Background technology
Vitamin C is that vitamin C supplements medicine, there is the effect that improves immunity, be mainly used in enhancing body resistance, for preventing and treat various acute and chronic infectious diseases or other diseases, for the auxiliary treatment of convalescent period, During Wound Healing and anaphylactic disease after being ill, for prevention and treatment vitamin C deficiency.
Effervescent tablet is a kind of tablet of making taking suitable bronsted lowry acids and bases bronsted lowry as disintegrating agent.Thereby effervescent tablet can dissolve rapidly by generation great amount of carbon dioxide gas after entering water, and drug effect is rapid, and bioavailability is high, easy to carry, therefore developed recently is very fast.
The present existing procucts of vitamin C effervescent tablet are for clinical.But there are some shortcomings in vitamin C effervescent tablet prepared by prior art: 1) the usually long clinical use that is unfavorable for this kind of disintegration time of effervescent tablet; 2) vitamin C principal agent is unstable; 3) weight differential is large etc.Therefore, need to improve for vitamin C fizzy tablet recipe and preparation technology, thereby develop a kind of vitamin C effervescent tablet and preparation technology thereof that can overcome above shortcoming.
The object of this invention is to provide vitamin C effervescent tablet of a kind of quality improvement and preparation method thereof.Compared with the vitamin C effervescent tablet of the present invention tablet known with prior art, there is the advantages such as disintegrate is fast, principal agent vitamin C is more stable, weight differential is little, can provide more stable, effective, safe product for patient.
Summary of the invention
The invention provides a kind of vitamin C effervescent tablet, it is characterized in that: utilize water soluble starch as lubricant.Water soluble starch is through superfine powder technical finesse.
The invention provides a kind of vitamin C fizzy piece preparation method, wherein principal agent vitamin C is 10:1 with the amount ratio of water soluble starch.
The invention provides a kind of preferred vitamin C fizzy piece preparation method, wherein principal agent vitamin C is 5:1 with the amount ratio of water soluble starch.
Water soluble starch content in vitamin C effervescent tablet provided by the present invention is 0.5% ~ 8%.
In vitamin C effervescent tablet provided by the present invention, preferred water soluble starch content is 2% ~ 5 %.
The present invention also provides a kind of preparation method of vitamin C effervescent tablet, it is characterized in that: using vitamin C as active component, using the water soluble starch of micronizing as lubricant, be prepared into effervescent tablet according to conventional method.
Detailed description of the invention
Inventor adopts screening prescription with the following method, and each prescription is made to vitamin C effervescent tablet, and specification is 0.5g, makes 10,000:
1) vitamin C raw material and anhydrous citric acid were pulverized to 80 mesh sieves, sodium bicarbonate was pulverized 80 mesh sieves, and lubricant is crushed to regulation order number, and it is for subsequent use that other material is crossed 80 mesh sieves;
2) prepare 10%PVP solution 1000ml, stir, dissolve for subsequent use;
3) taking vitamin C, starch, lactose, anhydrous citric acid by recipe quantity pours into successively in blender and is dry mixed 30 minutes;
4) add the PVP solution of above-mentioned preparation, wet mixing 30 minutes, makes suitable soft material 30 mesh sieves and granulates;
5) dry: wet granular is put in drying tray, put into drying baker, 50 DEG C~60 DEG C dry;
6) taking sodium bicarbonate, aspartame by recipe quantity pours into successively in blender and is dry mixed 30 minutes;
7) add the PVP solution of above-mentioned preparation, wet mixing 30 minutes, makes suitable soft material 30 mesh sieves and granulates;
8) dry: wet granular is put in drying tray, put into drying baker, 50 DEG C~60 DEG C dry;
9) granulate is with total mixed: by 24 mesh sieve granulate for dried granule, then add water soluble starch, riboflavin sodium phosphate, the silicon dioxide of recipe quantity always to mix 15 minutes, sample examination pellet moisture and drug content;
10) tabletting: calculate institute's tabletting according to surveyed granule content and heavily carry out tabletting; Mould specification: the flat punching of Φ 22mm; Unit type: ZPW-21A rotary tablet machine; 600 slices/minute of machine speeds; Sheet is heavily about 1800mg, tablet weight variation≤± 5%;
11) packaging: aluminum pipe packaging.
Embodiment 1
Embodiment 2
Embodiment 3
Embodiment 4
Embodiment 5
Contrast with the embodiment of prior art 1~4 with embodiments of the invention 5, draw the following conclusions.
1. comparing result
2. according to the inventive method, the application manually produces 150 batches of vitamin C effervescent tablets, conforming product rate 100% altogether;
3. according to national standard, 24 months vitamin C effervescent tablet effect duration, the applicant's reserved sample observing to 36 month, every quality index has not yet to see obvious change;
4. embodiment 5 explanations the invention solves the slow difficult problem of effervescent tablet disintegrate, by the screening to lubricant, make vitamin C effervescent tablet of the present invention obtain best effervescent effect;
5. can find out by above-mentioned result of the test, it is fast that vitamin C effervescent tablet of the present invention has disintegrate compared with prior art products, good stability, and the advantage such as weight differential is little, can provide more stable, effective, safe product for patient;
6. owing to having described the present invention according to above preferred embodiment, any to be equal to replacement be all apparent for a person skilled in the art, and be included among the present invention.