Film coating agent as well as preparation method and application thereof

Abstract

The invention discloses a film coating agent and a preparation method and application thereof, medicinal materials or decoction pieces in medicinal and edible / new resource food / common food raw materials are selected as base materials, the film coating agent is prepared through the steps of cleaning, drying and mixing, and the film coating agent can be applied to coating of tablet products. The method avoids the harm of synthetic colorants to the body health of consumers and the use limitation of poor stability of natural pigments, has the characteristics of low price and wide source, is convenient to operate, and is easy for industrial production.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of film coating agents, and particularly relates to a film coating agent based on medicinal and edible resources / new resource food / ordinary food raw materials and a preparation method and application thereof. BACKGROUND

[0002] The film coating agent can not only improve the surface color and flatness of products, but also improve the stability of products, control the release rate of drugs and meet the needs of different consumers. The working principle is that the film coating agent is dissolved and sprayed onto the surface of the tablet core during the operation of the coating equipment, and a film is formed after drying and solidification, so that the product coating effect is achieved. The film coating agent is generally composed of colorants, light shielding agents, film formers, plasticizers and the like, and has a wide application in the production and processing of drugs, health products and functional foods.

[0003] The colorant is also called pigment, and its main function is to impart or improve the color of food, enhance the visual appeal of products and achieve the purpose of enhancing the purchase desire of consumers. According to the source of the pigment, it can be divided into synthetic pigments and natural pigments. At present, synthetic pigments are mainly prepared by artificial synthesis method, and in the actual production process, synthetic pigments not only have good dyeing effect, but also have low price, good stability and are not easy to fade, so they gradually occupy the main position of food processing colorants.

[0004] There are 28 synthetic pigments allowed to be added in food in China, which can be divided into four categories. The first category is organic synthetic pigments, such as new red, amaranth, cochineal, erythrosine, allura red, lemon yellow, brilliant blue, sunset yellow, and indigo and its aluminum lake, quinoline yellow. The second category is inorganic synthetic pigments, mainly including synthetic iron oxide and titanium dioxide. However, the General Office of the Ministry of Health pointed out in the reply (No. 919) that iron oxide cannot be used as a food processing aid due to the lack of necessary food additive technology. If the above substances are intended to be used as food additives or food processing aids, they should apply for administrative permission for new food additive varieties according to law. The third category is natural equivalent synthetic pigments, mainly including lycopene and beta-carotene. The fourth category is other synthetic pigments, mainly including copper and potassium sodium salt of chlorophyll. In recent years, it has been found that the toxic effects of chemical synthetic pigments not only show general toxicity, but also have genetic toxicity, carcinogenicity, and joint toxicity. The study of "Edible pigment toxicity test on silkworm" showed that the addition of edible synthetic pigments in the body of five-year-old silkworm directly affected the survival rate, yield, and cocoon quality. The study of "SCGE detection of cochineal DNA damage on 3T3 cells" found that different concentrations of cochineal caused different degrees of single-strand breakage of DNA in 3T3 cells cultured in vitro. The higher the concentration of cochineal, the more serious the cell damage, and the two were positively correlated. The results of "Excessive intake of artificial pigments affects the development of children" showed that seven kinds of artificial food pigments such as tartrazine and sunset yellow may reduce the IQ of children. From 1968 to 1970, the Soviet Union conducted long-term animal experiments on amaranth, and the results showed that the cancer rate was as high as 22%. Subsequent studies in the United States, the United Kingdom, and other countries also found that many other synthetic pigments can harm the human body, and some may be converted into carcinogens, including causing reduced fertility, deformities, and other conditions. Titanium dioxide and talcum powder are commonly used as sunscreen agents in film coating agents. In 2006, the International Agency for Research on Cancer (IARC) listed titanium dioxide as a 2B carcinogen, and in 2020, France banned the addition of titanium dioxide in food. In 2021, the European Union banned titanium dioxide as a food additive (E171). In addition, some synthetic pigments may contain heavy metals such as arsenic and lead during the synthesis process, and long-term consumption may cause infant intelligence impairment and chronic poisoning. Therefore, synthetic pigments not only cannot provide nutrients to the human body, but also may even harm the body's health. As early as 1994, the Joint Expert Committee on Food Additives (JECFA) (Food and Agriculture Organization / World Health Organization) published the results of the toxicological evaluation of pigments and proposed the reference value of the maximum daily intake (ADI) of the human body. In the content of the Domestic "Food Additive Standard" (GB 2760-2024), the variety, use range, and maximum limit of pigments also have strict legal requirements. Therefore, natural pigments (such as caramel color and beet red) have gradually become the trend of industry development.

