CN110882393A - Preparation for preventing and treating critical hyperuricemia, hyperuricemia and gout and preparation method thereof - Google Patents

Preparation for preventing and treating critical hyperuricemia, hyperuricemia and gout and preparation method thereof Download PDF

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CN110882393A
CN110882393A CN201811098278.1A CN201811098278A CN110882393A CN 110882393 A CN110882393 A CN 110882393A CN 201811098278 A CN201811098278 A CN 201811098278A CN 110882393 A CN110882393 A CN 110882393A
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uric acid
alkaline
hyperuricemia
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alkaline protease
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王昌勇
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Abstract

A preparation for preventing and treating critical hyperuricemia, hyperuricemia and gout and a preparation method thereof belong to the field of biochemical pharmacy. The principle is as follows: the enteric slow release and alkaline controllable alkaline buffer pair is applied, and the alkaline protease is a macromolecular substance, is not absorbed into blood by intestinal tracts and has no toxic or side effect; alkaline protease is used for assisting autologous trypsin to decompose intestinal tract digesta, so that uric acid wrapped by the intestinal tract digesta is fully exposed, and the uric acid is effectively neutralized face to face by an alkaline controllable buffer pair. The feedback mechanism that uric acid discharged by the intestinal tract is prevented from being absorbed into blood again along with sodium ions in food is achieved, and the continuous rising of the uric acid value is effectively prevented to generate supersaturated crystallization; and, the vicious circle in which uric acid crystals accumulate continuously. The intestinal tract alkalescent physiological environment is maintained, the blood uric acid value is kept in a beneficial range of 300-350 umol/L for a long time, and the aim of artificially throttling and controlling the application amount of uric acid is fulfilled.

Description

Preparation for preventing and treating critical hyperuricemia, hyperuricemia and gout and preparation method thereof
Technical Field
The invention relates to a preparation for preventing and treating critical hyperuricemia, hyperuricemia and gout and a preparation method thereof; in particular to a biological product, belonging to the field of biochemical pharmacy.
Technical Field
In our country, hyperuricemia and gout are the fourth chronic common disease that appears after hypertension, hyperlipidemia and hyperglycemia. The specific method for preventing and treating critical hyperuricemia, hyperuricemia and gout is implemented by applying urate oxidase, which is an antagonistic substance, in an injection form; however, urate oxidase is an foreign protein, and although the chemical modification reduces the antigen, the injection in vivo still causes the reaction of pyrogen and allergen to the people with acute constitution, and the cachexia is formed. The domestic patent technology 200710018951.1 applies urate oxidase by oral enteric method, which solves the problem of pyrogen and allergen reaction, but urate oxidase is obtained from fermentation liquor of microorganism such as ox kidney, pig liver, torula priogenes and candida, and has high cost. At present, no enterprise has mass production in China, and the national food and drug standards are also included; therefore, the large-scale clinical application of urate oxidase in China is restricted.
Uric acid is an endogenous strong antioxidant and maintains that cells in a body are not excessively oxidized by free oxygen and are prematurely weakened, aged and mutated (cancerated); in addition, the uric acid amount in blood is gradually increased along with the increase of the age of a human body, and the uric acid is a decisive substance for the long life of the human body; moreover, uric acid levels not exceeding a critical level are specific substances for maintaining daily facial image and body state rejuvenation. However, before the age of 60, if the blood uric acid value continuously exceeds the saturation level, urate crystals and stones are generated, and the kidney and bone joints are damaged; therefore, uric acid is for humans, an extremely sharp-handled and typical double-edged sword. Human, unlike other less-lived mammals, there is no specific urate oxidase to uric acid in the body, but only 2% of other non-specific urate-specific oxidases break down uric acid into soluble, non-crystallizable allantoin, which is then metabolized out of the body.
The human body uric acid is a weak organic acid, is expressed in a sodium salt form, has low solubility, is easy to crystallize, is produced by the liver and is the only generation port; two discharge ports are provided, one is a kidney discharge port accounting for 70% of total uric acid discharge and the other is an intestine discharge port accounting for 30% of total uric acid discharge, so as to maintain the supply and demand balance of the uric acid required by a human body.
