resin, and dried under reduced pressure.

[0023] c) Panax notoginseng flowers were extracted by hot reflux with 70% ethanol and processed using the same method as the root.

[0024] d) Dissolve the three extracts in purified water in proportion, filter, fill and sterilize.

[0025] Preferably, the vacuum drying conditions are 70-80℃ for 12-24 hours.

[0026] (1) Preparation: Add 105% purified water to the mixing tank, turn on the heating and stirring at 20±5 Hz, keep the water temperature at 80-90℃ for 10 minutes, stop stirring, and release 15% of the purified water into a stainless steel container for later use; turn on the stirring at 20±5 Hz, keep the water temperature, and add the raw materials such as Panax notoginseng extract, Panax notoginseng stem and leaf extract, and Panax notoginseng flower extract in sequence according to the production instructions, stir until completely dissolved, turn off the stirring and heating, slowly add the previously released purified water to the predetermined volume, turn on the stirring at 20±5 Hz, and inject cooling water to cool down to 40±5℃.

[0027] (2) Filtration: Filter the solution through a 5-10μm filter cartridge to obtain the filtered solution.

[0028] (3) Filling: Fill and seal according to the specification of 10mL / vial.

[0029] (4) Sterilization: Sterilization is carried out at 105-121℃ for 20-40 minutes.

[0030] (5) Light inspection: After the light inspection process, unqualified products such as incomplete bottle caps, obvious abnormalities in the liquid level inside the bottle, and visible foreign matter in the solution are rejected.

[0031] (6) Packaging: Take the products that pass the light inspection and package them to obtain the final product.

[0032] Preferably, a characteristic spectrum containing six characteristic peaks is established using HPLC, wherein:

[0033] Peak 1 is notoginsenoside R1, peak 2 is ginsenoside Rg1, peak 4 is ginsenoside Rb1, and peak 5 is ginsenoside Rb3.

[0034] The retention time of peak 3 relative to peak 2 is 1.04 ± 10%;

[0035] The retention time of peak 6 relative to peak 5 is 1.05 ± 10%.

[0036] Preferably, the HPLC chromatographic conditions are as follows:

[0037] The chromatographic column was SepaChrom TCM C18, 250 mm × 4.6 mm, 5 μm.

[0038] Mobile phase A: acetonitrile; Mobile phase B: water; Gradient: 0-30 min 20% A, 30-80 min 20%-46% A; Flow rate: 1 mL / min; Detection wavelength: 203 nm; Column temperature: 25 °C.

[0039] The present invention also provides the use of the composition of the first aspect in the preparation of health food with functions of improving hypoxia tolerance and relieving physical fatigue.

[0040] Preferably, the health food is packaged in a sodium-calcium glass bottle with a shelf life of 24 months.

[0041] Compared with the prior art, the technical effect of the present invention is that it can be used to prepare health food with the functions of improving hypoxia tolerance and relieving physical fatigue. Attached Figure Description

[0042] Figure 1 This is a comparative feature map provided by the present invention. Specific Implementation

[0043] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limiting purposes, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that this application may also be implemented in other embodiments without these specific details.

[0044] like Figure 1 As shown, the quality requirements for raw and auxiliary materials

[0045] 1. Purified water should comply with the provisions of the Pharmacopoeia of the People's Republic of China.

[0046] 2. Panax notoginseng extract

[0047] Source: This product is the dried root and rhizome of Panax notoginseng, a plant of the Araliaceae family, and should comply with the provisions of the Pharmacopoeia of the People's Republic of China.

[0048] Preparation: Coarse crushing, alcohol extraction (using 5-6 times the amount of 70±2% ethanol under hot reflux, temperature controlled at 60-80℃, extraction 3 times, the first extraction with 6 times the amount of ethanol for 2h, the second extraction with 5 times the amount of ethanol for 2h, the third extraction with 5 times the amount of ethanol for 1h), concentration, water precipitation, separation with macroporous resin, decolorization, concentration, vacuum drying (70-80℃, 12-24h), pulverization and mixing, and packaging.

[0049] Extraction rate: 7%–16%.

[0050] Sensory requirements: A white to pale yellow amorphous powder with a bitter and slightly sweet taste.

[0051] Identification: The chromatogram of the test sample should show chromatographic peaks with the same retention times as those of notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, and ginsenoside Rd in the reference extract of total saponins of Panax notoginseng. Fingerprint chromatogram: The chromatogram of the test sample should be similar to that of the reference extract; the similarity of the chromatographic peaks after 5 minutes should not be less than 0.95.

[0052] Content determination: The content of ginsenoside Rb1 shall not be less than 30.0%, ginsenoside Rg1 shall not be less than 25.0%, notoginsenoside R1 shall not be less than 5.0%, ginsenoside Re shall not be less than 2.5%, and ginsenoside Rd shall not be less than 5.0%, and the total amount of ginsenoside Rb1, ginsenoside Rg1, notoginsenoside R1, ginsenoside Re, and ginsenoside Rd shall not be less than 75.0%.

