Buddleja officinalis solution preparation for atomizing and fumigating eyes as well as preparation method and application of buddleja officinalis solution preparation

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and discloses a butterflybush flower solution preparation for atomizing and fumigating eyes as well as a preparation method and application of the butterflybush flower solution preparation. According to the invention, aqueous ethyl acetate, propyl acetate or butyl acetate is used as an extraction solvent to extract effective components in butterflybush flower, and the butterflybush flower solution preparation for atomizing and fumigating eyes is prepared by scientifically combining an extract taking butterflybush flower as a core marking component with an osmotic pressure regulator and a solvent. The preparation has excellent physical performance parameters, is easy to atomize to form aerosol, is simple and easy to operate, and has a good treatment effect on eye diseases such as asthenopia, xerophthalmia, diabetic retinopathy and conjunctivitis.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations. Specifically, it relates to a Buddleja officinalis Maxim solution preparation for eye atomization fumigation, its preparation method and application. Background Art

[0002] Buddleja officinalis Maxim is the dried flower buds and inflorescences of Loganiaceae, also known as Menghua, Xiaojinhua, Huangfanflower, etc. In ancient Chinese herbal classics and ethnic minority medicinal classics, Buddleja officinalis Maxim has been used as the "sacred medicine for ophthalmology". It has the effects of dispelling wind and clearing heat, nourishing the liver and improving eyesight, and removing nebula. It is used for symptoms such as red and swollen eyes, excessive tearing and photophobia, corneal nebula, liver deficiency with dim vision, and blurred vision. Clinically, it is mainly used for eye diseases such as asthenopia, dry eye, diabetic retinopathy and conjunctivitis, and has significant curative effects.

[0003] Research shows that Buddleja officinalis Maxim is rich in phenylethanoid glycosides and flavonoid components, and the content is significantly higher than other components. The former includes acteoside, isoacteoside, salidroside, echinacoside, forsythoside B, etc.; the latter includes buddleoaside, neobuddleoside, robinin, luteolin, apigenin, etc. Among them, the contents of acteoside and buddleoaside are prominent, significantly higher than other components. Both phenylethanoid glycosides and flavonoid components in Buddleja officinalis Maxim have antibacterial and anti-inflammatory activities, can inhibit aldose reductase, can effectively improve the abnormal polyol metabolic pathway of diabetic patients, so as to prevent and relieve diabetic complications and effectively relieve diabetic retinopathy; flavonoids can also effectively treat dry eye caused by decreased androgen level. It can be seen that phenylethanoid glycosides and flavonoid components are the material basis for Buddleja officinalis Maxim to exert its clinical efficacy.

[0004] Buddleja officinalis Maxim, also known as Huangfanflower and Ranfanflower, in addition to containing effective components such as phenylethanoid glycosides and flavonoids, also contains a large amount of natural pigments. When using traditional extraction solvents such as water and ethanol to extract Buddleja officinalis Maxim, the extract is dark brown in color, and the content ratio of effective components is relatively low. The dosage form of the extract medicine can only be a single solid oral preparation. If it is made into an external liquid preparation, a decolorization technology with complex process is required, and the production cost is high, which is not conducive to industrial production. When using ethyl acetate or butyl acetate or propyl acetate alone to extract Buddleja officinalis Maxim, although the problem of high pigment content in the extract is solved, the content of effective substances is extremely low, and the extract is not suitable for medicinal preparations. With the increase in the number of clinical drug users, a single dosage form has been difficult to meet the clinical needs. Currently, there is no solution dosage form for Buddleja officinalis Maxim atomization fumigation for the treatment of eye diseases, which is difficult to meet the growing clinical needs. Summary of the Invention

[0005] In view of this, the present invention provides a Buddleja officinalis Maxim solution preparation for eye atomization fumigation, its preparation method and application.

[0006] The technical solution of the present invention is as follows:

[0007] The present invention provides a Buddleja officinalis Maxim. solution preparation for atomization fumigation, and the solution preparation includes: Buddleja officinalis Maxim. extract, an osmotic pressure regulator and a solvent; the Buddleja officinalis Maxim. extract is obtained by extracting Buddleja officinalis Maxim. with an extraction solvent containing 2% to 5% water, and the extraction solvent is any one or more of the following: ethyl acetate, propyl acetate and butyl acetate.

[0008] Preferably, in each liter of the Buddleja officinalis Maxim. solution preparation for atomization fumigation, the dosage of Buddleja officinalis Maxim. is 5 to 35 g, and the dosage of the inorganic salt osmotic pressure regulator is 1 - 15 g.

[0009] Preferably, the Buddleja officinalis Maxim. extract contains more than 5% of buddleoside and more than 15% of acteoside.

[0010] As an implementation manner, the osmotic pressure regulator is an inorganic salt or a saccharide. Further, the inorganic salt is one or more of sodium chloride, magnesium chloride and calcium chloride; the saccharide is one or two of glucose and fructose.

[0011] The present invention also provides a preparation method of the above-mentioned Buddleja officinalis Maxim. solution preparation for atomization fumigation, including the following steps:

[0012] Extract Buddleja officinalis Maxim. with an extraction solvent containing 2% to 5% water, and concentrate to dry paste, and the extraction solvent is any one or more of the following: ethyl acetate, propyl acetate and butyl acetate; mix the obtained dry paste with the solvent and the osmotic pressure regulator, refrigerate and stand still, then filter, and fill and seal to obtain the Buddleja officinalis Maxim. solution preparation for eye atomization fumigation.

[0013] Preferably, the extraction method includes maceration, heating reflux extraction, microwave-assisted extraction or ultrasonic-assisted extraction.

[0014] As an implementation manner, the temperature of the reflux extraction is 70 to 120°C, and the extraction time for each time is 30 - 60 min; the maceration is maceration at room temperature, and the extraction time for each time is 6 - 12 h; the power of the microwave-assisted extraction is 300 - 600 W, and the extraction time for each time is 20 - 30 min; the extraction time for each time of the ultrasonic-assisted extraction is 30 - 60 min.

[0015] As an implementation manner, the filling and sealing process includes a sterile filling and sealing process or a filling and sealing - sterilization process.

[0016] The present invention also includes the application of the above-mentioned Buddleja officinalis Maxim. solution preparation for atomization fumigation, or the Buddleja officinalis Maxim. solution preparation obtained by the above method in the preparation of eye drugs, and the eye drugs are used for visual fatigue, dry eye, diabetic retinopathy or conjunctivitis.

