Preparation of traditional Chinese medicine nanoemulsion gel spray for treating post-herpes zoster neuralgia

Abstract

The invention relates to preparation of a traditional Chinese medicine nanoemulsion gel spray for treating post-herpes zoster neuralgia. The nanoemulsion gel spray is prepared from the following raw material components: rhizoma corydalis, rhizoma chuanxiong, honeysuckle flowers, radix scutellariae, peach kernels, flos carthami, poloxamer 407, soybean oil, glycerol and pure water. Corydalis tuber, ligusticum wallichii, honeysuckle, radix scutellariae, peach kernel and safflower are adopted as traditional Chinese medicine raw material components, the traditional Chinese medicine raw material components are green, natural, free of hormone and capable of being used for a long time, effective components can effectively relieve and treat neuralgia after herpes zoster, soybean oil, glycerol and pure water are adopted as auxiliary materials, the auxiliary materials and the traditional Chinese medicine components are mixed and subjected to ultrasonic treatment, and the nano-emulsion is obtained. Then the nano-emulsion and poloxamer 407 are fully mixed to prepare nano-emulsion gel, and finally the nano-emulsion gel is canned to obtain the spray.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine nano-drug preparation, and relates to the preparation of a traditional Chinese medicine nano-emulsion gel spray for treating post-herpetic neuralgia. Background Art

[0002] Post-herpetic neuralgia (PHN) is a persistent chronic pain manifested after the outbreak of herpes zoster, which greatly reduces the quality of life of patients. So far, many treatment methods have been studied. Currently, the commonly used clinical treatment methods include drug treatment, physical therapy, and interventional therapy, etc. The drugs used in drug treatment include gabapentin, pregabalin, amitriptyline, nortriptyline, etc. However, the treatment effects of these drugs are not ideal and are accompanied by more or less side effects that are harmful to the human body. Therefore, it is an urgent matter to research and prepare drugs that can effectively treat PHN and have less side effects on the human body.

[0003] Among the drug treatment methods introduced above, the drugs used are all Western medicines, and there are few drugs developed based on traditional Chinese medicine. As a medicine that has been continuously developed and improved since ancient times, traditional Chinese medicine has the advantages of overall conditioning and fewer side effects, and plays a very important role in the treatment of chronic diseases. However, the reason why traditional Chinese medicine is less used clinically is that the traditional preparation process of traditional Chinese medicine will lead to disadvantages such as loss of active ingredients or uneven distribution, ultimately resulting in problems such as slow onset of drugs and low efficiency of ingredient release. If we can solve these problems, traditional Chinese medicine can be further promoted to the treatment of PHN.

[0004] Nanotechnology is a very important technology in current pharmacology. This technology can further improve the traditional preparation process of traditional Chinese medicine, reduce the loss of active ingredients in traditional Chinese medicine, and at the same time increase the absorption degree of the human body to the active ingredients of traditional Chinese medicine. Therefore, it is very important to combine nanotechnology with traditional Chinese herbal medicine to design and prepare drugs that can effectively treat PHN. Summary of the Invention

[0005] Aiming at the defects in the prior art, the present invention provides a preparation of a traditional Chinese medicine nano-emulsion gel spray for treating post-herpetic neuralgia. The application of the provided composition can effectively relieve post-herpetic neuralgia. Moreover, since the present invention is an external traditional Chinese medicine directly acting on the lesion site, it has a fast onset and few side effects.

[0006] Specifically, the object of the present invention can be achieved by the following technical solutions:

[0007] The first aspect of the present invention provides a preparation of a traditional Chinese medicine nano-emulsion gel spray for treating post-herpetic neuralgia. The raw materials used include Corydalis yanhusuo, Ligusticum chuanxiong, Lonicera japonica, Scutellaria baicalensis, Prunus persica, Carthamus tinctorius, soybean oil, glycerol, pure water, and poloxamer 407.

