CN104784239B - The Zhenju Jiangya Tablet and its preparation technology of a kind of Fast Stripping - Google Patents
The Zhenju Jiangya Tablet and its preparation technology of a kind of Fast Stripping Download PDFInfo
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- CN104784239B CN104784239B CN201510209957.1A CN201510209957A CN104784239B CN 104784239 B CN104784239 B CN 104784239B CN 201510209957 A CN201510209957 A CN 201510209957A CN 104784239 B CN104784239 B CN 104784239B
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Abstract
The invention discloses a kind of Zhenju Jiangya Tablet of Fast Stripping and its preparation technology, contain copolyvidone, polacrilin potassium in preparation prescription, prepared using following technique：1. copolyvidone is added into stirring in purified water, and, to dissolving, then addition Hydrochioro, clonidine hydrochloride are stirred to dissolving, standby；2. taking chrysanthemum indicum cream powder, nacreous layer powder, rutin and polacrilin potassium, sieve, be well mixed, the mixed solution 1. prepared using fluid bed top spray method penetrating step is pelletized, and is dried；Mix, tabletting, produce 3. weighing 2. dry particl that step is prepared and adding lubricant.Zhenju Jiangya Tablet compressibility of the invention is good, disintegration is rapid, dissolution rate is high, while has the advantages of preparation technology is simple, easily operated.
Description
Technical field
The invention belongs to technical field of medicine, is disintegrated rapid, Fast Stripping precious chrysanthemum drop in particular to a kind of
Tabletting and its preparation technology.
Background technology
In Zhenju Jiangya Tablet system, Western medicine compound antihypertensive formulation, by chrysanthemum indicum cream powder 100mg, nacreous layer powder 100mg, hydrochloric acid
Clonidine 0.03mg, Hydrochioro 5mg, rutin 20mg and pharmaceutic adjuvant composition.Wherein, chrysanthemum indicum it is bitter in taste, it is pungent, be slightly cold, return
Lung and Liver Channel, have heat-clearing wind-dispelling, soothing the liver buck functionality, and modern study finds that chrysanthemum indicum cream powder has increase coronary flow, drop
Low coronary resistance, reduce myocardial oxygen consumption, improve the effect such as myocardial ischemia, it is by suppressing sympathetic nerve and vasomotor center
And peripheral vascular is expanded, total peripheral resistance is reduced, antihypertensive effect is played to antiadrenergic drug.Pearl nourishing disney and strengthening bone, arresting convulsion of calming the nerves,
Improving eyesight disappears screen, solution taking poison and growing muscle due, and modern study finds that nacreous layer powder contains abundant calcium carbonate and several amino acids, is beneficial to stable
Cardiovascular structure and function, that is, there are calm the nerves arresting convulsion, regulation human body control ability.Clonidine hydrochloride is set to the sympathetic god of central
Inhibited medicine, there is preferable antihypertensive effect, and have certain effect for reducing fat, but use can decline glomerular filtration rate(GFR long, cause water
Sodium retention, Treatment of Hypertension should not be applied individually to any.Hydrochioro is thiazide diuretic, suitable for light, moderate hypertension, small dose
Amount treatment hypertension (<25mg/d) adverse reaction is few, and can water-sodium retention caused by antagonism clonidine hydrochloride, but dosage is excessive can
Blood glucose, blood fat, blood uric acid rise and blood potassium can be caused to reduce.Rutin heat-clearing, cool blood, hemostasis, capillary permeability can be reduced
And increase its tension force, there are decompression and triglyceride lowering effect.This five kinds of drug ingedient low dose compatibilities can play diuresis, suppress
Sympathetic activity, expansion blood vessel, improve myocardial blood supply, sedation, antihypertensive effect is cooperateed with mutually, and side reaction is cancelled out each other.
Zhenju Jiangya Tablet has the collaboration of Chinese and Western medicine advantage, is formulated the advantages of reasonable, therefore can reach preferable antihypertensive effect.
At present, there is many problems in the preparation of Zhenju Jiangya Tablet：1. the easy moisture absorption of chrysanthemum indicum cream powder, is not easy to pelletize, is
The viscosity of particle is reduced, the general alcohol granulation for using higher concentration, not only increases cost, is also unfavorable for labour protection；②
It is easy to moisture absorption in preparation storing process, causes disintegration of tablet slack-off；3. nacreous layer powder poor compressibility, it is also easy to produce loose pieces phenomenon.
