Nauclea officinalis extract syrup and production process thereof

Abstract

The invention discloses nauclea officinalis extract syrup and a production process thereof, and belongs to the technical field of traditional Chinese medicine extracts.The process comprises the steps that nauclea officinalis stems and branches are smashed, extracted and concentrated to obtain nauclea officinalis extract, then the nauclea officinalis extract is mixed with a sweetening agent and a modification additive, and filtering and sterilizing are conducted to obtain the nauclea officinalis extract syrup. Compared with the prior art, the nauclea officinalis extract syrup disclosed by the invention is mainly used for clearing away heat and toxic materials and relieving swelling and pain, is suitable for treating diseases such as acute tonsillitis, acute pharyngitis, acute conjunctivitis and upper respiratory infection, has good biological safety, has a remarkable treatment effect on pharyngitis, and is free of toxic and side effects. In addition, excellent stability is shown under the conditions of high temperature, high humidity and illumination, and wide application prospects are achieved.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine extracts, in particular to a gallwood extract syrup and a production process thereof. Background Art

[0002] In the field of Chinese medicine extract technology, Gallwood, as a traditional Chinese medicine, has been widely used to treat a variety of diseases. Gallwood contains a variety of bioactive ingredients, such as alkaloids, flavonoids, etc., which have the effects of clearing away heat and detoxification, reducing swelling and relieving pain. In particular, it shows significant potential in promoting wound healing and treating trauma, burns or ulcerative wounds.

[0003] Nevertheless, the storage performance and efficacy of the gallwood extract in the prior art still have room for improvement. The gallwood extract is easily affected by the environment during storage, resulting in degradation of the active ingredients and affecting the efficacy. In addition, the preparation method of the traditional gallwood extract may not be able to fully extract the active ingredients in the gallwood, limiting its application in the medical field. Therefore, developing a new gallwood extract and its production process to improve the stability and bioavailability of the extract is of great significance for enhancing the medicinal value of gallwood.

[0004] Chinese invention patent CN108743696A discloses a gallwood extract that promotes wound healing. The gallwood stem is taken, cut into sections, crushed, and a certain amount of water is added to soak and extract, the extract is collected, and the extract is concentrated under reduced pressure to obtain a gallwood extract. The extract is extracted to obtain a dichloromethane part and an ethyl acetate part, and different ratios of dichloromethane-ethyl acetate and dichloromethane-methanol are used as eluents, respectively, and the monomer components are separated by repeated silica gel columns. The invention deeply studies the in vitro proliferation activity of the alkaloid components of gallwood. Experimental studies have shown that the gallwood alkaloids obtained by the invention, including abnormal spring flower glycoside lactam and short snake root glycoside, can significantly promote the proliferation of HUVEC cells, and can be widely used in the preparation of drugs for wound, burn or ulcerative wound healing. However, the storage performance and efficacy of the gallwood extract prepared by the invention need to be improved. Summary of the invention

[0005] The present invention aims to solve the deficiencies of the prior art and provides a gallwood extract syrup and a production process thereof, which optimizes the stability and therapeutic effect of the gallwood extract by precisely controlling the crushing, extraction and concentration processes of the gallwood stems and branches, as well as the preparation and addition of modified additives.

[0006] In order to achieve the above-mentioned object of the invention, the present invention adopts the following technical solutions:

[0007] A production process of gallwood extract syrup is as follows:

[0008] Step 1, cutting the stems and branches of the gallwood tree into segments, crushing the cut stems and branches of the gallwood tree, passing through a 20-60 mesh sieve, adding the crushed gallwood tree into water, extracting at 90-100° C., repeating 2-5 times, each time for 3-8 hours, combining the extracted liquids, and concentrating the combined extracts under reduced pressure to obtain a gallwood extract;

[0009] Step 2: Mix the gallwood extract with the sweetener and the modification aid, filter, and sterilize to obtain the gallwood extract syrup.

[0010] The sieving in step 1 is through a 20-60 mesh sieve.

[0011] The gallwood crushed in step 1 is added into water with a volume of 4 to 8 times the mass of the gallwood.

