CN112022979A

CN112022979A - Traditional Chinese medicine composition for relieving swelling after eye surgery and application thereof

Info

Publication number: CN112022979A
Application number: CN202011137565.6A
Authority: CN
Inventors: 刘畅
Original assignee: Huashan Hospital of Fudan University
Current assignee: Huashan Hospital of Fudan University
Priority date: 2020-10-22
Filing date: 2020-10-22
Publication date: 2020-12-04

Abstract

The invention relates to a traditional Chinese medicine composition for relieving postoperative swelling of eye surgery and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 6-12 parts of lily, 12-18 parts of phaseolus calcaratus, 6-12 parts of poria cocos, 9-15 parts of lophatherum gracile, 4-8 parts of sophora flower, 6-12 parts of herba cepbalanoplosis segeti, 6-12 parts of dandelion, 6-12 parts of lalang grass rhizome and 4-8 parts of mulberry leaf. Animal acute toxicity tests prove that the traditional Chinese medicine composition does not have obvious toxic effect; the traditional Chinese medicine composition has an obvious effect on treating the swelling around the eyes after the double eyelid shaping operation, also has a certain pain relieving effect, and is also effective on the swelling of soft tissues around the eyes caused by other eye operations; compared with the current treatment method of periocular swelling after clinical double-eyelid shaping, the traditional Chinese medicine composition has more obvious effect, can obviously shorten the time for eliminating swelling, reduces the influence of postoperative complications of double-eyelid operation on work and social activities, and ensures good operation effect.

Description

Traditional Chinese medicine composition for relieving swelling after eye surgery and application thereof

Technical Field

The invention relates to the field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for relieving postoperative swelling of eye surgery and application thereof.

Background

Double eyelid plasty is a surgical method to artificially change the structural hierarchy of an upper eyelid to form the appearance of double eyelid folds when the eyelid is open, and accounts for more than 40% of outpatient plastic cosmetic surgery. The main complications faced in the postoperative recovery process of double eyelid are: local blood stasis and hematoma, swelling of soft tissue, and poor healing of incision. The swelling is usually eliminated in 1-3 months, the work and social activities of the double-eyelid operation patients are influenced to a certain extent, and the untimely treatment of hematoma can influence the operation effect. Therefore, in order to ensure the curative effect and relieve the psychological pressure of the double-eyelid operation person, measures for shortening the time of the stasis and swelling of the wound surface are needed to restore the nature as soon as possible.

The local swelling reduction around the eyes is mainly carried out by adopting the modes of wet compression, cold compression and the like of ethanol and magnesium sulfate in the past clinic, but the effect does not reach the satisfactory degree. The literature (Qi Li taimen, Liuyufeng, Liuning, etc.. clinical research on promoting postoperative recovery of double-eyelid with external rhubarb mirabilite powder [ J ] Chinese medical cosmetology, 2019,009(005):13-16.) reports that local external application of a rhubarb mirabilite powder medicine bag can effectively promote the recovery of postoperative soft tissue swelling and incision healing and shorten the postoperative recovery period. The literature (clinical research on the curative effect of a yellow silver detumescence mask on swelling after a eyelid operation [ D ]) reports that higher patient satisfaction is obtained in the aspects of reducing the swelling degree or promoting local swelling to subside by applying the detumescence mask containing herbal components after the operation compared with the traditional method, and the detumescence mask contains the following herbal components: five barks, giant knotweed rhizome, myrobalan, dandelion, divaricate saposhnikovia root, lightyellow sophora root and mint, and other components are as follows: purified water, isopropanol, sunflower oil, emulsifying wax, ethoxy glycol, isopropyl myristate, carbomer, di-tert-butyl-p-cresol and sodium hydroxide. The literature (Liu Xiao Yan, Wang Ying Jiang, Guangjun. analysis of intervention effect of degression prevention to swelling after heavy eyelid plastic surgery [ J ]. J.Utility and medicine, 2017(11): 1011-. The technical scheme is that the yunnan white drug capsule is used for evaluating the treatment effect of swelling after the double-eyelid incision operation in the literature (Liu Xiaowei, yunnan white drug capsule is used for the initial evaluation of the treatment effect of swelling after the double-eyelid incision operation [ D ].2015 ]), and the yunnan white drug capsule is proved to be capable of effectively inhibiting the synthesis of C-reactive protein and cytokines, relieving the inflammatory reaction of a patient, improving the eye swelling degree of the patient and remarkably achieving the effect superior to that of a placebo after the operation. In addition, horse chestnut seed extract, diosmin, aescine sodium, serrapeptase enteric-coated tablets and the like are reported to treat the tissue swelling of double-fold eyelid surgery.

