Compound medicine for treating macular edema after cataract phacoemulsification and preparation method of compound medicine

Abstract

The invention provides a compound medicine for treating macular edema after cataract phacoemulsification and a preparation method of the compound medicine, and relates to the field of medicines. The compound medicine is prepared from the following raw materials in parts by weight: 18 to 23 parts of herba hedyotidis diffusae, 18 to 23 parts of rhizoma alismatis, 13 to 17 parts of herba artemisiae scopariae, 13 to 17 parts of rhizoma smilacis glabrae, 13 to 17 parts of semen plantaginis, 8 to 12 parts of rhizoma atractylodis, 8 to 12 parts of fructus gardeniae, 10 to 15 parts of white hyacinth bean, 10 to 15 parts of fructus rosae laevigatae, 8 to 12 parts of semen euryales The compound medicine disclosed by the invention is used for treating the macular edema after the cataract phacoemulsification, all the medicines are coordinated and synergistic, the effects of promoting urination and attacking evil, strengthening the spleen and consolidating the foundation, eliminating evil and calming the body resistance are achieved, microcirculation is improved, expression of peripheral blood VEGF (vascular endothelial growth factor) is reduced, vascular permeability is effectively promoted, retina recovery is promoted, and the like. The traditional Chinese medicine composition has a good clinical effect on treating macular edema after cataract ultrasonic emulsification, and has no side effect.

Description

Technical Field

[0001] The present invention relates to the field of medicines, and in particular to a compound medicine for treating macular edema after cataract phacoemulsification and a preparation method thereof. Background Art

[0002] Phacoemulsification is a common and effective method for treating cataracts, but the occurrence of macular edema (ME) after surgery often leads to unsatisfactory visual recovery in patients, becoming a major problem plaguing clinical treatment.

[0003] Diabetes is a common and frequent disease worldwide, and diabetic retinopathy (DR) is the main cause of macular edema after cataract surgery. Compared with the normal population, cataract surgery patients with DR are significantly more likely to develop macular edema after surgery.

[0004] There are many traditional methods for assessing macular thickness, but these methods have low sensitivity, making it difficult to detect macular edema in a timely manner. With the widespread use of optical coherence tomography (OCT), which can provide high-resolution retinal cross-sectional images and quantitatively measure retinal thickness in the macular area, it helps to promptly detect changes in retinal thickness and provides a reliable basis for studying the relationship between cataract surgery and macular edema.

[0005] Currently, the clinical treatment effect of macular edema after phacoemulsification is poor. The development of a compound drug that can effectively treat this disease has important clinical significance and application value. Summary of the Invention

[0006] In view of this, the present invention provides a compound medicine for treating macular edema after cataract phacoemulsification and a preparation method thereof, which has good clinical efficacy and no side effects.

[0007] The technical solution of the present invention is achieved as follows: a compound medicine for macular edema after cataract phacoemulsification, comprising the following raw materials in parts by weight: 18-23 parts of Hedyotis diffusa, 18-23 parts of Rhizoma Alismatis, 13-17 parts of Artemisia capillaris, 13-17 parts of Smilax glabra, 13-17 parts of Plantago seeds, 8-12 parts of Atractylodes, 8-12 parts of Gardenia, 10-15 parts of Lablab dahliae, 10-15 parts of Rosa laevigatae, 8-12 parts of Euryale ferox, and 3-8 parts of licorice.

[0008] Furthermore, the compound medicine includes the following raw materials in parts by weight: 20 parts of Hedyotis diffusa, 20 parts of Alisma orientalis, 15 parts of Artemisia capillaris, 15 parts of Smilax glabra, 15 parts of Plantago seed, 10 parts of Atractylodes lancea, 10 parts of Gardenia jasminoides, 12 parts of Lablab dahliae, 12 parts of Rosa laevigata, 10 parts of Euryale ferox, and 6 parts of Licorice.

[0009] The present invention also provides a method for preparing a compound medicine for treating macular edema after phacoemulsification, comprising the following steps:

[0010] (1) Grinding Hedyotis diffusa, Artemisia capillaris, Gardenia jasminoides, and Atractylodes lancea, adding 65-75% v / v ethanol solution at a material-liquid ratio of 1:8-10 kg / L, reflux extraction, combining the extracts, and concentrating under reduced pressure to obtain an extract;

[0011] (2) Grind the Chinese smilax glabra, rhizome of orientalis, and seed of plantain into powder, add water at a material-liquid ratio of 1:1 to 2 kg / L, then add complex enzyme for enzymatic hydrolysis, decoct with water, and filter to obtain an extract;

[0012] (3) mixing the extract from step (1) with the extract from step (2), spray drying, and obtaining a compound medicine.

