Tibetan medicine external patch plaster and preparation method thereof

Abstract

The invention relates to the technical field of plasters, and provides a Tibetan medicine external patch plaster and a preparation method thereof. The Tibetan medicine external patch plaster is prepared from the following components in parts by weight: 10-20 parts of radix aconiti kusnezoffii, 8-15 parts of herba taxilli, 13-25 parts of amber, 15-25 parts of semen strychni, 15-25 parts of polygala delavayi and 12-25 parts of alkali. The drug effect and the absorption efficiency are improved; the comfort of the patient is enhanced; the product quality and stability are improved; the application range is expanded; the modern development of the traditional Tibetan medicine is promoted.

Description

Technical Field

[0001] The present application belongs to the technical field of plasters, and in particular relates to a Tibetan medicine external plaster and a preparation method thereof. Background Art

[0002] The preparation process of traditional Tibetan medicine analgesic plasters is to directly crush the medicinal materials and mix them with water or ghee for direct external application, or to make the medicine into a paste and stick the paste on the affected area with adhesive tape. During use, there are problems such as inaccurate dosage and lack of corresponding standards to control its quality, which affects the safety and effectiveness of the medicine. Summary of the invention

[0003] The purpose of the present application is to provide a Tibetan medicine external plaster and a preparation method thereof, aiming to solve the above-mentioned problems existing in the existing analgesic compresses.

[0004] In order to achieve the above application purpose, the technical solution adopted in this application is as follows: In a first aspect, the present application provides a Tibetan medicine external plaster, which is made of the following components in parts by weight: 10-20 parts of Radix Aconitum, 8-15 parts of Rhizoma Zanthoxylum, 13-25 parts of Amber, 15-25 parts of Semen Nux Vomica, 15-25 parts of Erythrorhizoma Polychorii and 12-25 parts of Sodium Flos.

[0005] In the invention, both Aconitum kusnezoffii and Semen Strychnos nux vomica have the effects of dispelling wind and dampness, relieving swelling and relieving pain; Zhaxun and Alkali Flower can promote blood circulation and regulate the physiological balance in the human body; and the combination of amber and Polychaete strychnifolia has the effect of drying yellow water.

[0006] Aconitum: dispels cold and relieves pain, dispels wind and calms nerves. Aconitum has a good therapeutic effect on joint pain, stiffness and pain caused by wind-cold-dampness arthralgia. It is pungent, hot, ascending, dispersing, bitter and dry, and has the effects of dispelling wind and dampness, dispersing cold and relieving pain. It is especially suitable for treating symptoms caused by the predominance of cold evil. It can break up the accumulation in the body and dissipate heat evil. It also has a good effect on relieving symptoms such as headache and dysmenorrhea caused by cold stagnation in the meridians.

[0007] Modern pharmacological studies have shown that the alkaloid components in Radix Aconiti Kusnezoffii, such as aconitine and mesaconitine, have good anti-inflammatory and analgesic effects. These alkaloids can affect the pain transmission pathway in the central nervous system, reduce or block pain transmission, and thus achieve an analgesic effect.

[0008] Zha Xun: Clears heat from the stomach, liver, and kidneys. Zha Xun can effectively clear heat evil from the stomach, liver, kidneys, and other organs in the body, and has a significant therapeutic effect on various diseases caused by heat evil. Promotes menstruation and removes blood stasis. Zha Xun also has the effects of promoting menstruation and activating collaterals, removing blood stasis and relieving pain.

[0009] Modern pharmacological research shows that it can regulate the physiological balance in the human body, enhance the body's immunity, and promote the repair and regeneration of damaged tissues, thereby achieving the purpose of treating diseases.

[0010] Amber: detoxification, improving eyesight, and calming the nerves. Amber can remove toxins from the body, improve symptoms of eye diseases such as blurred vision, corneal ulcers, and cataracts; it has a therapeutic effect on symptoms such as insomnia, palpitations, convulsions, and epilepsy.

[0011] Modern research shows that amber mainly contains resin, volatile oil and various organic acids, which have multiple pharmacological effects such as anti-inflammatory, analgesic and antioxidant.

[0012] Strychnos nux vomica: promotes blood circulation and dredges, removes wind and dampness, has anti-inflammatory and antibacterial effects, relieves pain, removes blood stasis and promotes tissue regeneration.

[0013] Modern pharmacological research has found that strychnine has significant efficacy in treating rheumatic autoimmune diseases, pain left over from trauma, etc. Strychnine has significant analgesic effects, and both total alkaloids of strychnine and total alkaloids of strychnine have significant anti-inflammatory effects, which can significantly inhibit swelling and tissue hyperplasia caused by inflammation.