[0005] At present, natural colorants are derived from plants, animals or microorganisms, generally without toxic side effects, and some natural pigments (such as lycopene, carotene) not only provide nutritional ingredients, but also contain rich functional ingredients, which can effectively enhance immunity or delay aging. However, natural pigments also have problems such as poor stability, high cost, uneven dyeing, etc., which limit their application in actual production. The research of "Red grapefruit lycopene processing degradation mechanism and its quantitative structure-activity relationship" shows that high temperature will cause lycopene molecules to break into small molecular substances, and as the temperature rises, the degradation rate of lycopene increases, and the coloring ability and stability also decrease; The research of "Production and food applications of the red pigments of monascus rubber" shows that the light stability of red yeast color is poor, and it is easy to fade under direct sunlight, which cannot guarantee the color stability of food containing the pigment during the shelf life (usually 3 months); The results of "Extraction and stability of purple rice pigment" show that the light, oxidizing agent and reducing agent have significant effects on the purple rice pigment (P<0.05), and the color fading or discoloration easily occurs.

[0006] At present, the film coating agent commonly uses synthetic colorants of chemical origin, but there are health and safety hazards, which may cause allergic reactions, skin irritation (such as burning sensation, redness, itching, etc.), and there is a possibility of carcinogenicity; however, natural source colorants are generally prepared by extraction, and have poor stability, are easily affected by pH value, light, temperature, etc., and have rapid fading problems, and the natural source colorant process is complex and high in cost, which cannot be popularized and used, therefore, it is urgent to develop a natural stable source and non-toxic side effect colorant and sunscreen agent. SUMMARY

[0007] The purpose of the present application is to provide a film coating agent and its preparation method and application, which has simple and easy-to-understand process parameters, convenient operation and easy industrial production.

[0008] A preparation method of a film coating agent, comprising the following steps:

[0009] (1) Raw material selection: selecting medicinal materials or decoction pieces of the same origin as the base material;

[0010] (2) Cleaning: removing visible impurities in the base material by cleaning;

[0011] (3) Drying: drying the impurity-removed base material in an oven or a cold well, temperature-196-100℃, time 1-3 days;

[0012] (4) Grinding: grinding the dried base material by airflow grinding, freezing grinding or ultrafine grinding, and sieving to prepare fine powder;

[0013] (5) Mixing: 1-100 parts of the fine powder prepared in step (4) and 1-100 parts of the transparent coating powder are mixed according to the weight ratio to prepare a film coating agent.

[0014] Preferably, the medicinal materials or decoction pieces of the same origin as food in step (1) include one or more of heavy-petaled red roses, dried tangerine or orange peel, hawthorn fruit, red dates, Chinese wolfberry, raspberries, jujube kernel, fresh ginger, Cape jasmine fruit, redbud root, sea buckthorn, panax notoginseng, ginseng, kudzu root, sea buckthorn, polygonatum, milkvetch root, American ginseng, Chinese yam, poria cocos, baizhi, rattan fig, burdock root, sea buckthorn leaf, corn silk, magnolia leaf, neem leaf, tea tree flower, Danfeng peony flower, Chinese live oak leaf, Ampelopsis grossedentata leaf, Eucommia ulmoides male flower, cordyceps militaris, and lily.

[0015] Preferably, the moisture of the final control base in step (3) is 0-7%.

[0016] Preferably, the air inlet pressure of the jet milling in step (4) is 0.5-1.5 MPa, and the rotation speed is 1000-3000 r / min.

