CN1081032C - Medicinal preparation containing saccharin zinc - Google Patents
Medicinal preparation containing saccharin zinc Download PDFInfo
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- CN1081032C CN1081032C CN96122388A CN96122388A CN1081032C CN 1081032 C CN1081032 C CN 1081032C CN 96122388 A CN96122388 A CN 96122388A CN 96122388 A CN96122388 A CN 96122388A CN 1081032 C CN1081032 C CN 1081032C
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- zinc
- saccharin
- saccharin zinc
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Abstract
The present invention relates to a medicinal preparation containing saccharin zinc, which comprises oral tablets, capsules, granules, oral liquid, external medicinal powder, ointments and eye drops. The present invention is characterized in that the saccharin zinc is mixed into solid substrates or is dissolved into water solutions, and the solid substrates are selected from usual excipients, such as diluting agents, wetting agents, adhesive agents, disintegrating agents, etc. The oral saccharin zinc preparation can be used for treating and/or preventing obesity, epidemic (viral) common cold and various disease symptoms caused by the lack of zinc of the body.
Description
The present invention relates to a kind of pharmaceutical preparation that contains saccharin zinc, comprise the oral tablet, capsule, granule, the oral liquid that contain saccharin zinc, and the powder of external, ointment, eye drop.
Usually the zinc supplement medicament as anti-zinc deficiency treatment is zinc sulfate oral liquid and zinc gluconate granule.But because zinc sulfate and zinc gluconate all have the metallic taste of tasting bad, when making oral zinc supplement medicament, must add sweeting agent, antiseptic, flavoring agent can.As " Pharmacopoeia of People's Republic of China in 1995 version two ones " record: preparation 1000ml zinc sulfate oral administration solution, its prescription is: zinc sulfate 2g, citric acid 1g, sucrose 300g, antiseptic is an amount of, flavoring agent is an amount of, water is an amount of.Even so still exist the not good enough defective of mouthfeel, and, simultaneously, also gone bad by microbial contamination easily because of the additive compatibility produces certain toxic and side effects.
The object of the present invention is to provide a kind of pharmaceutical preparation that contains saccharin zinc, comprise oral tablet, capsule, granule, oral liquid, and the powder of external, ointment, eye drop.
The chemical name of saccharin zinc is: an adjacent benzoyl sulfimide zinc is a kind of organic zinc compound, also is the zinc salt of glucide, dissociates into glucide root and zinc ion after water-soluble.The crystalline molecular formula of saccharin zinc is C
14H
8N
2O
6S
2Zn6H
2O contains element zinc 12.5%, becomes anhydrous saccharin zinc C after the oven dry dehydration
14H
8N
2O
6S
2Zn contains element zinc 15.2%, and medicinal saccharin zinc can directly use 60-120 purpose saccharin zinc crystallite.Explanation about saccharin zinc sees " saccharin zinc and production technology thereof " (number of patent application: 95104822.8 for details; Publication number: CN1122336A).
Saccharin zinc is lighter to GI irritation.After saccharin zinc dissociated in human body, zinc ion can be by duodenum and little intestinal absorption, and was few from gastrointestinal absorption, go into blood after the overwhelming majority combine with serum albumin; Mainly discharged by feces, trace is discharged by urine, antiperspirant, desquamation, alopecia and seminal fluid.
Glucide can not be utilized in vivo, and is most of with the urine discharge, and do not damage renal function, do not change body endoenzyme system activity, also do not influence the utilization of vitamin.The World Health Organization (WHO) and FAO (Food and Agriculture Organization of the United Nation) (FAO) think that all glucide is safe at present artificial sweetening agent, but, for the purpose of prudent, stipulated that still every day, everyone consumption should not surpass the 5mg/kg body weight, can use the 5-10mg/kg body weight in the Diet Therapy.