The applicant develops a traditional Chinese medicine composition for relieving swelling and pain after an eye operation in an earlier stage, and clinical experiments show that the traditional Chinese medicine composition has a very remarkable effect and takes effect quickly, and the swelling relieving time is shortened remarkably. Now, the Chinese medicinal composition is further researched to discuss the toxic and side effects of the Chinese medicinal composition.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for relieving swelling after eye surgery aiming at the defects in the prior art.

The invention further aims to provide application of the traditional Chinese medicine composition.

In order to achieve the first purpose, the invention adopts the technical scheme that:

a traditional Chinese medicine composition for relieving swelling after eye surgery is prepared from the following raw material medicines in parts by weight: 6-12 parts of lily, 12-18 parts of phaseolus calcaratus, 6-12 parts of poria cocos, 9-15 parts of lophatherum gracile, 4-8 parts of sophora flower, 6-12 parts of herba cepbalanoplosis segeti, 6-12 parts of dandelion, 6-12 parts of lalang grass rhizome and 4-8 parts of mulberry leaf.

As a preferred example of the invention, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 8-10 parts of lily, 14-16 parts of phaseolus calcaratus, 8-10 parts of poria cocos, 11-13 parts of lophatherum gracile, 5-7 parts of sophora flower, 8-10 parts of herba cepbalanoplosis segeti, 8-10 parts of dandelion, 8-10 parts of lalang grass rhizome and 5-7 parts of mulberry leaves.

More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 9 parts of lily, 15 parts of phaseolus calcaratus, 9 parts of poria cocos, 12 parts of lophatherum gracile, 6 parts of sophora flower, 9 parts of herba cephalanoploris, 9 parts of dandelion, 9 parts of lalang grass rhizome and 6 parts of mulberry leaf.

As another preferable example of the invention, the traditional Chinese medicine composition has no toxic or side effect.

As another preferable example of the present invention, the Chinese medicinal composition is further formulated into granules, decoction, powder, capsules, tablets or mixture.

In order to achieve the second object, the invention adopts the technical scheme that:

the application of the traditional Chinese medicine composition in preparing a medicine for relieving swelling after eye surgery.

As a preferred embodiment of the invention, the medicament also comprises a pharmaceutically acceptable carrier.

As another preferred example of the present invention, the swelling after the eye surgery is swelling of soft tissues around the eyes caused after the eye surgery.

The invention has the advantages that:

1. the traditional Chinese medicine composition has an obvious effect of treating the swelling around the eyes after the double eyelid shaping operation, also has a certain pain relieving effect, and is also effective for the swelling of soft tissues around the eyes caused by other eye operations.

2. Animal acute toxicity tests prove that the traditional Chinese medicine composition has no obvious toxic effect.

3. Compared with the current treatment method of periocular swelling after clinical double-eyelid shaping, the traditional Chinese medicine composition has more obvious effect, can obviously shorten the time for eliminating swelling, reduces the influence of postoperative complications of double-eyelid operation on work and social activities, and ensures good operation effect.

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims.