[0013] Furthermore, in step (1), reflux extraction is performed 2 to 3 times, and each reflux extraction time is 1 to 2 hours.

[0014] Furthermore, in step (1), the reduced pressure concentration is performed to a relative density of 1.25 at 50°C.

[0015] Furthermore, in step (2), the complex enzyme is composed of cellulase, pectinase and papain in a mass ratio of 1:0.4-0.6:0.2-0.3; the added amount of the complex enzyme is 0.4-0.6% of the total mass of Smilax glabra, Alisma orientalis and Plantago seed.

[0016] Furthermore, in step (2), the enzymatic hydrolysis temperature is 45-55°C, and the enzymatic hydrolysis time is 0.8-1.2h.

[0017] Furthermore, in step (2), water is added and decocted for 2 to 3 times, with the amount of water added each time being 8 to 12 times the total mass of Smilax glabra, Rhizoma Alismatis and Semen Plantaginis, and the decocting time each time being 1 to 2 hours.

[0018] Furthermore, in step (3), the inlet air temperature of the spray drying is 170-190°C, and the outlet air temperature is 80-90°C.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] In the compound medicine of the present invention, Herba Hedyotis diffusae clears away heat and toxic substances, promotes dampness and dredges meridians, Rhizoma Alismatis promotes diuresis and eliminates dampness, Artemisia capillaris clears away damp-heat in the liver and gallbladder, and they are all monarch medicines; Rhizoma Smilacis Glabrae detoxifies and promotes dampness, Semen Plantaginis promotes diuresis and improves eyesight, and Rhizoma Atractylodis Macrocephalae dries dampness and strengthens the spleen, and they are all ministerial medicines; Fructus Gardeniae clears heat and cools blood, Lablab lentiscus strengthens the spleen and eliminates dampness, Fructus Rosae Laevigatae astringes and consolidates, and Fructus Euryale ferox consolidates the kidney and retains essence, and they are all adjuvant medicines; Radix Glycyrrhizae harmonizes all the medicines and is a guiding medicine. The compound medicine of the present invention is used to treat macular edema after phacoemulsification of cataracts, and all the medicines coordinate and enhance synergy, promotes diuresis and attacks pathogenic factors, strengthens the spleen and consolidates the foundation, removes pathogenic factors and calms the body, improves microcirculation, reduces peripheral blood VEGF (vascular endothelial growth factor) expression, effectively promotes vascular permeability, promotes retinal recovery, etc., and has a good clinical efficacy in treating macular edema after phacoemulsification of cataracts, and has no side effects. DETAILED DESCRIPTION

[0021] In order to better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention.

[0022] Unless otherwise specified, the experimental methods used in the examples of the present invention are all conventional methods.

[0023] Unless otherwise specified, the materials, reagents, etc. used in the examples of the present invention can be obtained from commercial sources.

[0024] Example 1

[0025] A compound medicine for treating macular edema after phacoemulsification of cataracts is prepared from the following raw materials in parts by weight: 20 parts of oldenlandia diffusa, 20 parts of rhizoma alismatis, 15 parts of artemisia capillaris, 15 parts of smilax glabra, 15 parts of plantago seeds, 10 parts of atractylodes, 10 parts of gardenia, 12 parts of labiatae, 12 parts of rosa laevigata, 10 parts of euryale ferox, and 6 parts of liquorice.

[0026] The preparation method of the compound medicine for treating macular edema after phacoemulsification of cataracts comprises the following steps:

[0027] (1) Grind Hedyotis diffusa, Artemisia capillaris, Gardenia jasminoides, and Atractylodes lancea, add 70% v / v ethanol solution at a material-liquid ratio of 1:9 kg / L, and reflux extract at 85°C ± 5°C for 3 times (2 h, 1 h, 1 h), combine the extracts, and concentrate under reduced pressure to a relative density of 1.25 (50°C) to obtain an extract;

[0028] (2) Grind the Chinese smilax glabra, rhizoma alismatis, and plantago seed into powder, add water at a material-liquid ratio of 1:1.5 kg / L, and then add a complex enzyme, which is composed of cellulase, pectinase, and papain at a mass ratio of 1:0.5:0.25. The amount of the complex enzyme added is 0.5% of the total mass of the Chinese smilax glabra, rhizoma alismatis, and plantago seed. Enzymolysis is carried out at 50°C for 1 hour, and then water is added and decocted twice (1 hour / time). The amount of water added each time is 10 times the total mass of the Chinese smilax glabra, rhizoma alismatis, and plantago seed. Then, water is added and decocted, and filtered to obtain an extract.

