Nutrient chewable tablet formula and preparation method thereof

Abstract

The invention belongs to the technical field of health-care food, and particularly relates to an excipient basic formula for preparing chewable tablets, an application formula of nourishment prepared on the basis of the excipient basic formula and a preparation method of the nourishment. The basic formula of the excipient disclosed by the invention comprises the following components in percentage by weight: about 15 percent to 55 percent of xylitol, about 20 percent to 45 percent of inulin, about 1 percent to 4 percent of a flow aid, about 1 percent to 5 percent of a lubricating agent and about 3 percent to 10 percent of essence. The excipient basic formula can be further used for preparing different nutriment application formulas including fruit and vegetable plant extracts, mineral substances, vitamins, digestive enzymes and the like. Compared with the traditional chewable tablet formula, the excipient basic formula and the nutriment application formula have the advantages of stable processability, shelf life, bad flavor shielding, texture improvement, flavor release and the like, and conform to the market trend of nutriment cleaning labels.

Description

Technical Field

[0001] The present invention belongs to the technical field of functional foods and health products, and specifically relates to a basic excipient formula for preparing chewable tablets, and an application formula of a nutrient product prepared based on the basic excipient formula and a preparation method thereof. Background Art

[0002] Chewable tablets are solid dosage forms that are chewed or taken orally and then swallowed after disintegration. Chewable tablets are a good alternative to capsules and swallowable tablets, especially for the elderly, children, patients with dysphagia and poor gastrointestinal function, or when taking medicine without water. Compared with capsules and swallowable tablets, chewable tablets have a short administration time and do not need to disintegrate on their own, so they can help improve the bioavailability of active ingredients. Studies have shown that the specifications and taste of different solid dosage forms can affect the swallowing and use of consumers or patients, and recommending inappropriate dosage forms to elderly patients will affect their treatment effects (Shariff et al., Does the formulation of oral solid dosage forms affect acceptance and adherence in old patients? A mixed methods systematic review, JAMDA, 2020, 21, 1015-1023). The study suggests that manufacturers should consider the impact of factors such as drug specifications, taste and appearance on drug administration in the elderly, and the medical team should provide patient-centered, most suitable dosage forms or dosage forms for patients on this basis. As one of the dosage forms of functional foods, nutritional supplements and pharmaceutical products, chewable tablets can serve as a supplementary dosage form, make up for the shortcomings of other dosage forms, and provide consumers with a wider range of product choices.

[0003] Because chewable tablets are a convenient and effective nutritional dosage form, and compared with capsules and swallowable tablets, chewable tablets can also deliver active ingredients, many clinical studies use chewable tablets as experimental dosage forms, such as aspirin, ibuprofen, etc. (Hattrem et al., The relative bioavailability of ibuprofen after administration with a novel soft chewable drug formulation, Clinical Pharmacology in Drug Development, 2018, 7(2), 168-176). In addition, a Swiss research team conducted an open-label, randomized clinical trial on approximately 400 children with hookworm infections in Tanzania, Africa. The study compared the efficacy of mebendazole chewable tablets and its swallowable tablets in preventing and treating hookworm infections in children; its clinical data confirmed that there was no significant difference between mebendazole chewable tablets and swallowable tablets in terms of the rate of egg reduction (Palmeirim et al., Efficacy, safety and acceptability of a new chewable formulation versus the solid tablet of mebendazole against hookworm infections in children: An open-label, randomized controlled trial. eClinicalMedicine, 2020, 27, 100556).

[0004] Chewable tablets are safe, ready-to-eat, stable, and easy to carry. This dosage form is not only suitable for nutritional products, but also for medicines. Traditional Chinese medicine exists in the form of decoctions, which are complicated to take and taste bitter and astringent. In contrast, chewable Chinese patent medicines are not only convenient to take but also have a fresh taste. At the same time, the product safety of chewable tablets on the market will be supervised and constrained by relevant standard clauses.

[0005] However, just like a coin has two sides, traditional chewable tablet formulations also have some inevitable disadvantages, including: side effects of excessive consumption, poor sensory experience, rough texture and unstable processing performance. Sorbitol is the most commonly used sweetener and binder in traditional chewable tablet formulations. Its sweetness is about 50 to 60% of sucrose, its physical and chemical properties are stable, and it is easy to absorb moisture; however, excessive consumption of sorbitol can easily cause adverse intestinal problems such as diarrhea and flatulence (Liauw, S., Saibil, F., Sorbitol: Often forgotten cause of osmotic diarrhea. Canadian Family Physician, 2019, 65(8), 557-558). When using traditional chewable tablet formulations to make nutritional supplements or medicines, they are often accompanied by the unpleasant odor and bitterness of the chemical active ingredients. Therefore, the flavor of such chewable tablets is not soft, unnatural, and will leave a chemical aftertaste. It is difficult for traditional chewable tablet formulas to cover up the unpleasant or irritating taste of active ingredients (e.g., plant extracts, chemical molecules). This is difficult for the main audience of chewable tablets (including children of different ages) to accept. Such chewable tablet products make it difficult for many children and the elderly to eat. From a sensory perspective, the bad sensory experience will hinder the commercialization of chewable tablets (Mennella et al., The bad taste of medicines: Overview of basic research on bitter taste. Clinical Therapeutics, 2013, 35 (8), 1225-1246). In addition, the gritty texture of traditional nutritional chewable tablets (e.g., high content of mineral calcium and magnesium) is often not popular with consumers. Compared with such a rough taste, delicate texture, smooth taste (e.g., chocolate) and cool and rich (e.g., mint candy) are the food textures favored by consumers. The taste or texture of chewable tablets is a complex sensory attribute that involves product hardness, adhesion, grittiness and disintegration; its taste is also related to saliva, chewing intensity and flavor components. The change in taste during tasting of chewable tablets is also related to the viscoelasticity and particle size of the chewable tablets. Because of this, it is challenging to add some active ingredients with poor taste (such as calcium and magnesium) to traditional chewable tablet formulas. Even if we use a lot of sweeteners to cover up the bitter taste, metallic taste or other aftertaste, it is difficult for us to obtain a chewable tablet product with a balanced overall taste ( et al., Natural ingredients-based gummy bear composition designedaccording to texture analysis and sensory evaluation in vivo. Molecules, 2019, 24(7), 1442).

