Papaya, radix puerariae and fructus lycii soft capsule and preparation process thereof
The soft capsule formulation of kudzu root, wolfberry, and papaya extracts addresses the imbalance in immune function by providing a scientifically processed, stable, and effective health food that enhances immunity and maintains physical health.
Patent Information
- Application Number
- CN202410689651.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-30
- Publication Date
- 2024-12-06
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Existing products fail to maintain the dynamic balance of the body's immune function and achieve health care functions at a scientific level, leading to frequent illnesses and decreased physical health.
A soft capsule formulation comprising kudzu root extract, wolfberry extract, and papaya extract, along with gelatin, purified water, soybean oil, glycerin, beeswax, and titanium dioxide, processed through mixing, homogenizing, pill pressing, drying, and packaging to enhance immunity.
The formulation provides a safe and effective health food that enhances immunity, is easy to swallow, quickly dissolves in the stomach, and maintains stability against light degradation, offering a reliable health care solution.
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Figure CN119074829A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of papaya root, kudzu root and wolfberry soft capsules, in particular to papaya root, kudzu root and wolfberry soft capsules and a preparation process thereof. Background Art
[0002] Immunity is the body's own defense mechanism, which is the body's ability to identify and eliminate any foreign bodies (viruses, bacteria, etc.) that invade from outside; to deal with aging, damaged, dead, and degenerated self-cells, and to identify and deal with mutant cells and virus-infected cells in the body. Modern immunology believes that immunity is the body's physiological reaction to identify and exclude "foreigners". The immune system has three physiological functions: the first is the immune defense function, which responds to antigens and eventually eliminates them, playing an anti-infective immune role; the second is the immune self-stabilization function, in which lymphocytes can identify and distinguish which are "non-self" and which are "self" antigens, and therefore respond to infectious factors and tumor cells to achieve the purpose of elimination, while the antigens on the body's own tissues are in a state of no response and self-tolerance, which is called immune self-stabilization; the third is the immune surveillance function, whose main function is that the body recognizes antigens on cancerous cells through immune cells, and destroys cancer cells through specific or non-specific killer cells.
[0003] The theory of traditional Chinese medicine is consistent with the three functions of immunity mentioned above in spirit. First, in terms of immune prevention, it is mainly reflected in the holistic view and the coordination and unity of the body in traditional Chinese medicine theory. The holistic view believes that the human body is a whole, and modern medicine also believes that the human body has a complete immune system that plays a role in defending against diseases; second, in terms of immune self-stabilization, the theory of yin and yang balance, the theory of the five internal organs, and the theory of the five elements are closely related to immune stability; third, in terms of immune surveillance, it is mainly reflected in the understanding of tumor occurrence. Traditional Chinese medicine believes that the formation of tumors is caused by the lack of positive energy in the body, and then the evil energy is occupied. Traditional Chinese medicine treatment of tumors emphasizes improving the body's own resistance or adjusting the immune response. The immune defense, immune self-stabilization, and immune surveillance functions of the immune system are in a certain dynamic balance. Only by maintaining the dynamic balance of the body's immune function can the health of the human body be maintained.
[0004] The most direct manifestation of low immunity is that it is easy to get sick. Because of frequent illness, the body's consumption is increased, so there are generally symptoms such as physical weakness, malnutrition, mental depression, fatigue, decreased appetite, and sleep disorders. Getting sick, taking injections and taking medicine have become commonplace. It takes a long time to recover from each illness, and it often recurs. In the long run, it will affect physical health and easily induce major diseases, so it must not be underestimated. China has attached great importance to health preservation since ancient times, and one of the most important contents of health preservation is to enhance immunity. The old saying goes well: "If the righteousness is inside, evil cannot do anything." That is, as long as you are strong and have strong resistance, no illness will find you. Therefore, physical health is the element and guarantee of our high-quality life, and good immunity is the cornerstone of human health. It is now a consensus among modern people to enhance immunity and pay attention to physical health.
[0005] However, the existing products are unable to maintain the dynamic balance of the body's immune function and achieve health care functions and scientific levels. Summary of the invention
[0006] The purpose of the present invention is to provide a papaya, kudzu root and wolfberry soft capsule with the function of enhancing immunity and health care in view of the shortcomings of the prior art. This product is made of kudzu root extract, wolfberry extract and papaya extract as main raw materials and is processed by a scientific and reasonable production process. It is not only easy to take and highly safe, but also has a unique effect in enhancing immunity. Putting it on the market will surely bring health benefits to the majority of people with low immunity.
[0007] To achieve the above purpose, the present invention provides the following technical solution: a papaya, kudzu root and wolfberry soft capsule, characterized in that it uses wolfberry extract, kudzu root extract and papaya extract as main ingredients, and gelatin, purified water, soybean oil, glycerin, beeswax, caramel color and titanium dioxide as auxiliary materials.
[0008] A papaya, kudzu root and wolfberry soft capsule, wherein kudzu root extract accounts for 5%-8%, wolfberry extract accounts for 6%-9%, papaya extract accounts for 1%-4%, beeswax accounts for 0.5%-2%, soybean oil accounts for 30-40%, and other contents account for 40-60%.
[0009] Preferably, kudzu root extract accounts for 5.5%-7%, wolfberry extract accounts for 7%-8%, papaya extract accounts for 2%-4%, beeswax accounts for 0.5%-2%, soybean oil accounts for 35-40%, and other contents account for 45-55%.
