CN113244183A - Inosine oral instant tablet and preparation method thereof - Google Patents
Inosine oral instant tablet and preparation method thereof Download PDFInfo
- Publication number
- CN113244183A CN113244183A CN202110633120.5A CN202110633120A CN113244183A CN 113244183 A CN113244183 A CN 113244183A CN 202110633120 A CN202110633120 A CN 202110633120A CN 113244183 A CN113244183 A CN 113244183A
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- Prior art keywords
- inosine
- percent
- agent
- orally
- tablet according
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- UGQMRVRMYYASKQ-KQYNXXCUSA-N Inosine Chemical compound O[C@@H]1[C@H](O)[C@@H](CO)O[C@H]1N1C2=NC=NC(O)=C2N=C1 UGQMRVRMYYASKQ-KQYNXXCUSA-N 0.000 title claims abstract description 56
- 229960003786 inosine Drugs 0.000 title claims abstract description 56
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
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Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
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Abstract
The invention discloses an inosine oral instant tablet, which comprises the following components in percentage by weight: inosine accounts for 30-60%; 40-70% of medicinal auxiliary materials; wherein, the pharmaceutic adjuvant comprises 5 to 10 percent of disintegrant, 0.5 to 10 percent of effervescent agent, 0 to 5 percent of adhesive, 1 to 5 percent of lubricant, 1 to 2 percent of flavoring agent and the balance of filler; the preparation is 50-400 mg. A preparation method of an inosine oral instant tablet comprises the following steps: pulverizing inosine, sieving with 100-150 mesh sieve, sieving with 50-80 mesh sieve, and respectively storing; step 2: weighing inosine, a filling agent, a disintegrating agent, a flavoring agent and an alkaline effervescent agent according to the prescription amount, and fully and uniformly mixing; and step 3: granulating the above uniformly mixed components by wet method, drying at 40-80 deg.C, and grading; and 4, step 4: adding acidic effervescent agent and lubricant into the above granules, and mixing completely; and 5: and (6) tabletting.
Description
Technical Field
The invention relates to an inosine oral instant tablet.
The invention also relates to a preparation method of the inosine oral instant tablet.
Background
Inosine is used as a cofactor drug. Inosine is a component of ATP, coenzyme A, ribonucleic acid and deoxyribonucleic acid in the body and is involved in substance metabolism and energy metabolism of the body. It can raise ATP level of body, convert it into several nucleotides and participate in protein synthesis. Inosine has good permeability on cell membranes, can directly enter cells, is converted into nucleotide, is further converted into ATP to participate in metabolism, has the effects of promoting recovery of liver cells and preventing fatty liver, can improve the activity of various enzymes, and stimulates an organism to generate antibodies. Inosine can be used as an auxiliary liver protection medicine when liver function is abnormal due to acute and chronic hepatitis and liver cirrhosis, and can also be used for rescuing hepatic coma.
At present, inosine is available in the market for preparing tablets, capsules, oral solution and injection. The standard is 200mg at most. Tablets and capsules need a large amount of drinking water for taking, and oral liquid is inconvenient to carry and injection is inconvenient to apply.
The instant buccal tablet can disintegrate and dissolve rapidly in short time after contacting with saliva, so that the medicine is in liquid state and enters stomach from esophagus with swallowing action. The oral fast dissolving tablets are generally prepared by the following process: (1) and (3) a freeze drying process: the process is mature, the clinical effect of the product is ideal, but the cost is high, large-scale freeze drying equipment is needed, the production period is long, the uniformity of gaps of the product is poor, the bad taste of the medicine cannot be effectively covered, and the conditions are strictly controlled in the preparation process; (2) the solid solution technology has the advantages that the strength of the tablet is improved compared with that of a freeze-dried tablet, the gap is uniform, the selection of a solvent and a medicament is limited to a certain extent, the cost is high, and most of the medicaments are added after a skeleton is formed; (3) the spray drying process comprises the following steps: the tablet has high strength and good integrity, but the drug selection has a certain range, the auxiliary material range is limited, and the process is more complex; (4) the direct tabletting process comprises the following steps: low cost and simple preparation, and has the defects that the dosage of the medicine cannot be overlarge and the fluidity of auxiliary materials needs to be controlled.
