A composition containing ginseng, oviductus ranae oil, longan aril and medlar and a preparation method and application thereof

Abstract

The present application belongs to the field of traditional Chinese medicine composition and dietary technology, and relates to a composition containing ginseng, forest frog oil, longan aril and medlar and a preparation method and application thereof. The composition comprises the following raw materials in parts by weight: 1-5 parts of ginseng, 0.5-3 parts of forest frog oil, 1-5 parts of longan aril and 1-5 parts of medlar. The present application takes ginseng as the monarch, forest frog oil as the minister, longan aril as the assistant and medlar as the guide, and can be used for preparing health food or special dietary food for improving iron deficiency anemia and / or enhancing immunity. Animal experiments show that the present application can significantly improve the hemoglobin and hematocrit levels of blood loss anemia model rats, and the effect is better than that of single ginseng or single forest frog oil.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition and dietary technology, and relates to a composition containing ginseng, frog oil, longan pulp and wolfberry, its preparation method and application. Background Technology

[0002] Northeast my country is an important production area for authentic medicinal herbs, with ginseng and other varieties listed in the National Catalogue of Substances that are Traditionally Both Food and Medicinal Herbs, possessing both medicinal value and food safety. The theory of food and medicine sharing the same origin provides a rich material basis for disease prevention, chronic disease management, and constitution conditioning. In recent years, numerous health food products have been developed using ginseng and other medicinal herbs. However, most products simply use a single herb or its crude extract, failing to fully reflect the synergistic effects of traditional Chinese medicine's "mutual reinforcement and mutual assistance" principle. This results in vague product efficacy positioning, unclear material basis, and limited market competitiveness.

[0003] Forest frog oil is a novel food ingredient unique to Northeast China. It is rich in protein, sialic acid, amino acids, and various bioactive substances. Traditionally, it is used to tonify the kidneys and replenish essence, nourish yin and moisten dryness, possessing unique value in nourishing and strengthening the body. Currently, there are reports on technologies for developing health foods using forest frog oil.

[0004] For postpartum, post-operative recovery, nutritional anemia, and elderly individuals with weak constitutions, most existing health supplements focus on supplementing single nutrients, lacking formulation designs based on the holistic conditioning principles of Traditional Chinese Medicine. While some products containing ginseng and frog oil exist, they are often based on empirical combinations, lacking scientific compatibility data derived from actual clinical use. This results in issues such as arbitrary dosage, poor quality control, and unstable content of active ingredients, failing to meet consumers' demands for safe, effective, and quantifiable high-quality health products.

[0005] Therefore, it is necessary to develop a scientifically formulated, effective, quality-controllable, and easily industrialized composition containing ginseng, frog oil, longan pulp, and wolfberry, to provide a replicable technical solution for the high-value utilization of authentic medicinal materials from Northeast China. Summary of the Invention

[0006] To address the shortcomings of existing technologies that utilize ginseng, frog oil, and other medicinal materials, such as those using single herbs or their crude extracts, neglecting the synergistic effects of traditional Chinese medicine formulations, having unclear active ingredients, and exhibiting poor quality control, this invention provides a composition containing ginseng, frog oil, longan pulp, and wolfberry, derived from a clinically frequent and advantageous combination, with scientific formulation, clear efficacy, controllable quality, and easy industrialization, along with its preparation method and applications. This composition has a significant regulating effect of simultaneously replenishing qi, blood, and essence, targeting fatigue, anemia, and decreased immunity caused by qi and blood deficiency and insufficient essence and blood.

[0007] To achieve the above objectives, the present invention adopts the following technical solution.

[0008] A composition containing ginseng, frog oil, longan pulp and wolfberry, comprising the following raw materials in parts by weight: 1-5 parts ginseng, 0.5-3 parts frog oil, 1-5 parts longan pulp and 1-5 parts wolfberry.

[0009] The preferred ingredients are 1.5 parts ginseng, 1 part frog oil, 2 parts longan pulp, and 2 parts goji berries.

[0010] Furthermore, the ginseng must be sun-dried ginseng or red ginseng cultivated for five years or less, with a total ginsenoside Rg1+Re content of not less than 0.30%; the forest frog oil must be the dried oviduct of female forest frogs, with a protein content of not less than 40% and an expansion rate of not less than 80mL / g; longan pulp and wolfberry should comply with the relevant provisions of the Chinese Pharmacopoeia.

