Diclofenac sodium external solution composition and preparation method thereof

Abstract

The invention discloses an external diclofenac sodium solution composition which comprises a component A and a component B. The component A comprises the following raw materials in parts by weight: 0.1-0.3 part of nonionic cellulose ether and 40-60 parts of purified water; the component B is prepared from the following raw materials in parts by weight: 0.5 to 1.5 parts of diclofenac sodium, 40 to 50 parts of ethanol, 4.5 to 5.5 parts of diisopropyl adipate, 0.05 to 0.15 part of epigallocatechin gallate and 0.04 to 0.06 part of lactic acid; the sum of the parts by weight of the component A and the component B is 100. The diclofenac sodium external solution composition disclosed by the invention contains epigallocatechin gallate for inhibiting growth and reproduction of various pathogenic bacteria at wounds and promoting wound healing, and also has an anti-oxidation effect, so that the stability of a preparation is improved.

Description

Technical Field

[0001] The invention relates to a diclofenac sodium external solution composition, belonging to the technical field of medicines. Background Art

[0002] Diclofenac sodium is a nonsteroidal anti-inflammatory drug that produces analgesic, anti-inflammatory and antipyretic effects by inhibiting cyclooxygenase and blocking the synthesis of prostaglandins. It is often used to relieve mild to moderate pain in muscles, soft tissues and joints. Molecular formula C 14 H 10 Cl 2 NNaO 2 , the structural formula is Diclofenac sodium contains oxidizable groups in its structure, which can be easily oxidized and degraded to produce highly toxic impurities B and C, thus affecting the effectiveness and safety of the drug.

[0003] Patent TWI716394B Kobayashi Pharmaceutical Co., Ltd. invented a pharmaceutical composition for external use containing diclofenac and / or its salts and capsaicinoids to improve the anti-inflammatory and analgesic effects. Diclofenac and / or its salts are used together with capsaicinoids, tocopherol and / or its derivatives and ester derivatives of nicotinic acid, and the pH value is set to 6.1 or above to prepare a liquid composition, and 220 μl is applied to the right hind foot of the experimental rats. Then, the rats are subjected to acute inflammation modeling, and the foot edema inhibition rate is calculated 6 hours after application. The foot edema inhibition rate of the composition is higher than that of the diclofenac sodium fenac group alone, the diclofenac sodium and capsaicinoid combination group, and the diclofenac sodium and tocopherol and / or its derivatives and ester derivatives of nicotinic acid group, that is, the anti-inflammatory effect is improved.

[0004] The diclofenac sodium ointment currently available on the market is only suitable for intact skin and cannot be used on damaged skin or infected wounds. Although patent TWI716394B improves the anti-inflammatory effect, it is still not suitable for damaged skin and infected wounds, and the stability of the composition has not been studied. Summary of the invention

[0005] In view of at least one problem existing in the above-mentioned prior art, the present invention provides a diclofenac sodium external solution composition, which contains epigallocatechin gallate which inhibits the growth and reproduction of various pathogenic bacteria in the wound and promotes wound healing, and also has an antioxidant effect, improves the stability of the preparation, and is a local external solution preparation that can be used to relieve mild to moderate pain in muscles, soft tissues and joints.

[0006] In order to achieve the above-mentioned object, the present invention adopts the following technical scheme: a diclofenac sodium external solution composition, comprising component A and component B, in parts by weight: component A comprises the following raw materials: 0.1-0.3 parts of non-ionic cellulose ether and 40-60 parts of purified water; component B comprises the following raw materials: 0.5-1.5 parts of diclofenac sodium, 40-50 parts of ethanol, 4.5-5.5 parts of diisopropyl adipate, 0.05-0.15 parts of epigallocatechin gallate and 0.04-0.06 parts of lactic acid; and the sum of the parts by weight of component A and component B is 100 parts.

[0007] Preferably, the mass ratio of diclofenac sodium to epigallocatechin gallate is 10:1.

[0008] Preferably, the diclofenac sodium external solution composition, in parts by weight: component A comprises the following raw materials: 0.2 parts of non-ionic cellulose ether and 48.65 parts of purified water; component B comprises the following raw materials: 1 part of diclofenac sodium, 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.1 parts of epigallocatechin gallate and 0.05 parts of lactic acid.

[0009] Preferably, the diclofenac sodium external solution composition, in parts by weight: component A comprises the following raw materials: 0.2 parts of non-ionic cellulose ether and 48.1 parts of purified water; component B comprises the following raw materials: 1.5 parts of diclofenac sodium, 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.15 parts of epigallocatechin gallate and 0.05 parts of lactic acid.

