Fructus podophylli jelly with efficacy of improving qi deficiency and blood stasis and preparation method of fructus podophylli jelly

Abstract

The invention provides fructus podophylli jelly with the efficacy of improving qi deficiency and blood stasis and a preparation method of the fructus podophylli jelly. A traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: 12-18 parts of spina date seeds, 8-12 parts of platycladi seeds, 8-12 parts of radix scutellariae, 10-14 parts of cortex phellodendri, 7-11 parts of rhizoma pinelliae preparata, 2-4 parts of cortex cinnamomi, 8-12 parts of caulis bambusae in taeniam, 7-11 parts of caulis polygoni multiflori, 8-12 parts of pericarpium citri reticulatae, 8-12 parts of coix seeds, 8-12 parts of Chinese yams, 20-26 parts of tortoise shells and 26-34 parts of raw oysters. By researching the influence of the traditional Chinese medicine composition on mRNA expression and 5-HIAA content of key egg white amino acid hydroxylase 2 (TPH2) and 5-HT transporter (Slc6a4) of a central 5-HT synaptic signaling pathway of a spleen-deficiency syndrome insomnia model rat caused by complex factors and a 5-HIAA / 5-HT ratio, the invention shows that the traditional Chinese medicine composition can be used for treating insomnia caused by spleen deficiency syndrome caused by complex factors. The traditional Chinese medicine composition can up-regulate the mRNA expression of TPH2 and Slc6a4 in the dorsal nucleus of a spleen deficiency syndrome insomnia model rat, up-regulate the content of 5-HIAA and the ratio of 5-HIAA to 5-HT, and finally improve the insomnia symptom.

Description

Technical Field

[0001] The invention relates to the technical field of food, in particular to a small-leaf lotus jelly with the effect of improving qi deficiency and blood stasis and a preparation method thereof. Background Art

[0002] Qi deficiency and blood stasis are a common syndrome type in traditional Chinese medicine. Qi deficiency refers to insufficient vital energy in the body, which is often manifested as fatigue, lack of energy, pale or sallow complexion, etc.; blood stasis refers to poor blood circulation and stagnation, which may cause symptoms such as skin and nail discoloration, limb numbness, and fixed pain. This syndrome is more common in people with various chronic diseases and some sub-healthy conditions, such as coronary heart disease, sequelae of stroke, and irregular menstruation in women with blood stasis symptoms. Long-term existence will affect the normal physiological functions of the human body, reduce the quality of life, and may even cause more serious health problems. Therefore, improving the condition of qi deficiency and blood stasis is of great significance to maintaining human health.

[0003] At present, there are some Chinese patent medicines for qi deficiency and blood stasis in clinical practice, such as Fufangdan dripping pills and Xuefu Zhuyu capsules. These drugs have certain effects in improving blood stasis symptoms and regulating qi and blood, but they are often inconvenient to take (they need to be taken on time and in the right amount, and some drugs may have specific requirements for taking, such as before or after meals, etc.), and there may be certain side effects of the drugs (such as irritation to the gastrointestinal tract). For some people who are just in a sub-healthy state and hope to improve their qi and blood conditions through daily conditioning, they may not be willing to choose drug treatment.

[0004] There are also some dietary products or health products on the market that claim to improve the function of qi and blood. For example, red dates and longan-based nourishing soups have a certain effect of replenishing qi and nourishing blood, but the targeted improvement effect on blood stasis may not be obvious enough. There are also some health products containing Chinese herbal ingredients, which may have deficiencies in the rationality of the formula, extraction and absorption of effective ingredients, etc., making it difficult to achieve the ideal actual effect. In addition, some products may contain more artificial additives and preservatives, etc., which pose certain food safety risks.

[0005] As a common snack food, jelly is loved by many people for its chewy texture and convenience. However, most of the jellies on the market are mainly fruit flavored, focusing on satisfying consumers' taste needs, and lacking in specific health conditioning effects. In particular, there are almost no jelly products targeting specific health needs such as improving qi deficiency and blood stasis, leaving a large market gap.

