TWI301414B - Rapid onset medical composition and manufacturing method - Google Patents

Description

1301414 IX. INSTRUCTIONS OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention is directed to a quick-acting pharmaceutical composition and a process for its preparation, particularly in the form of a film-coating bond, which has an age of __, face toj ^_M(dGxylamine succinate) and vitamin B6 (pyrid〇Xine HC1) are referred to as "Ds p" in this specification. Ds_p is suitable for treatment and vomiting. It is especially effective, but it is not limited to the treatment of morning sickness. In the following, the heart and vomiting during pregnancy is called "NW". So the present invention is different from? It is now related to the indications for treatment. [Prior Art] The pharmaceutical formulation of DS-P is well known. The formula used today, manufactured in the Canadian market under the name of Diclectinpuchesnay, contains the following active ingredients, vitamin B6 and deoxygenated amine-acid salts, as well as additional excipients, lactose, microcrystals. Cellulose, magnesium tricaprate, cerium oxide, and magnesium stearate. Regarding medication safety during pregnancy, Diclectin^ is one of the most widely studied drugs in the world. Due to its excellent safety, Didectin is particularly suitable for the treatment of Nvp. The current formula is outsourcing sugar coatings, but there are many disadvantages, one of which It is the slow effect of the drug. After the current formula is taken, it may take more than 4 hours for the two active ingredients (vitamin and deoxygenated succinate) to be almost completely dissolved in the small intestine, and New Intestine Wei. This extended-time patient, such as a woman who suffers from NVP's urgent need to relieve symptoms, is too long. Another disadvantage of current formulations is related to the patient's suitability for the drug. Many women who suffer from Nvp complain that their money is overly sensitive, so that all tastes or smells can cause vomiting. At present, the scent and taste of the sugar-coated formula, as well as the organic 1301414 Ling and the benzene-method used in the preparation of the film-coated ship towel, are not available to women at all. The size of the marketed u is also a problem. Smaller drug keys can improve the patient's adaptability, because women who suffer from NW often have money to swallow. Moreover, smaller tablets may appear to be less harmful, and patients will have an impression that they are taking less dose. This will further enhance the patient's adaptability. Finally, the current (four) formula contains lactose, which can cause discomfort to patients with lactose. Therefore, for patients suffering from vomiting and vomiting, there is a need for an improved quick-acting pharmaceutical composition and a process for its preparation to improve the shortcomings of the known formula. However, because DS-P is an oral enteric ingot, the new formula should pass through the stomach without damage, and when the agent reaches the target, that is, the small intestine, it can quickly release two active ingredients. SUMMARY OF THE INVENTION The main problem to be overcome by the present invention is that it is required to reach the working organ in the form of a dosage form to improve the deficiency of the conventional formula, and at the same time release two synergistic active ingredients for rapid drug efficacy. . Further, the present invention also provides a pharmaceutical composition in which the dissolution profiles of the two active ingredients are similar, so that the effect of dissolving one of the active ingredients first and damaging the other ingredient can be avoided. This is important for the two active ingredients that work synergistically. In general, the present invention provides a novel liquid film-coating pharmaceutical composition comprising DS_p, the dissolution profile of which is shown to be rapid in its efficacy. The present invention also provides a pharmaceutical ingredient which has a special dissolution profile in the test tube, indicating that its active ingredient acts rapidly. This pharmaceutical ingredient is simple and reproducible. The utility of the invention will be more apparent from the detailed description which follows. However, the detailed description of the preferred embodiment of the present invention is intended to be illustrative of the