• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    A method of producing an oral preparation of dipyridamol by mixing it with an auxiliary substance followed by granulating, characterized in that, in order to reduce the fluctuations of its level in the blood, dipyridamole is mixed with an acidic substance in the amount of 5-30 equivalents per 1 mole of dipipamole, and the resulting mixture granulated to a grain size of 0.1-2.0 mm.
    公开号:SU1151193A3
    申请号:SU823452105
    申请日:1982-06-17
    公开日:1985-04-15
    发明作者:Брикль Рольф；Грубер Петер；Шепки Готтфрид；Больцер Герхард
    申请人:Др.Карл Томэ Гмбх (Фирма)；
    IPC主号:
    专利说明:

    i WITH
    with
    00 1 The invention relates to the chemical and pharmaceutical industry, in particular to a method for preparing an oral preparation based on dipyridamole (2,6-bis {diethanolamino-4,8 dipyperidinopyrimido-C3, A-d C-pyrimidine). A known method for the preparation of oral preparation of dipyridamole by mixing it with auxiliary substances, for example, polyvinyl-pyrrolidone, cellulose derivatives, corn starch, milk sugar, flavoring acids and magnesium stearate, followed by granulating D 3 "The disadvantage of this method is that after administration The resulting oral preparation shows large fluctuations in its blood level due to uneven release of the active substance. which negatively affects the therapeutic effect. In addition, such a low blood level is possible, at which resorption is absent. The purpose of the invention is to reduce the fluctuations of its blood level. The goal is achieved by the fact that according to the method of obtaining the oral preparation of dipyridamole by mixing it with a flexible substance, followed by granulating and premixing with an acidic substance in an amount of 5-30 equivalents per 1 mole of dipyridamole, the resulting mixture is granulated to a grain size of 0.1 -2.0 mm. Before transferring to a preparative form, auxiliary substances can be added to the mixture of dipyridamole and an acidic substance. Example 1.3 kg (5.95 mol) of dipyridamole is mixed with 6.3. kg (108.6 equivalents 18.25 equivalents per mole of dipyridamole) fumaric acid and the resulting mixture is moistened with 2 kg of a 15% alcoholic solution of polyvinylpyrrolidone. After drying, the granules are mixed with 300 g of powdered polyvinylpyrrolidone and a limited liability company of magnesium stearate during sieving. The mixture pressed into tablets is crushed in a dry npo granulator, sown and a fraction j containing grains of 0.4-1.0 mm in size is filled into capsules of hard gelatin. 32 The therapeutic effect is determined by the release of dipyridamole, the rate of its release. The time interval between 50% and more than 90% release is determined in vitro as follows. Conditions: US standard USP XX, 100 rpm, Z7 ° G pH 1.2 gastric juice according to USP pH 4.01 pH 6.0 Mack-Ilvine buffer. A weighed 75 mg (in terms of dipyridamole). Release of dipyridamole: 90% 8 min t2 min 15 min Example 2. The process is carried out as in Example 1, but instead of fumaric acid, 108.6 equivalents of malic acid are used. At the same time, the following dipyridamole release is observed: 1.2 3 min 8 min 4.0 5 min 13 min 6.0 5.5 min 16 min PRI me R 3. 45 kg (89.29 mol) dipyrvdamol, 45 kg (775.86 equivalents of 8.69 equivalents per mole of dipyridamole) fumaric acid and 9 kg of polyvinylpyrrolidone are stirred for 20 minutes. About 5 kg of magnesium stearate is then added and the mixture is stirred for another 5 minutes. The mixture is fed through a roller compactor to which a dry granulator with a sieve is connected. The fraction containing 0.4-0.0 mm grains is filled into hard gelatin capsules. The release of dipyridamole is determined according to example 1. The following results are obtained: Example 4. An example is repeated with the difference that A5 kg (89, 29 mol of dipyridamole is mixed with 155.36 kg (2678.6 equivalents of 30 equivalents per mole of dipyridamole) and 20 kg of