[0006] In summary, existing products for improving qi deficiency and blood stasis have many deficiencies in different aspects. Applying Chinese medicinal materials with the effect of improving qi deficiency and blood stasis to jelly, a food form that is convenient to eat and tastes good, is expected to fill the market gap and provide consumers with a new and more advantageous choice to meet the needs of those who want to regulate their health in a natural way in daily life. Summary of the invention

[0007] In view of the above situation, the first object of the present invention is to provide a small-leaf lotus jelly with the effect of improving qi deficiency and blood stasis to treat insomnia with complex pathogenesis caused by spleen and stomach weakness.

[0008] The second object of the present invention is to provide the application of the above-mentioned Chinese medicine composition.

[0009] To achieve the above first purpose, the technical solution adopted by the present invention is:

[0010] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0011] The invention comprises 100-400 parts by weight of active ingredients and 200-400 parts by weight of a gel matrix, wherein the active ingredients are prepared from the following raw materials in parts by weight: 10-50 parts of lithospermum officinale, 10-50 parts of angelica dahurica, 30-100 parts of angelica sinensis, 30-100 parts of liquorice, 10-40 parts of dragon's blood, 10-50 parts of sanguisorba officinalis, 10-20 parts of borneol and 1-10 parts of phellodendron chinense.

[0012] 12-18 parts of spiny jujube seeds, 8-12 parts of cypress seeds, 8-12 parts of scutellaria baicalensis, 10-14 parts of phellodendron, 7-11 parts of pinellia ternata, 2-4 parts of cinnamon bark, 8-12 parts of bamboo shavings, 7-11 parts of Polygonum multiflorum, 8-12 parts of tangerine peel, 8-12 parts of coix seeds, 8-12 parts of yam, 20-26 parts of tortoise shell, and 26-34 parts of raw oysters.

[0013] Preferably, the Chinese medicine composition is made from the following raw materials in parts by weight:

[0014] 12-14 parts of spinulosa jujube seeds, 10-12 parts of cypress seeds, 10-12 parts of scutellaria baicalensis, 12-14 parts of phellodendron chinense, 7-9 parts of pinellia ternata, 2-3 parts of cinnamon bark, 8-10 parts of bamboo shavings, 8-10 parts of Polygonum multiflorum vine, 8-10 parts of tangerine peel, 8-10 parts of coix seeds, 8-10 parts of yam, 22-24 parts of tortoise shell, and 28-32 parts of raw oysters.

[0015] Preferably, the Chinese medicine composition is made from the following raw materials in parts by weight:

[0016] 15 parts of spinulosa jujube seeds, 10 parts of cypress seeds, 10 parts of scutellaria baicalensis, 12 parts of phellodendron chinense, 9 parts of pinellia tuber, 3 parts of cinnamon bark, 10 parts of bamboo shavings, 9 parts of radix polygoni multiflori, 10 parts of tangerine peel, 10 parts of coix seeds, 10 parts of yam, 24 parts of tortoise shell, and 30 parts of raw oysters.

[0017] To achieve the second object, the technical solution adopted by the present invention is: use of the Chinese medicine composition in preparing a medicine for treating insomnia.

[0018] The dosage form of the drug is an oral preparation.

[0019] The oral preparations include tablets, capsules, granules, oral liquids, pills, and syrups.

[0020] The insomnia is a complex pathogenesis insomnia caused by spleen and stomach weakness.

[0021] The advantages of the present invention are:

[0022] In the formula of the above-mentioned Chinese medicine composition, the Chinese date seeds, cypress seeds and Polygonum multiflorum are used to nourish the heart and calm the mind, and the combination of tortoise shell and raw oyster nourishes yin and suppresses yang, which increases the calming effect. Scutellaria baicalensis and Phellodendron chinense purge heat and eliminate lumps, clear the heart and relieve restlessness; cinnamon bark leads fire back to the origin, and cooperates with Scutellaria baicalensis and Phellodendron chinense to connect the heart and kidney. Pinellia ternata dries dampness and resolves phlegm, harmonizes the stomach and reduces adverse reactions; bamboo shavings clear heat and resolve phlegm, relieve restlessness and harmonize the stomach; tangerine peel and yam strengthen the spleen and regulate qi; coix seed resolves dampness and calms the mind, and together helps Pinellia ternata drenches the spleen and resolves phlegm, harmonizes the stomach and calms the mind. The combination of all the medicines can play the role of strengthening the spleen and nourishing blood, connecting the heart and kidney, drying dampness and moving the spleen, resolving phlegm and regulating qi, so that the spleen and stomach qi mechanism rises and falls normally, and the qi, blood, yin and yang return to their respective positions, and the sleep and wakefulness are peaceful.