[0011] A method for preparing an oral liquid containing a composition of ginseng, frog oil, longan pulp, and wolfberry includes the following steps: Step 1, Preparation of plant extract: Ginseng slices, longan pulp crushed, and wolfberry impurities removed are mixed together to obtain a mixture. Purified water is added, heated and extracted, and then filtered. The residue is extracted again with water. The filtrates are combined, cooled to below 40°C, and finely filtered to obtain the plant extract. Step 2, Pretreatment of frog oil: Frog oil is placed in purified water and expanded at low temperature. The colloid mill is used to homogenize the mixture until it is fine, so as to obtain frog oil homogenate. Step 3, Preparation: Add the frog oil homogenate to the plant extract and mix well. Add honey to taste, adjust the pH, add purified water to the total volume (1000mL), and mix well to obtain the liquid. Step 4: Homogenize and sterilize the liquid to obtain an oral liquid.

[0012] Furthermore, in step 1, the mass of purified water is 8-12 times the mass of the mixture, the heating temperature is 90-100℃, and the extraction time is 1-2 hours each time.

[0013] Furthermore, in step 1, a 200-mesh stainless steel filter screen is used for filtration; a plate and frame filter is used for fine filtration, with a filter membrane pore size of 0.45μm.

[0014] Furthermore, in step 2, the low temperature is 4°C and the puffing time is 12-16 hours.

[0015] Furthermore, in step 2, the frog oil expands to 15-20 times its original volume.

[0016] Furthermore, in step 2, the temperature of the slurry is controlled below 40°C during the homogenization process.

[0017] Furthermore, in step 3, the pH is adjusted to 6.0-7.0 using either a 10% citric acid solution (food grade) or a 10% sodium bicarbonate solution (food grade).

[0018] Further, step 4 specifically involves heating the liquid to 50-60℃, homogenizing it under high pressure at 20-30MPa for 1-3 times, filling it, and then sterilizing it at 115℃ for 15 minutes or 121℃ for 8 minutes to obtain the finished oral liquid product.

[0019] The content of the marker components in the finished product is as follows: ginsenoside Rg1+Re is not less than 1.3 mg per vial, protein is not less than 0.9 g per vial, and each vial contains 20 mL.

[0020] The present invention also provides the use of the composition in the preparation of health foods or special dietary foods that improve iron deficiency anemia and / or help enhance immunity.

[0021] Compared with the prior art, the beneficial effects of the present invention are as follows.

[0022] First, the prescriptions were selected based on real-world clinical data, and their functional positioning is clear and reliable. The core compatibility of the composition in this invention is not based solely on theoretical speculation or empirical patchwork, but rather on a systematic analysis of 12,836 real prescriptions from eight provincial-level tertiary hospitals in Northeast China over six consecutive years. Using the Apriori association rule algorithm, with support, confidence, and lift as quantitative indicators, core compatibility structures exhibiting strong correlation and high-frequency co-occurrence characteristics in actual clinical use for Qi and Blood Deficiency syndrome were objectively screened. Specifically, the ginseng-longan pulp-goji berry combination showed a stable co-occurrence relationship in prescriptions related to Qi and Blood Deficiency syndromes, and the combination of ginseng and frog oil also demonstrated a clear synergistic application basis in tonifying and conditioning prescriptions. This prescription selection path, validated through clinical practice, allows for more precise product functional positioning and significantly reduces blind development and post-market risks.

