Application of the active ingredients of Manlong Liquid in the preparation of medicines for improving human immunity

Abstract

The present invention discloses the application of the effective ingredients of Manlong Liquid in the preparation of medicines for improving human immunity. The effective ingredients of Manlong Liquid are hyperoside and psoralen. The mass ratio of the hyperoside to psoralen is 1:(2-4), preferably 1:3. The effective ingredients of Manlong Liquid are added with excipients to first prepare a solid dispersion of the effective ingredients of Manlong Liquid, and then a filler, a disintegrant and a lubricant are added to prepare a sustained-release tablet. It is found that hyperoside and psoralen have a synergistic effect in improving human immunity and have great application prospects.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceutical preparations, and more specifically, relates to the application of the effective ingredients of Manlong Liquid in the preparation of medicines for improving human immunity. Background Art

[0002] Manlong Liquid, a drug exclusively produced by Yunnan Yunlong Pharmaceutical Co., Ltd., is composed of male silkworm moth, Acanthopanax senticosus, Epimedium, Cuscuta australis (prepared with wine), Rehmannia glutinosa (prepared with salt), and Psoralea corylifolia (prepared with salt). It has the effects of tonifying the kidneys and strengthening yang, replenishing essence and nourishing the marrow. It is used for kidney deficiency, impotence, premature ejaculation, nocturnal emission, spermatorrhea, low back and knee pain, and frequent urination.

[0003] The male silkworm moth is the entire male moth of the Bombyx mori family. In summer, the moths are harvested, scalded to death in boiling water, and then sun-dried. It nourishes the liver and kidneys, strengthens yang, and astringes semen. It treats impotence, spermatorrhea, leukorrhea, hematuria, trauma, ulcers, and burns. Male silkworm moths contain a variety of amino acids, vitamins, and trace elements. In particular, they contain significant amounts of bioactive substances such as androgens, juvenile hormones, brain hormones, and molting hormones. They are a superior "medicine and food" that combines blood sugar reduction, complication relief, health promotion, and aphrodisiac properties. The main components of Acanthopanax senticosus are glycosides and polysaccharides. Glycosides are the characteristic and active ingredients. 1. Glycosides such as hyperoside, eleutherosides A, B, B1, C, D, E, F, and G. 2. Polysaccharides: The content of alkaline polysaccharides is generally 2% to 6%, and the content of water-soluble polysaccharides is 2.3% to 5.7%. 3. Other ingredients include isoflurane, chlorogenic acid, sesamin, stearic acid, and β-sitosterol. Epimedium contains icariin, volatile oils, wax alcohols, phytosterols, tannins, and vitamin E. It can stimulate sexual function and promote semen secretion in animals. It also has antihypertensive (causing peripheral vasodilation), hypoglycemic, diuretic, antitussive, and expectorant effects, as well as vitamin E-like properties. Pharmacological studies have shown that epimedium can increase cardiovascular blood flow, promote hematopoiesis, immune function, and bone metabolism, and possess anti-aging and anti-tumor properties. Cuscuta seeds contain alkaloids, anthraquinones, coumarins, flavonoids, glycosides, sterols, tannic acid, and carbohydrates. Flavonoids include quercetin, astragalin, and hyperoside; sterols include cholesterol, campesterol, β-sitosterol, stigmasterol, and β-amyrin. The main components of Rehmannia glutinosa are various iridoids, monoterpenes, and their glycosides; various sugar components; over 20 amino acids (with high concentrations of arginine and alanine); various organic acids; and over 20 elements, including iron, zinc, manganese, and chromium, including psoralens. Psoralea corylifolia contains coumarins such as psoralen, isopsoralen, zanthoxylum toxin, psoralenidine, isopsoralenidine, and psoralea furanocoumarins; it also contains flavonoids, benzofurans, fatty acids, and psoralen polysaccharides and amino acids. Manlong Liquid has been shown to have various therapeutic effects in clinical practice, but the underlying mechanisms remain unclear. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to address the defects and shortcomings of the technology and provide the application of the effective ingredients of Manlong Liquid in the preparation of medicines for improving human immunity. The effective ingredients of Manlong Liquid are hyperoside and psoralen.

