Traditional Chinese medicine composition for perioperative period of fundus surgery and preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition used in the perioperative period of fundus surgery and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition for the perioperative period of the fundus surgery is prepared from the following components in parts by weight: 9 to 15 parts of radix astragali seu hedysari, 6 to 12 parts of radix angelicae sinensis, 6 to 12 parts of radix rehmanniae, 6 to 12 parts of herba ecliptae, 3 to 9 parts of radix paeoniae rubra, 3 to 9 parts of rhizoma atractylodis macrocephalae, 6 to 12 parts of semen plantaginis, 1 to 6 parts of radix saposhnikoviae and 1 to 6 parts of ramulus cinnamomi. By adopting the traditional Chinese medicine composition, the postoperative vision of a patient subjected to fundus surgery can be effectively improved, the retina sensitivity is improved, and the visual function of a macular region is improved; absorption of fundus hemorrhage is effectively promoted, the central fovea thickness of a macular region is reduced, and absorption of postoperative macular edema is promoted; the traditional Chinese medicine composition can improve eye local and whole body traditional Chinese medicine syndromes, and is safe in clinical medication.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine composition for perioperative use in fundus surgery, its preparation method and application. Background Technology

[0002] Vitrectomy (pars plana vitrectomy, PPV) is the most effective and commonly used surgical treatment for serious fundus diseases such as vitreous hemorrhage and retinal detachment. It can remove vitreous hemorrhage and proliferative membranes in the fundus, and reposition the detached retina, thereby saving the patient's vision.

[0003] However, PPV surgery is complex, and the likelihood of postoperative visual recovery is highly uncertain. Vitreous re-hemorrhagic recurrence is a common complication after PPV surgery, caused by factors such as retinal neovascularization leakage, residual proliferative membrane, insufficient peripheral retinal laser spot, and external force. Furthermore, serious complications such as persistent macular edema, endophthalmitis, neovascular glaucoma, and secondary retinal detachment may occur postoperatively, leading to unsatisfactory visual recovery and severely impacting patients' quality of life. Therefore, effectively reducing postoperative inflammation, rebleeding, and macular edema to improve postoperative visual quality is a pressing issue that needs to be addressed. Summary of the Invention

[0004] In view of this, the purpose of this invention is to provide a traditional Chinese medicine composition for the perioperative period of fundus surgery, its preparation method, and its application. This invention, through the use of a traditional Chinese medicine compound that invigorates qi and nourishes blood, stops bleeding, and promotes diuresis, effectively reduces postoperative bleeding, promotes edema absorption, and reduces the occurrence of postoperative inflammatory reactions, thus demonstrating good clinical efficacy in improving patients' visual function.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for use in the perioperative period of fundus surgery, comprising the following components in parts by weight: Astragalus membranaceus 9-15 parts, Angelica sinensis 6-12 parts, Rehmannia glutinosa 6-12 parts, Eclipta prostrata 6-12 parts, Paeonia lactiflora 3-9 parts, Atractylodes macrocephala 3-9 parts, Plantago asiatica 6-12 parts, Saposhnikovia divaricata 1-6 parts, and Cinnamomum cassia 1-6 parts.

[0006] As a preferred option, the ingredients include the following components in parts by weight: 10-13 parts Astragalus membranaceus, 8-10 parts Angelica sinensis, 8-10 parts Rehmannia glutinosa, 8-10 parts Eclipta prostrata, 5-7 parts Paeonia lactiflora, 5-7 parts Atractylodes macrocephala, 8-10 parts Plantago asiatica, 2-4 parts Saposhnikovia divaricata, and 2-4 parts Cinnamomum cassia.

[0007] As a preferred option, the ingredients include the following components in parts by weight: 12 parts Astragalus membranaceus, 9 parts Angelica sinensis, 9 parts Rehmannia glutinosa, 9 parts Eclipta prostrata, 6 parts Paeonia lactiflora, 6 parts Atractylodes macrocephala, 9 parts Plantago asiatica, 3 parts Saposhnikovia divaricata, and 3 parts Cinnamomum cassia.