CN101829175B discloses a kind of quickly disintegrated Zhenju Jiangya Tablet agent and preparation method thereof, with CMS
Sodium, PVPP, lauryl sodium sulfate three combination are used as disintegrant, for solving preparation homogeneity shakiness
Fixed, disintegration absorbs the problem of slow.The technology fails fundamentally to solve traditional Chinese medicine ingredients viscosity and is not easy to pelletize greatly, and tablet can press
Property is poor, and being easy to moisture absorption in storing process causes to be disintegrated the problems such as slack-off, while lauryl sodium sulfate is used in prescription, increases
The excitant of intestines and stomach.
CN102973627A is related to a kind of preparation method of Zhenju Jiangya Tablet, and the invention dissolves clonidine hydrochloride with ethanol
Be well mixed afterwards with Hydrochioro, nacreous layer powder, through drying, crush after be well mixed again with chrysanthemum indicum cream powder, rutin, be made
Grain and tabletting.The invention is used and pelletized twice, complex process, and fails solve tablet poor compressibility, is easy to inhale in storing process
It is wet to cause to be disintegrated the problem of slack-off.
The content of the invention
In view of the deficiencies in the prior art, it is an object of the invention to provide a kind of compressibility is good, disintegration is rapid, dissolution rate is high
And the simple Zhenju Jiangya Tablet of preparation technology.
In order to realize the purpose of the present invention, inventor is finally obtained as follows by lot of experiments research and persistent exploration
Technical scheme：
A kind of Zhenju Jiangya Tablet of Fast Stripping, it is made up of the supplementary material of following parts by weight：
The purpose of the present invention can also be achieved in that：Above-mentioned Zhenju Jiangya Tablet, its by following parts by weight supplementary material group
Into：
Preferably, Zhenju Jiangya Tablet as described above, copolyvidone therein account for the 0.5%-1.5% of total weight of tablet；
Polacrilin potassium therein accounts for the 7.0%-9.0% of total weight of tablet.
In addition, Zhenju Jiangya Tablet of the present invention, lubricant therein is magnesium stearate, sodium stearyl fumarate, silicon
One or more in sour magnalium and silica.
The invention provides the preparation method of Zhenju Jiangya Tablet, this method comprises the following steps：
1. copolyvidone is added into purified water stirring to dissolving, then add Hydrochioro, clonidine hydrochloride stir to
Dissolving, it is standby；
2. taking chrysanthemum indicum cream powder, nacreous layer powder, rutin and polacrilin potassium, 80-120 mesh sieves are crossed respectively, are well mixed, are adopted
The mixed solution 1. prepared with fluid bed top spray method penetrating step is pelletized, and is dried；
Mix, tabletting, produce 3. weighing 2. dry particl that step is prepared and adding lubricant.
Compared with prior art, Zhenju Jiangya Tablet compressibility of the present invention is good, disintegration is rapid, dissolution rate is high, simultaneously
It is simple with preparation technology, it is easily operated the advantages of.
Embodiment
Now the preparation process of Zhenju Jiangya Tablet and implementation result are further described by following examples, but the present invention
Protection domain is not limited to following examples.Wherein, chrysanthemum indicum cream powder is feverfew mother chrysanthemum Chrysanthemum indicum
L. the processed manufactured extract of dry capitulum, preparation method are as follows：Take chrysanthemum indicum, add water to cook it is secondary, 1 hour every time,
Collecting decoction, it is concentrated into 1g concoctions and measures 90% ethanol equivalent to 1g crude drugs, one times of addition, stir evenly, staticly settle, leaching supernatant
Liquid, the clear cream that relative density is 1.30 (65~75 DEG C) is concentrated into, the starch of clear cream weight 50% is added, mixes thoroughly, is dried, powder
It is broken, produce.In addition, nacreous layer powder is bought in the fine pharmaceutical Co. Ltd in Guangdong, authentication code：Chinese medicines quasi-word Z44023031,
2011-03-01。
Embodiment 1
Preparation technology：
1. copolyvidone is added into purified water stirring to dissolving, then add Hydrochioro, clonidine hydrochloride stir to
Dissolving, it is standby；2. recipe quantity weighs chrysanthemum indicum cream powder, nacreous layer powder, rutin and polacrilin potassium and is well mixed, using fluid bed
Top spray method sprays into 1. mixed solution that step is prepared, granulation, sets 60 DEG C of EAT, air quantity 100m3/ h, atomizing pressure
0.3MPa, whitewashing finish, and continue to dry 30min；It is well mixed 3. weighing 2. dry particl that step is prepared and adding magnesium stearate, Φ
The shallow arc stampings of 9mm, average hardness 70-90N is controlled, is produced.