[0010] Preferably, kudzu root extract accounts for 6%-8%, wolfberry extract accounts for 8%-9%, papaya extract accounts for 2%-3%, beeswax accounts for 1%, soybean oil accounts for 30-35%, and other contents account for 40-50%.
[0011] A preparation process of papaya, kudzu root and wolfberry soft capsules comprises a mixing process, a homogenizing process, a pill pressing process, a drying process and a packaging process.
[0012] Preferably, in the drying process, the gas introduced passes through a dry filter before drying the product; The dry filter includes a filter box, and the left and right sides of the filter box are respectively fixedly connected with an exhaust pipe and an air inlet pipe, and three filter frames are arranged inside the filter box, and the upper and lower sides of each filter frame are plugged with a socket, and the side of each socket away from the filter frame is fixedly connected to the inner wall of the filter box, and the interiors of the three filter frames are respectively inlaid with a first filter element, a second filter element and a third filter element, and the inner side wall of each socket is provided with two symmetrical clamping mechanisms, and the inner top wall of the filter box is provided with two sets of symmetrical conveying mechanisms.
[0013] Two symmetrical fixed plates are provided inside the filter box, and the bottom surface of each of the fixed plates is rotatably connected to two symmetrical ash sticking cylinders and brush rollers, and the ash sticking cylinders and brush rollers are in contact with the filter frame. The front side of the filter box is hinged with three first sealing doors through hinges, and the back side of the filter box is provided with a motor. The back side of the filter box is rotatably connected to two symmetrical rotating wheels through bearings, and the outer surfaces of the two rotating wheels are transmission-connected with transmission belts, and the output end of the motor is fixedly connected to one end of one of the rotating wheels, and the bottom surface of the filter box is fixedly connected to a fixed base, and the four corners of the bottom surface of the fixed base are fixedly connected to support legs.
[0014] Preferably, two symmetrical material receiving frames are provided inside the filter box, and each of the left and right sides of the material receiving frame are clamped with a clamping plate, and the side of the clamping plate away from the material receiving frame is fixedly connected to the outer surface of the clamping seat, and the front of the filter box has two symmetrical second sealing doors through hinges.
[0015] Furthermore, the conveying mechanism includes a reciprocating screw, both ends of the reciprocating screw are rotatably connected to the inner wall of the filter box through bearings, and the end of the reciprocating screw close to the rotating wheel penetrates the filter box and is fixedly connected to the rotating wheel, a movable plate is provided on the outer surface of the reciprocating screw, a threaded tube is inlaid on the outer surface of the movable plate, and the threaded tube is threadedly sleeved on the outer surface of the reciprocating screw, and the bottom surface of the movable plate is fixedly connected to the upper surface of the fixed plate.
[0016] Preferably, a top plate is fixedly connected to the upper surface of the movable plate, two symmetrical guide grooves are provided on the inner top wall of the filter box, a roller is rotatably connected to the upper surface of the top plate, and the roller is slidably connected to the guide groove.
[0017] Preferably, the clamping mechanism includes a slot, an inner wall of the slot is fixedly connected to a first compression spring, the right end of the first compression spring is fixedly connected to a slide, the inner wall of the slot is provided with two symmetrical slide grooves, the inner wall of each slide groove is fixedly connected to a limit rod, the upper surface and the bottom surface of the slide groove are respectively slidably connected to the inner wall of the slide groove, one end of each limit rod passes through the slide groove and is slidably connected to the inside of the slide groove, the outer surface of each limit rod is wrapped with a second compression spring, the two ends of each second compression spring are respectively fixedly connected to the inner wall of the slide groove and the outer surface of the slide groove, a hemisphere is fixedly connected to a side of the slide groove away from the first compression spring, and two sets of symmetrical slots are provided on the left and right sides of the filter frame, and the hemispheres are inserted into the inside of the slots.
[0018] Preferably, the bottom surface of each supporting leg is fixedly connected with rubber anti-slip strips arranged at equal distances, the upper surface of each fixed plate is fixedly connected with two symmetrical supporting plates, and the side surface of the supporting plate close to the movable plate is fixedly connected to the outer surface of the movable plate.
[0019] The beneficial effects of the present invention are: (1) The present invention uses kudzu root extract, wolfberry extract and papaya extract as the main raw materials to produce the Nubele brand papaya kudzu root and wolfberry soft capsules. The production process of this product is scientific and reasonable, and the quality is stable and controllable. It provides consumers with a safe, effective and reliable health food. Compared with other similar health foods, it has certain comprehensive advantages.
[0020] (2) The soft capsule of the present invention is a new dosage form developed after tablets and injections. It can quantitatively inject and encapsulate oily drugs, drug solutions or drug suspensions, pastes and even drug powders in a film to form sealed capsules of various sizes and shapes. Compared with other dosage forms, soft capsules have the following characteristics that other dosage forms cannot compare with: 1) The soft capsule contains accurate drug dosage and high precision; 2) It is neat and beautiful, easy to swallow, and can cover up the bitter taste and unpleasant smell of the drug; 3) The soft capsule dissolves quickly in the stomach, has good bioavailability, and works quickly; 4) In addition, in order to prevent the drug from decomposing in the light, a light-shielding material can be added to the capsule material for preparing the capsule, which will achieve good light stability. The capsule material of the soft capsule is composed of glycerin and gelatin, with a thick wall and no air permeability, so it is also an excellent preparation for preventing drug oxidation. .