The most basic reasons for high uric acid production are rich nutrition and special living habits; the secondary reason is that the uric acid metabolic enzyme group in the liver is continuously activated due to serious diseases and the like, and the uric acid amount larger than the demand is produced. If the abnormal increase amount is not controlled, the blood uric acid value is continuously increased and is continuously accumulated in the blood at high concentration, and the abnormal phenomenon is clinically called hyperuricemia; the conversion from hyperuricemia to gout is caused by the fact that the kidney can not discharge excessive uric acid load or disorder, so that uric acid supersaturated crystals are deposited and accumulated at the bone joints with high charge fields, and severe pain of non-pathogenic inflammation occurs.
When the kidney is loaded or obstructed, the compensatory function of the human body is promoted to break through 30 percent of physiological excretion of the intestinal tract, so that the excretion is forced to be increased continuously; once the intestinal tract is forced to become the main discharge channel of uric acid, the physiological environment of the intestinal tract is changed from weak alkalinity to weak acidity, and the original ecological physiological environment of the intestinal tract is thoroughly changed. In human body, 70% of lymphatic immune system is in intestinal tract and is responsible for producing vitamin B, and is the largest immune organ in vivo; once a disorder occurs, a series of extremely complex complications arise.
Aiming at critical hyperuricemia, hyperuricemia and gout, the western medicine adopts a strategy of distinguishing excessive generation type, deficient discharge type and mixed type and then coping with corresponding blockage or dredging. If liver formation is vigorous, a chemosynthesis inhibitor such as allopurin, febuxostat or topiroxostat is used to inhibit the activity of uricase group produced in liver and forcibly reduce the amount of production. This causes not only accumulation of the concentrations in the body of xanthine and hypoxanthine, precursors for producing uric acid, but also final precipitation in the kidney; while kidney function is impaired, chronic toxic reactions also occur in liver, spleen, heart, pancreas and bone marrow. The most common clinical symptoms are rash, pain in liver area, general trembling, fast heartbeat, somnolence and tinnitus; and, elevated transaminase. If the weak or old people take the chemical synthesis inhibitor for a long time, the liver and kidney cells are easily damaged, and finally two organs fail to form larger accidents; moreover, the chemical synthesis inhibitor inhibits the activity of the group of enzymes, the activities of other enzyme groups are preferentially developed, the relatively normal physiological balance is forcibly disturbed, and linked adverse reactions are generated to frost on snow; for example, hyperlipidemia, cardiac dysfunction, and the like occur. Moreover, once the administration of the chemical synthesis inhibitor is stopped or interrupted, a large amount of accumulated xanthine and hypoxanthine in the body can rapidly generate uric acid, so that the blood uric acid value is increased and the reverse feeding is caused. The method is characterized in that the situation that the gourd is pressed to gourd ladle is realized by taking a chemical synthesis inhibitor to forcibly inhibit enzymes in the liver from generating uric acid; therefore, the strong inhibition of the production of uric acid by the enzymes in the liver is a typical flood-stopping method of Gun water control, and as a result, it is useless to raise soup and stop boiling.
Uric acid is produced much like a sudden flood. The torrential flood is actually life water, and is beneficial to large and has small disadvantages; if the blockage is forced, the great disaster of breakup is caused. Obviously, the strong blockage is not intelligent, and the water discharge method must be adopted to aim at the blockage. But let out the intelligence to let out; otherwise, the situation that the gourd is pressed down to be lifted up also occurs. Two outlets are provided, and the western medicine adopts a single kidney outlet aiming at the type of hyporrhea. In particular, a chemosynthesis inhibitor of benzbromarone, probenecid and the like is used for inhibiting reabsorption of kidney tubules on uric acid so as to forcibly increase excretion of the uric acid; however, the physiological excretion function of the kidney is broken through by artificially forcibly increasing the excretion amount, so that the diseases such as soreness and weakness of waist and knees, impotence, tinnitus, waist pain, fatigue, elevation of blood creatinine value and the like are caused; moreover, when a large amount of uric acid is forcibly overloaded and is discharged by the kidney, the uric acid is easy to be attached and deposited in renal tubules, renal pelvis and ureter to form renal calculus and calculus in the ureter, thereby causing renal colic and renal function damage; this phenomenon is commonly known as gout kidneys.