[0017] Compared with the prior art, the present invention has the following technical effects:

[0018] The Buddleja officinalis Maxim. solution preparation for atomizing fumigation of the present invention is prepared from the Chinese medicinal material Buddleja officinalis Maxim. as the raw material by extraction with an ethyl acetate solution containing water. The extract with Buddleja officinalis Maxim. as the core labeled component, after being supplemented with a scientific formula in the form of an aqueous solution at a specific concentration, is made into a sterile single-dose Buddleja officinalis Maxim. solution preparation for atomizing fumigation. By adopting the combination of medicine and device, atomizing administration is carried out with an atomizer and is used for the treatment of patients with eye diseases.

[0019] The present invention dissolves the active ingredients of Buddleja officinalis Maxim. in a suitable medium and directly delivers them to the eyes in the form of an aerosol by means of an atomizer. The administration reaches the site of action directly, reducing the distribution of the drug in other tissues and organs. Compared with oral administration, the total effective rate of the atomizing fumigation administration method is greatly improved. It can avoid the damage caused to patients by the first-pass effect of the liver required for oral administration, increase the compliance of patients, and has the characteristics of being safe, effective, high bioavailability, and low toxic and side effects. The advantages are obvious. At the same time, it is a good administration route for the elderly and children who are inconvenient to take oral medicine.

[0020] The Buddleja officinalis Maxim. solution preparation for eye atomizing fumigation of the present invention has excellent physical performance parameters and is easy to atomize to form an aerosol; it also has the advantages of reliable quality, high safety, high stability, and long storage time. It is not only simple and easy to operate, has low production costs, but also is easy to industrialize production. Description of the Drawings

[0021] Figure 1 It is the HPLC detection result diagram of the buddleoside standard product;

[0022] Figure 2 It is the HPLC detection diagram of buddleoside in the Buddleja officinalis Maxim. solution preparation for atomizing fumigation of the present invention;

[0023] Figure 3 It is the HPLC detection result diagram of acteoside standard product;

[0024] Figure 4 It is the HPLC detection diagram of acteoside in the Buddleja officinalis Maxim. solution preparation for atomizing fumigation of the present invention. Detailed Embodiments

[0025] The present invention provides a Buddleja officinalis Maxim. solution preparation for atomization fumigation, and the solution preparation includes: Buddleja officinalis Maxim. extract, an osmotic pressure regulator, and a solvent. The Buddleja officinalis Maxim. extract in the present invention is obtained by extracting Buddleja officinalis Maxim. with an extraction solvent containing 2% - 5% water, and further preferably extracted with an extraction solvent containing 3% - 4.5% water. The extraction solvent is any one or more of the following: ethyl acetate, propyl acetate, and butyl acetate. Extracting the active ingredients of Buddleja officinalis Maxim. with an aqueous extraction solvent can increase the content ratio of the active ingredients of Buddleja officinalis Maxim. and lighten the color of the extract, enabling it to be used for preparing a Buddleja officinalis Maxim. solution preparation for eye atomization fumigation.

[0026] Preferably, the Buddleja officinalis Maxim. extract in the present invention contains more than 5% of buddleoaside and more than 15% of acteoside. Further preferably, the Buddleja officinalis Maxim. extract in the present invention contains more than 6% of buddleoaside and more than 20% of acteoside.

[0027] As an implementation manner, in each liter of the Buddleja officinalis Maxim. solution preparation for atomization fumigation in the present invention, it includes the active ingredients of Buddleja officinalis Maxim. prepared from 5 - 35 g of Buddleja officinalis Maxim., preferably 6 - 30 g, and further preferably 10 - 20 g, such as any value among 10 g, 12 g, 16 g, 20 g, 24 g, or 28 g or the range between any two values. By reasonably adjusting the concentration of the active ingredients of Buddleja officinalis Maxim. in the Buddleja officinalis Maxim. solution preparation for atomization fumigation, it is not only beneficial for the formation of aerosol, improves its medicinal effect, but also can reduce its irritation to patients.

[0028] In the Buddleja officinalis Maxim. solution preparation for atomization fumigation of the present invention, as a preferred implementation manner, the osmotic pressure regulator is an inorganic salt or a saccharide. The inorganic salt osmotic pressure regulator is preferably one or more of sodium chloride, magnesium chloride, and calcium chloride, and more preferably sodium chloride. The saccharide osmotic pressure regulator is preferably one or two of glucose and fructose. As a preferred implementation manner, in each liter of the Buddleja officinalis Maxim. solution preparation for atomization fumigation, the mass of the inorganic salt osmotic pressure regulator is 1 - 15 g, such as any value among 1.5 g, 2 g, 3 g, 4 g, 5 g, 6 g, 7 g, 8 g, 9 g, 10 g, 11 g, 12 g, 13 g, and 14 g or the range between any two values.

[0029] In the Buddleja officinalis Maxim. solution preparation for atomization fumigation of the present invention, as a preferred implementation manner, the solvent is water, preferably sterile water.

[0030] For the Buddleja officinalis Maxim. solution preparation for atomization fumigation of the present invention, an ultrasonic nebulizer, a compressed air nebulizer, or a vibrating mesh nebulizer is used to directly act on the lesion site in the form of atomization, with a fast onset of action and being safer and more effective.

[0031] The present invention also provides a method for preparing the Buddleja officinalis Maxim solution preparation for atomization fumigation, comprising the following steps: extracting Buddleja officinalis Maxim with an extraction solvent containing 2% - 5% water, and concentrating to a dry extract. The extraction solvent is any one or more of the following: ethyl acetate, propyl acetate, and butyl acetate; mixing the obtained dry extract with the solvent and the osmotic pressure regulator, refrigerating and standing, filtering, and filling and sealing to obtain the Buddleja officinalis Maxim solution preparation for eye atomization fumigation.

[0032] In the present invention, the Buddleja officinalis Maxim is the dried inflorescence or flower bud of a shrub plant of the genus Buddleja in the family Loganiaceae. In order to fully extract the active ingredients in Buddleja officinalis Maxim, the present invention preferably pulverizes Buddleja officinalis Maxim and then extracts it with an aqueous extraction solvent. The present invention preferably pulverizes Buddleja officinalis Maxim to 10 - 24 mesh, more preferably 24 - 50 mesh.