From the above, it is known that, since inosine has a large size, it is difficult to prepare an orally-dissolvable tablet by a direct tabletting method, and problems such as taste masking of inosine and improvement of solubility of inosine are also considered.
Therefore, the preparation of inosine orally-soluble tablets by a direct tabletting method is difficult.
Disclosure of Invention
In order to solve the technical problems, the invention provides an inosine oral instant tablet.
The invention also provides a preparation method of the inosine oral instant tablet. The prepared inosine can be rapidly disintegrated, released and shield bad taste.
The invention provides the following technical scheme:
an oral instant inosine tablet comprises a main drug inosine and pharmaceutical excipients, and comprises the following components in percentage by weight:
inosine accounts for 30-60%;
40-70% of medicinal auxiliary materials;
wherein, the pharmaceutic adjuvant comprises 5 to 10 percent of disintegrant, 0.5 to 10 percent of effervescent agent, 0 to 5 percent of adhesive, 1 to 5 percent of lubricant, 1 to 2 percent of flavoring agent and the balance of filler; the preparation is 50-400 mg.
Further, the preparation size is 200 mg.
The key of the oral instant tablet is the disintegration and dissolution speed in water, so the selection of a disintegrant system in the tablet is very important, and the selected disintegrant comprises one or more of sodium carboxymethyl starch (CMS-Na), cross-linked sodium carboxymethyl starch (CCNa), low-substituted hydroxypropyl cellulose (L-HPC) and cross-linked polyvinylpyrrolidone (PVPP).
The filler is used for increasing the weight and the volume of the tablet and is beneficial to forming, and the filler of the oral instant tablet comprises one or more of lactose, sucrose, mannitol, sorbitol, maltose and pregelatinized starch.
The adhesive of the oral instant tablet comprises water or alcohol solution of one or more auxiliary materials of polyvinylpyrrolidone (PVP), hydroxypropyl cellulose and hydroxypropyl methyl cellulose, and can also be directly used with water or ethanol solution with different concentrations.
The lubricant used by the oral instant tablet comprises one or more of magnesium stearate, calcium stearate, polyethylene glycol, silicon dioxide, superfine silica powder, talcum powder, lauryl magnesium sulfate, lauryl sodium sulfate, sodium stearyl fumarate and glyceryl behenate.
The flavoring agent used in the invention comprises one or more of aspartame, glycyrrhizin, stevioside, saccharin sodium and medicinal essence.
The alkaline effervescent agent in the effervescent agent comprises one or more of sodium bicarbonate, potassium bicarbonate, sodium carbonate, potassium carbonate, calcium carbonate and magnesium carbonate.
The acidic effervescent agent in the effervescent agent comprises one or more of citric acid, tartaric acid, potassium hydrogen tartrate and malic acid.
Compared with the prior art, the invention has the beneficial effects that: the oral instant tablet prepared by the tabletting method has high content of main drugs, good taste, no obvious bad taste, convenient taking and good compliance of patients.
A preparation method of an inosine oral instant tablet comprises the following steps:
step 1: pulverizing inosine, sieving with 100-150 mesh sieve, sieving with 50-80 mesh sieve, and respectively storing;
step 2: weighing inosine, a filling agent, a disintegrating agent, a flavoring agent and an alkaline effervescent agent according to the prescription amount, and fully and uniformly mixing;
and step 3: granulating the above uniformly mixed components by wet method, drying at 40-80 deg.C, and grading;
and 4, step 4: adding acidic effervescent agent and lubricant into the above granules, and mixing completely;
and 5: and (6) tabletting.
The inosine oral instant tablet related by the invention is convenient to take and good in taste, can be quickly disintegrated and dissolved when meeting saliva in the oral cavity, and provides convenience for the old, children or patients with swallowing medicine obstacle and inconvenient water taking.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
The weight percentage content of the prescription
30% of inosine;
8% of crosslinked polyvinylpyrrolidone;
1% of sodium bicarbonate;
0.5 percent of citric acid;
0.5% of magnesium stearate;
4% of micropowder silica gel;
0.5 percent of aspartame;
0.5% of orange essence;
the remainder being mannitol to 100%.