[0012] The reduced pressure concentration in step 1 is completed when the relative density of the extract obtained after concentration is 1.10-1.20 at a temperature of 50-70° C.

[0013] The mass ratio of the gallwood extract, the sweetener and the modification auxiliary agent is 95-97:1-3:1-3.

[0014] The sweetener is at least one of fructose, maltose, white sugar, xylitol and erythritol.

[0015] The sterilization in step 2 is performed at 110 to 140° C. for 10 to 30 seconds.

[0016] The preparation method of the modification aid is as follows, in parts by weight:

[0017] S1, adding stevioside, tartaric acid and sodium hypophosphite to water, mixing evenly; drying, treating the obtained mixture at high temperature; then adding to water, precipitating with anhydrous ethanol, washing the product, and drying to obtain a pretreated product;

[0018] S2. Add the pretreated product prepared in step S1 and stearic acid to anhydrous ethanol, stir, add 3-aminopropylbis(trimethylsilyloxy)methylsilane and water, stir, adjust the pH with a pH adjuster, stir, dry, wash, and dry again to obtain a modified auxiliary agent.

[0019] Preferably, the preparation method of the modification aid is as follows, in parts by weight:

[0020] S1. Add 0.5-2 parts of stevioside, 0.5-0.7 parts of tartaric acid and 0.5-2 parts of sodium hypophosphite to 12-18 parts of water and mix well; dry in an oven at 90-110° C. for 2-4 hours, treat the obtained mixture at 120-150° C. for 10-30 minutes; then add to 8-12 parts of water, precipitate with anhydrous ethanol, wash the product with anhydrous ethanol for 1-3 times and dry to obtain a pretreated product;

[0021] S2. Add 0.2-0.4 parts of the pretreated material prepared in step S1 and 0.4-0.6 parts of stearic acid to 5-7 parts of anhydrous ethanol, stir at 80-95°C for 0.5-2 hours, add 0.02-0.06 parts of 3-aminopropylbis(trimethylsiloxy)methylsilane and 0.5-2 parts of water, stir at room temperature for 10-30 minutes, adjust the pH to 7-8.5 with a pH adjuster, stir at 40-60°C for 10-30 minutes, place at 80-120°C for 0.5-2 hours, wash with water and anhydrous ethanol for 1-3 times respectively, and then dry to obtain a modified auxiliary agent.

[0022] The pH regulator is a 4-6 wt % sodium bicarbonate aqueous solution.

[0023] The functions of the various substances described in the present invention are as follows:

[0024] The stems and branches of the Gallwood tree are the main raw materials for preparing the Gallwood tree extract syrup, which contains biologically active ingredients and is used to extract effective ingredients.

[0025] Water is used as an extraction medium in the extraction process of the stems and branches of the gallwood to help release the active ingredients in the gallwood.

[0026] Sweeteners (such as fructose, maltose, white sugar, xylitol, erythritol) are used to adjust the taste of the gallwood extract syrup, increase the sweetness of the product, and improve the patient's acceptance when taking it.

[0027] The modification auxiliary agent in the present invention mainly functions to improve the stability of the gallwood extract syrup, improve its physical and chemical properties, and enhance its biological activity and therapeutic effect. Through the synergistic effect of specific organic acids and silane coupling agents, the modification auxiliary agent helps to protect the active ingredients in the syrup, reduce its degradation during storage and use, and improve the taste and nutritional value of the syrup, thereby improving the efficacy and quality of the gallwood extract syrup as a whole.

[0028] The main function of stevioside is as one of the key ingredients of modified additives. It can enhance the taste of gallwood extract syrup and improve the patient's medication experience. In addition, stevioside may also interact with other ingredients to promote the formation of modified additives, thereby further improving the biological activity and efficacy of the syrup, ensuring the superiority of the final product in terms of therapeutic effect and safety.

[0029] As a part of the modification auxiliary, tartaric acid may form a complex with steviol glycosides to improve their thermal stability and chemical stability, while masking the aftertaste of steviosides, improving the taste and enhancing its biological activity, thereby providing better sweetness characteristics and application performance in food and beverages.