[0008] This invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for the perioperative period of fundus surgery.

[0009] Preferably, the dosage form of the drug is a decoction or granules.

[0010] This invention provides a decoction for use in the perioperative period of fundus surgery, and the preparation method of the decoction is as follows: (6.1) Weigh the drug components according to the proportions of the traditional Chinese medicine composition, mix them, and obtain the traditional Chinese medicine composition; (6.2) After soaking the Chinese herbal composition in water for 20-40 minutes, decoct it 1-3 times, filter it, collect and combine the liquids to obtain a decoction.

[0011] Preferably, the mass ratio of the traditional Chinese medicine composition to water is 1:8~10; Each simmering time should be 20-40 minutes; The sieve used for filtration has a mesh size of 80-120.

[0012] The present invention also provides a granule preparation for use in the perioperative period of fundus surgery, the granule preparation method being as follows: (8.1) Weigh the drug components according to the proportions of the traditional Chinese medicine composition, mix them, and obtain the traditional Chinese medicine composition; (8.2) Mix the Chinese herbal composition with water, decoct 1 to 3 times, filter, collect and combine the decoctions, and concentrate the combined decoctions to a thick paste with a relative density of 1.20 to 1.30 at 50 to 60°C to obtain a Chinese herbal paste; (8.3) The herbal paste is dried and pulverized to obtain herbal powder; (8.4) The Chinese herbal powder is mixed with filler, lubricant and flavoring agent, and granulated to obtain granules.

[0013] Preferably, the mass ratio of the traditional Chinese medicine composition to water is 1:8~10; Each simmering time is 50-70 minutes; The sieve used for filtration has a mesh size of 80-120.

[0014] Preferably, the herbal paste is dried by vacuum drying, and the temperature of vacuum drying is 60~80℃; The mass ratio of the herbal powder to the filler is 1~4:1; The filler is any one of maltodextrin, dextrin, and soluble starch; The amount of lubricant added is 0.1% to 3% of the total granulation volume, and the lubricant is magnesium stearate; The amount of flavoring agent added is 0.1% to 0.3% of the total granulation volume, and the flavoring agent is sucralose; The particle size of the granules is 10-20 mesh.

[0015] Compared with the prior art, the present invention has the following beneficial effects: (1) The present invention adopts a combination of holistic and local ocular syndrome differentiation to treat perioperative ophthalmic diseases. The results show that the Chinese medicine composition of the present invention can effectively improve postoperative visual acuity, increase retinal sensitivity, and improve macular visual function in PPV patients; effectively promote the absorption of fundus hemorrhage, effectively reduce the thickness of the fovea of ​​the macular region, reduce the volume of the macular region, reduce the average thickness of the macular region, and effectively promote the absorption of postoperative macular edema; it can improve the local ocular and systemic TCM syndrome manifestations and is safe for clinical use.

[0016] (2) After vitrectomy, the surgical trauma leads to depletion of qi and blood, and dysfunction of the internal organs. Astragalus membranaceus invigorates qi and strengthens the exterior, Atractylodes macrocephala invigorates the spleen and promotes diuresis, and Saposhnikovia divaricata dispels wind and dampness. The three herbs work together to invigorate qi and strengthen the exterior, promoting the rapid recovery of the body's vital energy after surgery. Angelica sinensis nourishes blood and relieves pain, Rehmannia glutinosa cools blood and nourishes yin, Paeonia lactiflora disperses blood stasis and clears liver fire, and Eclipta prostrata nourishes the liver and kidneys, cools blood and stops bleeding. The combination of Angelica sinensis, Rehmannia glutinosa, Paeonia lactiflora, and Eclipta prostrata is most suitable for blood deficiency and blood stasis after vitrectomy. Plantago asiatica promotes diuresis and eliminates dampness, while Cinnamomum cassia assists yang and transforms qi, promoting the absorption of fundus edema. The whole formula works together to invigorate qi and nourish blood, stop bleeding and promote diuresis. It has the characteristics of dispersing and astringing, and tonifying without stagnation. It can treat both the root cause and the symptoms, and treat qi and blood at the same time.

