A Chinese medicine compound oral liquid for moistening intestines and relieving constipation and preparation method thereof

Abstract

The invention discloses a Chinese medicine compound oral liquid for moistening the intestine and promoting bowel movement and a preparation method thereof. The oral liquid comprises the following components by weight: 10-50 parts of gardenia, 10-25 parts of sophora japonica seeds, 0.1-10 parts of sea buckthorn juice, 10-100 parts of sucrose, 10-100 parts of honey, 0.1-1 parts of citric acid, 0.5-5 parts of vanillin and 0.5-5 parts of potassium sorbate. The preparation method of the Chinese medicine compound oral liquid for moistening the intestine and promoting bowel movement provided by the invention is simple. The compound liquid is prepared by extracting gardenia and sophora japonica seeds together. The two can synergistically exert good bowel moistening and promoting bowel movement effects and antioxidant effects. The oral liquid has high safety, good taste, appropriate sweet and sour taste, strong stability, can promote gastrointestinal motility, and has obvious therapeutic effect on constipation.

Description

Technical Field

[0001] The invention belongs to the technical field of preparation of Chinese medicine oral liquid, and relates to a Chinese medicine compound oral liquid for moistening intestines and relieving constipation and a preparation method thereof. Background Art

[0002] Constipation is a fairly common health problem. Moderate and severe constipation requires medication intervention. Chinese herbal compound oral liquid retains the advantages of Chinese herbal compound to a certain extent, while overcoming the shortcomings of traditional decoctions in terms of storage, carrying, and taking. Traditional Chinese medicine theory focuses on the compatibility of drugs, especially the effect of drug compatibility on the efficacy of drugs. Therefore, how to use scientific compatibility, explore the compatibility mechanism, give full play to the synergistic efficacy of drugs, enhance stability to obtain high-quality taste, and increase patient compliance is an important direction for the research of compound oral liquid.

[0003] Both Sophora japonica and Gardenia jasminoides have the effects of clearing away heat and purging fire, cooling blood and detoxifying, dispelling wind and relieving itching, promoting blood circulation and removing blood stasis, etc. As a commonly used Chinese medicine pair, they have good therapeutic effects in the treatment of hemorrhoids, psoriasis, etc. Quercetin, the main active substance in Sophora japonica, has multiple pharmacological activities such as anti-cancer, anti-inflammatory, and antioxidant, but quercetin belongs to BCS IV class drugs and has problems of low solubility and low permeability. Gardenia glycoside is the main active ingredient of Gardenia jasminoides, which has good water solubility and rich alcohol hydroxyl structure. Studies have found that when Sophora japonica and Gardenia jasminoides are used in combination, Gardenia glycoside controls the growth of quercetin crystals through hydrogen bonding to form nanocrystals. This result can well explain the use of Sophora japonica and Gardenia jasminoides in Chinese medicine to treat diseases.

[0004] Based on the research results on the compatibility mechanism of traditional Chinese medicine and oral liquid preparations, the present invention is specially proposed. Summary of the invention

[0005] In view of the above technical problems, the present invention aims to provide a Chinese medicine compound oral liquid for moistening the intestine and relieving constipation and a preparation method thereof. The oral liquid uses a compound liquid obtained by water extraction of gardenia and sophora japonica seeds as a main ingredient, supplemented by seabuckthorn juice, sucrose, honey, citric acid, vanillin, potassium sorbate and other auxiliary materials, and is formed after mixing and filling to form the final Chinese medicine compound oral liquid; the oral liquid of the present invention has a wide range of raw materials, low price, high safety, simple preparation method, good taste, strong stability, can promote gastrointestinal motility, not only has a significant therapeutic effect on constipation, but also has better antioxidant properties.

