CN109745337A - Compound tetrazine Reserpine In Tablets and preparation method - Google Patents
Compound tetrazine Reserpine In Tablets and preparation method Download PDFInfo
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- CN109745337A CN109745337A CN201711085560.1A CN201711085560A CN109745337A CN 109745337 A CN109745337 A CN 109745337A CN 201711085560 A CN201711085560 A CN 201711085560A CN 109745337 A CN109745337 A CN 109745337A
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Abstract
The present invention relates to a kind of compound tetrazine Reserpine In Tablets and preparation method thereof.The piece is prepared from the following ingredients in percentage by weight: label includes reserpine, hydralazine hydrochloride, Cyclopenthiazide, vitamin B1, vitamin B6, Hydrochioro, promethazine hydrochloride, potassium chloride, rutin, chloroquine diphosphate, starch, dextrin, magnesium stearate, ethyl alcohol.Sugar-coat clothing layer includes talcum powder, sucrose, gelatin, famille rose and lemon yellow.The present invention improves the clinical efficacy of compound tetrazine Reserpine In Tablets, avoids drug in the stimulation of stomach, degrades in the stimulation of enteron aisle, so that side effect reduces, reaches quick-acting, efficient effect, significantly improve its bioavilability also.Compared with prior art, the present invention has dosage form novel, convenient to take, work rapid, easy to carry, transport and storage, it is easy to use the features such as.
Description
Technical field
The invention belongs to the formulation arts such as reserpine, hydralazine hydrochloride and Cyclopenthiazide, and in particular to reserpine and its
Preparation method.
Background technique
A kind of indoles type alkaloid.Molecular formula C33H40N2O9.It is present in Rauwolfia various plants, in mitoridine
Content reaches as high as 1% in wood.Colourless prismatic crystal.264 ~ 265 DEG C of fusing point (decomposition), -117.7 ° of specific rotatory power (chloroform, C=
1).It is soluble in chloroform, methylene chloride, glacial acetic acid, benzene, ethyl acetate can be dissolved in, is slightly dissolved in acetone, methanol, ethyl alcohol, ether, second
The dilute aqueous solution of acid and citric acid.The solution placement of reserpine turns yellow after a certain period of time, and has significant fluorescence, acid adding and exposure
Fluorescence enhancement afterwards.Reserpine is a weak base, its hydrochloride is clear crystal, 224 DEG C of fusing point (decomposition);Pyridine complex is
Yellow crystal, 183 ~ 186 DEG C of fusing point (decomposition).Reserpine can reduce blood pressure and reducing heart rate, and effect is slow, mild and lasting,
Central nervous system has lasting stable effect, is a kind of good sedative.
It is widely used in slight and moderate hypertension treatment;Blood pressure lowering and tranquilizer.Antihypertensive effect works slowly, but effect is held
Long.It can also be shared with other depressor, for severe and advanced stage or acute hypertension.
Summary of the invention
That the purpose of the present invention is to provide a kind of bioavilabilities is high, stability is good, avoids to the hurtful compound of stomach
Tetrazine Reserpine In Tablets can improve its bioavilability, reduce blood pressure, moreover it is possible to reduce production cost.For this purpose, inventor passes through greatly
Experimental study is measured, compound tetrazine Reserpine In Tablets enteric coatel tablets and preparation method thereof of the invention are finally obtained, which is characterized in that by
Label and sugarcoating layer composition, wherein label includes reserpine, hydralazine hydrochloride, Cyclopenthiazide, vitamin B1, vitamin B6, hydrogen
Chlorothiazide, promethazine hydrochloride, potassium chloride, rutin, chloroquine diphosphate, starch, dextrin, magnesium stearate, ethyl alcohol；Sugar-coat clothing layer includes sliding
Mountain flour, sucrose, gelatin, famille rose and lemon yellow.
