Application of tripterygium wilfordii extract in preparation of medicine for treating burns and scalds
By using different solvents to extract and treat Tribute Vine extract, the problem that existing burn drugs cannot treat peripheral nerve function damage is solved, and the comprehensive treatment of burns and scalds is achieved is achieved, and the safety and industrialization potential of the drug are improved.
Patent Information
- Application Number
- CN202311702159.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-12-12
- Publication Date
- 2025-06-13
AI Technical Summary
Existing burn and scald drugs cannot effectively treat peripheral nerve damage, and the thunder god is difficult to use for burn and scald treatment due to skin irritation.
The dried leaves, stems and roots of the triptych vine were extracted with solvents of different water and ethanol ratios, and the triptych vine extract was prepared, and then the mixture was dissolved appropriately and applied to the wound.
Triplet vine extract can not only promote wound healing, but may also have the potential to promote neurological recovery, providing a comprehensive treatment plan for mild burns and scalds, and improving the safety and industrialization potential of related drugs.
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Figure CN120131730A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a drug for treating burns and scalds, and particularly to the use of a Tripterygium wilfordii extract in the preparation of a drug for treating burns and scalds. Background Art
[0002] Burns and scalds are daily injuries, and related drugs are commonly used in households. After skin injury, during the recovery period, due to damage to nerve endings, a certain degree of peripheral nerve function injury may occur. Currently, burn creams on the market have a certain degree of promoting wound healing effect, but have no obvious therapeutic effect on peripheral nerve injury function.
[0003] Tripterygium wilfordii, as a commonly used traditional Chinese medicine, has marketed drugs applied clinically, mainly for immune diseases, and has a systemic immunosuppressive effect. There are also literature reports that Tripterygium wilfordii topical preparations have shown certain clinical efficacy in the treatment of diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, facial contact dermatitis, and eczema. Currently, due to certain irritation, Tripterygium wilfordii topical preparations are difficult to apply to burns and scalds, and there are few reports on the application of Tripterygium wilfordii extracts to burns and scalds. Summary of the Invention
[0004] The purpose of the present invention is to provide the use of a Tripterygium wilfordii extract in the preparation of a drug for treating burns and scalds. The scalds referred to herein mean various skin injuries caused by high temperature (including mild burns), and do not include mucosal burns or scalds in the body or cavity. And solve the obvious skin irritation and safety problems of raw Tripterygium wilfordii.
[0005] To achieve the above-mentioned invention purpose, the present invention provides a Tripterygium wilfordii extract that may have a potential therapeutic effect on burns and scalds. This extract may be used as a drug active ingredient in the manufacture of drugs for burns and scalds. This extract is extracted with solvents with different ratios of water to ethanol, dried, and appropriately dissolved and then applied to the wound.
[0006] Specifically, in the Tripterygium wilfordii extraction solvent, the ratio of water to ethanol is 100:0 - 20:80 (W / W). The extraction parts of Tripterygium wilfordii are dry leaves, stems, and roots. The extraction time is not less than 1 hour.
[0007] The positive effect of the present invention is that due to the high toxicity of Tripterygium wilfordii, there is a high safety risk for internal use. Fresh leaves or other parts of Tripterygium wilfordii have been recorded to be used in the treatment of skin diseases, but there is no comprehensive report on the effect on burns and scalds, and raw Tripterygium wilfordii without further processing has obvious skin irritation and cannot be industrialized and used at home. Moreover, after the wound at the burn and scald site recovers, the local nerve function is damaged. The Tripterygium wilfordii extract may have a potential effect of promoting nerve function recovery while promoting wound recovery. This comprehensive therapeutic effect may be applied to the treatment of mild burns and scalds diseases and provide a reference for the development of related drugs.
[0008] The present invention will be described in more detail below in conjunction with embodiments. The following embodiments do not constitute any limitation to the present invention. BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Figure 1 Effect of Tripterygium wilfordii Hook. f. leaf extract on scald (**: P<0.01).
[0010] Figure 2 Effect of Tripterygium wilfordii Hook. f. stem extract on scald (**: P<0.01).
[0011] Figure 3 Effect of Tripterygium wilfordii Hook. f. root extract on scald (**: P<0.01, ##: P<0.01).