[0006] To achieve the above object, the technical solution adopted by the present invention is:

[0007] A Chinese medicinal compound oral liquid for moistening the intestine and relieving constipation comprises the following components in parts by weight: 10-50 parts of gardenia, 10-25 parts of sophora japonica seeds, 0.1-10 parts of seabuckthorn juice, 10-100 parts of sucrose, 10-100 parts of honey, 0.1-1 parts of citric acid, 0.5-5 parts of vanillin and 0.5-5 parts of potassium sorbate.

[0008] As a limitation of the Chinese medicine compound oral liquid of the present invention, it includes the following components in parts by weight: 12 parts of gardenia, 24 parts of sophora japonica seeds, 0.2 parts of seabuckthorn juice, 58.8 parts of sucrose, 42.5 parts of honey, 0.2 parts of citric acid, 1.1 parts of vanillin, and 3 parts of potassium sorbate.

[0009] The present invention also provides a method for preparing a Chinese medicine compound oral liquid for moistening the intestine and relieving constipation, which is carried out in the following steps:

[0010] (1) Composite liquid extraction

[0011] After the gardenia and the sophora japonica seeds are evenly mixed, water is added to the mixture for the first time, and the mixture is boiled at a low heat in a stainless steel or ceramic extractor for 1-2 h. After the extract is filtered out, water is added to the mixture for the second time, and the mixture is boiled at a low heat for 0.5-1 h for a second extraction. The two extracts are mixed for later use;

[0012] (2) Mixed

[0013] The extracted composite liquid is mixed with sea buckthorn juice, sucrose, honey, citric acid, vanillin and potassium sorbate, and stirred evenly to obtain an oral liquid raw material liquid;

[0014] (3) Filling

[0015] The final Chinese medicine compound oral liquid is obtained by filling the oral liquid raw material liquid in a filling machine.

[0016] As a limitation of the preparation method of the present invention, in step (1), the mass ratio of the gardenia to the sophora japonica bud is 1:2-2:1.

[0017] As another limitation of the preparation method of the present invention, in step (1), the mass ratio of the gardenia to the water added for the first time is 1:50.

[0018] As a third limitation of the preparation method of the present invention, in step (1), the volume ratio of water added for the first time to water added for the second time is 1:1.

[0019] As a fourth limitation of the preparation method of the present invention, in step (2), the stirring rate is 1000-5000 rpm, and the time is 5-30 min.

[0020] Since the main component quercetin in Sophora japonica is a BCS IV drug, its solubility can only be improved during the decoction process or when extracted with ethanol, but precipitation will be formed during the cooling or mixing with water, affecting the efficacy of the preparation. In the water extraction method, the dissolution rate of quercetin in the raw material is poor, the bioavailability is low, and it is difficult to exert its pharmacodynamic effect. In the study of the compatibility of gardenia and Sophora japonica for treating damp-heat accumulation and damp-heat type constipation complicated with hemorrhoids according to the compatibility rule of the drug pair, it was found that the co-decoction of gardenia and Sophora japonica can increase the solubility of quercetin, and the solution is slightly turbid after the extract is cooled, but no precipitation will be produced. Further research found that the crystallization process of quercetin in Gardenia glycoside solution is carried out according to the non-classical crystal growth theory. Quercetin first nucleates in the solution and forms quercetin nanorods, the nanorods are directional attached and the lateral surfaces are close to each other to form a bundle structure, and as the aging time is extended, the nanorods grow into nanowires with a high aspect ratio, and the nanowires that are finally closely arranged form needle-shaped microcrystals. Therefore, the synergistic combination of gardenia and sophora japonica can not only maximize the dissolution of quercetin in the raw materials and improve the bioavailability of the active ingredients of traditional Chinese medicine, but also regulate the particle size and morphology of the product through hydrogen bonding between quercetin and gardenia glycosides to obtain quercetin nanocrystals. Therefore, the extracts of gardenia and sophora japonica can remain stable after the cooling process, and have excellent laxative effects and antioxidant properties.