The piece is prepared from the following ingredients in percentage by weight:
Reserpine 0.02-0.03%
Hydralazine hydrochloride 1.0-1.5%
Cyclopenthiazide 0.02-0.03%
Vitamin B1 1.0%
Vitamin B6 1.0%
Hydrochioro 1.0-2.0-%
Promethazine hydrochloride 1.0-2.0%
Potassium chloride 30%-40%
Rutin 5.0%
Chloroquine diphosphate 2.0-3.0%
Starch 10-15%
Dextrin 20-25%%
Magnesium stearate 1.0%
Appropriate amount of ethanol
Sweet tablet prescription are as follows:
Talcum powder 80-85g
Sucrose 60-65g
Lemon yellow 15-20g
Carmine 70-80g
Its optimizing prescriptions are as follows:
Reserpine 0.03%
Hydralazine hydrochloride 1.0%
Cyclopenthiazide 0.025%
Vitamin B1 1.0%
Vitamin B6 1.0%
Hydrochioro 1.5%
Promethazine hydrochloride 1.0%
Potassium chloride 30%
Rutin 5.0%
Chloroquine diphosphate 2.5%
Starch 12%
Dextrin 20%
Magnesium stearate 1.0%
Ethyl alcohol 55%
Sweet tablet prescription are as follows:
Talcum powder 80g
Sucrose 65g
Lemon yellow 20g
Carmine 70g
Talcum powder, sucrose, gelatin, famille rose and lemon yellow weight proportion are 1.5:1.0:0:5:1.0:0.3 in the sugarcoating layer
Clothing layer sugarcoating layer is additionally added in enteric coatel tablets of the invention among label and enteric coating layer, active constituent compound can be increased
The stability of tetrazine Reserpine In Tablets, inventor filter out talcum powder, sucrose, gelatin, famille rose and lemon yellow by many experiments
Coating material as sugarcoating layer.
Conventional tabletting, packaging technique preparation can be used in enteric coatel tablets of the present invention.Claim the potassium chloride of formula ratio, rutin, dimension
Raw element B1 and vitamin B6 cross 80-100 mesh, and after weighing, mixed in equal amounts, addition ethanol in proper amount solution are pelletized in proportion respectively,
It is 2 hours dry, 20 meshes are crossed, dextrin is added, are mixed, hydralazine hydrochloride, Cyclopenthiazide mixing 2-3 minutes is added, is being added
Chloroquine diphosphate, promethazine hydrochloride mixing are pelletized after ten minutes, and 45% ethyl alcohol is being added, was mixing 16 mesh screens, and stearic acid is being added
Magnesium mixes 30 minutes, discharging, to be tested into intermediate station.Calculated weight, tabletting, sugar coating, the piece that dries in the air packing.
Some embodiments wherein, compound tetrazine Reserpine In Tablets of the present invention, wherein the filler, which is selected from, to form sediment
One or more of powder, lactose, pregelatinized starch, microcrystalline cellulose.
Some embodiments wherein, compound tetrazine Reserpine In Tablets of the present invention, which is characterized in that the filler
Selected from one or more of starch, potassium chloride, pregelatinized starch, microcrystalline cellulose and Icing Sugar.
Some embodiments wherein, compound tetrazine Reserpine In Tablets of the present invention, which is characterized in that described adhesive is selected from
It is one or more of in starch, pregelatinized starch, hydroxypropylcellulose, hydroxypropyl methylcellulose and povidone.
Some embodiments wherein, compound tetrazine Reserpine In Tablets of the present invention, which is characterized in that the lubricant
Selected from one or more of magnesium stearate, talcum powder and superfine silica gel powder.
The beneficial effects of the present invention are:
1. improving the dissolution rate of compound tetrazine Reserpine In Tablets, bioavilability is aobvious by the way that reserpine is added in said preparation
It writes and improves；
2. improving the stability of compound tetrazine Reserpine In Tablets after being coated in said preparation by this method, it is viscous to stomach to avoid it
The stimulation of film；
3. specific embodiment
Below in conjunction with the embodiments, a kind of compound tetrazine Reserpine In Tablets of the invention and preparation method thereof are further illustrated, it is following
Embodiment be it is illustrative, be not restrictive, cannot be limited the scope of protection of the present invention with following embodiments.It is all this
Made any modification, equivalent replacement and improvement etc., should be included in guarantor of the invention within the spirit and principle of invention
Within the scope of shield.