preferred embodiments of the present invention. [Embodiment] The objects and other features of the present invention will be more readily and easily understood from the following detailed description of the preferred embodiments illustrated. Broadly, the present invention provides a quick-acting pharmaceutical composition and a process for the preparation thereof comprising a vitamin B6 and a deoxyhydroxylamine succinate. The pharmaceutical composition of the present invention can be applied to human and veterinary medicine as a symptom for treating nausea and/or vomiting. Since the pharmaceutical composition of the present invention is used for medical purposes, the composition of the pharmaceutical composition must be based on pharmaceutical principles. A preferred pharmaceutical composition is formulated as an oral preparation such as a pill, a capsule or an oral solution. The preferred dosage form is a keying agent. The pharmaceutical composition of the tablet is relatively non-destructive. In order to test this property, the tablet of the pharmaceutical composition is placed in a gastric acid solution (SGF) for at least one hour to test its resistance to gastric acid decomposition. According to the present invention, the crane composition is required to satisfy the following dissolution impurities, and a second type dissolver is used in a citrate buffer of a pH of 6.8 in a milliliter acid test at 37 degrees Celsius (type-η 响 -, per In minutes (10), the dissolution measurement is performed; it is best to use the high performance liquid chromatography method to measure. (a) After 30 minutes of measurement, there are at least 4 〇. The vitamin B6 & deoxylamine succinate is completely dissolved. (b) In the 60 minutes of the test, j small right 7〇% from the Jun to the evening. Vitamin B6 and deoxygenated aminosuccinic acid The salt is completely dissolved. 1301414 At least 8G% of vitamin B6 and deoxyazepine have at least 90% of vitamin B6 and deoxygenated by amine (C). After 9 minutes of measurement, the sodium salt is completely dissolved. (4) The succinate is completely dissolved after 120 minutes of measurement. The dissolution curve mentioned in the present invention refers to the use of the United States Pharmacopoeia in a sulphate buffer of ML acid test at 37 ° C. Just the second type of dissolver, the result of the dissolution test in the case of a sub-rotation per minute. High performance liquid chromatography analysis. As mentioned in the above and the scope of the patent, "enteric coating" refers to the outer garment containing one or more layers that are resistant to human gastric acid decomposition but in the human intestinal fluid. Decomposition, or refers to a multi-layer outer garment, the decomposition rate of the stomach acid towel in the human body is very slow, but in the small intestine (four) is much faster. In a broad sense, * the intestinal coating * includes any coating on the outer surface of the ingot before coating the film coating The layer on the core, and after coating the film, covers the outer layer on which the appearance is modified. In a preferred embodiment, the pharmaceutical composition of the invention comprises a core, overlying a liquid enteric film coat. ^Including active ingredients of vitamin B6 and deoxygenated succinyl salt, and non-pharmaceutical excipients such as fillers, or binders, disintegrating agents, lubricants, turbulence regulators (silicafl〇w conditioner), And stabilizers. For example, acacia, alginate acid can be used as a filler or a binder. Calcium carbonate (binary) carboxymethylcellulose (car) 3〇Xymethyiceiiui〇se), carboxy Carboxymethylcellulose sodium, hydroxyethylcellulose Hydroxypropylcellulose, hydroxypropylcellulose hydroxypropylcellulose, hydroxypropylmethylcellulose hydr〇xypr〇pyl methylcellulose, dextrin, dextrin, sucrose, methylcellulose (tyl〇se), pre-adhesive 1301414 Pregelatinized starch, sulfuric acid, amylase, glycine, bentonite, maltose, sorbitol, ethyl cellulose, disodium hydrogen phosphate, Disodium phosphate, disodium pyrosulfite, polyvinyl alcohol, animal glue, grape vine, Guar Gum, liquid glucose, compressible sugar, town Magnesium aluminum silicate, maltodextrin (11^11:0 (16乂11), polyoxyethylene (^〇15^1:11) 46116 0乂丨(16), polyacrylic acid 6 (polymethacrylate), povidone, sodium alginate, tragacanth microcrystalline cellulose, starch, alcohol-soluble protein (zein). The most preferred