Preparation method of ginsenoside freeze-drying flash release tablet

Abstract

This invention relates to the field of health food and pharmaceutical preparation technology, specifically to a method for preparing ginsenoside freeze-dried flash-release tablets. These ginsenoside freeze-dried flash-release tablets are made from the following raw materials in the indicated weight ratios: 3-5 parts ginseng extract, 8-12 parts matrix support agent, 1.5-2.5 parts binder, and 0.3-0.5 parts prebiotics. The method includes the following steps: S1, ingredient dissolution; S2, high-speed emulsification; S3, vacuum degassing; S4, quantitative filling; S5, ultra-low temperature quick-freezing; S6, programmed freeze-drying; and S7, aluminum-aluminum sealed packaging. This invention has the advantages of convenient administration, rapid absorption, pure formulation, good stability, and excellent taste.

Description

Technical Field

[0001] This invention relates to the field of health food and pharmaceutical preparation technology, specifically a method for preparing ginsenoside freeze-dried flash-release tablets. Background Technology

[0002] Ginsenosides, as the core active ingredient of ginseng, are widely used in anti-fatigue and immune-enhancing applications. Currently, commercially available products are mainly in traditional dosage forms such as hard capsules and ordinary tablets, which have the following drawbacks: Inconvenient to take: It needs to be taken with water, which cannot meet the needs of the elderly, children or outdoor scenarios.

[0003] Slow onset of action: Absorbed through the gastrointestinal tract, the first-pass effect may affect bioavailability.

[0004] Excessive excipients: In order to meet the tableting requirements, a large amount of fillers, disintegrants, etc. are often added, resulting in a low proportion of active ingredients.

[0005] While freeze-drying flash release technology can achieve rapid disintegration in the oral cavity, applying ginsenosides to this technology faces challenges: ginsenosides themselves are non-sticky, and their aqueous solutions are difficult to form a solid skeleton during freeze-drying, which can easily lead to product cracking, collapse, and poor stability. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides a ginsenoside freeze-dried flash-release tablet that disintegrates rapidly, is convenient to take, has a good taste, and is highly stable, as well as a stable preparation method for it on a pilot-scale basis, thus solving the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution: A method for preparing ginsenoside freeze-dried flash release tablets, characterized in that: the ginsenoside freeze-dried flash release tablets are made from the following raw materials in the following weight ratio: 3-5 parts ginseng extract, 8-12 parts skeleton support agent, 1.5-2.5 parts binder, and 0.3-0.5 parts prebiotics. The preparation method of this ginsenoside freeze-dried flash-release tablet includes the following steps: S1. Ingredient Dissolution: This includes the following steps: S11. Adhesive Dissolution: Stir the adhesive and water in a dissolving tank until completely dissolved; S12. Add the main ingredients and auxiliary ingredients, weigh the remaining raw materials into the dissolving tank according to the proportion, and stir until completely dissolved. S2, High-speed emulsification: The liquid obtained in S1 is emulsified at high speed in an emulsifier; S3, Vacuum Degassing: The emulsified liquid is degassed under vacuum; S4. Quantitative filling: The liquid material after vacuum degassing in S3 is quantitatively filled into the bubble holes of the aluminum-plastic blister pack. S5. Ultra-low temperature quick freezing: Place the blister pack after filling with liquid into a -100℃ liquid nitrogen tunnel for pre-freezing; S6. Programmatic freeze drying: Transfer the blister packs after ultra-low temperature quick-freezing to the freeze dryer for freeze drying. S7. Aluminum-aluminum sealed packaging: Remove the blister pack from the freeze dryer, cover it with film and cut it on the sealing machine.

[0008] Compared with the prior art, the present invention provides a method for preparing ginsenoside freeze-dried flash-release tablets, which has the following beneficial effects: This invention is convenient to take: it disintegrates in 3-5 seconds after ingestion, requiring no water, and is especially suitable for certain groups of people.

[0009] This invention is rapidly absorbed: it can be absorbed through the oral mucosa, has a fast onset of action, and high bioavailability.

[0010] The formula of this invention is pure: the proportion of excipients is low, the tablet weight is only about 90mg, and the content of active ingredients is high.

[0011] This invention exhibits excellent stability: through adhesive compounding technology, it solves the industry problem of brittle freeze-dried tablets, and the product does not shrink or collapse under accelerated testing conditions.