Example 1 the present invention provides a Chinese medicinal composition for relieving swelling after eye surgery

Taking the following raw material medicines in parts by weight: 9 parts of lily, 15 parts of phaseolus calcaratus, 9 parts of poria cocos, 12 parts of lophatherum gracile, 6 parts of sophora flower, 9 parts of herba cephalanoploris, 9 parts of dandelion, 9 parts of lalang grass rhizome and 6 parts of mulberry leaves; decocting by conventional method.

Embodiment 2 the present invention provides a Chinese medicinal composition for relieving swelling after eye surgery

Taking the following raw material medicines in parts by weight: 6 parts of lily, 12 parts of phaseolus calcaratus, 12 parts of poria cocos, 15 parts of lophatherum gracile, 4 parts of sophora flower, 6 parts of herba cephalanoploris, 12 parts of dandelion, 12 parts of lalang grass rhizome and 4 parts of mulberry leaves; decocting by conventional method.

Embodiment 3 the present invention provides a Chinese medicinal composition for relieving swelling after eye surgery

Taking the following raw material medicines in parts by weight: 12 parts of lily, 18 parts of phaseolus calcaratus, 6 parts of poria cocos, 9 parts of lophatherum gracile, 8 parts of sophora flower, 12 parts of common cephalanoplos herb, 6 parts of dandelion, 6 parts of lalang grass rhizome and 8 parts of mulberry leaves; decocting by conventional method.

Example 4A Chinese medicinal composition for relieving swelling after eye surgery (IV) of the present invention

Taking the following raw material medicines in parts by weight: 6 parts of lily, 12 parts of phaseolus calcaratus, 6 parts of poria cocos, 9 parts of lophatherum gracile, 4 parts of sophora flower, 12 parts of herba cephalanoploris, 12 parts of dandelion, 12 parts of lalang grass rhizome and 8 parts of mulberry leaves; decocting by conventional method.

Example 5A Chinese medicinal composition for relieving swelling after eye surgery (V) of the present invention

Taking the following raw material medicines in parts by weight: 12 parts of lily, 18 parts of phaseolus calcaratus, 12 parts of poria cocos, 15 parts of lophatherum gracile, 4 parts of sophora flower, 6 parts of herba cephalanoploris, 6 parts of dandelion, 6 parts of lalang grass rhizome and 4 parts of mulberry leaves; decocting by conventional method.

Example 6A Chinese medicinal composition for relieving swelling after eye surgery (VI) of the present invention

Taking the following raw material medicines in parts by weight: 6 parts of lily, 18 parts of phaseolus calcaratus, 6 parts of poria cocos, 15 parts of lophatherum gracile, 4 parts of sophora flower, 12 parts of herba cephalanoploris, 6 parts of dandelion, 12 parts of lalang grass rhizome and 4 parts of mulberry leaves; decocting by conventional method.

Example 7 the present invention provides a Chinese medicinal composition for relieving swelling after eye surgery

Taking the following raw material medicines in parts by weight: 12 parts of lily, 12 parts of phaseolus calcaratus, 12 parts of poria cocos, 9 parts of lophatherum gracile, 8 parts of sophora flower, 6 parts of herba cephalanoploris, 12 parts of dandelion, 6 parts of lalang grass rhizome and 8 parts of mulberry leaves; decocting by conventional method.

Embodiment 8 the present invention provides a Chinese medicinal composition for relieving swelling after eye surgery (VIII)

Taking the following raw material medicines in parts by weight: 8 parts of lily, 14 parts of phaseolus calcaratus, 10 parts of poria cocos, 13 parts of lophatherum gracile, 5 parts of sophora flower, 8 parts of herba cephalanoploris, 10 parts of dandelion, 10 parts of lalang grass rhizome and 5 parts of mulberry leaves; decocting by conventional method.

Example 9A Chinese medicinal composition for relieving swelling after eye surgery (nine) of the present invention

Taking the following raw material medicines in parts by weight: 10 parts of lily, 16 parts of phaseolus calcaratus, 8 parts of poria cocos, 11 parts of lophatherum gracile, 7 parts of sophora flower, 10 parts of herba cephalanoploris, 8 parts of dandelion, 8 parts of lalang grass rhizome and 7 parts of mulberry leaves; decocting by conventional method.