[0014] Polypulse Cat Milk: It can astringe septicemia and yellow water. Polypulse Cat Milk can treat skin diseases such as scabies and has a significant effect on curing ulcers.

[0015] Alkali flower: It has multiple pharmacological effects such as eliminating accumulation, removing blood stasis, detoxifying and draining pus. Alkali flower can remove blood stasis, promote blood circulation, and has a certain therapeutic effect on diseases caused by blood stasis. It is often used in combination with other drugs in the treatment of surgical diseases such as sores, ulcers, and wounds.

[0016] As a possible design, the Tibetan medicine external plaster is made of the following components in parts by weight: 15-18 parts of Aconitum kusnezoffii, 10-13 parts of Zhaxun, 18-23 parts of Amber, 18-23 parts of Strychnos nux vomica, 18-22 parts of Polyporus catium and 14-17 parts of Sodium flower.

[0017] As a possible design, the Tibetan medicine external plaster is made of the following components in parts by weight: 16 parts of Radix Aconiti Kusnezoffii, 12 parts of Rhizoma Zanthoxylum, 20 parts of Amber, 20 parts of Semen Nux Vomica, 20 parts of Radix Catnip and 16 parts of Sodium Flos.

[0018] In a second aspect, the present application provides a method for preparing a Tibetan medicine external plaster, comprising: Weigh aconite, dregs of rice, amber, strychnine, cat milk and alkali flower, put them into water and heat them for processing; Separating and concentrating the processed liquid to obtain a concentrated liquid; Mixing the concentrate and the base; After mixing, vacuum homogenization is performed to obtain a paste; Apply the paste on the elastic tape, press it into shape and then cut it into plasters; The plaster is sterilized and inspected, and finally packaged.

[0019] As a possible design, the matrix is ​​glycerol.

[0020] As a possible design, the amount of the base added is based on the amount of the base added to form a paste after mixing it with the concentrate.

[0021] The beneficial effects of the present invention are: 1. Improve drug efficacy and absorption efficiency: Direct application of plasters allows the active ingredients of the drug to pass through the skin barrier more quickly and fully and reach the affected area directly, thereby improving the bioavailability and therapeutic effect of the drug; 2. Enhance patient comfort: The use of elastic tape, due to its good elasticity and skin-friendliness, reduces skin irritation and allergic reactions, making the patch fit the body curve better and remain stable even in joints and other parts with frequent movements, thus improving the patient's wearing comfort; 3. Improve product quality and stability: The application of vacuum homogenization and emulsification ensures the uniformity and stability of drug production, and ensures that the quality of each patch is controllable and the effect is consistent; 4. Expand the scope of application: The improved Tibetan medicine plaster is not only suitable for pain in common parts such as the neck, shoulders, waist, elbows, and knees, but also because of its better fit and comfort, it may be suitable for more diverse symptoms and populations, meeting a wider range of needs; 5. Promote the modernization of traditional Tibetan medicine: Combining traditional Tibetan medicine theory with modern science and technology, it has promoted the transformation of Tibetan medicine from traditional manual production to modern, standardized, and large-scale production, and improved the scientific nature and international recognition of Tibetan medicine; 6. Environmental protection and sustainability: Reduce energy consumption and waste in the production process, improve resource utilization, and comply with the concept of modern sustainable development. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0023] Figure 1 This is a flow chart of the preparation process of the Tibetan medicine external plaster provided in Example 6 of the present application. DETAILED DESCRIPTION

[0024] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application more clearly understood, the present application is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0025] In this application, the term "and / or" describes the association relationship of associated objects, indicating that there may be three relationships. For example, A and / or B can mean: A exists alone, A and B exist at the same time, and B exists alone. A and B can be singular or plural. The character " / " generally indicates that the associated objects are in an "or" relationship.

[0026] In this application, "at least one" means one or more, and "plurality" means two or more. "At least one of the following" or similar expressions refers to any combination of these items, including any combination of single items or plural items. For example, "at least one of a, b, or c", or "at least one of a, b, and c" can all mean: a, b, c, ab (i.e., a and b), ac, bc, or abc, where a, b, and c can be single or multiple.

[0027] It should be understood that in the various embodiments of the present application, the size of the serial numbers of the above-mentioned processes does not mean the order of execution, some or all of the steps can be executed in parallel or sequentially, and the execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application.

[0028] The terms used in the embodiments of the present application are only for the purpose of describing specific embodiments, and are not intended to limit the present application. The singular forms "a", "said" and "the" used in the embodiments of the present application and the appended claims are also intended to include plural forms, unless the context clearly indicates other meanings.