[0021] The oral liquid of the present invention uses a composite liquid obtained by twice water extraction of gardenia and sophora japonica seeds as a main ingredient, supplemented by seabuckthorn juice, sucrose, honey, citric acid, vanillin, potassium sorbate and other auxiliary materials, and forms a final Chinese medicine compound oral liquid after mixing and filling. In the oral liquid, the auxiliary materials and the main materials are reasonably matched, and the main materials synergistically have the effects of clearing away heat and purging fire, cooling blood and detoxifying, and promoting blood circulation and removing blood stasis, and are used for treating constipation caused by damp-heat accumulation and damp-heat infiltration. After the auxiliary materials are matched, the oral liquid is guaranteed to be clear and transparent, free of precipitation, good in stability and suitable in taste.

[0022] The above technical solution of the present invention is taken as a whole, and each step is closely related and influences each other, which jointly determine the morphological characteristics and performance of the product.

[0023] The above technical solution has the following advantages or beneficial effects:

[0024] 1. The Chinese medicine compound oral liquid for moistening the intestine and relieving constipation prepared by the present invention has good taste and strong stability. The decoction liquid is highly clear by combining Sophora japonica seeds and Gardenia jasminoides. It has significant function of moistening the intestine and relieving constipation caused by loss of gastrointestinal fluid due to blood heat, and also has antioxidant function.

[0025] 2. The Chinese herbal compound oral liquid for moistening the intestine and relieving constipation prepared by the present invention has a simple preparation method, high safety, low cost, and is suitable for promotion and application.

[0026] The invention is suitable for preparing a Chinese medicine compound oral liquid for moistening the intestine and relieving constipation.

[0027] The technical solution of the present invention will be further described in detail below in conjunction with the accompanying drawings and specific implementation methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 Graphs of the extracts of Example 1 and Comparative Example 1 of the present invention, wherein: a is a graph of the extract extracted from Sophora japonica seeds alone in Comparative Example 1, b is a graph of the extract extracted from Gardenia jasminoides and Sophora japonica seeds together in Example 1, and c is a graph of the extract extracted from Gardenia jasminoides and Sophora japonica seeds together in Example 1 after being left for 1 week;

[0029] Figure 2 The oral liquid prepared in Example 1 of the present invention, wherein: a is a picture of the oral liquid after preparation, b is a picture of the oral liquid after being placed for 3 months, and c is a picture of the oral liquid after being frozen and thawed 5 times;

[0030] Figure 3 FIG. 1 is a diagram showing the growth process of quercetin in Sophora japonica buds forming nanocrystals under the action of Gardenia jasminoides in step (1) of Example 1 of the present invention;

[0031] Figure 4 The electron microscope images of the formation of nanocrystals of quercetin in Sophora japonica buds under the action of Gardenia jasminoides in step (1) of Example 1 of the present invention, wherein: (a) is a scanning electron microscope image, (b) is a transmission electron microscope image, and the inset in (b) is a high-magnification transmission electron microscope image;

[0032] Figure 5 The infrared spectra of quercetin nanocrystals and quercetin prepared in Example 1 and Comparative Example 1 of the present invention;

[0033] Figure 6 This is a diagram showing the therapeutic effects of the oral liquids prepared in Examples 1-3 of the present invention and Comparative Examples 1-2 on constipated mice. DETAILED DESCRIPTION

[0034] The following embodiments are only some embodiments of the present invention, rather than all embodiments. Therefore, the detailed description in the embodiments of the present invention provided below is not intended to limit the scope of the present invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative work belong to the protection scope of the present invention.