[0033] Extract Buddleja officinalis Maxim with the aqueous extraction solvent of the present invention N times (N is a natural number greater than or equal to 1, and N is preferably 1 or 2 or 3 or 4 or 5). The material - liquid ratio of Buddleja officinalis Maxim to the extraction solvent is (1:6) - (1:16), preferably (1:8) - (1:12). After each extraction, filter to obtain N portions of filtrate, combine the N portions of filtrate and concentrate to a dry paste.

[0034] When using the aqueous extraction solvent of the present invention to extract Buddleja officinalis Maxim, any known extraction method can be used, which can improve the content of active ingredients in the Buddleja officinalis Maxim extract and reduce the pigment content. As an implementation method, the extraction method of Buddleja officinalis Maxim in the present invention can be leaching, heating reflux extraction, microwave - assisted extraction, or ultrasonic - assisted extraction.

[0035] As an implementation method, the present invention reflux - extracts Buddleja officinalis Maxim in an aqueous extraction solvent. The preferred temperature for reflux extraction is 70 - 120°C, more preferably 80 - 100°C. The preferred extraction time for each reflux extraction is 30 - 90 min, further 40 - 60 min.

[0036] As an implementation method, the present invention leaches Buddleja officinalis Maxim at room temperature in an aqueous extraction solvent. The preferred leaching time for each time is 6 - 12 h, further 8 - 10 h.

[0037] As an implementation method, the present invention performs microwave - assisted extraction on Buddleja officinalis Maxim in an aqueous extraction solvent. The power of the microwave - assisted extraction is preferably 300 - 600 W, more preferably 400 - 500 W; the preferred time for each microwave - assisted extraction is 20 - 30 min.

[0038] As an implementation method, the present invention performs ultrasonic - assisted extraction on Buddleja officinalis Maxim in an aqueous extraction solvent. The preferred time for ultrasonic - assisted extraction is 30 - 60 min.

[0039] The present invention mixes dry extract with a solvent and an osmotic pressure regulator, refrigerates and stands still, and filters to obtain a Buddleja officinalis Maxim solution. The refrigeration and standing time is 24 - 48 hours. The filtration is preferably carried out by filtering with a 0.22 μm microporous membrane.

[0040] The present invention fills and seals the Buddleja officinalis Maxim solution to obtain a preparation of Buddleja officinalis Maxim solution for eye atomization and fumigation. The present invention does not particularly limit the filling and sealing process, and a known filling and sealing process in the art can be adopted. As an implementation manner, the filling and sealing process includes a sterile filling and sealing process or a filling - sterilization process. It is preferably filled and sealed using a pharmaceutical system BFS (blow - fill - seal integrated machine) that is sterile and light - proof.

[0041] The preparation of Buddleja officinalis Maxim solution for eye atomization and fumigation of the present invention has a good curative effect on eye diseases. When used in conjunction with an atomizer, the use process is convenient, and it can be used for the treatment of eye fatigue, dry eye, diabetic retinopathy, conjunctivitis, and other eye diseases caused by them.

[0042] The following further details the technical solutions of the present invention with specific embodiments. The technical solutions of the present invention include but are not limited to the following embodiments.

[0043] Example 1

[0044] Using a 2% ethyl acetate solution as the extraction solvent to extract the Buddleja officinalis Maxim extract, the steps are as follows:

[0045] Weigh 1000 g of Buddleja officinalis Maxim Chinese herbal pieces. For the first time, add 12 L of 2% ethyl acetate solution containing water, heat - reflux at 70 °C for 1 hour. For the second time, add 10 L of 2% ethyl acetate solution containing water, heat - reflux at 70 °C for 45 min. For the third time, add 8 L of 2% ethyl acetate solution containing water, heat - reflux at 70 °C for 40 min. Combine the filtrates of the three times and concentrate under reduced pressure to obtain an extract.

[0046] Example 2

[0047] Using a 3.5% ethyl acetate solution as the extraction solvent to extract the Buddleja officinalis Maxim extract, the steps are as follows:

[0048] Weigh 1000 g of Buddleja officinalis Maxim Chinese herbal pieces. For the first time, add 12 L of 3.5% ethyl acetate solution containing water, heat - reflux at 70 °C for 1 hour. For the second time, add 10 L of 3.5% ethyl acetate solution containing water, heat - reflux at 70 °C for 45 min. For the third time, add 8 L of 3.5% ethyl acetate solution containing water, heat - reflux at 70 °C for 30 min. Combine the filtrates of the three times and concentrate under reduced pressure to obtain an extract.

[0049] Example 3

[0050] Using a 4.5% ethyl acetate solution as the extraction solvent to extract Buddleja officinalis Maxim extract, the steps are as follows:

[0051] Weigh 1000 g of Buddleja officinalis Maxim Chinese herbal pieces, add 12 L of 4.5% ethyl acetate solution containing water (12 times the amount) for the first time, heat under reflux at 70 °C for 1 hour, add 10 L of 4.5% ethyl acetate solution containing water (10 times the amount) for the second time, heat under reflux at 70 °C for 45 min, add 8 L of 4.5% ethyl acetate solution containing water (8 times the amount) for the third time, heat under reflux at 70 °C for 30 min, combine the filtrates of the three times, and concentrate to an extract under reduced pressure to obtain it.

[0052] Example 4

[0053] Using a 4.5% propyl acetate solution as the extraction solvent to extract Buddleja officinalis Maxim extract, the steps are as follows:

[0054] Weigh 1000 g of Buddleja officinalis Maxim Chinese herbal pieces, add 12 L of 4.5% propyl acetate solution containing water (12 times the amount) for the first time, heat under reflux at 90 °C for 1 hour, add 10 L of 4.5% propyl acetate solution containing water (10 times the amount) for the second time, heat under reflux at 90 °C for 50 min, add 8 L of 4.5% propyl acetate solution containing water (8 times the amount) for the third time, heat under reflux at 90 °C for 40 min, combine the filtrates of the three times, and concentrate to an extract under reduced pressure to obtain it.

[0055] Example 5

[0056] Using a 4.5% butyl acetate solution as the extraction solvent to extract Buddleja officinalis Maxim extract, the steps are as follows:

[0057] Weigh 1000 g of Buddleja officinalis Maxim Chinese herbal pieces, add 12 L of 4.5% butyl acetate solution containing water (12 times the amount) for the first time, heat under reflux at 110 °C for 1 hour, add 10 L of 4.5% butyl acetate solution containing water (10 times the amount) for the second time, heat under reflux at 110 °C for 45 min, add 8 L of 4.5% butyl acetate solution containing water (8 times the amount) for the third time, heat under reflux at 110 °C for 30 min, combine the filtrates of the three times, and concentrate to an extract under reduced pressure to obtain it.