[0006] We need to improve the basic formula of traditional chewable tablets to meet more stringent requirements for processing technology, sensory experience and shelf life. For example, magnesium stearate, a commonly used lubricant in chewable tablets, is sensitive to mixing time. Excessive mixing of materials containing magnesium stearate will have a negative impact on the tableting process. Traditional sweeteners and adhesives (such as sorbitol) will increase product viscosity and brittleness due to changes in particle size distribution, processing temperature and ambient humidity, as well as appearance defects or adhesion during product storage. These problems are particularly evident during the processing and storage of some chewable tablets with strange shapes. In addition, this series of problems with chewable tablets (such as the problem of chewable tablet adhesion) will further affect the shelf life and sales time of the product. These problems in processing, sensory experience, side effects and shelf life hinder the innovation of chewable tablet products. In order to solve these problems, we need to use additional resources (including time, personnel and equipment), which will slow down product research and development, production, marketing and supply chain. In this case, the market still needs a novel and robust chewable tablet basic formula to prepare chewable nutritional tablets with easy processing, good sensory perception and stable shelf life. Summary of the invention

[0007] In order to overcome the shortcomings of the above-mentioned existing chewable tablet technology, the primary purpose of the present invention is to provide an excipient basic formula, which can be used to prepare chewable tablet products with high-quality sensory experience and stable processing performance, while effectively avoiding adverse side effects. In other words, the present invention relates to a formula for preparing chewable tablets, aiming to prepare nutritional products that are easy to industrialize, have good sensory experience, stable shelf life, and are competitive in the market. The chewable tablet formula of the present invention is suitable for direct compression technology.

[0008] Another object of the present invention is to provide a series of nutritional product application formulas prepared based on the above-mentioned excipient basic formula. The nutritional product application formulas shown in the present invention can be used to prepare products with different nutritional and health functions, namely nutritional products and health products, including but not limited to fruit and vegetable plant extract chewable tablets, amino acid magnesium chewable tablets, and vitamins and digestive enzyme plant extract chewable tablets. These new nutritional product application formulas ensure smooth material flow, non-stick molds, and direct compression molding, thereby avoiding the degradation of active ingredients caused by additional processes (for example, dry / wet granulation processes, etc.) and the additional costs required to supplement the active ingredients. In addition, the nutritional product application formula gives the product a good sensory experience, reduces the risk of its edible side effects, and ensures a stable shelf life performance.

[0009] It is worth noting that the term "excipient" used in the present invention refers to a carrier of active ingredients and a non-active ingredient used to improve the processing of chewable tablets. Excipients can be small molecule sugar alcohols (e.g., sorbitol) or biopolymers (e.g., microcrystalline cellulose). Chewable tablet formulations use excipients with different functions, including: adhesives, fillers, and lubricants. The selection of appropriate excipients is conducive to improving the processing technology of chewable tablets, for example: increasing compressibility, increasing fluidity, or reducing the brittleness of the product.

[0010] The term "excipient base formulation" used in the present invention refers to a base formulation without any active ingredient.

[0011] The present invention is achieved through the following technical solutions:

[0012] First, the excipient basic formula involved in the present invention includes components such as xylitol, inulin, silicon dioxide, lubricants and spices. The excipient basic formula specifies the percentage range of each component, especially xylitol and inulin, and the specific numbers can be adjusted according to the actual needs of the application, which provides great flexibility for preparing the application formula of nutritional products. In a wide range embodiment (see Table 2), the excipient basic formula is composed of about 15% to 55% xylitol, about 20% to 45% inulin, about 1% to 4% glidant (e.g., silicon dioxide), and about 1% to 5% lubricant, and the percentage is calculated based on the total weight of the formula. The excipient basic formula can also further include various auxiliary ingredients, including but not limited to edible acids, colorants, surfactants, preservatives, colloids, antibacterial agents, etc., and the percentages of auxiliary ingredients contained in different chewable tablet formulas may be different. As a non-limiting example, the excipient basic formula can also include about 3% to 10% of flavors, and the percentage is calculated based on the total weight of the formula.

[0013] The excipient base formula of the present invention can be used to further prepare a nutritional product application formula, for example, to develop various fruit and vegetable plant extract chewable tablets to support different nutritional functional directions. In a further embodiment, the fruit and vegetable plant extract chewable tablet formula is composed of at least one fruit and vegetable plant extract and an excipient base formula (see Table 2), wherein the excipient base formula contains about 15% to 40% xylitol, about 20% to 40% inulin, about 1% to 3% glidant (e.g., silicon dioxide), about 1% to 4% lubricant, and about 3% to 6% flavor, the percentages being calculated based on the total weight of the formula.

[0014] The excipient base formula of the present invention can also be used to further develop other nutritional application formulas, and the active ingredients include vitamins, digestive enzymes and minerals with challenging taste. In other embodiments, these nutritional chewable tablet formulas are composed of at least one active ingredient and an excipient base formula (see Table 2), wherein the excipient base formula contains about 15% to 55% xylitol, about 20% to 45% inulin, about 1% to 4% glidant (e.g., silicon dioxide), about 1% to 5% lubricant, and about 3% to 10% flavor, and the percentages are calculated based on the total weight of the formula.

[0015] Secondly, the present invention mainly uses excipients including:

[0016] Inulin

[0017] Inulin is a biopolymer composed of furanose monomers with different degrees of polymerization (DP), ranging from 2 to 60 fructose units connected to the terminal glucose molecule. Inulin can be divided into oligofructose and polyfructose according to its chain length. It is composed of a number of β-D-fructose molecules linearly combined through (2→1) glycosidic bonds, usually ending with α-D-glucose (Mensink et al. Inulin, a flexible oligosaccharide I: Review of its physicochemical characteristics. Carbohydrate Polymers, 2015, 130(5), 405-419). In an embodiment of the present invention, the DP of inulin is about 20 to 30, and its number average molecular weight (M n ) is 5000Da. Inulin can be obtained from a variety of plants, including: Jerusalem artichoke tubers, dahlia tubers or chicory roots.

[0018] As a nutritional ingredient, inulin is used as a dietary fiber and prebiotic to positively regulate the growth or activity of one or a limited number of probiotics in the human intestine, thereby bringing health benefits to the host (for example, regulating the human immune system); as a food ingredient, inulin acts as a sweetener and stabilizer in the food structure. Inulin is very suitable for diabetic patients because it is not absorbed by the human small intestine and does not affect blood sugar concentration after ingestion.