[0012] This invention offers an excellent taste: mannitol provides a refreshing sweetness, while fructooligosaccharides can slightly improve the flavor. Attached Figure Description

[0013] The present invention will be further described below with reference to the accompanying drawings and specific embodiments: Figure 1 The present invention provides a process flow diagram for the preparation of ginsenoside freeze-dried flash release tablets. Detailed Implementation

[0014] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0015] like Figure 1 As shown, this invention provides a preparation process for ginsenoside freeze-dried flash-release tablets, which are made from the following raw materials in the indicated weight ratios: Ginseng extract 3-5 parts, skeleton support agent 8-12 parts, binder 1.5-2.5 parts, prebiotic 0.3-0.5 parts; In this invention, the ginseng extract preferably contains more than 80% ginsenosides.

[0016] In this invention, the adhesive is made from the following raw materials in the following weight ratio: 1 part pullulan and 1 part gelatin.

[0017] In this invention, mannitol is preferred as the skeleton support agent; In this invention, the prebiotic is fructooligosaccharide.

[0018] Example 1: A preparation process for ginsenoside freeze-dried flash-release tablets, which are made from the following raw materials in the indicated weight ratios: 3 parts ginseng extract, 8 parts skeleton support agent, 2.5 parts binder, and 0.5 parts prebiotic; The preparation method of this ginsenoside freeze-dried flash-release tablet includes the following steps: S1. Ingredient Dissolution: This includes the following steps: S11. Dissolving the adhesive: Measure purified water into a dissolving tank and heat it to 50°C. Weigh pullulan and gelatin into the dissolving tank according to the ratio of adhesive to water: 1.5-2.5:750-1250. Stir until completely dissolved. S12. Add main and auxiliary ingredients: Weigh ginseng extract, mannitol and oligofructose into a dissolving tank according to the proportion and stir until completely dissolved. S2, High-speed emulsification: The liquid obtained in S1 is emulsified at high speed in an emulsifier, specifically at an emulsifier speed of 10,000 rpm for 10 minutes; S3. Vacuum degassing: The emulsified liquid is vacuum degassed for 10 minutes.

[0019] S4. Quantitative filling: Dispense the liquid after vacuum degassing in S3 into the blister packs at 0.5ml / pieces; S5. Ultra-low temperature quick freezing: Place the blister pack after filling with liquid into a -100℃ liquid nitrogen tunnel for pre-freezing for 10 minutes; S6. Programmatic freeze drying: Transfer the blister packs after ultra-low temperature quick-freezing to the freeze dryer for freeze drying.

[0020] The freeze-drying curve for the freeze-drying treatment is as follows: -35℃ / 75min→-25℃ / 180min→-15℃ / 135min→-5℃ / 75min→25℃ / 180min.

[0021] S7. Aluminum-aluminum sealed packaging: Remove the blister pack from the freeze dryer, cover it with film and cut it on the sealing machine.

[0022] Example 2: A preparation process for ginsenoside freeze-dried flash-release tablets, which are made from the following raw materials in the indicated weight ratios: 4 parts ginseng extract, 10 parts skeleton support agent, 2 parts binder, and 0.4 parts prebiotic; Includes the following steps: S1. Ingredient Dissolution: This includes the following steps: S11. Dissolving the adhesive: Measure purified water into a dissolving tank and heat it to 50°C. Weigh pullulan and gelatin into the dissolving tank according to the ratio of adhesive to water: 1.5-2.5:750-1250. Stir until completely dissolved. S12. Add main and auxiliary ingredients: Weigh ginseng extract, mannitol and oligofructose into a dissolving tank according to the proportion and stir until completely dissolved. S2, High-speed emulsification: The liquid obtained in S1 is emulsified at high speed in an emulsifier, specifically at an emulsifier speed of 10,000 rpm for 10 minutes; S3. Vacuum degassing: The emulsified liquid is vacuum degassed for 10 minutes.

[0023] S4. Quantitative filling: Dispense the liquid after vacuum degassing in S3 into the blister packs at 0.5ml / pieces; S5. Ultra-low temperature quick freezing: Place the blister pack after filling with liquid into a -100℃ liquid nitrogen tunnel for pre-freezing for 10 minutes; S6. Programmatic freeze drying: Transfer the blister packs after ultra-low temperature quick-freezing to the freeze dryer for freeze drying.