[0010] Preferably, the nonionic cellulose ether is one of hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose or methyl cellulose.

[0011] Preferably, the nonionic cellulose ether is hydroxyethyl cellulose.

[0012] The present invention also provides a method for preparing a diclofenac sodium external solution composition, comprising the following steps:

[0013] (1) firstly add nonionic cellulose ether into purified water and stir to dissolve, and after stirring, obtain component A;

[0014] (2) placing ethanol, diisopropyl adipate, lactic acid, diclofenac sodium and epigallocatechin gallate in a liquid preparation bottle, stirring until completely dissolved, to obtain component B;

[0015] (3) Then, component A is added to component B under stirring, and after stirring, a solution composition for external use containing diclofenac sodium is obtained.

[0016] Preferably, the stirring rate of step (1), step (2) and step (3) is 400-600 rpm.

[0017] Preferably, the stirring time in step (1) is 3 to 4 hours.

[0018] Preferably, the stirring time in step (1) is 25 to 30 minutes.

[0019] Beneficial effects of the present invention:

[0020] (1) The diclofenac sodium external solution composition of the present invention contains a natural strong antioxidant active ingredient extracted from green tea, which reduces the degradation of diclofenac sodium, improves the stability of the preparation, and has a good effect on wound healing.

[0021] (2) The antioxidant component of the present invention uses epigallocatechin gallate, which can effectively remove free radicals and inhibit the growth and reproduction of various pathogenic bacteria in the wound, that is, it can effectively prevent infectious inflammation of the wound, promote wound healing, and reduce wound irritation during medication. DETAILED DESCRIPTION

[0022] The following is a clear and complete description of the technical solutions in the implementation of the present invention. The described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in the field without making creative work are within the scope of protection of the present invention. If the specific conditions are not specified in the embodiments, they are carried out according to the normal conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents, instruments, and components used, they are all conventional products that can be purchased commercially.

[0023] Example 1

[0024] A diclofenac sodium external solution composition, prepared by the following steps:

[0025] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 48.7 parts of purified water and stirred to dissolve, and then stirred at 500 rpm for 3.5 hours to obtain component A;

[0026] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 1 part of diclofenac sodium and 0.05 parts of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0027] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0028] Example 2

[0029] A diclofenac sodium external solution composition, prepared by the following steps:

[0030] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 48.6 parts of purified water, stirred and dissolved, and stirred at 500 rpm for 3.5 hours to obtain component A;

[0031] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 1 part of diclofenac sodium and 0.15 parts of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0032] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0033] The difference from Example 1 is that in Example 2, the component A contains 48.6 parts of purified water and the component B contains 0.15 parts of epigallocatechin gallate.

[0034] Example 3

[0035] A diclofenac sodium external solution composition, prepared by the following steps:

[0036] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 48.65 parts of purified water, stirred and dissolved, and stirred at 500 rpm for 3.5 hours to obtain component A;

[0037] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 1 part of diclofenac sodium and 0.1 parts of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0038] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0039] The difference from Example 1 is that in Example 3, the component A contains 48.65 parts of purified water and the component B contains 0.1 parts of epigallocatechin gallate.

[0040] Example 4

[0041] A diclofenac sodium external solution composition, prepared by the following steps:

[0042] (1) First, 0.1 parts of hydroxyethyl cellulose was added to 54.24 parts of purified water and stirred to dissolve, and then stirred at 500 rpm for 3.5 hours to obtain component A;

[0043] (2) 40 parts of ethanol, 4.5 parts of diisopropyl adipate, 0.06 parts of lactic acid, 1 part of diclofenac sodium and 0.1 parts of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0044] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0045] The difference from Example 3 is that in this Example 4, component A includes 0.1 parts of hydroxyethyl cellulose and 54.24 parts of purified water, and component B includes 40 parts of ethanol, 4.5 parts of diisopropyl adipate, and 0.06 parts of lactic acid.

[0046] Example 5

[0047] A diclofenac sodium external solution composition, prepared by the following steps:

[0048] (1) First, 0.3 parts of hydroxyethyl cellulose was added to 43.06 parts of purified water, stirred and dissolved, and stirred at 500 rpm for 3.5 hours to obtain component A;

[0049] (2) 50 parts of ethanol, 4.5 parts of diisopropyl adipate, 0.06 parts of lactic acid, 1 part of diclofenac sodium and 0.1 part of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0050] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0051] The difference from Example 3 is that in this Example 5, component A contains 0.3 parts of hydroxyethyl cellulose and 43.06 parts of purified water, and component B contains 50 parts of ethanol, 5.5 parts of diisopropyl adipate, and 0.04 parts of lactic acid.