[0023] Second, based on the "principal, assistant, adjuvant, and guide" combination, it achieves synergistic effects, and its comprehensive conditioning effect is superior to that of a single prescription. In existing technologies, the development of health foods using ginseng or frog oil often employs single medicinal herbs or their crude extracts, neglecting the synergistic effect of "mutual reinforcement and mutual assistance" in traditional Chinese medicine formulations. While ginseng alone has a strong effect in replenishing qi, it is also warm and drying in nature, making it difficult to address symptoms of deficiency of essence and blood when used alone. Similarly, while frog oil alone excels at replenishing essence and moisturizing dryness, it is insufficient in replenishing qi and generating blood. This invention uses ginseng as the principal ingredient to greatly replenish vital energy and provide the driving force for blood production; frog oil as the assistant ingredient to replenish essence and benefit the kidneys, nourish yin and moisten dryness, and is rich in protein, sialic acid and various bioactive substances. Combined with the principal ingredient, it replenishes qi, blood and essence simultaneously; longan pulp as an adjuvant ingredient to benefit the heart and spleen, nourish blood and calm the mind, enhancing the overall blood-replenishing effect of the formula; and wolfberry as a guide ingredient to nourish the liver and kidneys, benefit essence and improve eyesight, directing the medicine to the liver and kidney meridians. These four ingredients work synergistically to provide multi-level overall conditioning for fatigue, anemia, and decreased immunity caused by deficiency of qi and blood and insufficient essence and blood. This synergistic effect is not a simple addition of the effects of each ingredient, but rather a multi-target comprehensive intervention achieved through the organic combination of their properties and meridian tropism. Experiments have shown that the composition of this invention improves hemoglobin levels in rats with hemorrhagic anemia. The hemoglobin level in the medium-dose group increased by 18.6%, which is significantly better than that of the single-ingredient ginseng group (8.5%) and the single-ingredient frog oil group (6.2%), demonstrating the unexpected technical effect of synergistic effect of the combination.

[0024] Third, by standardizing and controlling marker components, a stable transition from "clinical efficacy" to "product dose-response" can be achieved. This invention directly links product efficacy to the content of key components such as ginsenoside Rg1+Re and protein. By optimizing key process parameters such as extraction temperature, time, solid-liquid ratio, homogenization pressure, and sterilization conditions, it ensures consistent quality and repeatable efficacy for each batch of product. Each vial of the finished product contains no less than 1.3 mg of ginsenoside Rg1+Re and no less than 0.9 g of protein. This design addresses the industry pain points of unstable efficacy and uncontrollable quality caused by the use of crude extracts in traditional health foods.

[0025] Fourth, it has a solid security foundation and is suitable for long-term application. The ginseng, longan pulp, and wolfberry in this invention's formulation are all nationally recognized medicinal and edible varieties, and the forest frog oil is an approved new food ingredient. All have a long history of consumption and are supported by sufficient clinical safety data. During animal experiments, there were no significant differences in food intake and weight gain between the treatment groups and the blank control group, and no animal deaths or obvious toxic reactions were observed. Detailed Implementation

[0026] The present invention will be further described in detail below with reference to specific embodiments. It should be understood that the following embodiments are only for illustrating the present invention and are not intended to limit the scope of the present invention. All equivalent substitutions or improvements made based on the technical concept of the present invention should be included within the protection scope of the present invention.

[0027] Ginseng: It should meet the requirements of the "Ginseng" entry in Part I of the 2020 edition of the Chinese Pharmacopoeia. The moisture content should not exceed 12.0%, and the total ash content should not exceed 5.0%; the total amount of ginsenosides Rg1 and Re should not be less than 0.30%, and the total amount of ginsenoside Rb1 should not be less than 0.20%; select 5-year-old sun-dried ginseng artificially cultivated in Fusong, Jilin Province, and cut it into 2-3 mm thin slices for later use.

[0028] Longan pulp: It should meet the requirements of the "Longan Pulp" item in Part I of the 2020 edition of the Chinese Pharmacopoeia. The moisture content should not exceed 15.0%, the total ash content should not exceed 4.0%, and the water-soluble extract should not be less than 60.0%. Longan pulp produced in Guangxi should be selected, and the pits and impurities should be removed. It should be crushed into 0.5-1 cm pieces for later use.

[0029] Goji berries: should comply with the requirements of the "Goji Berry" entry in Part I of the 2020 edition of the Chinese Pharmacopoeia. Moisture content should not exceed 13.0%, total ash content should not exceed 5.0%, and heavy metals and harmful elements should meet the pharmacopoeia limits. Goji berries produced in Zhongning County, Ningxia should be selected, and the fruit stems and impurities should be removed before use.

[0030] Forest frog oil: It should comply with the relevant announcements and requirements of the National Health Commission regarding new food raw materials (forest frog oil). The protein content should not be less than 40.0%, the moisture content should not exceed 12.0%, and the swelling degree should not be less than 80 mL / g; it should be made from the dried oviduct of female forest frogs (Rana temporaria chensinensis) from the Changbai Mountains of Jilin Province, after removing fascia, blood vessels and other impurities. It should be in irregular blocks, yellowish-white to yellowish-brown, and have a distinctive fishy odor.