[0019] In the present invention, inulin is mainly used as an excipient in the formula of chewable tablets rather than as an active ingredient, because its own nutritional value is not the nutritional function advocated by the present invention. On the contrary, inulin is used together with other components as an excipient for preparing chewable tablets, because it can act as a binder, filler or sweetener with a light taste in the direct compression process. Studies have shown that when inulin acts as a filler / binder for tablets, appropriately adjusting its degree of polymerization (DP), crystallinity and particle size can effectively improve the tableting properties of the material powder (Eissens et al., Inulin as filler-binder for tablets prepared by direct compaction. European Journal of Pharmaceutical Sciences, 2002, 15, 31-38); compared with other fillers / binders, inulin can significantly reduce the sensitivity of lubricants, and the change of inulin DP can be used to control tablet dissolution and drug release rate. In addition, compared with other binders, inulin also has the advantages of being stable, not prone to chemical reactions, safe, and recognized by most international regulatory authorities (for example: the US Food and Drug Administration and the High Health Committee of European countries).

[0020] Xylitol

[0021] Xylitol is a pentahydroxy sugar alcohol with the chemical formula (CHOH)3(CH2OH)2. As a non-cariogenic sweetener, it serves as a substitute for sucrose in different consumer products (e.g., ordinary foods, dietary supplements, and medicines). Xylitol can be produced by chemical and biosynthetic pathways from xylose, glucose, or biomass hydrolysates (Xu et al., Biosynthetic strategies to produce xylitol: an economical venture. Applied Microbiology and Biotechnology, 2019, 103, 5143-5160). Chemical synthesis requires energy consumption, resulting in production costs; the biotransformation of xylitol requires fermentation by specific microbial strains to hydrolyze xylose. Studies have shown that xylitol exhibits very low toxicity under various routes of administration (Ur-Rehman et al., Xylitol: A review on bioproduction, application, health benefits, and related safety issues. Critical Reviews in Food Science and Nutrition, 2015, 55, 1514-1528). In 1986, the U.S. Food and Drug Administration (FDA) approved xylitol as a food additive (21CFR172.395) and declared it safe for human consumption. The FAO / WHO Joint Expert Committee on Food Additives recommended that the acceptable daily intake (ADI) of xylitol is not limited and suggested that no additional toxicology studies are needed. As the Chinese food additive market becomes more standardized, we can also understand the relevant regulations on xylitol food additives issued by Chinese regulatory authorities through the national standard GB 1886.234-2016.

[0022] The sweetness of xylitol is comparable to that of sucrose, and it produces a slight cooling effect when dissolved in the mouth; xylitol has lower calories than sucrose and is quickly absorbed in the human body. In addition, xylitol is a "tooth-friendly" sugar alcohol that has multiple health benefits such as strengthening teeth, tooth mineralization, inhibiting oral pathogens, and preventing otitis, ear and upper respiratory tract infections. Studies have shown that eating chewing gum containing xylitol and blackberry extract can effectively reduce 6 types of microorganisms hidden deep in people's saliva, among which Streptococcus sanguinis and Actinomyces naeslundii are the main bacteria attached to tooth enamel (Miller et al., Effect of chewing gum containing xylitol and blackberry powder on oral bacteria: A randomized controlled crossover trial. Archive of Oral Biology, 2022, 143, 105523). Therefore, xylitol can prevent tooth decay and enhance dental health. Diabetics can consume xylitol to assist in the treatment of hyperglycemia (Janket et al., Oral and systemic effects of xylitol consumption. Caries Research, 2019, 53, 491-501), and xylitol can also act as a prebiotic to improve the distribution of probiotics in the human intestine. In addition, xylitol is often used as a product coating and a stabilizer to prevent protein denaturation because of its refreshing taste, so we often see it being used in the formulation and processing of various products, including nutritional products. It can be seen that xylitol is a multifunctional excipient that combines sweeteners, adhesives and health benefits.

[0023] Lubricants

[0024] Lubricants are excipients used to provide an intermediate coating between the molds to reduce friction during tablet compression and ejection. Most commonly used lubricants are hydrophobic materials, including: minerals (e.g., talc) and fatty acids or their derivatives (e.g., magnesium stearate). Proper use of lubricants can reduce the cohesive force and mechanical wear of tableting. Because screening suitable lubricants and their dosages are crucial for preparing high-quality chewable tablets, we select a variety of lubricants for the excipient base formula and nutritional application formula in the present invention. Non-limiting examples of lubricants selected in the present invention include: magnesium stearate, stearic acid, ascorbyl palmitate, coconut oil powder or rice bran extract. On the other hand, the range of lubricants used to prepare nutritional chewable tablets in the present invention is wide, ranging from traditional magnesium stearate to novel coconut oil powder, reflecting the good compatibility between the excipient base formula and various lubricants and flexible use.

[0025] Other auxiliary materials

[0026] Other auxiliary ingredients can also be used in nutritional product application formulas, including but not limited to: glidants (such as silicon dioxide), pressure aids (such as dicalcium phosphate), disintegrants (such as low-substituted hydroxypropyl cellulose L-HPC), colloids (such as xanthan gum, guar gum and carrageenan), surfactants (such as sodium lauryl sulfate SLS), etc. These additional ingredients provide different functions in nutritional product application formulas. The more important and typical auxiliary material is silicon dioxide, which can effectively improve the fluidity of the material by adding a small amount. At the same time, it can also act as a desiccant. Low-substituted hydroxypropyl cellulose has a large surface area and absorbs water quickly, which is conducive to the release of active ingredients and is a high-quality disintegrant. Dicalcium phosphate not only serves as a calcium source in pharmaceutical preparations, but can also be used as a pressure aid. Colloids such as xanthan gum are commonly used thickeners and stabilizers in food, medicine and nutritional products, which play a role in adjusting the texture and flavor of the product; various colloids have different physical and chemical properties. For example, a research team compared the effects of gelatin, xanthan gum, and guar gum on the flavor of rice bran tablets. The sensory evaluation data showed that adding 10% xanthan gum significantly improved the texture and overall acceptance of rice bran tablets (Pourfarzad and Yousefi, Effect of different excipients on physicochemical properties of the functional rice bran tablet: univariate and multivariate studies on a novel food supplement. Journal of Food Measurement and Characterization, 2021, 15, 1359-1369). These excipients help us improve the formulation of nutritional products from different aspects, and we also noticed that there is a synergistic effect between different excipients.