Embodiment 2
Preparation technology：
1. copolyvidone is added into purified water stirring to dissolving, then add Hydrochioro, clonidine hydrochloride stir to
Dissolving, it is standby；2. recipe quantity weighs chrysanthemum indicum cream powder, nacreous layer powder, rutin and polacrilin potassium and is well mixed, using fluid bed
Top spray method sprays into 1. mixed solution that step is prepared, granulation, sets 60 DEG C of EAT, air quantity 100m3/ h, atomizing pressure
0.3MPa, whitewashing finish, and continue to dry 30min；It is well mixed 3. weighing 2. dry particl that step is prepared and adding magnesium stearate, Φ
The shallow arc stampings of 9mm, average hardness 70-90N is controlled, is produced.
Embodiment 3
Preparation technology：
1. copolyvidone is added into purified water stirring to dissolving, then add Hydrochioro, clonidine hydrochloride stir to
Dissolving, it is standby；2. recipe quantity weighs chrysanthemum indicum cream powder, nacreous layer powder, rutin and polacrilin potassium and is well mixed, using fluid bed
Top spray method sprays into 1. mixed solution that step is prepared, granulation, sets 60 DEG C of EAT, air quantity 100m3/ h, atomizing pressure
0.3MPa, whitewashing finish, and continue to dry 30min；3. weighing 2. dry particl that step is prepared adds silica, stearic acid richness horse
Sour sodium is well mixed, the shallow arc stampings of Φ 9mm, is controlled average hardness 70-90N, is produced.
Comparative example 1
Preparation technology：
1. weigh chrysanthemum indicum cream powder, nacreous layer powder, rutin and diluent by proportioning recipe quantity.It is mixed uniformly, crushes
Cross 100 mesh sieves；
2., now will be after interior plus disintegrant mixes with Hydrochioro, then with step 1. in weighing in proportion plus disintegrant
Material is put 5min is mixed in mixer together；
3. clonidine hydrochloride is dissolved in into wetting agent, adds step and 2. pelletize, 16 mesh sieves, 70 DEG C of forced air dryings, 16 mesh are whole excessively
Grain；
4. additional disintegrant, lubricant and dry particl mix, tabletting, coating.
Comparative example 2
Preparation technology：
(1) Hydrochioro, nacreous layer powder equal increments is taken to mix to obtain mixed powder；
(2) clonidine hydrochloride is separately taken, adds the ethanol that volumetric concentration is 70% to dissolve, resulting solution is uniformly admixed above-mentioned mixed
Close in powder, stir to obtain mixture repeatedly；
(3) said mixture is dried at a temperature of 40~60 DEG C, and in being ground into powder in pulverizer, crosses No. 5 sieves；
(4) chrysanthemum indicum cream powder, rutin is taken to add in the powder of above-mentioned No. 5 sieves of mistake, mixing, granulation；
(5) tabletting, and be coated, coat weight is the 2%~3% of total formulation weight；
(6) pack.
Embodiment 4：The conventional detection of Zhenju Jiangya Tablet
1. tablet weight variation：According to weight differential method inspection under the A items of two annex of Chinese Pharmacopoeia 2010 edition I, test sample 20 is taken
Piece, accurately weighed gross weight, after trying to achieve average piece weight, then weight accurately weighed every respectively, calculate per sheet weight and average
Tablet weight variation limit.
2. friability：Determined according to the G tablet friabilities inspection technique of two annex of Chinese Pharmacopoeia 2010 edition Ⅹ.This product is taken to be about
6.5g, the powder to come off is blown away with hair-dryer, precise weighing, is put in cylinder, rotated 100 times, taken out, powder, essence are removed with method
It is close to weigh, calculate less loss weight.
3. hardness：Each prescription respectively takes 10 to determine respectively, takes its average value.
4. disintegration time limited：Determined according to two annex of Chinese Pharmacopoeia 2010 edition, Ⅹ A disintegration time limiteds inspection technique.This product 6 is taken, point
It is not placed in the glass tube of disintegration tester hanging basket, starts disintegration tester, record each complete disintegration time.
Measurement result is shown in Table 1.
The Zhenju Jiangya Tablet testing result of table 1
| Embodiment | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 |
| Tablet weight variation (%) | - 1.8~1.5 | - 1.6~2.1 | - 2.0~1.7 | - 5.8~6.5 | - 6.1~6.4 |
| Hardness (N) | 83 | 79 | 81 | 65 | 74 |
| Friability (%) | 0.22 | 0.13 | 0.17 | 0.79 | 0.89 |
| Disintegration time (min) | 1.5 | 2 | 2.5 | 6.5 | 10 |
Embodiment 5：Clonidine hydrochloride content cloud test
Chromatographic condition：It is filler with octadecylsilane chemically bonded silica, (is adjusted with 0.22% perfluorooctane sulfonate with phosphoric acid
PH value is to 2.7)-methanol-acetonitrile (65：20：15) it is mobile phase, flow velocity 1ml/min, 25 DEG C, Detection wavelength 210nm of column temperature,
The μ L of sample size 20.