Western medicine, if it is detected that the type is both the type with much production and the type with little excretion, it is judged as mixed type; the two chemical synthesis inhibitors are put on duty alternately to perform inhibition alternately, so that the harm caused by the inhibition is enlarged and complicated. In reality, due to panic and urgent psychology, it is very common and dangerous to privately use these two classes of chemical synthesis inhibitors to alternately inhibit enzyme activity in liver and kidney to treat hyperuricemia and gout.
The human body has great reaction to chemical synthesis preparations, which is particularly reflected in the toxic and side effects. The most intuitive understanding is that the transaminase and creatinine equivalent is increased due to liver and kidney damage. For example, proteins are of large molecular weight and are not permeable to the glomerular basement membrane under normal physiological conditions in humans; once kidney injury is caused by toxic and side effects of a chemical synthesis preparation, glomerular basement membranes are damaged to leak protein, and urine presents a large amount of foam and dark color which are not easy to dissipate; the early signals and the warning signs of the pathological changes of the liver and the kidney are displayed by the urine trace protein method.
The intestinal outlet of two outlets of the human body uric acid accounts for 30 percent of the total excretion of the uric acid; it excretes a large portion of uric acid, and is accompanied by reabsorption of sodium in the ingested food in the intestinal tract into the blood, forming physiological feedback. If hyperuricemia and gout occur, the excretion of the kidney and the intestines is just a great reversal value, which is an instinctive reaction made by a human body compensation mechanism; according to this physiological characteristic, the eyes should be put on the intestinal discharge opening.
Clinically, except for the application of the two chemically synthesized inhibitors, actually, a lot of natural substances specially and effectively corresponding to weakly acidic uric acid are provided. For example, various organic alkaloids extracted from plants, and various inorganic bases existing in the natural world; such as sodium carbonate, potassium carbonate, sodium bicarbonate, sodium hydroxide, potassium hydroxide, and the like. In domestic clinic, the most basic method is to take potassium citrate sustained release tablets and potassium sodium hydrogen citrate orally and drip sodium hydroxide solution; and alkaline substances such as sodium bicarbonate tablets, but the actual effect is low. The reason for this is that the digestion products of protein, starch and fat in the intestinal tract are deeply acidified by a large amount of excess uric acid, so that the intestinal flora is disordered, sufficient vitamin B cannot be produced, and enterokinase secreted by the intestinal tract is insufficient or inactivated, so that trypsin is not fully activated to exert the due enzymolysis effect; moreover, a large amount of excessive uric acid degrades trypsin, so that the activity of the trypsin is greatly reduced, and intestinal digesta can not be fully physiologically decomposed; thus, organic and inorganic potassium, sodium carbonate, sodium bicarbonate tablets; and alkaline elements such as potassium citrate sustained-release tablets, potassium sodium hydrogen citrate and the like can only perform neutralization reaction with uric acid on the surface of intestinal digests but cannot perform the neutralization reaction with uric acid comprehensively and deeply; residual uric acid wrapped by the intestinal tract digesta is caused, and sodium ions in the intestinal tract digesta are absorbed into blood again along with the residual uric acid, so that continuous physiological feedback is formed; finally, the adverse situation that the uric acid in the intestinal tract is not controlled manually appears. Moreover, if a large amount of alkaline elements is used, the alkaline elements are easily poisoned due to uncontrollable alkalinity.
On the premise that the body does not have serious diseases, the excessive production of uric acid is the expression that the activity of the enzyme is strong, the constitution is far stronger than that of most people, and the giant panda is a human panda. Therefore, sacrificing the enzymatic activities in the liver and kidney is equivalent to artificially and forcibly killing the good physiological mechanisms of the body, which is extremely unintelligible. Based on the principle of uric acid generation and excretion of human body, the aims of reducing uric acid, eliminating uric acid crystal and treating hyperuricemia and gout are achieved without sacrificing enzyme activity in liver and kidney. Therefore, the human body evolution is not only deprived but also damaged; moreover, the method causes linked physiological adverse reactions, and the correct method is to reverse the thinking.