[0027] Then, the processing technology and physical parameters of the excipient basic formula, nutrient application formula or nutrient chewable tablet embodiment mentioned in the present invention include:

[0028] The embodiments of the present invention are chewable nutritional tablets, which are prepared by direct compression. In the embodiments, at least one active ingredient and xylitol and inulin are first premixed for 15 to 30 minutes after being sieved through a 16-mesh sieve to allow the materials to be fully mixed; then, flavors, edible acids, and sweeteners are sieved through a 20-mesh sieve and added to the premix and mixed for 10 to 15 minutes; finally, lubricants and glidants are sieved through a 30-mesh sieve and added to the premix and mixed for a final period of 5 to 10 minutes. In the embodiments, if necessary, the active ingredients can be ground, dry granulated, or other additional processes to unify the particle size distribution of the raw materials; depending on the scale of the material, we use a V-shaped powder mixer of appropriate size to mix all components and ensure the uniformity of the final material. In the embodiment, we use a Stokes DD2 rotary tablet press equipped with 23 pairs of dies to press the uniformly mixed material into solid tablets, and the specifications of the solid tablets are 5 / 8" round, 7 / 16" round and 3 / 8" round. It is worth mentioning that the formulations related to the present invention can be matched with molds of different specifications according to the loading amount and packaging of the active ingredients, including but not limited to 3 / 4" round, 7 / 8" concave round and exotic fruits, animals and other specifications.

[0029] During the processing of the embodiments of the present invention, the physical parameters that we carefully observed include: tablet weight, thickness, hardness and friability. Among them, hardness and friability are two key physical parameters because the resistance of the finished tablet to delamination, wear or cracking during storage, transportation and pre-use handling depends on its hardness and friability. Tablet hardness is measured by determining the transverse rupture strength applied to a single tablet. Hardness is expressed in kilopounds (kp) or Strong Cobb units (SCU), where 1kp is equal to 1.4SCU. Friability is calculated by observing the ratio of the total weight of a certain number of tablets (usually 20 tablets or more) before and after repeated shocks under standard conditions. These tablets are usually placed in a transparent plastic drum that can rotate for observation and measurement. After repeated rotation, the tablets are reweighed and the percentage of wear debris powder is calculated. The chewable tablet hardness specifications of the present invention are 12 to 20kp (5 / 8" round), 7 to 12kp (7 / 16" round, 3 / 8" round), and the tablet friability is <2%.

[0030] The excipient base formula and nutritional product application formula disclosed in the present invention have several advantages over the traditional chewable tablet formula, including: (1) providing stable processing performance, effectively improving the compressibility and viscosity increase of the material during tableting; (2) having a certain effect of masking bad flavors, high compatibility with different active ingredients and flavors, improving flavor release and overall texture, and providing a good sensory experience; (3) easy to industrialize, and stable shelf life. In addition, these formulas are also in line with the current market trend of clean labels for nutritional products. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 Shown are ATR-FTIR spectra of Formula A chewable tablets at the start of stability testing, Formula A chewable tablets after passing 12 weeks of stability testing, and granulated xylitol, tart cherry extract, and organic inulin. FIG2 shows the panel sensory test results of Formula D, Formula E and Formula F amino acid magnesium chewable tablets. Figure 2A Shown are the sensory attribute scores for Formulation D, Formulation E, and Formulation F chewable tablets, showing the mean and positive deviation. Figure 2B Radar chart showing sensory scores for Formulation D, Formulation E, and Formulation F chewable tablets. Figure 3 The results of quantitative analysis of sensory descriptive feedback of formula C, formula D chewable tablets, multivitamin chewable tablets, and compound berry chewable tablets sold on the market are shown. Figure 4 Showing formula H chewable tablets and vitamin B sold on the market 12 Folic acid chewable tablets, B 12 Folic acid capsules, B 12 Results of quantitative analysis of sensory descriptive feedback of folic acid drops. DETAILED DESCRIPTION

[0031] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present invention can be combined with each other. The present invention will be described in detail below in conjunction with the embodiments.

[0032] Example 1 - Materials

[0033] We used granulated xylitol with a cool taste and high sweetness from Danisco Sweeteners (DuPont Nutrition & Health, Wilmington, DE). We obtained organic inulin from Tic Gum (Belcamp, MD), and Syloid 244FP silica was purchased from GRACE (Columbia, MD). We used various environmentally friendly and healthy lubricants, such as stearic acid from American International Chemical, LLC, ascorbyl palmitate from DSM, coconut oil powder from Stauber (Fullerton, CA), magnesium stearate from Anhui Shanhe Pharmaceutical Excipients Co., Ltd., and rice bran extract from Ribus, Inc. (St. Louis, MO).

[0034] Table 1 shows the physical properties of the main ingredients used in the excipient base formulation, with a special description of the sensory characteristics of each ingredient, which contributes to the development of high-quality chewable tablet products with clean sensory attributes. It is worth noting here that coconut oil powder contains a variety of medium-chain fatty acids (e.g., lauric acid, myristic acid, palmitic acid, etc.), and its molecular weight is calculated based on the molecular weight and content of each fatty acid. Table 1. Physical properties of the main ingredients in the excipient base formulation

[0035] Example 2 - Excipient Basic Formulation

[0036] The excipient basic formula in the present invention can help us develop fruit and vegetable plant extract chewable tablets formula A, formula B, formula C, amino acid magnesium chewable tablets formula D, vitamin, digestive enzyme chewable tablets formula G, formula H, formula I. The excipient basic formula stipulates that each component has a certain percentage range, which can be used to prepare different nutritional product application formulas, which gives the excipient basic formula a certain degree of flexibility. Table 2 shows the percentage range of the excipient basic formula components. The embodiment of the present invention, fruit and vegetable plant extract chewable tablets (for example: formula A, formula B and formula C), amino acid magnesium chewable tablets (for example: formula D) and vitamins, digestive enzyme chewable tablets (for example: formula G, formula H, formula I) are prepared based on the new excipient basic formula. In addition, other available excipients include: edible acid, colloid, surfactant (for example: sodium lauryl sulfate), and antibacterial agent (for example: sodium benzoate) etc. can be added in amount according to the requirements of other nutritional product application formulas. Table 2. Basic formula of excipients

[0037] Example 3 - Fruit and vegetable plant extract chewable tablets

[0038] The nutraceutical application formulation or the fruit and vegetable extract chewable tablet formulation (e.g., formulation A, formulation B, and formulation C) was prepared by mixing the novel excipient base formulation with the active ingredient (e.g., fruit and vegetable extract). Thereafter, we prepared the fruit and vegetable extract chewable tablet by operating the Stokes DD2 23 punching and tableting machine equipped with a 5 / 8″ round flat grinder. Table 3 shows the fruit and vegetable extract chewable tablet formulations A, B, and C, calculated based on the total weight of the formulation. Table 3. Fruit and vegetable plant extract chewable tablet formula (calculated based on the total weight of the formula)

[0039] Formula A is used to prepare sour cherry extract chewable tablets (cherry flavor). Because Formula A contains 36.7% inulin, the chewable tablets have high hardness (~20 kp) and low brittleness (less than 1%). The citrus cherry flavor contained in the plant extract quickly promotes the release of the product flavor in the oral cavity and provides a large amount of nutrients such as anthocyanins to the human body. According to relevant reports, anthocyanins have certain in vitro antioxidant properties (Einbond et al., Anthocyanin antioxidants from edible fruits, Food Chemistry, 2004, 84 (1), 23-28). Clinical studies have shown that anthocyanins intake can effectively prevent various chronic inflammatory diseases by inhibiting the activation of NF-κB and reducing the blood concentrations of pro-inflammatory chemokines, cytokines, and inflammatory mediators (Anette et al., Anthocyanins inhibit nuclear factor κB activation in monocytes and reduce plasma concentrations of pro-inflammatory mediators in healthy adults, The Journal of Nutrition., 2007, 137(8), 1951-1954).