polyvinylpyrrolidone.At the same time, the fraction containing grains 0.1t, 0 mm in size is filled into capsules of hard gelatin.The following results are obtained on the release of dipyridamole: 10 minutes, 17 minutes, 22 minutes Example 5. Repeat example with the difference that 16.8 kg (33.3 mol) of dipyridamole mix 9.67 kg (166.72 ec vivalent 5 equivalents per mole of dipyridamole and 3.0 kg of polyvinylpyrrolidone. When this fraction is prepared, containing grains of 0.1-1.25 mm in size, they are filled into capsules of hard gelatin. The following release results are obtained dipi ridamol: pH 50% 90% 1.2 6.5 min 13.5 min 4.0 8 min 19.5 min 6.0 8 min 24 min Example 6. Repeat the example with the difference that 30 kg (59 , 52 moles of dipyridamole are mixed with 30 kg (517.24 equivalents of 8.69 equivalents per mole of dipyridamole) of fumaric acid, 29 kg of polyacrylic acid and 1 kg of magnesium stearate. The following results are obtained on the release of dipyridamo. Example 7. An example is repeated with the difference that 2.5 kg (4.96 mol of dipyridamole is mixed with 5.0 kg (86.2 equivalent of 17.38 equivalent per mole of dipyridamole) of fumaric acid , 1.3 kg of hydrogenated castor oil and O, 1 kg of pyrogenic silicic acid. The fraction containing grains 0.1-2.0 mm in size is filled into capsules of solid gelatin. The following results are obtained for the release of dipyridamole: 75 % 90% 65 min 105 min 72 min 123 min 74 min 126 min PRE im 8. 8. 8.5 kg (16.87 mol) of dipyridamole see Betaine hydrochloride is sutured from 19.0 kg (124.18 equivalent to 7.36 equivalent per mole of dipyridamole) and the mixture is moistened with 2.2 kg of 10% isopropanol solution of polyvinylpyrrolidone. After drying at 40 ° C and sieving, the granules are mixed with 100 g of magnesium stearate and 230 g of pyrogenic silicic acid.The mixture pressed into tablets is crushed, sieved and the fraction, l / i containing grains of 0.4-1.2 mm in size, is filled into capsules of hard gelatin. The following results are obtained on the release of dipyridamole: Example 9. 200 kg (2666.7 equivalent to 11.2 equivalent per mole; used dipyridamole) tartaric acid with a particle size of 0.5-0.8 mm is moistened with a 10% alcoholic solution of polyvinylpyrrolidone and then a powder mixture of 80 kg (158.7 mol) of dipyridamole and 20 kg (344.8 equivalents of 2.17 equivalents per mole of dipyridamole) of fumaric acid is fed until the granules move freely. After drying at 40 ° G, the solution of polyvinylpyrrolidone is again sprayed and then another powder mixture of 40 kg (79.36 mol) of dipyridamole and 10 kg (172.4 equivalents of 2.17 equivalents per mole of dipyridamole) is added to the mixture. A total of 75 kg of this solution of polyvinylpyrrolidone is used. After drying at 40 ° C, granules with a size of 0.6-0.9 mm are selected and subjected to experience in determining the release of dipyridamole as in Example 1. The following results are obtained: EXAMPLE 10 Example 9 is repeated with the difference that a mixture of 70 kg (138.9 mol) of dipyridamole and 30 kg of sodium hydrogensulfate (250 equivalents of 1.8 equivalents per mole of dipyridamole ). This gives the following results on the release of dipyridamole: (27.8 mol) dipyridamole is mixed with 0.5 kg of pyrogenic silicic acid, 0.7 kg of corn starch, 2.5 kg of powdered polyethylene glycol with an average molecular weight of 6000 I 25 kg ( 423.7 equivalents of 15.2 equivalents per mole of dipyridamole) succinic acid for 2 hours.
    After cooling, it is sieved and 0.4% of magnesium stearate with a particle size of 0.1-2.0 mm is added to the fraction containing grains O, 2.0 mm, after which the mixture is filled into capsules of hard gelatin.
    The release of dipyridamole is determined analogously to example 1. The following results are obtained:
    Example 12. Dipyridamole tablets with 80 mg of tartaric acid, coated.
    Example 13. Dipirndamol tablets with 60 mg of fumaric acid, provided with a coating.
