CN1042696C - Film coating technique for strong VC Yinqiao tablets - Google Patents

Abstract

The present invention relates to membrane coating technology for strong VC Yinqiao tablets. In the technology, the coating technology of the existing strong VC Yinqiao tablet is substituted by membrane technology. The membrane coating comprises the components: 30 to 40 parts of methyl cellulose, 5 to 8 parts of II intestine soluble acrylic resin, 6 to 10 parts of polyethylene glycol, 4 to 8 parts of castor oil, 4 to 8 parts of tween, 14 to 18 parts of titanium dioxide, 6 to 10 parts of talcum powder, 6 to 10 parts of magnesium stearate, 5 to 10 parts of an edible colorant solution, 350 to 420 parts of distilled water and 1000 parts of ethanol. The technology has the advantages of time saving, material saving, electricity saving, labor saving and high medicine quality. The moist resistance, the heat resistance, the cold resistance and the abrasion resistance are better than that of sugar coated tablets.

Description

The film coating procedure of strong VC Yinqiao tablets

The present invention relates to a kind of film coating procedure of tablet, especially a kind of film coating procedure of strong VC Yinqiao tablets.

At present, the manufacturing of strong VC Yinqiao tablets all is to adopt sugar-coat technology, and this technological operation time is long, and it is many to expend the energy, dust from flying, and environmental pollution is serious, influences the healthy of tablet quality and workman.The primary raw material of coated tablet is simple syrup and Pulvis Talci, and sugarcoating layer itself is unstable, and moisture resistance, heat resistanceheat resistant, cold tolerance are poor, easy to change, store improper easy the fission.In addition, amount of talc accounts for 35% of label weight in the coated tablet, and Pulvis Talci is cold in nature, contains micro-asbestos etc., after patient takes, health is caused potentiality harm.

The objective of the invention is to overcome the existing defective of strong VC Yinqiao tablets sugar-coat technology, a kind of film coating procedure of strong VC Yinqiao tablets is provided, save time, material-saving, power saving, saving of labor, and can improve moisture resistance, heat resistanceheat resistant, the cold tolerance of tablet, reduce the side effect of tablet.

Technical solution of the present invention is: at first make strong VC Yinqiao tablets, its fill a prescription following (parts by weight unit):

YINQIAO dry extract 900～1100, acetaminophen 650～750

Vitamin C 300～360 chlorphenamines 6～8

Calcium carbonate 90～110 starch 500～600

Dextrin 100～120 Oleum menthae 7～7.5

Jing Fang volatile oil 1.8～2.2 Forsythia volatile oils 1.2～1.8

The method for making of strong VC Yinqiao tablets is:

1) in 900～1100 parts of YINQIAO dry extracts, add 150～220 parts of starch, make soft material, morsel, dry under≤90 ℃ temperature, be crushed into powder, add 250～300 parts of starch again, stir into soft material with ethanol, make wet grain through 16 mesh sieves, dry under≤70 ℃ temperature, make granule water content≤3%, granulate is stand-by

2) in 90～110 parts of calcium carbonate, add 50～100 parts of starch, 10～15 parts of dextrin, starch slurry system soft material with 10%, through the wet grain of 16 mesh sieve systems, dry then, granulate, with 7～7.5 portions of Oleum menthae, 1.8～2.2 parts of Jing Fang volatile oil and 1.2～1.8 parts of Forsythia volatile oils spray in the granule with nebulization, moistening is standby

3) get 6～8 parts of chlorphenamines, 650～750 parts of acetaminophen and 300～360 parts of vitamin Cs, add 105～110 parts of dextrin, the starch slurry with 10% is granulated, and drying makes granule moisture content≤2%, and granulate is standby,

4) with above-mentioned three kinds of granule mix homogeneously, in the ratio adding low-substituted hydroxypropyl cellulose of 0.2～0.3% (weight), in the ratio adding magnesium stearate of 0.4～0.6% (weight), mix homogeneously is with the recessed punch die tabletting of shallow circle of Φ 9mm/mm.