[0021] In summary, the present invention has the advantages of being health-care and scientific. BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Figure 1 A sectional view of the front view of the present invention; Figure 2 It is a front view structural schematic diagram of the present invention; Figure 3It is a rear view structural schematic diagram of the present invention; Figure 4 For the present invention Figure 1 A schematic diagram of the structure enlargement in the middle; Figure 5 For the present invention Figure 1 Enlarged schematic diagram of the structure at point B in the middle.
[0023] Figure 6 It is a schematic diagram of the preparation process of the present invention.
[0024] In the figure: 1. filter box; 2. exhaust duct; 3. air inlet duct; 4. conveying mechanism; 401. reciprocating screw; 402. threaded tube; 403. moving plate; 404. top plate; 405. guide groove; 406. roller; 5. clamping mechanism; 501. hemisphere; 502. slot; 503. slide plate; 504. slide groove; 505. first compression spring; 506. slot; 507. limit rod; 508. second compression spring; 6. seat; 7. filter frame; 8. first filter element; 9. second filter element; 10. third filter element; 11. material receiving frame; 12. fixed base; 13. transmission belt; 14. ash sticking cylinder; 15. brush roller; 16. support leg; 17. fixed plate; 18. first sealing door; 19. second sealing door; 20. rotating wheel; 21. motor. DETAILED DESCRIPTION
[0025] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0026] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "multiple" is two or more, unless otherwise clearly and specifically defined.
[0027] Embodiment 1 This embodiment provides a papaya, kudzu root and wolfberry soft capsule, wherein kudzu root extract accounts for 5%-8%, wolfberry extract accounts for 6%-9%, papaya extract accounts for 1%-4%, beeswax accounts for 0.5%-2%, soybean oil accounts for 30-40%, and other contents account for 40-60%.
[0028] Preferably, kudzu root extract accounts for 5.5%-7%, wolfberry extract accounts for 7%-8%, papaya extract accounts for 2%-4%, beeswax accounts for 0.5%-2%, soybean oil accounts for 35-40%, and other contents account for 45-55%.
[0029] Preferably, kudzu root extract accounts for 6%-8%, wolfberry extract accounts for 8%-9%, papaya extract accounts for 2%-3%, beeswax accounts for 1%, soybean oil accounts for 30-35%, and other contents account for 40-50%.
[0030] Living in today's society, a series of sub-health clinical symptoms have been produced, such as memory loss, poor appetite, lack of energy, sleepiness, dreaminess, fatigue, susceptibility to colds, etc., which seriously affect people's daily life, study and work. The World Health Organization has long confirmed that the most essential and core problem is the low immunity of the human body.
[0031] Sub-health is a state between health and disease. A global survey by the World Health Organization shows that only 5% of people are truly healthy, 20% are sick, and 75% are in a sub-healthy state. The number of people in a sub-healthy state is increasing year by year in many countries and regions, especially in economically developed countries and regions with fierce social competition.
[0032] In short, low immunity has become an important factor affecting people's normal life, work and physical health. To enhance immunity and stay away from sub-health, it is also necessary to eat health foods that have the function of enhancing immunity on the basis of insisting on participating in more physical exercise and paying attention to diet. To this end, our company, in line with the principle of meeting market demand and promoting the development of health, has initiated the development of the Nubele brand papaya, kudzu root and wolfberry soft capsules, which are designed for adults and provide a convenient daily health food for the majority of people with low immunity. As a traditional Chinese medicine health food that enhances immunity, the raw materials are natural and safe to eat. Therefore, this product will have a huge market demand and suitable population after it is launched on the market.
[0035] Pueraria root extract is extracted from the dried root of Pueraria lobata, a plant of the leguminous family. Pueraria root tastes sweet and spicy, is cool in nature, and mainly enters the spleen, stomach, and lung meridians. It has the functions of relieving muscles and raising yang, quenching thirst, promoting body fluid, and activating collaterals. Pueraria root is rich in flavonoid compounds, such as puerarin and other nutrients, as well as proteins, amino acids, sugars, and essential minerals for the human body. It is a precious tonic suitable for all ages and is known as the "millennium ginseng". As early as the Han Dynasty, Zhang Zhongjing's "Treatise on Febrile Diseases" had the famous prescription "Pueraria Decoction", which is still an important prescription for relieving exterior symptoms. "Ben Cao Zheng Yi" also said that Pueraria root "can best develop the spleen and stomach clear yang qi". Therefore, eating Pueraria root regularly is believed to regulate human functions, strengthen physical fitness, improve the body's disease resistance, resist aging and prolong life, and maintain youthful vitality.
[0036] Bone marrow and HL60 cells from 18 patients with acute non-lymphocytic leukemia (ANLL) were co-cultured with Pueraria extract, homoharringtonine (HHT), cytosine arabinoside (Ara-c) and HA (HHT+Arac) for 24 hours. The effects of the above treatments on apoptosis of leukemia cells were observed by cell morphology, DNA gel electrophoresis, and DNA fragment percentage determination. Immunohistochemistry was used to detect the expression of bcl2 and c-myc (B cell lymphoma / leukemia 2, cell oncogene family) gene proteins in 10 bone marrow cells before and after treatment. Results: Typical apoptotic morphology and DNA ladder bands were observed in all treatment groups, but not in the control group. The expression of bcl2 and c-myc gene proteins in bone marrow cells treated with Pueraria extract was significantly downregulated. Conclusion: Pueraria extract can induce apoptosis in ANLL cells and HL60 cells. The downregulation or inhibition of bcl2 and c-myc gene protein expression by Pueraria extract may be one of its mechanisms for promoting apoptosis. The effect of Pueraria lobata crude extract (CP, ethanol extract of Pueraria lobata) on the proliferation of small cell lung cancer H446 cells was observed. The experiment showed that after 72 hours of action, the half inhibitory concentration of CP was 435μg / ml, and the cell apoptosis rate was 14.71%; the G0 / G1 phase cell composition ratio was 79.20%, and the G2 / M phase cell composition ratio was 8.94%, compared with the control group P<0.05; after CP acted on H446 cells, the expression of Bcl-2 protein in the cells was reduced, and the protein expression of Bax was increased, compared with the control group P<0.05, indicating that CP has an inhibitory effect on the proliferation of small cell lung cancer H446 cells and can induce cell apoptosis with a good effect.