Although the human body does not have the specific and unique variety of urate oxidase, other 100-120 non-professional oxidase varieties aiming at uric acid exist; oxidase groups such as peroxidase, catalase, cytochrome oxidase, etc. These oxidase groups are sensitive to organic elements of magnesium, manganese, copper, selenium, germanium and zinc. On the one hand, the organic elements are used for critically activating the oxidase groups in the body, so that the oxidase groups have strong activity and can balance the amount of uric acid naturally to the best. On the other hand, the intestinal tract discharge port of uric acid is fully applied to supplement natural protein digestive enzyme suitable for intestinal tract alkalescent environment by oral administration, and strong auxiliary autologous trypsin is removed to ensure normal enzymolysis function; and, use organic element potassium and phosphate of high electric charge, happen to be due to the trend of high uric acid, digest and neutralize the surplus uric acid amount of the overflow, maintain the high value of the blood uric acid value of ordinary person; and before the age of 60 years, the application amount of uric acid is artificially controlled in a throttling manner, so that the blood uric acid value is kept at an ideal level of 300-350 umol/L. Because the molecular weight of the externally-supplemented protein digestive enzyme in the intestinal tract is extremely large, the externally-supplemented protein digestive enzyme is difficult to absorb into blood by the intestinal tract; therefore, the medicine can not participate in the physiological process of human body to cause physiological reaction, and organs such as liver, kidney, heart, pancreas and the like can be affected; moreover, the traditional Chinese medicine composition is applied to the natural digestive tract, so that no toxic or side effect exists.
Disclosure of Invention
The invention provides a preparation for preventing and treating critical hyperuricemia, hyperuricemia and gout and a preparation method thereof. The principle is as follows: applying enteric slow-release and alkalinity-controllable elements; and the protease is a macromolecular substance, is not absorbed into blood by intestinal tracts, has the characteristic of no toxic or side effect, assists the trypsin secreted by pancreas and completes the physiological decomposition of intestinal tract digesta. The elements with controllable alkalinity provide an optimum reaction environment for protease, so that intestinal digesta is fully decomposed, and uric acid wrapped by the intestinal digesta is completely exposed; the alkaline controllable elements are fully and effectively contacted with uric acid face to cause neutralization, and the intestinal non-uric acid can be absorbed in a kettle bottom sucking mode. By the method, a physiological feedback mechanism that 30-70% of uric acid discharged from intestinal tracts is completely inhibited and sodium ions in food are absorbed into blood again is effectively prevented, and the continuous rising of the uric acid value is effectively prevented to generate supersaturated crystallization; and, the vicious circle in which uric acid crystals accumulate continuously. The intestinal tract alkalescent physiological environment is maintained, the blood uric acid value is kept in a beneficial range of 300-350 umol/L for a long time, and the aim of artificially throttling and controlling the application amount of uric acid is fulfilled.
The technical problem to be solved by the invention is as follows:
1. selection of enzymes
The pH of human blood is 7.35-7.40, the pH of small intestine fluid is 7.6-7.8, and the pH of large intestine fluid is 8.4-8.55, which are both alkalescent; maintain the physiological mechanism of blood and intestinal alkalescence and exert the efficacy of the used enzyme, and the enzyme conforming to the physiological mechanism of alkalescence of a human body needs to be selected.
2. Selection of basic elements
The basic element is selected to provide an optimum reaction environment for the enzyme selected and to be sufficiently effective to contact uric acid for neutralization; also, the alkalinity can be controlled.
3. Application route and method of enzyme and alkaline element
Degrading neutral and alkaline enzymes by gastric acid to inactivate zymogen; and the alkaline element is subjected to neutralization reaction, so that the alkaline element loses efficacy, gastric enzyme and gastric secretions such as gastrodin are damaged, and the gastric function is damaged; the killing ability of miscellaneous viruses and bacteria in the diet is further weakened. Therefore, the stomach is avoided, and the selected enzyme and alkaline elements are delivered to the intestinal tract in a weakly alkaline environment for slow release application.
4. Enteric material
The enteric material which can avoid the hyperacidity and can be disintegrated and released in the intestinal tract is selected.
5. Blood cleaning
Critical hyperuricemia, hyperuricemia and gout, and accumulating metabolites in blood to form garbage of blood metabolites; therefore, the metabolites in the blood must be efficiently cleared.
6. Activating proenzyme
The activity of the oxidase group and the selected enzyme in vivo is improved.