[0017] Preferably, the temperature of the freeze crushing in step (4) is set to -80-0℃, and the time is 20-60 min.

[0018] Preferably, the time of the ultrafine grinding in step (4) is 10-50 min.

[0019] Preferably, the mesh screen of the step (4) is more than 200.

[0020] As another object of the present application, the present application also provides a film coating agent prepared by the above method.

[0021] As another object of the present application, the present application also provides the application of the above film coating agent. The film coating agent is mixed with an ethanol aqueous solution according to a weight ratio of 1:1-100 to prepare a coating slurry, which is then sprayed on the surface of a tablet product for coating. The spraying atomization pressure is 0.05-0.8 MPa, the spraying liquid rate is 0.05-500 ml / min, and the air inlet temperature is 0-88℃.

[0022] Preferably, the concentration of the ethanol aqueous solution is 0-100%.

[0023] Preferably, the tablet product includes a medicine and a food.

[0024] The application adopts the whole powder of unextracted medicinal and edible homologous, new resource food, common food raw medicinal materials or decoction pieces as the coloring agent and light shielding agent of film coating, avoids the harm to the health of consumers caused by synthetic coloring agent and the use limitation caused by poor stability of natural pigment, has the characteristics of low price, wide source, convenient operation and easy industrial production, is not only suitable for the field of medicines and health foods, but also can be applied to common foods, especially in functional foods such as tabletting candies, can significantly improve the color, aroma, taste and stability of products, meet the needs of different consumers, and effectively improve the market competitiveness. DETAILED DESCRIPTION

[0025] The technical solutions in the embodiments of the application will be clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the application, rather than all the embodiments. Based on the embodiments in the application, all other embodiments obtained by those skilled in the art without creative work belong to the protection scope of the application.

[0026] Embodiment 1

[0027] The embodiment provides a preparation method of a film coating agent, comprising the following steps:

[0028] (1) raw material selection: selecting rose bittersweet and Chinese yam as the base material;

[0029] (2) cleaning: removing visible impurities such as dust, sand and insect eyes in the rose bittersweet and Chinese yam;

[0030] (3) drying: drying the rose bittersweet and Chinese yam after impurity removal in an oven, the temperature is 80 DEG C, the time is 24 h, and the water content of the base material is 6%;

[0031] (4) crushing: preparing rose bittersweet superfine powder by crushing the treated rose bittersweet in an ultramicro grinder for 20 min and then passing through a 200-mesh screen; preparing Chinese yam superfine powder by crushing the treated Chinese yam in an ultramicro grinder for 25 min and then passing through a 200-mesh screen;

[0032] (5) mixing: mixing 8 parts of rose bittersweet superfine powder, 8 parts of Chinese yam superfine powder and 40 parts of transparent coating powder according to the weight ratio to prepare the film coating agent.

[0033] The film coating agent is mixed with water according to the weight ratio of 1:10 to prepare a coating slurry, and then is uniformly sprayed on the surface of a collagen tablet core, the spraying atomization pressure is 0.3 MPa, the spraying liquid rate is 100 ml / min, and the air inlet temperature is 68 DEG C.

[0034] Embodiment 2

[0035] The embodiment provides a preparation method of a film coating agent, comprising the following steps:

[0036] (1) Raw material selection: rose bayberry, double red rose, yam are selected as base materials;

[0037] (2) Cleaning: visible impurities such as dust, sand, insect eyes and the like in the rose bayberry, double red rose and yam are removed;

[0038] (3) Drying: the rose bayberry, double red rose and yam after impurity removal are placed in an oven for drying treatment, the temperature is 80℃, the time is 24h, and the water content of the base material is 6%;

[0039] (4) Pulverization: the treated rose bayberry is ultra-micro pulverized for 20min and then passed through a 200-mesh screen to prepare rose bayberry superfine powder; the treated double red rose is ultra-micro pulverized for 20min and then passed through a 200-mesh screen to prepare double red rose superfine powder; the treated yam is ultra-micro pulverized for 25min and then passed through a 200-mesh screen to prepare yam superfine powder;

[0040] (5) Mixing: 4 parts of rose bayberry superfine powder, 4 parts of double red rose superfine powder and 8 parts of yam superfine powder are mixed according to the weight ratio to prepare a film coating agent.