[0017] (3) Modern pharmacological studies have shown that Rehmannia glutinosa has anti-inflammatory, antipyretic, hemostatic, and hematopoietic-promoting effects, and its active ingredient, ziziphus jujuba, can effectively inhibit neuropathic pain. Atractylodes macrocephala can inhibit the proliferation and migration of inflammatory factors such as TNF-α and IL-6, as well as vascular smooth muscle cells, thereby achieving an anti-inflammatory effect. The polysaccharide components in Angelica sinensis can stimulate the production of hemoglobin and red blood cells and promote the recovery of bone marrow hematopoietic function. Saposhnikovia divaricata has the effects of dilating microvessels, accelerating blood flow, improving blood circulation, anti-inflammatory, anticoagulant, and indirect analgesia. Astragaloside IV has a strong ability to improve microcirculation and dilate blood vessels. By participating in and regulating the body's immunity, Plantago asiatica polysaccharide has a good effect on inhibiting the increase of capillary permeability, reducing exudation, and alleviating inflammatory reactions. In summary, it can be seen that the traditional Chinese medicine composition of the present invention can effectively promote ocular microcirculation, accelerate the absorption and resolution of inflammatory factors, and has a definite and positive effect on alleviating postoperative reactions, promoting the absorption of bleeding and macular edema, promoting surgical wound healing, preventing postoperative recurrence, and improving visual function. Attached Figure Description

[0018] Figure 1 The changes in BCVA (LogMAR) before and after 12 weeks of drug use in two groups of subjects; Figure 2 The changes in the thickness of the fovea of ​​the macular region before and after 12 weeks of drug use in two groups of subjects; Figure 3 The changes in macular volume before and after 12 weeks of drug use in two groups of subjects; Figure 4 The changes in the average thickness of the macular region before and after 12 weeks of medication in two groups of subjects; Figure 5 This is a recovery diagram for Case 1; Figure 6 This is a recovery diagram for Case 2; Figure 7 This is a recovery diagram for Case 3; Figure 8 This is a recovery diagram for Case 4. Detailed Implementation

[0019] This invention provides a traditional Chinese medicine composition for use in the perioperative period of fundus surgery, comprising the following components in parts by weight: Astragalus membranaceus: 9-15 parts, preferably 10-13 parts, and more preferably 12 parts; Angelica sinensis 6-12 parts, preferably 8-10 parts, more preferably 9 parts; 6-12 parts of raw Rehmannia root, preferably 8-10 parts, and more preferably 9 parts; 6-12 parts of Eclipta prostrata, preferably 8-10 parts, and more preferably 9 parts; 3-9 parts of red peony root, preferably 5-7 parts, and even more preferably 6 parts; 3-9 parts of Atractylodes macrocephala, preferably 5-7 parts, and more preferably 6 parts; 6 to 12 parts of plantain seeds, preferably 8 to 10 parts, and more preferably 9 parts; 1 to 6 parts of windproof material, preferably 2 to 4 parts, and more preferably 3 parts; The amount of cinnamon twigs is 1 to 6 parts, preferably 2 to 4 parts, and even more preferably 3 parts.

[0020] This invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for the perioperative period of fundus surgery.

[0021] In this invention, the dosage form of the drug is a decoction or granules.

[0022] This invention provides a decoction for use in the perioperative period of fundus surgery, and the preparation method of the decoction is as follows: (6.1) Weigh the drug components according to the proportions of the traditional Chinese medicine composition, mix them, and obtain the traditional Chinese medicine composition; (6.2) After soaking the Chinese herbal composition in water for 20-40 minutes, decoct it 1-3 times, filter it, collect and combine the liquids to obtain a decoction.

[0023] In this invention, the mass ratio of the traditional Chinese medicine composition to water is 1:8~10; the soaking time is preferably 25~35 min, more preferably 30 min; the decoction is preferably performed twice, and the decoction time is 20~40 min. Preferably, the first decoction is performed by bringing the mixture to a boil over high heat, and then simmering it over low heat for 30 min. The second decoction is performed by bringing the mixture to a boil over high heat, and then simmering it over low heat for 20 min. The mesh size of the sieve used for filtration is 80~120 mesh, preferably 90~110 mesh, more preferably 100 mesh.