Example 10 the present invention provides a Chinese medicinal composition for relieving swelling after eye surgery (ten)

Taking the following raw material medicines in parts by weight: 8 parts of lily, 14 parts of phaseolus calcaratus, 8 parts of poria cocos, 11 parts of lophatherum gracile, 5 parts of sophora flower, 10 parts of herba cephalanoploris, 10 parts of dandelion, 10 parts of lalang grass rhizome and 7 parts of mulberry leaves; decocting by conventional method.

Example 11A Chinese medicinal composition for relieving swelling after eye surgery (eleven)

Taking the following raw material medicines in parts by weight: 10 parts of lily, 16 parts of phaseolus calcaratus, 10 parts of poria cocos, 13 parts of lophatherum gracile, 7 parts of sophora flower, 8 parts of herba cephalanoploris, 8 parts of dandelion, 8 parts of lalang grass rhizome and 5 parts of mulberry leaves; decocting by conventional method.

Example 12A Chinese medicinal composition for relieving swelling after eye surgery (twelve)

Taking the following raw material medicines in parts by weight: 8 parts of lily, 16 parts of phaseolus calcaratus, 8 parts of poria cocos, 13 parts of lophatherum gracile, 5 parts of sophora flower, 10 parts of herba cephalanoploris, 8 parts of dandelion, 10 parts of lalang grass rhizome and 5 parts of mulberry leaves; decocting by conventional method.

Example 13A Chinese medicinal composition for relieving swelling after eye surgery (thirteen)

Taking the following raw material medicines in parts by weight: 10 parts of lily, 14 parts of phaseolus calcaratus, 10 parts of poria cocos, 11 parts of lophatherum gracile, 7 parts of sophora flower, 8 parts of herba cephalanoploris, 10 parts of dandelion, 8 parts of lalang grass rhizome and 7 parts of mulberry leaves; decocting by conventional method.

It should be noted that the conventional method for decocting the raw materials described in examples 1 to 13 is a conventional method for preparing a decoction of a Chinese medicine, i.e., the raw materials are decocted into a decoction by adding water.

EXAMPLE 14 preparation of tablets/capsules of the Chinese medicinal composition of the present invention

The Chinese medicinal composition of any one of embodiments 1-13 is taken, added with 8-12 times of water, decocted for 1-3 hours, and the decoction is filtered. Adding 10 times of water, decocting for 1.5-2.5 hr, filtering to obtain decoction, mixing decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 2.5 times of ethanol, stirring, and precipitating overnight. Taking supernatant, and concentrating to obtain thick extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule.

Example 15 preparation of granules of the Chinese medicinal composition of the present invention

The Chinese medicinal composition of any one of embodiments 1 to 13 is taken, added with 8 to 10 times of water, decocted for 2.5 to 3.5 hours and filtered to obtain decoction. Adding 10 times of water, decocting for 2 hours, filtering out the decoction, combining the two decoctions, standing, filtering to obtain the supernatant, concentrating, cooling, adding 2 times of alcohol, stirring and precipitating overnight. Taking supernatant, and concentrating to obtain thick extract; adding appropriate pharmaceutical adjuvants, granulating, drying, grading to obtain 20g granule, and packaging into 10 g/bag.

EXAMPLE 16 preparation of a combination of the Chinese medicinal composition of the present invention

The Chinese medicinal composition of any one of embodiments 1 to 13 is taken, added with 8 to 10 times of water, decocted for 3 hours, and the decoction is filtered. Adding 8 times of water, decocting for 2 hours, filtering out the decoction, combining the two decoctions, standing, filtering to obtain the supernatant, concentrating, cooling, adding 2 times of alcohol, stirring and precipitating overnight. Taking supernatant, and concentrating to obtain thick extract; adding appropriate pharmaceutical adjuvants, and making into mixture, oral liquid or syrup.