[0037] In recent years, puerarin, a biologically active ingredient of puerarin, has been proven to regulate and promote the improvement of the body's immune function in many ways. Jin Lehong et al. observed the protective effect of puerarin on experimental rats ionizing radiation damage and proved that ionizing radiation caused a significant decrease in the thymus and spleen indexes of rats, while puerarin could alleviate the trend of the decrease in the thymus and spleen indexes of rats, indicating that puerarin can reduce the damage of ionizing radiation to the thymus and spleen of rats, that is, it has a certain protective effect on radioimmune organ damage. Qiu Shicui's experiment proved that puerarin can significantly enhance the proliferation reaction of T lymphocytes stimulated by ConA (P<0.01), indicating that puerarin has an enhancing effect on T lymphocyte function and also has a significant enhancing effect on B cell immune function. Pueraria can also stimulate the production of mouse antibodies and increase the secretion of antibodies, which is very significantly different from the control group (P<0.01).
[0038] It can be seen that Pueraria root and its extracts have a clear function of regulating the body's immunity, so this formula uses Pueraria root extract as one of the main raw materials.
[0039] Lycium barbarum extract is extracted from the dried mature fruit of Ningxia Lycium barbarum, a plant of the Solanaceae family. Lycium barbarum is sweet and mild in nature. It enters the liver and kidney meridians and has the effect of nourishing the liver and kidney. It is used for deficiency of essence, soreness of waist and knees, internal heat and thirst, blood deficiency and sallow complexion, etc. "Compendium of Materia Medica" records: "Lycium barbarum can nourish the kidney and produce essence, nourish the liver... relieve fatigue... and make people live longer." "Famous Doctors' Records" says that Lycium barbarum is good at "replenishing essence and qi"; "Food Therapy Materia Medica" also records that Lycium barbarum "can benefit people and relieve deficiency and fatigue." Modern medical research shows that Lycium barbarum has antioxidant and immune regulation effects. If taken regularly, "you will live a hundred years, walk like flying, your white hair will turn black, your teeth will grow again, and your Yang will be strong."
[0040] The wolfberry was ground into powder and given to the test mice by gavage at three doses of 0.085 g / kg, 0.17 g / kg and 0.5 g / kg, i.e. low, medium and high. The immune regulation experiment showed that the antibody volume counts in the medium and high dose groups increased significantly, the number of hemolytic plaques in the high dose group increased significantly, the auricle swelling in the high dose group and the absorbance difference of the lysozyme transformation test in the medium and high dose groups increased significantly, the phagocytic index of monocytes and macrophages in the high dose group increased significantly, and the activity of NK cells in the high dose group increased significantly, indicating that wolfberry can enhance the cellular immunity of mice and has a significant regulatory effect on the immune function of mice.
[0041] The low, medium and high dose groups of Lycium barbarum polysaccharide were gavaged into H22 liver cancer tumor-bearing mice at doses of 5, 10 and 20 mg / (kg·bw·d) respectively. The study showed that LBP could not only significantly inhibit the growth of transplanted liver cancer H22 tumors, but also significantly improve the T lymphocyte transformation ability and NK cell activity in tumor-bearing mice, suggesting that its anti-tumor effect may be achieved by enhancing the immune function of tumor-bearing mice.
[0042] The effect of wolfberry decoction on the immune function of mice was studied. The experiment was divided into three concentration groups, and mice were given 0.2ml / 10g body weight for 10 consecutive days to observe its effect on immune function. The experimental results showed that wolfberry decoction could significantly increase the spleen index, thymus index, lymphocyte transformation rate and OD value of mice, which was significantly different from the control group, indicating that wolfberry decoction had a significant promoting effect on the humoral and cellular immune function of mice.
[0043] The wolfberry fruit was decocted, filtered, and concentrated and then gavaged into mice to observe its effect on the phagocytic function of peritoneal macrophages and the weight of immune organs such as the spleen and thymus. The experiment found that all doses of wolfberry fruit could increase the phagocytic percentage and phagocytic index of peritoneal macrophages, increase the spleen and thymus index, and increase the weight of the spleen and thymus, confirming that wolfberry fruit water extract can promote the body's immune function. The tonic effect of wolfberry fruit is mild, and the author believes that long-term drinking can indeed enhance physical fitness and prevent and treat diseases.
[0044] Wolfberry is a food and medicine, known as a good food for medical treatment. It has good immunity-enhancing effects. Therefore, this formula uses wolfberry extract as one of the main raw materials.
[0045] Papaya and other Chinese herbal decoctions were gavaged into mice to study their effects on the immune function of normal mice. The results showed that papaya and other Chinese herbal decoctions could significantly inhibit the DTH of mice caused by sheep red blood cells (SRBC); papaya and other Chinese herbal decoctions could significantly promote the function of the mononuclear phagocytic system of mice; papaya and other Chinese herbal decoctions could significantly reduce the thymus index of mice, and the effect was quite obvious.
