Preparation method of kiwi fruit compound tablet for preventing and treating oral diseases

Abstract

The application relates to a preparation method of a kiwi fruit compound tablet capable of preventing and treating oral diseases, belonging to the technical field of oral health care. Fresh kiwi fruit juice is centrifugally filtered, the filter cloth has a mesh size not less than 40 meshes, and the rotating speed is not less than 1500 revolutions per minute; after crystalline sorbitol is added and dissolved, freeze-drying is carried out until the moisture content is less than 8%; the freeze-dried powder is crushed into 40-60 mesh particles; the activity of kiwi fruit protease in the freeze-dried powder is measured; if the activity is not less than 1500 U / g, the freeze-dried powder is qualified kiwi fruit powder; the qualified kiwi fruit freeze-dried powder is prepared into a compound tablet, 15-50 g of the qualified kiwi fruit freeze-dried powder, 0-30 g of vitamin C and 0.1-1.5 g of vitamin B2 are contained in 100 g of the compound tablet, and the rest is conventional auxiliary materials. Compared with the prior art product, the obtained compound tablet has the same effect of cleaning the oral cavity, the production cost is reduced by 3 / 5, the storage period is prolonged, and the taste and flavor are closer to natural fruits.

Description

Technical Field

[0001] This invention belongs to the field of oral health care technology. Background Technology

[0002] Chinese patent document ZL201210125469.9 discloses a "compound fruit protease solid preparation for the prevention and treatment of oral diseases." This technology uses fruit protease to compensate for the insufficient cleaning of food residue proteins in the mouth by human saliva, effectively intervening in the formation of dental plaque and thus having a good effect on the prevention and treatment of oral diseases. However, the main component of the preparation is a natural extract of fruit protease that has been separated and purified, such as kiwi protease. Because the extraction and separation process of fruit protease is lengthy, complex, and requires strict process conditions, the production cost is high, and it also generates a lot of waste, hindering the widespread use of the preparation and its benefit to the public. Summary of the Invention

[0003] The purpose of this invention is to overcome the above-mentioned shortcomings of the prior art and provide a method for preparing kiwi fruit compound tablets for the prevention and treatment of oral diseases, which can significantly reduce production costs while maintaining the same or better effect as existing products in preventing and treating oral diseases.

[0004] The method of this invention is performed according to the following steps:

[0005] 1. Select fresh, ripe, and edible kiwifruit with intact peels, remove the stems at both ends, disinfect, wash, and drain.

[0006] 2. Juice extraction, centrifugation and filtration, with filter cloth mesh size not less than 40 mesh and rotation speed not less than 1500 rpm;

[0007] 3. Add 6-20% by weight of crystalline sorbitol to the filtered juice and dissolve it. Then, put it into a freeze dryer and freeze dry until the moisture content is less than 8%.

[0008] 4. Grind into 40-60 mesh particles and determine the activity of kiwifruit protease. If the activity of kiwifruit protease is not less than 1500 U / g, it is considered a qualified kiwifruit freeze-dried powder.

[0009] 5. Qualified kiwi freeze-dried powder is made into compound tablets. The compound tablets are composed of active ingredients and conventional excipients for tablet preparation. Each 100g compound tablet contains 15-50g of qualified kiwi freeze-dried powder, 0-30g of vitamin C, 0-1g of vitamin B2, and the remainder is conventional excipients.