[0030] Sodium hypophosphite mainly plays the role of a reducing agent in the preparation of the modification aid. It can promote the formation of active ingredients in the modification aid. At the same time, during the heat treatment process, sodium hypophosphite may participate in complex chemical changes, which helps to improve the stability and solubility of stevioside and enhance its application performance in the final product.

[0031] As a component of the modification aid, stearic acid mainly provides stability and emulsification properties, enhances the dispersibility of the pretreated material, and improves the physicochemical stability and bioavailability of the final product, thus playing a key role in the preparation of gallwood extract syrup.

[0032] As a silane coupling agent, 3-aminopropylbis(trimethylsiloxy)methylsilane mainly provides good interaction and bonding performance between the modification agent and other components in the gallwood extract syrup. It can enhance the stability and dispersibility of the modification agent and improve the physical and chemical properties of the syrup, such as improving its antifreeze and heat resistance, and enhancing its stability during storage and use, thereby improving the overall performance and effect of the gallwood extract syrup.

[0033] Sodium bicarbonate aqueous solution was used to adjust the pH value of the modification aid to optimize its performance and the stability of the gallwood extract syrup.

[0034] Anhydrous ethanol is used in the precipitation and washing steps during the preparation of the modification aid to remove impurities and dry the product.

[0035] The combination and interaction of these substances make the gallwood extract syrup have the therapeutic effect of improving pharyngitis symptoms, while improving the stability and safety of the product.

[0036] Compared with the prior art, it has the following beneficial effects:

[0037] 1) The present invention optimizes the stability and therapeutic effect of the gallwood extract syrup by precisely controlling the crushing, extraction and concentration process of the gallwood stems and branches, as well as the preparation and addition of the modified auxiliary agent. In particular, the biological activity and safety of the syrup are enhanced by using specific organic acids and silane coupling agents, as well as precise pH control and sterilization treatment.

[0038] 2) The production process of the present invention improves the storage performance of the Gallwood extract, making it more stable during storage, reducing the degradation of the active ingredients, and extending the shelf life of the product, which is of great significance for the long-term preservation and application of Chinese medicine extracts.

[0039] 3) The gallwood extract syrup of the present invention shows good therapeutic effects in the treatment of pharyngitis and the like, which is due to the synergistic effect of the modified auxiliary agent, which improves the bioavailability and efficacy of the drug and reduces side effects, making the product of the present invention more advantageous in clinical applications. DETAILED DESCRIPTION

[0040] Main sources of substances:

[0041] The stems and branches of the Gallwood tree are produced in Qiongzhong Li and Miao Autonomous County, Hainan Province.

[0042] White sugar, particle size: 100 mesh, item number: 01, product grade: food grade, Shandong Guangcai Biotechnology Co., Ltd.

[0043] Stevioside, particle size: 100 mesh, product grade: food grade, Henan Yiduoyuan Biotechnology Co., Ltd.

[0044] β-Cyclodextrin, particle size: 100 mesh, product grade: food grade, Henan Yiduoyuan Biotechnology Co., Ltd.

[0045] The remaining raw materials in the examples and comparative examples of the present invention are all commercially available products.

[0046] The design idea of ​​the present invention is to provide a gallwood extract syrup and a production process thereof, aiming to improve the storage performance and efficacy of the gallwood extract. The stability and therapeutic effect of the syrup are optimized by precisely controlling the crushing, extraction, and concentration process of the gallwood stems and branches, as well as the preparation and addition of modified additives. The preparation of the modified additive of the process is carried out by using specific organic acids, silane coupling agents, and precise pH control and sterilization treatment to enhance the biological activity and safety of the syrup, thereby improving its efficacy in treating pharyngitis and the like.

[0047] Example 1

[0048] A production process of gallwood extract syrup is as follows:

[0049] Step 1, cutting the stems and branches of the gallwood into segments, crushing the cut gallwood stems and branches, passing through a 40-mesh sieve, adding the crushed gallwood to water 6 times the mass of the gallwood, extracting at 95°C, repeating 3 times, each time for 5 hours, combining the three extractions, and concentrating the combined extract under reduced pressure, and completing the concentration when the relative density of the extract obtained after concentration is 1.15 at a temperature of 60°C to obtain gallwood extract;

[0050] Step 2: Mix the gallwood extract with white sugar and a modification aid in a mass ratio of 96:2:2; filter; and sterilize at 120° C. for 20 seconds to obtain a gallwood extract syrup.