[0058] Example 6

[0059] Using a 5% ethyl acetate solution as the extraction solvent to extract Buddleja officinalis Maxim extract, and the remaining steps are the same as those in Example 3.

[0060] Comparative Example 1

[0061] Using water as the extraction solvent to extract Buddleja officinalis Maxim extract, the steps are as follows:

[0062] Weigh 1000 g of Buddleja officinalis Maxim. Chinese herbal pieces. For the first time, add 12 times the amount of water, i.e., 12 L, and heat under reflux at 100 °C for 1 hour. For the second time, add 10 times the amount of water, i.e., 10 L, and heat under reflux at 100 °C for 45 min. For the third time, add 8 times the amount of water, i.e., 8 L, and heat under reflux at 100 °C for 30 min. Combine the filtrates of the three times and concentrate them under reduced pressure to an extract, thus obtaining it.

[0063] Comparative Example 2

[0064] Use 95% ethanol as the extraction solvent to extract the Buddleja officinalis Maxim. extract. The steps are as follows:

[0065] Weigh 1000 g of Buddleja officinalis Maxim. Chinese herbal pieces. For the first time, add 12 times the amount of 95% ethanol, i.e., 12 L, and heat under reflux at 80 °C for 1 hour. For the second time, add 10 times the amount of 95% ethanol, i.e., 10 L, and heat under reflux at 80 °C for 45 min. For the third time, add 8 times the amount of 95% ethanol, i.e., 8 L, and heat under reflux at 80 °C for 30 min. Combine the filtrates of the three times and concentrate them under reduced pressure to an extract, thus obtaining it.

[0066] Comparative Example 3

[0067] Use ethyl acetate as the extraction solvent to extract the Buddleja officinalis Maxim. extract, and the remaining steps are the same as in Example 3.

[0068] Comparative Example 4

[0069] Use propyl acetate as the extraction solvent to extract the Buddleja officinalis Maxim. extract, and the remaining steps are the same as in Example 4.

[0070] Comparative Example 5

[0071] Use butyl acetate as the extraction solvent to extract the Buddleja officinalis Maxim. extract, and the remaining steps are the same as in Example 5.

[0072] Comparative Example 7

[0073] Use ethyl acetate containing 1.5% water as the extraction solvent to extract the Buddleja officinalis Maxim. extract, and the remaining steps are the same as in Example 3.

[0074] Comparative Example 8

[0075] Use ethyl acetate containing 5.5% water as the extraction solvent to extract the Buddleja officinalis Maxim. extract, and the remaining steps are the same as in Example 3.

[0076] Example 7

[0077] Use the maceration method to extract the Buddleja officinalis Maxim. extract. The steps are as follows:

[0078] Weigh 1000 g of Buddleja officinalis Maxim. Chinese herbal pieces. For the first time, add 12 L of ethyl acetate solution containing 4.5% water, which is 12 times the amount, and extract for 10 hours. For the second time, add 10 L of ethyl acetate solution containing 4.5% water, which is 10 times the amount, and extract for 8 hours. For the third time, add 8 L of ethyl acetate solution containing 4.5% water, which is 8 times the amount, and extract for 6 hours. Combine the filtrates of the three times and concentrate them under reduced pressure to obtain an extract paste.

[0079] Example 8

[0080] The steps for extracting Buddleja officinalis Maxim. extract by microwave-assisted extraction method are as follows:

[0081] Weigh 1000 g of Buddleja officinalis Maxim. Chinese herbal pieces. For the first time, add 12 L of ethyl acetate solution containing 4.5% water, which is 12 times the amount, and perform microwave extraction for 30 min with a microwave power of 500 W. For the second time, add 10 L of ethyl acetate solution containing 4.5% water, which is 10 times the amount, and perform microwave extraction for 20 min with a microwave power of 500 W. For the third time, add 8 L of ethyl acetate solution containing 4.5% water, which is 8 times the amount, and perform microwave extraction for 20 min with a microwave power of 500 W. Combine the filtrates of the three times and concentrate them under reduced pressure to obtain an extract paste.

[0082] Example 9

[0083] The steps for extracting Buddleja officinalis Maxim. extract by ultrasonic-assisted extraction method are as follows:

[0084] Weigh 1000 g of Buddleja officinalis Maxim. Chinese herbal pieces. For the first time, add 12 L of ethyl acetate solution containing 4.5% water, which is 12 times the amount, and perform ultrasonic extraction for 1 hour. For the second time, add 10 L of ethyl acetate solution containing 4.5% water, which is 10 times the amount, and perform ultrasonic extraction for 45 min. For the third time, add 8 L of ethyl acetate solution containing 4.5% water, which is 8 times the amount, and perform ultrasonic extraction for 30 min. Combine the filtrates of the three times and concentrate them under reduced pressure to obtain an extract paste.

[0085] Experimental Example 1

[0086] The contents of luteolin glycoside and acteoside in Buddleja officinalis Maxim. extract were detected by high performance liquid chromatography.

[0087] Preparation of reference substance solution: Take an appropriate amount of luteolin glycoside or acteoside reference substance, weigh it accurately, and dissolve it in methanol to prepare a solution containing 50 μg of luteolin glycoside per 1 mL.

[0088] Chromatographic conditions for luteolin glycoside: Chromatographic column: Agilent ZORBAX Eclipse XDB-C18 column (4.6 mm × 250 mm, 5.0 μm); Mobile phase: methanol: water: glacial acetic acid = 45:54.5:0.5; Flow rate: 1.0 mL / min; Injection volume: 10 μL; Column temperature: 30 °C; Detection wavelength: 326 nm.

[0089] Chromatographic conditions for acteoside: Chromatographic column: Agilent ZORBAX Eclipse XDB-C18 column (4.6 mm × 250 mm, 5.0 μm); Mobile phase: acetonitrile: 0.1% glacial acetic acid 16:84; Flow rate 1.0 mL / min; Injection volume: 10 μL; Column temperature 30 °C; Detection wavelength: 334 nm.

[0090] Sample determination: Accurately weigh 10 μL (or the same volume) of the reference solution and the test solution each, inject them into a high-performance liquid chromatograph for separation and determination. Qualitative analysis is carried out based on the retention time of the reference solution, and quantitative analysis is carried out by the external standard method.