[0024] The freeze-drying curve for the freeze-drying treatment is as follows: -35℃ / 75min→-25℃ / 180min→-15℃ / 135min→-5℃ / 75min→25℃ / 180min.

[0025] S7. Aluminum-aluminum sealed packaging: Remove the blister pack from the freeze dryer, cover it with film and cut it on the sealing machine.

[0026] Example 3: A preparation process for ginsenoside freeze-dried flash-release tablets, which are made from the following raw materials in the indicated weight ratios: 5 parts ginseng extract, 12 parts skeleton support agent, 1.5 parts binder, and 0.3 parts prebiotic; Includes the following steps: S1. Ingredient Dissolution: This includes the following steps: S11. Dissolving the adhesive: Measure purified water into a dissolving tank and heat it to 50°C. Weigh pullulan and gelatin into the dissolving tank according to the ratio of adhesive to water: 1.5-2.5:750-1250. Stir until completely dissolved. S12. Add main and auxiliary ingredients: Weigh ginseng extract, mannitol and oligofructose into a dissolving tank according to the proportion and stir until completely dissolved. S2, High-speed emulsification: The liquid obtained in S1 is emulsified at high speed in an emulsifier, specifically at an emulsifier speed of 10,000 rpm for 10 minutes; S3. Vacuum degassing: The emulsified liquid is vacuum degassed for 10 minutes.

[0027] S4. Quantitative filling: Dispense the liquid after vacuum degassing in S3 into the blister packs at 0.5ml / pieces; S5. Ultra-low temperature quick freezing: Place the blister pack after filling with liquid into a -100℃ liquid nitrogen tunnel for pre-freezing for 10 minutes; S6. Programmatic freeze drying: Transfer the blister packs after ultra-low temperature quick-freezing to the freeze dryer for freeze drying.

[0028] The freeze-drying curve for the freeze-drying treatment is as follows: -35℃ / 75min→-25℃ / 180min→-15℃ / 135min→-5℃ / 75min→25℃ / 180min.

[0029] S7. Aluminum-aluminum sealed packaging: Remove the blister pack from the freeze dryer, cover it with film and cut it on the sealing machine.

[0030] This invention has the advantages of convenient administration, rapid absorption, pure formula, good stability, and excellent taste.

[0031] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0032] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method for preparing ginsenoside freeze-dried flash-release tablets, characterized in that: This ginsenoside freeze-dried flash-release tablet is made from the following raw materials in the indicated weight ratios: 3-5 parts ginseng extract, 8-12 parts matrix support agent, 1.5-2.5 parts binder, and 0.3-0.5 parts prebiotics. The preparation method of this ginsenoside freeze-dried flash-release tablet includes the following steps: S1. Ingredient Dissolution: This includes the following steps: S11. Adhesive Dissolution: Stir the adhesive and water in a dissolving tank until completely dissolved; S12. Add the main ingredients and auxiliary ingredients, weigh the remaining raw materials into the dissolving tank according to the proportion, and stir until completely dissolved. S2, High-speed emulsification: The liquid obtained in S1 is emulsified at high speed in an emulsifier; S3, Vacuum Degassing: The emulsified liquid is degassed under vacuum; S4. Quantitative filling: The liquid material after vacuum degassing in S3 is quantitatively filled into the bubble holes of the aluminum-plastic blister pack. S5. Ultra-low temperature quick freezing: Place the blister pack after filling with liquid into a -100℃ liquid nitrogen tunnel for pre-freezing; S6. Programmatic freeze drying: Transfer the blister packs after ultra-low temperature quick-freezing to the freeze dryer for freeze drying. S7. Aluminum-aluminum sealed packaging: Remove the blister pack from the freeze dryer, cover it with film and cut it on the sealing machine.

2. The method for preparing ginsenoside freeze-dried flash-release tablets according to claim 1, characterized in that, Ginseng extract contains more than 80% ginsenosides.

3. The method for preparing ginsenoside freeze-dried flash-release tablets according to claim 1, characterized in that, The adhesive is made from the following raw materials in the following weight ratio: 1 part pullulan and 1 part gelatin.

4. The method for preparing ginsenoside freeze-dried flash-release tablets according to claim 1, characterized in that, The skeletal support agent is mannitol.

5. The method for preparing ginsenoside freeze-dried flash-release tablets according to claim 1, characterized in that, Prebiotics are fructooligosaccharides.

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