[0010] The Tang Dynasty text *Huangdi Neijing Taisu* states, "Eating it on an empty stomach is food; eating it while ill is medicine," reflecting the idea of ​​"medicine and food sharing the same origin." The *Neijing* contains profound theories on dietary therapy, such as, "Severe poisons cure diseases, removing six out of ten; moderate poisons cure diseases, removing seven out of ten; slightly poisonous diseases cure diseases, removing eight out of ten; non-toxic diseases cure diseases, removing nine out of ten; grains, meat, fruits, and vegetables should be consumed to nourish the body, without excess, lest it harm the body's vital energy." This can be considered the earliest principle of dietary therapy. This invention follows the idea that "food supplementation is worse than medicinal supplementation, and medicine and food share the same origin," maximizing the preservation of the complete nutritional components of the kiwifruit, the king of fruits, such as various soluble trace elements, vitamins B1 and C, carotene, as well as calcium, phosphorus, iron, sodium, potassium, magnesium, chlorine, and chlorophyll. This invention does not pursue deliberate purification of raw materials, thus avoiding environmental pollution caused by purification processes (the production of protease requires salt and alcohol, generating large amounts of wastewater). Actual production calculations show that the cost of producing 100,000 active units of kiwifruit protease can be reduced by 30%, water consumption can be reduced by 5-3L, wastewater discharge can be reduced, and the consumption of resin, salt and alcohol is zero. Furthermore, due to the shortened process flow, refrigeration and preservation are no longer required, which reduces energy consumption and labor.

[0011] Those skilled in the art generally believe that using pure fruit protease as the main active ingredient in a formulation is definitely more effective than using fruit containing that protease directly. However, after in-depth experimental research, the patent applicant unexpectedly discovered that not only are the effects of the two comparable, but using fruit containing that protease directly (i.e., qualified kiwi freeze-dried powder) can also extend the shelf life of the compound tablets. For example, the enzyme activity decay period of the product in Example 1 is extended, and the protease activity of the product is more stable during the shelf life.

[0012] In the steps of this invention, the filter cloth sieve for centrifugal filtration must have a mesh size of not less than 40 mesh. This is a key process parameter to ensure that the kiwifruit protease activity in the freeze-dried kiwifruit powder meets the required standards. When the kiwifruit variety and other process conditions are exactly the same, except for the mesh size of the filter cloth during centrifugal filtration, the following experimental results were obtained;

[0013] Serial Number Filter cloth sieve mesh size Kiwifruit protease activity in freeze-dried kiwifruit powder 1 25 800U / g 2 35 1200U / g 3 40 1550U / g

[0014] Beneficial effects: Compared with existing technology products (i.e., the kiwi protease preparation in the "Compound Fruit Protease Solid Preparation for Prevention and Treatment of Oral Diseases" published in Chinese Patent Document No. ZL201210125469.9), the compound tablets obtained by the method of the present invention have the same oral cleaning effect, reduce production costs by 3 / 5, extend shelf life, and have a taste and flavor closer to natural fruit. Detailed Implementation

[0015] Example 1: Select kiwifruit with intact peels and nine to ten ripeness. Remove the stems at both ends with a sharp knife. Soak in 0.1 ppm potassium permanganate solution for 5 minutes, drain, and wash three times with drinking water to remove dirt, dust, and disinfectant from the fruit peel. Drain again. Juice the fruit, centrifuge and filter using an 80-mesh filter cloth at 2000 rpm. Add 10% crystalline sorbitol to the juice, dissolve and mix well, then freeze-dry until the moisture content is less than 8%. Grind into 60-mesh particles to obtain kiwifruit freeze-dried powder for later use. By weight, mix 1 part vitamin C, 0.5 parts vitamin B2, 44 parts kiwifruit freeze-dried powder, and 54.4 parts crystalline sorbitol thoroughly. Add 0.1 parts magnesium stearate (an anti-caking agent) and mix well. Compress the powder into tablets using direct powder compression technology to obtain the product of Example 1. Kiwi fruit lozenges.

[0016] Twenty-nine boarding high school students were selected to participate in the experiment. To facilitate staining and observation during the experiment, all participants had well-developed upper and lower central incisors with no visible tartar and good oral health. At the start of the experiment, after brushing their teeth normally the previous night, the next morning, before brushing, plaque display agent (2% basic fuchsin) was evenly applied to the front of the central incisors (front teeth) using a cotton swab. After 15 seconds, the students rinsed their mouths twice with water, gently swishing twice to remove any excess dye for observation. The size and location of the stained plaque were observed under natural light, serving as a control group; the results were recorded.