7. Selection of coenzymes
Vitamin B is used as coenzyme, so that the vitamin B which is lost due to intestinal flora imbalance caused by the acidity of the intestinal environment is met, and the metabolism of the organism is promoted; it also needs to activate the selected enzyme and the zymogen of the in vivo oxidase group, and improve the enzyme activity.
The technical scheme adopted by the invention for solving the technical problems is as follows:
1. selection of enzymes
Alkaline protease is selected. Alkaline proteases are the only enzyme species that have enzymatic reactions in alkaline environments; has the commonness similar to urate oxidase, is suitable for alkaline environment, and accords with the physiological mechanism of intestinal weakly alkaline original ecology. The molecular weight is 2-3 thousands, the powder is light brown, yellow brown to white, is suitable for the environment with the pH of 7.5-10.5, the applicable temperature range is 30-60 ℃, the enzyme activity is 1-200 thousands u/g, and the method is described in national food standard GB/T23527-2009.
2. Selection of basic elements
A phosphoric acid buffer pair of dipotassium hydrogen phosphate and potassium dihydrogen phosphate with controllable alkalinity and pH of 7.1-9.0 is applied, and the phosphoric acid buffer pair is in the standards of national food Standard GB25560-2010 and Chinese pharmacopoeia; and a carbonic acid buffer pair of sodium carbonate and sodium bicarbonate with controllable alkalinity and pH of 7.1-9.0, the national food standards GB1886.1 and GB1886.2, and the Chinese pharmacopoeia standards.
3. Application route and method of enzyme and alkaline element
The alkaline protease and the buffer with controllable alkalinity are equivalent, and are respectively coated by enteric materials, and the enteric materials are orally taken to be delivered to intestinal tracts for disintegration, and contents are slowly released.
4. Enteric material
Applying enteric polymer cellulose solution and finished enteric capsules.
5. Blood cleaning
Organic germanium 132 is applied. Among numerous elements, organogermanium is the only substance with high-efficiency blood purification effect. The principle is as follows: germanium, which is trapped between metals and nonmetals and has a charge affinity for metabolites in blood; because germanium is not accumulated in the body and must be discharged out of the body in 24 hours, the metabolite in the blood is attached by using the characteristic, and the blood metabolite such as the excessive uric acid is efficiently and auxiliarily eliminated; national New resource food Q3210NZ 40-2003.
6. Activating proenzyme
Organic magnesium, manganese, copper, selenium, germanium, potassium and zinc elements in the trace elements are used for critically activating oxidase groups and alkaline zymogen in the body, so that the enzyme activity is improved.
7. Selection of coenzymes
The elemental vitamin B6 is applied to assist in activating zymogens of alkaline protease and self-enzyme and increasing enzyme activity; promoting metabolism of human body.
The invention has the beneficial effects that:
1. the alkaline protease assists pancreatic secreted trypsin to decompose intestinal tract digesta into small peptides and amino acids, so that the decomposition rate and the absorption rate of ingested substances are improved; the uric acid wrapped by the intestinal tract digesta is fully exposed, and the uric acid is neutralized by effectively and face-to-face contact of the alkaline controlled buffer pair. Completely inhibiting 30-70% of uric acid discharged from intestinal tracts and absorbing into blood again along with sodium ions in food, and preventing supersaturated crystallization from occurring in continuous rising of blood uric acid value; and, the vicious circle in which uric acid crystals accumulate continuously. Effectively maintains the alkalescent physiological environment of the intestinal tract, maintains the blood uric acid value in a beneficial range of 300-350 umol/L for a long time, and achieves the aim of artificially throttling and controlling the application amount of uric acid.
2. The alkaline protease and the alkaline buffer with controllable alkalinity are equivalent, so that uric acid in the intestinal tract is neutralized into salt and urea which are dissolved in water and are discharged out of the body along with intestinal tract digesta without being metabolized by the liver and the kidney; therefore, liver and kidney damage caused by taking Chinese and western medicines does not occur, and transaminase and creatinine values in blood are not increased.
3. With the elimination of the uric acid in the intestinal tract, when the blood uric acid value is reduced to be below 500umol/L, the condition of operable operation is caused for large uric acid crystals and stones; small uric acid crystals and stones are also caused to flow back into blood because of the isoosmotic autolysis into thin and soft fluid due to the high-low fall of the huge uric acid concentration in the body; the returned uric acid is neutralized and digested when being fed back by the intestinal tract; finally, small uric acid crystals and calculi are indirectly eliminated.
