Active multi-enzyme preparation with spleen-strengthening and stomach-harmonizing effects and preparation method of active multi-enzyme preparation

Abstract

The invention relates to the field of functional food and pharmaceutical preparations, and discloses an active multienzyme preparation with spleen and stomach strengthening effects. The solid beverage is prepared from the following components in parts by weight: 10 to 20 parts of radix astragali seu hedysari extract, 5 to 10 parts of rhizoma atractylodis macrocephalae extract, 10 to 20 parts of poria cocos extract, 5 to 10 parts of pericarpium citri reticulatae extract, 5 to 10 parts of fructus crataegi extract, 5 to 10 parts of malt extract, 5 to 10 parts of alpha-amylase, 5 to 10 parts of protease, 2 to 5 parts of cellulase, 2 to 5 parts of pectinase, 2 to 5 parts of lipase, 10 to 15 parts of prebiotics, 2 to 5 parts of xylitol and 3 to 8 parts of microcapsule wrapping materials. The compound preparation with high stability and multiple functions is prepared by scientifically combining traditional Chinese medicine extracts and multiple active enzymes, combining with reasonable addition of prebiotics and auxiliary materials, adopting a micro-capsule wrapping technology to protect enzyme activity and optimizing traditional Chinese medicine extraction, component mixing and forming processes.

Description

Technical Field

[0001] The invention relates to the technical field of functional foods and pharmaceutical preparations, in particular to an active multi-enzyme preparation with spleen-strengthening and stomach-regulating effects and a preparation method thereof. Background Art

[0002] With the improvement of social living standards and changes in dietary structure, digestive system problems have gradually attracted people's attention. At present, the products used to improve spleen and stomach function on the market mainly include functional preparations based on Chinese herbal extracts and nutritional supplements based on enzyme preparations. These two types of products each have certain technical advantages, but they also have shortcomings in practical applications and are difficult to meet the market's demand for efficient, stable and multifunctional preparations.

[0003] In the prior art, Chinese herbal extract preparations mainly obtain active ingredients through traditional extraction processes (such as water extraction and alcohol precipitation) to improve spleen and stomach function. However, the single use of Chinese herbal extracts has certain technical limitations in terms of component diversity, absorption efficiency and comprehensiveness of action. For example, in actual use, the function of Chinese herbal extracts mainly depends on the individual's digestion and absorption capacity, and its effect is limited for groups with insufficient digestion and absorption.

[0004] Enzyme preparations, with α-amylase, protease, lipase and other enzymes as main ingredients, improve the efficiency of nutrient absorption by participating in the food decomposition process. Existing enzyme preparations are usually directly added to products, but this type of technology has the following technical problems in actual production and use: First, enzymes are easily inactivated during high-temperature processing and storage, making it difficult to maintain enzyme activity; second, the release rate of directly added enzymes in the digestive system is uncontrollable, which may lead to the problem of too fast release; third, the addition of a single or small amount of enzyme is difficult to cover the decomposition requirements of multiple nutrients, and the functional range is limited.

[0005] In recent years, some technologies have attempted to combine Chinese herbal extracts with enzyme preparations in order to utilize the conditioning effects of Chinese herbal ingredients and the decomposition ability of enzyme preparations to achieve synergistic effects. However, due to the different physical and chemical properties of the two, this combination has the following problems in practical applications: some components of Chinese herbal extracts may have an adverse effect on the activity of the enzyme; imperfect mixing processes lead to uneven distribution of components; in addition, the physical properties of Chinese herbal extracts and enzyme preparations are quite different, making it difficult to achieve a stable combination of the two, and the long-term storage stability of the preparations is insufficient.

[0006] In terms of preparation technology, the existing technology has room for improvement in extraction purity, component uniformity, enzyme activity protection and industrial production of preparations. For example, the extraction process of traditional Chinese medicine is inefficient in removing impurities and enriching active ingredients, making it difficult to achieve high-purity extraction of ingredients; the encapsulation technology of enzyme preparations lacks refined design in particle size control, encapsulation material selection and release performance optimization, resulting in unstable preparation performance; at the same time, the preparation form of the existing technology is mainly tablets or powders, and the adaptability to granules and liquid dosage forms is poor.