[0008] The components for relieving and treating postherpetic neuralgia provided by the present invention use Corydalis yanhusuo, Ligusticum chuanxiong, Lonicera japonica, Scutellaria baicalensis, Prunus persica, and Carthamus tinctorius as the components of traditional Chinese medicine raw materials. These components can soothe pain and effectively inhibit neuralgia. Moreover, the provided components meet the prescription requirements of drugs and health care products stipulated by the state, and a highly valuable drug for treating postherpetic neuralgia is invented.

[0009] According to the embodiments of the present invention, the traditional Chinese medicine nanoemulsion gel spray for relieving and treating postherpetic neuralgia provided above may further include the following technical features:

[0010] In some embodiments of the present invention, by weight, the nanoemulsion gel spray includes the following raw materials: 50 - 300 parts of Corydalis yanhusuo, 50 - 300 parts of Ligusticum chuanxiong, 50 - 300 parts of Lonicera japonica, 50 - 300 parts of Scutellaria baicalensis, 50 - 300 parts of soybean oil, 50 - 300 parts of Prunus persica, 50 - 300 parts of Carthamus tinctorius, 50 - 300 parts of glycerol, 50 - 300 parts of pure water, and 50 - 300 parts of poloxamer 407.

[0011] In some embodiments of the present invention, by weight, the nanoemulsion gel spray includes the following raw materials: 120 - 150 parts of Corydalis yanhusuo, 120 - 150 parts of Ligusticum chuanxiong, 120 - 150 parts of Lonicera japonica, 120 - 150 parts of Scutellaria baicalensis, 120 - 150 parts of soybean oil, 120 - 150 parts of Prunus persica, 120 - 150 parts of Carthamus tinctorius, 120 - 150 parts of glycerol, 120 - 150 parts of pure water, and 50 - 300 parts of poloxamer 407. In some embodiments of the present invention, the nanoemulsion gel spray can effectively relieve and treat postherpetic neuralgia.

[0012] The second aspect of the present invention provides a preparation of a traditional Chinese medicine nanoemulsion gel spray for treating postherpetic neuralgia. The nanoemulsion gel spray is prepared from raw materials including the following components: Corydalis yanhusuo, Ligusticum chuanxiong, Lonicera japonica, Scutellaria baicalensis, soybean oil, Prunus persica, Carthamus tinctorius, glycerol, pure water, and poloxamer 407.

[0013] The third aspect of the present invention provides a method for preparing any of the above nanoemulsion gels sprays, including:

[0014] (1) Mash Corydalis yanhusuo, Ligusticum chuanxiong, Lonicera japonica, Scutellaria baicalensis, Prunus persica, and Carthamus tinctorius and mix and stir with glycerol to obtain mixture A;

[0015] (2) Slowly add mixture A to pure water and stir to allow the solvent to diffuse to obtain mixture B;

[0016] (3) Mix and stir mixture B with soybean oil to obtain mixture C;

[0017] (4) Ultrasonically emulsify the mixture C to break the droplets and obtain nanoemulsion;

[0018] (5) Thoroughly stir and mix the nanoemulsion obtained in step (4) with poloxamer 407 to obtain a nanoemulsion gel;

[0019] (6) Package the nanoemulsion gel obtained in step (5) to obtain a nanoemulsion gel spray.

[0020] The present invention provides a method for preparing the above nanoemulsion gel spray, which has simple operation, stable process, strong operability, can rapidly release the active ingredients of the drug while maximizing the retention of the active ingredients of each raw material, and the prepared nanoemulsion gel spray can effectively relieve and treat postherpetic neuralgia.

[0021] According to the embodiments of the present invention, the method for preparing the nanoemulsion gel spray for treating postherpetic neuralgia described above may further include the following additional technical features:

[0022] In some embodiments of the present invention, in step (1), the rotation speed of the mixing and stirring is 1000 rpm, and stirring is carried out at this speed for 2 to 3 hours.

[0023] In some embodiments of the present invention, in step (2), the rotation speed of the stirring is 1000 rpm, and stirring is carried out at this speed for 2 to 3 hours.

[0024] In some embodiments of the present invention, in step (3), the rotation speed of the stirring is 1000 rpm, and stirring is carried out at this speed for 2 to 3 hours.