[0051] The preparation method of the modified auxiliary agent is as follows:

[0052] S1. Add 1 kg of stevioside, 0.6 kg of tartaric acid and 1 kg of sodium hypophosphite to 15 kg of water and mix well; dry in an oven at 100° C. for 3 hours, and treat the obtained mixture at 140° C. for 20 minutes; then add to 10 kg of water, precipitate with anhydrous ethanol, wash the product with anhydrous ethanol for 3 times, and dry to obtain a pretreated product;

[0053] S2. Add 0.3 kg of the pretreated material prepared in step S1 and 0.5 kg of stearic acid to 6 kg of anhydrous ethanol, stir at 90 ° C for 1 hour, add 0.04 kg of 3-aminopropylbis(trimethylsilyloxy)methylsilane and 1 kg of water, stir at room temperature for 20 minutes, adjust the pH to 8 with a pH adjuster, the pH adjuster is 5 wt% sodium bicarbonate aqueous solution, stir at 50 ° C for 20 minutes, place at 100 ° C for 1 hour, wash with water and anhydrous ethanol for 3 times respectively, and then dry to obtain a modified auxiliary agent.

[0054] Example 2

[0055] The production process of a gallwood extract syrup is basically the same as that of Example 1, the only difference being that the preparation method of the modification auxiliary agent is different.

[0056] The preparation method of the modified auxiliary agent is as follows:

[0057] S1. Add 1 kg of stevioside, 0.6 kg of fumaric acid and 1 kg of sodium hypophosphite to 15 kg of water and mix well; dry in an oven at 100° C. for 3 hours, and treat the obtained mixture at 140° C. for 20 minutes; then add to 10 kg of water, precipitate with anhydrous ethanol, wash the product with anhydrous ethanol for 3 times, and dry to obtain a pretreated product;

[0058] S2. Add 0.3 kg of the pretreated material prepared in step S1 and 0.5 kg of stearic acid to 6 kg of anhydrous ethanol, stir at 90 ° C for 1 hour, add 0.04 kg of 3-aminopropylbis(trimethylsilyloxy)methylsilane and 1 kg of water, stir at room temperature for 20 minutes, adjust the pH to 8 with a pH adjuster, the pH adjuster is 5 wt% sodium bicarbonate aqueous solution, stir at 50 ° C for 20 minutes, place at 100 ° C for 1 hour, wash with water and anhydrous ethanol for 3 times respectively, and then dry to obtain a modified auxiliary agent.

[0059] Example 3

[0060] The production process of a gallwood extract syrup is basically the same as that of Example 1, the only difference being that the preparation method of the modification auxiliary agent is different.

[0061] The preparation method of the modified auxiliary agent is as follows:

[0062] S1. Add 1 kg of stevioside, 0.6 kg of citric acid and 1 kg of sodium hypophosphite to 15 kg of water and mix well; dry in an oven at 100° C. for 3 hours, and treat the obtained mixture at 140° C. for 20 minutes; then add to 10 kg of water, precipitate with anhydrous ethanol, wash the product with anhydrous ethanol for 3 times, and dry to obtain a pretreated product;

[0063] S2. Add 0.3 kg of the pretreated material prepared in step S1 and 0.5 kg of stearic acid to 6 kg of anhydrous ethanol, stir at 90 ° C for 1 hour, add 0.04 kg of 3-aminopropylbis(trimethylsilyloxy)methylsilane and 1 kg of water, stir at room temperature for 20 minutes, adjust the pH to 8 with a pH adjuster, the pH adjuster is 5 wt% sodium bicarbonate aqueous solution, stir at 50 ° C for 20 minutes, place at 100 ° C for 1 hour, wash with water and anhydrous ethanol for 3 times respectively, and then dry to obtain a modified auxiliary agent.

[0064] Example 4

[0065] The production process of a gallwood extract syrup is basically the same as that of Example 1, the only difference being that the preparation method of the modification auxiliary agent is different.