[0023] The present invention studies the effect of the above-mentioned Chinese medicine composition on the mRNA expression of tryptophan hydroxylase 2 (TPH2), a key protein of the central 5-HT synaptic signaling pathway, and the 5-HIAA content and the 5-HIAA / 5-HT ratio of the 5-HIAA transporter (Slc6a4) in the rat model of insomnia with spleen deficiency syndrome caused by complex factors. The results show that the Chinese medicine composition can up-regulate the mRNA expression of TPH2 and Slc6a4 in the dorsal raphe nucleus of the rat model of insomnia with spleen deficiency syndrome, and up-regulate the 5-HIAA content and the 5-HIAA / 5-HT ratio, thereby finally improving the insomnia symptoms. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 This is a comparison of the relative expression levels of some differentially expressed genes in the dorsal raphe nucleus tissue of rats in group A (normal group), group B (model group), group C (high-dose Chinese medicine group), and group D (low-dose Chinese medicine group) (n=6 samples in each group). The data in the figure represent the mean ± standard deviation of each group (*, p value <0.05; ***, p value <0.001);

[0025] Figure 2PCR amplification curves of GAPDH, TPH2 and SLC6a4, with the cycle number as the abscissa and the real-time fluorescence signal intensity during the reaction as the ordinate;

[0026] Figure 3 PCR melting curves of GAPDH, TPH2, and SLC6a4, with solubility as the ordinate and Celsius temperature as the abscissa;

[0027] Figure 4 The comparison of 5-HT, 5-HIAA content and 5-HIAA / 5-HT ratio in dorsal raphe nucleus tissue of rats in groups A, B, C and D. The data in the figure represent the mean ± standard deviation of each group (compared with group A, a P<0.001; compared with group B, b P<0.001);

[0028] Figure 5 Comparison of changes in serum BDNF and GFAP levels in rats in groups A, B, C, and D (n=12 samples in each group). The data in the figure represent the mean ± standard deviation of each group (compared with group A, a P<0.001; compared with group B, b P<0.001);

[0029] Figure 6 Comparison of changes in serum TNF-α, IL-1β, and IL-6 levels in rats in groups A, B, C, and D (n=12 samples in each group). The data in the figure represent the mean ± standard deviation of each group (compared with group A, a P<0.001; compared with group B, b P < 0.001, c P<0.05). DETAILED DESCRIPTION

[0030] In order to facilitate understanding of the present invention, the present invention will be described more fully below with reference to various embodiments, but the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thorough and comprehensive.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0032] The following is a further description of the embodiments of the present invention in multiple embodiments. The embodiments of the present invention are not limited to the following specific embodiments. Within the scope of the unchanged main rights, appropriate changes can be made to the implementation.

[0033] Example 1

[0034] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0035] 15 parts of spinulosa jujube seeds, 10 parts of cypress seeds, 10 parts of scutellaria baicalensis, 12 parts of phellodendron chinense, 9 parts of pinellia tuber, 3 parts of cinnamon bark, 10 parts of bamboo shavings, 9 parts of radix polygoni multiflori, 10 parts of tangerine peel, 10 parts of coix seeds, 10 parts of yam, 24 parts of tortoise shell, and 30 parts of raw oysters.

[0036] Example 2

[0037] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0038] 12-18 parts of spiny jujube seeds, 8-12 parts of cypress seeds, 8-12 parts of scutellaria baicalensis, 10-14 parts of phellodendron, 7-11 parts of pinellia ternata, 2-4 parts of cinnamon bark, 8-12 parts of bamboo shavings, 7-11 parts of Polygonum multiflorum, 8-12 parts of tangerine peel, 8-12 parts of coix seeds, 8-12 parts of yam, 20-26 parts of tortoise shell, and 26-34 parts of raw oysters.

[0039] Example 3

[0040] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0041] 12-18 parts of spiny jujube seeds, 8-12 parts of cypress seeds, 8-12 parts of scutellaria baicalensis, 10-14 parts of phellodendron, 7-11 parts of pinellia ternata, 2-4 parts of cinnamon bark, 8-12 parts of bamboo shavings, 7-11 parts of Polygonum multiflorum, 8-12 parts of tangerine peel, 8-12 parts of coix seeds, 8-12 parts of yam, 20-26 parts of tortoise shell, and 26-34 parts of raw oysters.

