External essential oil composition for treating diabetic peripheral neuropathy and application thereof

Abstract

The invention provides an external essential oil composition for treating diabetic peripheral neuropathy. The external essential oil composition is prepared from the following raw materials in parts by volume: 1-3 parts of radix astragali essential oil and 3-7 parts of cassia twig essential oil. The invention also provides application of the essential oil composition. Compared with the traditional oral administration mode, the essential oil composition is used for direct local administration of lesion, so that the bioavailability of the medicine is improved, the action time is prolonged, the compliance of a patient is improved, the influence of factors such as digestive enzyme and acid-base environment in the digestive tract is also effectively avoided, the liver and kidney toxicity and side effects of oral traditional Chinese medicine are reduced, and the curative effect of the oral traditional Chinese medicine is improved. And all essential oil raw materials are compounded to generate a synergistic effect.

Description

Technical Field

[0001] The invention relates to an external-use essential oil composition for treating diabetic peripheral neuropathy. Background Art

[0002] Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of diabetes. Its pathogenesis is complex and its clinical manifestations are diverse, which seriously affects the quality of life of patients. Currently, the main topical treatments for diabetic peripheral neuropathy (DPN) include lidocaine patches and capsaicin. Lidocaine is an amide local anesthetic that blocks nerve sodium channels, reduces the sensitivity of peripheral nociceptors, and thus reduces the overexcitation of the central nervous system. Li Chong et al., Research progress on Huangqi Guizhi Wuwu Decoction for the treatment of diabetic peripheral neuropathy, Chinese Herbal Medicine, Volume 55, Issue 12, June 2024. The study found that Huangqi Guizhi Wuwu Decoction (HGD) has a good effect in the prevention and treatment of DPN. The efficacy basis, clinical application and related mechanism of action of HGD in the treatment of DPN were reviewed. Qu Xinliang et al., "A systematic review of the efficacy and safety of Huangqi Guizhi Wuwu Decoction combined with acupuncture for the treatment of diabetic peripheral neuropathy," Chinese Journal of Hospital Drug Evaluation and Analysis, Vol. 22, No. 8, 2022. The combined use of Huangqi Guizhi Wuwu Decoction and acupuncture in the treatment of DPN, in addition to conventional Western medicine, has a good efficacy rate and is superior to conventional Western medicine alone. This article reports on the oral use of Huangqi Guizhi Wuwu Decoction in the treatment of diabetic peripheral neuropathy. Currently reported applications of Huangqi Guizhi Wuwu Decoction in the treatment of diabetic peripheral neuropathy are primarily oral medications, combined with other treatments. Oral administration of Chinese medicine is affected by factors such as digestive enzymes and the acid-base environment in the digestive tract, and may result in a "first-pass effect" of liver and gastrointestinal damage. Furthermore, drug bioavailability and duration of action are lower than those of topical administration. Furthermore, oral administration of Chinese medicine is prolonged, and patient compliance is lower than that of topical administration. Summary of the Invention

[0003] The present invention provides an external essential oil composition for treating diabetic peripheral neuropathy and also provides uses of the essential oil composition.

[0004] The present invention provides an external essential oil composition for treating diabetic peripheral neuropathy, which is prepared from the following raw materials in the following volume ratios:

[0005] 1-3 parts of astragalus essential oil and 3-7 parts of cassia twig essential oil.

[0006] Furthermore, it is prepared from the following raw materials in the following volume ratios:

[0007] 2 parts of astragalus essential oil and 5 parts of cassia twig essential oil.

[0008] Furthermore, the raw materials also include peony essential oil, and the volume ratio thereof is:

[0009] 2-6 parts of astragalus essential oil, 2-7 parts of cassia twig essential oil, 1-3 parts of peony essential oil.

[0010] Preferably, it is prepared from the following raw materials in the following volume ratios:

[0011] 4 parts of astragalus essential oil, 5 parts of cassia twig essential oil, 2 parts of peony essential oil.

[0012] Furthermore, the raw materials also include ginger essential oil and jujube essential oil, and the volume ratio thereof is:

[0013] 2 parts of astragalus essential oil, 4-5 parts of cassia twig essential oil, 2 parts of peony essential oil, 6-13 parts of ginger essential oil, and 4-8 parts of jujube essential oil.