[0029] (3) The extract from step (1) and the extract from step (2) are mixed, spray-dried (inlet air temperature 180° C., outlet air temperature 85° C.), and pulverized to obtain a powder to prepare a compound medicine.

[0030] Example 2

[0031] A compound medicine for treating macular edema after phacoemulsification of cataracts is prepared from the following raw materials in parts by weight: 18 parts of oldenlandia diffusa herb, 23 parts of rhizoma alismatis, 17 parts of artemisia capillaris, 13 parts of smilax glabra, 17 parts of plantago seeds, 8 parts of atractylodes, 12 parts of gardenia, 10 parts of labiatae, 15 parts of rosa laevigata fruit, 8 parts of euryale ferox, and 4 parts of liquorice.

[0032] The preparation method of the compound medicine for treating macular edema after phacoemulsification of cataracts comprises the following steps:

[0033] (1) Grind Hedyotis diffusa, Artemisia capillaris, Gardenia jasminoides, and Atractylodes lancea, add 70% v / v ethanol solution at a material-liquid ratio of 1:9 kg / L, and reflux extract at 85°C ± 5°C for 3 times (2 h, 1 h, 1 h), combine the extracts, and concentrate under reduced pressure to a relative density of 1.25 (50°C) to obtain an extract;

[0034] (2) Grind the Chinese smilax glabra, rhizoma alismatis, and plantago seed into powder, add water at a material-liquid ratio of 1:1.5 kg / L, and then add a complex enzyme, which is composed of cellulase, pectinase, and papain at a mass ratio of 1:0.4:0.3. The amount of the complex enzyme added is 0.5% of the total mass of the Chinese smilax glabra, rhizoma alismatis, and plantago seed. Enzymolysis is carried out at 50°C for 1 hour, and then water is added and decocted twice (1 hour / time). The amount of water added each time is 10 times the total mass of the Chinese smilax glabra, rhizoma alismatis, and plantago seed. Then, water is added and decocted, and filtered to obtain an extract.

[0035] (3) The extract from step (1) and the extract from step (2) are mixed, spray-dried (inlet air temperature 180° C., outlet air temperature 85° C.), and pulverized to obtain a powder to prepare a compound medicine.

[0036] Example 3

[0037] A compound medicine for treating macular edema after phacoemulsification of cataracts is prepared from the following raw materials in parts by weight: 22 parts of oldenlandia diffusa herb, 18 parts of rhizoma alismatis, 13 parts of artemisia capillaris, 16 parts of smilax glabra, 13 parts of plantago seeds, 12 parts of atractylodes, 8 parts of gardenia, 15 parts of labiatae, 10 parts of rosa laevigata fruit, 12 parts of euryale ferox, and 6 parts of liquorice.

[0038] The preparation method of the compound medicine for treating macular edema after phacoemulsification of cataracts comprises the following steps:

[0039] (1) Grind Hedyotis diffusa, Artemisia capillaris, Gardenia jasminoides, and Atractylodes lancea, add 70% v / v ethanol solution at a material-liquid ratio of 1:9 kg / L, and reflux extract at 85°C ± 5°C for 3 times (2 h, 1 h, 1 h), combine the extracts, and concentrate under reduced pressure to a relative density of 1.25 (50°C) to obtain an extract;

[0040] (2) Grind the Chinese smilax glabra, rhizoma alismatis, and plantago seed into powder, add water at a material-liquid ratio of 1:1.5 kg / L, and then add a composite enzyme, which is composed of cellulase, pectinase, and papain at a mass ratio of 1:0.6:0.2. The amount of the composite enzyme added is 0.5% of the total mass of the Chinese smilax glabra, rhizoma alismatis, and plantago seed. Enzymolysis is carried out at 50°C for 1 hour, and then water is added and decocted twice (1 hour / time). The amount of water added each time is 10 times the total mass of the Chinese smilax glabra, rhizoma alismatis, and plantago seed. Then, water is added and decocted, and filtered to obtain an extract.

[0041] (3) The extract from step (1) and the extract from step (2) are mixed, spray-dried (inlet air temperature 180° C., outlet air temperature 85° C.), and pulverized to obtain a powder to prepare a compound medicine.

[0042] Comparative Example 1

[0043] The main difference from Example 1 is that Hedyotis diffusa is replaced by Patrinia scabra. Specifically, the compound medicine comprises the following raw materials in parts by weight: 20 parts of Patrinia scabra, 20 parts of Rhizoma Alismatis, 15 parts of Artemisia capillaris, 15 parts of Smilax glabra, 15 parts of Plantago seed, 10 parts of Atractylodes macrocephala, 10 parts of Gardenia jasminoides, 12 parts of Lablab dahliae, 12 parts of Rosa laevigatae, 10 parts of Euryale ferox, and 6 parts of Licorice.

