A method for preparing a furosemide tablet

Abstract

The application provides a preparation method of fudosteine tablets and belongs to the technical field of pharmaceutical preparations. The application provides a preparation method of fudosteine tablets, which adopts water as a lubricant, and solves the existing problem of poor fluidity in the granulation process by wet granulation under the formula of the application, and the obtained tablets and the original preparation have good dissolution consistency. The fudosteine tablets prepared by the technical scheme of the application have a significantly smaller rest angle relative to the raw material, and the water content is less than or equal to 2%. The fudosteine tablets prepared by the technical scheme of the application have good fluidity and good compressibility, and the appearance is a smooth white to white-like round tablet, which improves the compressibility of the product and the product pass rate, reduces dust and reduces the production risk. The preparation process of the technical scheme of the application is smooth, the shape of the prepared fudosteine tablets is good, and the dissolution behavior conforms to the in-vivo absorption process of the drug.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of pharmaceutical preparations, and particularly relates to a preparation method of fudosteine tablets. BACKGROUND

[0002] Fudosteine is a kind of cysteine derivative with expectorant and mucous sputum dissolving effect, and is mainly used for the treatment of bronchial asthma, chronic asthmatic bronchitis, bronchiectasis, pulmonary tuberculosis, pneumoconiosis, emphysema and other long sputum and chronic cough diseases. The main dosage forms include tablets and oral solutions.

[0003] The patent CN1155373C discloses a prescription composition and a preparation method of fudosteine original preparation. In the prescription, the content of fudosteine raw material is up to 90%, and the content of auxiliary materials is low. The fudosteine tablets are prepared by mixing the raw materials with a V-type mixer and then using a tablet machine, so that the discoloration problem of fudosteine after long-term storage is solved. However, the content of raw materials is high in the preparation method, and the total mixed granules have poor flowability and compressibility due to the direct compression of mixed powder.

[0004] The patent CN1463698A uses sodium carboxymethyl starch as a filler to solve the discoloration problem of fudosteine after long-term storage. However, the high-viscosity sodium carboxymethyl starch as a binder is difficult to obtain, and the flowability and compressibility of mixed powder cannot be improved due to the direct compression of mixed powder, which inevitably causes production problems.

[0005] The patent CN101152172B provides a pharmaceutical composition containing fudosteine. The content of fudosteine raw material in the pharmaceutical composition is only 26.7%, the tablet weight is large, the content of auxiliary materials is high, and the production cost is increased. Swallowing is difficult, and the treatment compliance is poor.

[0006] The patent CN115624535A provides a preparation method of fudosteine tablets. The method uses 50% ethanol as a wetting agent to improve the flowability and compressibility of fudosteine raw materials. However, the method needs to screen the fudosteine raw materials, and the process is complex. The use of ethanol as a wetting agent is not environmentally friendly and increases the production cost. The patent CN102908328A uses 95% ethanol as a wetting agent to prepare fudosteine tablets, which increases the content of auxiliary materials by more than 16.4% compared with the original preparation, and increases the production cost.

[0007] The patent CN100404026C provides a pharmaceutical composition containing fudosteine, fillers and various auxiliary materials, and a preparation process thereof. The prepared granules have good flowability and strong compressibility, and the discoloration problem of fudosteine after long-term storage is solved. However, the content of auxiliary materials is high in the preparation, the tablet weight of the prepared granules is large, the content of raw materials is only 33%-63.5%, and the production cost is increased. SUMMARY

[0008] In view of the above, the present application provides a preparation method of Fosfomycin tablets. The present application provides a preparation method of Fosfomycin tablets, which uses water with a specific content as a lubricant, and solves the problem of poor flowability in the granulation process in the prior art under the present application formula, and the obtained tablets and the original preparation have good dissolution consistency. The Fosfomycin tablets prepared by the technical scheme of the present application have a significantly smaller rest angle than the raw material drug, and the water content is ≤2%. The Fosfomycin tablets prepared by the technical scheme of the present application have a smooth white to white-like appearance, and the active ingredient content of the raw tablets is as high as 90% and above, and the flowability and compressibility are good, which improves the compressibility and product pass rate of the product, reduces dust, and reduces production risk. The preparation process of the technical scheme of the present application is smooth, and the Fosfomycin tablets prepared have good shape and dissolution behavior consistent with the in vivo absorption process of the drug.