[0005] While researching the active ingredients of Manlong Liquid, the company's scientific and technical personnel, through extensive experimental studies, unexpectedly discovered that hyperoside and psoralen have a synergistic effect in improving human immunity. However, since hyperoside is insoluble in water while psoralen is soluble in water, finding a suitable solvent for preparing the formulation was difficult. Therefore, the inventors, after research, determined that a sustained-release tablet would be a better option.

[0006] The first object of the present invention is to provide the use of the effective ingredients of Manlong Liquid in the preparation of medicines for improving human immunity.

[0007] The second object of the present invention is to provide a sustained-release tablet of the hyperoside and psoralen pharmaceutical composition.

[0008] The above-mentioned object of the present invention is achieved through the following technical solutions:

[0009] The invention discloses an application of the effective ingredients of Manlong Liquid in the preparation of medicines for improving human immunity. The effective ingredients of Manlong Liquid are hyperoside and psoralen; the mass ratio of the hyperoside to psoralen is 1:(2-4).

[0010] The effective ingredients of Manlong Liquid are used in the preparation of medicines for improving human immunity, wherein the mass ratio of hyperoside to psoralen is 1:3.

[0011] The effective ingredients of Manlong Liquid are used in the preparation of medicines for improving human immunity. The effective ingredients of Manlong Liquid are added with excipients to first prepare a solid dispersion of the effective ingredients of Manlong Liquid, and then fillers, disintegrants, and lubricants are added to prepare sustained-release tablets.

[0012] The effective ingredients of Manlong Liquid are used in the preparation of medicines for improving human immunity. The solid dispersion of the effective ingredients of Manlong Liquid is obtained by suspending the effective ingredients of Manlong Liquid, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate in anhydrous ethanol and drying to remove the ethanol.

[0013] The effective ingredients of the Manlong Liquid are used in the preparation of medicines for improving human immunity. The fillers are starch, pregelatinized starch, mannitol, chitin, microcrystalline cellulose, sucrose, sodium carboxymethyl cellulose, cross-linked polyvinyl pyrrolidone, low-substituted hydroxypropyl cellulose, and cross-linked sodium carboxymethyl cellulose; the disintegrants are one or more of alginic acid, cross-linked hydroxymethyl cellulose, microcrystalline cellulose, cereal starch, and sodium starch glycolate; and the lubricants are one or more of magnesium stearate, sodium lauryl sulfate, talc, and silicon dioxide.

[0014] The effective ingredients of the Manlong liquid are used in the preparation of medicines for improving human immunity, and the weight ratio of hyperoside, psoralen, cross-linked polyvinyl pyrrolidone and sodium lauryl sulfate is 1:3:(3-5):(2-4).

[0015] The effective ingredients of the Manlong liquid are used in the preparation of medicines for improving human immunity, and the weight ratio of hyperoside, psoralen, cross-linked polyvinyl pyrrolidone and sodium lauryl sulfate is 1:3:4:3.

[0016] The application of the effective ingredients of Manlong Liquid in the preparation of medicines for improving human immunity comprises 1 part of solid dispersion of the effective ingredients of Manlong Liquid, 4 parts of filler, 2 parts of disintegrant, and 0.1 part of lubricant.

[0017] The effective ingredients of Manlong Liquid are used in the preparation of medicines for improving human immunity, wherein the filler is cross-linked sodium carboxymethyl cellulose; the disintegrant is sodium starch glycolate; and the lubricant is magnesium stearate.