[0042] Example 4

[0043] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0044] 12-18 parts of spiny jujube seeds, 8-12 parts of cypress seeds, 8-12 parts of scutellaria baicalensis, 10-14 parts of phellodendron, 7-11 parts of pinellia ternata, 2-4 parts of cinnamon bark, 8-12 parts of bamboo shavings, 7-11 parts of Polygonum multiflorum, 8-12 parts of tangerine peel, 8-12 parts of coix seeds, 8-12 parts of yam, 20-26 parts of tortoise shell, and 26-34 parts of raw oysters.

[0045] Example 5

[0046] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0047] 12-18 parts of spiny jujube seeds, 8-12 parts of cypress seeds, 8-12 parts of scutellaria baicalensis, 10-14 parts of phellodendron, 7-11 parts of pinellia ternata, 2-4 parts of cinnamon bark, 8-12 parts of bamboo shavings, 7-11 parts of Polygonum multiflorum, 8-12 parts of tangerine peel, 8-12 parts of coix seeds, 8-12 parts of yam, 20-26 parts of tortoise shell, and 26-34 parts of raw oysters.

[0048] Example 6

[0049] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0050] 12-18 parts of spiny jujube seeds, 8-12 parts of cypress seeds, 8-12 parts of scutellaria baicalensis, 10-14 parts of phellodendron, 7-11 parts of pinellia ternata, 2-4 parts of cinnamon bark, 8-12 parts of bamboo shavings, 7-11 parts of Polygonum multiflorum, 8-12 parts of tangerine peel, 8-12 parts of coix seeds, 8-12 parts of yam, 20-26 parts of tortoise shell, and 26-34 parts of raw oysters.

[0051] Example 7

[0052] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0053] 12-18 parts of spiny jujube seeds, 8-12 parts of cypress seeds, 8-12 parts of scutellaria baicalensis, 10-14 parts of phellodendron, 7-11 parts of pinellia ternata, 2-4 parts of cinnamon bark, 8-12 parts of bamboo shavings, 7-11 parts of Polygonum multiflorum, 8-12 parts of tangerine peel, 8-12 parts of coix seeds, 8-12 parts of yam, 20-26 parts of tortoise shell, and 26-34 parts of raw oysters.

[0054] Example 8

[0055] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0056] 12-18 parts of spiny jujube seeds, 8-12 parts of cypress seeds, 8-12 parts of scutellaria baicalensis, 10-14 parts of phellodendron, 7-11 parts of pinellia ternata, 2-4 parts of cinnamon bark, 8-12 parts of bamboo shavings, 7-11 parts of Polygonum multiflorum, 8-12 parts of tangerine peel, 8-12 parts of coix seeds, 8-12 parts of yam, 20-26 parts of tortoise shell, and 26-34 parts of raw oysters.

[0057] Example 9

[0058] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0059] 12-18 parts of spiny jujube seeds, 8-12 parts of cypress seeds, 8-12 parts of scutellaria baicalensis, 10-14 parts of phellodendron, 7-11 parts of pinellia ternata, 2-4 parts of cinnamon bark, 8-12 parts of bamboo shavings, 7-11 parts of Polygonum multiflorum, 8-12 parts of tangerine peel, 8-12 parts of coix seeds, 8-12 parts of yam, 20-26 parts of tortoise shell, and 26-34 parts of raw oysters.

[0060] Example 10

[0061] A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0062] 12-18 parts of spiny jujube seeds, 8-12 parts of cypress seeds, 8-12 parts of scutellaria baicalensis, 10-14 parts of phellodendron, 7-11 parts of pinellia ternata, 2-4 parts of cinnamon bark, 8-12 parts of bamboo shavings, 7-11 parts of Polygonum multiflorum, 8-12 parts of tangerine peel, 8-12 parts of coix seeds, 8-12 parts of yam, 20-26 parts of tortoise shell, and 26-34 parts of raw oysters.

[0063] Embodiment 11

[0064] A tablet for treating insomnia is prepared by weighing various medicinal materials according to the ratio of Example 1, washing and mixing the medicinal materials, adding 5.5 times of the total weight of the medicinal materials and boiling for 3 times, each time for 1 hour, combining the 3 decoctions, filtering, and concentrating to obtain a fluid extract with a specific gravity of 1.3 at 60°C.