4. Small uric acid crystals and stones are dissolved into fluid uric acid by isotonic autolysis, so that the conditions of negative pressure suction by a vacuum pump and rapid minimally invasive surgery are also caused; thereby greatly shortening the time, pain and cost of indirect dissolution and elimination.
5. The alkaline protease is produced in large scale in China for many years, is widely applied to industries such as food, biochemical raw material extraction, fine chemical industry, organic chemical industry, daily chemical industry and the like, and has wide application, low cost and strong market competition. The alkaline protease is applied to preventing and treating critical hyperuricemia, hyperuricemia and gout, so that the application range of the alkaline protease is expanded, and the application value is improved; and thoroughly get rid of the limitation of single application of urate oxidase, and avoid the disadvantages of high price, various defects in application and incapability of overcoming the defects.
6. Organic magnesium, manganese, copper, selenium, germanium, potassium and zinc are used for activating zymogen, so that the critical activity of an oxidase group in vivo and the applied alkaline protease is improved, and the application amount of the alkaline protease is reduced.
7. The application of the organic germanium in blood cleaning achieves the aim of safely and quickly removing metabolites in blood.
8. The vitamin B6 is used as coenzyme, which not only makes up the deficiency of the coenzyme in the intestinal tract of the patient, but also improves the enzymolysis effect.
9. The alkaline protease is applied in enteric-coated sustained release, which not only accords with the physiological mechanism of intestinal alkalescence, but also is safe and effective.
10. The alkaline protease is roughly prepared, so that the activity of the final product enzyme reaches 1-5 ten thousand u/g, and the final product enzyme is prepared into a food-grade product for application; further refining to ensure that the enzyme activity of the final product reaches 5-10 ten thousand u/g, and preparing the final product into a health-care product for application; and further removing foreign protein and decoloring to ensure that the activity of the enzyme of the final product reaches 50-60 mu/g, and preparing the final product into a pharmaceutical grade oral product for application.
The present invention will be further described with reference to the following examples.
Specific example 1 encapsulating: uniformly mixing alkaline protease and a phosphoric acid buffer pair of dipotassium hydrogen phosphate and potassium dihydrogen phosphate, wherein the pH value of the phosphoric acid buffer pair is 10-70% of the weight of the alkaline protease and is 7.1-9.0; adding enteric polymer cellulose solution, mixing, and spray drying to obtain yellowish brown granule. Uniformly mixing vitamin B6 accounting for 0.001-2.0% of the weight of alkaline protease, 0.001-0.5% of each of organic magnesium, manganese, copper, selenium, zinc and potassium and 0.001-1.0% of organic germanium element by a mixer; adding enteric polymer cellulose solution, mixing, and spray drying to obtain white fine particles. Yellow brown and white particles were mixed at a ratio of 1: mixing the mixture in a mixer according to the proportion of 1-6, and filling the enteric-coated capsules to obtain finished products. The traditional Chinese medicine is taken before meals three times a day, and 1-5 granules are taken each time; the shelf life is 18 months when stored at 5 ℃ and more than 6 months when stored at 25 ℃.
Specific example 2 food preparation: adding alkaline protease, sodium carbonate with pH of 7.1-9.0 and 10-70% of the weight of the alkaline protease and sodium bicarbonate into a mixing machine for uniformly mixing, adding an enteric polymer cellulose solution for wetting and uniformly mixing, preparing into yellow brown small particles by a granulator, and drying in a dryer at 25-30 ℃ for later use; vitamin B6 accounting for 0.001-2.0% of the weight of the alkaline protease, organic magnesium, manganese, copper, selenium, zinc and potassium which account for 0.001-0.5% of the weight of the alkaline protease and organic germanium which accounts for 0.001-1.0% of the weight of the alkaline protease are added into a mixer to be mixed uniformly, an enteric polymer cellulose solution is added to be wetted and mixed uniformly, white small particles are prepared by a granulator, and the white small particles are dried in a dryer at 35-55 ℃ for standby. Mixing the yellow brown and the white small particles in a mixing machine according to the proportion of 1: 1-6, adding the enteric polymer cellulose solution to wet and mix uniformly, making the mixture into tablets and balls by using a tablet making machine and a pill making machine, drying the tablets and the balls in a drying machine at the temperature of 30-37 ℃, and coating the tablets and the balls in a coating machine by using the enteric polymer cellulose solution to obtain a finished product. The food is eaten before meals three times a day, and 1-5 tablets/tablet are eaten each time; the shelf life is 18 months when stored at 5 ℃ and more than 6 months when stored at 25 ℃.