[0024] The present invention also provides a granule preparation for use in the perioperative period of fundus surgery, the granule preparation method being as follows: (8.1) Weigh the drug components according to the proportions of the traditional Chinese medicine composition, mix them, and obtain the traditional Chinese medicine composition; (8.2) Mix the Chinese herbal composition with water, decoct 1 to 3 times, filter, collect and combine the decoctions, and concentrate the combined decoctions to a thick paste with a relative density of 1.20 to 1.30 at 50 to 60°C to obtain a Chinese herbal paste; (8.3) The herbal paste is dried and pulverized to obtain herbal powder; (8.4) The Chinese herbal powder is mixed with filler, lubricant and flavoring agent, and granulated to obtain granules.

[0025] In this invention, the decoction is preferably performed twice; the mass ratio of the herbal composition to water is 1:8 to 10; preferably, the mass ratio of the herbal composition to water is 1:10 in the first decoction and 1:8 in the second decoction, and the decoction time is 50 to 70 minutes each time, preferably 55 to 65 minutes, and more preferably 60 minutes; the mesh size of the sieve used for filtration is 80 to 120 mesh, preferably 90 to 110 mesh, and more preferably 100 mesh.

[0026] In this invention, the preferred method for drying the herbal paste is to place the herbal paste in a pulse vacuum dryer at 60-80°C and dry it under reduced pressure until the moisture content is less than 5%, then pulverize it through a No. 4 sieve to obtain a dry paste powder; the temperature of the reduced pressure drying is preferably 65-75°C, and more preferably 70°C.

[0027] In this invention, the mass ratio of the herbal powder to the filler is 1-4:1; the filler is any one of maltodextrin, dextrin, and soluble starch; the amount of lubricant added is 0.1%-3% of the total granulation volume, and the lubricant is magnesium stearate; the amount of flavoring agent added is 0.1%-0.3% of the total granulation volume, and the flavoring agent is sucralose; the granulation method is dry granulation; and the particle size of the granules is 10-20 mesh.

[0028] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0029] Example 1

[0030] Weigh out 15g of Astragalus membranaceus, 12g of Angelica sinensis, 12g of Rehmannia glutinosa, 12g of Eclipta prostrata, 9g of Paeonia lactiflora, 9g of Atractylodes macrocephala, 12g of Plantago asiatica, 6g of Saposhnikovia divaricata, and 6g of Cinnamomum cassia. Place them in 930g of water and soak for 30 minutes. Bring to a boil over high heat, then reduce to a simmer and cook for 30 minutes. Filter the decoction through a 100-mesh sieve and collect the liquid. Add 744g of water again for a second decoction, bringing to a boil over high heat, then reduce to a simmer and cook for 20 minutes. Filter the decoction through a 100-mesh sieve and collect the liquid. Combine the two decoctions to obtain a decoction for use in the perioperative period of fundus surgery.

[0031] Example 2

[0032] Weigh out 120g of Astragalus membranaceus, 90g of Angelica sinensis, 90g of Rehmannia glutinosa, 90g of Eclipta prostrata, 60g of Paeonia lactiflora, 60g of Atractylodes macrocephala, 90g of Plantago asiatica, 30g of Saposhnikovia divaricata, and 30g of Cinnamomum cassia. Place them in 6.6kg of water and decoct for 60 minutes. Filter the decoction through a 100-mesh sieve and collect the liquid. Add 5.28kg of water again and decoct for 60 minutes. Filter the decoction through a 100-mesh sieve and collect the liquid. Combine the two decoctions. Concentrate the combined decoction to a thick paste with a relative density of 1.20 at 60℃ to obtain a traditional Chinese medicine paste. Place the paste in a pulse vacuum dryer and dry under reduced pressure at 70℃ until the moisture content is below 5%. Pulverize the paste through a No. 4 sieve to obtain a dry paste powder (dry paste rate 34%). The dry powder was mixed with dextrin (4:1), 1.5% magnesium stearate, and 0.2% sucralose (by weight of the total granulation volume) for 15 minutes to obtain a mixture. The mixture was then subjected to dry granulation with the following parameters: feed speed 20 rpm, roller speed 10 rpm, granulation speed 70 rpm, hydraulic pressure 20 bar, and granulation through a 20-mesh sieve. The resulting granules were then placed in a three-dimensional mixer for final mixing with parameters of 15 rpm for 20 minutes.