[0091] Result calculation: X i = A s / A std × C std × V / m / 10000

[0092] Among them, X i —— The content of luteolin glycoside or acteoside in the sample, %;

[0093] A s —— The peak area of the test solution;

[0094] A std —— The peak area of the reference solution;

[0095] C std —— The concentration of the reference solution, in micrograms per milliliter (μg / mL);

[0096] V —— The volume for constant volume of the test sample, in milliliters (mL);

[0097] m —— The weighed amount of the sample, in grams (g);

[0098] 10000 —— Unit conversion factor.

[0099] The detection results of the contents of luteolin glycoside and acteoside in the Buddleja officinalis Maxim. extracts in Examples 1 - 6 are shown in Table 1. Among them, when ethyl acetate containing 4.5% water is used as the extraction solvent, the contents of luteolin glycoside and acteoside in the Buddleja officinalis Maxim. extract are the highest.

[0100] Table 1 Contents of active ingredients in the Buddleja officinalis Maxim. extracts in Examples 1 - 5

[0101]

[0102] Comparison of the contents of active ingredients in the Buddleja officinalis Maxim. extracts between Example 3 and Comparative Examples 1 - 5, the results are shown in Table 2. It can be seen from Table 2 that in the Buddleja officinalis Maxim. extracts obtained by extraction with a water-containing extraction solvent, the contents of luteolin glycoside and acteoside are greatly increased, and the color of the extract becomes lighter, and the content of colored substances decreases.

[0103] Table 2 Comparison of the Contents of Active Ingredients in Buddleja officinalis Extract of Example 3 and Comparative Examples 1-7

[0104]

[0105] The comparison of the contents of active ingredients in the Buddleja officinalis extracts of Example 3 and Examples 7-9 is shown in Table 3. It can be seen from Table 3 that when using ethyl acetate containing 4.5% water as the extraction solvent and adopting any one of the extraction methods such as soaking extraction, heating reflux extraction, microwave-assisted extraction or ultrasonic-assisted extraction, good extraction effects can be achieved. In the obtained Buddleja officinalis extract, the content of buddleoside is above 7.4%, the content of acteoside is above 25%, and the color of the extract becomes lighter and the content of colored substances decreases.

[0106] Table 3 Contents of Active Ingredients in Buddleja officinalis Extracts Obtained by Different Extraction Methods

[0107]

[0108] Example 10

[0109] The prescription of the Buddleja officinalis solution for eye atomization fumigation is as follows:

[0110] Buddleja officinalis 20g

[0111] Sodium chloride 9g

[0112] Sterile water q.s. to 1000 mL.

[0113] Take Buddleja officinalis, add 240 mL of ethyl acetate solution containing 4% - 4.5% water for the first time, heat under reflux at 70°C for 1 hour, add 200 mL of ethyl acetate solution containing 4% - 4.5% water for the second time, heat under reflux at 70°C for 45 min, add 160 mL of ethyl acetate solution containing 4% - 4.5% water for the third time, heat under reflux at 70°C for 30 min, combine the filtrates of the three times, concentrate under reduced pressure to an extract, add 1000 mL of injection water, add 9 g of sodium chloride, stir to dissolve, refrigerate and stand for 24 hours, filter and sterilize with a 0.22 μm microporous membrane, and seal by BFS to obtain the solution preparation of the present invention.

[0114] Example 11

[0115] Buddleja officinalis solution for eye atomization fumigation:

[0116] Buddleja officinalis 20g

[0117] Glucose 50g

[0118] Sterile water q.s. to 1000 mL.

[0119] The preparation method is the same as that in Example 10.

[0120] Example 12

[0121] Buddleja officinalis Maxim. solution for eye atomization fumigation:

[0122] 10 g of Buddleja officinalis Maxim.

[0123] 7.5 g of sodium chloride

[0124] Add sterile water to make up 1000 mL.

[0125] Take Buddleja officinalis Maxim., add 12 times the amount of ethyl acetate solution containing 4% - 4.5% water (120 mL) for the first time, extract by microwave for 30 min with a microwave power of 500 W, add 10 times the amount of ethyl acetate solution containing 4% - 4.5% water (100 mL) for the second time, extract by microwave for 20 min with a microwave power of 500 W, add 8 times the amount of ethyl acetate solution containing 4% - 4.5% water (80 mL) for the third time, extract by microwave for 20 min with a microwave power of 500 W, combine the filtrates of the 3 times, concentrate under reduced pressure to an extract, add 1000 mL of injection water, add 7.5 g of sodium chloride, stir to dissolve, refrigerate and stand for 24 hours, filter and sterilize with a 0.22 μm microporous membrane, and seal by BFS to obtain the solution preparation of the present invention.

[0126] Example 13

[0127] Buddleja officinalis Maxim. solution for eye atomization fumigation:

[0128] 30 g of Buddleja officinalis Maxim.

[0129] 8 g of sodium chloride

[0130] Add sterile water to make up 1000 mL.

[0131] Take Buddleja officinalis Maxim., add 12 times the amount of ethyl acetate solution containing 4% - 4.5% water (360 mL) for the first time, extract by ultrasound for 1 hour, add 10 times the amount of ethyl acetate solution containing 4% - 4.5% water (300 mL) for the second time, extract by ultrasound for 50 min, add 8 times the amount of ethyl acetate solution containing 4% - 4.5% water (240 mL) for the third time, extract by ultrasound for 30 min, combine the filtrates of the 3 times, concentrate under reduced pressure to an extract, add 1000 mL of injection water, add 8 g of sodium chloride, stir to dissolve, refrigerate and stand for 48 hours, filter and sterilize with a 0.22 μm microporous membrane, and seal by BFS to obtain the solution preparation of the present invention.

[0132] Detect the solution color, state, active ingredient content, osmotic pressure, viscosity and relative density of the Buddleja officinalis Maxim. solution preparation for atomization fumigation. The detection methods of the active ingredients buddleoside and acteoside are the same as those in Experimental Example 1. The results are shown in Table 4.

[0133] Table 4 Parameters of Buddleja officinalis Maxim. solution for eye atomization fumigation

[0134]

[0135] Since the content of active substances in the extract of Buddleja officinalis Maxim. is the highest when the extraction solvent is ethyl acetate containing 4% - 4.5% water, the Buddleja officinalis Maxim. solution preparation for eye atomization fumigation is prepared therefrom. It can be seen from Table 4 that the Buddleja officinalis Maxim. solution preparation for eye atomization fumigation has a high content of active substances, excellent physical property parameters such as viscosity and relative density, and is easy to atomize to form aerosol.