Example 17 acute toxicity test report of the Chinese medicinal composition of the present invention

Purpose of the test

The toxic reaction and death condition of the mice after oral gavage of the traditional Chinese medicine composition particles are observed, and the method is used for preliminarily knowing the toxic effect of the tested substances.

2 test materials

1.1 test article

Name: the agricultural prescription granule (the traditional Chinese medicine composition granule of the invention).

The characteristics are as follows: yellowish brown to brown granules.

Preparation: 28.4g of the agricultural prescription granules are weighed, and pure water is added to the mixture to reach the constant volume of 39.0ml, so that suspension with the concentration of 0.73g/ml is obtained.

1.2 solvent

Pure water.

1.3 animals

Species and strains: ICR mice.

Grade: SPF grade.

Providing a unit: shanghai Spikes laboratory animals, Inc.

Quantity: 8 males and 8 females. The number of the devices is 16.

Week age/body weight range: 20.0-23.0 g.

3 test method

3.1 dose setting and basis

This experiment was performed by oral gavage of mice at the maximum concentration (0.73g/ml) and maximum dose capacity (40ml/kg) that could be handled with the agricultural formulation granule, at a single dose of 29.2 g/kg.

3.2 test grouping

Animals were bred adaptively in an SPF-class breeding room for 1 day, and then divided into two groups, each half male and female, each group containing 8 animals. See table 1 for details.

Table 1 packet situation table

3.3 animal identification

After animals were grouped, each animal was marked with an animal marker pen (head marked No. 1, back marked No. 2, tail marked No. 3, No. 4) and was noted for immediate countermarking.

3.4 methods of administration

The administration route is as follows: and (5) performing oral gavage.

Dose capacity: 40 ml/kg.

The administration frequency is as follows: the medicine is taken once.

The administration period is as follows: for 1 day.

Animal preparation prior to dosing: all animals were fasted overnight for about 4-6 hours without water deprivation.

3.5 Observation period after administration

Observations started on day of administration (D1) and ended on day 15 (D15).

3.6 Observation of clinical signs

The animals are mainly observed for physical signs, behavior activity, glandular secretion, respiration, excrement, symptoms of abnormal reaction of the animals, initial time, severity, duration, reversibility and death of the animals, and the observation frequency can be increased appropriately if the animals are found to be abnormal. The observation frequency at each stage of the experiment is shown in Table 2.

TABLE 2 frequency of observation at each stage of the experiment

3.7 weight and food intake

Body weights of mice were measured on day of administration, day 2, day 8, day 15; the food intake on the 4 th to 7 th days and the 11 th to 14 th days (food intake on the 4 th and 11 th days after administration, 150.0 to 155.0g per cage on the 4 th day, and 200.0g per cage on the 11 th day) was measured, and if abnormal, follow-up observation was carried out.

3.8 gross anatomic visualization

Necropsy is needed when dead animals are found; animals found to be moribund or to be euthanized from the animal welfare perspective are necropsied in time after euthanization. Other mice are killed by isoflurane anesthesia and exsanguination after the observation period is finished, the heart, the lung, the kidney, the liver, the spleen, the gastrointestinal tract, the injection part and the like are mainly observed, whether abnormal conditions such as bleeding points, edema and the like exist or not is observed, and the pathological change condition is recorded. Histopathological examination is performed when changes in volume, color, texture, etc. are found in the organ.

3.9 statistical analysis of data

All data of the test are counted by SPSS software, and the results of all measured data use the mean value plus or minus standard deviation

And (4) showing. The variance is checked for homogeneity by t, and the variance is checked for irregularity by corrected t.

4 results of the test

4.1 Observation of clinical signs

The mice have no abnormal reaction from the day after the test article or the reference article is given to the 15 th day, the mice have good activity and mental status, and the urine are normal.

At the end of the test, animals are roughly dissected, and viscera such as heart, lung, kidney, liver, spleen, gastrointestinal tract and the like are observed by naked eyes, and two groups of mice are normal and have no bleeding point, edema and the like. Mice in each group did not die within 15 days.