[0040] We conducted an accelerated stability test on Formula A chewable tablets. The test time span and storage conditions can fully simulate the storage, transportation and subsequent use of the finished product during the sales process. During the 12-week stability test, the Formula A chewable tablets were stored in 250 ml polyethylene terephthalate (PET) plastic bottles. According to the ICH Q1A Stability Testing Guidelines for New APIs, the Formula A chewable tablets in the present invention adopt a temperature of 40℃±2℃, a relative humidity of 75%±5% and a test condition of 12 weeks. The 12-week stability test data can well help us predict the 2-year shelf life performance of the finished chewable tablets.

[0041] Figure 1 The attenuated total reflectance Fourier transform infrared spectra of formula A chewable tablets (stability test: 0 weeks), formula A chewable tablets (stability test: 12 weeks), xylitol, sour cherry and organic inulin are shown. We collected Fourier transform infrared spectra for detecting the movement of functional groups of chemical molecules to verify the chemical structure changes of the substances. Table 4 shows the distribution of characteristic wavenumbers of infrared spectra. Table 4. Characteristic wavenumbers of attenuated total reflection Fourier transform infrared spectra <![CDATA[Wave number, cm -1 > Molecular motion 1003 CO stretch 1011-1125 CC stretch, CO stretch 3162 CH Stretch 3300 OH stretching (hydrogen bonding)

[0042] For ease of measurement, we compressed the fine powder samples into compact solid flakes. Solid chewable tablets can be directly measured for infrared spectroscopy without additional processing. The infrared spectra of solid chewable tablets and powder samples were collected at room temperature using a ThermoNicolet 670 infrared spectrometer (Thermo Electron Corp, Madison, WI). At the same time, equipped with smart miracle accessories and reference 4cm -1 The sample spectrum was accurately collected by 512 repeated scans with a resolution of 10000. We selected and prepared representative samples and directly pressed them onto Ge germanium crystals for measurement.

[0043] Infrared spectroscopy is a scientific technique that collects infrared spectra absorbed or emitted by solid, liquid and gaseous substances. Infrared spectrometers equipped with attenuated total reflectance (ATR) accessories can provide wider spectral or wavenumber range and high-resolution scanning data. We can use this technology to observe characteristic molecular behaviors under wide-frequency beamline scanning, which may imply specific chemical bonds, molecular interactions (such as hydrogen bonds) and structural changes before and after chemical reactions or degradation. Figure 1 The attenuated total reflectance Fourier transform infrared spectra of Formula A chewable tablets (stability test: 0 weeks), Formula A chewable tablets (stability test: 12 weeks), coarse particle xylitol, sour cherry and organic inulin are shown. Table 4 summarizes the characteristic wavenumbers of the infrared spectra of the samples.

[0044] like Figure 1 As shown, the main infrared wave number is located at 1003cm -1 , which reflects the -CO stretching movement on the sour cherry anthocyanin molecule. In the chewable tablet formulation containing inulin and xylitol, sour cherry infrared absorption contributes the main spectral absorption signal. We can clearly see that the infrared spectral characteristic region of granular xylitol (1011-1125cm -1 ) does not appear in the infrared curve of the chewable tablet sample. This region reflects the stretching of -CC and -CO. Wave number 3300cm -1 The area near the -OH stretching motion reflects the OH stretching motion, indicating the possible existence of hydrogen bonds between molecules. There is no significant change in the infrared spectra of the chewable tablet samples before (0 week) and after (12 weeks) the stability test (e.g., the appearance of a new infrared peak or the disappearance of the original infrared peak). The -OH stretching at 3300 cm -1 The wide band at is probably due to the increase in water activity inside the chewable tablets after the 12-week accelerated stability test, which leads to active dynamic hydrogen bonds. Nevertheless, based on infrared spectroscopy measurements, we did not find major chemical reactions or degradation during the accelerated stability test of the chewable tablets, which indicates that the nutritional formula product of the present invention has a stable shelf life.

[0045] We conducted sensory evaluation, hardness and friability measurements on the chewable tablets of Formula A. Table 5 shows the sensory evaluation, hardness and friability test results of the chewable tablets of Formula A before the stability test (Formula A-control group), during the test (Formula A-4 weeks and Formula A-8 weeks) and after the test (Formula A-12 weeks). Table 5. Sensory evaluation, hardness and friability test results of formula A chewable tablets sample Sensory evaluation hardness Friability, % Formula A - Control Group NA 16 99 Formula A - 4 weeks Similarity 100% 18 99.5 Formula A - 8 weeks Similarity 92% 20 99.5 Formula A - 12 weeks Similarity 85% 23 99.8

[0046] The chewable tablet sensory evaluation panel consisted of 15 trained professionals aged between 20 and 50 years old. Each member of the sensory evaluation panel tasted the chewable tablets "Formula A-Control", "Formula A-4 weeks", "Formula A-8 weeks" and "Formula A-12 weeks" in a fasting state. Before consuming different chewable tablet samples, the panelists had to consume warm water or flavored biscuits to eliminate the aftertaste of the miscellaneous taste in the mouth. After the sensory test, each panelist gave a descriptive result and explained whether the overall taste of "Formula A-Control" and other samples was consistent.

[0047] Table 5 shows the changes in sensory and physical properties between the chewable tablets "Formula A-control group" and chewable tablets at different test time points. The friability of the chewable tablets of Formula A did not change after 12 weeks of accelerated stability testing and remained within 1%; the hardness of the chewable tablets of Formula A increased from 16 kp to 23 kp, which may be due to the increase in water activity of the chewable tablets in a high humidity environment during the stability test, which is consistent with the infrared spectrum of the chewable tablets "Formula A-12 weeks" at 3300 cm -1 The physical test results (tablet hardness and friability) of the chewable tablet "Formula A-12 Weeks" indicate that the chewable tablet is strong enough to pass through a series of processes such as packaging, transportation and storage. For the sensory evaluation of chewable tablets, most of the professionals participating in the sensory evaluation (85%) believed that the overall taste of Formula A-Control and Formula A-12 Weeks was consistent.