[0031] Honey: It should comply with the provisions of the National Food Safety Standard for Honey (GB 14963), with fructose and glucose content not less than 60% and water content not exceeding 20%. Acacia honey should be selected, with a light yellow color and a fragrant aroma.

[0032] Example 1.

[0033] A method for preparing an oral liquid containing a composition of ginseng, frog oil, longan pulp, and wolfberry includes the following steps: Step 1: Preparation of plant extract: Mix 15 g of ginseng slices, 20 g of longan pulp pieces, and 20 g of wolfberry and put them into a multi-functional extraction tank (5 L capacity, equipped with a stirring device and reflux condenser); add 10 times the amount of purified water (i.e., 550 mL) for the first time, turn on the stirring speed of 80 r / min, heat to 100℃, maintain a gentle boil (liquid temperature maintained at 100℃) for 1.5 hours; record the temperature every 30 minutes during the extraction process to ensure that the liquid temperature is not lower than 90℃; after the extraction is completed, filter the solution while hot through a 200-mesh stainless steel filter and collect the filtrate; The filter residue was subjected to a second extraction: 8 times the volume of purified water (i.e., 440 mL) was added, and the mixture was heated to boiling in the same manner, and extracted at a gentle boil for 1.5 hours; after extraction, the mixture was filtered through a 200-mesh stainless steel filter while still hot, and the filtrate was collected. Combine the two filtrates and place them in a stainless steel storage tank to cool to below 40°C. Then, filter them using a plate and frame filter (0.45μm pore size). The filtrate volume is 820 mL, and it is a brownish-yellow to brownish-brown transparent liquid with a pH of 5.8, which is the plant extract.

[0034] Step 2, Pretreatment of frog oil: Take 10 g of frog oil, cut it into 0.5 cm pieces, place it in a clean stainless steel container, add 300 mL of purified water below 40℃, gently stir to completely submerge the frog oil pieces, cover the container and place it in a 4℃ refrigerator for 14 hours to allow it to expand. During this period, gently turn it twice to ensure that the frog oil absorbs water evenly. The expansion endpoint is judged when the frog oil pieces expand to 20 times their original volume, and become a translucent, soft, and elastic gel-like substance without a hard core. Transfer the expanded frog oil along with the soaking solution to the colloid mill hopper, turn on the colloid mill, adjust the mill head gap to the minimum setting (0.05 mm), and circulate the homogenate 4 times until the homogenate is a fine, uniform milky white to slightly yellow emulsion. Take a small amount and spread it on a glass slide. It is ready when there are no particles visible to the naked eye. During the homogenization process, the temperature of the liquid is controlled at 40℃ to prevent protein denaturation. The volume of the homogenate is 320 mL.

[0035] Step 3, Preparation: Slowly add the frog oil homogenate to the plant extract while stirring (100-120 r / min) to ensure the two liquids are fully mixed. Add 30 g of honey and continue stirring for 10 minutes until completely dissolved. The pH of the solution was measured with a pH meter and was 6.0. The pH was then adjusted to 6.5 with a 10% citric acid solution (food grade). The solution was added drop by drop while stirring to avoid large local pH fluctuations. Purified water was added to bring the total volume to 1000 mL and the solution was stirred for 5 minutes to ensure it was fully homogeneous.

[0036] Step 4: Heat the prepared liquid to 60℃ (heating helps reduce the viscosity of the liquid and improve the homogenization efficiency), and send it into a high-pressure homogenizer. Set the homogenization pressure to 25 MPa and homogenize twice. The first homogenization initially refines the protein particles in the liquid, and the second homogenization further disperses the particles evenly to form a stable suspension system. After homogenization, the liquid should be a uniform light brownish-yellow to brownish-brown color, with no visible particles, no oil droplets, and no obvious stratification. Take a small amount of the liquid and let it stand for 2 hours. There should be no significant precipitation. Immediately fill the homogenized liquid into 20 mL brown soda-lime glass oral liquid bottles (filling volume controlled at 20.0±0.5 mL). The brown bottle can protect chlorophyll and other photosensitive components from light. Seal with aluminum-plastic combination caps. The seal should be checked for leaks. After filling and sealing, place the oral liquid bottles into a high-pressure steam sterilizer (moist heat sterilizer). When placing the bottles, leave an appropriate gap between them to ensure steam circulation. Set the sterilization program to 115°C for 15 minutes (sterilization time starts from when the temperature inside the cabinet reaches 115°C). After sterilization, immediately turn on the cooling water to lower the temperature inside the bottles to below 40°C within 30 minutes to prevent prolonged heating from causing degradation of the active ingredients. The oral liquid is then obtained.