[0035] In the present invention, unless otherwise specified, all equipment and raw materials can be purchased from the market or are commonly used in the industry. The methods in the following embodiments are all conventional methods in the art unless otherwise specified. Example 1

[0036] (1) Composite liquid extraction

[0037] After 12 g of Gardenia jasminoides and 24 g of Sophora japonica seeds are mixed evenly, 600 mL of water is added to the mixture for the first time, and the mixture is boiled at low heat for 1 h in a stainless steel or ceramic extractor. After the extract is filtered out, 600 mL of water is added to the mixture for the second time, and the mixture is boiled at low heat for 0.5 h for the second extraction. The two extracts are mixed for later use;

[0038] (2) Mixed

[0039] The extracted composite liquid was mixed with 0.2 g of sea buckthorn juice, 58.8 g of sucrose, 42.5 g of honey, 0.2 g of citric acid, 1.1 g of vanillin, and 3 g of potassium sorbate, and stirred at a stirring rate of 1000 rpm for 30 min to obtain an oral liquid raw material solution;

[0040] (3) Filling

[0041] The final Chinese medicine compound oral liquid is obtained by filling the oral liquid raw material liquid in a filling machine.

[0042] Figure 1 Figure 2 is a graph of the extracted extract, where: a is a graph of the extract extracted from Sophora japonica seeds alone, b is a graph of the extract extracted from Gardenia jasminoides and Sophora japonica seeds, and c is a graph of the extract extracted from Gardenia jasminoides and Sophora japonica seeds after being left for one week. It can be seen from the figure that precipitation will occur when Sophora japonica seeds are extracted alone, while the extract becomes clear and transparent after adding Gardenia jasminoides. This indicates that after adding Gardenia jasminoides, the gardenoside in Gardenia jasminoides will promote the dispersion of quercetin in Sophora japonica seeds in the aqueous solution and improve its bioavailability. However, the extract will become turbid after being left at room temperature for one week.

[0043] Figure 2 These are the oral liquids prepared in Example 1, where a is the oral liquid after preparation, b is the oral liquid after being placed for 3 months, and c is the oral liquid after being frozen and thawed 5 times. It can be seen from the figures that no precipitation or turbidity occurs in all samples, and the oral liquid has good stability.

[0044] Figure 3 The figure is a diagram of the growth process of quercetin nanocrystals prepared in step (1) of Example 1. The (100) face of the quercetin crystal is hydrophilic and grows through polar hydrogen bonds; the (001) face is a high-energy face of the quercetin crystal, and both polar and non-polar effects contribute to its growth. In the anti-solvent precipitation process assisted by gardenia glycoside, quercetin first forms nanorods in a supersaturated solution, and the quercetin nanorods gradually connect end to end to form nanofibers, and grow rapidly. The (100) face of the quercetin crystal forms hydrogen bonds with water and gardenia glycoside, which hinders the (100) faces of the nanofibers from approaching each other, thereby forming loose bundle aggregates. The anisotropy of the quercetin crystal surface ultimately determines that quercetin crystals with a high aspect ratio can be formed under the action of gardenia glycoside.

[0045] Figure 4 The electron microscope images of quercetin nanocrystals, where: (a) is a scanning electron microscope image, (b) is a transmission electron microscope image, and the illustration in (b) is a high-magnification transmission electron microscope. It can be seen from the figure that the quercetin nanocrystals are nanoparticles with uniform particle size and monodisperse. This is because when the active ingredient of the main ingredient is extracted, the cavitation bubbles formed during the slow boiling can reduce the agglomeration between the crystals, thereby significantly improving the mixing efficiency of quercetin, gardenia glycoside and water. On the one hand, it avoids the agglomeration of nanorods, and on the other hand, it hinders the self-assembly of nanorods to form nanowires, thereby improving the solubility of quercetin. Example 2

[0046] (1) Composite liquid extraction

[0047] After 10 g of Gardenia jasminoides and 10 g of Sophora japonica seeds are mixed evenly, 500 mL of water is added to the mixture for the first time, and the mixture is boiled in a stainless steel or ceramic extractor for 2 h at a low heat. After the extract is filtered out, 500 mL of water is added to the mixture for the second time, and the mixture is boiled at a low heat for 1 h for a second extraction. The two extracts are mixed for later use;