[0048] The chewable tablet formula B in Table 3 is used to prepare another specification of sour cherry extract chewable tablets. In terms of composition, compared with formula A, formula B has a higher xylitol content and a lower inulin content; under the same tableting conditions, the hardness of the chewable tablets of formula A will be higher than that of the chewable tablets of formula B. In terms of taste, formula B is sweeter and has a lower hardness (about 14kp) than formula A. Although the tablet hardness of formula B is lower than that of formula A, its higher content of xylitol gives formula B a sweeter sensory characteristic. It can be seen that changing the content of xylitol and inulin in the basic excipient formula can help us adjust the flavor and taste of chewable tablets.

[0049] The chewable tablet formula C in Table 3 is used to prepare Camu camu extract chewable tablets, wherein the Camu camu extract is rich in vitamin C, phenolic compounds, carotenoids and various minerals and amino acids (MS Akter et al., Nutritional compositions and health promoting phytochemicals of camu-camu (myrciaria dubia) fruit: A review, Food Research International, 2011, 7 (44), 1728-1732). Studies have reported that Camu camu extract has multiple effects such as anti-oxidation, antibacterial, anti-inflammatory and lipid-lowering and weight-loss (Langley et al., Antioxidant and associated capacities of Camu Camu (Myrciaria dubia): A Systematic Review, Journal of Alternative and Complementary Medicine, 2015, 21 (1), 8-14). Genovese et al. studied and compared the active substances and antioxidant effects of 5 kinds of fruit extracts and commercial pulp purees. Among them, the camu camu extract showed the highest vitamin C, total phenol content and DPPH free radical scavenging ability (Genovese et al., Bioactive compounds and antioxidant capacity of exotic fruits and commercial frozen pulps from Brazil, Food Science and Technology International, 2008, 14, 207-214). In addition, Yazawa et al. used a mouse edema model to verify the anti-inflammatory effect of camu camu methanol extract. The in vivo and in vitro test results provided by the research team showed that the camu camu extract can inhibit the local inflammatory factors (such as nitric oxide) produced by RAW264.7 cells derived from macrophages in vitro and eliminate edema (Yazawa et al., Anti-inflammatory effects of seeds of the tropical fruit camu-camu (Myrciaria dubia). Journal of Nutritional Science and Vitaminology (Tokyo), 2011, 57, 104-107).The active ingredient in the extract is a triterpenoid compound called betulinic acid, which has been identified as an effective anti-inflammatory agent. In formula C, we used more diversified sweeteners (including xylitol and natural sweetener stevioside) to further enhance the sweetness and reduce the aftertaste of fruit and vegetable plant extracts, which also reflects the flexibility of the excipient base formula in the present invention in the development of nutritional products.

[0050] Example 4 - Amino Acid Magnesium Chewable Tablets

[0051] In addition, chewable tablet formula D, formula E and formula F are all used to prepare amino acid magnesium chewable tablets, and Table 6 shows the ingredient list of each amino acid magnesium chewable tablet. Formula D amino acid magnesium chewable tablets are nutritional product application formulas developed based on the excipient basic formula of the present invention, while formula E and formula F chewable tablets are experimental control groups for formula D chewable tablets. As shown in Table 6, formula D, formula E and formula F have similar components, and the main difference is the binder used in the formula, namely, inulin in formula D, cellulose in formula E and sorbitol in formula F. Table 6. Amino Acid Magnesium Chewable Tablets Formula (calculated based on the total weight of the chewable tablet formula)

[0052] We conducted professional panel sensory evaluation tests on Formula D, Formula E and Formula F Amino Acid Magnesium Chewable Tablets. The panel test results can help us to quantitatively and qualitatively evaluate the chewable tablet samples from different sensory attributes. The sensory evaluation panel consisted of 15 professionals aged between 20 and 50 years old. The panel members tasted the chewable tablet samples of Formula D, Formula E and Formula F in a fasting state. Before consuming the different chewable tablet samples, the panel members had to drink warm water or flavored biscuits to eliminate the aftertaste in the mouth. After consuming the chewable tablet samples, the sensory evaluation panel members scored the five sensory attributes of the chewable tablets, including sweetness, sourness, flavor release, texture and aftertaste. The sensory attribute scores are shown in Table 7. In addition to providing sensory attribute scores, the panel members will leave descriptive comments for each chewable tablet sample to summarize the tasting experience. The basic taste of Amino Acid Magnesium Chewable Tablets should be fresh orange with sweet and sour taste. Appropriate sourness helps stimulate the human taste buds and accelerate the experience of sensory testing. Finally, we used the overall performance index (OPI) to conduct an overall quantitative evaluation of each chewable tablet sample. When calculating OPI, we give different weights to different sensory attributes. For example, sweetness and texture are the two most important sensory attributes, and their weights are higher than other sensory attributes such as flavor release and acidity. The calculation of OPI refers to the following equation 1: Overall performance index (OPI) = sweetness × 0.25 + texture × 0.30 + flavor release × 0.2 + acidity × 0.15 + aftertaste × 0.1 Formula 1 Table 7. Sensory evaluation reference standards

[0053] We used statistical tools of Microsoft Excel and IBM SPSS software to analyze the data, and we were able to obtain the mean and standard deviation of each sensory index of the chewable tablets. We used one-way analysis of variance (ANOVA) to determine whether there were significant differences and the degree of differences between chewable tablets of different formulations, with the p value set at 0.05. We determined whether the data group had significant differences in the 95% confidence interval by understanding whether the calculated p value was less than 0.05. At the same time, we also observed whether the statistical test F value was greater than the critical F value of 95% confidence to further test whether there were significant differences between the data groups.

[0054] We used a text sentiment analysis method based on an external word library to quantitatively analyze the sensory evaluation panel's descriptive comment data on chewable tablet samples. This analysis method uses the NLTK tool to reasonably disassemble the text and classify the text words into positive and negative for summary; in addition, this method uses the Vader sentiment analysis tool to obtain the positive, negative and overall scores of the words. These word fragments will be classified as positive, negative, neutral and contribute to the score. Finally, each chewable tablet sample will receive a comprehensive score ranging from -100 (extremely negative) to +100 (extremely positive). The higher the comprehensive score, the higher the overall feedback of the chewable tablet sample.