Pharmacodynamic study shows, zinc participates in the synthetic of plurality of enzymes (as carbonic anhydrase, DNA and RNA polymerase, lactic acid dehydrogenase, thymidine kinase, alkali phosphatase, pancreas peptidase or the like) and activates, to protein, synthetic, the proteic performance important physiological function of assimilating of intestinal of nucleic acid, promote growth promoter; By to the synthetic of gustin in the taste bud and prevent buccal mucosa epithelial cell parakeratosis, keep the normal appetite and the sense of taste, strengthen the phagocyte phagocytic activity, chemotactic vigor and sterilizing ability; And by free radical level in the sudismase maintenance phagocyte, the cell membrane of free radical energy destroy microorganisms, performance bactericidal action, acceleration of wound, burn, ulcer healing; Metabolism and vision to vitamin A play an important role; Promote and the maintenance function; Stabilizing cell membrane improves and organizes energy metabolism and Tissue respiration; Can improve the lower extremity blood flow perfusion as zinc supplement, reduce the lactic acid savings, be the biochemical basis of treatment intermittent claudication; Zinc ion energy precipitating proteins, external has the convergence antisepsis, helps granulation tissue to form.
Zinc can enhancing body immune function, strengthen the phagocyte phagocytic activity, chemotactic vigor and sterilizing function, popularity (viral) flu can be treated and prevent to zinc supplement, one of Main Ingredients and Appearance of anti-flu new drug " compound paracetamol and zinc gluconate tablets " is exactly a zinc salt.The saccharin zinc oral formulations can be given human body complementary element zinc, and it not only can be used for the treatment of zinc deficiency, also can be as the treatment of flu.
Saccharin zinc has the sweet taste of good mouthfeel, and its sugariness is about 500 times of sugar.And chemical property is stable, when being used to make pharmaceutical preparation, need not add sugar sweetener, flavoring agent (certainly interpolation again, but it is unnecessary), do not add or reduce the addition of antiseptic, thereby reduce the toxic and side effects that produces because of the additive compatibility, also more difficultly gone bad, be beneficial to the shelf-life that prolongs medicament by microbial contamination.Saccharin zinc can replace zinc sulfate and zinc gluconate, it is a kind of good medicinal zinc supplement agent, it can be used for the treatment of and/or prevent obesity, popular (viral) flu, and the inappetence, anemia, growth retardation, nutritional dwarf, acrodermatitis enteropathica, rheumatoid arthritis, intermittent claudication, hepatolenticular degeneration (be applicable to and use penicillamine person), acne (acne), casual ulcer, conjunctivitis, the aphtha that cause because of the body zinc deficiency.
People eat the too many sweet food that contains sugar at ordinary times can make blood glucose increase, and causes the fat accumulation and causes body obesity.Take the saccharin zinc oral formulations and can quicken the human body metabolism, raise libido, and make people anorexia glucide and minimizing sugar intake gradually, thereby reach fat-reducing effect.The saccharin zinc oral formulations is during as the anti-obesity drug use, is preferably in to take with a large amount of boiled water (generally more than 500ml, The more the better) ante cibum or take after mixing it with water, and fasting outside three meals in a day.Saccharin zinc and boiled water are beneficial to body intracellular metabolic and steatolysis.
When making contains oral tablet, capsule, granule (electuary), the oral liquid of saccharin zinc, also can add calcium salt (as calcium sulfate), iodine salt (as potassium iodate or potassium iodide), thereby can become the pharmaceutical preparation that contains various trace elements.Saccharin zinc also can only be used in the pharmaceutical preparation as sweeting agent.
The solid preparation that contains saccharin zinc provided by the invention comprises oral tablet, capsule, granule (electuary), external pulvis (conspergative), ointment, the liquid preparation that contains saccharin zinc comprises oral liquid and eye drop, wherein solid preparation is that saccharin zinc is blended in a kind of solid matrix, this solid matrix is selected from the usual excipients of diluent, lubricant, binding agent, disintegrating agent and so on, and excipient is the pharmaceutical aids that is used for the raw material principal agent is made certain dosage form; Liquid preparation is that saccharin zinc is dissolved in the aqueous solution, and institute's water is a purified water, is meant filtered distilled water, deionized water or boiled water.With the tablet that saccharin zinc makes as zinc supplement agent or sweeting agent, it is 0.01-0.9g that every g contains the saccharin zinc general quantity, is preferably 0.2-0.6g; The general content of saccharin zinc is 0.01-0.2g in every of the capsule that makes, and is preferably 0.04-0.1g, and 0.04g, 0.08g and 0.1g are typically arranged; The general content of saccharin zinc is 1-20mg among the every g of the granule that makes (electuary), is preferably 2-10mg; The general content of saccharin zinc is 1-50mg in every milliliter of the oral liquid that makes, and is preferably every milliliter and contains 4-10mg; The content of saccharin zinc is 0.01-0.5g among the every g of the powder that makes (conspergative), is preferably 0.05-0.35g; The general content of saccharin zinc is 0.01-0.5g among the every g of the ointment that makes, and is preferably 0.05-0.2g; The eye drop that makes, the general content of saccharin zinc is 1-20mg in every milliliter, is preferably 2-10mg.