    1 tablet contains mg: Dipyridamole 75 (0.149 mmol)
    Fumaric
    60 (1.03 mEq, 94 equivalents per mole of dipyridamole)
    Potato glycolate
    Starch Polyvinylpyrrolidone Magnesium Stearate 1 tablet contains, mg: 75 (0.149 mol) Dipyridamol Vinna Kis7, 0 mg polyvinyllot pyrrolidone and talc (1: 1) 80 mg (1.07 equivalents per mole of dipyridamole) Sodium glycolate, starch, 40.0, 04.0 g n 3.0 Stearate 1.0. Cooking Dipyridamole, tartaric acid and the indicated glycolate are subjected to water granulation using polyvinylpyrrolidone in the form of a 10% alcohol solution, followed by drying. The obtained granules with a size of 0.1-1.25 mm are mixed with magnesium stearate and the mixture is pressed into two-folded two-dummy products with a diameter of 9 mm, on which, in order to give the tablet a pleasant taste, a coating of hydroxypropylmethylcellulose is applied. The release of dipyrgvdamol is determined analogously to example 1. At the same time, the following results are obtained: preparation. Dipyridamole is mixed with fumaric acid and the mixture is subjected to wet granulation using polyvinylpyrrolidone in the form of a 10% alcohol solution. After drying, the granules of size O, 11, 5 mm are mixed with the other components and the mixture is pressed into 8 double round convex products with a diameter of 8 mm, to which, in order to make a tablet of pleasant taste, is coated with hydroxypropyl methylcellulose. The release of dipyridamole is determined in a manner similar to Example 1. The following results are obtained: Example 14. Dipyridamole tablets with 60 mg of fumaric acid, provided with a coating. Example 13 is repeated, with the difference that dipyridamole is mixed with all components and the resulting mixture is granulated to grains of 0.4-1.0 mm in size. I Obtain the following results on the release of dipyridamole: Comparative example I. Repeat example 5 with the difference that the FuMapOBno acid is used in a quantity of 7.7 kg (86.2 equivalents of 4 eq valence per mole of dipyridamole). The following results are obtained on the release of dipyridamole: Comparison of the results of example 5 and 1 suggests that in therapy 3 we can expect a good therapeutic effect, since for all 13 38 values of the pH of the medium between the periods of 50% more than 90% - the release does not matter a large time interval, whereas in example 1 it is expected: a) an unsatisfactory therapeutic effect due to a comparative time interval from 50% to 90% release of dipyridamole at pH 1.2; b) insufficient therapeutic effect at pH 4.0 and 6.0, and the time interval between the 50% and 90% release of dipyridamole also shows large fluctuations in its blood level. Comparative example II. Example 5 is repeated, with the difference that fucolichimeric acid is used in a weight of 7.7 kg (86.2 equivalents of 4 equivalents per mole of dipyridamole) and the mixture is granulated to a grain size of 0.01-0.99 mm. The following results are obtained on the release of dipyridamole: pH Comparison of the results of comparative examples I and II shows that, if there is a ratio of dipyridamole and an acidic substance, less than the claimed lower limit, and grains outside the limits of comparative example 1, wherein the grain size is still within the specified limits, is still deteriorating. Comparative example III. Example 4 is repeated, with the difference that the umaric acid is used in a quantity of 181.26 kg (3125.1 equivalent to 35 equivalents per mole of dipiidamol). At the same time, the following results are obtained on the release of ipiridamol: that when transient
    of the upper limit of the ratio of the pH of 50% to 90% of dipyridamole and acidic substances positive effect
    almost no further enhances - 4.0 86 min 300 min
     6.0 90 min 320 min
    Comparative example IV. Repeated Comparison of the results of Example 7 is shown in Example 7, with the difference that Comparative Example IV is mixed granularly to the grains. It is noted that when using 2.0–3.0 mm, the following results are obtained. by release-limits, the release characteristic of dipyridamole: nor dipyridamole is significantly impaired.
    权利要求:
    Claims (1)
    [1]
    METHOD FOR OBTAINING DIPYRIDAMOL ORAL DRUG by mixing it with an auxiliary substance followed by granulation, characterized in that, in order to reduce fluctuations in its blood level, dipyridamole is first mixed with an acidic substance in the amount of 5-30 equivalents per 1 mol of dipipidamole, and the resulting mixture granulate to a grain size of 0.1-2.0 mm
    类似技术:
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    同族专利:
    公开号 | 公开日
    JPH0251402B2|1990-11-07|
    FI822173L|1982-12-20|
    EP0068191A2|1983-01-05|
    IL66075A|1985-09-29|
    GR76503B|1984-08-10|
    DK269682A|1982-12-20|
    NZ201008A|1985-11-08|
    AU555951B2|1986-10-16|
    GB2101484B|1984-09-19|
    FI80829B|1990-04-30|
    MY8700727A|1987-12-31|
    EP0068191B1|1986-01-08|
    ES513235A0|1983-03-16|
    PT75077A|1982-07-01|
    DK158540C|1990-11-12|
    IE53543B1|1988-12-07|
    AR228779A1|1983-04-15|
    DE3124090A1|1983-01-05|
    PH25637A|1991-08-21|
    EP0068191B2|1991-09-11|
    FI80829C|1990-08-10|
    DE3268380D1|1986-02-20|
    KR880001090B1|1988-06-23|
    ZA824315B|1984-02-29|
    EP0068191A3|1983-08-10|
    IL66075D0|1982-09-30|
    AU8496582A|1982-12-23|
    DD202505A5|1983-09-21|
    CA1200496A|1986-02-11|
    US4427648A|1984-01-24|
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    HU186078B|1985-05-28|
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    FI822173A0|1982-06-17|
    KR840000229A|1984-02-18|
    AT17317T|1986-01-15|
    IN158513B|1986-11-29|
    MA19503A1|1982-12-31|
    PT75077B|1985-05-31|
    DE3124090C2|1991-11-21|
    DK158540B|1990-06-05|
    IE821453L|1982-12-19|
    GB2101484A|1983-01-19|
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    DE3124090A|DE3124090C2|1981-06-19|1981-06-19|
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