Meclofenoxate hydrochloride capsule

Abstract

The invention relates to a meclofenoxate hydrochloride capsule. Specifically, the invention provides the meclofenoxate hydrochloride capsule, and the meclofenoxate hydrochloride capsule comprises meclofenoxate hydrochloride and a capsule shell. After the meclofenoxate hydrochloride gelatin capsule and a drying agent are subpackaged in a bottle body together, the meclofenoxate hydrochloride gelatin capsule has excellent stability, and in addition, the meclofenoxate hydrochloride hydroxypropyl methylcellulose capsule also has excellent stability, so that the stability of meclofenoxate hydrochloride in the transportation and storage process is improved, and the quality of the meclofenoxate hydrochloride capsule is improved. And the quality of meclofenoxate hydrochloride is ensured.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical preparations, in particular to a meclofenoxate hydrochloride capsule. Background Art

[0002] Meclofenoxate hydrochloride is a drug that improves brain metabolism. It can promote the redox of brain cells, regulate the metabolism of nerve cells, and increase the utilization of carbohydrates. It is often used to prevent and treat traumatic coma, alcohol poisoning, neonatal hypoxia, or enuresis in children. The structure of meclofenoxate hydrochloride is as follows:

[0003]

[0004] In the clinical preparation of meclofenoxate hydrochloride, meclofenoxate hydrochloride capsule has the advantages of low production cost and strong patient compliance as oral preparation, and is a common preparation for clinical administration. However, there is a problem of poor stability in existing meclofenoxate hydrochloride capsule, and problems such as contents caking and impurity content exceeding the standard are more likely to occur under high temperature and high humidity conditions. The poor stability of meclofenoxate hydrochloride capsule not only causes the production, transportation and storage costs of meclofenoxate hydrochloride to increase, but also easily causes quality and drug safety problems, thereby limiting the application value of meclofenoxate hydrochloride capsule. Therefore, how to improve the stability of meclofenoxate hydrochloride capsule becomes the focus of current research.

[0005] Therefore, there is a need in the art to develop a meclofenoxate hydrochloride capsule with excellent stability. Summary of the Invention

[0006] The object of the present invention is to provide a meclofenoxate hydrochloride capsule with excellent stability, thereby improving the stability of meclofenoxate hydrochloride during production, transportation and storage.

[0007] In a first aspect, the present invention provides a meclofenoxate hydrochloride capsule, comprising meclofenoxate hydrochloride and a capsule shell.

[0008] Preferably, the capsule shell comprises a gelatin capsule shell or a hypromellose capsule shell.

[0009] Preferably, the capsule shell is a gelatin capsule shell.

[0010] Preferably, the capsule shell is a hypromellose capsule shell.

[0011] Preferably, the gelatin capsule shell is a gelatin hollow capsule shell

[0012] Preferably, the hypromellose capsule shell is a hollow hypromellose capsule shell.

[0013] Preferably, the meclofenoxate hydrochloride is filled in a capsule shell.

[0014] Preferably, the meclofenoxate hydrochloride is filled in a gelatin capsule shell.

[0015] Preferably, the meclofenoxate hydrochloride is filled in a hypromellose capsule shell.

[0016] Preferably, the meclofenoxate hydrochloride capsules further comprise calcium hydrogen phosphate.

[0017] Preferably, the amount of meclofenoxate hydrochloride is 1 part by weight.

[0018] Preferably, the calcium hydrogen phosphate is filled in a capsule shell.

[0019] Preferably, the amount of calcium hydrogen phosphate is 0.8-1.2 parts by weight.

[0020] Preferably, the amount of calcium hydrogen phosphate is 0.8 parts by weight or 1.2 parts by weight.

[0021] Preferably, the weight ratio of the meclofenoxate hydrochloride to the calcium hydrogen phosphate is 1:(0.5-1.5), more preferably 1:(0.8-1.2).

[0022] Preferably, the meclofenoxate hydrochloride capsules further comprise dextrin.

[0023] Preferably, the dextrin is filled in the capsule shell.

[0024] Preferably, the dextrin is 0.23-0.27 parts by weight.

[0025] Preferably, the dextrin is 0.23 parts by weight or 0.27 parts by weight.

[0026] Preferably, the weight ratio of the meclofenoxate hydrochloride to the dextrin is 1:(0.2-0.3), more preferably 1:(0.23-0.27).

[0027] Preferably, the meclofenoxate hydrochloride capsules further comprise magnesium stearate.

[0028] Preferably, the magnesium stearate is filled in the capsule shell.

[0029] Preferably, the magnesium stearate is 0.05-0.12 parts by weight.