filler, or binder, is microcrystalline cellulose. As a disintegrating agent, for example, alginic acid, carboxymethylcellulose, carboxymethylcellulose sodium, hydroxypropylcellulose hydroxypropylcellulose (low substitute), microcrystalline cellulose ( Microcrystalline cellulose), powdered cellulose, colloidal silica, evening cross-bonded sodium croscarmelose, (crospovidone), methylcellulose, amber stone (polacrilinpotassium) Povidone, sodium alginate, sodium starch glycolate, disodium disulfite, chelating agents disodium edathamil and disodium edatate, ethylenediamine acetate di-sodium salt (EDTA), crosslinked polyvinylpyrollidine, pregelatinized starch, carboxymethyl starch, sodium carboxymethyl starch, microcrystalline cellulose (microcrystalline cellulose). The best disintegrating agent is cross-bonded sodium carboxymethylcellulose 1301414 (sodium croscarmelose). It can be used as a lubricant such as calcium stearate, canola oil, glycerin brown stearin. Acid, hydrogenated vegetable oil (type 1), magnesium oxide, magnesium stearate, mineral oil, active surface cleaner (poloxamer), polyethylene glycol, sodium lauryl sulfate, butylene diacid Sodium stearate fUmarate, stearic acid, talc, zinc stearate, glyceryl behapate, magnesium laurate, boric acid, sodium benzoate, sodium acetate, sodium benzoate/acetic acid Sodium mixture, DL-leucine. The best lubricant is the town of stearic acid. It can be used as a turbulence rate regulator, such as colloidal cerium oxide, aluminum magnesium silicate, and Guar Gum. The best regulator is cerium oxide. It can be used as a stabilizer for example, acacia, albumin, polyvinyl alcohol, alginic acid, bentonite, dicalcium phosphate, carboxymethylcellulose, hydroxypropylcellulose. , colloidal cerium oxide, cyclodextrin, glycerol monostearate, hydroxypropylmethylcellulose (Hydr〇xypr〇pyl Methylcellulose), magnesium tricaprate, magnesium aluminum citrate, propylene glycol , alginate propylene glycol, sodium alginate, palm wax, Xanthangum, starch, stearate, stearic acid, glyceryl stearate, octadecanol. The best stabilizer is magnesium tricaprate. In a preferred embodiment, the core of the new quick-acting pharmaceutical composition of Diclectin contains about 4. /0 to 10% of vitamin B6, the optimum ratio is 7% by weight; about 4% to 10% of deoxyhydroxyl succinate, the optimum ratio is 7%; about 40% to 80% of microcrystalline cellulose The optimum ratio is 62〇/〇; about 10% to 30% of magnesium tricaprate, the optimum ratio is 18%; about 5% to 5% of cerium oxide, 1301414, the optimal ratio is 1%, 0 • 5% to 5% of sodium croscarmelose, with an optimum ratio of 3%; and about 0.5% to 5°/. The optimum ratio of magnesium stearate is 3%. An example is 145 mg of Diclectin fast-acting core pharmaceutical composition. Table 1: Core component weight mg/ingot weight%/key batch 100g deoxyhydroxyl succinate 10.0 6.9 6.897 Vitamin B6 10.0 '6.9 6.897 Magnesium tristearate 26.4 18.2 18.207 Microcrystalline cellulose PH102 90.0 62· 1 62.069 Cross-bonded sodium carboxymethylcellulose type A 3.6 2.5 2.483 Magnesium stearate 4.0 2.8 & 59 cerium oxide NF 1.0 0.7 0.690 Total 145.0 100 100 — NF Refers to national prescription (National Formulary) The core is coated with a liquid casing film, allowing the pharmaceutical composition to pass through the stomach without damage and dissolve rapidly in the small intestine. The outer coat is prescribed as follows: Table 2: Applicator component weight mg/ingot weight % Batch 100g Intact film OpadryTMClear YS-1-7472 4.82 3.33 3.327 Purified water USP (United States Pharmacopoeia) Total 4.82 3.33 3.33 Casing film - Estacryl TM30D casing solution 39.58 27.29 27.294 Talc USP 200 Mesh 2.85 1.97 1.968 Polyethylene glycol 400USP 1.20 0.83 0.826 Anti-foaming agent 0.12 0.08 0.081 Pure water USP (United States Pharmacopoeia) 1301414

Total 116.04 coated, film OpadryTM White YS-1-7003) [1 61 watt water USP (United States _