[0048] (2) Mixed

[0049] The extracted composite liquid was mixed with 0.1 g of sea buckthorn juice, 10 g of sucrose, 100 g of honey, 0.1 g of citric acid, 0.5 g of vanillin, and 5 g of potassium sorbate, and stirred at a stirring rate of 5000 rpm for 5 min to obtain an oral liquid raw material solution;

[0050] (3) Filling

[0051] The final Chinese medicine compound oral liquid is obtained by filling the oral liquid raw material liquid in a filling machine. Example 3

[0052] (1) Composite liquid extraction

[0053] After 50 g of Gardenia jasminoides and 25 g of Sophora japonica seeds are mixed evenly, 2500 mL of water is added to the mixture for the first time, and the mixture is boiled in a stainless steel or ceramic extractor over low heat for 1.5 h. After the extract is filtered out, 2500 mL of water is added to the mixture for the second time, and the mixture is boiled over low heat for 0.8 h for a second extraction. The two extracts are mixed for later use;

[0054] (2) Mixed

[0055] The extracted composite liquid was mixed with 10 g of sea buckthorn juice, 100 g of sucrose, 10 g of honey, 1 g of citric acid, 5 g of vanillin, and 0.5 g of potassium sorbate, and stirred at a stirring rate of 3000 rpm for 20 min to obtain an oral liquid raw material solution;

[0056] (3) Filling

[0057] The final Chinese medicine compound oral liquid is obtained by filling the oral liquid raw material liquid in a filling machine.

[0058] Experimental example

[0059] In order to screen the flavoring agents and preservatives of the Chinese medicine compound oral liquid, the following experiments were conducted, as follows:

[0060] Experimental Example 1

[0061] In this experimental example, the flavoring agent in the Chinese medicine compound oral liquid was screened. 10 mL of the stock solution was taken, and the addition amount was designed. Different types of sweeteners, sour agents, and flavors were weighed, stirred and dissolved evenly at room temperature, and samples were taken to examine their taste. (The taste of the flavoring agent is presented in the form of high and low scores. The scoring standard is: no bitterness of the drug, appropriate sweetness and sourness, and no foreign taste is 80-70 points; no bitterness of the drug, slightly sour / sweet sweetness and sourness, and no foreign taste is 70-60 points; no bitterness of the drug, too sour / sweet sweetness and sourness, and no foreign taste is 60-50 points). The analysis results are shown in Table 1.

[0062] Table 1: Screening of flavor correctors for Chinese herbal compound oral liquid

[0063]

[0064] As can be seen from the table, Experiment 8 scored the highest, and the formula of Experiment 8 was finally selected as the formula material of the present invention.

[0065] Experimental Example 2

[0066] In this experiment, the preservatives of the Chinese medicine compound oral liquid were screened. 30 mL of the stock solution was taken, and 0.1%, 0.15%, 0.2%, 0.25%, and 0.3% potassium sorbate were added respectively under stirring. After stirring evenly, the mixture was put into a stoppered conical bottle and placed at room temperature away from light for 2 weeks to investigate its stability. The results are shown in Table 2.

[0067] Table 2: Screening of preservatives for Chinese herbal compound oral liquid

[0068]

[0069] As can be seen from the table, when the preservative addition amount is 0.25% and 0.3%, the oral solution is clear, transparent, without precipitation and no odor. According to the provisions of China's Food Safety Law, the amount of Class J preservatives contained in food shall not exceed 0.3%, so 0.25% potassium sorbate was finally selected as the preservative. Comparative Example

[0070] In order to better explore the effects of different drugs in Chinese medicine compound oral liquid on the efficacy of oral liquid, the following comparative experiments were conducted, as follows: Comparative Example 1

[0071] This comparative example prepares a Chinese medicine compound oral liquid similar to that of Example 1, except that Gardenia jasminoides is not added to the formula.