[0030] Preferably, the magnesium stearate is 0.05 parts by weight or 0.12 parts by weight.

[0031] Preferably, the weight ratio of the meclofenoxate hydrochloride to the magnesium stearate is 1:(0.03-0.15), more preferably 1:(0.05-0.12).

[0032] The second aspect of the present invention provides a combination comprising the meclofenoxate hydrochloride capsules as described in the first aspect of the present invention and a desiccant.

[0033] Preferably, the desiccant comprises a moisture desiccant.

[0034] Preferably, the desiccant comprises a molecular sieve desiccant.

[0035] Preferably, the meclofenoxate hydrochloride capsules and the desiccant are separately packed in containers.

[0036] Preferably, the container comprises a bottle.

[0037] Preferably, the bottle body comprises a polyethylene bottle body.

[0038] Preferably, the polyethylene bottle body comprises a high-density polyethylene bottle body.

[0039] The third aspect of the present invention provides a medicine bottle, wherein the medicine bottle contains the meclofenoxate hydrochloride capsules as described in the first aspect of the present invention.

[0040] Preferably, the medicine bottle also contains a desiccant.

[0041] Preferably, the desiccant comprises a moisture desiccant.

[0042] Preferably, the desiccant comprises a molecular sieve desiccant.

[0043] Preferably, the medicine bottle comprises a bottle body and meclofenoxate hydrochloride capsules.

[0044] Preferably, the meclofenoxate hydrochloride capsules are packaged in the bottle body of the medicine bottle.

[0045] Preferably, the desiccant is packaged in the bottle body of the medicine bottle.

[0046] Preferably, the bottle body comprises a polyethylene bottle body.

[0047] Preferably, the polyethylene bottle body comprises a high-density polyethylene bottle body.

[0048] In a fourth aspect, the present invention provides a medicine box, wherein the medicine box comprises the medicine bottle as described in the second aspect of the present invention.

[0049] In a fifth aspect, the present invention provides a use of the meclofenoxate hydrochloride capsules according to the first aspect of the present invention for preparing a medicament for preventing and / or treating traumatic coma, alcohol poisoning, neonatal hypoxia or enuresis in children.

[0050] It should be understood that within the scope of the present invention, the above-mentioned technical features of the present invention and the technical features specifically described below (such as embodiments) can be combined with each other to form new or preferred technical solutions. DETAILED DESCRIPTION

[0051] The present invention provides meclofenoxate hydrochloride capsules, comprising meclofenoxate hydrochloride and a capsule shell. After the meclofenoxate hydrochloride gelatin capsules are packaged together with a desiccant in a bottle, the meclofenoxate hydrochloride gelatin capsules exhibit excellent stability. Furthermore, meclofenoxate hydrochloride-containing hypromellose capsules also exhibit excellent stability.

[0052] the term

[0053] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0054] As used herein, the terms "comprise," "include," and "contain" are used interchangeably to include not only closed definitions but also semi-closed and open definitions. In other words, the terms include "consisting of," "consisting essentially of."

[0055] As used herein, the term "hydroxypropyl methylcellulose" is Hydroxypropyl methyl cellulose in English.

[0056] As used herein, the term "parts by weight" can be any fixed weight expressed in milligrams, grams, or kilograms (e.g., 1 mg, 1 g, or 1 kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b can be composed of 1 gram of component a + 9 grams of component b, or 10 grams of component a + 90 grams of component b, etc. In such a pharmaceutical composition, the percentage content of a component = (parts by weight of the component / sum of the parts by weight of all components) × 100%. Therefore, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10%, and the content of component b is 90%.

[0057] Meclofenac Hydrochloride Capsules

[0058] The invention provides a meclofenoxate hydrochloride capsule. The meclofenoxate hydrochloride capsule comprises meclofenoxate hydrochloride and a capsule shell.

[0059] In a preferred embodiment of the present invention, the meclofenoxate hydrochloride capsules of the present invention may further include calcium hydrogen phosphate. Preferably, the weight ratio of the meclofenoxate hydrochloride to the calcium hydrogen phosphate is 1:(0.5-1.5), preferably 1:(0.8-1.2).

[0060] In a preferred embodiment of the present invention, the meclofenoxate hydrochloride capsules of the present invention may further comprise dextrin. Preferably, the weight ratio of the meclofenoxate hydrochloride to the dextrin is 1:(0.2-0.3), more preferably 1:(0.23-0.27).

[0061] In a preferred embodiment of the present invention, the meclofenoxate hydrochloride capsules of the present invention may further comprise magnesium stearate. Preferably, the weight ratio of the meclofenoxate hydrochloride to the magnesium stearate is 1:(0.03-0.15), more preferably 1:(0.05-0.12).