[0007] Therefore, the present invention proposes an active multi-enzyme preparation with spleen and stomach strengthening effects and a preparation method thereof to solve the deficiencies of the prior art. Summary of the invention

[0008] In view of the deficiencies of the prior art, the present invention provides an active multi-enzyme preparation with spleen-strengthening and stomach-regulating effects and a preparation method thereof, by scientifically combining Chinese medicine extracts (such as Astragalus, Atractylodes macrocephala, Poria cocos, etc.) with a variety of active enzymes (such as α-amylase, protease, lipase, etc.), combined with the reasonable addition of prebiotics and excipients, using microencapsulation technology to protect enzyme activity, and by optimizing Chinese medicine extraction, component mixing and molding processes, a composite preparation with high stability and versatility is prepared. The preparation can be made into granules, capsules or liquid dosage forms, solving the problems of single function of Chinese medicine extracts, insufficient protection of enzyme activity and uneven preparation in the prior art, and is widely applicable to application scenarios for improving spleen and stomach function.

[0009] To achieve the above object, the present invention is implemented by the following technical scheme: an active multi-enzyme preparation with spleen and stomach strengthening effects comprises the following components by weight:

[0010] Astragalus extract: 10-20 parts;

[0011] Atractylodes macrocephala extract: 5-10 parts;

[0012] Poria cocos extract: 10-20 parts;

[0013] Tangerine peel extract: 5-10 parts;

[0014] Hawthorn extract: 5-10 parts;

[0015] Malt extract: 5-10 parts;

[0016] α-amylase: 5-10 parts;

[0017] Protease: 5-10 parts;

[0018] Cellulase: 2-5 parts;

[0019] Pectinase: 2-5 parts;

[0020] Lipase: 2-5 parts;

[0021] Prebiotics: 10-15 servings;

[0022] Xylitol: 2-5 parts.

[0023] Preferably, the astragalus extract is astragalus polysaccharide extracted by water extraction and alcohol precipitation method, and the extraction conditions are: solid-liquid ratio 1:10, extraction temperature 60°C-70°C, and extraction time 30-50 minutes.

[0024] Preferably, the activity of α-amylase, protease, cellulase, pectinase and lipase in the enzyme preparation is protected by microencapsulation technology, which specifically includes the following steps:

[0025] Dissolve α-amylase, protease, cellulase, pectinase and lipase in a buffer to prepare an enzyme solution with a concentration of 0.5-1.0%;

[0026] Chitosan and sodium alginate were mixed in a mass ratio of 1:2 to prepare an encapsulation liquid;

[0027] The enzyme solution is dropped into the encapsulation liquid to form encapsulated microspheres under stirring conditions;

[0028] Microcapsules with a particle size of 100-200 μm are formed by spray drying or freeze drying.

[0029] Preferably, the prebiotics are selected from oligofructose, oligoisomaltose or a mixture thereof, and the added amount of the prebiotics is 10-15% of the total weight of the preparation.

[0030] Preferably, the preparation further comprises a group of Chinese medicine excipients, the weight parts of which are as follows: licorice extract: 2-5 parts, ginger extract: 1-3 parts.

[0031] Preferably, the preparation method of the active multi-enzyme preparation having the effect of strengthening the spleen and stomach comprises the following steps:

[0032] S1. Preparation of Chinese herbal medicine extracts:

[0033] Grind astragalus, atractylodes, tuckahoe, tangerine peel, hawthorn and malt into 100 mesh fine powder according to weight proportion;

[0034] The active ingredients were extracted by water extraction and alcohol precipitation process, and the extraction conditions were: solid-liquid ratio 1:10, extraction temperature 60-70°C, and extraction time 40-50 minutes;

[0035] After centrifugation, the extract was added with 75% ethanol, and allowed to stand for 12 hours to precipitate polysaccharides, and then centrifuged and freeze-dried to obtain a Chinese medicine extract powder;

[0036] S2. Preparation of multi-enzyme preparation:

[0037] α-amylase, protease, cellulase, pectinase and lipase are mixed in proportion;

[0038] Chitosan and sodium alginate were used for microencapsulation, and the encapsulation conditions were as follows: chitosan-sodium alginate mass ratio was 1:2, and the stirring rate was 200-300 rpm. After the microencapsulation was formed, multienzyme microparticles were prepared by spray drying;

[0039] S3, compounding and molding:

[0040] The prepared Chinese medicine extract powder, multi-enzyme microparticles, prebiotics, xylitol and other auxiliary materials are mixed evenly according to proportion;

[0041] Use extrusion granulation equipment to prepare granules, or use capsule filling equipment to fill double-layer capsules, or formulate liquid preparations.