The preparation of reference substance solution：Precision weighs clonidine hydrochloride reference substance 10mg, puts in 100mL measuring bottle, uses
0.01mol/L dissolving with hydrochloric acid is simultaneously diluted to scale.It is appropriate to measure above-mentioned solution for precision again, with 0.01mol/L hydrochloric acids into every
The hydrochloric μ g of clonidine 1 of 1mL reference substance solution.
The preparation of need testing solution：This product 20 is taken, accurately weighed, finely ground, precision weighs (is approximately equivalent to 1 in right amount
Amount), put in 25mL volumetric flask, add suitable quantity of water to make dissolving, be ultrasonically treated 10min, cool down and add water to scale, centrifuge
(3000r/min, 10min), filtration, precision add sodium hydroxide test solution (4.3%) 5mL, and precision measures mixed liquor 20mL and put point
In liquid funnel, extracted 3 times, each 20mL with dichloromethane, after combined dichloromethane extract solution, with 0.01mol/L hydrochloric acid 20mL
Extraction, as need testing solution.
Measurement result is shown in Table 2.
The clonidine hydrochloride content cloud test (%) of table 2
| Embodiment | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 |
| A+1.8S | 3.5 | 2.8 | 3.1 | 10.9 | 12.5 |
As can be known from Table 2, embodiment 1-3 uniformity of dosage units is preferable, although comparative example 1-2 meets the requirements, but close to limit
Angle value (≤15).
Embodiment 6：Hydrochioro Determination of Content Uniformity
Chromatographic condition：It is filler with octadecylsilane chemically bonded silica, with 0.05mol/L citric acids-acetonitrile (80：20)
It is mobile phase with triethylamine regulated value pH4.1, flow velocity 1ml/min, 25 DEG C, Detection wavelength 270nm of column temperature, the μ L of sample size 20.
The preparation of reference substance solution:Precision weighs Hydrochioro and appropriate control substance of Rutin, with 0.05mol/L citric acids-
Acetonitrile (80: 20) dissolves and is diluted to 25 μ g/mL and 100 μ g/mL mixed liquor.
The preparation of need testing solution:Zhenju Jiangya Tablet 20 is taken, finely ground, precision weighs appropriate (being approximately equivalent to 1 amount), puts
In 200mL measuring bottles, add 0.05mol/L citric acids-acetonitrile (80: 20) dissolving to be ultrasonically treated 30min, be diluted to scale.Measure knot
Fruit is shown in Table 3.
The Hydrochioro Determination of Content Uniformity (%) of table 3
| Embodiment | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 |
| A+1.8S | 3.9 | 3.0 | 2.8 | 13.3 | 14.1 |
As can be known from Table 3, Hydrochioro is dissolved in adhesive and sprayed into mixed powder by embodiment 1-3, and uniformity of dosage units is preferable,
Comparative example 1-2 is progressively increased mixing using equivalent, although uniformity of dosage units meets the requirements, close to limit value (≤15).
Embodiment 7：Hydrochioro and the dissolution determination of rutin
For chromatographic condition with checking example 2, sample size is 50 μ L.This product is taken, according to dissolution method (Chinese Pharmacopoeia version in 2010
Two methods of annex XC second), using 0.1mol/L hydrochloric acid 500ml as solvent, rotating speed is 50 turns per minute, is operated in accordance with the law, in 15 points
Zhong Shi, solution 5ml is taken, filter, take subsequent filtrate as need testing solution；Precision weighs Hydrochioro and appropriate control substance of Rutin,
The mixed liquor for being dissolved by the use of 0.05mol/L citric acids-acetonitrile (80: 20) and being diluted to 10 μ g/mL and 40 μ g/mL is molten as reference substance
Liquid.Precision measures need testing solution and each 50 μ l injections liquid chromatograph of reference substance solution, chromatogram is recorded, by external standard method with peak
Areal calculation, produce.
The Hydrochioro of table 4 and the dissolution determination of rutin (%)
| Embodiment | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 |
| Hydrochioro | 99.7 | 98.3 | 98.8 | 80.3 | 73.2 |
| Rutin | 100.4 | 99.4 | 97.3 | 65.9 | 69.5 |
As can be known from Table 4, embodiment 1-3 dissolutions are substantially better than comparative example 1-2.