Claims (1)

1. A preparation for preventing and treating critical hyperuricemia, hyperuricemia and gout and a preparation method thereof are characterized by comprising enteric materials, protein digestive enzyme, alkaline elements, activators, blood-cleaning agents, coenzymes, finished product processes and a using and storing method, and the preparation method comprises the following specific operation steps:
(1) the enteric material is enteric polymer cellulose solution and finished enteric capsule shell;
(2) the protein digestive enzyme is alkaline protein digestive enzyme with the activity of 1-200 ten thousand u/g;
(3) the alkaline elements are phosphoric acid buffer pairs of dipotassium hydrogen phosphate and monopotassium phosphate with the pH value of 7.1-9.0, and carbonic acid buffer pairs of sodium carbonate and sodium bicarbonate with the pH value of 7.1-9.0;
(4) the activator is organic trace elements of magnesium, manganese, copper, selenium, germanium, potassium and zinc;
(5) a blood clearing agent which is a trace element of organic germanium 132;
(6) a coenzyme which is vitamin B6;
(7) finished product production process
① Capsule for infusion
Mixing alkaline protease, phosphoric acid buffer pairs of dipotassium hydrogen phosphate and potassium dihydrogen phosphate, wherein the pH value of the phosphoric acid buffer pairs is 7.1-9.0, the weight of the phosphoric acid buffer pairs is 10-70%, adding an enteric polymer cellulose solution, mixing uniformly, and putting the mixture into a spray dryer to form yellow brown particles for later use; mixing 0.001-2.0% of vitamin B6, 0.001-0.5% of organic magnesium, manganese, copper, selenium, zinc and potassium and 0.001-1.0% of organic germanium element by weight of alkaline protease in a mixer, adding enteric polymer cellulose solution, mixing uniformly, and adding into a spray dryer to obtain white particles for later use; uniformly mixing the yellow brown particles and the white particles in a mixing machine according to the proportion of 1: 1-6, and filling enteric-coated capsules to obtain finished products;
② food product
Adding alkaline protease, sodium carbonate with pH of 7.1-9.0 and 10-70% of the weight of the alkaline protease and sodium bicarbonate into a mixing machine for uniformly mixing, adding an enteric polymer cellulose solution for wetting and uniformly mixing, preparing into yellow brown small particles by a granulator, and drying in a dryer at 25-30 ℃ for later use; vitamin B6 accounting for 0.001-2.0% of the weight of the alkaline protease, organic magnesium, manganese, copper, selenium, zinc and potassium which account for 0.001-0.5% of the weight of the alkaline protease and organic germanium which accounts for 0.001-1.0% of the weight of the alkaline protease are added into a mixer to be mixed uniformly, an enteric polymer cellulose solution is added to be wetted and mixed uniformly, white small particles are prepared by a granulator, and the white small particles are dried in a dryer at 35-55 ℃ for standby; uniformly mixing the yellow brown and the white small particles in a mixing machine according to the proportion of 1: 1-6, adding the enteric polymer cellulose solution to wet and uniformly mix, making the yellow brown and the white small particles into tablets and balls by using a tablet making machine and a pill making machine, drying the tablets and the balls in a drying machine at the temperature of 30-37 ℃, and coating the tablets and the balls in a coating machine by using the enteric polymer cellulose solution to obtain a finished product;
(8) method of use and storage
The capsules are taken before meals three times a day, and 1-5 capsules are taken each time; the food is eaten before meals three times a day, and 1-5 tablets/granule is eaten each time; the capsule and food can be stored at 5 deg.C for 18 months, and at 25 deg.C for more than 6 months.
CN201811098278.1A 2018-09-07 2018-09-07 Preparation for preventing and treating critical hyperuricemia, hyperuricemia and gout and preparation method thereof Withdrawn CN110882393A (en)

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