[0055] On the one hand, we used a panel sensory evaluation method to evaluate the various sensory attributes of amino acid magnesium chewable tablets (e.g., sweetness, texture, and flavor release). On the other hand, we conducted a quantitative analysis of chewable tablets from different sensory attributes. We collected the panelists' descriptive evaluations of each chewable tablet sample, and then used the above-mentioned text sentiment analysis method to continue to quantitatively analyze these descriptive evaluation data of chewable tablets.

[0056] Figure 2 shows the results of the panel sensory evaluation test of Formulation D, Formulation E and Formulation F chewable tablets. Figure 2A The sensory attribute scores of Formula D, Formula E and Formula F chewable tablets are shown, including sweetness, texture and flavor release. Among the three chewable tablets, Formula E chewable tablets scored the lowest in the five sensory attributes; while the sensory attribute scores of Formula D and Formula F chewable tablets were closer, but the sweetness, sourness and texture scores of Formula D chewable tablets were higher than those of Formula F chewable tablets. By calculating with Equation 1, we obtained the overall performance index (OPI) of Formula D, Formula E and Formula F chewable tablets to be 3.88, 2.55 and 3.20 respectively. In addition, Figure 2BA radar chart consisting of sensory evaluation data of formula D, formula E and formula F chewable tablets is shown for intuitive evaluation and analysis. Among the three chewable tablets, formula D chewable tablets have the largest scoring area, indicating its all-round leading sensory attributes. The main difference between formula D, formula E and formula F chewable tablets is the use of different binders / sweeteners, including: inulin in chewable tablet formula D, cellulose in formula E and sorbitol in formula F. The sweetness ranking of these three excipients is sorbitol>inulin>cellulose, among which cellulose is a traditional binder used to prepare tablets by direct or indirect tableting process. In addition, the ANOVA statistical results show that there are significant differences in sweetness, texture and aftertaste between formula D and formula E chewable tablets, and no significant differences in other sensory attributes (such as flavor release); there are also significant differences in sweetness and texture between formula D and formula F chewable tablets, and no significant differences in other sensory attributes; at the same time, there is only a significant difference in texture between formula E and formula F chewable tablets. In addition, the result of the statistical test F value once again confirmed that there are significant differences in texture between the chewable tablets of Formula D and Formula E, and between the chewable tablets of Formula D and Formula F. Such sensory evaluation statistical results strongly suggest that the nutritional application formula of the present invention can greatly improve the flavor and taste of amino acid magnesium products, especially in terms of masking bad flavors and improving texture, and the nutritional application formula has won unanimous praise from professionals.

[0057] Figure 3 The results of the sensory evaluation descriptive data analysis of chewable tablets are shown, where Formula C and Formula D chewable tablets are respectively the sour cherry extract (a fruit and vegetable plant extract) chewable tablets and amino acid magnesium chewable tablets of the present invention, and the other two are finished chewable tablets currently on the market, including: multi-dimensional chewable tablets and compound berry chewable tablets. The sensory evaluation descriptive data of these two chewable tablets are derived from Amazon consumer reviews. Figure 3It can be seen that the formula C chewable tablets (tart cherry extract chewable tablets) and formula D chewable tablets (amino acid magnesium chewable tablets) are at the same level as the multi-dimensional chewable tablets and compound berry chewable tablets on the market in terms of positive and comprehensive scores. If we further compare the formula C chewable tablets and compound berry chewable tablets, we can see that although the positive score of the formula C chewable tablets is lower than that of the compound berry chewable tablets, the comprehensive score of the formula C chewable tablets is much higher than that of the compound berry chewable tablets. This is probably because different consumers have different opinions on the compound berry chewable tablets, resulting in many positive reviews and many negative reviews for this product. It is worth mentioning that the descriptive reviews of these chewable tablets come from many people and are rich in content. For example: the descriptive comments of the formula C chewable tablets include 337 words or 20 sentences; the consumer comments on the compound berry chewable tablets on the market include 335 words or 29 sentences. Therefore, these descriptive comments from different sources can be used as a reliable basis for quantitative analysis. It can be seen that the chewable tablets prepared by the nutritional product application formula in the present invention are very close to the chewable tablets sold on the market in terms of sensory experience, and even have fewer negative scores and higher comprehensive scores.

[0058] In the present invention, the cellulose in the chewable tablets of formula E masks the flavor and texture of the product, delays the flavor release of the product, and reduces the overall taste of the product. The high viscosity of cellulose reduces the overall texture of the chewable tablets. The sorbitol in the chewable tablets of formula F is a sweeter sweetener / binder, however, this did not help the chewable tablets of formula F become the most popular product. On the contrary, the inulin in the chewable tablets of formula D helped the chewable tablets score high in multiple sensory attributes, including: texture and flavor release; inulin improved the texture of the chewable tablets and promoted the release of flavors. We see that the radar chart score area of ​​the chewable tablets of formula D using inulin is the largest, which intuitively shows the comprehensive and balanced sensory contribution of inulin to the chewable tablets. This set of results indirectly reflects that compared with traditional binders / sweeteners (such as sorbitol and cellulose), inulin can provide more obvious sensory advantages for chewable tablet products.

[0059] Example 5 - Vitamin, digestive enzyme plant extract chewable tablets

[0060] Here, the present invention presents the last group of nutritional product application formulas developed based on the excipient basic formula, and the corresponding products are vitamin and digestive enzyme plant extract chewable tablets. Chewable tablet formula G, formula H and formula I are used to prepare folic acid chewable tablets, vitamin B 12 Table 8 shows the ingredient lists of three chewable tablets supporting different nutritional product applications, folic acid chewable tablets and digestive enzyme plant extract chewable tablets. Among them, the chewable tablet formula G claims 1000 micrograms of folic acid per tablet, and formula H claims 2000 micrograms of vitamin B 12, 800 micrograms of folic acid per capsule, Formula I claims that the digestive enzyme blend, ginger root extract, papaya leaf extract, L-glutamine, and Bacillus coagulans total about 200 mg per capsule. Table 8. Vitamin, digestive enzyme plant extract chewable tablet formula (calculated based on the total weight of the chewable tablet formula)

[0061] The folic acid in the chewable tablets of formula G and formula H can mainly prevent anemia in pregnant women and congenital malformations in infants, help sleep, and improve memory; the vitamin B12 methylcobalamin in the chewable tablets of formula H is mainly used to prevent various types of anemia and maintain the normal function of the nervous system; and the digestive enzyme mixture in formula I can help digest various components in food, including: protein, carbohydrates and fats. It can be seen that the excipient basic formula and the nutritional product application formula in the present invention can be used to prepare chewable tablet products supporting different functional directions. From the perspective of components, formulas G, H and I use different contents of xylitol and inulin, among which the xylitol content in formula G is close to 50%, and the inulin content in formula H exceeds 40%. Such a wide adjustment of components still conforms to the excipient basic formula of the present invention; on the other hand, formulas G, H and I use different lubricants, namely rice bran extract in formula G, ascorbyl palmitate in formula H and stearic acid in formula I, which once again verifies the compatibility between the excipient basic formula of this invention and various excipients and lubricants. Similarly, we selected Formula H chewable tablets and vitamin B12 folic acid chewable tablets, capsules and drops sold on the market for comparison; we also used the panel sensory evaluation method to judge the 12 , the overall sensory performance of folic acid nutrients. In addition, the above-mentioned text sentiment analysis method is used to further quantitatively analyze the performance of these vitamin B 12 , descriptive evaluation data of folic acid nutritional supplements.