1 compound tetrazine Reserpine In Tablets of embodiment
1000 prescriptions are as follows:
Reserpine 0.03g
Hydralazine hydrochloride 1.0g
Cyclopenthiazide 0.025g
Vitamin B1 1.0g
Vitamin B6 1.5g
Hydrochioro 1.5g
Promethazine hydrochloride 1.0g
Potassium chloride 30g
Rutin 5.0g
Chloroquine diphosphate 2.5g
Starch 12g
Dextrin 20g
Magnesium stearate 1.0g
Ethyl alcohol about 15g
Sweet tablet prescription are as follows:
Talcum powder 80g
Sucrose 65g
Lemon yellow 20g
Carmine 70g
Preparation method: claiming the potassium chloride of formula ratio, rutin, vitamin B1 and vitamin B6 crossing 80-100 mesh, after weighing, point
Ethanol in proper amount solution is added in not mixed in equal amounts in proportion, and granulation is 2 hours dry, crosses 20 meshes, and dextrin is added, and mixes, then plus
Enter hydralazine hydrochloride, Cyclopenthiazide mixing 2-3 minutes, pelletizes after ten minutes in addition chloroquine diphosphate, promethazine hydrochloride mixing,
45% ethyl alcohol is added, mixed 16 mesh screens, is mixed 30 minutes magnesium stearate is added, discharging is to be tested into intermediate station.Meter
Calculate weight, tabletting, sugar coating, the piece that dries in the air packing.
2 compound tetrazine Reserpine In Tablets of embodiment
1000 prescriptions are as follows:
Reserpine 0.02g
Hydralazine hydrochloride 1.0g
Cyclopenthiazide 0.03g
Vitamin B1 1.0g
Vitamin B6 1.5g
Hydrochioro 1.5g
Promethazine hydrochloride 1.0g
Potassium chloride 30g
Rutin 5.0g
Chloroquine diphosphate 2.5g
Starch 12g
Dextrin 20g
Magnesium stearate 1.0g
Ethyl alcohol about 15g
Sweet tablet prescription are as follows:
Talcum powder 80g
Sucrose 65g
Lemon yellow 20g
Carmine 70g
Preparation method: claiming the potassium chloride of formula ratio, rutin, vitamin B1 and vitamin B6 crossing 80-100 mesh, after weighing, point
Ethanol in proper amount solution is added in not mixed in equal amounts in proportion, and granulation is 2 hours dry, crosses 20 meshes, and dextrin is added, and mixes, then plus
Enter hydralazine hydrochloride, Cyclopenthiazide mixing 2-3 minutes, pelletizes after ten minutes in addition chloroquine diphosphate, promethazine hydrochloride mixing,
45% ethyl alcohol is added, mixed 16 mesh screens, is mixed 30 minutes magnesium stearate is added, discharging is to be tested into intermediate station.Meter
Calculate weight, tabletting, sugar coating, the piece that dries in the air packing.
3 compound tetrazine Reserpine In Tablets of embodiment
1000 prescriptions are as follows:
Reserpine 0.03g
Hydralazine hydrochloride 1.0g
Cyclopenthiazide 0.03g
Vitamin B1 1.0g
Vitamin B6 1.5g
Hydrochioro 1.5g
Promethazine hydrochloride 1.0g
Potassium chloride 30g
Rutin 5.0g
Chloroquine diphosphate 2.5g
Starch 12g
Dextrin 20g
Magnesium stearate 1.0g
Ethyl alcohol about 15g
Sweet tablet prescription are as follows:
Talcum powder 80g
Sucrose 65g
Lemon yellow 20g
Carmine 70g
Preparation method: claiming the potassium chloride of formula ratio, rutin, vitamin B1 and vitamin B6 crossing 80-100 mesh, after weighing, point
Ethanol in proper amount solution is added in not mixed in equal amounts in proportion, and granulation is 2 hours dry, crosses 20 meshes, and dextrin is added, and mixes, then plus
Enter hydralazine hydrochloride, Cyclopenthiazide mixing 2-3 minutes, pelletizes after ten minutes in addition chloroquine diphosphate, promethazine hydrochloride mixing,
45% ethyl alcohol is added, mixed 16 mesh screens, is mixed 30 minutes magnesium stearate is added, discharging is to be tested into intermediate station.Meter
Calculate weight, tabletting, sugar coating, the piece that dries in the air packing.