EstacrylTM 30D contains 30% solids and, therefore, in the intestinal coating. The total weight of the lozenge covered with the outer garment was 167.47 mg. The purpose of the seal coat is to provide a smooth surface of the casing film, so as to avoid uneven dents, cracks, etc., which may result in unevenness of the film coat. Dissolution data The dissolution profile of the above-mentioned fast-acting pharmaceutical composition in the test tube is shown in the following Table 3. In a phosphate buffer of 6.8 ml of pH 6.8, at 37 ° C, using a second type of dissolver per minute 1 Twist and measure. The value is a percentage indicating the amount of dissolved active ingredient compared to the initial amount. Table 3: Dissolution curve Vitamin B6 1st, 2nd, 3rd, 4th, 5th, 6th, 5th, 20th, 2nd, 2nd, 5th, 20th, 20th, 20th, 79th, 79th, 1st, 1st, 9th, 9th, 9th, 9th, 9th, 90th, 90th, 94th, 95th, 92nd, 96th 96 94 94 95 96 95 30 minutes 95 98 96 95 98 -------— 96 96 45 minutes 97 96 97 94 99 98 97 Deoxylamine succinate 1st, 2nd, 3rd, 4th 5th, 6th, average, 5 points, 17 2 0 70 75 76 40 10 minutes 90 87 89 89 97 96 91 15 points 98 97 96 92 98 97 96 30 points 97 98 96 94 99 97 97 45 points 98 96 98 92 100 ~ 99 97 The first time back to the third time, after 5 minutes from the start of the test, the extremely low dissolution rate was explained by the fact that the core of the pharmaceutical composition did not collapse during the 5-minute period. Examples of Manufacturing Methods The pharmaceutical compositions of the present invention can be prepared using the ingredients in Table 1 above. Deamination of the amine boroperic acid 12 1301414 salt and cerium oxide NF were pre-loaded into a 2 cubic foot V-type mixer. The resulting pre-mixed mixture was sieved into a powder using a Quadro Co Mill Model 196S with a 40 mesh wire mesh. . Vitamin B6 was also ground into a powder using a Quadro Co Mill 196S with a 40 mesh mesh screen. The ground vitamin B6 is then mixed with the deoxyhydroxylamine/ceria NF premix. The microcrystalline cellulose was ground with a sieve of 40 mesh wire mesh and roughly divided into two equal portions. One of them was combined with a previously prepared mixture of the two active ingredients, added to a 65 Å GalkyBin mixer, followed by another aliquot of microcrystalline cellulose. After mixing all the additives, add the three-stone acid-acid town and the cross-bonded financial base fiber, the vitamin steel (80 out __〇61〇), mix the newly formed mixture; add magnesium stearate After that, mix again to complete the preparation of the core formulation. The final mix (four) Cheng ingot type, the joint to (10), re-made the market can be liquid film coating, and finally the surface is recoated - the outer layer to modify the appearance. Figure 2 depicts the overall manufacturing process. All the coating process of the outer coating process refers to the opadry white titanium dioxide (colored coating layer) covered by m ^ , #(pe^ pump)0, Mli (coater pan) on the core surface of the drug. Example 2 The following is another example of a 145 mg Diclectin fast-acting core formulation. The manufacturing method of this formulation is the same as described in the example--. This example shows that the pharmaceutical composition of the present invention has a quick-acting property even when a different type of excipient is used. Table 4: Core Ingredients ^ Weight / / Key Weight % / Bond Deoxylamine succinate 10.5 — 7.2 " 13 1301414 Vitamin B6 10.5 7.2 Magnesium triacetate 30.0 20.6 Microcrystalline cellulose PH102 65.0 44.5 Calcium phosphate (two RMB) 25.0 17.1 Magnesium stearate 4.0 2.7 Colloidal cerium oxide 1.0 0.7 Total 146.0 100 Table 5: Applicator composition Weight/per spindle (mg) OpadryTM White YS-1-7003 4.38 Anti-foaming agent AF Emulsion 0.07 Sureteric YAE -6-18107 16.06 Pure Water USP (United States Pharmacopoeia) OpadryTM Clear YS-1-7472 0.73 The total weight of the coated lozenge is 167.24 mg. The dissolution profile of the aforementioned quick-acting pharmaceutical composition in a test tube is shown in the following Table 6. The measurement is carried out in 1000 ml of phosphate buffer having a pH of 6.8 at 37 ° C using a second type dissolver at 100 rpm. . The value is a percentage indicating the amount of active ingredient dissolved. Table 6: Dissolution curve Vitamin B6 1st, 2nd, 3rd, 4th, 5th, 6th, average, 15 points, 17 13 25 31 17 22 21 30 minutes 31 28 60 63 36 43 43 45 points 51 45 78 80 55 60 61 60 points 69 64 88 89 67 72 75 75 points 79 76 94 94 77 81 83 90 points 84 84 97 97 77 81 83 105 points 88 89 98 99 87 90 92 120 points 91 93 98 98 89 92 93 Go Deoxylamine succinate 1st, 2nd, 3rd, 4th, 5th, 6th, average, 15 points, 16 14 22 31 47 61 32 30 minutes 31 27 64 63 38 40 44 45 minutes 47 44 75 79 58 61 61 60 points 71 61 90 85 68 74 75 75 points 76 71 96 89 81 82 82 90 points 85 80 101 88 83 81 86 14 1301414 105 points 92 86 103 95 93 92 93 120 points 93 