[0025] In some embodiments of the present invention, in step (4), the ultrasonic frequency is 20 - 40 kHz, and ultrasonic treatment is carried out for 20 - 30 minutes.

[0026] In some embodiments of the present invention, in step (5), the rotation speed of the stirring is 1000 rpm, and stirring is carried out at this speed for 2 to 3 hours.

[0027] The fourth aspect of the present invention provides a synthesis of a nanoemulsion gel spray, and the nanoemulsion gel spray contains the above-mentioned traditional Chinese medicine components and a pharmaceutically acceptable carrier. Brief Description of the Drawings

[0028] Figure 1 is a schematic diagram of the model modeling of the above nanoemulsion gel spray;

[0029] Figure 2 is a transmission electron microscope test chart of the above nanoemulsion gel;

[0030] Figure 3 is a dynamic light scattering particle size analysis chart of the above nanoemulsion gel;

[0031] Figure 4 is the test chart of the apparent Zeta potential of the above nanoemulsion gel; Detailed implementation mode

[0032] Hereinafter, embodiments of the technical solution of the present invention will be described in detail. The following embodiments are only used to more clearly illustrate the technical solution of the present invention, so they are only examples and cannot be used to limit the protection scope of the present invention.

[0033] It should be noted that unless otherwise specified, the technical terms or scientific terms used in the present invention should have the ordinary meaning understood by those skilled in the art to which the present invention belongs.

[0034] The present invention provides a preparation of a traditional Chinese medicine nanoemulsion gel spray for treating postherpetic neuralgia, which is made from raw materials including the following components: Corydalis yanhusuo, Ligusticum chuanxiong, Lonicera japonica, Scutellaria baicalensis, Prunus persica, Carthamus tinctorius, soybean oil, glycerol, pure water, and poloxamer 407. The provided raw materials can be used to relieve and treat postherpetic neuralgia. Among the provided raw materials, Corydalis yanhusuo, Ligusticum chuanxiong, Lonicera japonica, Scutellaria baicalensis, Prunus persica, and Carthamus tinctorius are traditional Chinese medicine components that can provide active ingredients for relieving and treating postherpetic neuralgia; soybean oil, glycerol, pure water, and poloxamer 407 are used as auxiliary components to be mixed with the above traditional Chinese medicine to prepare a nanoemulsion gel spray. During the research process, it was found that if some components such as Lonicera japonica or Scutellaria baicalensis were missing, the relief and treatment effects of the prepared nanoemulsion gel spray would be greatly reduced.

[0035] In at least some embodiments, the weight parts of the raw materials are as follows: Corydalis yanhusuo 50 - 300 parts, Ligusticum chuanxiong 50 - 300 parts, Lonicera japonica 50 - 300 parts, Scutellaria baicalensis 50 - 300 parts, soybean oil 50 - 300 parts, Prunus persica 50 - 300 parts, Carthamus tinctorius 50 - 300 parts, glycerol 50 - 300 parts, pure water 50 - 300 parts, and poloxamer 407 50 - 300 parts.

[0036] In at least some embodiments, the raw materials include the following raw materials in weight parts: Corydalis yanhusuo 150 parts, Ligusticum chuanxiong 150 parts, Lonicera japonica 100 parts, Scutellaria baicalensis 100 parts, soybean oil 200 parts, Prunus persica 60 parts, Carthamus tinctorius 60 parts, glycerol 100 parts, pure water 100 parts, and poloxamer 407 50 parts. In at least some embodiments, the raw materials include the following raw materials in weight fractions: Corydalis yanhusuo 150 parts, Ligusticum chuanxiong 150 parts, Lonicera japonica 50 parts, Scutellaria baicalensis 50 parts, soybean oil 200 parts, Prunus persica 30 parts, Carthamus tinctorius 30 parts, glycerol 100 parts, pure water 100 parts, and poloxamer 407 50 parts. The nanoemulsion gel spray prepared therefrom shows excellent effects in relieving and treating postherpetic neuralgia.