[0009] The technical scheme of the present application comprises:

[0010] In one aspect, the present application provides a preparation method of Fosfomycin tablets, which comprises the following steps:

[0011] (1) premixing Fosfomycin raw material and corn starch to obtain a mixture 1;

[0012] (2) adding 12%-16.6% of purified water based on the total weight of the raw tablets to the mixture 1 of step (1), granulating, collecting the material, and sieving to obtain wet granules;

[0013] (3) sieving the wet granules after drying to a moisture content of ≤2%, adding talc and magnesium stearate, and then compressing to obtain raw tablets;

[0014] (4) coating the raw tablets of step (3) to obtain Fosfomycin tablets.

[0015] Specifically, the Fosfomycin raw material of step (1) has a particle size D90 of 200-450 μm, a D50 of 65-220 μm, and a D10 of 6-50 μm.

[0016] Specifically, the content of the Fosfomycin raw material of step (1) in the raw tablets is 90%-92%.

[0017] Preferably, the content of the Fosfomycin raw material of step (1) in the raw tablets is 90.91%-91.91%.

[0018] Further preferably, the content of the Fosfomycin raw material of step (1) in the raw tablets is 90.91% or 91.91%.

[0019] Further particularly, the purified water used in step (2) is 12%-13%, 13%-14%, 14%-15%, 15%-16%, 16%-16.6% of the total weight of the tablet.

[0020] Preferably, the purified water used in step (2) is 12%, 15%, 16.6% of the total weight of the tablet.

[0021] Particularly, the content of talc in step (2) is 0.1%-2.0% in the tablet.

[0022] Preferably, the content of talc in step (2) is 0.2%-1.0% in the tablet.

[0023] Particularly, the content of magnesium stearate in step (2) is 0.1%-2.0% in the tablet.

[0024] Preferably, the content of magnesium stearate in step (2) is 0.2%-1.0% in the tablet.

[0025] Particularly, the sieving in step (2) and step (3) is 20 mesh sieving.

[0026] Particularly, the hardness of the tablet in step (3) is 3-9 kg / cm 2 .

[0027] Particularly, the weight of the tablet in step (3) is 200-230 mg / tablet.

[0028] Further particularly, the weight of the tablet in step (3) is 200-210 mg / tablet; 210-220 mg / tablet; 220-230 mg / tablet.

[0029] Preferably, the weight of the tablet in step (3) is 220 mg / tablet.

[0030] Particularly, the drying in step (3) is to put the wet granules into an oven for drying.

[0031] Particularly, the moisture in step (3) is 0.1%-2.0%.

[0032] Particularly, the moisture in step (3) is 0.1%-0.2%, 0.2%-0.3%, 0.3%-0.4%, 0.4%-0.5%, 0.5%-0.6%, 0.6%-0.7%, 0.7%-0.8%, 0.8%-0.9%, 0.9%-1.0%, 1.1%-1.2%, 1.2%-1.3%, 1.3%-1.4%, 1.4%-1.5%, 1.5%-1.6%, 1.6%-1.7%, 1.7%-1.8%, 1.9%-2.0%.

[0033] Specifically, the coating weight gain in step (4) is 2%-5% of the total weight of the tablet.

[0034] Specifically, the coating weight gain in step (4) is 2%-5% of the total weight of the tablet.

[0035] In another aspect, the present application provides a furosemide tablet, which comprises furosemide 90%-92%; corn starch 6.18%-8.44%; talc 0.2%-1.0%; magnesium stearate 0.2%-1.0%; and tablet moisture ≤2%.

[0036] In another aspect, the present application provides a preparation method of the above furosemide tablet and the use of the furosemide tablet.

[0037] Specifically, the use is the use in the preparation of a drug for respiratory system diseases.

[0038] Preferably, the respiratory system diseases include bronchial asthma, chronic bronchitis, bronchiectasis, pulmonary tuberculosis, pneumoconiosis, emphysema, atypical mycobacterium infection, and diffuse bronchiolitis.

[0039] The technical effects achieved by the present application are as follows:

[0040] (1) The present application provides a preparation method of a furosemide tablet, and the furosemide tablet prepared by the technical scheme of the present application has a significantly smaller rest angle relative to the raw drug and a water content of ≤2%.