[0062] Specifically, the meclofenoxate hydrochloride capsules of the present invention are as described above in the first aspect of the present invention.

[0063] medicine bottle

[0064] The present invention provides a medicine bottle, which contains the meclofenoxate hydrochloride capsules of the present invention.

[0065] In a preferred embodiment of the present invention, the medicine bottle further contains a desiccant, such as a molecular sieve desiccant.

[0066] In a preferred embodiment of the present invention, the medicine bottle comprises a bottle body and meclofenoxate hydrochloride capsules.

[0067] Preferably, the meclofenoxate hydrochloride capsules are packaged in the bottle body of the medicine bottle.

[0068] Preferably, the desiccant is packaged in the bottle body of the medicine bottle.

[0069] In a preferred embodiment of the present invention, the bottle body comprises a polyethylene bottle body, such as a high-density polyethylene bottle body.

[0070] The main effects of the present invention include:

[0071] The invention provides meclofenoxate hydrochloride capsules. After the meclofenoxate hydrochloride gelatin capsules and a desiccant are packaged together in a bottle, the meclofenoxate hydrochloride gelatin capsules have excellent stability. In addition, the meclofenoxate hydrochloride hypromellose capsules also have excellent stability, thereby improving the stability of the meclofenoxate hydrochloride during transportation and storage, and ensuring the quality of the meclofenoxate hydrochloride.

[0072] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples where specific conditions are not specified are generally based on conventional conditions.

[0073] Example 1

[0074] 1. The product information of gelatin empty capsule shells and hypromellose empty capsule shells is shown in Table 1 below:

[0075] Table 1 Capsule shell product information

[0076] Capsule name factory Gelatin empty capsules Suzhou Capsule Co., Ltd. Hydroxypropyl methylcellulose empty capsules Suzhou Capsule Co., Ltd.

[0077] 2. APIs, contents, preparations, and vials

[0078] API: Meclofenoxate hydrochloride powder.

[0079] Preparation 1-1: Meclofenoxate hydrochloride was filled into gelatin hollow capsule shells to obtain Preparation 1-1.

[0080] Medicine bottle 1-1: Meclofenoxate hydrochloride was filled into the shells of hollow gelatin capsules, and then the capsules containing the drug were dividedly packed into high-density polyethylene bottles to obtain medicine bottles 1-1.

[0081] Medicine bottle 1-2: Meclofenoxate hydrochloride was filled into the shells of hollow gelatin capsules, and then the capsules containing the drug were dividedly packed into high-density polyethylene bottles filled with molecular sieve desiccant to obtain medicine bottle 1-2.

[0082] Prescription 2: 1.0 part by weight of meclofenoxate hydrochloride and 0.8 part by weight of calcium hydrogen phosphate were mixed to obtain a powder mixture of Prescription 2.

[0083] Preparation 2-1: 1.0 parts by weight of meclofenoxate hydrochloride and 0.8 parts by weight of calcium hydrogen phosphate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 2-1.

[0084] Preparation 2-2: 1.0 part by weight of meclofenoxate hydrochloride and 0.8 part by weight of calcium hydrogen phosphate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 2-2.

[0085] Medicine bottle 2-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 0.8 parts by weight of calcium hydrogen phosphate, the resulting mixture was filled into gelatin hollow capsule shells, and then the drug-containing capsules were dividedly packed into high-density polyethylene bottles to obtain medicine bottle 2-1.

[0086] Medicine bottle 2-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 0.8 parts by weight of calcium hydrogen phosphate, the resulting mixture was filled into gelatin hollow capsule shells, and then the drug-containing capsules were sub-packed into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 2-2.

[0087] Prescription 3: 1.0 parts by weight of meclofenoxate hydrochloride and 1.2 parts by weight of calcium hydrogen phosphate were mixed to obtain a powder mixture of Prescription 3.

[0088] Preparation 3-1: 1.0 parts by weight of meclofenoxate hydrochloride and 1.2 parts by weight of calcium hydrogen phosphate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 3-1.

[0089] Preparation 3-2: 1.0 parts by weight of meclofenoxate hydrochloride and 1.2 parts by weight of calcium hydrogen phosphate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 3-2.

[0090] Medicine bottle 3-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 1.2 parts by weight of calcium hydrogen phosphate, the resulting mixture was filled into gelatin hollow capsule shells, and then the drug-containing capsules were dividedly packed into high-density polyethylene bottles to obtain medicine bottle 3-1.