1 compound tetrazine Reserpine In Tablets of comparing embodiment
1000 prescriptions are as follows:
Reserpine 0.03g
Hydralazine hydrochloride 1.0g
Cyclopenthiazide 0.025g
Vitamin B1 1.0g
Vitamin B6 1.5g
Hydrochioro 1.5g
Promethazine hydrochloride 1.0g
Potassium chloride 30g
Rutin 5.0g
Chloroquine diphosphate 2.5g
Starch 12g
Dextrin 20g
Magnesium stearate 1.0g
Ethyl alcohol about 15g
Sweet tablet prescription are as follows:
Talcum powder 75g
Sucrose 70g
Lemon yellow 15g
Carmine 75g
Preparation method: claiming the potassium chloride of formula ratio, rutin, vitamin B1 and vitamin B6 crossing 80-100 mesh, after weighing, point
Ethanol in proper amount solution is added in not mixed in equal amounts in proportion, and granulation is 2 hours dry, crosses 20 meshes, and dextrin is added, and mixes, then plus
Enter hydralazine hydrochloride, Cyclopenthiazide mixing 2-3 minutes, pelletizes after ten minutes in addition chloroquine diphosphate, promethazine hydrochloride mixing,
45% ethyl alcohol is added, mixed 16 mesh screens, is mixed 30 minutes magnesium stearate is added, discharging is to be tested into intermediate station.Meter
Calculate weight, tabletting, sugar coating, the piece that dries in the air packing.
2 compound tetrazine Reserpine In Tablets of comparing embodiment
1000 prescriptions are as follows:
Reserpine 0.03g
Hydralazine hydrochloride 1.0g
Cyclopenthiazide 0.02g
Vitamin B1 1.0g
Vitamin B6 1.5g
Hydrochioro 1.5g
Promethazine hydrochloride 1.0g
Potassium chloride 30g
Rutin 5.0g
Chloroquine diphosphate 2.5g
Starch 12g
Dextrin 20g
Magnesium stearate 1.0g
Ethyl alcohol about 15g
Sweet tablet prescription are as follows:
Talcum powder 80g
Sucrose 60g
Lemon yellow 20g
Carmine 80g
Preparation method: claiming the potassium chloride of formula ratio, rutin, vitamin B1 and vitamin B6 crossing 80-100 mesh, after weighing, point
Ethanol in proper amount solution is added in not mixed in equal amounts in proportion, and granulation is 2 hours dry, crosses 20 meshes, and dextrin is added, and mixes, then plus
Enter hydralazine hydrochloride, Cyclopenthiazide mixing 2-3 minutes, pelletizes after ten minutes in addition chloroquine diphosphate, promethazine hydrochloride mixing,
45% ethyl alcohol is added, mixed 16 mesh screens, is mixed 30 minutes magnesium stearate is added, discharging is to be tested into intermediate station.Meter
Calculate weight, tabletting, sugar coating, the piece that dries in the air packing.
3 compound tetrazine Reserpine In Tablets of comparing embodiment
1000 prescriptions are as follows:
Reserpine 0.03g
Hydralazine hydrochloride 1.0g
Cyclopenthiazide 0.025g
Vitamin B1 1.0g
Vitamin B6 1.5g
Hydrochioro 1.5g
Promethazine hydrochloride 1.0g
Potassium chloride 30g
Rutin 5.0g
Chloroquine diphosphate 2.5g
Starch 12g
Dextrin 20g
Magnesium stearate 1.0g
Ethyl alcohol about 15g
Sweet tablet prescription are as follows:
Talcum powder 80g
Sucrose 60g
Lemon yellow 20g
Carmine 80g
Preparation method: claiming the potassium chloride of formula ratio, rutin, vitamin B1 and vitamin B6 crossing 80-100 mesh, after weighing, point
Ethanol in proper amount solution is added in not mixed in equal amounts in proportion, and granulation is 2 hours dry, crosses 20 meshes, and dextrin is added, and mixes, then plus
Enter hydralazine hydrochloride, Cyclopenthiazide mixing 2-3 minutes, pelletizes after ten minutes in addition chloroquine diphosphate, promethazine hydrochloride mixing,
45% ethyl alcohol is added, mixed 16 mesh screens, is mixed 30 minutes magnesium stearate is added, discharging is to be tested into intermediate station.Meter
Calculate weight, tabletting, sugar coating, the piece that dries in the air packing.