[0072] In order to explore the effect of geniposide, an active ingredient in gardenia, on quercetin, an active ingredient in sophora japonica, infrared spectroscopy was performed on the main ingredients prepared in Example 1 and Comparative Example 1 of the present invention. The test results are as follows: Figure 5 As shown in the figure, it can be seen that the peak position of the nanocrystals formed when Gardenia jasminoides and Sophora japonicae are basically consistent with that of quercetin, the main component of Sophora japonicae, and no new peaks appear. It can be seen that no new reactants are produced after the reaction with Gardenia glycoside. By comparing the relative intensities of the infrared peaks of the two, it is found that the quercetin nanocrystals prepared with the assistance of Gardenia glycoside have a peak intensity of 3000-3400 cm -1 The relative intensity of the hydroxyl peak at the position increases, that is, more hydroxyl groups are exposed, thereby promoting the dissolution of quercetin in Sophora japonica and improving its bioavailability. Comparative Example 2

[0073] This comparative example prepares a Chinese medicine compound oral liquid similar to that of Example 1, except that no Sophora japonica seed is added to the formula.

[0074] The Chinese medicine compound oral liquids prepared in the above Examples 1-3 and Comparative Examples 1-2 are analyzed from the two aspects of antioxidant capacity and animal experiments.

[0075] 1. Antioxidant capacity test

[0076] Different suspensions were prepared to test their antioxidant properties, as follows:

[0077] Group A: 10, 20, 30, 40, 50 μg∙mL prepared with distilled water -1 Gardenia glycoside-quercetin suspension (QUE-NRs);

[0078] The preparation method of the gardenia glycoside-quercetin mixed solution is as follows:

[0079] After 25 g of Gardenia jasminoides and 25 g of Sophora japonica seeds are mixed evenly, 1000 mL of water is added thereto for the first time, and the mixture is boiled at a low heat for 1 h in a stainless steel or ceramic extractor. After the extract is filtered out, 1000 mL of water is added thereto for the second time, and the mixture is boiled at a low heat for 0.5 h for a second extraction. The two extracts are mixed to obtain a mixed solution of Gardenia glycoside-quercetin;

[0080] According to the method for preparing the gardenia glycoside-quercetin mixed solution, gardenia glycoside-quercetin suspensions of different concentrations were prepared with distilled water.

[0081] Group B: 10, 20, 30, 40, 50 μg∙mL prepared with distilled water -1 quercetin aqueous solution (QUE);

[0082] The quercetin solution was prepared as follows:

[0083] 1000 mL of water was added to 25 g of Sophora japonica seeds for the first time, and the mixture was boiled in a stainless steel or ceramic extractor for 1 h. After the extract was filtered out, 1000 mL of water was added for the second time, and the mixture was boiled for 0.5 h at a low heat for a second extraction. The two extracts were mixed to obtain a quercetin solution.

[0084] The quercetin solution was prepared with distilled water to prepare quercetin aqueous solutions of different concentrations.

[0085] Group C: 10, 20, 30, 40, 50 μg∙mL prepared with distilled water -1 Gardenia glycoside aqueous solution;

[0086] The preparation method of Gardenia jasminoides solution is as follows:

[0087] 1000 mL of water was added to 25 g of Gardenia jasminoides for the first time, and the mixture was boiled in a stainless steel or ceramic extractor for 1 h under low heat. After the extract was filtered out, 1000 mL of water was added to the mixture for the second time, and the mixture was boiled under low heat for 0.5 h for a second extraction. The two extracts were mixed to obtain a Gardenia glycoside solution.

[0088] The gardenoside solution was prepared with distilled water to prepare gardenoside aqueous solutions of different concentrations.

[0089] Group D: 10, 20, 30, 40, 50 μg∙mL prepared with distilled water -1 Ascorbic acid aqueous solution (Vitamin C).