[0066] The preparation method of the modified auxiliary agent is as follows:

[0067] S1. Add 1 kg of stevioside, 0.6 kg of tartaric acid and 1 kg of sodium hypophosphite to 15 kg of water and mix well; dry in an oven at 100° C. for 3 hours, and treat the obtained mixture at 140° C. for 20 minutes; then add to 10 kg of water, precipitate with anhydrous ethanol, wash the product with anhydrous ethanol for 3 times, and dry to obtain a pretreated product;

[0068] S2. Add 0.3 kg of the pretreated material prepared in step S1 and 0.5 kg of stearic acid to 6 kg of anhydrous ethanol, stir at 90 ° C for 1 hour, add 0.04 kg of N-(2-aminoethyl)-3-aminopropyltrimethoxysilane and 1 kg of water, stir at room temperature for 20 minutes, adjust the pH to 8 with a pH adjuster, the pH adjuster is 5 wt% sodium bicarbonate aqueous solution, stir at 50 ° C for 20 minutes, place at 100 ° C for 1 hour, wash with water and anhydrous ethanol for 3 times respectively, and then dry to obtain a modified auxiliary agent.

[0069] Example 5

[0070] The production process of a gallwood extract syrup is basically the same as that of Example 1, the only difference being that the preparation method of the modification auxiliary agent is different.

[0071] The preparation method of the modified auxiliary agent is as follows:

[0072] S1. Add 1 kg of stevioside, 0.6 kg of tartaric acid and 1 kg of sodium hypophosphite to 15 kg of water and mix well; dry in an oven at 100° C. for 3 hours, and treat the obtained mixture at 140° C. for 20 minutes; then add to 10 kg of water, precipitate with anhydrous ethanol, wash the product with anhydrous ethanol for 3 times, and dry to obtain a pretreated product;

[0073] S2. Add 0.3 kg of the pretreated material prepared in step S1 and 0.5 kg of stearic acid to 6 kg of anhydrous ethanol, stir at 90 ° C for 1 hour, add 0.04 kg of 3-aminopropyl pentamethyldisiloxane and 1 kg of water, stir at room temperature for 20 minutes, adjust the pH to 8 with a pH adjuster, the pH adjuster is 5 wt% sodium bicarbonate aqueous solution, stir at 50 ° C for 20 minutes, place at 100 ° C for 1 hour, wash with water and anhydrous ethanol for 3 times respectively, and then dry to obtain a modified auxiliary agent.

[0074] Comparative Example 1

[0075] The production process of a gallwood extract syrup is basically the same as that of Example 1, the only difference being that the preparation method of the modification auxiliary agent is different.

[0076] The preparation method of the modified auxiliary agent is as follows:

[0077] S1. Add 1 kg of stevioside, 0.6 kg of succinic acid and 1 kg of sodium hypophosphite to 15 kg of water and mix well; dry in an oven at 100° C. for 3 hours, and treat the obtained mixture at 140° C. for 20 minutes; then add to 10 kg of water, precipitate with anhydrous ethanol, wash the product with anhydrous ethanol for 3 times, and dry to obtain a pretreated product;

[0078] S2. Add 0.3 kg of the pretreated material prepared in step S1 and 0.5 kg of stearic acid to 6 kg of anhydrous ethanol, stir at 90 ° C for 1 hour, add 0.04 kg of 3-aminopropylbis(trimethylsilyloxy)methylsilane and 1 kg of water, stir at room temperature for 20 minutes, adjust the pH to 8 with a pH adjuster, the pH adjuster is 5 wt% sodium bicarbonate aqueous solution, stir at 50 ° C for 20 minutes, place at 100 ° C for 1 hour, wash with water and anhydrous ethanol for 3 times respectively, and then dry to obtain a modified auxiliary agent.

[0079] Comparative Example 2

[0080] The production process of a gallwood extract syrup is basically the same as that of Example 1, the only difference being that the preparation method of the modification auxiliary agent is different.