4.2 body weight

After the mice are orally administrated with the stomach-filling agricultural prescription granule, the weight of the administration group has no significant difference (P is more than 0.05) compared with that of the control group when the male and female mice are administered with the stomach-filling agricultural prescription granule on days 1, 2, 8 and 15. See tables 3 and 4 for details.

TABLE 3 mice weight test of Male mice by oral gavage of agricultural prescription granule acute toxicity

Note: n is 4.

TABLE 4 weight test of female mice by oral gavage of agricultural prescription granule acute toxicity test

Note: n is 4.

4.3 food intake

After the mice were orally administered with the stomach-drenching formulation granule, the food intake data of male and female mice are shown in tables 5 and 6. It was found that the food intake of mice on days 4 to 7 and 11 to 14 in the administration group was not statistically analyzed because n is 1 (per cage).

TABLE 5 mice oral gavage agriculture prescription granule acute toxicity test male mice food intake (g/day/mouse)

Note: n is 1.

TABLE 6 mice oral gavage recipe granule acute toxicity test female mice food intake (g/day/mouse)

Note: n is 1.

4.4 pathological examination

On the 15 th day after administration, all animals of the control group and the administration group were subjected to a necropsy, and no obvious abnormality was observed in the body surface and organs of each group of animals at the time of the necropsy.

4.5 analysis of results

The experiment shows that the maximum concentration (0.73g/ml) and the maximum administration volume (40ml/kg) of the mice which can be operated by using the agricultural prescription granule are orally gavaged to the mice, and no mice die within 15 days. From the day after administration to day 15, no abnormal reaction was observed in both groups of mice, and the mice had good physical and mental status and normal urination and defecation. The weight of the administration group has no significant difference compared with the control group, and has no obvious influence on food intake. The maximum dosage of the oral gavage agricultural prescription granule for mice is calculated to be 29.2 g/kg.

Conclusion of the test

The stomach-filling agricultural prescription granule is orally administrated by the maximum dose (29.2g/kg) of mice, and has no obvious toxic effect.

The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims

1. The traditional Chinese medicine composition for relieving swelling after eye surgery is characterized by being prepared from the following raw material medicines in parts by weight: 6-12 parts of lily, 12-18 parts of phaseolus calcaratus, 6-12 parts of poria cocos, 9-15 parts of lophatherum gracile, 4-8 parts of sophora flower, 6-12 parts of herba cepbalanoplosis segeti, 6-12 parts of dandelion, 6-12 parts of lalang grass rhizome and 4-8 parts of mulberry leaf.

2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 8-10 parts of lily, 14-16 parts of phaseolus calcaratus, 8-10 parts of poria cocos, 11-13 parts of lophatherum gracile, 5-7 parts of sophora flower, 8-10 parts of herba cepbalanoplosis segeti, 8-10 parts of dandelion, 8-10 parts of lalang grass rhizome and 5-7 parts of mulberry leaves.

3. The traditional Chinese medicine composition according to claim 2, which is prepared from the following raw materials in parts by weight: 9 parts of lily, 15 parts of phaseolus calcaratus, 9 parts of poria cocos, 12 parts of lophatherum gracile, 6 parts of sophora flower, 9 parts of herba cephalanoploris, 9 parts of dandelion, 9 parts of lalang grass rhizome and 6 parts of mulberry leaf.

4. The Chinese medicinal composition according to any one of claims 1 to 3, wherein the Chinese medicinal composition has no toxic or side effect.

5. The composition of any one of claims 1-3, wherein the composition is further formulated as a granule, decoction, powder, capsule, tablet, or mixture.

6. Use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of a medicament for relieving swelling after ocular surgery.

7. The use of claim 6, wherein the medicament further comprises a pharmaceutically acceptable carrier.

8. The use according to claim 6, wherein the post-ocular surgery swelling is periocular soft tissue swelling caused after ocular surgery.