[0041] (2) The furosemide tablet prepared by the technical scheme of the present application has good flowability and compressibility, and has a smooth white to white-like round appearance, thereby improving the compressibility and product qualification rate of the product, reducing dust, and reducing production risk.

[0042] (3) The preparation process of the technical scheme of the present application is smooth, and the furosemide tablet prepared has a good shape and a dissolution behavior conforming to the in-vivo absorption process of a drug. DETAILED DESCRIPTION

[0043] The following non-limiting examples can enable those skilled in the art to have a more comprehensive understanding of the present application, but do not limit the present application in any way. The following content is only an exemplary description of the scope of the present application, and those skilled in the art can make various changes and modifications to the present application according to the disclosed content, and it should also belong to the scope of the present application.

[0044] When the embodiments give numerical ranges, it is understood that unless the disclosure specifically states otherwise, each numerical range's two endpoints, and any number that falls between the two endpoints, are optional. Unless otherwise defined, all technical and scientific terms used in the present disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0045] The present application is further described in the following specific examples. The various chemical reagents used in the examples of the present application were obtained from common commercial sources unless otherwise described.

[0046] Example 1-11

[0047] The commercially available furosemide bulk drug (purchased from Sichuan Xinkaiyuan Pharmaceutical Co., Ltd., item number HD230813) was subjected to the determination of the angle of repose, bulk density, tap density, and Karl coefficient according to the Chinese Pharmacopoeia 2020 edition, part IV. The specific results are shown in Tables 1-2.

[0048] Table 1 Determination of the angle of repose

[0049] Times 1 2 3 Average Rest angle / ° 60.3 61 60 60.3

[0050] Table 2 Determination of the bulk density, tap density, and Karl coefficient

[0051]

[0052] According to the determination of the angle of repose in Tables 1 and 2, the angle of repose is much greater than 45, and the Karl coefficient is also much greater than 25%, indicating that the bulk drug itself has poor flowability.

[0053] Example 1-11

[0054] The prescription of Example 1-11 is shown in Table 3.

[0055] Table 3 Prescription of Example 1-11

[0056]

[0057] Note: The content of furosemide, corn starch, talc, and magnesium stearate in the table is the percentage in the base tablet, and the amount of water and the coating weight gain are calculated based on the total weight of the base tablet.

[0058] The preparation process of Example 1-11 is as follows:

[0059] (1) Weighing: Weigh the prescribed amount of furosemide bulk drug, corn starch, magnesium stearate, talc, and purified water; among them, the particle size D90 of the furosemide bulk drug is 300 μm, D50 is 95.5 μm, and D10 is 13.8 μm.

[0060] (2) Premixing: Take the prescription amount of Fosfomycin raw material and corn starch into the wet granulator for premixing;

[0061] (3) Granulation: Add the prescription amount of purified water into the above mixture for granulation, collect the material through a 20 mesh sieve to obtain wet granules.

[0062] (4) Drying and sizing: Put the wet granules into an oven, dry at 60°C until the moisture content is ≤2%, then take out and sieve through a 20 mesh sieve to size.

[0063] (5) Total mixing: Add the prescription amount of talc and magnesium stearate and mix;

[0064] (6) Tabletting: Select appropriate tabletting parameters for tabletting, so that the tablet hardness is 3-9 kg / cm 2 , and the weight is 220 mg / tablet, to obtain Fosfomycin tablets.

[0065] (7) Coating: Open the spray gun and use a high-efficiency coating kettle for coating. When the coating weight increases to 2-5%, stop coating to obtain Fosfomycin tablets;

[0066] The coating liquid used for coating is purchased from Shanghai Kalikang Coating Technology Co., Ltd., with the product number 03K18416-CN.

[0067] Example 12

[0068] The difference between Example 12 and Example 1 is only that the Fosfomycin raw material in step (1) is sieved and then weighed, with a D90 of 450 μm, a D50 of 220 μm, and a D10 of 50 μm.

[0069] Example 13

[0070] The difference between Example 13 and Example 1 is only that the Fosfomycin raw material in step (1) is sieved and then weighed, with a D90 of 200 μm, a D50 of 65 μm, and a D10 of 6 μm.