[0037] The preparation method of the provided nanoemulsion gel spray is as follows:

[0038] (1) Grind Corydalis Rhizome, Chuanxiong Rhizome, Honeysuckle Flower, Scutellaria Root, Peach Kernel, and Safflower, and mix and stir them with glycerol to obtain mixture A;

[0039] (2) Slowly add mixture A to pure water and stir to allow the solvent to diffuse to obtain mixture B;

[0040] (3) Mix mixture B with soybean oil to obtain mixture C;

[0041] (4) Subject mixture C to ultrasonic emulsification to break the liquid droplets and obtain nanoemulsion;

[0042] (5) Thoroughly stir and mix the nanoemulsion obtained in step (4) with poloxamer 407 to obtain nanoemulsion gel;

[0043] (6) Package the nanoemulsion gel obtained in step (5) to obtain nanoemulsion gel spray.

[0044] In at least some preferred embodiments, in step (1), the rotation speed of the mixing and stirring is 1000 rpm, and stirring is carried out at this rotation speed for 2 - 3 hours; in some embodiments of the present invention, in step (2), the rotation speed of the stirring is 1000 rpm, and stirring is carried out at this rotation speed for 2 - 3 hours; in some embodiments of the present invention, in step (3), the rotation speed of the stirring is 1000 rpm, and stirring is carried out at this rotation speed for 2 - 3 hours; in step (4), the ultrasonic frequency is 20 - 40 kHz, and the ultrasonic time is 20 - 30 minutes; in step (5), the rotation speed of the stirring is 1000 rpm, and stirring is carried out at this rotation speed for 2 - 3 hours. The finally prepared product exhibits excellent relief and treatment of postherpetic neuralgia.

[0045] The present invention also provides a synthesis of a nanoemulsion gel spray, and the nanoemulsion gel spray contains the above-mentioned traditional Chinese medicine components and a pharmaceutically acceptable carrier.

[0046] The technical solution of the present invention will be described below through specific examples. The listed examples are only for the convenience of those skilled in the art to understand.

[0047] Example 1

[0048] Example 1 prepared a nanoemulsion gel spray and verified the relief and treatment effects on postherpetic neuralgia. The experimental process is as follows:

[0049] I. Sources of raw material components, as shown in Table 1 specifically.

[0050] Table 1 Sources of each raw material

[0051]

[0052] The preparation method is as follows:

[0053] (1) Grind Corydalis Rhizoma, Ligusticum Chuanxiong, Flos Lonicerae, Radix Scutellariae, Semen Persicae, and Flos Carthami, and mix and stir with glycerol to obtain mixture A;

[0054] (2) Slowly add mixture A to pure water and stir to allow the solvent to diffuse to obtain mixture B;

[0055] (3) Mix mixture B with soybean oil to obtain mixture C;

[0056] (4) Subject mixture C to ultrasonic emulsification to break the droplets and obtain nanoemulsion;

[0057] (5) Thoroughly stir and mix the nanoemulsion obtained in step (4) with poloxamer 407 to obtain nanoemulsion nanoemulsion gel;

[0058] (6) Package the nanoemulsion nanoemulsion gel obtained in step (5) to obtain nanoemulsion gel spray.

[0059] II. Experimental content

[0060] The therapeutic effect of the above-prepared product on postherpetic neuralgia was verified.

[0061] The verification was mainly carried out by asking 10 patients in the hospital to fill out questionnaires before and after medication, with a 3-day interval between before and after medication. The content of the questionnaire included pain scores before and after medication. The above pain scores used a 4-level scoring method, namely level 1 (no pain), level 2 (mild pain), level 3 (moderate pain), and level 4 (severe pain); the patients self-evaluated the degree of improvement after treatment. The above degree was set at 5 levels, namely level 1 (significant improvement), level 2 (improvement), level 3 (nothing happened), level 4 (pain aggravated), and level 5 (deterioration); the Pittsburgh Sleep Quality Index was set at 5 levels, namely level 1 (good sleep onset), level 2 (normal sleep onset), level 3 (mild difficulty), level 4 (moderate disorder), and level 5 (severe difficulty).