[0046] 96 weaned New Zealand white rabbits were randomly divided into 4 groups. The control group was fed a basic diet, and the experimental group was fed a basic diet with 2%, 5% and 8% papaya powder added to the diet. The 60-day feeding experiment showed that adding papaya powder to the feed can improve the growth performance of meat rabbits, and papaya powder has a tendency to improve the immunity of meat rabbits.
[0047] The inhibitory effect of the crude extract of papaya (the fruit of the plant Malus pedunculata of the genus Chaenomeles in the Rosaceae family) on mouse transplanted tumor H22 was studied to study the extract's promoting effect on mouse immunity. The experimental results showed that compared with the control group, the tumor inhibition rate of cyclophosphamide reached 48.53% (P<0.01), and the average tumor inhibition rates of the three dose groups of low, medium and high: 75mg / kg·d, 150mg / kg·d, and 300mg / kg·d were 2.94%, 20.59%, and 26.47% (P<0.05), respectively; delayed hypersensitivity reactions were enhanced; and SOD activity was increased. The experimental results showed that the papaya extract could enhance the humoral immunity of tumor-bearing mice at a certain dose.
[0048] Mixed fruit powder (SDMFP) composed of papaya and other fruits was used to analyze the effect of SDMFP on mouse immunity by measuring the phagocytic function of mouse mononuclear macrophages and delayed-type hypersensitivity (DTH). The experiment found that when mice were fed with SDMFP, the macrophage phagocytic index and the quality of the thymus and spleen immune organs of the mice were significantly improved, indicating that mixed fruit powder composed of papaya and other fruits can enhance cellular immunity to a certain extent.
[0049] Papaya is also a food and medicine, and has been shown to have good immunity-enhancing effects, so this formula uses papaya extract as one of the main ingredients.
[0050] This formula uses extracts of kudzu root, wolfberry and papaya as the main raw materials. Kudzu root, wolfberry and papaya are all raw materials with medicinal and edible properties, so they have high food safety. The amount of each raw material is within the safe range.
[0051] The safety evaluation test of this product confirmed that the MTD for mice was greater than 20.00g / kg·bw, which is non-toxic. The results of three genetic toxicity tests showed that the Ames test, the mouse bone marrow polychromatic erythrocyte micronucleus test, and the mouse sperm abnormality test were all negative. No toxic effects were found on various indicators of rats after 30 days of feeding. These experimental data further confirmed the safety of this product and it is suitable for people to consume with confidence.
[0052] The auxiliary materials for the soft capsule contents include: diluents, suspending agents, emulsifiers, etc. The diluent is used to increase the fluidity of the drug, ensure the accurate and stable dosage of the preparation, and ensure safe and effective filling. The selection of diluent is very important, which affects the bioavailability of the contents and the quality of the finished product. Soybean oil is the most commonly used diluent in soft capsules. In actual production, suitable suspending agents are often added to the contents of soft capsules to improve the stability of the mixed solution. Beeswax is the most commonly used suspending agent in soft capsules.
[0053] Therefore, this formula selects soybean oil and beeswax as auxiliary materials for contents.
[0054] The shell of soft capsule is similar to that of hard capsule. The commonly used excipients of the capsule shell mainly include gelatin, plasticizers (such as glycerin), opacifiers and pigments. The quality of soft capsule is closely related to the choice of capsule material. In actual production, it is most common to use gelatin, glycerin and purified water in a certain proportion to make the capsule shell. Therefore, this prescription uses gelatin, glycerin and purified water as the main capsule materials.
[0055] In addition, taking the appearance and other needs into consideration, an appropriate amount of caramel color and titanium dioxide with a light-shielding effect are added to the capsule shell, so that the capsule shell meets the production requirements, makes the quality of the contents more stable, and has a neat and beautiful effect.
[0056] Embodiment 2 like Figure 1 As shown, the components identical or corresponding to those in the first embodiment are marked with the corresponding reference numerals in the first embodiment. For the sake of simplicity, only the differences from the first embodiment are described below. The second embodiment differs from the first embodiment in that: A preparation process of papaya, kudzu root and wolfberry soft capsules comprises a mixing process, a homogenizing process, a pill pressing process, a drying process and a packaging process.
[0057] Preferably, in the mixing process, screening, weighing and batching are performed; The ingredients are kudzu root extract, wolfberry extract, papaya extract, beeswax and soybean oil.
[0058] Preferably, in the homogenizing step, gelatin, glycerin, purified water, caramel color, and titanium dioxide are subjected to colloidal treatment, filtration, and heat preservation.
[0059] Preferably, the batched materials and the materials in the homogenization process are pelletized, shaped, dried and washed.
[0060] Preferably, finished product inspection and storage are carried out after the packaging process.
[0061] The excipients for the contents should be selected in a reasonable ratio, on the one hand to ensure the fluidity of the content material liquid, which is convenient for filling the soft capsule, and on the other hand to ensure the stability of the content and not easy to stratify. Therefore, different dosages of soybean oil and beeswax prescriptions were designed, and the fluidity and sedimentation ratio of the obtained mixed liquid were examined to finally screen out the optimal dosage ratio of the content excipients.