[0018] The application of the effective ingredients of Manlong Liquid in the preparation of medicines for improving human immunity comprises the following steps:

[0019] (1) taking the active ingredient of Manlong liquid, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate, suspending them in anhydrous ethanol, and drying to remove the ethanol to obtain a solid dispersion of the active ingredient of Manlong liquid;

[0020] (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45° C. to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] The present invention provides the use of the active ingredients of Manlong Liquid in the preparation of a drug for enhancing human immunity. The active ingredients of Manlong Liquid are hyperoside and psoralen. The applicant unexpectedly discovered that hyperoside and psoralen have a synergistic effect in enhancing human immunity. The composition of the present invention can be further prepared into a sustained-release tablet, which has great application prospects. DETAILED DESCRIPTION

[0023] The present invention is further described below with reference to specific examples, which, however, are not intended to limit the present invention in any way. Unless otherwise specified, the reagents, methods, and equipment used in the present invention are conventional reagents, methods, and equipment in the art.

[0024] Unless otherwise specified, the reagents and materials used in the following examples were commercially available.

[0025] Example 1:

[0026]

[0027] The preparation process includes the following steps:

[0028] (1) taking the active ingredient of Manlong liquid, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate, suspending them in anhydrous ethanol, and drying to remove the ethanol to obtain a solid dispersion of the active ingredient of Manlong liquid;

[0029] (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45° C. to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

[0030] Example 2:

[0031]

[0032] The preparation process includes the following steps:

[0033] (1) taking the active ingredient of Manlong liquid, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate, suspending them in anhydrous ethanol, and drying to remove the ethanol to obtain a solid dispersion of the active ingredient of Manlong liquid;

[0034] (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45° C. to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

[0035] Example 3:

[0036]

[0037] The preparation process includes the following steps:

[0038] (1) taking the active ingredient of Manlong liquid, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate, suspending them in anhydrous ethanol, and drying to remove the ethanol to obtain a solid dispersion of the active ingredient of Manlong liquid;

[0039] (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45° C. to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

[0040] Comparative Example 1:

[0041]

[0042] The preparation process includes the following steps:

[0043] (1) Hyperoside, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate are suspended in anhydrous ethanol, and the ethanol is removed by drying to obtain a solid dispersion of the active ingredient of Manlong Liquid;

[0044] (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45° C. to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

[0045] Comparative Example 2:

[0046]

[0047] The preparation process includes the following steps:

[0048] (1) Psoralen, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate are suspended in anhydrous ethanol, and the ethanol is removed by drying to obtain a solid dispersion of the active ingredient of Manlongye;

[0049] (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45° C. to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

[0050] Comparative Example 3:

[0051]

[0052]

[0053] The preparation process includes the following steps:

[0054] (1) taking the active ingredient of Manlong liquid and cross-linked polyvinyl pyrrolidone, suspending them in anhydrous ethanol, and drying to remove the ethanol to obtain a solid dispersion of the active ingredient of Manlong liquid;

[0055] (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45° C. to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

[0056] Comparative Example 4

[0057]

[0058] The preparation process includes the following steps:

[0059] (1) taking the active ingredient of Manlong liquid and sodium lauryl sulfate, suspending them in anhydrous ethanol, and drying to remove the ethanol to obtain a solid dispersion of the active ingredient of Manlong liquid;

[0060] (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45° C. to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

[0061] Comparative Example 5:

[0062]

[0063] The preparation process includes the following steps:

[0064] (1) taking the active ingredient of Manlong liquid, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate, suspending them in anhydrous ethanol, and drying to remove the ethanol to obtain a solid dispersion of the active ingredient of Manlong liquid;

[0065] (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45° C. to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

[0066] Comparative Example 6:

[0067]

[0068] The preparation process includes the following steps:

[0069] (1) taking the active ingredient of Manlong liquid, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate, suspending them in anhydrous ethanol, and drying to remove the ethanol to obtain a solid dispersion of the active ingredient of Manlong liquid;

[0070] (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45° C. to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

[0071] Example 4: Study on the Effect of Improving Immunity in Mice

[0072] 1. Test drugs and materials

[0073] 1.1 Experimental subjects: Kunming aged mice (10 months old), weighing 18-22 g, male.