[0052] Example 6

[0053] A diclofenac sodium external solution composition, prepared by the following steps:

[0054] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 49.2 parts of purified water and stirred to dissolve, and then stirred at 500 rpm for 3.5 hours to obtain component A;

[0055] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 0.5 parts of diclofenac sodium and 0.05 parts of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0056] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0057] The difference from Example 1 is that in this Example 6, component A contains 49.2 parts of purified water and component B contains 0.5 parts of diclofenac sodium.

[0058] Example 7

[0059] A diclofenac sodium external solution composition, prepared by the following steps:

[0060] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 48.1 parts of purified water and stirred to dissolve, and then stirred at 500 rpm for 3.5 hours to obtain component A;

[0061] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 1.5 parts of diclofenac sodium and 0.15 parts of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0062] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0063] The difference from Example 2 is that in this Example 7, component A contains 48.1 parts of purified water and component B contains 1.5 parts of diclofenac sodium.

[0064] Example 8

[0065] A diclofenac sodium external solution composition, prepared by the following steps:

[0066] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 48.15 parts of purified water, stirred and dissolved, and stirred at 500 rpm for 3.5 hours to obtain component A;

[0067] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 1.5 parts of diclofenac sodium and 0.1 parts of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0068] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0069] The difference from Example 3 is that in this Example 8, component A contains 48.15 parts of purified water and component B contains 1.5 parts of diclofenac sodium.

[0070] Example 9

[0071] A diclofenac sodium external solution composition, prepared by the following steps:

[0072] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 49.1 parts of purified water, stirred and dissolved, and stirred at 500 rpm for 3.5 hours to obtain component A;

[0073] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 0.5 parts of diclofenac sodium and 0.15 parts of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0074] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0075] The difference from Example 2 is that in this Example 9, component A contains 49.1 parts of purified water and component B contains 0.5 parts of diclofenac sodium.

[0076] Example 10

[0077] A diclofenac sodium external solution composition, prepared by the following steps:

[0078] (1) First, 0.2 parts of hydroxypropyl methylcellulose was added to 48.7 parts of purified water and stirred to dissolve, and then stirred at 500 rpm for 3.5 hours to obtain component A;

[0079] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 1 part of diclofenac sodium and 0.05 parts of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0080] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0081] The difference from Example 1 is that in this Example 10, hydroxypropyl methylcellulose replaces hydroxyethyl cellulose.

[0082] Embodiment 11

[0083] A diclofenac sodium external solution composition, prepared by the following steps:

[0084] (1) First, 0.2 parts of hydroxypropyl cellulose was added to 48.7 parts of purified water and stirred to dissolve, and then stirred at 500 rpm for 3.5 hours to obtain component A;

[0085] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 1 part of diclofenac sodium and 0.05 parts of epigallocatechin gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0086] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0087] The difference from Example 1 is that in this Example 11, hydroxypropyl cellulose replaces hydroxyethyl cellulose.

[0088] Comparative Example 1

[0089] A diclofenac sodium external solution composition, prepared by the following steps:

[0090] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 48.75 parts of purified water, stirred and dissolved, and stirred at 500 rpm for 3.5 hours to obtain component A;

[0091] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid and 1 part of diclofenac sodium are placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0092] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0093] The difference from Example 1 is that in this comparative example 1, the purified water of component A is 48.75 parts and the epigallocatechin gallate of component B is 0 part.

[0094] Comparative Example 2

[0095] A diclofenac sodium external solution composition, prepared by the following steps:

[0096] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 48.75 parts of purified water, stirred and dissolved, and stirred at 500 rpm for 3.5 hours to obtain component A;

[0097] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 1 part of diclofenac sodium and 0.05 parts of epigallocatechin gallate are placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0098] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0099] The difference from Example 1 is that in this comparative example 2, the purified water of component A is 48.75 parts and the lactic acid of component B is 0 parts.

[0100] Comparative Example 3

[0101] A diclofenac sodium external solution composition, prepared by the following steps:

[0102] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 48.7 parts of purified water and stirred to dissolve, and then stirred at 500 rpm for 3.5 hours to obtain component A;

[0103] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 1 part of diclofenac sodium and 0.05 parts of edetate disodium are placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0104] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0105] The difference from Example 1 is that in this comparative example 3, disodium edetate replaces epigallocatechin gallate.