[0041] The film coating agent and water are mixed according to a weight ratio of 1:9.5 to prepare a coating slurry, which is then uniformly sprayed on the surface of the collagen protein tablet core, the spraying atomization pressure is 0.3MPa, the spraying liquid rate is 100ml / min, and the air inlet temperature is 68℃.

[0042] Example 3

[0043] The embodiment provides a preparation method of a film coating agent, which comprises the following steps:

[0044] (1) Raw material selection: double red rose, yam are selected as base materials;

[0045] (2) Cleaning: visible impurities such as dust, sand, insect eyes and the like in the double red rose and yam are removed;

[0046] (3) Drying: the double red rose and yam after impurity removal are placed in an oven for drying treatment, the temperature is 80℃, the time is 24h, and the water content of the base material is 6%;

[0047] (4) Pulverization: the treated double red rose is ultra-micro pulverized for 20min and then passed through a 200-mesh screen to prepare double red rose superfine powder; the treated yam is ultra-micro pulverized for 25min and then passed through a 200-mesh screen to prepare yam superfine powder;

[0048] (5) Mixing: 8 parts of double red rose superfine powder and 8 parts of yam superfine powder are mixed according to the weight ratio to prepare a film coating agent.

[0049] The coating slurry was prepared by mixing the above film coating agent with water in a weight ratio of 1:9, and then uniformly sprayed on the surface of the collagen tablet core. The spraying atomization pressure was 0.3 MPa, the spraying liquid rate was 100 ml / min, and the air inlet temperature was 68°C.

[0050] Comparative Example 1

[0051] The present comparative example provides a preparation of a film coating agent for general food, comprising the following steps:

[0052] According to the coating agent formula and dosage, hydroxypropyl methylcellulose 30 parts, propylene glycol 8 parts, magnesium stearate 6 parts, calcium carbonate 20 parts, and natural amaranth 1 part were weighed according to weight.

[0053] The hydroxypropyl methylcellulose, propylene glycol, magnesium stearate, calcium carbonate, and amaranth were mixed uniformly in a mechanical stirrer to prepare a film coating agent.

[0054] The coating slurry was prepared by mixing 1 part of the film coating agent with 10 parts of water according to weight, and then uniformly sprayed on the surface of the collagen tablet core. The spraying atomization pressure was 0.3 MPa, the spraying liquid rate was 90 ml / min, and the air inlet temperature was 75°C.

[0055] Comparative Example 2

[0056] The present comparative example provides a preparation of a film coating agent for general food, comprising the following steps:

[0057] According to the coating agent formula and dosage, hydroxypropyl methylcellulose 30 parts, propylene glycol 8 parts, magnesium stearate 6 parts, calcium carbonate 20 parts, and natural amaranth 1 part were weighed according to weight.

[0058] The hydroxypropyl methylcellulose, propylene glycol, magnesium stearate, calcium carbonate, and amaranth were mixed uniformly in a mechanical stirrer to prepare a film coating agent.

[0059] The coating slurry was prepared by mixing 1 part of the film coating agent with 10 parts of water according to weight, and then uniformly sprayed on the surface of the collagen tablet core. The spraying atomization pressure was 0.3 MPa, the spraying liquid rate was 90 ml / min, and the air inlet temperature was 75°C.

[0060] The collagen coated tablets prepared in the examples and comparative examples were subjected to sensory, colorimetric value, and accelerated stability tests.

[0061] The detection method is as follows:

[0062] The sensory evaluation method is as follows: 10 samples were taken and placed on a clean white porcelain plate. The appearance, color, and state of the samples were observed directly under natural light, the smell was smelled, and the taste was tasted after rinsing with warm water.