88 101 96 96 95 y 95 The conclusion drawn from these results is that the new pharmaceutical composition shows that the efficacy of the drug is extremely fast, as shown by the dissolution curve. Vitamin B6, after starting measurement, has an average dissolution rate of over 9〇% within 12〇. Similarly, deoxyhydroxyl succinate was dehydrated and the average dissolution rate was over 90% within 12 minutes from the start of the measurement. Example 3 (using a conventional formulation as a control group) The following is an example of a conventional Diclectin formulation, which is an I46.2 mg heavy lozenge. This example shows the dissolution starting point of the conventional formulation, which is significantly slower than the present invention. Table 7: Core Ingredient Weight mg/ingot Weight %/Ingot η Vitamin B6 11.0 Ts Deoxygenated Aminosuccinate 10.2 7.0 --, Lactose NF 25.0 17.1 Microcrystalline Cellulose NF 65.0 44.4 Magnesium Trinitrate 30.0 20.6 —~ ~, cerium oxide 1.0 0.7 Magnesium stearate 4.0 2.7 ~ ^ Total 146.2 100 ^ The outer coating formula is as follows. Table VIII. Coating Formula _Ingredients _ Coating Solution Νο·714 Coating PowderNo.303 CAP solutionlO% CAP solution 5% Colloidal Solution No .105 Dusting Powder No.755 White Smoothing Syrup Syrup No.lll 15 1301414 _Opalux AS-7000-B White Wax Solution No.^ The dissolution profile of the above-mentioned formula used in the test tube is shown in Table IX below. Measure the concentration of 6.8 ml of phosphate buffer at 3.7 ° C using a second type dissolver at 100 rpm. The value is a percentage indicating the amount of active ingredient dissolved. Table 9: Dissolution curve () 1st, 2nd, 3rd, 4th, 5th, 6th, average, 15 points, 9 11 18 11 16 12 13 30 minutes 22 23 32 25 28 23 1·___ 25 45 points 37 34 45 39 42 34 38 60 points 50 44 56 49 51 44 ----- 49 90 points 69 63 73 69 67 63 67 120 points 83 76 84 82 80 76 80 150 points 94 86 91 91 86 86 89 180 points 94 98 '96 fo 92 95 — 240 points 93 93 100 100 99 101 98 Deoxy-hydroxylamine amber from --------- — J 1 back to the 2nd, 3rd, 4th, 5th, 6th Level 15 minutes 12 15 17 8 18 16 14 — 30 minutes 17 5Γ 31 18 27 30 24 — 45 minutes 24 32 45 25 38 38 34 ~ 60 points 34 41 56 36 46 49 44 90 points 52 55 69 55 62 66 6〇 ~ Deoxylamine succinate 1st, 2nd, 3rd, 4th, 5th, 6th, average, 120 points 69 65 75 68 71 75 1 J ISL 71 — 150 points 1 ΟΛ 8 80 74 80 78 79 82 79一一o (J yj /V ' ·~ 82 78 86 82 80 84 82 —^ 241) 分/tt Λ 1_ m ^ . 95 89 89 82 80 87 —---, 87 Push from 5^ The conclusion is a conventional formula. Compared to the new formula, the dissolution is quite slow. In fact, after 90 minutes, the average is only 6〇% of amine-deoxy go and do 67% plus vitamin solution. A slow dissolution profile in the test tube indicates a slow effect of the drug. The new formulation, as shown in Examples 1 and - shows a rather rapid dissolution profile, resulting in a rapid pharmacodynamic effect. The new formula overcomes the big drawbacks, though not all, the shortcomings of conventional formulations. 16 1301414 As described here; Μ and description is Wei british _, turn to _ the invention, know that this artist _ she # 继. Outline (4) ★ Variants,, and are covered by the following patent applications. In summary, the case is not only new in space (4), but also able to (4) use the articles to enhance the above-mentioned multiple functions. 'It should have fully complied with the statutory requirements for novelty and progressiveness _ patent requirements, Mai applied for it according to law, and you are requested to approve This new type of patent application, in order to invent, to the sense of building. BRIEF DESCRIPTION OF THE DRAWINGS Fig. - shows the dissolution profile of two embodiments of the invention, compared with the dissolution profile of the formulation. The first strip dissolution curve of the present invention (Example D shows that almost all of the two active ingredients are released within 45 minutes. The second dissolution profile of the present invention (Example 2) shows that within 12 minutes, About 95% of the two active ingredients are released. Finally, the dissolution curve of the current formula shows that in about 24 minutes, about 100 〇 / 〇 of vitamin B6 and 9 〇 % of deoxygenation The amine succinate is released; and Figure 2 is a simplified flow chart of the manufacturing process of the preferred embodiment of the pharmaceutical composition of the present invention.