[0033] Experimental Example 1

[0034] A randomized, controlled, double-blind clinical trial was conducted to collect data from 60 patients who underwent vitrectomy for diabetic retinopathy at the Department of Diabetic Ophthalmology, Ophthalmology Hospital of China Academy of Chinese Medical Sciences, between August 2022 and October 2023. The inclusion criteria were: (1) meeting the diagnostic criteria for diabetes; (2) meeting the diagnostic criteria for proliferative diabetic retinopathy; (3) undergoing vitrectomy; (4) aged between 18 and 70 years; and (5) signing informed consent. Patients were randomly divided into an experimental group and a control group (30 patients each) in a 1:1 ratio. The experimental group received oral administration of the granules described in Example 2 of this invention for 12 weeks (11g each time, 3 times a day), while the control group received oral administration of placebo granules for 12 weeks. The placebo consisted of dextrin and was identical to the experimental group granules in appearance, odor, weight, and volume. Ophthalmological examinations were performed 1 week post-surgery and 12 weeks after medication to observe the best corrected visual acuity, postoperative rebleeding, and absorption of macular edema. The therapeutic effect of this formula on patients after vitrectomy was evaluated.

[0035] 1. Comparison and evaluation of BCVA

[0036] After 12 weeks of medication, the median visual acuity (LogMAR) of the experimental group was 0.40 (0.30, 0.70), while the median visual acuity (LogMAR) of the control group was 0.79 (0.40, 1.10). Wilcoxon test showed a statistically significant difference in the overall BCVA distribution between the two groups after the trial (Z=-3.115, P=0.002), indicating that the LogMAR visual acuity distribution of the experimental group was significantly lower than that of the control group after 12 weeks of medication. The results are shown in Table 1. Figure 1 Paired rank-sum test showed a statistically significant difference in visual acuity (LogMAR) before and after drug intervention in the experimental group (Z=-4.766, P<0.001), while there was no statistically significant difference in visual acuity (LogMAR) before and after observation in the control group (Z=-0.543, P=0.587). This indicates that the visual acuity distribution in the experimental group was significantly lower than their baseline after 12 weeks of medication. The results are shown in Table 2. Figure 1 .

[0037] Table 1 Comparison of BCVA between the two groups after 12 weeks of experimental observation.

[0038] Note: This indicates that P < 0.05.

[0039] Table 2 Comparison of self-BCVA between the two groups after 12 weeks of experimental observation.

[0040] Note: This indicates that P < 0.05.

[0041] 2. Comparison and evaluation of macular parameters

[0042] After 12 weeks of observation (Table 3), the CST in the experimental group was (319.40±53.47) μm, and the CST in the control group was (356.43±80.73) μm. A t-test showed a statistically significant difference in the overall CST mean between the two groups (difference 37.03, 95% CI 1.65-72.42, t=2.095, P=0.041). The CV in the experimental group was (12.49±1.85) mm. 3 The CV of the control group was (13.20±2.18) mm. 3 The t-test showed no statistically significant difference in the overall mean CV between the two groups (difference 0.71, 95% CI -0.33-1.77, t=1.368, P=0.176). The CAT in the experimental group was (336.53±43.58) μm, and the CAT in the control group was (365.47±63.49) μm. The t-test showed a statistically significant difference in the overall mean CAT between the two groups (difference 14.06, 95% CI 0.79-57.07, t=2.058, P=0.044). This indicates that after 12 weeks of drug intervention, the CST and CAT in the experimental group were lower than those in the control group, while the CV between the two groups was not significantly different.

[0043] Table 3 Comparison of CST, CV, and CAT levels between the two groups after 12 weeks of medication.