Claims (6)
1. a kind of Zhenju Jiangya Tablet of Fast Stripping, it is characterised in that be made up of the supplementary material of following parts by weight：
100 parts of chrysanthemum indicum cream powder
100 parts of nacreous layer powder
0.03 part of clonidine hydrochloride
5 parts of Hydrochioro
20 parts of rutin
Copolyvidone 1-10 parts
Polacrilin potassium 15-30 parts
Lubricant 1-3 parts
The preparation method of described Zhenju Jiangya Tablet comprises the following steps：
1. copolyvidone is added in purified water, stirring is to dissolving, and then addition Hydrochioro, clonidine hydrochloride are stirred to dissolving,
It is standby；
2. taking chrysanthemum indicum cream powder, nacreous layer powder, rutin and polacrilin potassium, 80-120 mesh sieves are crossed respectively, are well mixed, using stream
Change bed top spray method and spray into 1. mixed solution granulation that step is prepared, dry；
Mix, tabletting, produce 3. weighing 2. dry particl that step is prepared and adding lubricant.
2. Zhenju Jiangya Tablet according to claim 1, it is characterised in that be made up of the supplementary material of following parts by weight：
100 parts of chrysanthemum indicum cream powder
100 parts of nacreous layer powder
0.03 part of clonidine hydrochloride
5 parts of Hydrochioro
20 parts of rutin
Copolyvidone 1-4 parts
Polacrilin potassium 17-23 parts
Lubricant 1-3 parts.
3. Zhenju Jiangya Tablet according to claim 1, it is characterised in that copolyvidone accounts for the 0.5%- of total weight of tablet
1.5%。
4. Zhenju Jiangya Tablet according to claim 1, it is characterised in that polacrilin potassium accounts for the 7.0%- of total weight of tablet
9.0%。
5. according to the Zhenju Jiangya Tablet described in claim any one of 1-4, it is characterised in that described lubricant is stearic acid
One or more in magnesium, sodium stearyl fumarate, Magnesiumaluminumsilicate and silica.
6. a kind of preparation method according to any one of the claim 1-4 Zhenju Jiangya Tablets, it is characterised in that this method includes
Following steps：
1. copolyvidone is added in purified water, stirring is to dissolving, and then addition Hydrochioro, clonidine hydrochloride are stirred to dissolving,
It is standby；
2. taking chrysanthemum indicum cream powder, nacreous layer powder, rutin and polacrilin potassium, 80-120 mesh sieves are crossed respectively, are well mixed, using stream
Change bed top spray method and spray into 1. mixed solution granulation that step is prepared, dry；
Mix, tabletting, produce 3. weighing 2. dry particl that step is prepared and adding lubricant.
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| CN102357085A (en) * | 2011-10-27 | 2012-02-22 | 苏州中化药品工业有限公司 | Stable method for preparing repaglinide compressed tablets |
| KR20120134545A (en) * | 2011-06-02 | 2012-12-12 | 현대약품 주식회사 | Method for preparing immediate release pharmaceutical composition having improved stability and content uniformity |
| CN102973627A (en) * | 2011-09-02 | 2013-03-20 | 天圣制药集团股份有限公司 | Preparation method of pearl layer powder-wild chrysanthemum cream powder hypotensive tablet |
| CN104523644A (en) * | 2015-01-27 | 2015-04-22 | 严白双 | Rapidly-dissolved loratadine tablets and preparation process thereof |
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2015
- 2015-04-28 CN CN201510209957.1A patent/CN104784239B/en not_active Expired - Fee Related
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101128189A (en) * | 2005-02-25 | 2008-02-20 | 弗·哈夫曼-拉罗切有限公司 | Tablets with improved drug substance dispersibility |
| CN101716156A (en) * | 2010-01-08 | 2010-06-02 | 成都苑东药业有限公司 | Ubenimex dispersive tablet composition |
| CN101829175A (en) * | 2010-06-03 | 2010-09-15 | 浙江得恩德制药有限公司 | Rapidly disintegrable Zhenju antihypertensive tablets and preparation method thereof |
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| CN104523644A (en) * | 2015-01-27 | 2015-04-22 | 严白双 | Rapidly-dissolved loratadine tablets and preparation process thereof |
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Effective date of registration: 20171130 Address after: 453100 No. 88 health Road, Weihui, Henan, Xinxiang Applicant after: The First Affiliated Hospital of Xinxiang Medical University Address before: 211200 Jintian Pharmaceutical Co., Ltd., No. 1, economic development zone, Yong Yang Town, Lishui District, Jiangsu, Nanjing Applicant before: Sun Qiaoling |
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