[0136] Experimental Example 2

[0137] Intervention effect of Buddleja officinalis Maxim. solution preparation for atomization fumigation on castrated rabbit dry eye model

[0138] Animals: 20 ordinary New Zealand white rabbits, male, weighing 1.5 - 2.0 kg.

[0139] Main reagents: Buddleja officinalis Maxim. solution preparation for atomization fumigation (Example 10), sodium hyaluronate eye drops (commercially available).

[0140] Establishment of castrated rabbit dry eye model: By using the castration method, bilateral orchiectomy was performed. 8 weeks after modeling, the basic tear secretion test (Schirmer’s test I, SIT) was detected to confirm that the dry eye model of castrated rabbits was successful before administration.

[0141] Grouping and intervention method

[0142] There were 20 New Zealand white rabbits. Among them, 5 New Zealand white rabbits were not modeled as the normal group (Group A); after the other 15 rabbits were successfully modeled, the experimental animals were randomly divided into the model group (Group B); the Buddleja officinalis Maxim. solution preparation for atomization fumigation (Group C); and the sodium hyaluronate eye drop group (Group D) by using the random number table method. Groups A and B were not treated; in Group C, the Buddleja officinalis Maxim. solution was used for atomization fumigation, 5 mL each time, 3 times a day; in Group D, sodium hyaluronate eye drops were used for local eye drops, 3 times a day. Medication was continued for 4 weeks until the end of the experiment. During this experimental process, no experimental animals died, and the modeling success rate was 100%.

[0143] Detection indexes and methods

[0144] SIT detection: The SIT values were measured and recorded before modeling, before medication, and after medication in each experimental group. SIT test: According to the usage instructions, the tear secretion test paper was placed at the outer middle 1 / 3 junction of the lower conjunctival sac of the tested eye, the eyes were gently closed, and after 5 minutes, the test paper was taken out and the wet length of the test paper strip was measured, calculated in mm.

[0145] Table 5 Comparison of SIT value levels in each group (mm / 5min, X±S)

[0146]

[0147] The results showed that before modeling, there was no significant difference in the SIT values among groups (P>0.05); compared with the normal group before and after medication, the SIT values of the model decreased (P<0.01); compared with the model group after medication, the SIT values of the treatment group increased (P<0.01); compared with before medication in the treatment group after medication, the SIT values increased (P<0.01). The Buddleja officinalis Maxim solution preparation for atomization fumigation has a strong intervention effect on the dry eye model of castrated rabbits.

[0148] Experimental Example 3

[0149] Effect of the Buddleja officinalis Maxim solution preparation for atomization fumigation on the acute and chronic conjunctivitis models of white rabbits

[0150] Animals: 48 ordinary New Zealand white rabbits, weighing 1.5 - 2.0 kg.

[0151] Main reagents: Buddleja officinalis Maxim solution preparation for atomization fumigation (Example 10), bear bile eye drops (commercially available).

[0152] Modeling

[0153] 1) Modeling of Staphylococcus aureus acute conjunctivitis: Inoculate Staphylococcus aureus into ordinary broth medium 2 days before the experiment. After culturing at 37°C for 24 h, adjust the concentration to 1×10 9 / mL with normal saline for standby. Take 24 healthy New Zealand white rabbits without eye diseases. Pull the eyelid into a small cup shape with the hand, and inject 0.1 mL of the bacterial solution per eye under the lower eyelid conjunctiva with a 0.25 mL syringe, and gently restore the eyelid.

[0154] Grouping and drug administration: 24 white rabbits were randomly divided into 4 groups according to the degree of inflammatory reaction 24 h after infection, with 8 rabbits in each group (half male and half female, 16 eyes), namely the model control group (Group A); the positive control group (bear bile eye drops, Group B); the Buddleja officinalis Maxim solution preparation for atomization fumigation (Group C). In Group A, local eye drops with normal saline were given 3 times a day; in Group B, local eye drops with bear bile eye drops were given 3 times a day; in Group C, the Buddleja officinalis Maxim solution preparation for atomization fumigation was given, 5 mL for each fumigation, 3 times a day. Medication was continued for 4 days until the end of the experiment. After modeling, the palpebral conjunctiva of the animals in each group was significantly congested and edematous, and the purulent secretions increased significantly. No experimental animals died during this experimental process, and the modeling success rate was 100%.

[0155] 2) Modeling of chronic conjunctivitis: The white rabbits were anesthetized by intravenous injection of 30 mg / kg of 3% pentobarbital sodium at the ear edge. Subconjunctival embedding suture was performed at the superior bulbar conjunctiva 2 mm away from the corneal limbus (range: 180° superior), and the suture end was not exposed. After modeling, the palpebral conjunctiva and bulbar conjunctiva of the animals were significantly edematous and the secretions increased. No experimental animals died during this experimental process, and the modeling success rate was 100%.

[0156] Grouping and administration: 24 white rabbits were randomly divided into 3 groups according to the degree of inflammatory reaction 24 hours after modeling, with 8 rabbits in each group (half male and half female, 16 eyes in total). They were the model control group (Group A); the positive control group (bear bile eye drops, Group B); and the Buddleja officinalis solution preparation for atomization fumigation (Group C). In Group A, normal saline was instilled locally into the eyes 3 times a day; in Group B, bear bile eye drops were instilled locally into the eyes 3 times a day; in Group C, the Buddleja officinalis solution preparation for atomization fumigation was used, with 5 mL for each fumigation and 3 times a day. Medication was continued for 3 weeks until the end of the experiment. During this experimental process, no experimental animals died, and the modeling success rate was 100%.

[0157] Observation of therapeutic effect and lesion scoring criteria: Special personnel observed the changes in ocular inflammation with a flashlight every day, and slit lamp examination with fluorescence staining was performed once a week. Scoring criteria: 0 - 0.5 points indicate cure; > 0.5 - 1.5 points indicate marked effect; > 1.5 - 2.5 points indicate improvement; above 2.5 points indicate no effect.