[0074] 1.2 Test samples: samples prepared in Examples 1-3.

[0075] 1.3 Grouping and Dosing

[0076] Six groups of 50 mice were randomly divided into each group, including a blank control group (normal group), groups 1-3 of Examples, and groups 1-2 of Comparative Examples. The above-mentioned drugs were converted to the human dosage (using the common dosage conversion method, see Chen Qi. Methodology of Chinese Materia Medica Pharmacology Research. Beijing: People's Medical Publishing House [M]. 2006: 116) and dissolved in appropriate amounts of water for oral administration. During the experiment, the animals in each group were allowed to drink 0.1% BSA acidified water ad libitum. The blank group received normal saline daily, and the other three groups received the test samples once daily for 30 consecutive days.

[0077] 2 Methods and Results

[0078] 2.1 Determination of Organ / Body Weight Ratio: At the end of the experiment, 10 mice were taken, weighed, and then sacrificed. The thymus and spleen were removed and weighed on an electronic analytical balance to calculate the organ / body weight ratio. The results are shown in Table 1 below.

[0079] 2.2 Dinitrofluorobenzene (DNFB)-Induced DTH Test in Mice (Ear Swelling Method): Five days before the end of the experiment, 10 mice from each group were sensitized by smearing their abdominal skin with 50 μl of DNFB solution. Five days later, 10 μl of DNFB was applied to both sides of the right ear to induce sensitization. 24 hours later, the mice were sacrificed, and 8 mm diameter ear pieces from the left and right ear shells were removed using a punch and weighed. The difference in weight between the two ear pieces indicated the degree of DTH. The results are shown in Table 1 below.

[0080] 2.3 Mouse Carbon Clearance Assay: Ten mice in each group were injected via the tail vein with 4-fold diluted India ink (0.1 ml per 10 g body weight) 1 hour after the last sample administration. Immediately after ink injection, a timer was started. At 2 and 10 minutes after ink injection, 20 μl of blood was collected from the venous plexus of the inner canthus, added to 2 ml of 0.1% Na₂CO₃ solution, and shaken well. The Na₂CO₃ solution served as a blank control. Optical density (OD) was measured at 600 nm using a semi-automatic biochemical analyzer. Mice were sacrificed, and the liver and spleen were removed, weighed, and the phagocytic index was calculated. The results are shown in Table 2 below.

[0081] 2.4 Mouse Peritoneal Macrophage Phagocytosis of Chicken Red Blood Cells (Ex vivo Method): At the end of the experiment, 10 mice from each group were intraperitoneally injected with 1 ml of a 20% (v / v, prepared in physiological saline) packed chicken red blood cell suspension. Each mouse was sacrificed by cervical dislocation at 30-min intervals. The phagocytic rate and phagocytic index were calculated using the "ex vivo method." The results are shown in Table 2 below.

[0082] 2.5 NK cell activity assay: After 30 days of continuous administration, the animals were sacrificed by cervical dislocation, and the spleen was removed to prepare a cell suspension (effector cells). YAC-1 cells were cultured 24 hours after passage and added with PRMI1640 complete culture medium to adjust the cell concentration to 4×105 ml-1 (target cells). 100 μl of target cells and 100 μl of effector cells (effector-target ratio 50:1) were taken and added to a U-shaped 96-well culture plate. 100 μl of target cells and culture medium were added to the wells for natural release of target cells, and 100 μl of target cells and NP40 were added to the wells for maximum release. Three replicates were set up for each well and cultured in a 37°C, 5% CO2 incubator for 4 hours. 100 μl of supernatant was aspirated from each well and placed in a flat-bottom 96-well culture plate. 100 μl of lactate dehydrogenase (LDH) substrate solution was added simultaneously. The reaction was allowed to proceed for 3 minutes. 30 μl of 1 mol·L-1 HCl was added to each well to terminate the reaction. The optical density (OD) was measured at 490 nm using a microplate reader. The results are shown in Table 2.