[0017] Dental plaque size is classified into four grades based on the location and area of ​​staining: Grade 0, no staining on the tooth surface and neck; Grade 1, staining only at the neck (the neck is the most common site of plaque formation); Grade 2, staining covering more than 1 / 5 but less than 1 / 2 of the tooth surface, excluding the neck; Grade 3, staining covering more than 1 / 2 of the tooth surface. Observation results: Grade 0: 0 people; Grade 1: 2 people; Grade 2: 20 people; Grade 3: 7 people.

[0018] The 29 people were then divided into two groups of 15 and 14 people, and each group took one tablet after brushing their teeth every night for three consecutive days. The group that took kiwifruit lozenges was observation group I, while observation group II took one lozenge each. Fresh breath compressed tablets (the product of Example 6 in Chinese Patent Document No. ZL201210125469.9). Dental plaque growth and adhesion were observed on the morning of the 4th day after staining. The results are as follows: Observation Group I (15 people): Grade 0 4 people, Grade 1 7 people, Grade 2 4 people, Grade 3 0 people; Observation Group II (14 people): Grade 0 5 people, Grade 1 4 people, Grade 2 5 people, Grade 3 0 people.

[0019] Table 1. Effects of two fruit protease preparations on dental plaque.

[0020]

[0021] Observation group I: p<0.05; Observation group II: p<0.05

[0022] Table 2 Comparison of the effects of two fruit protease preparations on dental plaque.

[0023]

[0024] P = 0.45 (Fisher's exact test was used because the sample size was less than 40 cases).

[0025] Based on the results of the above two groups of preparations on the control or removal of dental plaque, Kiwi lozenges and Fresh breath tablets have essentially the same inhibitory and removal effects on dental plaque.

[0026] Furthermore, it was found that the enzyme activity decay period of the product in Example 1 was prolonged, and the protease activity of the product was more stable during its shelf life. Enzyme activity measurements of lozenges produced from the two raw materials showed that, under the same storage conditions, the enzyme activity decay of the product in Example 1 was reduced by nearly 50%. The experimental results are shown in Tables 3 and 4 below. This may be due to the protective effect of pectin, inorganic salts or metal ions naturally present in fruits, and the presence of soluble cellulose on enzyme activity.

[0027] To investigate this phenomenon, in addition to using sample data from the production process, samples and formulations of active kiwifruit granules were specifically produced for the experiment. To compare the differences between the two products / formulations within a short period, accelerated storage tests were conducted on the formulations produced using active kiwifruit granules, according to the "Technical Guidelines for Stability Studies of Chemical Drugs (Active Pharmaceutical Ingredients and Formulations)". The conditions were 40℃±2℃ / 75%RH±5%RH, and the observation period was 6 months. The activity, appearance, color, and shape of the protease were then tested according to the enterprise standard Q / KQJ "Plant Protease Mouthwash Tablets". Sample No. 3, manufactured nearly a year ago, also had data collected during the 6-month accelerated stability test included. The experimental equipment used was the CHS-800SD-CM stability test chamber manufactured by Chongqing Chuangce Technology Co., Ltd. Enzyme activity determination of the tablets produced from the two raw materials showed that under the same storage conditions, the enzyme activity decreased, possibly due to the protective effect of the presence of pectin and soluble cellulose on enzyme activity.

[0028] Made with pure enzymes The breath-freshening compressed tablets, after a certain period of storage, exhibit a lower enzyme activity compared to the product in this embodiment (which also contains other soluble components from kiwifruit). The product yield of the kiwifruit lozenges is nearly 10 percentage points higher. This shows that the product obtained by the method of this invention is not a product of cutting corners or being poorly made compared with existing products. On the contrary, it can guarantee efficacy, save human and material resources, be green and environmentally friendly, and extend the product's storage time, with significant beneficial effects.