[0158] Table 6 Acute conjunctivitis lesion scoring criteria

[0159]

[0160]

[0161] Table 7 Chronic conjunctivitis lesion scoring criteria

[0162] project 0 points 1 point 2 points 3 points palpebral fissure Eyes open normally Small obvious Not opening eyes Eyelid margin normal Wet, bunchy Congestion, edema Outward wrinkles Secretions none A small amount at the canthus Conjunctival sac secretion Eyelid adhesion Conjunctival hyperemia none Mild Moderate Severe Conjunctival hyperemia none Mild Moderate Severe Conjunctival edema none Slightly transparent ridge Swelling Bubble cornea normal Micro mist dyeing infiltration Pannus Iris normal swelling Vasodilation - pupil normal Zoom out - -

[0163] The effects of acute bacterial conjunctivitis are shown in Table 8. One day after administration, the secretions of the animals in the administration group were significantly reduced; three days after administration, the eye irritation symptoms were significantly alleviated; four days after administration, the inflammatory reactions of most animals in the administration group had returned to normal, showing a significant difference compared with the model control group (P < 0.01).

[0164] Table 8 Effects of Buddleja officinalis solution preparation for atomization fumigation on the inflammatory scores of rabbit acute bacterial conjunctivitis at different times (X ± S, n = 6, rabbit eyes = 12)

[0165] Group Before administration 1 day 2 days 3 days 4 days A 4.50±0.80 4.67±0.78 3.92±1.16 3.08±0.79 2.73±1.16 B 4.25±0.45 3.92±0.79 3.00±1.21 1.83±1.19 0.54±1.19 C 4.26±1.14 3.16±1.38 3.52±1.31 1.66±1.36 0.69±0.79

[0166] The effects of chronic bacterial conjunctivitis are shown in Table 9. One week after treatment, only 3 eyes in the model control group improved, and the ocular symptoms in the administration group all improved to some extent, but there was no significant difference compared with the model control group (P > 0.05). Two weeks after administration, except for the model control group, the symptoms in each group improved significantly, and there was a significant difference between the treatment group and the model control group (P < 0.01). Three weeks after administration, except for the model control group, each group basically returned to normal, and there was a significant difference between the treatment group and the model control group (P < 0.01).

[0167] Observation Results of the Efficacy of Buddleja officinalis Maxim Solution Preparation for Nebulization and Fumigation on Rabbit Chronic Conjunctivitis (n)

[0168]

[0169] Note: Total effective rate = cured + markedly effective.

[0170] Test Example 3

[0171] Effect of Buddleja officinalis Maxim Solution Preparation for Nebulization and Fumigation on Diabetic Retinopathy in Rats

[0172] Animals: Clean-grade male Sprague-Dawley (SD) rats, about 8 weeks old, weighing 200 - 260 g.

[0173] Main reagents: Buddleja officinalis Maxim solution preparation for nebulization and fumigation (Example 10), calcium dobesilate capsules (commercially available).

[0174] Model establishment: After 1 week of adaptive feeding of the animals, they were fasted for 12 hours. Streptozotocin (STZ) was dissolved in 0.1 M, pH = 4.6 citrate buffer solution at a concentration of 2%, and immediately injected intraperitoneally into the left lower abdomen at a dose of 55 mg / Kg body weight to establish a DM animal model. A total of 90 animals were modeled.

[0175] Three days later, all animals were fasted for more than 8 hours, and blood was taken from the tail vein to measure blood glucose. Rats with fasting blood glucose ≥ 16.7 mmol / L were regarded as successfully modeled DM rats, and the modeling success rate was 100%.

[0176] Grouping and administration: They were divided into a model control group (Group A); a positive control group (calcium dobesilate capsules, Group B); and a Buddleja officinalis Maxim solution preparation group for nebulization and fumigation (Group C). In Group A, normal saline was instilled locally into the eyes 3 times a day; in Group B, calcium dobesilate capsules were administered by gavage 3 times a day; in Group C, the Buddleja officinalis Maxim solution preparation for nebulization and fumigation was used, with 5 mL for each fumigation, 3 times a day. Administration was continued for 3 months.

[0177] Observation index: Before treatment and 3 months after treatment, the change in the retinal thickness of rats was compared.

[0178] Effect evaluation

[0179] Markedly effective: The retinal symptoms of the rats were significantly improved, and the number of fundus bleeding points decreased by more than 20%;

[0180] Effective: The retinal symptoms of the rats were significantly improved, and the number of fundus bleeding points decreased by 10% - 19% or more;

[0181] Ineffective: The retinal symptoms of the rats were not significantly improved or deteriorated.

[0182] The results are shown in Table 10. After 3 months of treatment, the retinal thickness of rats in the positive control group and the treatment group decreased significantly. The effective rate of the Buddleja officinalis Maxim solution preparation for atomization fumigation was 76%, showing a significant difference compared with the model control group.

[0183] Table 10 Observation results of the efficacy of the examples on diabetic retinopathy in rats (X±S)

[0184]

[0185] Test Example 4

[0186] Effect of the Buddleja officinalis Maxim solution preparation for atomization fumigation on New Zealand white rabbits with asthenopia

[0187] Animals: 24 ordinary New Zealand white rabbits, weighing 1.5 - 2.0 kg.

[0188] Main reagents: Buddleja officinalis Maxim solution preparation for atomization fumigation (Example 10), polyvinyl alcohol eye drops (commercially available).

[0189] Model establishment: After 7 days of adaptive feeding of New Zealand white rabbits, the experimental animals were divided into 4 groups by random lottery method, with 6 rabbits in each group, namely the blank control group (Group A), the asthenopia model group (Group B), the treatment group with Buddleja officinalis Maxim solution preparation for atomization fumigation (Group C), and the treatment group with polyvinyl alcohol eye drops (Group D).

[0190] From the first day of the experiment, an asthenopia animal model was established. The blank control group was under normal light cycle, day: 100 Lux; night: 0 Lux. Except for the blank control group, the asthenopia model group, the treatment group with Buddleja officinalis Maxim solution preparation for atomization fumigation, and the treatment group with polyvinyl alcohol eye drops were under low - light conditions with a day - night light cycle, day: 30 Lux; night: 0 Lux. About 20 white smooth stones with a diameter of about 1 cm were added to each New Zealand white rabbit cage to induce visual fatigue.

[0191] Drug administration method: Administration started on the first day of model establishment, and model establishment and drug administration were carried out simultaneously, twice a day (8 am and 2 pm). For the treatment group with Buddleja officinalis Maxim solution preparation for atomization fumigation, 5 mL was fumigated each time; for the treatment group with polyvinyl alcohol eye drops, 2 - 3 drops were instilled locally.