[0037] The oral liquid underwent comprehensive quality testing, and the results are as follows: Appearance: This product is a light brownish-yellow to brownish-red uniform suspension. After standing, a small amount of fine sediment may appear at the bottom of the bottle. After shaking, it quickly returns to a uniformly dispersed state without clumping or flocculent matter.

[0038] pH value: 6.4 (as determined by pharmacopoeia method, should be 6.0-7.0).

[0039] Relative density: 1.03 (measured at 20℃, should not be lower than 1.02).

[0040] Content of key ingredients: Total amount of ginsenoside Rg1+Re: 1.5 mg / vial (determined by high performance liquid chromatography, not less than 1.3 mg / vial); Protein content: 0.95 g / vial (determined by Kjeldahl method, conversion factor 6.25, should not be less than 0.9 g / vial); Total polysaccharide content: 0.42 g / vial (determined by phenol-sulfuric acid method, calculated as glucose).

[0041] Microbial limits (tested according to the National Food Safety Standard for Health Foods GB 16740): Total bacterial count: <10 CFU / mL (Standard: ≤1000 CFU / mL); Molds and yeasts: <10 CFU / mL (standard: ≤100 CFU / mL); Coliform bacteria: Not detected (Standard: Not detectable); Salmonella: Not detected; Staphylococcus aureus: Not detected.

[0042] Heavy metals and harmful elements: Lead (Pb): 0.02 mg / kg (Standard: ≤2.0 mg / kg); Arsenic (As): 0.01 mg / kg (Standard: ≤1.0 mg / kg); Mercury (Hg): Not detected (Standard: ≤0.3 mg / kg).

[0043] Example 2.

[0044] Experimental animals and grouping: Seventy-two healthy adult male SD rats, weighing 180-220 g, were purchased from Liaoning Changsheng Biotechnology Co., Ltd. and housed at the Experimental Animal Center of Liaoning University of Traditional Chinese Medicine. After 7 days of acclimatization, they were randomly divided into 6 groups of 12 rats each according to their body weight: blank control group, model control group, low-dose group of this product, medium-dose group of this product, high-dose group of this product, and positive control group (compound donkey-hide gelatin oral liquid, administered by gavage at 10 times the clinically equivalent dose).

[0045] Modeling method: Except for the blank control group, rats in other groups underwent bloodletting via the fundus venous plexus once every other day for three consecutive times, with approximately 1.5 mL / 100 g body weight bloodletted each time, to establish a blood loss-induced hemoglobin reduction model. The tail blood hemoglobin content was measured 24 hours after modeling to confirm successful model establishment (Hb decrease ≥25% compared with the blank control group).

[0046] Dosage regimen: The low, medium, and high dose groups were administered the product by gavage at 5, 10, and 30 times the recommended human dose (2 vials daily, totaling 40 mL), respectively, i.e., 2.5 mL / kg, 5.0 mL / kg, and 15.0 mL / kg. The blank control group and the model control group were administered an equal volume of purified water by gavage. The positive control group was administered compound donkey-hide gelatin oral liquid at 5.0 mL / kg by gavage. The administration was once daily for 30 consecutive days. During the treatment period, rats in all groups had free access to food and water.

[0047] Detection indicators and methods: After fasting for 12 hours following the last administration, tail blood was collected, and hemoglobin (Hb), red blood cell count (RBC), and hematocrit (HCT) were measured using a fully automated hematology analyzer. At the same time, the weight changes, food intake, and general condition of rats in each group during the administration period were recorded as safety observation indicators.

[0048] Statistical analysis: Data are expressed as mean ± standard deviation (x±s). One-way ANOVA was performed using SPSS 26.0 software. LSD-t test was used for pairwise comparisons between groups. P<0.05 was considered statistically significant.

[0049] Table 1. Changes in hemoglobin content in rats of each group.