[0029] This invention does not aim to produce a final product using pure enzymes. Instead, it utilizes the soluble nutrients in kiwifruit, drawing upon traditional Chinese medicine's health preservation theories and practices. Specifically, it leverages the proteases in kiwifruit to compensate for the lack of protein digestion in saliva. Furthermore, unseparated cellulase and pectinase also participate in the digestion and removal of food residues. Additionally, beneficial sugars, vitamins, and trace elements aid digestion and replenish electrolytes. The synergistic effect of other soluble components in kiwifruit with the proteases also yields unexpected technical benefits, resulting in a reduced rate of enzyme activity decay during product storage.

[0030] The reduced degradation of enzyme activity in the product not only extends its shelf life but also improves its quality and efficiency.

[0031] The effect of "impurities" in kiwifruit on the protease activity of the formulation within its shelf life was observed.

[0032] Two batches of samples retained at room temperature The breath freshening compressed candy was observed for appearance after 24 months. The appearance was uniform in color, without any looseness or powdering. The activity of its protease was also tested. The protease activity was determined using the appendix method of the enterprise standard Q / KQJ "Plant Protease Breath Cleansing Tablets". Sample No. 3, manufactured approximately one year ago, used data collected from a 6-month accelerated stability test. The test results are shown in the table below:

[0033] Table 3 Changes in proteases during the shelf life of breath freshening compressed tablets

[0034]

[0035] After statistical processing: S 2 =0.89S=0.94 Average decrease rate: 19.7%

[0036] Three batches of formulations were prepared using the same batch of active kiwifruit granules as described in Example 1. The changes in protease in the kiwifruit lozenges after a 6-month accelerated stability test are shown in Table 4.

[0037] Table 4 Changes in protease in kiwifruit lozenges during their shelf life

[0038]

[0039] After statistical processing: S2 =1.56S=1.25 Average decrease rate: 10.3%

[0040] It is evident that enzymes made from pure enzymes... Fresh breath compressed tablets, after a certain period of storage, exhibit a decrease in enzyme activity compared to those containing soluble substances from kiwifruit. Kiwifruit lozenges are nearly 10 percentage points more effective. Because it retains other soluble substances from the fruit, it reduces the amount of excipients (crystalline sorbitol) used in the formulation process. Therefore, the technology applied for in this patent application is not a case of cutting corners or producing substandard products; rather, it saves resources, aligns with the concept of green development, improves product quality, reduces product costs, and ultimately benefits consumers.

[0041] Compared with the product in this embodiment, which is a patented compound fruit protease solid preparation for the prevention and treatment of oral diseases, consumers reported that the former can taste the flavor of kiwifruit, while still maintaining the effects of removing bad breath, moisturizing the throat, and clearing thick, greasy tongue coating.

[0042] Example 2: The following active ingredient combination experiment was conducted, and the rest was the same as in Example 1. The resulting kiwi fruit compound tablets showed good efficacy.

[0043] Active ingredients per 100 grams of product

[0044]

[0045] Note: Since qualified freeze-dried kiwi fruit powder itself contains a certain amount of vitamin C and vitamin B2, the formulation in item 1 does not need to add vitamin C and vitamin B2.

Claims

1. A method for preparing kiwifruit compound tablets for preventing and treating oral diseases, characterized in that... Follow these steps: 1) Select fresh, ripe, and edible kiwifruit with intact peels, remove the stems at both ends, disinfect, wash, and drain. 2) Juice extraction, centrifugal filtration, filter cloth with a mesh size of 40-80, rotation speed of 1500-2000 rpm; 3) Add 6-20% by weight of crystalline sorbitol to the filtered juice and dissolve it. Then, put it into a freeze dryer and freeze dry until the moisture content is less than 8%. 4) Grind into 40-60 mesh particles and determine the activity of kiwifruit protease. If the activity of kiwifruit protease is not less than 1500 U / g, it is considered a qualified kiwifruit freeze-dried powder. 5) Qualified kiwi freeze-dried powder is made into compound tablets. The compound tablets are composed of active ingredients and conventional excipients for tablet preparation. Each 100g compound tablet contains 15-50g of qualified kiwi freeze-dried powder, 0-30g of vitamin C, 0-1g of vitamin B2, and the remainder is conventional excipients.

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