[0192] Detection indexes:

[0193] Observation of general status: Observe the diet, behavior, spirit, hair, urine and feces and other status of the experimental New Zealand white rabbits.

[0194] Measurement of refractive power value: The method used for measuring the refractive power of New Zealand white rabbits is streak retinoscopy. The examiner measures without knowing the grouping of the New Zealand white rabbits. Since New Zealand white rabbits are naturally gentle and lively, anesthesia is not required during the measurement. Under dim light conditions, after the experimenter grasps the New Zealand white rabbit and exposes the eye to be examined, the examiner measures the refractive power at 0 day, 14 days, and 28 days at a measurement distance of 50 cm. The examiner holds the trial lens by hand at 0.5 D intervals and performs retinoscopy on the horizontal and vertical meridians, and calculates the astigmatism and the spherical equivalent of half the amount. Each eye is measured 3 times, and the average value is taken in diopters (D). The entire operation process is completed by the same examiner.

[0195] Measurement of intraocular pressure value: The intraocular pressure of New Zealand white rabbits is measured using a contact tonometer. The examiner measures without knowing the grouping of the New Zealand white rabbits. First, 1 drop of proxymetacaine hydrochloride eye drops is instilled onto the surface of the eyeball of the New Zealand white rabbit for surface anesthesia, and the eye to be examined is exposed. The changes in intraocular pressure of each group of New Zealand white rabbits are measured using a contact tonometer at 0 day, 14 days, and 28 days respectively. Each eyeball is measured 3 times, and the average value is taken. The entire operation process is completed by the same examiner.

[0196] Experimental results

[0197] General condition examination of New Zealand white rabbits: During the experiment, there were no obvious changes in the diet, behavior, spirit, hair, urine, and feces of the New Zealand white rabbits in the normal control group; due to being in a dim light environment for a long time and continuously staring at the inducing object (stones), the New Zealand white rabbits in the visual fatigue model group showed symptoms such as weight loss, dry stools, yellowish urine, more active reactions and actions, and irritability; compared with the animals in the model group, the mimosae solution preparation treatment group for atomization fumigation and the polyvinyl alcohol eye drops treatment group had certain improvements in the above situations.

[0198] Effect of mimosae medicine on the refractive power value of New Zealand white rabbits with visual fatigue: At 28 days after modeling and administration, compared with the blank control group, the refractive power value of the model group increased significantly (P < 0.01); compared with the model group, the refractive power values of the mimosae solution preparation treatment group for atomization fumigation and the polyvinyl alcohol eye drops treatment group decreased significantly (P < 0.01).

[0199] Table 11 Effect of mimosae solution preparation for atomization fumigation on the refractive power value of New Zealand white rabbits with visual fatigue

[0200]

[0201] Effect of Buddleja officinalis Maxim. agent on intraocular pressure of New Zealand white rabbits with asthenopia: On the 28th day after modeling and administration, compared with the blank control group, the intraocular pressure value of the model group increased significantly (P < 0.01); compared with the model group, the intraocular pressure values of the treatment groups with Buddleja officinalis Maxim. solution preparation for atomization fumigation and polyvinyl alcohol eye drops decreased significantly (P < 0.01).

[0202] Table 12 Effect of Buddleja officinalis Maxim. solution preparation for atomization fumigation on intraocular pressure of New Zealand white rabbits with asthenopia

[0203]

[0204] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A Buddleja officinalis Maxim solution preparation for atomization fumigation, characterized in that, The solution preparation comprises: Buddleja officinalis Maxim. extract, an osmotic pressure regulator and a solvent; the Buddleja officinalis Maxim. extract is obtained by extracting Buddleja officinalis Maxim. with an extraction solvent containing 2% to 5% water, and the extraction solvent is any one or more of the following: ethyl acetate, propyl acetate and butyl acetate.

2. The Buddleja officinalis Maxim. solution preparation according to claim 1, characterized in that, In each liter of the Buddleja officinalis Maxim. solution preparation for atomizing fumigation, the dosage of Buddleja officinalis Maxim. is 5 to 35 g, and the dosage of the inorganic salt osmotic pressure regulator is 1 - 15 g.

3. The Buddleja officinalis Maxim. solution preparation according to claim 1, wherein The Buddleja officinalis Maxim. extract contains more than 5% of buddleoaside and more than 15% of acteoside.

4. The Buddleja officinalis Maxim solution preparation according to claim 1, characterized in that, The osmotic pressure regulator is an inorganic salt or a saccharide.

5. The Buddleja officinalis Maxim solution preparation according to claim 4, characterized in that, The inorganic salt is one or more of sodium chloride, magnesium chloride and calcium chloride; the saccharide is one or two of glucose and fructose.

6. The preparation method of the Buddleja officinalis Maxim. solution preparation for atomization fumigation according to any one of claims 1-5, characterized in that, It includes the following steps: Extract Buddleja officinalis Maxim. with an extraction solvent containing 2% to 5% water, and concentrate to a dry extract. The extraction solvent is any one or more of the following: ethyl acetate, propyl acetate and butyl acetate; mix the obtained dry extract with the solvent and the osmotic pressure regulator, filter after refrigerating and standing still, and seal to obtain the Buddleja officinalis Maxim. solution preparation for eye atomizing fumigation.

7. The preparation method according to claim 6, characterized in that, The extraction method includes maceration extraction, heating reflux extraction, microwave-assisted extraction or ultrasonic-assisted extraction.

8. The preparation method according to claim 7, characterized in that, The temperature of the reflux extraction is 70 to 120 °C, and the extraction time for each time is 30 - 60 min; the maceration extraction is carried out at room temperature, and the extraction time for each time is 6 - 12 h; the power of the microwave-assisted extraction is 300 - 600 W, and the extraction time for each time is 20 - 30 min; the extraction time for each time of the ultrasonic-assisted extraction is 30 - 60 min.

9. The preparation method according to claim 6, characterized in that, The sealing process includes a sterile sealing process or a sealing-sterilization process.

10. Use of the Buddleja officinalis Maxim. solution preparation for atomizing fumigation according to any one of claims 1 - 5, or the Buddleja officinalis Maxim. solution preparation for atomizing fumigation prepared by the method according to any one of claims 6 - 9 in the preparation of eye drugs, wherein the eye drugs are used for visual fatigue, dry eye, diabetic retinopathy or conjunctivitis.

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