[0014] Preferably, it is prepared from the following raw materials in the following volume ratios:

[0015] 2 parts of astragalus essential oil, 5 parts of cassia twig essential oil, 2 parts of peony essential oil, 13 parts of ginger essential oil, and 8 parts of jujube essential oil;

[0016] Or 2 parts of astragalus essential oil, 4 parts of cassia twig essential oil, 2 parts of peony essential oil, 6 parts of ginger essential oil, and 4 parts of jujube essential oil.

[0017] The composition of the present invention is prepared by compounding the essential oil raw materials and adding pharmaceutically acceptable excipients or auxiliary components to form a commonly used pharmaceutical preparation.

[0018] The present invention also provides use of the essential oil composition in preparing an external-use medicine for treating diabetic peripheral neuropathy.

[0019] Wherein, the medicine is a medicine for massaging the lower limbs of patients with diabetic peripheral neuropathy along the meridian points.

[0020] Experiments have shown that the essential oil composition of the present invention can achieve good drug administration effects through the transdermal route, and can avoid the "first-pass effect" of liver and gastrointestinal damage. It has the advantages of strong penetration, rapid efficacy, and low toxic and side effects, and achieves multiple therapeutic effects such as promoting blood circulation and removing blood stasis, unblocking meridians, clearing away heat and detoxifying.

[0021] The beneficial effects of the present invention are:

[0022] 1. In terms of economic cost, the drugs are mainly sourced from common and relatively cheap Chinese medicinal materials on the market, which are low in cost;

[0023] 2. In terms of preparation methods, the preparation processes adopted are all very suitable for industrial production, and conventional Chinese medicinal material extraction and production equipment can be used.

[0024] 3. In terms of mode of action, the essential oil composition of the present invention is an external application treatment method with the advantages of being easy to operate, painless for the patient, having few side effects, directly reaching the lesion, having concentrated efficacy, and being highly accepted by the patients.

[0025] 4. In terms of product efficacy, the essential oil composition of the present invention can still prevent and treat diabetic peripheral neuropathy through external treatment, and the compounding of the essential oils has a synergistic effect, which is worthy of clinical promotion and application.

[0026] Compared with traditional oral administration, the present invention uses a combination of essential oils for direct local administration of the lesion, thereby improving the bioavailability of the drug, prolonging the duration of action, and improving patient compliance. It also effectively avoids the influence of factors such as digestive enzymes in the digestive tract and the acid-base environment, reduces the hepato-renal toxicity and side effects of oral Chinese medicine, and the essential oil raw materials are compounded to produce a synergistic effect. DETAILED DESCRIPTION

[0027] Example 1 Preparation of essential oil composition of the present invention

[0028] Essential oil group 1: Astragalus essential oil 2ml, cinnamon twig essential oil 5ml, peony essential oil 2ml, ginger essential oil 13ml, jujube essential oil 8ml. Ratio 2:5:2:13:8;

[0029] Essential oil group 2: Astragalus essential oil 2ml, cinnamon twig essential oil 4ml, peony essential oil 2ml, ginger essential oil 6ml, jujube essential oil 4ml. Ratio 2:4:2:6:4;

[0030] Essential oil group 3: Astragalus essential oil 4ml, cinnamon twig essential oil 2ml, peony essential oil 2ml, ginger essential oil 6ml, jujube essential oil 6ml. Ratio 4:2:2:6:6;

[0031] Essential oil group 4: Astragalus essential oil 4ml, cinnamon twig essential oil 5ml, peony essential oil 2ml;

[0032] Essential oil group 5: Astragalus essential oil 2ml, ginger essential oil 13ml, jujube essential oil 8ml;

[0033] Essential oil group 6: Astragalus essential oil 2ml, cinnamon twig essential oil 5ml.

[0034] The preparation process of the above essential oil is:

[0035] Radix Astragali, Radix Paeoniae Alba, Ramulus Cinnamomi, Rhizoma Zingiberis and 5 kinds of Chinese jujube are cut into respectively the tiny block thing of particle size (long 0.3cm * wide 0.3cm), add in round-bottomed flask, according to solid-liquid ratio, add a certain amount of distilled water, after the constant temperature electric heating jacket heats, the water in the flask starts to boil, produce water vapor and enter extractor, enter condenser subsequently, in condenser, start liquefaction, oil and water splash in extractor simultaneously, start timing when dripping distillate, continue to extract 2.5h, whole leaching process keeps mild boiling state, finally can obtain single product essential oil after carrying out oil-water separation in centrifugal 5 minutes by centrifuge 5000g / min.Essential oil is mixed by proportioning, the essential oil base oil that different proportions mix is ​​diluted, is prepared into Chinese medicinal compound essential oil of the present invention, concentration is 5%.With Chinese medicinal compound essential oil combined meridian acupoint massage patient's two lower limbs, evaluation is to the improvement or therapeutic effect of diabetic peripheral neuropathy.Chinese medicinal compound essential oil adopts above-mentioned 6 prescription ratios to prepare.