[0042] Preferably, the spray drying conditions for the microcapsule encapsulation are:

[0043] The inlet temperature is 110-130℃, and the outlet temperature is 70-90℃;

[0044] The atomizing air flow pressure is 0.2-0.3MPa;

[0045] Feed rate is 1-5mL / min;

[0046] The particle size of the microcapsules ranges from 100 to 150 μm.

[0047] Preferably, the compounding and molding steps include:

[0048] The Chinese herbal medicine extract powder was subjected to a secondary vacuum drying treatment before mixing, with the drying conditions being 50-60°C and the vacuum degree being 0.08-0.1MPa;

[0049] The multi-enzyme microparticles were treated with an antistatic agent before mixing;

[0050] The mixing equipment speed is set to 100-200 rpm, and the mixing time is controlled to 15-20 minutes;

[0051] The granulation step uses a 20-40 mesh screen, and the particle size is 300-600 μm.

[0052] Preferably, the preparation steps of the liquid preparation include:

[0053] The preparation process of the base solution includes adding 0.1-0.5% of stabilizer to purified water at 35-40°C;

[0054] The Chinese herbal medicine extract powder and the multi-enzyme microparticles are pre-mixed in a ratio of 1:1.2-1.5 and then added to the liquid base solution;

[0055] The homogenization conditions are as follows: the homogenizer pressure is 20-30 MPa and the processing time is 10-15 minutes;

[0056] During the bottling step, the product was filtered using a 0.22 μm filter membrane and sealed in a nitrogen environment.

[0057] The present invention provides an active multi-enzyme preparation having the effects of strengthening the spleen and stomach and a preparation method thereof. It has the following beneficial effects:

[0058] 1. The present invention constructs a synergistic composite active multi-enzyme preparation through the scientific combination of Chinese herbal extracts (Astragalus, Atractylodes macrocephala, Poria cocos, etc.) and active multi-enzymes (α-amylase, protease, cellulase, etc.), combined with the rational addition of prebiotics (fructoligosaccharides or isomaltooligosaccharides) and functional excipients (such as xylitol). The design of this formula provides a functional basis for the homology of medicine and food through Chinese herbal extracts, enzyme preparations optimize the efficiency of food decomposition, and prebiotics balance the intestinal flora, and the three form a mutually synergistic composite system. Compared with the preparations of the prior art that use Chinese herbal extracts or enzyme preparations alone, the present invention solves the shortcomings of single function, insufficient stability and lack of targeted compatibility through scientific integration of ingredients, so that the preparation has multi-level and multi-pathway application potential in strengthening the spleen and stomach.

[0059] 2. The present invention adopts innovative microcapsule packaging technology, and realizes effective protection and controlled release of active multi-enzymes through composite packaging materials of chitosan and sodium alginate in a specific ratio (1:2), combined with spray drying or freeze drying technology. By controlling the packaging process parameters (such as inlet temperature 110-130°C, outlet temperature 70-90°C, air flow pressure 0.2-0.3MPa), the microcapsule particle size is uniformly controlled at 100-150μm, thereby realizing efficient preservation and slow release of enzyme activity during processing, storage and human use of enzyme preparations. Compared with the problems of inactivation, uneven release or short action time caused by direct addition or simple packaging of enzyme preparations in the prior art, the present invention solves the problem of enzyme activity loss during high-temperature processing and long-term storage, and enhances the decomposition ability and continuous action of enzyme preparations in the human body, providing technical guarantee for achieving the effects of strengthening the spleen and stomach.