Claims (1)

1301414 9? - ;. ·- ' X. Patent application: a quick-acting pharmaceutical composition, including a core, surrounded by an outer casing, the main components of which are vitamin B6 and deoxyhydroxyl succinic acid. a salt comprising a disintegrating agent consisting of more than one of the following components: sodium carboxymethylcellulose, alginic acid, carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropylcellulose (low Substituted), microcrystalline cellulose, powdered 'Davi's cerebral oxidized cerium oxide, methyl cellulose, amber stone, povidone, sea vine vinegar I; Sodium, chelating agents disodium edathamil and disodium edatate, ethylenediamine acetate disodium salt (EDTA), cross-bonded poly & alkenyl, pregelatinized starch, methylol starch, sodium hydroxymethyl starch, microcrystalline Cellulose; the quick-acting pharmaceutical composition has a dissolution profile when measured in a phosphate buffer solution of 6.8 ml of pH 6.8 at 37 ° C using a second type dissolver at 100 rpm. Meet the following: (4) After measuring for 3 minutes, at least 4%% of vitamin Μ and de-deoxidized surface chlorpyrifosate completely dissolved; (b) After 60 minutes of measurement, at least 7% of the amount of vitamins and deoxygenated amine boroperate completely dissolved; (0) After 90 minutes of measurement, at least 80% of the vitamins and deoxygenated amines are completely dissolved; and (d) at least 9% after 120 minutes of measurement μ人^ Knife 攸 啕 啕 〇 〇 〇 的 的 的 及 及 及 及 及 及 及 及 及 及 及 及 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. 2. In the citrate buffer of 8 °C at 37 °C, the second dissolution mode is used to measure the melting characteristics per minute. The dissolution curve meets the following dissolution characteristics: 1301414 (a) After 15 minutes of measurement, At least 20% of the vitamin B6 and deoxyhydroxylamine 1 acid salt are completely dissolved; (b) at least 60% of the vitamin B6 and deoxyhydroxylamine succinate are completely dissolved after 45 minutes of measurement; (c) At least 80% of the amount of vitamins beta 6 and detached after 75 minutes of measurement The oxyhydroxylamine succinate is completely dissolved. The quick-acting pharmaceutical composition according to claim 1 or 2, wherein in the (7) (8) ml of phosphate buffer having a pH of 6.8, at 37 ° C, the second type is dissolved. When the lake is rotated every minute, at least 40% of the total amount of vitamin β6 and deoxyhydroxyl succinate will dissolve in 5 minutes. 4. Quick-acting medicine as described in the second or second patent application. a composition, wherein the core further comprises a filler or binder, a lubricant, a turbulent flow cycle regulator, and a stabilizer; the filler or binder is composed of more than one of the following components : microcrystalline cellulose, calcium phosphate (binary), gum arabic, alginic acid, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl fiber Dextrin, dextrin, sucrose, methylcellulose, pregelatinized starch, sulphate, amylose, glycine, bentonite, malt mash, sorbitol, ethyl cellulose, phosphoric acid Hydrogen di-nano Salt, sodium bisulfite, polyethylene glycol, animal glue, glucose, Guar Gum, liquid grape vine, compressible bismuth, magnesium aluminate, maltodextrin, polyoxyethylene, polyacrylic acid An oxime ester, povidone, sodium alginate, goat thorn gum microcrystalline cellulose, temple powder, alcohol soluble protein (zein); the lubricant is composed of more than one of the following components 19 1301414: stearic acid Magnesium, calcium stearate, canola oil, glycerin palm stearic acid, hydrogenated vegetable oil (type 1), magnesium oxide, mineral oil, active surface cleaner (poloxamer), polyethylene glycol , sodium laurate sulfate, sodium butyrate, stearic acid, talc, zinc stearate 'glycerin, magnesium laurate sulfate, boric acid, sodium benzoate, sodium acetate, sodium benzoate / sodium acetate mixture, DL-leucine; the Shishi flow rate regulator consists of more than one of the following