Film-coated prescription is:

30～40 parts of hydroxypropyl methylcellulose (weight)

5～8 parts of II enteric acrylic resins (weight)

6～10 parts of Polyethylene Glycol-6000 (weight)

4～8 parts of Oleum Ricini (volume)

4～8 parts of tween 80s (volume)

14～18 parts of titanium dioxides (weight)

6～10 parts of Pulvis Talci (weight)

6～10 parts of magnesium stearate (weight)

5～10 parts of 1% edible pigment solutions (volume)

Distilled water (40～50 ℃) 350～420 parts (volume)

95% ethanol adds to 1000 parts (volumes)

Wherein said weight portion is in gram, and parts by volume is in milliliter,

Film-coated manufacture method is:

1) respectively with 40～50 ℃ dissolved in distilled water hydroxypropyl methylcellulose and standby with dissolve with ethanol II enteric acrylic resin,

2) adding Oleum Ricini and tween 80 are standby in II enteric acrylic resin ethanol liquid,

3) with behind the above-mentioned two liquid mix homogeneously, added titanium dioxide, Pulvis Talci and the magnesium stearate of 80 mesh sieves successively, added edible pigment solution again, stirred, standby after colloid mill grinds 4～5 times,

4) screen out fine powder, fragment and chip in the tablet,

5) tablet is placed coating pan be preheated to 45～55 ℃,, behind Swertia Tablet surface coverage one deck coating material, stops hydrojet, use hot blast drying to tablet spraying coating material,

6) the tablet temperature is controlled at 40-50 ℃, presses the per kilogram label, the ratio of spray coating solution 400 ± 50ml is to its batch (-type) spraying coating material, and constantly detect the wettability on tablet surface, prevent the mutual adhesion of tablet, spray one deck, dry one deck is till the coating material has sprayed

7) after last one deck coating material drying, continue to open coating pan, change and blow a cold wind over, till surface-brightening,

8) tablet behind the taking-up coating places drying under the temperature below 40 ℃, makes finished product.

Compared with the prior art the present invention has the following advantages:

1. the film forming matter chemical property is stable, enzyme system is falling property, no physiology toxicity; 2. art for coating operation cycle short (only be sugar-coat technological operation time 1/5) saves time, material-saving, power saving, saving of labor, and clothing layer fast drying, and medicine is influenced by heat less, helps improving drug quality; 3. behind the coating, sheet heavily increases seldom, can keep former shape, has significantly reduced the talcous consumption of adjuvant, does not use sucrose; 4. the moisture resistance of this film-coat, heat resistanceheat resistant, the cold-resistant abrasion resistance properties that reaches all are better than coated tablet, have improved the stable bamboo of tablet, prolong storage period.

Strong VC Yinqiao tablets that technology of the present invention is made and the strong VC Yinqiao tablets sampling inspection that makes with sugar-coat technology, the result is as follows:

One, outward appearance

Coated tablet: the surface is not whole, even, the bright-coloured light of color and luster.

Film coated tablets: profile is complete, and the clothing layer is firm, the thickness unanimity, and color and luster is even, and fineness is better, but color and luster is dim slightly bright not as good as coated tablet.

Two, hardness (with 73X-2 matrix agent four-function analyzer)

Project	Film coated tablets	Coated tablet
			Former label hardness (kg/mm)	≥4kg/mm 2	3kg/mm 2
Hardness behind the coating (kg/mm)	≥8kg/mm 2	≥5kg/mm 2

Three, average sheet is heavy

Project	Film coated tablets	Coated tablet
			Former label weight (g)	0.26～0.262	0.26～0.262
Weight behind the coating (g)	0.28～0.29	0.42～0.43

Four, disintegration: instrument: IB-B ₁₂The of A type six pipe disintegration tester: 37 ℃ in water

Film coated tablets	Coated tablet
		≤35mln	40～59mln

Five, the test apparatus that resistance to wears: 78X-2 matrix agent four-function analyzer