[0081] The preparation method of the modified auxiliary agent is as follows:

[0082] S1. Add 1 kg of stevioside, 0.6 kg of tartaric acid and 1 kg of sodium hypophosphite to 15 kg of water and mix well; dry in an oven at 100° C. for 3 hours, and treat the obtained mixture at 140° C. for 20 minutes; then add to 10 kg of water, precipitate with anhydrous ethanol, wash the product with anhydrous ethanol for 3 times, and dry to obtain a pretreated product;

[0083] S2. Add 0.3 kg of the pretreated material prepared in step S1 and 0.5 kg of stearic acid to 6 kg of anhydrous ethanol, stir at 90 ° C for 1 hour, add 0.04 kg of 3-aminopropyldimethoxymethylsilane and 1 kg of water, stir at room temperature for 20 minutes, adjust the pH to 8 with a pH adjuster, the pH adjuster is 5 wt% sodium bicarbonate aqueous solution, stir at 50 ° C for 20 minutes, place at 100 ° C for 1 hour, wash with water and anhydrous ethanol respectively 3 times, and then dry to obtain a modified auxiliary agent.

[0084] Comparative Example 3

[0085] The production process of a gallwood extract syrup is basically the same as that of Example 1, the only difference being that the preparation method of the modification auxiliary agent is different.

[0086] The preparation method of the modified auxiliary agent is as follows:

[0087] S1. Add 1 kg of β-cyclodextrin, 0.6 kg of tartaric acid and 1 kg of sodium hypophosphite to 15 kg of water and mix well; dry in an oven at 100° C. for 3 hours, and treat the obtained mixture at 140° C. for 20 minutes; then add to 10 kg of water, precipitate with anhydrous ethanol, wash the product with anhydrous ethanol for 3 times, and dry to obtain a pretreated product;

[0088] S2. Add 0.3 kg of the pretreated material prepared in step S1 and 0.5 kg of stearic acid to 6 kg of anhydrous ethanol, stir at 90 ° C for 1 hour, add 0.04 kg of 3-aminopropylbis(trimethylsilyloxy)methylsilane and 1 kg of water, stir at room temperature for 20 minutes, adjust the pH to 8 with a pH adjuster, the pH adjuster is 5 wt% sodium bicarbonate aqueous solution, stir at 50 ° C for 20 minutes, place at 100 ° C for 1 hour, wash with water and anhydrous ethanol for 3 times respectively, and then dry to obtain a modified auxiliary agent.

[0089] Comparative Example 4

[0090] A production process of gallwood extract syrup is as follows:

[0091] Step 1, cutting the stems and branches of the gallwood into segments, crushing the cut gallwood stems and branches, passing through a 40-mesh sieve, adding the crushed gallwood to water 6 times the mass of the gallwood, extracting at 95°C, repeating 3 times, each time for 5 hours, combining the three extractions, and concentrating the combined extract under reduced pressure, and completing the concentration when the relative density of the extract obtained after concentration is 1.15 at a temperature of 60°C to obtain gallwood extract;

[0092] Step 2: Mix the gallwood extract with white sugar and stevioside in a mass ratio of 96:2:2, filter, and sterilize at 120° C. for 20 seconds to obtain the gallwood extract syrup.

[0093] Test Example 1

[0094] Stability test

[0095] The gallwood extract syrup prepared in the examples of the present invention and the comparative examples was placed in a suitable clean container and placed under high temperature (80°C), high humidity (25°C, relative humidity 92.5%), light (light intensity 5000±500lx and 90μw / cm 2 ) conditions, placed for 5 days, sampled on the 5th day, and tested according to the stability inspection items. The test results are shown in Table 1.

[0096] Table 1

[0097]

[0098]

[0099] Test Example 2

[0100] Safety Test

[0101] 90 SD rats of SPF level were taken, 10 rats in each group, half male and half female, 8 to 10 weeks old. Standardized process feeding was adopted, the breeding laboratory was clean, the bedding was changed every day, free diet, light / dark cycle was 12h, the temperature was maintained at 25°C, and the relative humidity was 60%. The original drug dose of rats was 0.5g / kg / d, and the gallwood extract syrup prepared by the embodiment of the present invention and the comparative example was used to gavage SD rats, once a day, for 21 days, during the medication period and 3 days after the end of the medication, the adverse changes and deaths of the SD rats such as weight, food intake, movement, and spirit were continuously observed, and then the blood routine was tested by removing the eyeballs to take blood, and the supernatant obtained after whole blood centrifugation was tested for liver function and renal function biochemical indicators by a fully automatic biochemical analyzer.