[0062] Figure 4 Vitamin B 12 The results of the descriptive data analysis of the sensory evaluation of folic acid nutritional products, wherein the product displays are respectively vitamin B 12 Folic acid chewable tablets (Formula H chewable tablets) and commercially available vitamin B 12 Folic acid chewable tablets, capsules and drops. Figure 4 It can be seen that formula H chewable tablets (vitamin B 12 Folic acid chewable tablets) has higher positive and comprehensive scores than vitamin B 12Folic acid capsules and drops products, and its negative ratings are lower than those of capsules and drops products on the market. It can be said that such feedback to a certain extent reflects the unique dosage form advantages of the new nutritional chewable tablets. 12 Compared with the folic acid chewable tablets, although the overall score of the formula H chewable tablets is slightly lower, its positive score is higher and the negative score is lower, suggesting that the vitamin B 12 Folic acid chewable tablets can be quickly accepted by consumers and recognized by the market. This group of examples once again clearly shows that the chewable tablets prepared by the nutritional product application formula of the present invention have sensory advantages that other dosage forms do not have, and compared with similar products, they can quickly gain recognition from consumers and have fewer negative reviews.

[0063] Although the present invention has been described in some preferred embodiments, the technical knowledge and application protected by the present invention are not limited to this content. Without departing from the scope of the invention, the preferred embodiments can be appropriately added, deleted and modified. In addition, the features of one embodiment can be combined with the features of another embodiment while still being included in the scope of the present invention.

Claims

1. A basic excipient formula for preparing a chewable tablet, characterized in that: Calculated by weight percentage, the composition comprises about 15% to 55% of xylitol, about 20% to 45% of inulin, about 1% to 4% of a glidant, and about 1% to 5% of a lubricant.

2. The excipient basic formulation according to claim 1, wherein a narrowed excipient basic formulation is obtained, characterized in that: Calculated by weight percentage, about 15% to 40% of xylitol, about 20% to 40% of inulin, about 1% to 3% of glidant, and about 1% to 4% of lubricant, wherein inulin is not considered as an active ingredient.

3. The excipient basic formula according to claim 1, characterized in that: The glidant may be silicon dioxide.

4. The excipient basic formula according to claim 1, characterized in that: The lubricant can be natural materials such as magnesium stearate, stearic acid, ascorbyl palmitate, coconut oil powder and rice bran extract.

5. The excipient basic formula according to claim 1, characterized in that: The invention can further comprise at least one active ingredient, and inulin is not used as an active ingredient, so as to prepare a nutritional product application formula.

6. The excipient basic formula according to claim 1, characterized in that: Calculated by weight percentage, the composition may further contain about 3% to 10% of flavor.

7. The excipient base formulation according to claim 6, characterized in that: The invention can be further used to prepare chewable tablets of nutritional products.

8. The nutritional product application formula according to claim 5, characterized in that: The active ingredients can be vitamins, fruit and vegetable extracts, minerals, edible enzymes, medicines and other edible nutrients.

9. The nutritional product application formula according to claim 8, characterized in that: The vitamins among the active ingredients can be vitamins A, C, D3, E, B1, B2, B6, B 12 , niacin, folic acid, etc., or other combinations.

10. The nutritional product application formula according to claim 8, characterized in that: The minerals among the active ingredients can be calcium, magnesium, zinc, iron, selenium, etc., or a combination thereof.

11. The nutritional product application formula according to claim 8, characterized in that: Other edible nutrients among the active ingredients can be proteins, polypeptides, amino acids, probiotics, fatty acids, carbohydrates, or other combinations.

12. The nutritional product application formula according to claim 8, characterized in that: The active ingredients may include analgesics, digestive health agents, allergy relief agents, etc.

13. The excipient base formulation according to claim 5, characterized in that: The formulation can be used in combination with direct compression technology to prepare chewable tablets.

14. The nutritional product application formula according to claim 8, characterized in that: The formula can be used to prepare finished chewable nutritional tablets.

15. The nutritional product application formula according to claim 14, characterized in that: The formula can be further used to prepare a fruit and vegetable plant extract chewable tablet formula, which comprises, by weight percentage, about 30% to 40% of fruit and vegetable plant extracts, about 15% to 40% of xylitol, about 20% to 40% of inulin, about 1% to 3% of a glidant, and about 1% to 4% of a lubricant.

16. The nutritional product application formula according to claim 14, characterized in that: The formula can be further used to prepare a mineral chewable tablet formula, which comprises, by weight percentage, about 20% to 40% of minerals, about 15% to 40% of xylitol, about 20% to 40% of inulin, about 1% to 3% of a glidant, and about 1% to 4% of a lubricant.

17. The nutritional product application formula according to claim 14, characterized in that: The formula can be further used to prepare a vitamin and edible enzyme chewable tablet formula, which, calculated by weight percentage, contains about 0% to 10% of vitamins, or 0% to 40% of edible enzymes and a mixture of plant extracts, about 15% to 55% of xylitol, about 20% to 45% of inulin, about 1% to 4% of a glidant, and about 1% to 5% of a lubricant.

18. The excipient base formula according to claim 5 and the nutritional product application formula according to claim 14, wherein the preparation method thereof comprises the following steps: The active ingredients, xylitol and inulin are sieved and mixed, and then sieved and mixed with flavors and flow aids, and finally sieved and mixed with lubricants, and the resulting mixture is pressed into tablets; the above mixture is passed through a suitable 20-mesh or 30-mesh sieve, the mixing time is 30 to 50 minutes, the tablet hardness is 12 to 20 kp (5 / 8" round), 7 to 12 kp (7 / 16" round, 3 / 8" round), and the tablet friability is <2%.

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