Time (min)	Film coated tablets	Coated tablet
			10	No change	The forfeiture of sheet surface-brightening tone
30	Sheet lustrous surface is dark slightly	The sheet surface obviously tarnishes, and obvious friction trace is arranged
			60	The same (30min)	Rhegma appears individually in unilateral coarse fluffing
120	The same (30min)	The unilateral damage seriously has a large amount of fine powders and falls

Six, moisture absorption contrast (37 ℃ of 90%RH)

Time (d)	Film coated tablets	Coated tablet
			1	No change	Fade in the surface
2	Flowability still can	The surface pasty state, the end, glued in deliquescing
			7	Mobile relatively poor, color stagnates light	Sliver, extractum oozes out unilateral
12	The sticking end, the deliquescing of sheet top layer	Gelatinizing fully, surperficial Lycoperdon polymorphum Vitt
			Remarks	Vc, acetaminophen content drop to 84.3% and 90.2% of former tablet	Vc, acetaminophen content are 30% and 62.4% of former tablet

The condition time (d)	Infrared ray		70～80℃		-5℃
							Outward appearance	Disintegrate	Outward appearance	Disintegrate	Outward appearance	Disintegrate
	Before the placement	Light	31min	Light	31min	Light							31min
7							No change	31min	No change	31min	No change	30min
	14	No change	22min	No change	30min	No change							20min
21							No change	22min	No change	20min	No change	20min

* coated tablet infrared ray directly according under, can occur fading under 70～80 ℃ ,-5 ℃ the situation, split cruelly, dissolving, disintegration time＞60min.

Below in conjunction with embodiment the present invention is described in more detail.

Embodiment 1:

One, system strong VC Yinqiao tablets

1) in 1000 gram YINQIAO dry extracts, add 150 gram starch, make soft material, morsel, dry under 60 ° ± 2 ℃ temperature, be crushed into powder.Add 300 gram starch again, stir into soft material, make wet grain through 16 mesh sieves with ethanol, dry under 50 ° ± 2 ℃ temperature, make granule water content＜3%, granulate is stand-by,

2) in 100 gram calcium carbonate, add 100 gram starch and 10 gram dextrin, starch slurry system soft material with 10% makes wet grain through 16 mesh sieves, dry then, granulate, 7 gram Oleum menthae, 2 gram Jing Fang volatile oil and 1.5 gram Forsythia volatile oils are sprayed in the granule with nebulization, and moistening is standby;

3) get 7 gram chlorphenamines, 700 gram acetaminophen and 330 gram vitamin Cs, add 100 gram dextrin, the starch slurry with 10% is granulated, and drying makes granule moisture content＜2%, and granulate is standby;

4) with above-mentioned three kinds of granule mix homogeneously, in the ratio adding low-substituted hydroxypropyl cellulose of 0.3% (weight), in the ratio adding magnesium stearate of 0.5% (weight), mix homogeneously is with the recessed punch die tabletting of shallow circle of Φ 9mm/mm.

Two, made membrane coating

Prescription: hydroxypropyl methylcellulose 32 grams, II enteric acrylic resin 6 grams, Polyethylene Glycol-60008 gram, 7 milliliters of Oleum Ricini, 5 milliliters of tween 80s, titanium dioxide 14 grams, Pulvis Talci 6 grams, magnesium stearate 10 grams, 8 milliliters of 1% edible pigment solutions, 360 milliliters of 42 ± 1 ℃ distilled water, 95% ethanol add to 1000 milliliters.