components: cerium oxide, aluminum magnesium citrate, Guar Gum; the stabilizer is more than one or less Composition of ingredients: Sanshixi acid town, gum arabic, albumin, polyethylene Alginic acid, bentonite, diammonium phosphate, m-mercapto cellulose, propyl cellulose, colloidal silica, cyclamate, glyceryl monostearate, propylmethylcellulose, stone Xishou Shaozhen, propylene glycol, propylene glycol alginate, sodium alginate, brown (four), Sanxianjiao, temple powder, stearate, stearic acid, glycerol citrate, octadecyl alcohol. Wherein the filler or the junction wherein the disintegrating agent is composed of a lubricant in which the turbulent flow rate is circulated, wherein the stabilizer is a mixture of the quick-acting pharmaceutical composition as described in claim 4 of the patent application scope Crystal cellulose composition. 6. A quick-acting pharmaceutical composition as described in the scope of claim 2, comprising a cross-bonded sodium carboxymethylcellulose. 7. A quick-acting pharmaceutical composition as described in claim 4, which is composed of magnesium stearate. 8. The quick-acting pharmaceutical composition according to claim 4, wherein the regulator is composed of cerium oxide. 9. A quick-acting f-drug composition as described in claim 4 of claim 5, consisting of magnesium sulphate. The fast-acting pharmaceutical composition according to claim 1 or 2, wherein the core comprises: (a) about 4% to 10% by weight of vitamin Β6; (b) about 4% to 10% Percent by weight of deoxyhydroxylamine succinate; (c) from about 40% to 80% by weight of microcrystalline fibers; (d) from about 10% to 30% by weight of magnesium tricaprate; (e) about 0.5 % to 5% by weight of cerium oxide; (f) about 0.5% to 5% by weight of intercalated sodium carboxymethylcellulose; and (g) about 0.5% to 5% by weight of stearic acid magnesium. 11. The fast-acting pharmaceutical composition according to claim 10, wherein the core comprises: (a) about 7% by weight of vitamin B6; (b) about 7% by weight of deoxyhydroxylamine succinate; (c) about 62% by weight of microcrystalline fibers; (d) about 18% by weight of magnesium tricaprate; (e) about 0.7% by weight of cerium oxide; (f) about 2.5% by weight of Indole carboxymethyl cellulose sodium; and (g) about 2.8% by weight magnesium stearate. 12. The quick-acting pharmaceutical composition of claim 1, wherein the outer casing comprises: an inner membrane overlying the core; a casing film coated on the inner membrane; 21 1301414 A finishing film covering the outer layer of the enteric film. 13. The instant pharmaceutical composition of claim 12, wherein the outer casing has at least one film that is a liquid film. 14. A fast-acting pharmaceutical composition according to claim 1 or 2, which is for use in relieving sputum sputum and sigma vomiting in a mammal. 15. The quick-acting pharmaceutical composition according to claim 1 or 2, which is used for alleviating nausea and 11-stage spitting symptoms during pregnancy. 16. A method for preparing a quick-acting pharmaceutical composition for use in preparing a quick-acting pharmaceutical composition as described in the scope of the patent application, the method comprising the following steps: • mixing deoxyhydroxyl succinate and a turbulent flow cycle regulator, Forming a pre-formed mixture; • blending the preformed mixture with vitamin B6 to form a mixture of active ingredients; • further mixing the active ingredient with a non-pharmaceutically effective excipient such as a filler, or a binder, a disintegrating agent, a lubricant, And stabilizers, blended together to form the final mixture; and • the final mixture is made into a bond and the outer film is applied. 17. The method of preparing a quick-acting pharmaceutical composition according to claim 16, wherein the final step of forming the suspect and the film comprises compressing the final mixture into an ingot form, followed by coating the inner film, and then coating the liquid film coat. Then apply a colored layer. twenty two