[0091] Medicine bottle 3-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 1.2 parts by weight of calcium hydrogen phosphate, the resulting mixture was filled into gelatin hollow capsule shells, and the drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 3-2.

[0092] Prescription 4: 1.0 part by weight of meclofenoxate hydrochloride and 0.23 part by weight of dextrin were mixed to obtain Prescription 4, a powder mixture.

[0093] Preparation 4-1: 1.0 part by weight of meclofenoxate hydrochloride and 0.23 part by weight of dextrin were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 4-1.

[0094] Preparation 4-2: 1.0 part by weight of meclofenoxate hydrochloride and 0.23 part by weight of dextrin were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 4-2.

[0095] Medicine bottle 4-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 0.23 parts by weight of dextrin, the resulting mixture was filled into gelatin hollow capsule shells, and then the drug-containing capsules were dividedly packed into high-density polyethylene bottles to obtain medicine bottle 4-1.

[0096] Medicine bottle 4-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 0.23 parts by weight of dextrin, the resulting mixture was filled into gelatin hollow capsule shells, and the drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 4-2.

[0097] Prescription 5: 1.0 part by weight of meclofenoxate hydrochloride and 0.27 part by weight of dextrin were mixed to obtain Prescription 5 of a powder mixture.

[0098] Preparation 5-1: 1.0 part by weight of meclofenoxate hydrochloride and 0.27 part by weight of dextrin were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 5-1.

[0099] Preparation 5-2: 1.0 part by weight of meclofenoxate hydrochloride and 0.27 part by weight of dextrin were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 5-2.

[0100] Medicine bottle 5-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 0.27 parts by weight of dextrin, the resulting mixture was filled into gelatin hollow capsule shells, and then the drug-containing capsules were dividedly packed into high-density polyethylene bottles to obtain medicine bottle 5-1.

[0101] Medicine bottle 5-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 0.27 parts by weight of dextrin, the resulting mixture was filled into gelatin hollow capsule shells, and the drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 5-2.

[0102] Prescription 6: 1.0 part by weight of meclofenoxate hydrochloride and 0.05 part by weight of magnesium stearate were mixed to obtain a powder mixture of Prescription 6.

[0103] Preparation 6-1: 1.0 part by weight of meclofenoxate hydrochloride and 0.05 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 6-1.

[0104] Preparation 6-2: 1.0 part by weight of meclofenoxate hydrochloride and 0.05 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 6-2.

[0105] Medicine bottle 6-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 0.05 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells, and then the drug-containing capsules were dividedly packed into high-density polyethylene bottles to obtain medicine bottle 6-1.

[0106] Medicine bottle 6-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 0.05 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 6-2.

[0107] Formulation 7: 1.0 part by weight of meclofenoxate hydrochloride and 0.12 part by weight of magnesium stearate were mixed to obtain a powder mixture of Formulation 7.

[0108] Preparation 7-1: 1.0 part by weight of meclofenoxate hydrochloride and 0.12 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 7-1.

[0109] Preparation 7-2: 1.0 part by weight of meclofenoxate hydrochloride and 0.12 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 7-2.

[0110] Medicine bottle 7-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 0.12 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells, and then the drug-containing capsules were dividedly packed into high-density polyethylene bottles to obtain medicine bottle 7-1.

[0111] Medicine bottle 7-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride and 0.12 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells, and the drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 7-2.

[0112] Prescription 8: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.23 part by weight of dextrin were mixed to obtain a powder mixture of Prescription 8.

[0113] Preparation 8-1: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.23 part by weight of dextrin were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 8-1.

[0114] Preparation 8-2: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.23 part by weight of dextrin were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 8-2.

[0115] Medicine bottle 8-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.8 parts by weight of calcium hydrogen phosphate and 0.23 parts by weight of dextrin, the resulting mixture was filled into gelatin hollow capsule shells, and then the drug-containing capsules were dividedly packed into high-density polyethylene bottles to obtain medicine bottle 8-1.

[0116] Medicine bottle 8-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.8 parts by weight of calcium hydrogen phosphate, and 0.23 parts by weight of dextrin, the resulting mixture was filled into gelatin hollow capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 8-2.

[0117] Formulation 9: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.27 part by weight of dextrin were mixed to obtain Formulation 9 of a powder mixture.

[0118] Preparation 9-1: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.27 part by weight of dextrin were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 9-1.

[0119] Preparation 9-2: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.27 part by weight of dextrin were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 9-2.

[0120] Medicine bottle 9-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.8 parts by weight of calcium hydrogen phosphate and 0.27 parts by weight of dextrin, the resulting mixture was filled into gelatin hollow capsule shells, and then the drug-containing capsules were dividedly packed into high-density polyethylene bottles to obtain medicine bottle 9-1.