[0044] Comparative Example 2

[0045] The main difference from Example 1 is that Artemisia capillaris is replaced by Polygonum cuspidatum. Specifically, the compound medicine comprises the following raw materials in parts by weight: 20 parts of Hedyotis diffusa, 20 parts of Rhizoma Alismatis, 15 parts of Polygonum cuspidatum, 15 parts of Smilax glabra, 15 parts of Plantago seed, 10 parts of Atractylodes, 10 parts of Gardenia, 12 parts of Lablab dahliae, 12 parts of Rosa laevigatae, 10 parts of Euryale ferox, and 6 parts of Licorice.

[0046] Comparative Example 3

[0047] The main difference from Example 1 is that Plantago seed is replaced by Dianthus. Specifically, the compound medicine comprises the following raw materials in parts by weight: 20 parts of Hedyotis diffusa, 20 parts of Rhizoma Alismatis, 15 parts of Artemisia capillaris, 15 parts of Smilax glabra, 15 parts of Dianthus diffusa, 10 parts of Atractylodes, 10 parts of Gardenia, 12 parts of Lablab dalbergiae, 12 parts of Rosa laevigatae, 10 parts of Euryale ferox, and 6 parts of Licorice.

[0048] Comparative Example 4

[0049] The main difference from Example 1 is that the Rosa laevigata fruit is replaced with lotus seeds. Specifically, the compound medicine comprises the following raw materials in parts by weight: 20 parts of Hedyotis diffusa, 20 parts of Rhizoma Alismatis, 15 parts of Artemisia capillaris, 15 parts of Smilax glabra, 15 parts of Plantago seed, 10 parts of Atractylodes lancea, 10 parts of Gardenia jasminoides, 12 parts of Lablab dahliae, 12 parts of lotus seeds, 10 parts of Euryale ferox, and 6 parts of Licorice.

[0050] Research example

[0051] Methods: A total of 240 patients (240 eyes) with macular edema after phacoemulsification were enrolled. The patients included 119 males (119 eyes) and 121 females (121 eyes), aged 40 to 79 years. The patients were randomly divided into 8 groups, each consisting of 30 patients (30 eyes), including a control group and study groups 1 to 7. The gender ratio, mean age, and distribution of affected eyes were similar among the groups, indicating comparability.

[0052] 2 Diagnostic criteria

[0053] (1) Cataract: Slit lamp examination shows obvious lens opacities (including posterior subcapsular opacities, wedge-shaped opacities, and hydropic fissures or vacuoles, etc.); if the patient's corrected visual acuity is less than or equal to 0.5, other non-cataract factors that may cause decreased vision, such as retinal disease, glaucoma, corneal disease, etc., are excluded.

[0054] (2) Macular edema: There is no history of macular edema; central vision decreases after surgery; fundus examination shows that the foveal reflection disappears, and the retinal reflection is enhanced and has a satin-like reflection; slit lamp microscopy plus contact lens examination shows macular retinal thickening, and optical coherence tomography detects that the foveal thickness is greater than 250μm; the diagnosis is confirmed by fundus fluorescein angiography.

[0055] 3. Medication method

[0056] Patients in the control group were treated with pranoprofen eye drops and tobramycin dexamethasone eye drops, 1 drop 4 times a day, and the dosage was gradually reduced to once a week for 4 consecutive weeks.

[0057] Patients in study group 1 to 7 were given the compound medicines of Examples 1 to 3 and Comparative Examples 1 to 4, respectively, and taken with boiled water, 10 g each morning and evening, for 4 consecutive weeks.

[0058] 4 Observation indicators

[0059] (1) Best corrected visual acuity: The international standard logarithmic visual acuity chart was used to measure the best corrected visual acuity before and after treatment, and statistical analysis was performed after LogMAR conversion.

[0060] (2) Central retinal thickness: Optical coherence tomography was used to measure the central retinal thickness of patients before and after treatment.

[0061] (3) Time of macular edema regression: Using an optical coherence tomography scanner, the macular edema was considered to have resolved if the foveal thickness was less than 250 μm.

[0062] (4) Observe the patient's adverse reactions, including eye pain, conjunctival congestion, photophobia, corneal inflammation, etc.