Capsule of the present invention be meant a certain amount of saccharin zinc added adjuvant or do not add adjuvant after making powder or granule filling in Capsules and the pharmaceutical preparation of making.Capsules is to add the rubber-like two pitch circle tubes that adjuvant is made by gelatin or other suitable medicinal materials (as methylcellulose, calcium alginate), and can tight mutually fit.
Diluent (or filler) be when medicine because of dosage too small so that make that certain dosage form adds when having any problem in order to increase the excipient of unit formulation (for example 1,1,1 bag) volume.The suitable diluents that the present invention selects for use is starch and/or dextrin, and also available diluent comprises lactose, mannitol, Sorbitol, cellulose, xylitol, dextrose, fructose, calcium sulfate, aluminium hydroxide, polyvinyl alcohol butyraldehyde, sucrose and composition thereof.
Wetting agent itself is inviscid, but it is energy moistening medicated powder, inspires the excipient of the viscosity of medicated powder own.The suitable wetting agent that the present invention is suitable for is distilled water or ethanol.Wetting agent vapors away when preparation is dried, so not as the composition of preparation.
Binding agent is to be used for making granule to have the excipient of viscosity, to make the more stable dosage unit of physical characteristic, comprise that microcrystalline Cellulose, starch slurry, syrup, maltose, crystallite glucose, sodium carboxymethyl cellulose, Mel, carboxymethyl dextran sodium, dextrin for basic binding agent, are used for binding agent preferably microcrystalline cellulose of the present invention or starch slurry.Binding agent generally accounts for 0.5% to 30% of the resulting solid preparation weight that contains saccharin zinc.
Disintegrating agent is to be added to make it take back easy disintegrate and the material of stripping or mixture of this material in gastrointestinal tract in the tablet, and generally this class material is dried starch, carboxymethyl starch, hydrocellulose, starch ethoxy acid sodium, carboxyl starch propionate.Preferred use is dried starch among the present invention.Disintegrating agent generally accounts for 5% to 50% of prepared particle weight, and preferred 5% to 20%.
The used lubricant of conventional method is to improve the tablet and powder turnover rate, prevents that the tabletting material is bonded at punch die and press surface, reduces intergranular friction, and helps the excipient that tablet is discharged the punch die groove.Lubricant commonly used is Pulvis Talci, magnesium stearate, liquid Paraffin, Stepanol MG, long-chain fatty acid, stearic acid.Be used for lubricant preferably talc powder of the present invention.Lubricant generally account for resulting granules heavy 0.25% to 10%.
Ointment base is the excipient that makes ointment have certain denseness, cohesiveness and stretchability, comprises greasing bases such as hydro carbons, lipoid, animal oil, Vegetable oil lipoprotein, as vaseline, lanoline; Water-soluble base is as methylcellulose, Mel, sodium carboxymethyl cellulose, glycerol, gelatin; Emulsion-type substrate.Be applicable to preferred vaseline of ointment base of the present invention and/or lanoline.Ointment base can account for 50% to 95% of ointment Unit Weight.
It also is admissible using other typical additives or other excipient such as coloring agent, stabilizing agent or antioxidant, but this is inessential.