[0062] Inspection index and judgment criteria: 1) Fluidity: Take an appropriate amount of mixed liquid with a medicine spoon, and place the medicine spoon at a 45° angle to the horizontal plane, and observe the mixed liquid dripping from the medicine spoon. 2) Sedimentation ratio determination method: Place the contents in the same measuring cylinder, measure the original height h1 and the sedimentation height h2 after standing still. The sedimentation ratio F=h2 / h1. The larger the F value, the better the stability. The specific results are shown in the table below: prescription Pueraria root extract (g) Lycium barbarum extract (g) Papaya extract (g) Soybean oil (g) beeswax(%) Liquidity Sedimentation ratio (F) 1 80 90 30 400 0 good 0.84 2 80 90 30 394 6(1%) good 0.92 3 80 90 30 388 12(2%) good 1.00 4 80 90 30 376 24(4%) Poor 1.00 5 80 90 30 364 36(6%) Difference 1.00 The test results show that prescription 3 has suitable fluidity and sedimentation ratio. Therefore, we choose prescription 3 as the prescription of this product.
[0063] The selection of capsule shell is the key technology to ensure the stability of soft capsule quality, which is directly related to the molding and appearance of soft capsule. This formula uses gelatin, glycerin and purified water as the main capsule materials. The quality of the capsule shell mainly depends on the dosage ratio of gelatin and glycerin. Therefore, by designing multiple prescriptions and optimizing through repeated tests, the optimal dosage of gelatin, glycerin and purified water is screened out. The specific results are shown in the table below:
[0064] The test results show that the capsule shell of Prescription 2 has better hardness and softness, and the disintegration time also meets the requirements. Therefore, Prescription 2 is finally determined to be the best prescription for the capsule shell of this product.
[0065] According to the preliminary determined process parameters, the raw and auxiliary materials that meet the requirements are divided into 3 batches, and the production is enlarged according to the formula amount. The deviation between the small test and the pilot test is corrected, which shows that this production process is scientific and reasonable and has the operability of large-scale production. The pilot products are used for safety evaluation, functional testing, detection of effective ingredients, stability testing, hygiene inspection, etc. The relevant pilot production verification data are shown in Tables 1 and 2 below.
[0066] Table 1 Three batches of product pilot production verification data
[0067] Table 2 Pilot production verification data of three new batches of products
[0068] Conclusion: The above data show that the pilot-scale production has a high yield rate, good production process reproducibility, strong operability, and stable and controllable product quality. Therefore, this process can be used as the basis for large-scale production conditions of this product.
[0069] Embodiment 3 like Figure 1 As shown, the components identical or corresponding to those in the second embodiment are marked with the corresponding reference numerals in the second embodiment. For the sake of simplicity, only the differences from the second embodiment are described below. The difference between the third embodiment and the second embodiment is that: A preparation process of papaya, kudzu root and wolfberry soft capsules, in the drying process, the introduced gas passes through a dry filter and then dries the product; The dry filter comprises a filter box 1, the left and right sides of the filter box 1 are respectively fixedly connected with an exhaust pipe 2 and an air inlet pipe 3, three filter frames 7 are arranged inside the filter box 1, the upper and lower sides of each filter frame 7 are plugged with a holder 6, a side of each holder 6 away from the filter frame 7 is fixedly connected to the inner wall of the filter box 1, the interiors of the three filter frames 7 are respectively inlaid with a first filter element 8, a second filter element 9 and a third filter element 10, the inner side wall of each holder 6 is provided with two symmetrical clamping mechanisms 5, and the inner top wall of the filter box 1 is provided with two sets of symmetrical conveying mechanisms 4.
[0070] Two symmetrical fixed plates 17 are provided inside the filter box 1, and the bottom surface of each fixed plate 17 is rotatably connected to two symmetrical ash sticking cylinders 14 and brush rollers 15, and the ash sticking cylinders 14 and brush rollers 15 are in contact with the filter frame 7. The front of the filter box 1 is hinged with three first sealing doors 18 through hinges, and the back of the filter box 1 is provided with a motor 21. The back of the filter box 1 is rotatably connected to two symmetrical rotating wheels 20 through bearings. The outer surfaces of the two rotating wheels 20 are transmission-connected with a transmission belt 13, and the output end of the motor 21 is fixedly connected to one end of one of the rotating wheels 20. The bottom surface of the filter box 1 is fixedly connected to a fixed base 12, and the four corners of the bottom surface of the fixed base 12 are fixedly connected to support legs 16.
[0071] Furthermore, two symmetrical material receiving frames 11 are provided inside the filter box 1, and a card is clamped on the left and right sides of each material receiving frame 11, and a side of the card away from the material receiving frame 11 is fixedly connected to the outer surface of the card seat 6, and the front of the filter box 1 has two symmetrical second sealing doors 19 through hinges. Through the arrangement of the material receiving frame 11 and the second sealing door 19, the dust on the surface of the filter frame 7 can be effectively collected, thereby effectively ensuring the working environment inside the filter box 1.
[0072] Furthermore, the conveying mechanism 4 includes a reciprocating screw 401, both ends of which are rotatably connected to the inner wall of the filter box 1 through bearings, and one end of the reciprocating screw 401 close to the rotating wheel 20 penetrates the filter box 1 and is fixedly connected to the rotating wheel 20, and a movable plate 403 is provided on the outer surface of the reciprocating screw 401, and a threaded tube 402 is inlaid on the outer surface of the movable plate 403, and the threaded tube 402 is threadedly sleeved on the outer surface of the reciprocating screw 401, and the bottom surface of the movable plate 403 is fixedly connected to the upper surface of the fixed plate 17. Through the coordination between the above structures, the effect of reciprocating movement of the ash sticking cylinder 14 and the brush roller 15 can be effectively achieved, so that the ash sticking cylinder 14 and the brush roller 15 sweep the surface of the filter frame 7, thereby improving the filtering effect of the device.