[0060] 3. The present invention has comprehensively optimized the preparation methods of Chinese medicine extracts and active multi-enzymes. The Chinese medicine components are extracted by water extraction and alcohol precipitation (solid-liquid ratio 1:10, temperature 60-70°C, time 30-50 minutes), combined with process steps such as centrifugation, polysaccharide precipitation and freeze drying, and the active ingredients such as astragalus polysaccharide are effectively extracted and concentrated, thereby improving the purity and activity of the Chinese medicine extract. In addition, the preparation of active multi-enzymes achieves the stability and uniformity control of the enzyme components through microencapsulation technology and precise proportion mixing (α-amylase, protease, etc. in proportion of 5-10 parts). Compared with the problems of insufficient refinement of Chinese medicine extraction and enzyme processing technology and serious loss of active components in the prior art, the present invention significantly improves the extraction efficiency of active ingredients in the preparation and the overall preparation quality, laying a stable foundation for the spleen and stomach functions of the preparation.

[0061] 4. In the process of compounding and molding, the present invention innovatively adopts the vacuum drying process of Chinese medicine extract (50-60℃, vacuum degree 0.08-0.1MPa) to reduce the moisture content and improve the physical stability of the extract; at the same time, the active multi-enzyme microparticles are treated with antistatic agents to improve the dispersion performance of the multi-enzyme microparticles in mixing. By using high-speed mixing equipment (rotation speed 100-200rpm, mixing time 15-20 minutes), the Chinese medicine extract, multi-enzyme microparticles, prebiotics and other excipients are uniformly compounded, and combined with the molding process of different formulation forms (granules, capsules or liquid dosage forms), the physical stability and functional consistency of the preparation are improved. Compared with the problem of unstable component distribution or poor molding effect caused by uneven mixing in the prior art, the present invention solves the defects of insufficient stability and uniformity of the preparation during large-scale production, broadens the application scope of the product in multiple dosage forms, and provides a feasible industrial preparation path for the precise design of spleen and stomach functions. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Figure 1 The present invention is a flow chart of the preparation method of an active multi-enzyme preparation having the effects of strengthening the spleen and stomach. DETAILED DESCRIPTION

[0063] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0064] Please see attached Figure 1 :

[0065] Embodiment 1:

[0066] Raw material formula:

[0067] Chinese herbal medicine extracts: Astragalus extract (15 parts), Atractylodes macrocephala extract (8 parts), Poria cocos extract (15 parts), Tangerine peel extract (8 parts), Crataegus pinnatifida extract (7 parts), and Malt extract (6 parts).

[0068] Enzyme preparation: α-amylase (7 parts), protease (7 parts), cellulase (3 parts), pectinase (3 parts), lipase (3 parts).

[0069] Excipients: prebiotics (fructooligosaccharides and isomaltooligosaccharides, 12 parts), xylitol (4 parts), microcapsule encapsulation materials (chitosan and sodium alginate, 5 parts).

[0070] Preparation steps:

[0071] Preparation of Chinese herbal medicine extracts:

[0072] The mixture was crushed to 100 mesh, and water was added at a solid-liquid ratio of 1:10 for extraction at 65°C for 45 minutes. The extract was centrifuged, and 75% ethanol was added and allowed to stand for 12 hours to precipitate polysaccharides. After centrifugation, the extract was freeze-dried to obtain an extract powder.

[0073] Microencapsulation of enzyme preparations:

[0074] A 0.8% enzyme solution was prepared, and chitosan and sodium alginate were mixed in a mass ratio of 1:2 to form an encapsulation liquid; the enzyme solution was dropped into the encapsulation liquid, the stirring rate was 250 rpm, and the solution was spray-dried (inlet temperature 120° C., outlet temperature 80° C.) to prepare microcapsules (particle size 150 μm).

[0075] Compounding and molding:

[0076] The Chinese herbal medicine extract, multi-enzyme microcapsules and auxiliary materials were mixed in proportion, the speed of the mixing equipment was 150 rpm, and the time was 20 minutes; granules (particle size 400 μm) were prepared by extrusion granulation equipment.

[0077] Tests and Results

[0078] Enzyme activity preservation rate: 92%;

[0079] Microcapsule particle size distribution uniformity: 98%;

[0080] Polysaccharide content of Chinese herbal medicine extract: 85%.

[0081] Summarize:

[0082] The prepared granules performed well in terms of activity protection, uniformity and stability. Thanks to the microencapsulation technology, the enzyme activity was significantly higher than that of the unencapsulated samples, solving the problem of enzyme inactivation during storage and processing. At the same time, the purity of the Chinese medicine extract was high, overcoming the low efficiency of the existing extraction process.