[0012] Figure 4 Effect of Tripterygium wilfordii Hook. f. root extract on peripheral nerve function after partial recovery of scald (*: P<0.05, **: P<0.01, ##: P<0.01). DETAILED DESCRIPTION OF THE EMBODIMENTS
[0013] The materials and reagents used in the following embodiments are as follows:
[0014] Qianglie Brand Burn Ointment, batch number 20220421 (Changchun Overseas Pharmaceutical Group Co., Ltd.); Tripterygium wilfordii Hook. f. decoction pieces (root), batch number 20220701 (produced in Zhejiang), purchased from the Chinese Medicine Decoction Pieces Factory of Guangdong Provincial Medicinal Materials Company; dried stems and leaves of Tripterygium wilfordii Hook. f., fresh leaves of Tripterygium wilfordii Hook. f. (produced in Zhejiang), purchased from Puning Chinese Medicinal Materials Wholesale Market. Sodium carboxymethylcellulose, batch number 20200304, purchased from Xilong Chemical Co., Ltd. SD rats and Kunming mice were purchased from Guangdong Provincial Medical Experimental Animal Center.
[0015] Example 1 Preparation of Tripterygium wilfordii Hook. f. Extract
[0016] Take different parts of the Tripterygium wilfordii Hook. f. plant and extract according to the
[0017] process parameters in Table 1. The extraction solvent is prepared with 95% alcohol and is prepared in a weight ratio to prevent the ratio from being inaccurate due to volume differences introduced by different environmental temperatures during future industrial scale-up.
[0018] After extraction, filter while it is hot with thick filter cloth, centrifuge to obtain the supernatant, and the spray drying parameters are set with reference to [Feng Li. Research and Development of Aztreonam Pulmonary Inhalation Powder [D]. Chongqing Medical University, 2007] as follows: Each parameter of the spray drying process: vacuum degree: 90%-100%; inlet temperature: 120°C-130°C; outlet temperature: 100°C-120°C; solution spray speed 4%-12%; nozzle compressed air flow rate: 500-700 L / h; nozzle aperture 0.5 mm.
[0019] Table 1 Preparation process parameters of Tripterygium wilfordii Hook. f. extract
[0020]
[0021] After collection and drying, each test substance powder was prepared into a thick paste of 0.3 g / mL with 1% sodium carboxymethylcellulose solution for standby use.
[0022] Example 2 Investigation on the therapeutic effect of Tripterygium wilfordii Hook. f. extraction on scald
[0023] Refer to Section 1.4 of [Yuan Zhouxin, Zhang Xiaoqin, Liu Zhongda. Study on the repair effect of Zhou's scald ointment on deep second-degree scald wounds in SD rats [J]. Zhejiang Journal of Traditional Chinese Medicine, 2019, 54(02): 150-152.], and make appropriate adjustments. The scalded part with a weight was scalded twice with the weight to establish a scald animal model. When this experiment was carried out, after modeling, according to
[0024] Table 2 Random grouping according to body weight, using 1% sodium carboxymethylcellulose solution as the blank group and the scald ointment as the treatment control group.
[0025] After grouping, 0.5 mL was respectively absorbed and coated on the scalded part once a day. After continuously coating for 20 days, the changes in the scalded part were observed and the wound healing rate was calculated.
[0026] Table 2 Experimental scheme for the effect of the extract on the scalded part
[0027]
[0028] As Figure 1 shown, the effect of Tripterygium wilfordii Hook. f. leaf extract on scald (**: P<0.01).
[0029] As Figure 2 shown, the effect of Tripterygium wilfordii Hook. f. stem extract on scald (**: P<0.01).
[0030] As Figure 3 shown, the effect of Tripterygium wilfordii Hook. f. root extract on scald (**: P<0.01, ##: P<0.01). Example 3 Investigation on the effect of Tripterygium wilfordii Hook. f. extract on peripheral nerve function after scald
[0031] Refer to the measurement method of [Li Yabin, Wang Shuangyan, Wang Zerenrui. Experimental study on the external use of self-made earthworm extract in the treatment of scald in rats [J]. Chinese Journal of Rational Drug Use, 2020, 13(22): 55-56.], and make appropriate adjustments to the method to measure the effect of Tripterygium wilfordii Hook. f. extract on the peripheral nerve function of mice after scald.
[0032] Respectively, the required number of Kunming mice (male, body weight 18 - 22 g) were used. The toes of the mice were scalded with heated weights by the method in the above-mentioned reference literature, resulting in a model of the mouse toe area. The success of model production was judged according to the criteria in the above-mentioned literature. All animals with successful model production were randomly grouped according to body weight (15 in each group, see Table 3). Among them, the normal group was not modeled.
[0033] Table 3 Overview of the animal protocol of Tripterygium wilfordii on peripheral nerve function after scald
[0034]
[0035] After the drug was applied to the scalded area of the mice, it was difficult to ensure the drug contact time due to the licking of the mice. Therefore, the extract was appropriately dissolved into a viscous solution state and placed in a clean cage. All the mice were placed in the cage so that the mice could crawl in it to ensure sufficient contact time between the drug and the toe area. The animals were placed in the cage with the drug for one hour every day and then returned to the normal breeding cage for breeding, and the drug was administered continuously for 7 days.