[0050] The Hb levels in the medium-dose and high-dose groups increased by 18.6% and 25.2% respectively compared to the model control group, and the differences were statistically significant. Although the low-dose group showed an increasing trend (+7.6%), it did not reach a statistically significant level.

[0051] Table 2. Changes in hematocrit of rats in each group.

[0052] As shown in Table 2, regarding hematocrit, the HCT in the model control group was (30.2±3.1)%, significantly lower than that in the blank control group (42.5±2.8)%, indicating successful model establishment. The HCT in the medium-dose group was (35.6±3.0)%, 17.9% higher than that in the model control group, a statistically significant difference (P<0.05); the HCT in the high-dose group was (38.1±3.4)%, 26.2% higher than that in the model control group, a statistically significant difference (P<0.01). The HCT in the high-dose group was close to that of the blank control group, indicating that this product can effectively increase hematocrit in rats with hemorrhagic anemia, improve blood oxygen-carrying capacity, and exhibits a certain dose-dependent trend.

[0053] General condition and safety observation of rats: Throughout the experiment, rats in all treatment groups exhibited glossy fur, normal activity, and no significant differences in food and water intake compared to the blank control group; no animal deaths or obvious toxic reactions were observed in any group. Compared to the model control group, rats in the medium- and high-dose groups recovered their mental state more quickly and showed better activity levels.

[0054] Conclusion: This product has a clear effect on improving iron deficiency anemia in rats with hemorrhagic anemia and has good safety. Compared with the positive control drug Compound Donkey-hide Gelatin Oral Liquid, the medium dose group of this product (equivalent to 10 times the human recommended dose) can achieve a similar improvement, which reflects the dosage advantage and formulation efficiency of this invention.

[0055] Example 3.

[0056] Prepared according to the method of Example 1, except that: the amount of honey is adjusted to 15 g, and 20 g of xylitol is added as a synergistic sweetener; the sterilization conditions are adjusted to sterilize at 121°C for 8 minutes.

[0057] The product obtained in this embodiment has a moderate sweetness and lower calories, making it more suitable for people with high blood sugar and weak constitutions. Testing of the finished oral liquid showed the following: ginsenoside Rg1+Re content 1.4 mg / vial, protein content 0.92 g / vial, pH 6.6, and microbial limits and heavy metal indicators all met the requirements. Animal experiments conducted in Example 2 verified that the product's efficacy in improving anemia was not significantly different from that in Example 1.

[0058] Example 4.

[0059] Prepared according to the method of Example 1, with the following differences: the amount of ginseng is adjusted to 12g, the amount of longan pulp is adjusted to 30g, the amount of wolfberry is adjusted to 25g, and the amount of frog oil remains unchanged. This formula increases the proportion of longan pulp and wolfberry, focusing on nourishing the heart and spleen, replenishing blood and calming the mind, making it suitable for people with blood deficiency accompanied by insomnia and palpitations.

[0060] The oral liquid product tested positive for ginsenoside Rg1+Re at 1.3 mg / vial and protein at 0.93 g / vial, meeting the requirements. In a hemorrhagic anemia model, the Hb increase in the medium-dose group of this formula was 17.2%, which was not statistically significant compared with the medium-dose group in Example 1 (18.6%) (P>0.05). However, the sleep latency of the test animals was shortened, suggesting that it has additional advantages in nourishing blood and calming the mind. The specific experimental procedure and results are as follows.

[0061] Sleep improvement experiment (synergistic experiment of subthreshold hypnotic dose of sodium pentobarbital) Experimental animals and grouping: Sixty healthy adult Kunming mice, half male and half female, weighing 18-22 g, were purchased from Liaoning Changsheng Biotechnology Co., Ltd. and raised at the Experimental Animal Center of Liaoning University of Traditional Chinese Medicine. After 7 days of acclimatization, they were randomly divided into 5 groups of 12 mice each according to their weight: blank control group, medium dose group of Example 1, low dose group of this example, dose group of this example, and positive control group (An Shen Bu Nao Ye, administered by gavage at 10 times the clinically equivalent dose).