[0090] The ascorbic acid solution was prepared as follows:

[0091] Accurately weigh 1.25 mg of ascorbic acid solution and prepare it into a 50 μg∙mL solution in a 25 mL brown volumetric flask. -1 The aqueous solution was then diluted to 10, 20, 30, 40, and 50 μg∙mL -1 ;

[0092] According to the ascorbic acid solution preparation method, ascorbic acid aqueous solutions of different concentrations were prepared with distilled water.

[0093] The performance measurement method is carried out as follows:

[0094] Prepare DPPH (1,1-diphenyl-2-trinitrophenylhydrazine) ethanol solution (40 μg∙mL -1 ), and put them into a brown bottle for later use; 50 μL of the above four solutions with different concentrations were mixed with 150 μL of DPPH solution, reacted at room temperature in the dark for 30 min, and then the absorbance was measured at 517 nm with an enzyme marker, which was recorded as A1; under the same measurement conditions, anhydrous ethanol was used instead of DPPH as a control, which was recorded as A2; distilled water was used instead of the above four groups of test solutions, which was recorded as A0.

[0095]

[0096] The antioxidant capacity of the above solutions in groups A, B, C and D was tested, and the test results are shown in Table 3.

[0097] Table 3: Antioxidant capacity test results of solutions in groups A, B, C, and D

[0098]

[0099] Quercetin is a flavonoid compound with antioxidant capacity, which has a scavenging effect on various free radicals. The 3′, 4′-vicinal dihydroxy structure of the B ring, the conjugation of the C2=C3 double bond with the 4-oxo group in the C ring, the 3-hydroxyl group of the C ring and the intramolecular hydrogen bond in the quercetin structure determine the high antioxidant capacity of quercetin.

[0100] From the analysis results of the four groups of antioxidant capacity in Table 3, it can be seen that the oral liquid prepared by the present invention can significantly improve the scavenging rate of DPPH free radicals, and the difference in effect between the gardenia glycoside-quercetin suspension, the quercetin aqueous solution, and the gardenia glycoside aqueous solution shows that the quercetin and gardenia glycoside dissolved in the sophora japonica seeds and gardenia after water extraction can not only synergistically promote the dissolution rate between the components, but also promote the formation and growth of quercetin nanocrystals, thereby improving its antioxidant performance and stability.

[0101] 2. Animal experiments

[0102] Experimental groups: 50 male Kunming mice were weighed after one day of adaptation and feeding, and randomly divided into a modeling group of 42 mice and a blank group of 8 mice.

[0103] Observation indicators during the experiment: the spirit, fur, activity, diet, drinking water, etc. of the mice, and the body weight was measured before the administration of therapeutic drugs and after the last oral gavage.

[0104] Experimental plan: The mice in the modeling group were given 0.4 mg / mL loperamide suspension by gavage at a dosage of 0.2 mL / 10 g once a day for 4 consecutive days to establish a constipation model in mice; the mice in the blank group were given 0.2 mL / 10 g normal saline by gavage once a day for 4 consecutive days; after the drug administration on the 4th day, the feces within 6 hours were collected and weighed and recorded (wet weight W1), and then the feces were placed in a culture dish and dried at 60 ℃ in a constant temperature drying oven for 12 hours, and weighed and recorded (dry weight W2), and the feces moisture content = [(W1-W2) / W1]×100%.

[0105] Success index: if the feces of the model group mice collected for 6 hours on the 4th day of modeling have a significantly lower water content than that of the blank group mice, and the difference is statistically significant, the modeling is successful. The mice with successful modeling were divided into a model control group, a positive control group, a test group 1-3, and a control group 1-2 by a random number table method, with 6 mice in each group. In order to keep the number of mice in each group consistent, 6 mice were also selected by a random number table method in the blank group. Starting from the 5th day of the experiment, each mouse in the test group 1-3 (respectively given the oral solution in Example 1-3) and the control group 1-2 (respectively given the oral solution in Comparative Example 1-2) was given 10 mL of the Chinese medicine compound oral solution, and the blank control group and the model control group mice were given 10 mL of normal saline, each group was given once a day for 7 consecutive days; each mouse in the positive control group was given 10 mL of the commercially available lactulose oral solution with a concentration of 300 mg / mL, once a day, for 7 days.