[0029] The weight of the relevant components mentioned in the embodiment description of the present application can not only refer to the specific content of each component, but also indicate the proportional relationship between the weights of the components. Therefore, as long as the content of the relevant components is proportionally enlarged or reduced according to the embodiment description of the present application, it is within the scope disclosed in the embodiment description of the present application. Specifically, the mass described in the embodiment description of the present application can be a mass unit known in the chemical industry such as µg, mg, g, kg, etc.

[0030] The term "PET" is the abbreviation of "Polyethylene terephthalate", which means polyethylene terephthalate; the term "PU" is the abbreviation of "polyurethane", which means polyurethane material and is the abbreviation of polyurethane.

[0031] Example 1 This example discloses a Tibetan medicine external plaster, which is made of the following components in parts by weight: 10 parts of Radix Aconiti Kusnezoffii, 8 parts of Rhizoma Zanthoxylum, 13 parts of Amber, 15 parts of Semen Nux Vomicae, 15 parts of Rhizoma Catae Polyvesiculosus and 12 parts of Sodium Flos.

[0032] Example 2 This example discloses a Tibetan medicine external plaster, which is made of the following components in parts by weight: 15 parts of Radix Aconiti Kusnezoffii, 10 parts of Rhizoma Zanthoxylum, 18 parts of Amber, 18 parts of Semen Nux Vomicae, 18 parts of Rhizoma Catae Polyvesiculosum and 14 parts of Sodium Flos.

[0033] Example 3 This example discloses a Tibetan medicine external plaster, which is made of the following components in parts by weight: 18 parts of Radix Aconiti Kusnezoffii, 3 parts of Rhizoma Zhaxun, 23 parts of Amber, 23 parts of Semen Nux Vomica, 22 parts of Radix Catnip and 17 parts of Sodium Flos.

[0034] Example 4 This example discloses a Tibetan medicine external plaster, which is made of the following components in parts by weight: 16 parts of Radix Aconiti Kusnezoffii, 12 parts of Rhizoma Zanthoxylum, 20 parts of Amber, 20 parts of Semen Nux Vomica, 20 parts of Radix Catnip and 16 parts of Sodium Flos.

[0035] Example 5 This example discloses a Tibetan medicine external plaster, which is made of the following components in parts by weight: 20 parts of Radix Aconiti Kusnezoffii, 15 parts of Rhizoma Zanthoxylum, 25 parts of Amber, 25 parts of Semen Nux Vomicae, 25 parts of Erythrorhizoma Polychorii and 25 parts of Sodium Flos.

[0036] Example 6 This example discloses a method for preparing the Tibetan medicine external plasters used in Examples 1-5. Figure 1 As shown, the preparation method comprises the following steps: S1. Weigh aconite, dregs, amber, strychnine, cat milk and alkali flower and heat them in water for processing; The temperature during the preparation process is based on the boiling water. The amount of water added is based on the amount of water that can immerse the raw materials. Before preparation, the water and raw materials can be mixed and brewed.

[0037] S2. The finished liquid is separated and concentrated to obtain a concentrate; The purpose of separation is mainly to separate the raw medicinal materials that are insoluble in water to facilitate the subsequent concentration process.

[0038] The concentration was stopped when no obvious water was found to obtain a concentrated solution.

[0039] S3. Mixing the concentrate and the matrix; The main purpose is to make a paste, which is convenient for subsequent coating on a support. The matrix is ​​generally a commonly used moisturizing substance such as glycerol and vaseline. The amount of matrix added ensures that the obtained paste can be easily spread.

[0040] S4. After mixing, vacuum homogenization is performed to obtain a paste; Vacuum homogenization is mainly to mix the concentrate and the base evenly to ensure the therapeutic effect of each plaster.

[0041] S5. Apply the paste on the elastic tape, press it into shape and cut it into a plaster; The thickness of the paste on the elastic tape is 2~5mm.

[0042] S6. Sterilize and inspect the plaster and then package it.

[0043] Comparative Example 1 The comparative example discloses a Tibetan medicine compress, which is made of the following components in parts by weight: 16 parts of Aconitum kusnezoffii, 20 parts of Amber, 20 parts of Nux vomica and 16 parts of Sodium flower.

[0044] Also disclosed is a method for preparing the Tibetan medicine compress, as follows: Grind the raw materials into 1-2um powder, mix it with ghee and apply it directly to the affected area.