Because saccharin zinc solution is more stable when pH value is 5.0 left and right sides, when pH value reaches 7.0 when above, produce the emulsus zinc hydroxide and precipitate, therefore, should add the pH value regulator, be controlled to be 4.5-6.0 so that contain the pH value of the liquid preparation of saccharin zinc.PH value regulator commonly used comprises boric acid, citric acid, citric acid, gluconic acid, hydrochloric acid, sulphuric acid.Among the present invention, the oral liquid that contains saccharin zinc preferably uses citric acid, citric acid; The eye drop that contains saccharin zinc preferably uses boric acid.
Solid-based mass-energy of the present invention is made into tablet, capsule, granule, powder or ointment etc., this technology is known in the prior art, and be disclosed in " pharmaceutics " and (pass the good fortune chief editor by what, the People's Health Publisher publishes, November in 1986 the 1st edition) 22-30 page or leaf, 39-40 page or leaf, 167-176 page or leaf, and 215-216 page or leaf.
The general chemistry method of inspection of saccharin zinc preparation is as follows:
One, differentiate:
1, gets saccharin zinc solid preparation 0.2g, add the 10ml distilled water; If granule is then got 10g, add the 20ml distilled water.Add 1 of dilute hydrochloric acid, shook 10 minutes, filter.Get filtrate or directly get saccharin zinc liquid preparation 10ml, add potassium ferrocyanide test solution 4-6 and drip, generate white precipitate, separate, this white precipitate is insoluble to dilute hydrochloric acid, thus, and the existence of provable zinc.
2, get saccharin zinc solid preparation 0.2g, add the 10ml distilled water; If granule is then got 5g, add the 20ml distilled water.Add 1 of dilute hydrochloric acid, shook 10 minutes, filter.Get filtrate or get saccharin zinc liquid preparation 5ml and place little flask low baking temperature heating, evaporated under reduced pressure moisture, add 40mg resorcinol, 0.5ml concentrated sulphuric acid, low baking temperature is heated to reactant liquor and is bottle green, cool, add the 10ml distilled water, liquid is brownish red, sodium hydroxide (NaOH) solution that adds 100ml4% then is formed with the liquid of green fluorescence.The existence of provable glucide thus.
Two, assay:
Get saccharin zinc solid preparation 1g, if granule is then got 20g.Precision weighing, adding distil water 100ml, 2 of dilute hydrochloric acid shook 10 minutes, filtered.Get filtrate or directly get saccharin zinc liquid preparation 50ml, delicate metering adds NH
3-NH
4Cl buffer solution (pH=10.0) 10ml adds 3 of chromium black T indicators, and with the EDTA standard solution titration of 0.05M, every 1mlEDTA standard solution is equivalent to 26.89mg saccharin zinc crystal C
14H
8N
2O
6S
2Zn6H
2O.If use gel aluminum hydroxide, then be not suitable for this determination in the saccharin zinc buccal sheet.
Except that carrying out chemical analysis, the pharmaceutical preparation that contains saccharin zinc also should be tested by the rules of preparations of Chinese Pharmacopoeia regulation.
With the following example the present invention is described in further detail.
Embodiment 1:
Get dried starch 200g, place under 105 ℃ of temperature dry 1 hour, standby.Get saccharin zinc crystallite 800g, cross 80 mesh sieve, be mixed together evenly with 350g microcrystalline Cellulose, 100g Pulvis Talci, the standby dried starch of 150g then, cross twice of 40 mesh sieve, through after the assay was approved, adopt the direct compression process known technology, be pressed into 10000 oral tablets.
This tablet is a white tablets, and it is sweet to distinguish the flavor of.Every contains saccharin zinc 80mg, contains the about 10mg of element zinc.Wherein, dried starch is diluent, disintegrating agent, and Pulvis Talci is a lubricant, and microcrystalline Cellulose is dilution, bonding, fluidizer, disintegrating agent.
Embodiment 2:
Get dried starch 1500g, placed under 105 ℃ of temperature dry 1 hour, cross 120 mesh sieves, standby.With 100 order saccharin zinc 1000g and standby dried starch 1200g mix homogeneously, cross 100 mesh sieves twice, abundant mix homogeneously, equivalent branch are packed in the Capsules, and every capsules 0.22g powder of packing into promptly makes 10000 capsules.Every capsules contains saccharin zinc 100mg, contains the about 12.5mg of element zinc.