[0036] The above essential oils can be extracted according to the preparation process, or they can be directly purchased from the market.

[0037] The beneficial effects of the present invention are demonstrated through clinical trials below.

[0038] 1. A total of 160 volunteers, aged 18-75 years, with both genders, who were diagnosed with diabetic peripheral neuropathy between September 2024 and May 2025 in a tertiary hospital in Chengdu were selected.

[0039] 2 Inclusion criteria ① Age 18-75 years, regardless of gender; ② Inpatients who meet the diagnostic criteria for type 2 diabetic peripheral neuropathy; ③ Normal thinking, independent behavior ability, and ability to communicate verbally; ④ Voluntary participation in this study and signed the informed consent form.

[0040] 3 Exclusion criteria ① Patients with severe liver and kidney damage or severe cardiovascular and cerebrovascular diseases; ② Patients with acute complications of diabetes or severe infection in the past month; ③ Patients with severe vascular lesions in both lower limbs, venous thrombosis or edema; ④ Patients with cognitive dysfunction, impaired consciousness, hearing and communication disorders and those unwilling to cooperate; ⑤ Patients with damaged skin integrity at the operation site, dermatitis, allergies and other skin diseases, or skin allergies to drugs or essential oils; ⑥ Patients with malignant tumors; ⑦ Patients who are pregnant or breastfeeding; ⑧ Patients who are participating in other research trials that may affect the results of this study.

[0041] 4. Dosage

[0042] The patient's lower limbs were massaged along the meridian acupoints using the Chinese herbal compound essential oil, once a day, using about 8 ml of the Chinese herbal compound essential oil prepared in Example 1 per time, 25-30 minutes per time, and 10 consecutive days as a course of treatment.

[0043] Oral treatment: Patients received Huangqi Guizhi Wuwu Decoction (Huangqi Guizhi Wuwu Decoction) orally. The dosage was based on the dosage of Huangqi Guizhi Wuwu Decoction in the book "Formulas: Warming the Interior, Warming the Meridians and Dispersing Cold" edited by Li Ji and published by China Traditional Chinese Medicine Press, and related literature: 9g of Huangqi, 9g of Paeonia lactiflora, 9g of Guizhi, 18g of ginger, and 4 jujubes per dose. One dose was taken daily, decocted in water to a volume of 200mL, divided into two doses for a 10-day course. Before intervention, baseline data, vibration perception thresholds, segmental galvanic perception thresholds, and Toronto clinical scores were measured. Eight groups, each with 20 participants, were included. Ten days after intervention, vibration perception thresholds, segmental galvanic perception thresholds, and Toronto clinical scores were reassessed.

[0044] 5. Efficacy on diabetic peripheral neuropathy

[0045] 5.1 Effects of different prescription compatibility on vibration perception threshold

[0046] Except for the first toe of the right foot and the first toe of the left foot in the essential oil group 6, which showed no significant effect, all other essential oil groups performed significantly better than the blank group. Compared with the oral group, the effects of essential oil groups 1 and 2 were significantly better than the oral group. (See Table 1.)

[0047] Table 1 Comparison of vibration perception thresholds of patients after intervention

[0048]

[0049] Note: Compared with the blank group, ▲ P<0.05, ▲▲ P<0.01; compared with the oral group, * P<0.05, ** P<0.01.

[0050] 5.2 Effects of different prescription compatibility on the segmental current perception threshold

[0051] Compared with the blank group, essential oil groups 1, 2, and the oral administration group significantly reduced the threshold for segmental current sensation, achieving the best results. Compared with the oral administration group, essential oil group 1 demonstrated significantly better current sensation in all segments, and essential oil group 2 also demonstrated better current sensation in the right foot segment (see Table 2).