[0063] 5. Efficacy evaluation criteria

[0064] Cured: visual acuity improved by more than 3 lines, and macular edema completely disappeared;

[0065] Markedly effective: visual acuity improved by 2-3 lines, and macular edema was significantly improved;

[0066] Ineffective: There is no significant improvement in visual acuity, and macular edema does not subside or worsens.

[0067] Cure rate = number of cured eyes / total number of eyes × 100%;

[0068] Total effective rate = (number of eyes cured + number of eyes with marked effect) / total number of eyes × 100%.

[0069] The statistical results are shown in Table 1:

[0070] Table 1 Comparison of clinical efficacy

[0071]

[0072] The above results show that the cure rates of study groups 1 to 3 are significantly better than those of the control group, and the differences are statistically significant. Among them, the clinical efficacy of Example 1 is relatively good, especially the cure rate is increased to more than 80%.

[0073] In addition, compared with Example 1, the clinical efficacy of Comparative Examples 1 to 4 was significantly reduced, including a decrease in the total effective rate and cure rate.

[0074] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A compound medicine for treating macular edema after phacoemulsification, characterized in that: The invention comprises the following raw materials in parts by weight: 18-23 parts of Hedyotis diffusa herb, 18-23 parts of Rhizoma Alismatis, 13-17 parts of Artemisia capillaris, 13-17 parts of Smilax glabra, 13-17 parts of Plantago seeds, 8-12 parts of Atractylodes lancea, 8-12 parts of Gardenia jasminoides, 10-15 parts of Lablab dahliae, 10-15 parts of Rosa laevigatae, 8-12 parts of Euryale ferox, and 3-8 parts of licorice.

2. The compound medicine for treating macular edema after phacoemulsification of cataract according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 20 parts of Hedyotis diffusa herb, 20 parts of Rhizoma Alismatis, 15 parts of Artemisia capillaris, 15 parts of Smilax glabra, 15 parts of Plantago seeds, 10 parts of Atractylodes lancea, 10 parts of Gardenia jasminoides, 12 parts of Lablab dahliae, 12 parts of Rosa laevigatae, 10 parts of Euryale ferox and 6 parts of licorice.

3. The method for preparing the compound medicine for treating macular edema after phacoemulsification of cataract according to claim 1 or 2, characterized in that: The following steps are involved: (1) Grinding Hedyotis diffusa, Artemisia capillaris, Gardenia jasminoides, and Atractylodes lancea, adding 65-75% v / v ethanol solution at a material-liquid ratio of 1:8-10 kg / L, reflux extraction, combining the extracts, and concentrating under reduced pressure to obtain an extract; (2) Grind the Chinese smilax glabra, rhizome of orientalis, and seed of plantain into powder, add water at a material-liquid ratio of 1:1 to 2 kg / L, then add complex enzyme for enzymatic hydrolysis, decoct with water, and filter to obtain an extract; (3) mixing the extract from step (1) with the extract from step (2), spray drying, and obtaining a compound medicine.

4. The method for preparing the compound medicine for treating macular edema after phacoemulsification of cataract according to claim 3, wherein: Step (1) is reflux extraction 2 to 3 times, with each reflux extraction time being 1 to 2 hours.

5. The method for preparing the compound medicine for macular edema after phacoemulsification of cataract according to claim 3, characterized in that: Step (1), the reduced pressure concentration is to a relative density of 1.25, 50°C.

6. The method for preparing the compound medicine for treating macular edema after phacoemulsification of cataract according to claim 3, characterized in that: In step (2), the complex enzyme is composed of cellulase, pectinase and papain in a mass ratio of 1:0.4-0.6:0.2-0.

3.

7. The method for preparing the compound medicine for macular edema after cataract phacoemulsification according to claim 3, characterized in that: In step (2), the added amount of the complex enzyme is 0.4-0.6% of the total mass of Smilax glabra, Rhizoma Alismatis and Semen Plantaginis.

8. The method for preparing the compound medicine for treating macular edema after phacoemulsification of cataract according to claim 3 or 7, characterized in that: In step (2), the enzymolysis temperature is 45 to 55° C., and the enzymolysis time is 0.8 to 1.2 h.

9. The method for preparing the compound medicine for treating macular edema after phacoemulsification of cataract according to claim 3, characterized in that: Step (2), adding water and decocting for 2 to 3 times, the amount of water added each time is 8 to 12 times the total weight of Smilax glabra, Rhizoma Alismatis and Semen Plantaginis, and the decocting time each time is 1 to 2 hours.

10. The method for preparing the compound medicine for treating macular edema after phacoemulsification of cataract according to claim 3, characterized in that: In step (3), the inlet air temperature of the spray drying is 170-190°C, and the outlet air temperature is 80-90°C.

Images