[0106] Comparative Example 4

[0107] A diclofenac sodium external solution composition, prepared by the following steps:

[0108] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 48.7 parts of purified water and stirred to dissolve, and then stirred at 500 rpm for 3.5 hours to obtain component A;

[0109] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 1 part of diclofenac sodium and 0.05 parts of propyl gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0110] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0111] The difference from Example 1 is that in this comparative example 4, propyl gallate replaces epigallocatechin gallate.

[0112] Comparative Example 5

[0113] A diclofenac sodium external solution composition, prepared by the following steps:

[0114] (1) First, 0.2 parts of hydroxyethyl cellulose was added to 48.7 parts of purified water and stirred to dissolve, and then stirred at 500 rpm for 3.5 hours to obtain component A;

[0115] (2) 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.05 parts of lactic acid, 1 part of diclofenac sodium and 0.05 parts of propyl gallate were placed in a liquid preparation bottle, and stirred at 400-600 rpm until completely dissolved to obtain component B;

[0116] (3) Then, component A is added to component B under stirring, and stirred at 400-600 rpm for 30 min to obtain an external solution composition containing diclofenac sodium.

[0117] The difference from Example 1 is that in this comparative example 4, sodium pyrosulfite replaces epigallocatechin gallate.

[0118] Effect test

[0119] 1. Prepare 0.05mmol / L DPPH solution with anhydrous ethanol; take 1ml of the diclofenac sodium external solution composition prepared in Comparative Examples 1 to 5 and Examples 1 to 11 respectively and place it in 1ml DPPH solution, and react for 30min in the dark; set 1ml anhydrous ethanol + 1ml DPPH mixed solution as the control group; measure the absorbance of the DPPH solution after the reaction at 517nm with an ultraviolet visible spectrophotometer, and calculate the free radical scavenging rate according to the formula: DPPH free radical scavenging rate / % = (A 0 -A 1 ) / A 0 ×100%,A 0 Indicates the absorbance value of the control, A i The absorbance values ​​of any one of Comparative Examples 1 to 5 and Examples 1 to 11; the results of DPPH radical scavenging rate (%) are shown in Table 1.

[0120] 2. The diclofenac sodium external solution compositions prepared in Comparative Examples 1 to 5 and Examples 1 to 11 were respectively packaged in polypropylene bottles and placed under 60° C., 40% RH conditions. The diclofenac sodium content (%) and the content of related substances (%) were detected at 0 d, 10 d, and 30 d, respectively. The results are shown in Table 1.

[0121] Table 1

[0122]

[0123]

[0124] 3. Mouse trauma modeling method: After the mice are anesthetized, shave the hair on the back spine of the mice with a 2cm×2cm shaving range. Mark a square with a side length of 1cm on the back of the mice, pinch the outer layer of skin with tweezers, carefully cut along the marked area with scissors, and finally cut the skin with a scalpel.

[0125] According to the diclofenac sodium external solution composition prepared in Comparative Examples 1 to 5 and Examples 1 to 11, each group of 8 trauma modeling mice was administered: once a day, 1 ml of the corresponding composition solution was evenly applied to the modeling site of the experimental mice at the same time, and the administration was continued for 9 days, and the wound healing of the mice was observed, and the wound healing ratio was calculated; a blank group: 8 trauma modeling mice were not treated in any way, and the wound healing ratio was calculated. The wound healing ratio calculation formula is: healing ratio / %=(S 0 -S 1 ) / S 0 ×100%,S 0 represents the initial wound area, S 1 The wound area after 9 days of administration is shown in Table 2.

[0126] Table 2

[0127]

[0128]

[0129] As can be seen from Tables 1 and 2 above, the diclofenac sodium external solution composition of the present invention contains a natural strong antioxidant active ingredient extracted from green tea, which reduces the degradation of diclofenac sodium, improves the stability of the preparation, and has a good effect on wound healing.

[0130] Compared with Comparative Example 1, the addition of epigallocatechin gallate as an antioxidant component in Example 1 can effectively remove free radicals and reduce the degradation of diclofenac sodium, improve the stability of the preparation, and effectively inhibit the growth and reproduction of various pathogenic bacteria in the wound, that is, it can effectively prevent infectious inflammation in the wound, promote local wound healing, and reduce wound irritation during medication.