[0083] Embodiment 2:

[0084] Raw material formula:

[0085] Chinese herbal medicine extracts: Astragalus extract (8 parts), Atractylodes macrocephala extract (4 parts), Poria extract (9 parts), Tangerine peel extract (4 parts), Crataegus pinnatifida extract (4 parts), Malt extract (4 parts).

[0086] Enzyme preparation: α-amylase (4 parts), protease (4 parts), cellulase (1.5 parts), pectinase (1.5 parts), lipase (1.5 parts).

[0087] Auxiliary materials: prebiotics (8 parts), xylitol (1.5 parts), microencapsulation material (2.5 parts).

[0088] Preparation steps:

[0089] Preparation of Chinese herbal medicine extracts:

[0090] The mixture was crushed to 120 mesh, with a solid-liquid ratio of 1:15, an extraction temperature of 55°C, and a time of 35 minutes; 50% ethanol was added and allowed to stand for 8 hours to precipitate polysaccharides; and the extract powder was obtained by freeze-drying after centrifugation.

[0091] Microencapsulation of enzyme preparations:

[0092] A 0.3% enzyme solution was prepared, and chitosan and sodium alginate were prepared into an encapsulation solution in a ratio of 1:3; the stirring rate was 180 rpm, and the spray drying conditions were an inlet temperature of 105° C. and an outlet temperature of 70° C., and microcapsules with a particle size of 90 μm were obtained.

[0093] Compounding and molding:

[0094] The Chinese herbal medicine extract, multi-enzyme microcapsules and auxiliary materials were mixed in proportion, the mixing equipment speed was 100 rpm, and the time was 10 minutes; the double-layer capsules (500 mg / capsule) were filled with capsule filling equipment.

[0095] Test and results:

[0096] Enzyme activity preservation rate: 78%;

[0097] Microcapsule particle size distribution uniformity: 70%;

[0098] Polysaccharide content of Chinese herbal medicine extract: 60%.

[0099] Summarize:

[0100] The composition ratio and process conditions below the range value lead to insufficient purity of the extract, incomplete microcapsule packaging, significantly reduced enzyme activity, and poor storage performance. The results show that the technical advantages of the present invention cannot be fully reflected when the parameters are low.

[0101] Embodiment 3:

[0102] Raw material formula:

[0103] Chinese herbal medicine extracts: Astragalus extract (22 parts), Atractylodes macrocephala extract (12 parts), Poria extract (22 parts), Tangerine peel extract (12 parts), Hawthorn extract (12 parts), Malt extract (12 parts).

[0104] Enzyme preparation: α-amylase (12 parts), protease (12 parts), cellulase (6 parts), pectinase (6 parts), lipase (6 parts).

[0105] Auxiliary materials: prebiotics (18 parts), xylitol (6 parts), microcapsule packaging materials (10 parts).

[0106] Preparation steps:

[0107] Preparation of Chinese herbal medicine extracts:

[0108] The extract was crushed to 80 mesh, with a solid-liquid ratio of 1:8, an extraction temperature of 75°C, and a time of 55 minutes; 90% ethanol was added to the extract and allowed to stand for 18 hours to precipitate polysaccharides; the extract was centrifuged and freeze-dried to obtain an extract powder.

[0109] Microencapsulation of enzyme preparations:

[0110] A 1.5% enzyme solution was prepared, and chitosan and sodium alginate were prepared into an encapsulation solution in a ratio of 1:1; the stirring rate was 320 rpm, and the spray drying conditions were an inlet temperature of 135° C. and an outlet temperature of 95° C., and microcapsules with a particle size of 200 μm were obtained.

[0111] Compounding and molding:

[0112] The mixing equipment has a rotation speed of 200 rpm and a time of 25 minutes. The liquid preparation is prepared by a homogenizer with a homogenization pressure of 40 MPa and a packaging specification of 10 mL / bottle.

[0113] Test and results:

[0114] Enzyme activity preservation rate: 88%;

[0115] Microcapsule particle size distribution uniformity: 85%;

[0116] Polysaccharide content of Chinese herbal medicine extract: 75%.

[0117] Summarize:

[0118] Although the components and parameters higher than the range values ​​have improved some indicators, the high extraction temperature and time have resulted in partial degradation of the Chinese medicine polysaccharides, and the excessively large particle size of the microcapsules has affected the release rate after dissolution. It is suitable for specific liquid preparation scenarios, but the overall performance is slightly inferior to that of Example 1.