[0121] Medicine bottle 9-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.8 parts by weight of calcium hydrogen phosphate and 0.27 parts by weight of dextrin, the resulting mixture is filled into gelatin hollow capsule shells, and the drug-containing capsules are then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 9-2.

[0122] Prescription 10: 1.0 part by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.23 parts by weight of dextrin were mixed to obtain Prescription 10 of a powder mixture.

[0123] Preparation 10-1: 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.23 parts by weight of dextrin were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 10-1.

[0124] Preparation 10-2: 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.23 parts by weight of dextrin were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 10-2.

[0125] Medicine bottle 10-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate and 0.23 parts by weight of dextrin, the resulting mixture is filled into gelatin hollow capsule shells, and then the drug-containing capsules are dividedly packed into high-density polyethylene bottles to obtain medicine bottle 10-1.

[0126] Medicine bottle 10-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate and 0.23 parts by weight of dextrin, the resulting mixture is filled into gelatin hollow capsule shells, and the drug-containing capsules are then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 10-2.

[0127] Prescription 11: 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.27 parts by weight of dextrin were mixed to obtain a powder mixture of Prescription 11.

[0128] Preparation 11-1: 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.27 parts by weight of dextrin were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 11-1.

[0129] Preparation 11-2: 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.27 parts by weight of dextrin were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 11-2.

[0130] Medicine bottle 11-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate and 0.27 parts by weight of dextrin, the resulting mixture is filled into gelatin hollow capsule shells, and then the drug-containing capsules are dividedly packed into high-density polyethylene bottles to obtain medicine bottle 11-1.

[0131] Medicine bottle 11-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate and 0.27 parts by weight of dextrin, the resulting mixture is filled into gelatin hollow capsule shells, and then the drug-containing capsules are dividedly packed in high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 11-2.

[0132] Formulation 12: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.05 part by weight of magnesium stearate were mixed to obtain a powder mixture of Formulation 12.

[0133] Preparation 12-1: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.05 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 12-1.

[0134] Preparation 12-2: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.05 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 12-2.

[0135] Medicine bottle 12-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.8 parts by weight of calcium hydrogen phosphate and 0.05 parts by weight of magnesium stearate, the resulting mixture is filled into gelatin hollow capsule shells, and then the drug-containing capsules are dividedly packed into high-density polyethylene bottles to obtain medicine bottle 12-1.

[0136] Medicine bottle 12-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.8 parts by weight of calcium hydrogen phosphate, and 0.05 parts by weight of magnesium stearate, the resulting mixture was filled into hollow gelatin capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 12-2.

[0137] Formulation 13: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.12 part by weight of magnesium stearate were mixed to obtain a powder mixture of Formulation 13.

[0138] Preparation 13-1: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.12 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 13-1.

[0139] Preparation 13-2: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, and 0.12 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 13-2.

[0140] Medicine bottle 13-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.8 parts by weight of calcium hydrogen phosphate, and 0.12 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles to obtain medicine bottle 13-1.

[0141] Medicine bottle 13-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.8 parts by weight of calcium hydrogen phosphate, and 0.12 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 13-2.

[0142] Formulation 14: 1.0 part by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.05 parts by weight of magnesium stearate were mixed to obtain a powder mixture of Formulation 14.

[0143] Preparation 14-1: 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.05 parts by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 14-1.

[0144] Preparation 14-2: 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.05 parts by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 14-2.

[0145] Medicine bottle 14-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.05 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells, and the drug-containing capsules were then divided into high-density polyethylene bottles to obtain medicine bottle 14-1.

[0146] Medicine bottle 14-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.05 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 14-2.

[0147] Formulation 15: 1.0 part by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.12 parts by weight of magnesium stearate were mixed to obtain a powder mixture of Formulation 15.

[0148] Preparation 15-1: 1.0 part by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.12 parts by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 15-1.

[0149] Preparation 15-2: 1.0 part by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.12 parts by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 15-2.

[0150] Medicine bottle 15-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate and 0.12 parts by weight of magnesium stearate, the resulting mixture is filled into gelatin hollow capsule shells, and then the drug-containing capsules are dividedly packed into high-density polyethylene bottles to obtain medicine bottle 15-1.

[0151] Medicine bottle 15-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, and 0.12 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 15-2.

[0152] Formulation 16: 1.0 part by weight of meclofenoxate hydrochloride, 0.23 part by weight of dextrin, and 0.05 part by weight of magnesium stearate were mixed to obtain a powder mixture of Formulation 16.