[0131] Compared with Comparative Example 2, the lactic acid added in Example 1 cooperates with epigallocatechin gallate to promote the removal of free radicals and improve the stability of diclofenac sodium. At the same time, it can also maintain the microecological environment at the wound, help wound healing, and protect the wound from infection.

[0132] Compared with Comparative Examples 3, 4 and 5, epigallocatechin gallate is added as an antioxidant component in Example 1, and its free radical removal rate is higher than that of disodium edetate, propyl gallate and sodium pyrosulfite, so that the content and stability of the active ingredient of the preparation are improved, and the irritation to the wound can be reduced during medication, thereby improving the healing effect and efficiency of the wound.

[0133] In addition, by comparing Example 3 with Examples 1 to 2 and Example 8, Example 6 with Example 1 and Example 9, and Example 7 with Example 2 and Example 8, it was also found that when the mass ratio of diclofenac sodium to epigallocatechin gallate in the diclofenac sodium external solution composition of the present invention was 10:1, the healing ratio of local wounds was higher and the healing effect on local wounds was better; further, the diclofenac sodium external solution compositions of Example 3 and Example 7 had a higher healing ratio for local wounds, showing a significant difference (P<0.05), and the formulas of the diclofenac sodium external solution compositions of Example 3 and Example 7 were preferred.

[0134] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the present invention can be implemented in other specific forms without departing from the spirit and essential features of the present invention. Therefore, the embodiments should be considered exemplary and non-restrictive in all respects, and the scope of the present invention is defined by the appended claims rather than the above description, and it is intended that all changes falling within the meaning and scope of the equivalent elements of the claims be included in the present invention.

[0135] In addition, it should be understood that although the present specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

Claims

1. A diclofenac sodium external solution composition, characterized in that: It includes component A and component B, and according to weight parts: component A includes the following raw materials: 0.1-0.3 parts of nonionic cellulose ether and 40-60 parts of purified water; Component B includes the following raw materials: 0.5-1.5 parts of diclofenac sodium, 40-50 parts of ethanol, 4.5-5.5 parts of diisopropyl adipate, 0.05-0.15 parts of epigallocatechin gallate and 0.04-0.06 parts of lactic acid; The total weight of component A and component B is 100 parts.

2. A diclofenac sodium external solution composition according to claim 1, characterized in that: The mass ratio of diclofenac sodium to epigallocatechin gallate is 10:

1.

3. A diclofenac sodium external solution composition according to claim 2, characterized in that: The diclofenac sodium external solution composition is calculated by weight: Component A includes the following raw materials: 0.2 parts of nonionic cellulose ether and 48.65 parts of purified water; Component B includes the following raw materials: 1 part of diclofenac sodium, 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.1 parts of epigallocatechin gallate and 0.05 parts of lactic acid.

4. A diclofenac sodium external solution composition according to claim 2, characterized in that: The diclofenac sodium external solution composition is calculated by weight: Component A includes the following raw materials: 0.2 parts of nonionic cellulose ether and 48.1 parts of purified water; Component B includes the following raw materials: 1.5 parts of diclofenac sodium, 45 parts of ethanol, 5 parts of diisopropyl adipate, 0.15 parts of epigallocatechin gallate and 0.05 parts of lactic acid.

5. A diclofenac sodium external solution composition according to any one of claims 1 to 4, characterized in that: The nonionic cellulose ether is one of hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose or methyl cellulose.

6. A diclofenac sodium external solution composition according to claim 5, characterized in that: The nonionic cellulose ether is hydroxyethyl cellulose.

7. A method for preparing the diclofenac sodium external solution composition according to claim 1, characterized in that: The following steps are involved: (1) firstly add nonionic cellulose ether into purified water and stir to dissolve, and after stirring, obtain component A; (2) placing ethanol, diisopropyl adipate, lactic acid, diclofenac sodium and epigallocatechin gallate in a liquid preparation bottle, stirring until completely dissolved, to obtain component B; (3) Then, component A is added to component B under stirring, and after stirring, a composition for external use solution containing diclofenac sodium is obtained.

8. The method for preparing a diclofenac sodium external solution composition according to claim 7, characterized in that: The stirring rate of step (1), step (2) and step (3) is 400-600 rpm.

9. The method for preparing a diclofenac sodium external solution composition according to claim 7, wherein the stirring time in step (1) is 3 to 4 hours.

10. The method for preparing a diclofenac sodium external solution composition according to claim 7, wherein the stirring time in step (1) is 25 to 30 minutes.

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