[0119] Comparative analysis of embodiments:

[0120]

[0121] Example 1 achieved component synergy and process optimization within the range values, with the best comprehensive performance, verifying the technical solution and beneficial effects of the present invention.

[0122] Example 2 shows that parameters below the range values ​​lead to significant decreases in extraction purity, microcapsule uniformity and enzyme activity, making it difficult to meet the requirements of high efficiency and stability, reflecting the necessity of range parameters.

[0123] Example 3 shows that although excessively high parameters increase the enzyme solution concentration and process conditions to a certain extent, they have a negative impact on the polysaccharide content and microcapsule performance, indicating that parameter design needs to balance function and stability.

[0124] Comparative experiment:

[0125] Comparative Example 1:

[0126] Experimental design

[0127] Existing technical solutions:

[0128] Raw material formula: Astragalus extract (15 parts), Atractylodes macrocephala extract (10 parts), Poria cocos extract (15 parts).

[0129] Preparation process:

[0130] The Chinese medicine raw materials were crushed into 120 mesh fine powder, purified water was added at a solid-liquid ratio of 1:10, the extraction temperature was 60°C, and the extraction time was 40 minutes.

[0131] After centrifugation, the extract was added with 75% ethanol and allowed to stand for 12 hours to precipitate polysaccharides, which were then freeze-dried to obtain extract powder.

[0132] The extract is directly filled into capsules to prepare the preparation.

[0133] Technical solution of the present invention:

[0134] Raw material formula: Astragalus extract (15 parts), Atractylodes macrocephala extract (8 parts), Poria extract (15 parts) + enzyme preparation (7 parts of α-amylase, 7 parts of protease, 3 parts of cellulase, 3 parts of pectinase, 3 parts of lipase).

[0135] Preparation process:

[0136] The Chinese herbal medicine extract is prepared according to the existing technical method.

[0137] The enzyme preparation was encapsulated by microcapsule: the enzyme was dissolved in buffer (concentration 0.8%), and the encapsulation solution was made of chitosan and sodium alginate (1:2), stirred at 250 rpm to form microspheres, and spray-dried (inlet temperature 120°C, outlet temperature 80°C) to obtain enzyme microcapsules with a particle size of 150 μm.

[0138] The extract was compounded and mixed with the enzyme microcapsules for 15 minutes, and granules (particle size 400 μm) were prepared using an extrusion granulation device.

[0139] Experimental indicators

[0140] In vitro simulated digestion:

[0141] Starch and protein degradation efficiency.

[0142] Digestion time.

[0143] Bioavailability:

[0144] Absorption rates of polysaccharides and flavonoid compounds from traditional Chinese medicine extracts.

[0145] Experimental data:

[0146]

[0147] Experimental results and analysis:

[0148] Existing technology: When Chinese herbal medicine extracts are used alone, their functions are limited, and their digestion efficiency depends on the enzyme system in the body, especially their ability to decompose starch and protein is low, and the digestion time is long.

[0149] The technology of the present invention: The addition of enzymes significantly improves digestion efficiency, the starch and protein decomposition rates are increased by about 210% and 290% respectively, and the digestion time is shortened by nearly 60%. The action of enzymes also promotes the bioavailability of traditional Chinese medicine ingredients, and the absorption rate is increased by about 30%.

[0150] Summary of embodiments:

[0151] The invention makes up for the deficiency of single function of traditional Chinese medicine through the synergistic effect of traditional Chinese medicine and enzyme, and verifies the scientificity and compatibility advantage of enzyme in the formula.

[0152] Comparative Example 2:

[0153] Experimental design:

[0154] Existing technical solutions:

[0155] Raw material formula: α-amylase (5 parts), protease (5 parts), cellulase (3 parts).

[0156] Preparation process:

[0157] The enzyme preparation is directly mixed with excipients (prebiotics, xylitol) without any protective measures.

[0158] After mixing for 15 minutes, granules were prepared directly.

[0159] Technical solution of the present invention:

[0160] Raw material formula: same as above.