[0153] Preparation 16-1: 1.0 part by weight of meclofenoxate hydrochloride, 0.23 part by weight of dextrin, and 0.05 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 16-1.

[0154] Preparation 16-2: 1.0 part by weight of meclofenoxate hydrochloride, 0.23 part by weight of dextrin, and 0.05 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 16-2.

[0155] Medicine bottle 16-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.23 parts by weight of dextrin, and 0.05 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles to obtain medicine bottle 16-1.

[0156] Medicine bottle 16-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.23 parts by weight of dextrin, and 0.05 parts by weight of magnesium stearate, the resulting mixture was filled into hollow gelatin capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 16-2.

[0157] Formulation 17: 1.0 part by weight of meclofenoxate hydrochloride, 0.23 part by weight of dextrin, and 0.12 part by weight of magnesium stearate were mixed to obtain a powder mixture of Formulation 17.

[0158] Preparation 17-1: 1.0 part by weight of meclofenoxate hydrochloride, 0.23 part by weight of dextrin, and 0.12 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 17-1.

[0159] Preparation 17-2: 1.0 part by weight of meclofenoxate hydrochloride, 0.23 part by weight of dextrin, and 0.12 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 17-2.

[0160] Medicine bottle 17-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.23 parts by weight of dextrin and 0.12 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells, and the drug-containing capsules were then divided into high-density polyethylene bottles to obtain medicine bottle 17-1.

[0161] Medicine bottle 17-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.23 parts by weight of dextrin, and 0.12 parts by weight of magnesium stearate, the resulting mixture was filled into hollow gelatin capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 17-2.

[0162] Formulation 18: 1.0 part by weight of meclofenoxate hydrochloride, 0.27 part by weight of dextrin, and 0.05 part by weight of magnesium stearate were mixed to obtain a powder mixture of Formulation 18.

[0163] Preparation 18-1: 1.0 part by weight of meclofenoxate hydrochloride, 0.27 part by weight of dextrin, and 0.05 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 18-1.

[0164] Preparation 18-2: 1.0 part by weight of meclofenoxate hydrochloride, 0.27 part by weight of dextrin, and 0.05 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 18-2.

[0165] Medicine bottle 18-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.27 parts by weight of dextrin, and 0.05 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles to obtain medicine bottle 18-1.

[0166] Medicine bottle 18-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.27 parts by weight of dextrin, and 0.05 parts by weight of magnesium stearate, the resulting mixture was filled into hollow gelatin capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 18-2.

[0167] Formulation 19: 1.0 part by weight of meclofenoxate hydrochloride, 0.27 part by weight of dextrin, and 0.12 part by weight of magnesium stearate were mixed to obtain a powder mixture of Formulation 19.

[0168] Preparation 19-1: 1.0 part by weight of meclofenoxate hydrochloride, 0.27 part by weight of dextrin, and 0.12 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 19-1.

[0169] Preparation 19-2: 1.0 part by weight of meclofenoxate hydrochloride, 0.27 part by weight of dextrin, and 0.12 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 19-2.

[0170] Medicine bottle 19-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.27 parts by weight of dextrin and 0.12 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells, and the drug-containing capsules were then divided into high-density polyethylene bottles to obtain medicine bottle 19-1.

[0171] Medicine bottle 19-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 0.27 parts by weight of dextrin and 0.12 parts by weight of magnesium stearate, the resulting mixture was filled into gelatin hollow capsule shells. The drug-containing capsules were then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 19-2.

[0172] Formulation 20: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, 0.23 part by weight of dextrin, and 0.05 part by weight of magnesium stearate were mixed to obtain Formulation 20 of a powder mixture.

[0173] Preparation 20-1: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, 0.23 part by weight of dextrin, and 0.05 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 20-1.

[0174] Preparation 20-2: 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, 0.23 part by weight of dextrin, and 0.05 part by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 20-2.

[0175] Medicine bottle 20-1: After mixing 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, 0.23 part by weight of dextrin and 0.05 part by weight of magnesium stearate, the resulting mixture is filled into gelatin hollow capsule shells, and the drug-containing capsules are then divided into high-density polyethylene bottles to obtain medicine bottle 20-1.

[0176] Medicine bottle 20-2: After mixing 1.0 part by weight of meclofenoxate hydrochloride, 0.8 part by weight of calcium hydrogen phosphate, 0.23 part by weight of dextrin and 0.05 part by weight of magnesium stearate, the resulting mixture is filled into gelatin hollow capsule shells. The drug-containing capsules are then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 20-2.

[0177] Formulation 21: 1.0 part by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, 0.27 parts by weight of dextrin, and 0.12 parts by weight of magnesium stearate were mixed to obtain a powder mixture of Formulation 21.