[0053] Moisture: ≤5%, Ash: ≤3.5%, Particle size: 95% can pass through a 100-mesh sieve, Solubility: Easily soluble in, Hexachlorocyclohexane (HCH): ≤0.2 mg / kg, DDT: ≤0.2 mg / kg, Lead (Pb): ≤2.0 mg / kg, Total Arsenic (As): ≤1.0 mg / kg, Total Mercury (Hg): ≤0.3 mg / kg, Cadmium (Cd): ≤0.3 mg / kg, Copper (Cu): ≤20.0 mg / kg, Total Bacterial Count: ≤30000 CFU / g, Coliform Bacteria: ≤0.92 MPN / g, Molds and Yeasts: ≤50 CFU / g, Staphylococcus aureus: ≤0 / 25g, Salmonella: ≤0 / 25g

[0054] 3. Panax notoginseng stem and leaf extract

[0055] Source: This product is the dried stem and leaves of Panax notoginseng, a plant of the Araliaceae family, and should comply with the provisions of "DBS53024-Yunnan Food Safety Local Standard-Dried Panax notoginseng Stems and Leaves".

[0056] Preparation method: coarse crushing, water extraction (decoct with 10-12 times the amount of water, extract twice, first add 12 times the amount of water, soak for 2 hours, extract for 1.5 hours, second add 10 times the amount of water, extract for 1.5 hours, start timing from boiling), concentration, alcohol precipitation, separation with macroporous resin, decolorization, concentration, vacuum drying (70-80℃, 12-24 hours), pulverization and mixing, packaging.

[0057] Extraction rate: 6%–8%

[0058] Sensory requirements: Light yellow to brownish-yellow powder, bitter taste followed by a slightly sweet taste.

[0059] Identification: (1) It should show a positive reaction. (2) The chromatogram of the test sample should show the same chromatographic peaks as ginsenoside Rb1 and ginsenoside Rb3 with the same retention time.

[0060] Content determination: Ginsenoside Rb3: ≥10.5g / 100g

[0061] Total saponins (calculated as ginsenoside Re): ≥50g / 100g

[0062] Moisture: ≤5%, Ash: ≤3.5%, Particle size: 95% can pass through a 100-mesh sieve, Solubility: Easily soluble in water, Hexachlorocyclohexane (HCH): ≤0.2 mg / kg, DDT: ≤0.2 mg / kg, Lead (Pb): ≤2.0 mg / kg, Total Arsenic (As): ≤1.0 mg / kg, Total Mercury (Hg): ≤0.3 mg / kg, Cadmium (Cd): ≤0.3 mg / kg, Copper (Cu): ≤20.0 mg / kg, Total Bacterial Count: ≤30,000 CFU / g, Coliform Bacteria: ≤0.92 MPN / g, Molds and Yeasts: ≤50 CFU / g, Staphylococcus aureus: ≤0 / 25g, Salmonella: ≤0 / 25g

[0063] 4. Panax notoginseng flower extract

[0064] Source: This product is the dried inflorescence of Panax notoginseng, a plant of the Araliaceae family, and should comply with the provisions of "DBS53023-Yunnan Food Safety Local Standard-Dried Panax notoginseng Flower".

[0065] Preparation: Sieving, alcohol extraction (using 6-10 times the amount of 70±2% ethanol under hot reflux at 60-80℃, extracting 3 times, first adding 10 times the amount of ethanol for 2 hours, second adding 8 times the amount of ethanol for 2 hours, and third adding 6 times the amount of ethanol for 1 hour), concentration, water precipitation, separation with macroporous resin, decolorization, concentration, vacuum drying (70-80℃, 12-24 hours), pulverization and mixing, and packaging.

[0066] Extraction rate: 5%–6%

[0067] Sensory requirements: off-white to yellow powder, bitter taste followed by a slightly sweet taste.

[0068] Identification: The chromatogram of the test sample should show a chromatographic peak with the same retention time as ginsenoside Rb3.

[0069] Content determination: Ginsenoside Rb3: ≥45g / 100g

[0070] Total saponins (calculated as ginsenoside Re): ≥65g / 100g

[0071] Moisture: ≤5%, Ash: ≤3.5%, Particle size: 95% can pass through a 100-mesh sieve, Solubility: Easily soluble in water, Hexachlorocyclohexane (HCH): ≤0.2 mg / kg, DDT: ≤0.2 mg / kg, Lead (as Pb): ≤2.0 mg / kg, Total Arsenic (as As): ≤1.0 mg / kg, Total Mercury (as Hg): ≤0.3 mg / kg, Cadmium (as Cd): ≤0.3 mg / kg, Copper (as Cu): ≤20.0 mg / kg, Total Bacterial Count: ≤30000 CFU / g, Coliform Bacteria: ≤0.92 MPN / g, Molds and Yeasts: ≤50 CFU / g, Staphylococcus aureus: ≤0 / 25g, Salmonella: ≤0 / 25g.