[0071] Comparative Example 1

[0072] The prescription of Comparative Example 1 is shown in Table 4:

[0073] Table 4 Prescription of Comparative Example 1

[0074] Weight of each component (%) Fodostane 90.91 Corn starch 8.19 Talc 0.45 Magnesium stearate 0.45

[0075] The specific preparation process of Comparative Example 1 is as follows:

[0076] Take the prescription amount of corn starch and add it to the prescription amount of Fosfomycin raw material, mix. Then add the prescription amount of talc and magnesium stearate and mix. Select appropriate tabletting parameters for tabletting, so that the tablet hardness is 3-9 kg / cm 2The weight of the tablet is about 220 mg, and the fadrozole tablet is obtained.

[0077] Comparative Example 2

[0078] The prescription of Comparative Example 2 is shown in Table 5:

[0079] Table 5 Prescription of Comparative Example 2

[0080]

[0081]

[0082] The specific preparation process of Comparative Example 2 is as follows:

[0083] The prescription amount of pregelatinized starch and the prescription amount of fadrozole raw material are mixed. Then, the prescription amount of talc and magnesium stearate is added and mixed for 10 min. The tablet is pressed by selecting appropriate tabletting parameters, and the tablet hardness is 3-9 kg / cm 2 The weight of the tablet is about 220 mg, and the fadrozole tablet is obtained.

[0084] Comparative Example 3

[0085] The prescription of Comparative Example 3 is shown in Table 6:

[0086] Table 6 Prescription of Comparative Example 3

[0087] Weight of each component (%) Fodostane 90.91 Corn starch 6.19 Talc 0.45 Magnesium stearate 0.45 Colloidal silicon dioxide 2

[0088] The specific preparation process of Comparative Example 3 is as follows:

[0089] (1) Weighing: The prescription amount of fadrozole raw material, corn starch, colloidal silicon dioxide, talc, and magnesium stearate is weighed;

[0090] (2) Mixing: The prescription amount of fadrozole raw material, corn starch, and colloidal silicon dioxide is mixed;

[0091] (3) Total mixing: The prescription amount of talc and magnesium stearate is added and mixed for 10 min;

[0092] (4) Tabletting: The tablet is pressed by selecting appropriate tabletting parameters, and the tablet hardness is 3-9 kg / cm 2 The weight of the tablet is about 220 mg, and the fadrozole tablet is obtained.

[0093] Comparative Example 4

[0094] The only difference between Comparative Example 4 and Comparative Example 3 is that the prescription composition is different. The prescription of Comparative Example 4 is shown in Table 7:

[0095] Table 7 Prescription of Comparative Example 4

[0096] Weight of each component (%) Fodostane 90.91 Corn starch 8.19 Talc 0.45 Magnesium stearate 0.45 Colloidal silicon dioxide 2

[0097] Comparative Example 5

[0098] The prescription of Comparative Example 5 is shown in Table 8:

[0099] Table 8 Prescription of Comparative Example 5

[0100] Weight of each component (%) Fodostane 90.91 Pre-gelatinized starch 6.09 Talc 2 Magnesium stearate 1 Colloidal silicon dioxide 1.96

[0101] The specific preparation process of Comparative Example 5 is as follows:

[0102] (1) Weighing: weigh the prescription amount of fondaparinux raw material, pregelatinized starch, colloidal silicon dioxide, talc, magnesium stearate;

[0103] (2) Take the prescription amount of raw materials, pregelatinized starch, colloidal silicon dioxide, and mix well;

[0104] (3) Add the prescription amount of talc and magnesium stearate, mix for 10 min;

[0105] (4) Select appropriate tabletting parameters, tablet, and make the tablet hardness 3-9 kg / cm 2 , weight 220 mg / tablet, get fondaparinux tablets.

[0106] Comparative Examples 6-8

[0107] According to the preparation process of Examples 1-11, Comparative Examples 6-8 were prepared according to the prescription in Table 9.

[0108] Table 9 Prescription of Comparative Examples 6-8

[0109]

[0110] Note: Note: The fondaparinux, corn starch, talc, and magnesium stearate content in the table is the proportion in the tablet, and the water content and coating weight gain are the proportions in the total prescription; NA represents not added.

[0111] Comparative Example 9

[0112] The difference between Comparative Example 9 and Example 2 is only that "dry to ≤2% moisture and take out" in step (4) is replaced with "dry to 2.29% moisture and take out".

[0113] Comparative Example 10

[0114] The difference between Comparative Example 10 and Example 6 is only that "water" in step (3) is replaced with "50% ethanol".