[0036] On the 8th day, all the animals were placed on a 50 °C hot plate in turn, and the time from placing the animals on the hot plate to licking the hind paw was measured to measure the peripheral nerve function.
[0037] The results showed that during the entire administration period, no significant ulceration occurred at the scalded area, and on the 7th day of administration, the toe swelling of all the animals had returned to normal.
[0038] The hot plate reaction time of the animals in the blank group and the scald cream group was significantly prolonged on the 7th day, indicating that the peripheral nerve function of the animals was damaged after scald. After administration of the extracts of Tripterygium wilfordii root with different extraction solvents, different degrees of recovery of nerve endings were shown. Among them, the extract with the ratio of water: ethanol = 60:40 (W / W) had the most significant effect, approaching that of the normal group.
[0039] As Figure 4 shown, the effect of Tripterygium wilfordii root extract on the recovery of peripheral nerve function after the scalded part recovered (*: P < 0.05, **: P < 0.01, ##: P < 0.01).
[0040] Example 4 Preliminary investigation on the long-term administration safety
[0041] Referring to the [Technical Guidelines for the Study of Repeated-dose Toxicity of Drugs] issued by China's NMPA, and referring to the administration method in Example 3 and making appropriate adjustments, the long-term administration safety of the above-mentioned extract was preliminarily investigated.
[0042] Remove the hair from both sides of the back of normal SD rats (male, body weight 180 - 220 g) (using an electric hair clipper). A small amount of hair that has not been completely removed can be left. Do not use a razor to remove the hair to prevent skin damage. The skin preparation area is approximately a square of 2 cm x 2 cm. The animals are randomly divided into 3 groups according to body weight (see Table 4). After skin preparation, allow the animals to adapt for 1 day. Then, according to the protocol in Table 5, apply 0.5 mL of each test substance to the corresponding skin preparation area and spread it evenly. Administer once a day for 4 consecutive weeks. After 4 weeks of administration, stop the drug administration and allow the animals to recover for 2 weeks.
[0043] During the drug administration and recovery periods, observe the overall clinical status of the animals. Since this safety drug administration is by local skin application, focus on observing the changes in the local drug administration site and the overall status.
[0044] Literature shows that the fresh leaf juice of Tripterygium wilfordii can be externally applied to skin diseases. However, due to its toxic effects, the application time needs to be strictly controlled, otherwise it will cause local skin ulceration (Jiangxi "Herbal Handbook" and "Hunan Pharmacopoeia"). Therefore, set the fresh leaf juice of Tripterygium wilfordii as one of the comparative drug administration groups.
[0045] After 4 weeks of drug administration, no obvious changes were shown at the drug administration sites in the vehicle group and the extract group, and there were no significant changes in the overall status of the animals compared with the control. Obvious swelling occurred after 3 consecutive days of application of the fresh leaf juice of Tripterygium wilfordii, and skin ulceration occurred in some animals. Therefore, end the drug administration for this group and enter the recovery period. Except for the local adverse reactions at the drug administration site, there were no obvious changes in body weight and the overall status of the animals compared with the vehicle group.
[0046] The experimental results show that the external local skin application of the Tripterygium wilfordii root extract group has relatively high safety.
[0047] Table 4 Results of long-term drug administration safety
[0048]
Claims
1. Use of Tripterygium wilfordii Hook. f. extract in the preparation of a drug for treating burns and scalds.
2. The use according to claim 1, wherein, the scalds refer to various skin injuries caused by high temperature, including mild burns, and do not include mucosal burns or scalds in the body or cavity.
3. The use according to claim 1 or 2, wherein, the Tripterygium wilfordii Hook. f. extract is an extract of dry leaves, stems and roots.
4. The use according to claim 3, wherein, the Tripterygium wilfordii Hook. f. extract is an extract of roots.
5. The use according to claim 3, wherein, the extraction solvent of the Tripterygium wilfordii Hook. f. extract: the ratio of water to ethanol is 100:0 - 20:80 (W / W).
6. The use according to claim 5, wherein, the extraction solvent of the Tripterygium wilfordii Hook. f. extract: the ratio of water to ethanol is 60:40 (W / W).
7. The use according to claim 6, wherein, the Tripterygium wilfordii Hook. f. extract is an extract of roots.
8. The use according to claim 1, wherein, the Tripterygium wilfordii Hook. f. extract is used in topical pharmaceutical preparations, including but not limited to topical ointments, creams and liquid preparations.