[0102] The safety test results show that during and after the medication, the weight, eating, and exercise of SD rats were good, and no abnormalities were found. Moreover, the whole blood and liver and kidney biochemical index tests all showed that the gallwood extract syrup of the present invention did not produce obvious toxic and side effects on the animals, and no abnormal reactions such as allergies occurred. This shows that the Chinese medicine mixture of the present invention has good biological safety.

[0103] Test Example 3

[0104] Testing the therapeutic effect on pharyngitis

[0105] Experimental subjects: 180 patients, with the main symptoms being discomfort, itching, pain, or dryness in the throat. Examination of the throat revealed dark red congestion in the throat, obvious pain when touched, and hyperplasia of follicles on the posterior pharyngeal wall.

[0106] Experimental method: 180 patients were randomly divided into 9 groups, 20 cases in each group, and they were respectively taken with the gallwood extract syrup prepared in the embodiment of the present invention and the comparative example, 10 mL at a time, 3 times a day, and 5 days as a course of treatment.

[0107] Experimental standards: ① Cured: Throat pain disappears, dry mouth and other symptoms disappear; ② Significantly effective: Throat pain basically disappears, dry mouth and other symptoms are significantly improved; ③ Effective: Throat pain is relieved, dry mouth and other symptoms are improved; ④ Ineffective: Throat pain is not relieved, dry mouth and other symptoms are not improved.

[0108] The test results are shown in Table 2.

[0109] Table 2

[0110] Experimental protocol get well Significant effect efficient invalid Total Effectiveness Example 1 5 12 2 1 95％ Example 2 4 11 3 2 90％ Example 3 3 12 2 3 85％ Example 4 2 11 3 4 80％ Example 5 2 12 3 3 85％ Comparative Example 1 1 12 2 5 75％ Comparative Example 2 1 11 2 6 70％ Comparative Example 3 1 11 2 6 70％ Comparative Example 4 0 10 1 9 55％

[0111] It can be seen from the data in Tables 1 and 2 that the Gallwood extract syrup prepared in Example 1 has the best stability and therapeutic effect on pharyngitis, and has good biosafety.

[0112] The metatartaric acid used in Example 1 shows better stability and therapeutic effect when preparing gallwood extract syrup than the fumaric acid of Example 2, the citric acid of Example 3 and the succinic acid of Comparative Example 1, which may be related to the unique chemical properties and biological activity of metatartaric acid. As an organic acid, metatartaric acid has the properties of regulating pH, anti-oxidation and antibacterial, which help to improve the stability of the syrup, prevent microbial contamination, and extend the shelf life. At the same time, the antioxidant properties of metatartaric acid may also help to protect the active ingredients in the syrup from oxidation, thereby maintaining its biological activity and therapeutic effect. Therefore, metatartaric acid plays a key role in the preparation of the modified auxiliary agent, improving the stability and therapeutic effect of the gallwood extract syrup.

[0113] The 3-aminopropylbis(trimethylsiloxy)methylsilane used in Example 1 performs better in stability and pharyngitis treatment effect than the different silane coupling agents used in other embodiments and comparative examples, which may be related to its unique molecular structure and reaction characteristics. 3-aminopropylbis(trimethylsiloxy)methylsilane has two trimethylsiloxy groups and one aminopropyl group, and this structure enables it to form a stable silicon-oxygen bond on the material surface, enhances the interaction between the modified auxiliary agent and other ingredients in the gallwood extract syrup, thereby improving the stability of the product. At the same time, this structure may help to improve the distribution and absorption of the gallwood extract syrup in the body, and enhances its therapeutic effect on pharyngitis. In addition, 3-aminopropylbis(trimethylsiloxy)methylsilane may help to protect the active ingredients in the syrup, reduce its degradation during storage and use, and further improve the stability and therapeutic effect of the product.