[0062] The survey results are shown in Table 1

[0063] Table 1 Questionnaire survey results

[0064]

[0065] The results of the investigation and statistics show that among the 10 randomly investigated patients, only two patients did not show obvious improvement after using the drug. This does not rule out the subconscious psychological effect of subjective consciousness, which makes the patients think that the drug has no effect. The remaining patients have improved after using the drug, and the drug use time is relatively short, only 3 days, indicating that the drug takes effect quickly.

[0066] In summary, the nanoemulsion gel spray of the present invention has the effects consistent with the above description.

[0067] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the foregoing embodiments without departing from the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered by the scope of the claims and the description of the present invention.

Claims

1. Preparation of a traditional Chinese medicine nanoemulsion gel spray for treating postherpetic neuralgia, characterized in that, It is made of Corydalis yanhusuo, Ligusticum chuanxiong, Lonicera japonica, Scutellaria baicalensis, Prunus persica, Carthamus tinctorius, Poloxamer 407, soybean oil, glycerol, and pure water; In parts by weight, the respective raw materials are: 50 - 300 parts of Corydalis yanhusuo, 50 - 300 parts of Ligusticum chuanxiong, 50 - 300 parts of Lonicera japonica, 50 - 300 parts of Scutellaria baicalensis, 50 - 300 parts of soybean oil, 50 - 300 parts of Prunus persica, 50 - 300 parts of Carthamus tinctorius, 50 - 300 parts of glycerol, 50 - 300 parts of pure water, 50 - 300 parts of Poloxamer 407.

2. Preparation of a traditional Chinese medicine nanoemulsion gel spray for treating postherpetic neuralgia, characterized in that, It is made of Corydalis yanhusuo, Ligusticum chuanxiong, Lonicera japonica, Scutellaria baicalensis, Prunus persica, Carthamus tinctorius, Poloxamer 407, soybean oil, glycerol, and pure water; In parts by weight, the respective raw materials are: 120 - 150 parts of Corydalis yanhusuo, 120 - 150 parts of Ligusticum chuanxiong, 120 - 150 parts of Lonicera japonica, 120 - 150 parts of Scutellaria baicalensis, 120 - 150 parts of soybean oil, 120 - 150 parts of Prunus persica, 120 - 150 parts of Carthamus tinctorius, 120 - 150 parts of glycerol, 120 - 150 parts of pure water, 50 - 300 parts of Poloxamer 407.

3. A method for preparing the nanoemulsion gel spray according to any one of claims 1 and 2, characterized in that, It includes: (1) Crush Corydalis yanhusuo, Ligusticum chuanxiong, Lonicera japonica, Scutellaria baicalensis, Prunus persica, and Carthamus tinctorius and mix and stir with glycerol to obtain mixture A; (2) Slowly add mixture A to pure water and stir to allow the solvent to diffuse to obtain mixture B; (3) Mix and stir mixture B with soybean oil to obtain mixture C; (4) Subject mixture C to ultrasonic emulsification to break the droplets and obtain nanoemulsion; (5) Thoroughly stir and mix the nanoemulsion obtained in step (4) with Poloxamer 407 to obtain nanoemulsion gel; (6) Package the nanoemulsion gel obtained in step (5) to obtain nanoemulsion gel spray.

4. The method according to claim 3, characterized in that, It includes: In step (1), the rotation speed of the stirring is 1000 rpm, and stirring is carried out at this speed for 2 - 3 hours. In step (2), the rotation speed of the stirring is 1000 rpm, and stirring is carried out at this speed for 2 - 3 hours. In step (3), the rotation speed of the stirring is 1000 rpm, and stirring is carried out at this speed for 2 - 3 hours. In step (4), the ultrasonic frequency is 20 - 40 kHz, and ultrasonic treatment is carried out for 20 - 30 minutes. In step (5), the rotation speed of the stirring is 1000 rpm, and stirring is carried out at this speed for 2 - 3 hours.

5. A traditional Chinese medicine nanoemulsion gel spray for treating postherpetic neuralgia, characterized in that, The nanoemulsion gel spray is made by the method described in any one of claims 1 and 2.

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