[0178] Preparation 21-1: 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, 0.27 parts by weight of dextrin, and 0.12 parts by weight of magnesium stearate were mixed, and the resulting mixture was filled into gelatin hollow capsule shells to obtain Preparation 21-1.

[0179] Preparation 21-2: 1.0 part by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, 0.27 parts by weight of dextrin, and 0.12 parts by weight of magnesium stearate were mixed, and the resulting mixture was filled into hollow capsules of hypromellose to obtain Preparation 21-2.

[0180] Medicine bottle 21-1: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, 0.27 parts by weight of dextrin and 0.12 parts by weight of magnesium stearate, the resulting mixture is filled into gelatin hollow capsule shells, and the drug-containing capsules are then divided into high-density polyethylene bottles to obtain medicine bottle 21-1.

[0181] Medicine bottle 21-2: After mixing 1.0 parts by weight of meclofenoxate hydrochloride, 1.2 parts by weight of calcium hydrogen phosphate, 0.27 parts by weight of dextrin and 0.12 parts by weight of magnesium stearate, the resulting mixture is filled into gelatin hollow capsule shells. The drug-containing capsules are then divided into high-density polyethylene bottles containing molecular sieve desiccant to obtain medicine bottle 21-2.

[0182] 3. High humidity stability test:

[0183] The high humidity stability test methods and results of the API, contents, preparations, and vials are as follows:

[0184] In accordance with the Chinese Pharmacopoeia Guidelines for Stability Testing of APIs and Preparations, the API, contents, preparations, and vials were placed at a temperature of 25°C and a relative humidity of 75% ± 5% for 0 days and 10 days. The meclofenoxate hydrochloride content (limit of 93-107%) and impurity A content (limit of ≤0.5%) were measured at different time points to investigate the high humidity stability of the API, contents, preparations, and vials. The results are shown in Table 2-21 below.

[0185] Table 2 Results of high humidity stability study of API, contents, preparation and vial

[0186]

[0187] Table 3 Results of high humidity stability study of API, contents, preparation and vial

[0188]

[0189] Table 4 Results of high humidity stability study of API, contents, preparation and vial

[0190]

[0191] Table 5 Results of high humidity stability study of API, contents, preparation and vial

[0192]

[0193] Table 6 Results of high humidity stability study of API, contents, preparation and vial

[0194]

[0195] Table 7 Results of high humidity stability study of API, contents, preparation and vial

[0196]

[0197] Table 8 High humidity stability test results of API, contents, preparation and bottle

[0198]

[0199] Table 9 Results of high humidity stability study of API, contents, preparation and vial

[0200]

[0201]

[0202] Table 10 Results of high humidity stability study of API, contents, preparation and vial

[0203]

[0204] Table 11 Results of high humidity stability study of API, contents, preparation and vial

[0205]

[0206] Table 12 Results of high humidity stability study of API, contents, preparation and vial

[0207]

[0208]

[0209] Table 13 Results of high humidity stability study of API, contents, preparation and vial

[0210]

[0211] Table 14 Results of high humidity stability study of API, contents, preparation and vial

[0212]

[0213] Table 15 Results of high humidity stability study of API, contents, preparation and vial

[0214]

[0215]

[0216] Table 16 Results of high humidity stability study of API, contents, preparation and vial

[0217]

[0218] Table 17 Results of high humidity stability study of API, contents, preparation and vial

[0219]

[0220] Table 18 High humidity stability test results of API, contents, preparation and vial

[0221]

[0222]

[0223] Table 19 Results of high humidity stability study of API, contents, preparation and vial

[0224]

[0225] Table 20 Results of high humidity stability study of API, contents, preparation and vial

[0226]

[0227] Table 21 Results of high humidity stability study of API, contents, preparation and vial

[0228]

[0229] Note: The structure of impurity A is as follows:

[0230]

[0231] As can be seen from Table 2-21, the gelatin capsules of meclofenoxate hydrochloride packaged in polyethylene bottles containing molecular sieve desiccant have excellent high-humidity stability. In addition, the hypromellose capsules of meclofenoxate hydrochloride also have excellent high-humidity stability, thereby improving the stability of meclofenoxate hydrochloride during transportation and storage and ensuring the quality of meclofenoxate hydrochloride.

[0232] 3. High temperature stability investigation:

[0233] The high temperature stability test methods and results of the API, contents, preparations, and vials are as follows:

[0234] In accordance with the Chinese Pharmacopoeia Guidelines for Stability Testing of APIs and Preparations, the API, contents, preparations, and vials were placed at 60°C for 0 days, 10 days, and 30 days. The meclofenoxate hydrochloride content (limit of 93-107%) and impurity A content (limit of ≤0.5%) at different time points were measured to investigate the high temperature stability of the API, contents, preparations, and vials. The results are shown in Tables 22-41 below.