[0072] This product showed no significant changes in its active ingredients, sensory properties, physicochemical indicators, and microbiological composition during storage at 37±2℃ and RH 75±5% for three months, remaining within the range specified in the quality standards. The packaging materials that directly contacted the product also had no impact. According to the "Guidelines for Stability Testing of Health Foods (2021 Edition)," the accelerated shelf life is generally set at two years; therefore, the shelf life of this product is 24 months.

[0073] The above-described embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application, and should all be included within the protection scope of this application.

Claims

1. A whole-plant oral liquid composition of Panax notoginseng, characterized in that, The oral liquid comprises, by weight percentage: 20-40% Panax notoginseng root extract; 3-8% Panax notoginseng stem and leaf extract; 0.5-2% Panax notoginseng flower extract; purified water to bring the total to 100%; and the total saponins in the oral liquid, calculated as ginsenoside Re, shall not be less than 1200 mg / 100 ml. mL.

2. The composition according to claim 1, characterized in that, The total saponins contain no less than 30 wt% ginsenoside Rb1, no less than 25 wt% ginsenoside Rg1, and no less than 5 wt% notoginsenoside R1.

3. The composition according to claim 1 or 2, characterized in that, The pH value is 4.5-7.5, the soluble solids content is not less than 1.5%, the lead content is not more than 0.5 mg / L, the total arsenic content is not more than 0.3 mg / L, and the hexachlorocyclohexane (HCH) and dichlorodiphenyltrichloroethane (DDT) content are both not more than 0.2 mg / L.

4. The composition according to any one of claims 1-3, characterized in that, The total bacterial count is no more than 1000 CFU / mL, the coliform count is no more than 0.43 MPN / mL, the mold and yeast count is no more than 50 CFU / mL, and pathogenic bacteria are not detected.

5. A method for preparing the composition according to any one of claims 1-4, characterized in that, include: a) Panax notoginseng roots were extracted by hot reflux with 70% ethanol, concentrated, water-precipitated, purified by macroporous resin, and dried under reduced pressure. b) Panax notoginseng stems and leaves were extracted with water, precipitated with alcohol, purified with macroporous resin, and dried under reduced pressure. c) Panax notoginseng flowers were extracted by hot reflux with 70% ethanol and processed using the same method as the root. d) Dissolve the three extracts in purified water in proportion, filter, fill and sterilize.

6. The method according to claim 5, characterized in that: The vacuum drying conditions are 70-80℃. 12-24 hours, including the following steps: (1) Preparation: Add 105% purified water to the mixing tank, turn on the heater and stir at 20±5 Hz, maintain the water temperature at 80-90℃ for 10 minutes, stop stirring, and release 15% of the purified water into a stainless steel container for later use; turn on the stirrer at 20±5 Hz to maintain the water temperature, and add the Panax notoginseng extract, Panax notoginseng stem and leaf extract, Panax notoginseng flower extract, etc. in sequence according to the production instructions, stirring until completely dissolved, turn off the stirrer and heating, slowly add the previously released purified water to the predetermined volume, and turn on the stirrer at 20±5 Hz. Cooling water was then injected to lower the temperature to 40±5℃. (2) Filtration: Filter the solution through a 5-10μm filter cartridge to obtain the filtered solution. (3) Filling: Fill and seal according to the specification of 10mL / vial. (4) Sterilization: Sterilization is carried out at 105-121℃ for 20-40 minutes. (5) Light inspection: After the light inspection process, unqualified products such as incomplete bottle caps, obvious abnormalities in the liquid level inside the bottle, and visible foreign matter in the solution are rejected. (6) Packaging: Take the products that pass the light inspection and package them to obtain the final product.

7. A method for controlling the quality of the composition according to any one of claims 1-4, characterized in that, A characteristic chromatogram containing six characteristic peaks was established using HPLC, wherein: Peak 1 is notoginsenoside R1, peak 2 is ginsenoside Rg1, peak 4 is ginsenoside Rb1, and peak 5 is ginsenoside Rb3. The retention time of peak 3 relative to peak 2 is 1.04 ± 10%; The retention time of peak 6 relative to peak 5 is 1.05 ± 10%.

8. The method according to claim 7, wherein the HPLC chromatographic conditions are: The chromatographic column was SepaChrom TCM C18, 250 mm × 4.6 mm, 5 μm. Mobile phase A: acetonitrile; Mobile phase B: water; Gradient: 0-30 min 20% A, 30-80 min 20%-46% A; Flow rate: 1 mL / min; Detection wavelength: 203 nm; Column temperature: 25 °C.

9. Use of the composition according to any one of claims 1-4 in the preparation of health food products that improve hypoxia tolerance and relieve physical fatigue.

10. The use according to claim 9, wherein the health food is packaged in a sodium-calcium glass bottle with a shelf life of 24 months.

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