[0161] Preparation process:

[0162] The enzyme preparation was dissolved in buffer, and the material was coated with chitosan and sodium alginate (1:2), and spray-dried to prepare microcapsules with a particle size of 150 μm.

[0163] The microcapsules and excipients were mixed in proportion for 15 minutes to prepare granules.

[0164] Experimental indicators:

[0165] Storage stability:

[0166] Enzyme activity preservation rate after storage at high temperature (40℃) for 30 days.

[0167] Release behavior in simulated digestive fluid:

[0168] Slow release rate in gastric fluid.

[0169] Concentrated release rate in intestinal fluid.

[0170] Experimental data:

[0171]

[0172] Experimental results and analysis:

[0173] Existing technology: Directly adding enzyme preparations will significantly reduce the activity in a high temperature environment, leaving only 40.2%; in the simulated gastric juice experiment, the enzyme is released too quickly, resulting in insufficient enzyme activity in the intestinal juice.

[0174] The technology of the present invention: microencapsulation significantly improves the stability and release behavior of the enzyme, the storage activity is increased by about 130%, and the release rate in intestinal fluid is increased by 8 times.

[0175] Summary of Examples

[0176] The present invention protects enzyme activity through microencapsulation technology, solves the problems of enzyme inactivation and uncontrollable release in the prior art, and achieves comprehensive improvement in storage stability and use effect.

[0177] Comparative Example 3:

[0178] Experimental design

[0179] Existing technical solutions:

[0180] Raw material formula: astragalus extract (15 parts), enzyme preparation (10 parts).

[0181] Preparation process:

[0182] The Chinese herbal medicine extracts were directly mixed with the enzymes without antistatic or drying treatment, and the mixing time was 10 minutes.

[0183] Technical solution of the present invention:

[0184] Raw material formula: same as above.

[0185] Preparation process:

[0186] The water content of the Chinese herbal medicine extract was reduced to below 3% by vacuum drying (50°C, vacuum degree 0.08MPa).

[0187] The enzyme preparation was treated with antistatic agent and mixed with auxiliary materials for 15 minutes to prepare granules.

[0188] Experimental indicators

[0189] Composition uniformity: standard deviation of enzyme activity and TCM content among different batches.

[0190] Storage stability: hygroscopicity and caking rate.

[0191] Experimental data

[0192] index Prior art The technology of the present invention Enzyme activity standard deviation (%) ±12.5 ±2.3 Standard deviation of content of Chinese herbal medicine extracts (%) ±10.8 ±1.8 Storage 30 days moisture absorption rate (%) 8.5 3.2 Agglomeration rate of granules (%) 20 2.5

[0193] Experimental results and analysis:

[0194] Existing technology: Untreated moisture and static electricity problems lead to uneven mixing, high hygroscopicity, and easy agglomeration during storage.

[0195] The technology of the present invention: vacuum drying and antistatic treatment significantly improve the mixing uniformity and storage stability, and the moisture absorption rate is reduced by 62%.

[0196] Summary of Examples

[0197] The present invention overcomes the mixing and storage problems in the prior art by optimizing the process, thus providing a guarantee for the consistency of preparation quality and industrial production.

[0198] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An active multi-enzyme preparation having the effect of strengthening the spleen and stomach, characterized in that: By weight, it contains the following ingredients: Astragalus extract: 10-20 parts; Atractylodes macrocephala extract: 5-10 parts; Poria cocos extract: 10-20 parts; Tangerine peel extract: 5-10 parts; Hawthorn extract: 5-10 parts; Malt extract: 5-10 parts; α-amylase: 5-10 parts; Protease: 5-10 parts; Cellulase: 2-5 parts; Pectinase: 2-5 parts; Lipase: 2-5 parts; Prebiotics: 10-15 servings; Xylitol: 2-5 parts; Microcapsule encapsulation materials (chitosan and sodium alginate): 3-8 parts.

2. The active multi-enzyme preparation having spleen-strengthening and stomach-regulating effects according to claim 1, characterized in that: The astragalus extract is astragalus polysaccharide extracted by water extraction and alcohol precipitation method, and the extraction conditions are: solid-liquid ratio 1:10, extraction temperature 60°C-70°C, and extraction time 30-50 minutes.