[0065] According to the conventional tablet operation method, the fluid extract is added with pharmaceutical excipients, the components are mixed evenly, wet granulated, sieved, and tableted into tablets using a conventional tablet preparation method. The dosage of each component is: 55 parts of fluid extract, 35 parts of starch, 15 parts of microcrystalline cellulose, 15 parts of talc, and 10 parts of polyethylene glycol.

[0066] Example 12

[0067] A capsule for treating insomnia is prepared by weighing various medicinal materials according to the ratio of Example 1, washing and mixing the medicinal materials, adding 5.5 times of the total weight of the medicinal materials and boiling for 3 times, each time for 1 hour, combining the 3 decoctions, filtering, and concentrating to obtain a fluid extract with a specific gravity of 1.3 at 60°C.

[0068] According to the conventional capsule operation method, add pharmaceutical excipients, mix the components evenly, granulate, and fill the capsules using the conventional capsule preparation method. The dosage of each component is: 90 parts of fluid extract, 45 parts of pregelatinized starch, 20 parts of anhydrous lactose, 10 parts of microcrystalline cellulose, and 15 parts of calcium hydrogen phosphate.

[0069] Example 13

[0070] An oral liquid for treating insomnia is prepared by weighing various medicinal materials according to the ratio of Example 1, washing and mixing the medicinal materials, adding 9 times of water as the total weight of the medicinal materials and boiling for 3 times, each time for 1 hour, combining the 3 decoctions, filtering, and concentrating to obtain a fluid extract with a specific gravity of 1.3 at 60°C.

[0071] According to the conventional oral liquid operation method, ethanol precipitation is performed twice, filtered, concentrated, water is added for precipitation, filtered, pharmaceutical excipients are added, filtered, and packaged for sterilization. The dosage of each component is: 95 parts of fluid extract, 120 parts of ethanol, 70 parts of sucrose, 25 parts of sodium carboxymethyl cellulose, 15 parts of peppermint oil, and 8 parts of sorbic acid.

[0072] Embodiment 14

[0073] A decoction for treating insomnia is prepared by weighing various medicinal materials according to the proportions in Example 1, washing the medicinal materials, mixing them, and adding water to boil them to obtain the decoction.

[0074] Embodiment 15

[0075] Animal experiments

[0076] 1. Materials and Methods

[0077] 1.1 Materials

[0078] 48 healthy male SD rats aged 2 months, weighing (180-220 g), were purchased from the Experimental Animal Science and Technology Center of Jiangxi University of Traditional Chinese Medicine, with the experimental animal production license number: SCXK (Gan) 2018-0003, and the certificate number: 0004137. They were fed with ordinary feed, had free access to food, water and activities, and were placed at room temperature of 22-24°C, humidity of 40%-60%, and light from 7:00am to 19:00pm. All experiments were conducted during the day and were implemented in accordance with the relevant provisions of the Regulations on the Administration of Experimental Animals of the People's Republic of China.

[0079] 1.2 Experimental methods

[0080] 1.2.1 Chinese medicine preparation

[0081] The decoction was obtained according to the method described in Example 14, and the decoction was packaged in sterile bottles, sealed and stored in a 4°C refrigerator for later use.

[0082] 1.2.2 Replication and grouping of the insomnia model

[0083] After the animals were purchased, they were fed adaptively for 7 days. 48 healthy female SD rats were randomly assigned to the normal control group (group A), model group (group B), high-dose Chinese medicine composition group [20g / (kg·d)] (group C), and low-dose Chinese medicine composition group [10g / (kg·d)] (group D) according to the digital table method, with 12 rats in each group. The insomnia model was established by using the rat chronic tail clamp stimulation and intraperitoneal injection of para-chlorophenylalanine (PCPA) compound factor modeling method. The tails of the rats were gently clamped with hemostatic forceps wrapped with gauze at the tip, causing the rats to provoke and fight each other for 45 minutes / day. Fighting should not break the skin. The experiment lasted for 20 days. PCPA was given to rats from the 16th day of modeling. PCPA was dissolved in weak alkaline saline (pH 7-8) at 300 mg / kg to prepare a suspension, which was intraperitoneally injected at 10 ml / kg for 2 consecutive days. The rats' circadian rhythm disappeared and their food and water intake increased, indicating that the model was successfully established. Rats in the normal group were intraperitoneally injected with an equal volume of 0.9% sodium chloride solution.