Embodiment 3:
Get 100g saccharin zinc crystallite; the 20g citric acid; the 10kg dextrin; cross sieve twice No. three, mix homogeneously is put into mixer with blended powder; spray into the Diluted Alcohol of 1500ml50% while stirring; stir the soft material of making " that holds is agglomerating, and that presses promptly looses " in 15 minutes, soft material is joined in the granulation machine granulate.Wet grain is dried under 80 ℃ of temperature, and the dry granular gross weight 10.2kg of drying removes coarse grain with a sieve sieve then, and No. four sieve sieves of reuse remove particulate or fine powder.The fine powder that sifts out adds an amount of Diluted Alcohol granulates again, screening again after the coarse grain that sifts out is suitably smashed to pieces.Sieve suitable particles agent well is distributed into 1000 bags through after the assay was approved with lucifuge non-toxic plastic bag equivalent, and sealing is preserved.This granule (electuary) is a white particle, and it is sweet to distinguish the flavor of, and every bag of net weight 10.2g contains saccharin zinc 100mg, contains the about 12.5mg of element zinc.
Each just before the meal with 2 glasss of boiled water, the 2 bags of granules of taking after mixing it with water, can treat acne diseases such as (being commonly called as comedo, acne) because of zinc deficiency causes, but also treatment of obesity, and make people's anorexia glucide gradually, especially more suitable to the obesity that causes because of diabetes.
Embodiment 4:
Get the 400ml distilled water, boil, add citric acid 2g, saccharin zinc 4g successively, make dissolving, put coldly, filter, add sterile purified water on the inherent filtration device, make 1000ml saccharin zinc mixture (oral liquid), pack in the brown ampoule for the unit branch with 10ml, sealing is preserved.This product is no clear solution, and it is sweet to distinguish the flavor of, pH=5, and every ampoule oral liquid contains saccharin zinc 40mg, contains element zinc 5mg.
Embodiment 5:
Earlier with after 20g Oleum menthae and the 20g Camphora grinding liquefaction, adding a small amount of Pulvis Talci of 100g grinds well, again 60g salicylic acid, 100g undecylenic acid, 300g saccharin zinc crystallite were sieved with No. seven, mix homogeneously, together lapping-in is even with Oleum menthae, Camphora, and is last, adds the 400g Pulvis Talci one by one to 1000g, cross the sieve mix homogeneously No. seven, promptly get 1000g30% saccharin zinc conspergative (being powder).
This conspergative is a white powder, but the external spreading has antipruritic, moisture absorption, convergence and mildew making effect.Wherein Oleum menthae, Camphora are dispelling wind, heat-clearing formula, and Pulvis Talci is lubricant, diluent, and salicylic acid and undecylenic acid are disinfectant, and saccharin zinc is the convergence antiseptic.
Embodiment 6:
700g white vaseline heating in water bath is melted, divide and get about 100g fusion white vaseline, add 150g saccharin zinc, 50g undecylenic acid, 100g lanoline and 1g ethylparaben, grind well, gradually add remaining 600g fusion white vaseline again, be stirred to condensation, promptly get 1000g15% white saccharin zinc ointment.Wherein ethylparaben is an antibacterial, is gone bad by germ contamination in order to prevent lanoline.
Glucide is a sulfimide class material, and zinc has bacteriostasis because of the dna structure that can destroy antibacterial.Zinc is lost in a large number in fire victim's body, use saccharin zinc ointment can compensate the zinc loss, thereby the ability of wound healing is infected and promotes in the enhancing body opposing.Saccharin zinc ointment can be used for fresh wound surface due to treatment burn, the wound, chronic ulcer, skin fungus disease, tinea pedis.
Embodiment 7:
Get 80ml aseptic distillation water boil, add 1.9g boric acid, 0.03g ethylparaben (antibacterial) and 0.5g saccharin zinc crystal successively, make molten, put cold, fine straining adds sterile purified water to 100ml on the inherent filtration device, and is aseptic subpackaged, in 100 ℃ of circulation steam sterilizations 30 minutes, promptly get 0.5% saccharin zinc eye drop.This eye drop is a colourless transparent solution, and pH=5.0 can be used for treating conjunctivitis.