Manufacturing process:

1) use 42 ± 1 ℃ dissolved in distilled water hydroxypropyl methylcellulose and standby respectively with dissolve with ethanol II enteric acrylic resin,

2) adding Oleum Ricini and tween 80 are standby in II enteric acrylic resin ethanol liquid,

3) with behind the above-mentioned two liquid mix homogeneously, added titanium dioxide, Pulvis Talci and the magnesium stearate of 80 mesh sieves successively, added edible pigment solution again, stirred, standby behind colloid mill 5 times,

4) screen out fine powder, fragment and chip in the tablet,

5) tablet is placed coating pan be preheated to 48 ± 2 ℃, to tablet spraying coating material, the Swertia Tablet surface coverage behind one deck coating material, stop hydrojet, use hot blast drying,

6) the tablet temperature is controlled at 42 ± 1 ℃, the ratio of spraying coating solution 400ml with the per kilogram label sprays the coating material to its batch (-type), and constantly detects the wettability on tablet surface, prevents the mutual adhesion of tablet, spray one deck, and dry one deck, till the coating material has sprayed,

7) after last one deck coating material drying, continue to open coating pan, change and blow a cold wind over, till surface-brightening,

8) tablet behind the taking-up coating places under the room temperature dry.

Embodiment 2:

The prescription of powerful dimension C silver fin is identical with embodiment 1 with method for making.

Film-coated prescription is: hydroxypropyl methylcellulose 38 grams, II enteric acrylic resin 7 grams, Polyethylene Glycol-60006 gram, 5 milliliters of Oleum Ricini, 7 milliliters of tween 80s, titanium dioxide 17 grams, Pulvis Talci 8 grams, magnesium stearate 7 grams, 6 milliliters of 1% edible pigment solutions, 400 milliliters of distilled water (47 ± 1 ℃), 95% ethanol adds to 1000 milliliters.

The coating operation is identical with embodiment 1.

Claims (1)

1, a kind of film coating procedure of strong VC Yinqiao tablets is granulated with YINQIAO dry extract and starch respectively; Granulate with calcium carbonate, starch, dextrin, Oleum menthae, Jing Fang volatile oil and Forsythia volatile oil; With chlorphenamine, acetaminophen, vitamin C, dextrin and starch slurry granulation, with above-mentioned three kinds of granule mix homogeneously, add low-substituted hydroxypropyl cellulose and magnesium stearate, mix homogeneously backlash molded tablet makes strong VC Yinqiao tablets,

It is characterized in that film-coated prescription is

30～40 parts of hydroxypropyl methylcellulose (weight)

5～8 parts of II enteric acrylic resins (weight)

6～10 parts of Polyethylene Glycol-6000 (weight)

4～8 parts of Oleum Ricini (volume)

4～8 parts of tween 80s (volume)

14～18 parts of titanium dioxides (weight)

6～10 parts of Pulvis Talci (weight)

6～10 parts of magnesium stearate (weight)

5～10 parts of 1% edible pigment solutions (volume)

Distilled water (40～50 ℃) 350～420 parts (volume)

95% ethanol adds to 1000 parts (volumes)

Wherein said weight portion is in gram, and parts by volume is in milliliter;

Film-coated manufacturing process is:

1) respectively with 40～50 ℃ dissolved in distilled water hydroxypropyl methylcellulose and standby with dissolve with ethanol II enteric acrylic resin,

2) adding Oleum Ricini and tween 80 are standby in II enteric acrylic resin ethanol liquid,

3) with behind the above-mentioned two liquid mix homogeneously, add titanium dioxide, Pulvis Talci and magnesium stearate that the people crosses 80 mesh sieves successively, add edible pigment solution again, stir, standby behind colloid mill mill 4～5 times,

4) screen out fine powder, fragment and chip in the tablet,

5) tablet is placed coating pan be preheated to 45～55 ℃,, behind Swertia Tablet surface coverage one deck coating material, stops hydrojet, use hot blast drying to tablet spraying coating material,

6) the tablet temperature is controlled at 40～50 ℃, presses the per kilogram label, the ratio of spray coating solution 400 ± 50ml is to its batch (-type) spraying coating material, and constantly detect the wettability on tablet surface, prevent the mutual adhesion of tablet, spray one deck, dry one deck is till the coating material has sprayed

7) after last one deck coating material drying, continue to open coating pan, change and blow a cold wind over, till surface-brightening,

8) tablet behind the taking-up coating places under the temperature below 40 ℃ dry