[0106] Experimental results: The statistical results are shown in Table 4.

[0107] Table 4: Effects of Examples 1-3 and Comparative Examples 1-2 on defecation in constipation model mice

[0108]

[0109] Figure 6 This is a diagram of the therapeutic effect of the oral liquid prepared in Examples 1-3 of the present invention and Comparative Examples 1-2 on constipated mice. It can be seen from the figure that the oral liquid prepared in Examples 1-3 has a good therapeutic effect on constipation, and the therapeutic effect is better than the efficacy of using only Sophora japonica extract and Gardenia jasmine extract in Comparative Examples 1 and 2.

[0110] From the analysis of the above experimental results, it can be seen that the oral liquid provided by the present invention can significantly promote gastrointestinal motility and increase the water content of feces, and the difference in the effect between the test group and the control group shows that Gardenia and Sophora japonica achieve the effect of moisturizing the intestine and relieving constipation through synergistic effect.

[0111] Finally, it should be noted that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein with equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicinal compound oral liquid for moistening the intestine and relieving constipation, characterized in that: The composition is prepared from the following components by weight: 10-50 parts of gardenia, 10-25 parts of sophora japonica seeds, 0.1-10 parts of seabuckthorn juice, 10-100 parts of sucrose, 10-100 parts of honey, 0.1-1 parts of citric acid, 0.5-5 parts of vanillin, and 0.5-5 parts of potassium sorbate; The preparation method of the Chinese medicine compound oral liquid for moistening the intestine and relieving constipation is carried out in the following steps in sequence: (1) Complex liquid extraction After the gardenia and the sophora japonica seeds are evenly mixed, water is added to the mixture for the first time, and the mixture is boiled at a low heat for 1-2 h in a stainless steel or ceramic extractor. After the extract is filtered out, water is added to the mixture for the second time, and the mixture is boiled at a low heat for 0.5-1 h for a second extraction. The two extracts are mixed for later use; (2) Mixed The extracted composite liquid is mixed with sea buckthorn juice, sucrose, honey, citric acid, vanillin and potassium sorbate, and stirred evenly to obtain an oral liquid raw material liquid; (3) Filling The final Chinese medicine compound oral liquid is obtained by filling the oral liquid raw material liquid in a filling machine.

2. A Chinese medicinal compound oral liquid for moistening the intestine and relieving constipation according to claim 1, characterized in that: The invention is prepared from the following components by weight: 12 parts of gardenia, 24 parts of sophora japonica seeds, 0.2 parts of seabuckthorn juice, 58.8 parts of sucrose, 42.5 parts of honey, 0.2 parts of citric acid, 1.1 parts of vanillin and 3 parts of potassium sorbate.

3. A Chinese medicinal compound oral liquid for moistening the intestine and relieving constipation according to claim 1, characterized in that: In step (1), the mass ratio of the gardenia to the sophora japonica bud is 1:2-2:

1.

4. A Chinese medicinal compound oral liquid for moistening the intestine and relieving constipation according to claim 1, characterized in that: In step (1), the mass ratio of the gardenia to the water added for the first time is 1:

50.

5. The Chinese medicinal compound oral liquid for moistening the intestine and relieving constipation according to claim 1, characterized in that: In step (1), the volume ratio of water added for the first time to water added for the second time is 1:

1.

6. A Chinese medicinal compound oral liquid for moistening the intestine and relieving constipation according to claim 1, characterized in that: In step (2), the stirring rate is 1000-5000 rpm and the time is 5-30 min.

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