[0062] Dosage regimen: In Example 1, the medium-dose group was administered 5.0 mL / kg of the drug solution from Example 1 via gavage; in this example, the low-dose group was administered 2.5 mL / kg of the drug solution from this example via gavage; in this example, the high-dose group was administered 5.0 mL / kg of the drug solution from this example via gavage; the blank control group was administered an equal volume of purified water via gavage; and the positive control group was administered 5.0 mL / kg of the calming and brain-nourishing liquid via gavage. Once daily for 7 consecutive days.

[0063] Sleep latency determination method: 30 minutes after the last administration, mice in each group were intraperitoneally injected with sodium pentobarbital 30 mg / kg (a subthreshold hypnotic dose; preliminary experiments determined that approximately 80% of mice would not lose their righting reflex at this dose). Immediately after injection, the mice were placed in a constant temperature observation chamber, and the sleep latency (time from injection of sodium pentobarbital to the disappearance of the righting reflex) and sleep duration (time from the disappearance to the recovery of the righting reflex) were recorded for each mouse. If the righting reflex did not disappear within 15 minutes, the sleep latency was recorded as 15 minutes.

[0064] Statistical methods: Data are expressed as x̄±s. One-way ANOVA was performed using SPSS 26.0 software. LSD-t test was used for pairwise comparisons between groups. P<0.05 was considered statistically significant.

[0065] Table 3. Improvement in sleep in each group of mice Note: Compared with the blank control group, *P<0.05.

[0066] Conclusion: Compared with the blank control group, the sleep latency in the dosage group of this embodiment was significantly shortened (P<0.05), and the sleep duration was significantly prolonged (P<0.05). Although the dosage group in Example 1 showed a trend of prolonged sleep time, the difference was not statistically significant (P>0.05). The above results indicate that this embodiment, by increasing the dosage of longan pulp and wolfberry, has a more significant improvement effect on nourishing blood and calming the mind than Example 1, providing a more precise formula selection for people with blood deficiency and insomnia.

[0067] Additional notes: The experimental data directly support the conclusion that "the shortened sleep latency in the test animals suggests an additional advantage in nourishing blood and calming the mind." Furthermore, the difference in sleep latency between the dosage group in this example and the dosage group in Example 1 was statistically significant (P<0.05), further demonstrating that the calming effect was significantly enhanced after the formula adjustment.

[0068] Example 5.

[0069] Prepared according to the method of Example 1, the difference being that the total volume was adjusted from 1000 mL to 500 mL in the preparation step, thus producing a concentrated oral liquid, with each vial containing 10 mL. This concentrated product is convenient for middle-aged and elderly people who require small doses and have limited gastrointestinal capacity. The finished product contains 2.6 mg of ginsenoside Rg1+Re per vial (based on 10 mL) and 1.8 g of protein per vial; after testing, all indicators met the requirements, and the microbial limits were qualified.

[0070] Comparative Example 1.

[0071] Prepared according to the method of Example 1, the difference being that only 15g of ginseng was used as the single ingredient, without the addition of longan pulp, wolfberry, and frog oil. Each bottle of the finished product contains 20 mL of ginsenoside Rg1+Re, with a content of 1.3 mg / bottle, but the protein content is 0, and it does not have the tonic effects of frog oil.

[0072] Following the modeling and administration methods of Example 2, and using the medium-dose group of this product as a control, the effect of single-herb ginseng oral liquid on improving anemia was tested under the same conditions. The results showed that the increase in Hb in the single-herb ginseng group (calculated based on an equal amount of ginsenosides) was 8.5%, which was significantly lower than that in the medium-dose group of Example 1 (18.6%, P<0.05).

[0073] Comparative Example 2.

[0074] Prepared according to the method of Example 1, except that only 10 g of frog oil was used as the single ingredient, without the addition of ginseng, longan pulp, and wolfberry. Each bottle contains 20 mL of the finished product, with a protein content of 0.9 g / bottle.

[0075] In the same rat experiment with hemorrhagic anemia, the increase in Hb in the frog oil-only group was only 6.2%, which was significantly lower than that in the medium-dose group of Example 1 (P<0.05). This indicates that although frog oil can provide protein nutrition, it lacks the synergistic effect of ginseng in replenishing qi and blood, longan pulp in nourishing blood, and wolfberry in nourishing yin, thus having a limited effect on improving anemia.

[0076] Comparative Example 3.