[0073] Furthermore, the upper surface of the movable plate 403 is fixedly connected to the top plate 404, the inner top wall of the filter box 1 is provided with two symmetrical guide grooves 405, the upper surface of the top plate 404 is rotatably connected to the roller 406, and the roller 406 is slidably connected to the guide groove 405. Through the coordinated arrangement between the top plate 404, the guide groove 405 and the roller 406, the movable plate 403 can be effectively limited, so that the movable plate 403 is more stable when moving.
[0074] Furthermore, the clamping mechanism 5 includes a slot 506, an inner side wall of the slot 506 is fixedly connected with a first compression spring 505, a right end of the first compression spring 505 is fixedly connected with a slide plate 503, the inner wall of the slot 506 is provided with two symmetrical slide grooves 504, the inner side wall of each slide groove 504 is fixedly connected with a limiting rod 507, the upper surface and the bottom surface of the slide plate 503 are respectively slidably connected with the inner wall of the slide groove 504, one end of each limiting rod 507 penetrates the slide plate 503 and is slidably connected with the inside of the slide plate 503, the outer surface of each limiting rod 507 is wrapped with a second compression spring 508, the two ends of each second compression spring 508 are respectively fixedly connected with the inner wall of the slide groove 504 and the outer surface of the slide plate 503, a hemisphere 501 is fixedly connected to a side of the slide plate 503 away from the first compression spring 505, and two sets of symmetrical slots 502 are provided on the left and right sides of the filter frame 7, and the hemisphere 501 is inserted into the inside of the slot 502. Through the coordination of the above structures, the filter frame 7 can be effectively clamped and fastened, thereby improving the stability of the filter frame 7 and preventing the filter frame 7 from sliding.
[0075] Furthermore, the bottom surface of each support leg 16 is fixedly connected with rubber anti-skid strips arranged at equal distances, and the upper surface of each fixed plate 17 is fixedly connected with two symmetrical support plates, and the side surface of the support plate close to the movable plate 403 is fixedly connected to the outer surface of the movable plate 403. The provision of the rubber anti-skid strips can effectively prevent the device from sliding, thereby improving the stability of the device, and the provision of the support plates can effectively improve the connection and fastening effect between the fixed plate 17 and the movable plate 403.
[0076] Working principle: First, connect the motor 21 to the power supply, so that the operation of the motor 21 will drive the rotating wheel 20 to rotate, and the transmission belt 13 will drive another rotating wheel 20 to rotate, so that the reciprocating screw rod 401 can rotate, and the rotation of the reciprocating screw rod 401 can make the threaded tube 402 drive the moving plate 403 to move back and forth, and then the exhaust gas is discharged through the air inlet pipe 3, so that the exhaust gas is filtered layer by layer through the first filter element 8, the second filter element 9 and the third filter element 10 respectively, which effectively purifies the exhaust gas, and the purified exhaust gas is finally discharged through the exhaust pipe 2. At the same time, the reciprocating movement of the moving plate 403 can drive the ash sticking cylinder 14 and the brush roller 15 to pass through the filter element 8, the second filter element 9 and the third filter element 10. The surface of the filter frame 7 is brushed to sweep the dust on the surface of the filter frame 7 and drop it into the material receiving frame 11 for easy dust processing. Later, the material receiving frame 11 can be taken out by opening the second sealing door 19. When the filter frame 7 needs to be disassembled and cleaned, the first sealing door 18 is opened and the filter frame 7 is pulled out. When the filter frame 7 is installed and connected, it is only necessary to insert the filter frame 7 into the card seat 6. When the filter frame 7 is connected, the hemisphere 501 can be inserted into the card slot 502 under the elastic force of the first compression spring 505 and the second compression spring 508 on the slide plate 503, so that the filter frame 7 has a limited and fixed effect, thereby improving the stability of the filter frame 7.
[0077] When the existing dry filter is used for a long time, the surface of the filter frame is easy to absorb dust. If it is not cleaned in time, the filtering effect of the filter element will be affected, thereby reducing the working efficiency of the filter element. In addition, the general filter frame usually slides directly into the holder, making the filter frame easy to loosen, which is not conducive to the use of the filter element. Compared with the prior art, the dry filter in this embodiment has the following beneficial effects: 1. The present invention uses the coordinated arrangement between the conveying mechanism, the second sealing door, the transmission belt and the rotating wheel. The operation of the motor can make the transmission belt drive the two rotating wheels to rotate, and the rotating wheel drives the reciprocating screw to rotate, so that the threaded tube moves on the reciprocating screw and drives the moving plate to move, so that the moving plate drives the fixed plate to move, and through the coordinated arrangement between the fixed plate, the ash sticking cylinder and the brush roller, the ash sticking cylinder and the brush roller can sweep the surface of the filter frame, thereby improving the working efficiency of the filter.
[0078] 2. The present invention clamps the filter frame into the holder through the setting of the clamping mechanism, that is, the matching setting between the hemisphere, the slot, the slide plate slot, the first compression spring, the slot, the limit rod and the second compression spring, so that the surface of the filter frame presses the clamping mechanism. When the filter frame is clamped, the hemisphere can be inserted into the slot under the elastic force of the first compression spring and the second compression spring on the slide plate, thereby achieving the effect of limiting and fixing the filter frame, thereby improving the stability of the filter frame.
[0079] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.
Claims
1. A papaya root, kudzu root and wolfberry soft capsule, characterized in that: The main ingredients are wolfberry extract, kudzu root extract, and papaya extract, and the auxiliary ingredients are gelatin, purified water, soybean oil, glycerin, beeswax, caramel color, and titanium dioxide.