[0045] Clinical experiments were conducted using the plasters obtained in Example 1 and Comparative Example 1, as follows: 1.1.1 Research subjects This study refers to the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases" and selects patients with neck, shoulder, waist, leg, and bone and joint pain who visited the outpatient department or inpatient department of Ganzi Tibetan Hospital from August 2023 to August 2024 as experimental subjects. Patients with special conditions such as severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, pregnant women and lactating women are excluded. According to the random number table method, they were divided into a control group and an experimental group. The control group had 45 people, including 23 males and 22 females; aged 25 to 60 years old, with an average age of 39 years old, including 16 cases of lumbar disc herniation pain, 18 cases of sciatica, 3 cases of frozen shoulder, 5 cases of lumbar muscle strain, and 3 cases of sprain pain; the experimental group had 45 people, including 25 males and 20 females; aged 30 to 60 years old, with an average age of 43 years old; including 15 cases of acute and chronic sprains, 12 cases of bruises and blood stasis, 10 cases of bone hyperplasia, and 8 cases of rheumatic bone and joint pain.

[0046] 1.1.2 Treatment Method The patients in the test group were treated with the patch obtained in Example 1. The patch obtained in Comparative Example 1 was used in the control group. All patients did not use any other drugs except the test drug and the control drug. The patients were required to return for a follow-up visit once a day and were observed for 5 consecutive days. Medication method: Clean the skin of the affected area, apply the patch obtained in Example 1 or Comparative Example 1 directly to the affected area, and replace one patch every day. Both groups set 5 days as one course of treatment, and continued treatment for one course of treatment to compare the efficacy.

[0047] 1.1.3 Observation points and indicators for efficacy (1) Compare the total effective rate of the two groups. Efficacy evaluation: The symptoms of waist and leg pain disappear, the bone and joint functions are restored, and the patient can work and live normally, which is markedly effective; the symptoms of waist and leg pain are significantly relieved, the bone and joint functions are restored, and the impact on work and life is slight, which is effective; the symptoms of waist and leg pain are not significantly relieved, the bone and joint functions are not significantly improved, and work and life are significantly affected, which is ineffective. The total effective rate of treatment = markedly effective rate + effective rate. (2) Observe the incidence of adverse reactions such as rash, vomiting, dizziness, nausea, abdominal discomfort and diarrhea in the two groups.

[0048] 1.1.4 Statistical methods SPSS 23.0 software was used to analyze the data, and the quantitative data were expressed as mean ± standard deviation. t test was used to express the data; the enumeration data were expressed as percentage (%) and χ 2 P<0.05 indicated that the difference was statistically significant.

[0049] 1.2 Results 1.2.1 Comparison of the total effective rate between the two groups The total effective rate of the study group was significantly higher than that of the control group (P<0.05). See Table 1.

[0050] Table 1 Comparison of total effective rate between the two groups [n(%)]

[0051] The adverse reaction rate in the study group was lower than that in the control group, and the difference was statistically significant (P < 0.05). See Table 2.

[0052] Table 2 Comparison of the incidence of adverse reactions between the two groups (n, %)

[0053] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A Tibetan medicine external plaster, characterized in that: Made from the following components in parts by weight: 10-20 parts of Aconitum kusnezoffii, 8-15 parts of Zhaxun, 13-25 parts of Amber, 15-25 parts of Strychnos nux vomica, 15-25 parts of Polyporus catium and 12-25 parts of Sodium flower.

2. The Tibetan medicine external plaster according to claim 1, characterized in that: Made from the following components in parts by weight: 15-18 parts of Aconitum kusnezoffii, 10-13 parts of Zhaxun, 18-23 parts of Amber, 18-23 parts of Strychnos nux vomica, 18-22 parts of Polyporus catium and 14-17 parts of Sodium flower.

3. The Tibetan medicine external plaster according to claim 2, characterized in that: Made from the following components in parts by weight: 16 parts of Radix Aconiti Kusnezoffii, 12 parts of Rhizoma Zanthoxylum, 20 parts of Amber, 20 parts of Semen Nux Vomica, 20 parts of Radix Catnip and 16 parts of Sodium Flos.

4. A method for preparing the Tibetan medicine external plaster according to any one of claims 1 to 3, characterized in that: The preparation method comprises: Weigh aconite, dregs of rice, amber, strychnine, cat milk and alkali flower, put them into water and heat them for processing; Separating and concentrating the processed liquid to obtain a concentrated liquid; Mixing the concentrate and the base; After mixing, vacuum homogenization is performed to obtain a paste; Apply the paste on the elastic tape, press it into shape and then cut it into plasters; The plaster is sterilized and inspected, and finally packaged.

5. The method for preparing the Tibetan medicine external plaster according to claim 4, characterized in that: The matrix is ​​glycerol.

6. The method for preparing the Tibetan medicine external plaster according to claim 4 or 5, characterized in that: The amount of the base added is based on the amount of the base to be mixed with the concentrate to form a paste.

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