[0077] Referring to Example 1, the difference is that: ginseng, longan pulp, and wolfberry are not extracted with water, but are directly pulverized into fine powder (80 mesh), directly mixed with puffed frog oil, and purified water is added to make up to 1000 mL without pH adjustment or homogenization; the resulting product quickly separates into layers after standing, with the upper layer being a clear liquid and the lower layer being a large amount of coarse precipitate.

[0078] Testing revealed that the dissolution rate of ginsenoside Rg1+Re was only 0.6 mg / vial, far lower than the 1.5 mg / vial in Example 1. This indicates that the product did not undergo water extraction and homogenization processes, resulting in insufficient dissolution of the active ingredient and substandard product quality.

[0079] The above comparative examples further demonstrate that the specific herbal compatibility, extraction process, and preparation steps (including water extraction, pH adjustment, and high-pressure homogenization) of this invention are key to ensuring the efficacy and stability of the product. Without any one of these steps, the purpose of this invention cannot be achieved.

Claims

1. A composition containing ginseng, frog oil, longan pulp, and wolfberry, characterized in that, The ingredients include the following parts by weight: ginseng 1-5 parts, frog oil 0.5-3 parts, longan pulp 1-5 parts, and wolfberry 1-5 parts.

2. The composition containing ginseng, frog oil, longan pulp, and wolfberry according to claim 1, characterized in that, Ginseng must be sun-dried ginseng or red ginseng cultivated for five years or less, with a total ginsenoside Rg1+Re content of not less than 0.30%; frog oil must be dried oviduct of female frogs in China, with a protein content of not less than 40% and an expansion of not less than 80 mL / g; longan pulp and wolfberry should comply with the relevant provisions of the Chinese Pharmacopoeia.

3. A method for preparing an oral liquid containing a composition of ginseng, frog oil, longan pulp, and wolfberry, characterized in that, Includes the following steps: Step 1, Preparation of plant extract: Ginseng slices, longan pulp crushed, and wolfberry impurities removed are mixed together to obtain a mixture. Purified water is added, heated and extracted, and then filtered. The residue is extracted again with water. The filtrates are combined, cooled to below 40°C, and finely filtered to obtain the plant extract. Step 2, Pretreatment of frog oil: Frog oil is placed in purified water and expanded at low temperature. The colloid mill is used to homogenize the mixture until it is fine, so as to obtain frog oil homogenate. Step 3, Preparation: Add the frog oil homogenate to the plant extract and mix well. Add honey to taste, adjust the pH, add purified water to the total volume, and mix well to obtain the liquid. Step 4: Homogenize and sterilize the liquid to obtain an oral liquid.

4. The method for preparing an oral liquid containing the composition of ginseng, frog oil, longan pulp, and wolfberry according to claim 3, characterized in that, In step 1, the mass of purified water is 8-12 times the mass of the mixture, the heating temperature is 90-100℃, and the extraction time is 1-2 hours each time.

5. The method for preparing an oral liquid containing the composition of ginseng, frog oil, longan pulp, and wolfberry according to claim 3, characterized in that, In step 2, the low temperature is 4°C and the puffing time is 12-16 hours.

6. The method for preparing an oral liquid containing the composition of ginseng, frog oil, longan pulp, and wolfberry according to claim 3, characterized in that, In step 2, the frog oil expands to 15-20 times its original volume.

7. The method for preparing an oral liquid containing the composition of ginseng, frog oil, longan pulp, and wolfberry according to claim 3, characterized in that, In step 2, the temperature of the slurry is controlled below 40°C during the homogenization process.

8. The method for preparing an oral liquid containing the composition of ginseng, frog oil, longan pulp, and wolfberry according to claim 3, characterized in that, In step 3, the pH is adjusted using a 10% citric acid solution or a 10% sodium bicarbonate solution to a pH of 6.0-7.

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9. The method for preparing an oral liquid containing the composition of ginseng, frog oil, longan pulp, and wolfberry according to claim 3, characterized in that, Step 4 specifically involves heating the liquid to 50-60℃, homogenizing it under high pressure at 20-30MPa for 1-3 times, filling it, and then sterilizing it at 115℃ for 15 minutes or 121℃ for 8 minutes to obtain the finished oral liquid product.

10. The use of the composition containing ginseng, frog oil, longan pulp and wolfberry according to claim 1 or 2 in the preparation of health foods or special dietary foods that improve iron deficiency anemia and / or help enhance immunity.

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