[0083] Table 1 Changes in immune parameters of mice in each group after 30 days of drug administration

[0084] Group Thymus / body ratio spleen / body ratio DTH Blank control group 0.23±0.04 0.48±0.06 7.42±1.53 Example 1 0.28±0.05 0.47±0.05 <![CDATA[14.42±2.17 **## ]]> Example 2 0.26±0.06 0.45±0.02 <![CDATA[14.23±2.45 **## ]]> Example 3 0.26±0.03 0.46±0.07 <![CDATA[13.96±2.34 **## ]]> Comparative Example 1 0.24±0.03 0.43±0.04 <![CDATA[8.34±1.35 * ]]> Comparative Example 2 0.25±0.05 0.42±0.06 7.96±1.23

[0085] *P<0.05, comparison between blank control group and Example 1 and Comparative Examples 1-2; #P<0.05, comparison between Example 1 and Comparative Examples 1-2.

[0086] Table 2 Changes in immune parameters of mice in each group after 30 days of administration

[0087]

[0088] *P<0.05, comparison between blank control group and Example 1 and Comparative Examples 1-2; #P<0.05, comparison between Example 1 and Comparative Examples 1-2.

[0089] The results show that the sample has an effect on the ratio of immune organs to body weight. The results show that the growth of mice in each group in the test was good, and there were no abnormalities in physiological signs, appearance, behavior, etc., indicating that the sample was safe. There was no statistically significant difference in the thymus / body weight and spleen / body weight ratios of the different sample groups compared with the control group (P>0.05); the weight difference of the left and right ear pieces in the delayed-type hypersensitivity (DTH) test of the mice in Example 1-3 was higher than that in the blank control group, and the difference was statistically significant compared with the control group (P<0.05), and the cellular immunity test result was determined to be positive. Moreover, the weight difference of the left and right ear pieces in the delayed-type hypersensitivity (DTH) test of the mice in Example 1-3 was higher than that in the comparative example 1-2 group, indicating that the combination of hyperoside and psoralen is better than the use of hyperoside or psoralen alone, hyperoside and psoralen have a synergistic effect, and the effect is better when the mass ratio of hyperoside to psoralen is 1:3. The results of the effects of the samples on the phagocytic function of monocytes and macrophages in mice showed that the phagocytic index of the carbon clearance test of monocytes and macrophages of mice at each dose of Examples 1-3 samples was higher than that of the control group, and the differences between each sample group and the negative control group were statistically significant (P<0.05); the phagocytic rate and phagocytic index of chicken red blood cells by peritoneal macrophages of the sample group mice and the NK cell activity of the sample group mice were not statistically significant compared with the negative control group (P>0.05), but were statistically significant compared with the comparative example 1-2 group (P<0.05). From the numerical value, the example 1 group was higher than the example 2-3 group. Therefore, the combination of hyperoside and psoralen was better than that of hyperoside or psoralen alone. Hyperoside and psoralen had a synergistic effect, and the effect was better when the mass ratio of hyperoside to psoralen was 1:3, indicating that the sample promoted the phagocytic function of monocytes and macrophages in mice and had a certain improvement effect on NK cell activity.

[0090] The test results show that the pharmaceutical composition has a significant effect on enhancing the immune function of mice.

[0091] Example 5: Investigation of the release rate of Manlongye active ingredient sustained-release tablets

[0092] Chromatographic conditions: Chromatographic conditions: Chromatographic column: Agilent Eclipse XDB-C18 (250 mm×4.6 mm, 5 μm); mobile phase: acetonitrile (A)-0.1% phosphoric acid aqueous solution (B); detection wavelength: 340 nm, column temperature: 25°C.