[0114] The steviol glycoside used in Example 1 is better than the β-cyclodextrin in Comparative Example 3 in the stability of gallwood extract syrup and the therapeutic effect of pharyngitis, which may be related to the unique structure and properties of steviol glycoside. As a naturally occurring polysaccharide, steviol glycoside has good solubility and stability, and can enhance the stability of the syrup. At the same time, steviol glycoside also has certain anti-inflammatory and immunomodulatory effects, which may be one of the reasons why it performs better in the therapeutic effect of pharyngitis. In addition, the addition of steviol glycoside may also help to improve the taste and nutritional value of the syrup, thereby improving the efficacy and quality of gallwood extract syrup as a whole.

Claims

1. A production process of gallwood extract syrup, characterized in that: The process is as follows: Step 1, cutting the stems and branches of the gallwood tree into segments, crushing the cut stems and branches of the gallwood tree, passing through a 20-60 mesh sieve, adding the crushed gallwood tree into water, extracting at 90-100° C., and concentrating the extract under reduced pressure to obtain a gallwood tree extract; Step 2, mixing the gallwood extract with the sweetener and the modification auxiliary agent, filtering, and sterilizing to obtain the gallwood extract syrup; The preparation method of the modification aid is as follows, in parts by weight: S1, adding stevioside, tartaric acid and sodium hypophosphite to water, mixing evenly; drying, treating the obtained mixture at high temperature; then adding to water, precipitating with anhydrous ethanol, washing the product, and drying to obtain a pretreated product; S2. Add the pretreated product prepared in step S1 and stearic acid to anhydrous ethanol, stir, add 3-aminopropylbis(trimethylsilyloxy)methylsilane and water, stir, adjust the pH with a pH adjuster, stir, dry, wash, and dry again to obtain a modified auxiliary agent.

2. The production process of gallwood extract syrup according to claim 1, characterized in that: The sieving in step 1 is through a 20-60 mesh sieve.

3. The production process of the gallwood extract syrup according to claim 1, characterized in that: The gallwood crushed in step 1 is added into water with a volume of 4 to 8 times the mass of the gallwood.

4. The production process of gallwood extract syrup according to claim 1, characterized in that: The reduced pressure concentration in step 1 is completed when the relative density of the extract obtained after concentration is 1.10-1.20 at a temperature of 50-70° C.

5. The production process of gallwood extract syrup according to claim 1, characterized in that: The mass ratio of the gallwood extract, the sweetener and the modification auxiliary agent is 95-97:1-3:1-3.

6. The production process of gallwood extract syrup according to claim 1, characterized in that: The sweetener is at least one of fructose, maltose, white sugar, xylitol and erythritol.

7. The production process of gallwood extract syrup according to claim 1, characterized in that: The sterilization in step 2 is performed at 110 to 140° C. for 10 to 30 seconds.

8. The production process of gallwood extract syrup according to claim 1, characterized in that: The preparation method of the modification aid is as follows, in parts by weight: S1. Add 0.5-2 parts of stevioside, 0.5-0.7 parts of tartaric acid and 0.5-2 parts of sodium hypophosphite to 12-18 parts of water and mix well; dry in an oven at 90-110° C. for 2-4 hours, treat the obtained mixture at 120-150° C. for 10-30 minutes; then add to 8-12 parts of water, precipitate with anhydrous ethanol, wash the product with anhydrous ethanol for 1-3 times and dry to obtain a pretreated product; S2. Add 0.2-0.4 parts of the pretreated material prepared in step S1 and 0.4-0.6 parts of stearic acid to 5-7 parts of anhydrous ethanol, stir at 80-95°C for 0.5-2 hours, add 0.02-0.06 parts of 3-aminopropylbis(trimethylsiloxy)methylsilane and 0.5-2 parts of water, stir at room temperature for 10-30 minutes, adjust the pH to 7-8.5 with a pH adjuster, stir at 40-60°C for 10-30 minutes, place at 80-120°C for drying for 0.5-2 hours, wash with water and anhydrous ethanol for 1-3 times respectively, and then dry to obtain a modified auxiliary agent.

9. The production process of gallwood extract syrup according to claim 1 or 8, characterized in that: The pH regulator is a 4-6 wt % sodium bicarbonate aqueous solution.

10. A gallwood extract syrup, characterized in that: The method is prepared by the production process as described in any one of claims 1 to 9.

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