[0235] Table 22 High temperature stability test results of API, contents, preparation and vial

[0236]

[0237]

[0238] Table 23 High temperature stability test results of API, contents, preparation and vial

[0239]

[0240] Table 24 High temperature stability test results of API, contents, preparation and vial

[0241]

[0242] Table 25 High temperature stability test results of API, contents, preparation and vial

[0243]

[0244] Table 26 High temperature stability test results of API, contents, preparation and vial

[0245]

[0246]

[0247] Table 27 High temperature stability test results of API, contents, preparation and vial

[0248]

[0249] Table 28 High temperature stability test results of API, contents, preparation and vial

[0250]

[0251]

[0252] Table 29 High temperature stability test results of API, contents, preparation and vial

[0253]

[0254] Table 30 High temperature stability test results of API, contents, preparation and vial

[0255]

[0256]

[0257] Table 31 Results of high temperature stability study of API, contents, preparation and vial

[0258]

[0259] Table 32 High temperature stability test results of API, contents, preparation and vial

[0260]

[0261]

[0262] Table 33 High temperature stability test results of API, contents, preparation and vial

[0263]

[0264] Table 34 High temperature stability test results of API, contents, preparation and vial

[0265]

[0266] Table 35 High temperature stability test results of API, contents, preparation and vial

[0267]

[0268] Table 36 High temperature stability test results of API, contents, preparation and vial

[0269]

[0270] Table 37 High temperature stability test results of API, contents, preparation and vial

[0271]

[0272] Table 38 High temperature stability test results of API, contents, preparation and vial

[0273]

[0274] Table 39 High temperature stability test results of API, contents, preparation and vial

[0275]

[0276]

[0277] Table 40 High temperature stability test results of API, contents, preparation and vial

[0278]

[0279] Table 41 Results of high temperature stability study of API, contents, preparation and vial

[0280]

[0281]

[0282] Note: The structure of impurity A is as follows:

[0283]

[0284] As can be seen from Tables 13-23, gelatin capsules of meclofenoxate hydrochloride packaged in polyethylene bottles containing molecular sieve desiccant have excellent high-temperature stability. In addition, meclofenoxate hydrochloride capsules of hypromellose also have excellent high-temperature stability, thereby improving the stability of meclofenoxate hydrochloride during transportation and storage and ensuring the quality of meclofenoxate hydrochloride.

[0285] The above is an implementation scheme of the present invention designed for a case. It should be pointed out that for ordinary technicians in this technical field, several improvements can be made without departing from the principles of the present invention, and these improvements should also be regarded as the scope of protection of the present invention.

Claims

1. A meclofenoxate hydrochloride capsule, characterized in that: The meclofenoxate hydrochloride capsule comprises meclofenoxate hydrochloride and a capsule shell.

2. The meclofenoxate hydrochloride capsule according to claim 1, wherein The capsule shell comprises a gelatin capsule shell or a hypromellose capsule shell.

3. The meclofenoxate hydrochloride capsule according to claim 1, wherein The meclofenoxate hydrochloride capsules further comprise calcium hydrogen phosphate.

4. The meclofenoxate hydrochloride capsule according to claim 3, wherein The weight ratio of the meclofenoxate hydrochloride to the calcium hydrogen phosphate is 1:(0.5-1.5), preferably 1:(0.8-1.2).

5. The meclofenoxate hydrochloride capsule according to claim 1, wherein The meclofenoxate hydrochloride capsules further comprise dextrin.

6. The meclofenoxate hydrochloride capsules according to claim 5, wherein The weight ratio of the meclofenoxate hydrochloride to the dextrin is 1:(0.2-0.3), preferably 1:(0.23-0.27).

7. The meclofenoxate hydrochloride capsules according to claim 1, wherein The meclofenoxate hydrochloride capsule further comprises magnesium stearate.

8. The meclofenoxate hydrochloride capsules according to claim 7, wherein The weight ratio of the meclofenoxate hydrochloride to the magnesium stearate is 1:(0.03-0.15), preferably 1:(0.05-0.12).

9. A combination, characterized in that The combination comprises the meclofenoxate hydrochloride capsules as claimed in claim 1 and a desiccant.

10. A medicine bottle, characterized in that: The medicine bottle contains the meclofenoxate hydrochloride capsules as claimed in claim 1; The medicine bottle also contains a desiccant.

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