The preparation method comprises the following steps:
pulverizing inosine, sieving with 100 mesh sieve, sieving adjuvants with 50 mesh sieve, mixing inosine, mannitol, crosslinked polyvinylpyrrolidone, etc., adding magnesium stearate and silica gel micropowder, mixing, and directly tabletting.
Example 2:
the weight percentage content of the prescription
Inosine 40 percent;
10% of crosslinked polyvinylpyrrolidone;
1% of sodium bicarbonate;
1% of citric acid;
0.5% of magnesium stearate;
1% of silica gel micropowder;
1% of aspartame;
0.5% of orange essence;
the remainder being mannitol to 100%.
The preparation method comprises the following steps:
pulverizing inosine, sieving with 150 mesh sieve, sieving adjuvants with 80 mesh sieve, mixing 50% inosine, mannitol, sorbitol, aspartame, fructus Citri Tangerinae essence, crosslinked polyvinylpyrrolidone and sodium bicarbonate, making into soft material with PVP anhydrous ethanol solution, sieving with 20 mesh sieve, granulating, and oven drying at 40 deg.C; and mixing the other 50% of the main and auxiliary materials and citric acid uniformly, adding absolute ethyl alcohol solution of PVP to prepare soft material, sieving with a 20-mesh sieve for granulation, drying at 40 ℃, mixing the two parts of granules uniformly after granulation, adding magnesium stearate and aerosil, mixing uniformly and tabletting.
Example 3:
the weight percentage content of the prescription
50% of inosine;
5% of sodium carboxymethyl starch;
10% of sodium bicarbonate;
10% of citric acid;
0.5% of magnesium stearate;
1.5 percent of micro silica gel powder;
1% of stevioside;
1% of orange essence;
the remainder being mannitol to 100%.
A preparation method;
pulverizing inosine, sieving with 100 mesh sieve, sieving adjuvants with 50 mesh sieve, mixing inosine, mannitol, CMS-Na, etc., adding magnesium stearate and silica gel micropowder, mixing, and tabletting.
Example 4:
the weight percentage content of the prescription
30% of inosine;
5% of crosslinked polyvinylpyrrolidone;
1% of sodium bicarbonate;
1% of citric acid;
0.5% of magnesium stearate;
0.5 percent of micro silica gel powder;
0.5 percent of aspartame;
0.5 percent of stevioside;
0.5% of orange essence;
the remainder being mannitol to 100%.
The preparation method comprises the following steps:
pulverizing inosine, sieving with 120 mesh sieve, sieving adjuvants with 80 mesh sieve, mixing inosine, mannitol, aspartame, stevioside, fructus Citri Tangerinae essence, cross-linked polyvinylpyrrolidone and sodium bicarbonate, making into soft material with PVP ethanol solution, sieving with 20 mesh sieve, granulating, and oven drying at 40 deg.C; adding citric acid, magnesium stearate and silica gel micropowder, mixing, and directly tabletting.
Example 5:
the weight percentage content of the prescription
Inosine 60 percent;
6% of crospovidone;
1% of low-substituted hydroxypropyl cellulose;
4% of sodium bicarbonate;
4% of citric acid;
1% of magnesium stearate;
1% of silica gel micropowder;
0.5 percent of aspartame;
1.5% of orange essence;
the remainder being sorbitol to 100%.
A preparation method;
pulverizing inosine, sieving with 120 mesh sieve, sieving adjuvants with 80 mesh sieve, mixing inosine, sorbitol, aspartame, orange essence, crosslinked polyvinylpyrrolidone and citric acid, making into soft material with PVP ethanol solution, sieving with 20 mesh sieve, granulating, and oven drying at 40 deg.C; adding sodium bicarbonate, magnesium stearate and silica gel micropowder, mixing, and directly tabletting.
The performance of each sample piece obtained in the examples was tested:
the sample tablets in each of the above examples all achieved the required disintegration within 1 min.
The orally-dissolving tablet prepared by the tabletting method has high content of main drugs, good taste, no obvious bad taste, convenient taking and good compliance of patients.