Clinical application effect:
L, employing tablet of the present invention are treated 18 routine influenza patients.Patient's onset is anxious, and General Symptoms is heavier, fear of cold, and hyperpyrexia, headache, weak, systemic pain, and slight respiratory tract mucositis symptom appears: pharyngalgia, watery nasal discharge, sneeze, dry cough.Allow the patient take to contain the tablet of saccharin zinc, each 2 (every contains saccharin zinc 80mg) every days three times are after meal with warm water delivery service.After 6 days as a result, 11 routine produce effects, symptom all disappears; 2 examples take a turn for the better, and cardinal symptom disappears; 5 examples are invalid, and cardinal symptom does not have improvement.Effective percentage is 72.2%.
2, adopt capsule of the present invention that 11 routine facial acne (acne) patients are treated.Patient's face has blackhead and reddish tone acne.Allow the patient take to contain the capsule of saccharin zinc, each 2 (every contains saccharin zinc 100mg) every days three times are after meal with warm water delivery service.After 6 days as a result, 8 patient's face acnes all disappear, and 2 patient's acne quantity reduce, and 1 patient is invalid.Effective percentage is 90.9%.
3, adopt granule of the present invention that 5 routine obesity index are treated described obesity index=body weight (kg) ÷ height greater than 24 obesity patient
2(m
2).These 5 obesity patient's body weight are respectively 74kg, 82kg, and 78.5kg, 76.5kg, 82kg, their height is respectively 1.69m, 1.75m, 1.74m, 1.71m, 1.725m.Allow the patient take to contain the granule (electuary) of saccharin zinc, each 2 bags (every bag contains saccharin zinc 100mg) every days three times, take after mixing it with water with 600-1000ml boiled water ante cibum, only allows every day to eat early, middle and late breakfast, lunch and dinner, mustn't take food outside the breakfast, lunch and dinner.After 30 days as a result, 5 weight in patients are respectively 69.5kg, 78kg, 72kg, 74.5kg, 79kg.Tachypnea alleviates after 5 patient's activities in addition, and libido is more preceding vigorous.
Claims (2)
1, the application of saccharin zinc in the preparation Retinoids, Retin-A, Renova, Accutane.
2, the application of saccharin zinc in preparation treatment of obesity medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96122388A CN1081032C (en) | 1996-12-19 | 1996-12-19 | Medicinal preparation containing saccharin zinc |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96122388A CN1081032C (en) | 1996-12-19 | 1996-12-19 | Medicinal preparation containing saccharin zinc |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1185316A CN1185316A (en) | 1998-06-24 |
| CN1081032C true CN1081032C (en) | 2002-03-20 |
Family
ID=5127315
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN96122388A Expired - Fee Related CN1081032C (en) | 1996-12-19 | 1996-12-19 | Medicinal preparation containing saccharin zinc |
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|---|---|
| CN (1) | CN1081032C (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101961321B (en) * | 2010-09-17 | 2012-03-28 | 山东司邦得制药有限公司 | Zinc gluconate sugar tablet preparation and preparation method thereof |
| US10799530B1 (en) * | 2019-12-20 | 2020-10-13 | Vector Vitale Ip Llc | Composition and method for the prevention and treatment of obesity |
| AU2019479023A1 (en) | 2019-12-20 | 2022-07-14 | Vector Vitale Ip Llc | Composition and method for the prevention and treatment of obesity |
| DK180598B1 (en) * | 2020-02-21 | 2021-10-14 | Sander Wilbek Theis | Starch propanoate used as an additive and / or dietary supplement for humans for the prevention of overweight and obesity |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1122336A (en) * | 1995-04-29 | 1996-05-15 | 张卫民 | Saccharin zinc and its producing process |
-
1996
- 1996-12-19 CN CN96122388A patent/CN1081032C/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1122336A (en) * | 1995-04-29 | 1996-05-15 | 张卫民 | Saccharin zinc and its producing process |
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| CN1185316A (en) | 1998-06-24 |
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