[0052] Table 2 Comparison of segmental current perception thresholds of patients after intervention

[0053]

[0054] Note: Compared with the blank group, ▲ P<0.05, ▲▲ P<0.01; compared with the oral group, * P<0.05, ** P<0.01.

[0055] 5.3 Effects of different prescription compatibility ratios on Toronto clinical scores

[0056] The results showed that compared with the blank group, essential oil group 1, essential oil group 2, and the oral group significantly reduced the patients' Toronto clinical scores, while the other groups showed no significant changes. Compared with the oral group, essential oil group 1 had a significantly better effect than the oral group (see Table 3).

[0057] Table 3 Comparison of Toronto clinical scores of patients after intervention

[0058]

[0059] Note: Compared with the blank group, ▲ P<0.05, ▲▲ P<0.01; compared with the oral group, * P<0.05, ** P<0.01.

[0060] 5.4 Effects of different prescription compatibility on TCM syndrome grading scores

[0061] The results showed that compared with the blank group, essential oil groups 1 and 2 significantly reduced the TCM syndrome grading score, with essential oil group 1 showing the greatest effect, while the other groups showed no significant changes. Compared with the oral group, essential oil group 1 showed a significantly better effect (see Table 4).

[0062] Table 4 Comparison of TCM syndrome grading scores of patients after intervention

[0063]

[0064] Note: Compared with the blank group, ▲ P<0.05, ▲▲ P<0.01; compared with the oral group, * P<0.05, ** P<0.01.

[0065] In summary, acupoint massage using the compound essential oil of the present invention in patients with diabetic peripheral neuropathy can effectively improve vibration perception threshold, segmental current perception threshold, and Toronto clinical score, with more significant therapeutic effects. The compound essential oil can exert its effects of invigorating qi, warming meridians, and promoting blood circulation and relieving numbness through multiple pathways, such as inhibiting inflammatory responses and resisting oxidative stress.

Claims

1. An external-use essential oil composition for treating diabetic peripheral neuropathy, characterized in that: It is prepared from the following raw materials in the following volume ratios: 1-3 parts of astragalus essential oil and 3-7 parts of cassia twig essential oil.

2. The topical essential oil composition for treating diabetic peripheral neuropathy according to claim 1, wherein: It is prepared from the following raw materials in the following volume ratios: 2 parts of astragalus essential oil and 5 parts of cassia twig essential oil.

3. The topical essential oil composition for treating diabetic peripheral neuropathy according to claim 1 or 2, characterized in that: The raw materials also include peony essential oil, and the volume ratio is: 2-6 parts of astragalus essential oil, 2-7 parts of cassia twig essential oil, 1-3 parts of peony essential oil.

4. The topical essential oil composition for treating diabetic peripheral neuropathy according to claim 3, wherein: It is prepared from the following raw materials in the following volume ratios: 4 parts of astragalus essential oil, 5 parts of cassia twig essential oil, 2 parts of peony essential oil.

5. The topical essential oil composition for treating diabetic peripheral neuropathy according to claim 3 or 4, characterized in that: The raw materials also include ginger essential oil and jujube essential oil, and the volume ratio thereof is: 2 parts of astragalus essential oil, 4-5 parts of cassia twig essential oil, 2 parts of peony essential oil, 6-13 parts of ginger essential oil, and 4-8 parts of jujube essential oil.

6. The topical essential oil composition for treating diabetic peripheral neuropathy according to claim 5, characterized in that: It is prepared from the following raw materials in the following volume ratios: 2 parts of astragalus essential oil, 5 parts of cassia twig essential oil, 2 parts of peony essential oil, 13 parts of ginger essential oil, and 8 parts of jujube essential oil; Or 2 parts of astragalus essential oil, 4 parts of cassia twig essential oil, 2 parts of peony essential oil, 6 parts of ginger essential oil, and 4 parts of jujube essential oil.

7. The topical essential oil composition for treating diabetic peripheral neuropathy according to any one of claims 1 to 6, characterized in that: The essential oil raw material is compounded and pharmaceutically acceptable auxiliary materials or auxiliary components are added to prepare a commonly used pharmaceutical preparation.

8. Use of the essential oil composition according to any one of claims 1 to 7 in the preparation of an external-use medicament for treating diabetic peripheral neuropathy.

9. The use according to claim 8, characterized in that: The medicine is a medicine for massaging the lower limbs of patients with diabetic peripheral neuropathy along the meridian points.

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