4 stability test of embodiment and result
1. accelerated stability test
Intensity of illumination 4500LX carries out assay using HPLC method after the 0th, 5 and 10 day timing sampling.
The condition of HPLC is: chromatographic column: ODS-C18 column (200 × 4.6mm, 5um), with octadecylsilane chemically bonded silica
For filler；Mobile phase: acetonitrile-water (volume ratio 30:70)；Detection wavelength: 254nm flow velocity: 1.0mL/min；Sample volume: 20 μ
L；Content is calculated using external standard method.Assay result (percentage of measured amount and labelled amount) see the table below 1. the result shows that this hair
The stability of active constituent reserpine is substantially better than comparative example in bright compound tetrazine Reserpine In Tablets.
1 accelerated stability test assay result (%) of table
2.
3. long-term stable experiment
25 DEG C of temperature, relative humidity 60% are lower to place 36 months, and sampling uses HPLC when 0,3,6,12,24 and 36 months
Method carries out assay.The same accelerated stability test of the condition of HPLC.Content is calculated using external standard method.(the examination of assay result
Test the percentage of measured amount and labelled amount) it see the table below 2.The result shows that active reserpine in compound tetrazine Reserpine In Tablets of the invention
Stability be substantially better than comparative example.
2 long-term stable experiment assay result (%) of table
5 bioavilability of embodiment
Four rats (being the male amount of showing) are administered orally, they are fed respectively and is implemented with the embodiment of the present invention 3, comparison
Compound tetrazine Reserpine In Tablets (the lower placement 12 of 25 DEG C of temperature, relative humidity 60% of example 1, comparative example 2, comparative example 3
Month), dosage is 20.00 μ g/ (in terms of Reserpine In Tablets), and the interval time being administered every time feeds 7 days.After giving drug, not
With acquiring blood sample under time point, and carry out Reserpine In Tablets maximum haemoconcentration (Cmax) and bioavilability (AUC0→48) calculating.
Acquisition time be 0h, 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, for 24 hours, 32h, 48h.
The following table 3, which is provided, gives the embodiment of the present invention 3, comparative example 1, comparative example 2, comparison to four beasle dogs
The resulting average result of blood plain film of embodiment 3.As seen from table, the sharp blood of compound tetrazine Reserpine In Tablets (embodiment 3) of the present invention
Plain film maximum plasma concentration and bioavilability are apparently higher than comparative example.
The comparison (10.0 μ g, n=3) of 3 bioavilability of table
| Embodiment 3 | Comparing embodiment 1 | Comparing embodiment 2 | Comparing embodiment 3 | |
| Cmax(ng/mL) | 1.35±0.71 | 0.75±0.36 | 0.37±0.24 | 1.13±0.27 |
| AUC0→48(ng*h/mL) | 14.7±2.64 | 8.4±3.18 | 8.2±2.96 | 11.1±2.23 |
Claims (10)
1. the preparation method that the present invention designs a kind of compound tetrazine Reserpine In Tablets.
2. compound tetrazine Reserpine In Tablets according to claim 1 are mainly made of reserpine and other auxiliary materials.
3. compound tetrazine Reserpine In Tablets according to claim 1, which is characterized in that the filler is selected from starch, chlorination
One or more of potassium, pregelatinized starch, microcrystalline cellulose and Icing Sugar.
4. compound tetrazine Reserpine In Tablets according to claim 1, which is characterized in that described adhesive is selected from starch, pre- glue
Change one or more of in starch, hydroxypropylcellulose, hydroxypropyl methylcellulose and povidone.