The inosine oral instant tablet related by the invention is convenient to take and good in taste, can be quickly disintegrated and dissolved when meeting saliva in the oral cavity, and provides convenience for the old, children or patients with swallowing medicine obstacle and inconvenient water taking.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (9)
1. An inosine oral instant tablet is characterized by comprising the following components in percentage by weight:
inosine accounts for 30-60%;
40-70% of medicinal auxiliary materials;
wherein, the pharmaceutic adjuvant comprises 5 to 10 percent of disintegrant, 0.5 to 10 percent of effervescent agent, 0 to 5 percent of adhesive, 1 to 5 percent of lubricant, 1 to 2 percent of flavoring agent and the balance of filler; the preparation is 50-400 mg.
2. An inosine orally-dissolvable tablet according to claim 1, wherein: the disintegrant comprises one or more of sodium carboxymethyl starch, cross-linked sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, and cross-linked polyvinylpyrrolidone.
3. An inosine orally-dissolvable tablet according to claim 1, wherein: the filler comprises one or more of lactose, sucrose, mannitol, sorbitol, maltose, and pregelatinized starch.
4. An inosine orally-dissolvable tablet according to claim 1, wherein: the adhesive comprises water or alcohol solution of one or more auxiliary materials of polyvinylpyrrolidone (PVP), hydroxypropyl cellulose and hydroxypropyl methyl cellulose, or water or ethanol solution with different concentrations.
5. An inosine orally-dissolvable tablet according to claim 1, wherein: the lubricant comprises one or more of magnesium stearate, calcium stearate, polyethylene glycol, silicon dioxide, superfine silica gel powder, talcum powder, magnesium lauryl sulfate, sodium stearyl fumarate and glyceryl behenate.
6. An inosine orally-dissolvable tablet according to claim 1, wherein: the correctant comprises one or more of aspartame, glycyrrhizin, stevioside, saccharin sodium, and medicinal essence.
7. An inosine orally-dissolvable tablet according to claim 1, wherein: the alkaline effervescent agent in the effervescent agent comprises one or more of sodium bicarbonate, potassium bicarbonate, sodium carbonate, potassium carbonate, calcium carbonate and magnesium carbonate.
8. An inosine orally-dissolvable tablet according to claim 1, wherein: the acidic effervescent agent in the effervescent agent comprises one or more of citric acid, tartaric acid, potassium hydrogen tartrate and malic acid.
9. The method for preparing an inosine orally-dissolvable tablet according to claim 1, wherein the method comprises the steps of:
step 1: pulverizing inosine, sieving with 100-150 mesh sieve, sieving with 50-80 mesh sieve, and respectively storing;
step 2: weighing inosine, a filling agent, a disintegrating agent, a flavoring agent and an alkaline effervescent agent according to the prescription amount, and fully and uniformly mixing;
and step 3: granulating the above uniformly mixed components by wet method, drying at 40-80 deg.C, and grading;
and 4, step 4: adding acidic effervescent agent and lubricant into the above granules, and mixing completely;
and 5: and (6) tabletting.
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| CN202110633120.5A CN113244183A (en) | 2021-06-07 | 2021-06-07 | Inosine oral instant tablet and preparation method thereof |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101829137A (en) * | 2009-03-09 | 2010-09-15 | 北京利乐生制药科技有限公司 | Solid preparation with citicoline sodium and inosine as active ingredients and applications thereof |
| CN102933207A (en) * | 2009-10-30 | 2013-02-13 | Ix生物医药私人有限公司 | Fast dissolving solid dosage form |
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- 2021-06-07 CN CN202110633120.5A patent/CN113244183A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101829137A (en) * | 2009-03-09 | 2010-09-15 | 北京利乐生制药科技有限公司 | Solid preparation with citicoline sodium and inosine as active ingredients and applications thereof |
| CN102933207A (en) * | 2009-10-30 | 2013-02-13 | Ix生物医药私人有限公司 | Fast dissolving solid dosage form |
Non-Patent Citations (1)
| Title |
|---|
| 万东华,周建平: "微泡型口腔速释片的制备", 中国药科大学学报, no. 03, pages 228 - 231 * |
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