[0115] Comparative Example 11

[0116] The difference between Comparative Example 11 and Example 1 is only that the furosemide raw material in step (1) is sieved before weighing, and the D90 thereof is 167 μm, the D50 thereof is 66.2 μm, and the D10 thereof is 13.5 μm.

[0117] Comparative Example 12

[0118] The difference between Comparative Example 12 and Example 1 is only that the furosemide raw material in step (1) is sieved before weighing, and the D90 thereof is 466 μm, the D50 thereof is 251 μm, and the D10 thereof is 78.9 μm.

[0119] Experimental Example 1 Investigation of the Example of the Invention

[0120] (1) Evaluation of particle-related parameters:

[0121] The furosemide tablets prepared in Examples 1-13 were evaluated for particle-related parameters (referring to the Chinese Pharmacopoeia 2020 Edition, Part IV General Rules), and the results are shown in Table 10.

[0122] Table 10 Evaluation of Resting Angle, Moisture Content, Flowability, Compressibility, and Appearance

[0123]

[0124] (2) Determination of dissolution:

[0125] The furosemide tablets prepared in the examples were compared with the reference preparation to investigate the dissolution curves, and the dissolution and release determination method (Chinese Pharmacopoeia 2020 Edition, Part IV General Rules 0931 Second Method) was used to determine the dissolution medium at 900 mL, the rotation speed was 50 revolutions per minute, the operation was carried out according to the law, 10 mL of sample dissolution liquid was taken at 5, 10, 15, 20, and 30 min, and the same temperature and volume of dissolution medium was supplemented at the same time, 0.45 μm water system filter membrane was filtered, and the filtrate was taken as the sample solution.

[0126] The HPLC method was used to determine the content of furosemide, and the HPLC parameters are as follows:

[0127] The chromatographic column used is an octadecylsilane bonded silica gel as a filler, Inersustain C18 column (4.6 mm x 150 mm, 5 μm);

[0128] The mobile phase is 0.05 mol / L phosphate buffer (pH value is adjusted to 4.0 with phosphoric acid);

[0129] The column flow rate is 1 mL / min;

[0130] The column temperature is 20℃;

[0131] The wavelength is 210 nm;

[0132] The sample size was 20 μL.

[0133] The dissolution test results are shown in Table 11.

[0134] Table 11 Evaluation of dissolution of the examples

[0135]

[0136] The experimental results show that the furosemide tablets prepared by the technical scheme of the present application have a significantly smaller rest angle than the raw material drug, the water content is ≤2%, the furosemide tablets prepared by the technical scheme of the present application have good flowability and good compressibility, and the appearance is smooth white to white-like round tablets. In addition, the furosemide tablets prepared by the technical scheme of the present application have a dissolution of more than 85% at 15 min, and the dissolution is similar to the reference.

[0137] The difference between Example 1 and Examples 9-11 is only the coating weight, and the results show that when the coating weight is in the range of 2-5%, the dissolution behavior of the furosemide tablets is more similar to the reference.

[0138] Investigation of the process of Experimental Example 2

[0139] The furosemide tablets prepared by Comparative Examples 1-5 were evaluated for granule-related parameters, and the results are shown in Table 12.

[0140] Table 12 Evaluation of granule-related parameters

[0141]

[0142] The experimental results show that the furosemide tablets prepared by the dry mixing and direct compression process of Comparative Examples 1-5 have a large total mixed granule rest angle and poor flowability. Among them, Comparative Example 1 has very poor granule flowability during tabletting, and cannot be automatically discharged from the discharge port. During filling, some of the corners of the mold are missing materials and cannot be filled. Comparative Example 3 has poor compressibility, and the appearance of the tablet core is unqualified, with cover lifting and top column phenomenon.

[0143] Investigation of the prescription of Experimental Example 3

[0144] (1) Evaluation of granule-related parameters:

[0145] The furosemide tablets prepared by Comparative Examples 6-12 were evaluated for granule-related parameters, and the test results are shown in Table 13.

[0146] Table 13 Evaluation of granule-related parameters

[0147]

[0148]

[0149] The results of Comparative Example 6 show that when talc is not added in the prescription (talc content is 0%) during tabletting, the core side has burrs and there is a sticking phenomenon.