[0044] Note: This indicates that P < 0.05.

[0045] Paired t-tests showed statistically significant differences in CST before and after drug intervention in the experimental group (t=8.752, P<0.001), and in the control group (t=3.779, P=0.001). Similarly, statistically significant differences in CV before and after drug intervention in the experimental group (t=8.621, P<0.001), and in the control group (t=2.846, P=0.008). Statistically significant differences in CAT before and after drug intervention in the experimental group (t=9.125, P<0.001), and in the control group (t=2.339, P=0.026). These results indicate that after 12 weeks of observation, CST and CV in both groups were significantly lower than their baseline values, and CAT in the experimental group was significantly lower than their baseline values ​​after intervention, while CAT in the control group was lower than their baseline values ​​after observation (Table 4). Figures 2-4 ).

[0046] Table 4 Comparison of CST, CV, and CAT levels before and after medication within the group.

[0047] Note: This indicates that P < 0.05.

[0048] The t-test showed statistically significant differences in the CST differences before and after the trial between the two groups (difference -75.43, 95% CI 26.17–124.70, t=3.065, P=0.003). The CV differences before and after the trial between the two groups also showed statistically significant differences (difference 1.60, 95% CI 0.89–2.31, t=4.530, P<0.001). The CAT differences before and after the trial between the two groups also showed statistically significant differences (difference 56.23, 95% CI 33.54–78.92, t=4.961, P<0.001). These results indicate that the decrease in CST, CV, and CAT after 12 weeks of drug intervention was significantly greater in the experimental group than in the control group (Table 5).

[0049] Table 5 Comparison of CST, CV, and CAT differences before and after medication between the two groups.

[0050] Note: This indicates that P < 0.05.

[0051] 3. Postoperative complications

[0052] The two groups of subjects were followed up by telephone from week 12 of medication (end of medication) until the end of the follow-up period (36 weeks after medication). The total complications of the two groups were compared and the results are shown in Table 6.

[0053] As shown in Table 6, there were 0 cases of complications in the experimental group (0.0%), while there were 5 cases of vitreous re-hemorrhagic in the control group (16.7%). The difference between the two groups was statistically significant (χ²=5.455, P=0.02, P<0.05).

[0054] Table 6. Occurrence of complications in the two groups at week 36 after medication (follow-up period)

[0055] Note: This indicates that P < 0.05.

[0056] The results above show that for patients after fundus surgery, the traditional Chinese medicine composition of this invention can effectively reduce the thickness of the fovea of ​​the macular region, reduce the volume of the macular region, reduce the average thickness of the macular region, effectively promote the absorption of postoperative macular edema, improve the best corrected visual acuity of patients, improve visual function, reduce the occurrence of postoperative rebleeding, improve the quality of life of patients, and is safe for clinical use.

[0057] Experiment Example 2

[0058] Case 1: Ms. Wang, 40 years old, with a 15-year history of diabetes and proliferative diabetic retinopathy, underwent vitrectomy and took the traditional Chinese medicine composition granules of this invention orally for one month. Her anterior retinal hemorrhage was completely absorbed, and her postoperative vision significantly improved. (See attached image) Figure 5 .

[0059] Case 2: Mr. Zhao, male, 45 years old, with a history of diabetes for more than 10 years, experienced visual impairment in his left eye for 1 month. Two months after PPV+PRP surgery in his left eye, he took the traditional Chinese medicine composition granules described in this invention orally. Postoperatively, his fundus hemorrhage significantly improved, and his visual acuity increased to 0.6. Figure 6 .

[0060] Case 3: Mr. Zhang, 40 years old, with a 10-year history of diabetes, experienced a 1-year decline in vision in his left eye. After undergoing vitrectomy and panretinal laser treatment in his left eye, he took the traditional Chinese medicine composition granules of this invention orally for one month. His postoperative visual acuity improved from 0.1 on the 3rd day after surgery to 0.8. (See...) Figure 7 .