3. The active multi-enzyme preparation having spleen-strengthening and stomach-regulating effects according to claim 1, characterized in that: The activity of α-amylase, protease, cellulase, pectinase and lipase in the enzyme preparation is protected by microencapsulation technology, which specifically includes the following steps: Dissolve α-amylase, protease, cellulase, pectinase and lipase in a buffer to prepare an enzyme solution with a concentration of 0.5-1.0%; Chitosan and sodium alginate were mixed in a mass ratio of 1:2 to prepare an encapsulation liquid; The enzyme solution is dropped into the encapsulation liquid to form encapsulated microspheres under stirring conditions; Microcapsules with a particle size of 100-200 μm are formed by spray drying or freeze drying.

4. The active multi-enzyme preparation having spleen-strengthening and stomach-regulating effects according to claim 1, characterized in that: The prebiotics are selected from oligofructose, oligomaltose or a mixture of the two, and the added amount of the prebiotics is 10-15% of the total weight of the preparation.

5. The active multi-enzyme preparation having spleen-strengthening and stomach-regulating effects according to claim 1, characterized in that: The preparation also comprises a group of Chinese medicinal excipients, which are as follows by weight: 2-5 parts of liquorice extract and 1-3 parts of ginger extract.

6. The method for preparing the active multi-enzyme preparation having spleen-strengthening and stomach-regulating effects according to any one of claims 1 to 5, characterized in that: The following steps are involved: S1. Preparation of Chinese herbal medicine extracts: Grind astragalus, atractylodes, tuckahoe, tangerine peel, hawthorn and malt into 100 mesh fine powder according to weight proportion; The active ingredients were extracted by water extraction and alcohol precipitation process, and the extraction conditions were: solid-liquid ratio 1:10, extraction temperature 60-70°C, and extraction time 40-50 minutes; After centrifugation, the extract was added with 75% ethanol, and allowed to stand for 12 hours to precipitate polysaccharides, and then centrifuged and freeze-dried to obtain a Chinese medicine extract powder; S2. Preparation of multi-enzyme preparation: α-amylase, protease, cellulase, pectinase and lipase are mixed in proportion; Chitosan and sodium alginate were used for microencapsulation, and the encapsulation conditions were as follows: chitosan-sodium alginate mass ratio was 1:2, and the stirring rate was 200-300 rpm. After the microencapsulation was formed, multienzyme microparticles were prepared by spray drying; S3, compounding and molding: The prepared Chinese medicine extract powder, multi-enzyme microparticles, prebiotics, xylitol and other auxiliary materials are mixed evenly according to proportion; Use extrusion granulation equipment to prepare granules, or use capsule filling equipment to fill double-layer capsules, or formulate liquid preparations.

7. The method for preparing the active multi-enzyme preparation having spleen-strengthening and stomach-regulating effects according to claim 6, characterized in that: The spray drying conditions of the microcapsule package are: The inlet temperature is 110-130℃, and the outlet temperature is 70-90℃; The atomizing air flow pressure is 0.2-0.3MPa; Feed rate is 1-5mL / min; The particle size of the microcapsules ranges from 100 to 150 μm.

8. The method for preparing the active multi-enzyme preparation having spleen-strengthening and stomach-regulating effects according to claim 6, characterized in that: The compounding and molding steps include: The Chinese herbal medicine extract powder was subjected to a secondary vacuum drying treatment before mixing, with the drying conditions being 50-60°C and the vacuum degree being 0.08-0.1MPa; The multi-enzyme microparticles were treated with an antistatic agent before mixing; The mixing equipment speed is set to 100-200 rpm, and the mixing time is controlled to 15-20 minutes; The granulation step uses a 20-40 mesh screen, and the particle size is 300-600 μm.

9. The method for preparing the active multi-enzyme preparation having spleen-strengthening and stomach-regulating effects according to claim 6, characterized in that: The preparation steps of the liquid preparation include: The preparation process of the base solution includes adding 0.1-0.5% of stabilizer to purified water at 35-40°C; The Chinese herbal medicine extract powder and the multi-enzyme microparticles are pre-mixed in a ratio of 1:1.2-1.5 and then added to the liquid base solution; The homogenization conditions are as follows: the homogenizer pressure is 20-30 MPa and the processing time is 10-15 minutes; During the bottling step, the product was filtered using a 0.22 μm filter membrane and sealed in a nitrogen environment.

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