[0150] In Comparative Example 7, the content of wetting agent is 20%, the prepared granules are slightly wet, have good flowability and compressibility, but have a sticking wall phenomenon; in Comparative Example 8, the content of wetting agent is 10%, the prepared granules have good flowability, but have a cover lifting and top cracking phenomenon during tabletting, and have poor compressibility.

[0151] The results of Comparative Example 9 show that when the total mixed granule moisture content is more than 2%, the granules are prone to agglomeration, the flowability of the granules is poor, and the granules are relatively wet, which leads to too low tablet hardness, so that tabletting is difficult, and therefore the moisture content of the granules should be less than 2%.

[0152] The granules obtained by using 50% ethanol as a wetting agent are relatively dry (Comparative Example 10), and the content of the granules is as follows:

[0153] 40 mesh or more 40-60 mesh 60-80 mesh 80-100 mesh 100 mesh or less Total weight Proportion / % 3.1 17.1 19.0 13.9 47.0 100.0

[0154] The granules obtained by using ethanol as a wetting agent are relatively dry, the content of the granules below 100 mesh is relatively large, the rest angle is also greater than 40°, and the loss weight of the friability of the obtained raw tablets is also greater than that of the raw tablets obtained by using purified water. In combination with the situation of mass production, the content of fine powder obtained by using a fluidized bed dryer will increase, the flowability will further deteriorate, and the use of ethanol as a wetting agent is not environmentally friendly compared with purified water. The use of purified water in the raw material composition of the present application has better effects.

[0155] (2) Determination of dissolution rate:

[0156] The furosemide tablets prepared in Comparative Examples 6, 9-12 were determined for dissolution rate by the method described in (2) of Experimental Example 1. The raw tablets prepared in Comparative Examples 7-8 have poor quality, and therefore are not determined for dissolution rate. The determination results are shown in Table 14.

[0157] Table 14 Evaluation of dissolution rate

[0158]

[0159]

[0160] From the dissolution rate detection results of Comparative Examples 11-12, the dissolution rate of the furosemide tablets prepared from the raw material granules with D90 of 167 μm and D90 of 460 μm is less than 85% at 15 min, which cannot meet the requirement of rapid dissolution, and the dissolution behavior is quite different from the reference.

[0161] The above detailed description is a specific description of one of the possible embodiments of the present application, which is not intended to limit the patent scope of the present application. It should be noted that any equivalent implementation or change made without departing from the present application shall be included in the scope of the technical solutions of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A process for the preparation of a fedosilatc tablet, characterized in that, The preparation method comprises the following steps: (1) premixing the fodositan raw material and corn starch to obtain a mixture 1; (2) adding purified water in an amount of 12%-16.6% of the total weight of the tablet to the mixture 1 of step (1) to perform granulation, collecting the material, and sieving to obtain wet granules; (3) after drying the wet granules to a moisture content of ≤2%, sieving, adding talc and magnesium stearate, mixing, and then compressing to obtain tablets; (4) coating the tablets of step (3) to obtain fodositan tablets; The fodositan raw material of step (1) has a particle size D90 of 200-450 μm, a particle size D50 of 65-220 μm, and a particle size D10 of 6-50 μm. The fodositan tablets comprise fodositan 90%-92%, corn starch 6.18%-8.44%, talc 0.1%-2.0%, and magnesium stearate 0.1%-2.0%, and the tablet moisture content is ≤2%.

2. The production method according to claim 1, characterized by, The content of the fodositan raw material of step (1) in the tablets is 90%-92%.

3. The preparation method according to claim 1, characterized in that, The content of the corn starch of step (1) in the tablets is 6.18%-8.64%.

4. The method of claim 1, wherein, The content of the talc of step (3) in the tablets is 0.1%-2.0%.

5. The preparation method according to claim 1, characterized in that, The content of the magnesium stearate of step (3) in the tablets is 0.1%-2.0%.

6. The method of claim 1, wherein, The green sheet of step (3) has a hardness of 3 to 9 kg / cm 2 .

7. A tablet of fondaparinux characterized in that, The fodositan tablets are prepared by the preparation method of any one of claims 1-6, and the fodositan tablets comprise fodositan 90%-92%, corn starch 6.18%-8.44%, talc 0.1%-2.0%, and magnesium stearate 0.1%-2.0%, and the tablet moisture content is ≤2%.

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