[0093] The release assay was performed according to the method described in Appendix XD, Method 2 of the Chinese Pharmacopoeia (2010 edition), using the dissolution apparatus (Appendix XC of the Chinese Pharmacopoeia (2010 edition)) with 900 ml of 0.02% Tween-80 solution as the solvent and a rotation speed of 50 rpm. After 0.25, 2, 4, 6, 8, and 12 hours, 5 ml of the solution was filtered and immediately added to the working container with the same volume of release medium at the same temperature. The filtrate was used as the test solution. Separately, an appropriate amount of hyperoside reference standard was dissolved in the mobile phase and diluted to a solution containing approximately 10 μg per 1 ml. This served as the reference solution. 20 μl of each of the test and reference solutions was accurately measured and injected into a liquid chromatograph. The chromatograms were recorded. The release amount per tablet at different times was calculated using the external standard method based on peak area. The release values of all samples in each group were averaged. The release results are shown in Table 3.

[0094] Table 3 Release determination results of sustained-release tablets prepared in each embodiment

[0095] Sample source 0.25h(％) 2h(％) 4h(％) 6h(％) 8h(％) 12h(％) Example 1 28.4 43.7 65.9 83.7 93.8 99.7 Comparative Example 3 16.7 28.9 36.6 52.6 61.6 78.4 Comparative Example 4 16.9 34.3 42.6 58.5 64.5 84.9 Comparative Example 5 27.8 42.9 62.7 80.2 92.3 97.9 Comparative Example 6 28.9 41.5 64.7 81.6 90.6 98.2

[0096] According to the test results in Table 3, the sustained-release tablet of Example 1 of the present invention has a smooth release. In Comparative Examples 3-4, cross-linked polyvinyl pyrrolidone or sodium lauryl sulfate was used in the preparation of the solid dispersion, and the release was incomplete, which shows the importance of preparing a solid dispersion. In addition, compared with Comparative Examples 5-6, it is shown that when the weight ratio of hyperoside, psoralen, cross-linked polyvinyl pyrrolidone and sodium lauryl sulfate is 1:3:4:3, the dissolution is most stable.

[0097] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. The application of the active ingredients of Manlong Liquid in the preparation of medicines for improving human immunity is characterized in that: The active ingredients of Manlong Liquid are hyperoside and psoralen; the mass ratio of hyperoside to psoralen is 1:

3. Excipients are added to the active ingredients of Manlong Liquid to prepare a solid dispersion of the active ingredients of Manlong Liquid, and then a filler, a disintegrant, and a lubricant are added to prepare a sustained-release tablet. The solid dispersion of the active ingredients of Manlong Liquid is obtained by suspending the active ingredients of Manlong Liquid, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate in anhydrous ethanol and drying to remove the ethanol. The filler is cross-linked sodium carboxymethyl cellulose; the disintegrant is sodium starch glycolate; the lubricant is magnesium stearate. The weight ratio of hyperoside, psoralen, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate is 1:3:4:

3. The solid dispersion of the active ingredients of Manlong Liquid, 1 part, 4 parts of filler, 2 parts of disintegrant, and 0.1 part of lubricant are prepared. The preparation process comprises the following steps: (1) The active ingredients of Manlong Liquid, cross-linked polyvinyl pyrrolidone, and sodium lauryl sulfate are suspended in anhydrous ethanol, and the ethanol is removed by drying to obtain a solid dispersion of the active ingredients of Manlong Liquid; (2) The solid dispersion of the active ingredient of Manlong Liquid obtained in step (1) is mixed evenly with a filler and a disintegrant, 60% ethanol is used as a binder, granulated, and dried at 45°C to obtain drug-containing granules; the drug-containing granules are sieved through an 18-mesh sieve, then mixed evenly with a prescribed amount of lubricant, and compressed into tablets.

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