[0061] Case 4: Ms. Wang, 40 years old, with a 16-year history of diabetes, experienced a 3-month decline in vision in her right eye. She was diagnosed with stage V proliferative diabetic retinopathy in her right eye, along with vitreous hemorrhage. She underwent vitrectomy and panretinal laser treatment. Three days post-surgery, her vision improved to 0.4. However, two weeks later, her right eye hemorrhaged again, and her vision decreased to hand motion. After the hemorrhage, she took the herbal decoction (a compound herbal decoction) described in this invention orally for one and a half months. The hemorrhage was absorbed, and her vision significantly improved. (See attached image). Figure 8 .

[0062] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for use in the perioperative period of fundus surgery, characterized in that, The formula includes the following components by weight: Astragalus membranaceus 9-15 parts, Angelica sinensis 6-12 parts, Rehmannia glutinosa 6-12 parts, Eclipta prostrata 6-12 parts, Paeonia lactiflora 3-9 parts, Atractylodes macrocephala 3-9 parts, Plantago asiatica 6-12 parts, Saposhnikovia divaricata 1-6 parts, and Cinnamomum cassia 1-6 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The formula includes the following components by weight: Astragalus membranaceus 10-13 parts, Angelica sinensis 8-10 parts, Rehmannia glutinosa 8-10 parts, Eclipta prostrata 8-10 parts, Paeonia lactiflora 5-7 parts, Atractylodes macrocephala 5-7 parts, Plantago asiatica 8-10 parts, Saposhnikovia divaricata 2-4 parts, and Cinnamomum cassia 2-4 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The formula includes the following components by weight: Astragalus membranaceus 12 parts, Angelica sinensis 9 parts, Rehmannia glutinosa 9 parts, Eclipta prostrata 9 parts, Paeonia lactiflora 6 parts, Atractylodes macrocephala 6 parts, Plantago asiatica 9 parts, Saposhnikovia divaricata 3 parts, and Cinnamomum cassia 3 parts.

4. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for the perioperative period of fundus surgery.

5. The application according to claim 4, characterized in that, The drug is available in the form of a decoction or granules.

6. A decoction for use in the perioperative period of fundus surgery, characterized in that, The preparation method of the decoction is as follows: (6.1) Weigh the drug components according to the proportions of the traditional Chinese medicine composition according to any one of claims 1 to 3, mix them, and obtain the traditional Chinese medicine composition; (6.2) After soaking the Chinese herbal composition in water for 20-40 minutes, decoct it 1-3 times, filter it, collect and combine the liquids to obtain a decoction.

7. The decoction according to claim 6, characterized in that, The mass ratio of the traditional Chinese medicine composition to water is 1:8~10; Each simmering time should be 20-40 minutes; The sieve used for filtration has a mesh size of 80-120.

8. A granular formulation for use in the perioperative period of fundus surgery, characterized in that, The preparation method of the granules is as follows: (8.1) Weigh the drug components according to the proportions of the traditional Chinese medicine composition according to any one of claims 1 to 3, mix them, and obtain the traditional Chinese medicine composition; (8.2) Mix the Chinese herbal composition with water, decoct 1 to 3 times, filter, collect and combine the decoctions, and concentrate the combined decoctions to a thick paste with a relative density of 1.20 to 1.30 at 50 to 60°C to obtain a Chinese herbal paste; (8.3) The herbal paste is dried and pulverized to obtain herbal powder; (8.4) The Chinese herbal powder is mixed with filler, lubricant and flavoring agent, and granulated to obtain granules.

9. The granule according to claim 8, characterized in that, The mass ratio of the traditional Chinese medicine composition to water is 1:8~10; Each simmering time is 50-70 minutes; The sieve used for filtration has a mesh size of 80-120.

10. The granule according to claim 8, characterized in that, The herbal paste is dried by vacuum drying, and the temperature of vacuum drying is 60~80℃; The mass ratio of the herbal powder to the filler is 1~4:1; The filler is any one of maltodextrin, dextrin, and soluble starch; The amount of lubricant added is 0.1% to 3% of the total granulation volume, and the lubricant is magnesium stearate; The amount of flavoring agent added is 0.1% to 0.3% of the total granulation volume, and the flavoring agent is sucralose; The particle size of the granules is 10-20 mesh.

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