5. compound tetrazine Reserpine In Tablets according to claim 1, which is characterized in that the lubricant be selected from magnesium stearate,
One or more of talcum powder and superfine silica gel powder.
6. the preparation method of compound tetrazine Reserpine In Tablets described in claim 1-6, which is characterized in that this method includes following step
It is rapid: claim the potassium chloride of formula ratio, rutin, vitamin B1 and vitamin B6 crossing 80-100 mesh, after weighing, respectively in proportion etc.
Ethanol in proper amount solution is added in amount mixing, and granulation is 2 hours dry, crosses 20 meshes, and dextrin is added, and mixes, it adds hydrazine hydrochloride and bends
Piperazine, lovers' thiazine mixing 2-3 minutes pelletize after ten minutes in addition chloroquine diphosphate, promethazine hydrochloride mixing, 45% second are being added
Alcohol mixed 16 mesh screens, mixed 30 minutes magnesium stearate is added, and discharging is to be tested into intermediate station.
7. calculated weight, tabletting, sugar coating, the piece that dries in the air packing.
8. both compound tetrazine Reserpine In Tablets of the invention.
9. the preparation method of compound tetrazine Reserpine In Tablets as claimed in claim 6, which is characterized in that this method includes following step
It is rapid:
Potassium chloride, rutin, vitamin B1 and vitamin B6 are crossed into 80 meshes, after weighing, mixed in equal amounts, addition are suitable in proportion respectively
Ethanol solution is measured, granulation is 2 hours dry, crosses 20 meshes, and dextrin is added, it mixes, it is mixed to add hydralazine hydrochloride, lovers' thiazine
It closes 2-3 minutes, pelletizes after ten minutes in addition chloroquine diphosphate, promethazine hydrochloride mixing, 45% ethyl alcohol is being added, was mixing 16 mesh
Sieve, mixes 30 minutes magnesium stearate is added, and discharging is to be tested into intermediate station.
10. calculated weight, tabletting, sugar coating, the piece that dries in the air packing.
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| CN103006696A (en) * | 2012-12-27 | 2013-04-03 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Preparation method of potassium chloride sustained-release tablet |
| CN103816191A (en) * | 2014-02-25 | 2014-05-28 | 江西百神药业股份有限公司 | Preparation method of ganoderma lucidum extract tablet |
| CN105193841A (en) * | 2015-11-03 | 2015-12-30 | 郑州泰丰制药有限公司 | Compound reserpine medicine composition for treating hypertension and preparation method of compound reserpine medicine composition |
| CN105213425A (en) * | 2015-11-03 | 2016-01-06 | 郑州泰丰制药有限公司 | One treats hypertensive compound recipe reserpine oral cavity disintegration tablet and preparation method thereof |
| CN105902564A (en) * | 2015-11-03 | 2016-08-31 | 郑州泰丰制药有限公司 | Pharmaceutical composition for treating hypertension and preparation method thereof |
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2017
- 2017-11-07 CN CN201711085560.1A patent/CN109745337A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000013676A1 (en) * | 1998-09-03 | 2000-03-16 | Isp Investments Inc. | A ph-dependent drug release composition |
| CN102499923A (en) * | 2011-11-18 | 2012-06-20 | 上海理工大学 | Drug combination, as well as preparation method and application of same |
| CN103006696A (en) * | 2012-12-27 | 2013-04-03 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Preparation method of potassium chloride sustained-release tablet |
| CN103816191A (en) * | 2014-02-25 | 2014-05-28 | 江西百神药业股份有限公司 | Preparation method of ganoderma lucidum extract tablet |
| CN105193841A (en) * | 2015-11-03 | 2015-12-30 | 郑州泰丰制药有限公司 | Compound reserpine medicine composition for treating hypertension and preparation method of compound reserpine medicine composition |
| CN105213425A (en) * | 2015-11-03 | 2016-01-06 | 郑州泰丰制药有限公司 | One treats hypertensive compound recipe reserpine oral cavity disintegration tablet and preparation method thereof |
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Application publication date: 20190514 |