2. The papaya root, kudzu root and wolfberry soft capsule according to claim 1, characterized in that: In terms of content proportion, Pueraria extract accounts for 5%-8%, wolfberry extract accounts for 6%-9%, papaya extract accounts for 1%-4%, beeswax accounts for 0.5%-2%, soybean oil accounts for 30-40%, and other contents account for 40-60%.
3. The papaya root, kudzu root and wolfberry soft capsule according to claim 1, characterized in that: In terms of content proportion, Pueraria extract accounts for 5.5%-7%, wolfberry extract accounts for 7%-8%, papaya extract accounts for 2%-4%, beeswax accounts for 0.5%-2%, soybean oil accounts for 35-40%, and other contents account for 45-55%.
4. The papaya root, kudzu root and wolfberry soft capsule according to claim 1, characterized in that: In terms of content proportion, Pueraria root extract accounts for 10%, wolfberry extract accounts for 7%, papaya extract accounts for 2%, beeswax accounts for 1%, soybean oil accounts for 30%, and other contents account for 50%.
5. The preparation process of a papaya, kudzu root and wolfberry soft capsule according to claim 1, characterized in that: It includes mixing process, homogenizing process, pilling process, drying process and packaging process.
6. The preparation process according to claim 5, characterized in that: In the drying process, the gas introduced passes through a dry filter and then dries the product; The dry filter comprises a filter box (1), the left and right sides of the filter box (1) are respectively fixedly connected with an exhaust pipe (2) and an air inlet pipe (3), three filter frames (7) are arranged inside the filter box (1), the upper and lower sides of each filter frame (7) are plugged with a holder (6), a side of each holder (6) away from the filter frame (7) is fixedly connected to the inner wall of the filter box (1), the inside of the three filter frames (7) are respectively inlaid with a first filter element (8), a second filter element (9) and a third filter element (10), the inner side wall of each holder (6) is provided with two symmetrical clamping mechanisms (5), and the inner top wall of the filter box (1) is provided with two sets of symmetrical conveying mechanisms (4); Two symmetrical fixed plates (17) are provided inside the filter box (1), and the bottom surface of each fixed plate (17) is rotatably connected to two symmetrical ash sticking cylinders (14) and brush rollers (15), and the ash sticking cylinders (14) and brush rollers (15) are in contact with the filter frame (7). The front surface of the filter box (1) is hinged with three first sealing doors (18) via hinges. The back surface of the filter box (1) is provided with a motor (21), and the back surface of the filter box (1) is rotatably connected to two symmetrical rotating wheels (20) via bearings. The outer surfaces of the two rotating wheels (20) are transmission-connected to a transmission belt (13), and the output end of the motor (21) is fixedly connected to one end of one of the rotating wheels (20). The bottom surface of the filter box (1) is fixedly connected to a fixed base (12), and the four corners of the bottom surface of the fixed base (12) are fixedly connected to support legs (16).
7. The preparation process according to claim 6, characterized in that: Two symmetrical material receiving frames (11) are arranged inside the filter box (1), and a clamping plate is clamped on the left and right sides of each of the material receiving frames (11), and a side of the clamping plate away from the material receiving frame (11) is fixedly connected to the outer surface of the clamping seat (6), and the front side of the filter box (1) is provided with two symmetrical second sealing doors (19) via hinges.
8. The preparation process according to claim 6, characterized in that: The conveying mechanism (4) comprises a reciprocating screw (401), both ends of the reciprocating screw (401) being rotatably connected to the inner wall of the filter housing (1) via bearings, and one end of the reciprocating screw (401) close to the rotating wheel (20) passes through the filter housing (1) and is fixedly connected to the rotating wheel (20), a movable plate (403) is provided on the outer surface of the reciprocating screw (401), a threaded tube (402) is inlaid on the outer surface of the movable plate (403), and the threaded tube (402) is threadedly sleeved on the outer surface of the reciprocating screw (401), and the bottom surface of the movable plate (403) is fixedly connected to the upper surface of the fixed plate (17).
9. The preparation process according to claim 6, characterized in that: The upper surface of the movable plate (403) is fixedly connected to a top plate (404); the inner top wall of the filter box (1) is provided with two symmetrical guide grooves (405); the upper surface of the top plate (404) is rotatably connected to a roller (406), and the roller (406) is slidably connected to the guide groove (405).
10. The preparation process according to claim 6, characterized in that: The clamping mechanism (5) comprises a slot (506), the inner wall of the slot (506) is fixedly connected to a first compression spring (505), the right end of the first compression spring (505) is fixedly connected to a slide plate (503), the inner wall of the slot (506) is provided with two symmetrical slide grooves (504), the inner wall of each slide groove (504) is fixedly connected to a limiting rod (507), the upper surface and the bottom surface of the slide plate (503) are respectively slidably connected to the inner wall of the slide groove (504), and one end of each limiting rod (507) penetrates the slide plate. (503) and is slidably connected to the inside of the slide plate (503), the outer surface of each of the limit rods (507) is wound with a second compression spring (508), the two ends of each of the second compression springs (508) are respectively fixedly connected to the inner wall of the slide groove (504) and the outer surface of the slide plate (503), a hemisphere (501) is fixedly connected to a side of the slide plate (503) away from the first compression spring (505), and the left and right sides of the filter frame (7) are each provided with two sets of symmetrical slots (502), and the hemisphere (501) is inserted into the inside of the slot (502).