[0063] Chromatic value detection method: the sample surface was determined by using a color difference meter (CR-410). The determination conditions were: light source D65, standard observation angle 2°, illumination aperture Instrument error ΔE*ab within 0.6, repeatability standard deviation ΔE*ab within 0.07, color space L*a*b*. Bacterial culture dish (bottom groove uniform and flat) sample loading thickness 5 cm;

[0064] Stability investigation method: according to the relevant provisions of the "Guiding Principles for Stability Test of Health Foods", the investigation time is 0 months, 1 month, 2 months, 3 months, 6 months, and the storage condition is: temperature 37±2℃, relative humidity RH75±5%.

[0065] The detection results of the accelerated stability test of the collagen film-coated tablets prepared in the examples and comparative examples are shown in Tables 1-4.

[0066] Table 1 Sensory evaluation of samples

[0067]

[0068]

[0069] Table 2 Chromatic value detection results of Example 1

[0070]

[0071] Table 3 Chromatic value detection results of Example 2

[0072]

[0073] Table 4 Chromatic value detection results of Example 3

[0074]

[0075] Table 5 Chromatic value detection results of Comparative Example 1

[0076]

[0077] Table 6 Chromatic value detection results of Comparative Example 2

[0078]

[0079] In addition to using the medicinal and edible medicinal materials or decoction pieces as the base material in the present application, new food raw materials medicinal materials or decoction pieces, ordinary food raw materials medicinal materials or decoction pieces can also be used as the base material.

[0080] The above only describes the preferred embodiments of the present application and is not intended to limit the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A method for preparing a film coating agent, characterized in that, Includes the following steps: (1) Raw material selection: Select medicinal materials or processed medicinal materials that are both food and medicine as base materials; (2) Cleaning: The visible impurities in the base material are removed by cleaning; (3) Drying: Place the impurity-removed base material in an oven or cold well for drying treatment at a temperature of -196-100℃ for 1-3 days; (4) Crushing: The dried base material is processed by air jet milling, freeze milling or ultra-fine milling, and then sieved to prepare fine powder; (5) Mixing: Mix 1-100 parts of the fine powder obtained in step (4) and 1-100 parts of the transparent coating powder in a weight ratio to prepare a film coating agent.

2. The preparation method according to claim 1, characterized in that, The medicinal materials or processed slices that are both food and medicine in step (1) include one or more of the following: double-petaled red rose, dried tangerine peel, hawthorn, red dates, wolfberry, raspberry, jujube seed, ginger, gardenia, rehmannia, sea buckthorn, notoginseng, ginseng, kudzu root, sea buckthorn, polygonatum, astragalus, codonopsis, American ginseng, yam, poria, angelica, five-finger peach, burdock root, sea buckthorn leaf, corn silk, lindera leaf, moringa leaf, tea tree flower, peony flower, eucommia leaf, ampelopsis leaf, eucommia male flower, cordyceps and lily.

3. The preparation method according to claim 1, characterized in that, In step (3), the moisture content of the base material is ultimately controlled to be 0-7%.

4. The preparation method according to claim 1, characterized in that, In step (4), the airflow pulverization has an inlet pressure of 0.5-1.5 MPa and a rotation speed of 1000-3000 r / min; the cryogenic pulverization temperature is set to -80-0℃ and the time is 20-60 min.

5. The preparation method according to claim 1, characterized in that, The time for ultrafine pulverization in step (4) is 10-50 min.

6. The preparation method according to claim 1, characterized in that, In step (4), the material is passed through a sieve with a mesh size of 200 or larger.

7. A film coating agent prepared by any one of claims 1-6.

8. The application of the film coating agent according to claim 7, characterized in that, A coating slurry is prepared by mixing a film coating agent with an ethanol aqueous solution at a weight ratio of 1:1-100. The slurry is then sprayed onto the surface of the tablet product for coating. The spraying atomization pressure is 0.05-0.8 MPa, the spraying rate is 0.05-500 ml / min, and the inlet air temperature is 0-88℃.

9. The application according to claim 8, characterized in that, The concentration of the ethanol aqueous solution is 0-100%.

10. The application according to claim 8, characterized in that, The tablet products include pharmaceuticals and food.

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