[0084] 1.2.3 Experimental drug administration

[0085] The rats in groups C and D were given the Chinese medicine composition suspension by gavage from the 7th day after the tail clamping stimulation, once a day for 14 consecutive days. The body weight was measured once a week.

[0086] 1.2.4 Collection of materials

[0087] On the 20th day of modeling, the rats were decapitated 1 hour after administration, the skull was quickly peeled open to obtain the brain, the dorsal raphe nucleus was separated on an ice bath, placed in a 1.5 ml EP tube, and quickly frozen in liquid nitrogen for later use. The dorsal raphe nucleus tissues of 12 rats in each group were randomly divided into 2 groups (6 rats in each group) for the determination of 5-HIAA and 5-HT content and qRT-PCR analysis of TPH2 and Slc6a4 mRNA expression.

[0088] 1.2.5 Analysis of serum biochemical indexes 5-8 mL of blood was collected from the abdominal aorta of rats, without anticoagulation, coagulated at 4°C for 60 min, centrifuged at 4°C, 3500 r / min for 15 min, and serum was collected; stored in a -80°C refrigerator for testing. According to the instructions of the kit, serum brain-derived neurotrophic factor (BDNF), tumor necrosis factor (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6) and glial fibrillary acidic protein (GFAP) were detected.

[0089] 1.2.6 qRT-PCR detection of TPH2 and Slc6a4 mRNA expression levels in rat dorsal raphe nucleus

[0090] There were 6 animals in each group. The dorsal nucleus of the raphe was immediately extracted with Trizol reagent to extract total RNA, and cDNA was synthesized using the RT First Strand cDNA Synthesis Kit of Servicebio. The primer sequences are shown in Table 3. qPCR was performed using a Bio-rad fluorescent quantitative PCR instrument, and the target gene and internal reference gene GAPDHCT data of each sample were obtained. The expression fold of the target gene of each sample to be tested was calculated according to the ΔΔCT formula: A = CT (target gene, sample to be tested) - CT (internal reference gene, sample to be tested), B = CT (target gene, control sample) - CT (internal reference gene, control sample), ΔΔCT = AB, target gene expression fold = 2 -ΔΔCT .

[0091] Table 1 RT-qPCR primer sequence list

[0092]

[0093] 1.2.7 Detection of 5-HT and 5-HIAA contents in dorsal raphe nucleus tissue of rats

[0094] After taking the dorsal nucleus of the raphe, rinse it with pre-cooled saline to remove blood, absorb it dry and weigh it, place it in a 2ml round-bottom centrifuge tube, add 300μl of saline, grind it into a homogenate in an ice bath, centrifuge it at 15000r / min for 15min at 4℃, take the supernatant, add 300μl of 0.1mol / L perchloric acid protein removal solution, centrifuge it at 12000r / min for 15min at 4℃, take the supernatant, filter it through a 0.22μm filter membrane and freeze it at -80℃ for later use. The 5-HT content was detected by a high-performance liquid coulometric array electrochemical detector, with an injection volume of 20μl, a flow rate of 0.8ml / min, and a column temperature of 38℃. The electrode potentials of the two channels of the high-performance liquid coulometric array electrochemical detector were set as follows: channel 1, +450mv (detection channel); channel 2, -150mv (reduction potential).

[0095] 1.3 Statistical analysis

[0096] The data were analyzed statistically using SPSS 27.0 software package. The difference was statistically significant when P < 0.05.

[0097] 2 Results

[0098] 2.1 Effect of Chinese herbal medicine combination on TPH2 and Slc6a4 gene expression in dorsal raphe nucleus of rats

[0099] Compared with group A (normal group), the expression of TPH2 and Slc6a4 genes in the dorsal raphe nucleus of rats in group B (model group) was significantly downregulated (all P<0.001); compared with group B (model group), the expression of TPH2 and Slc6a4 genes in the dorsal raphe nucleus of rats in group C (high-dose group) was significantly upregulated (all P<0.001), and the expression of TPH2 gene in the dorsal raphe nucleus of rats in group D (low-dose group) was upregulated (P<0.05), while there was no significant difference in the expression of Slc6a4 gene (P>0.05). For gene expression, PCR amplification curve and PCR melting curve, please refer to Figure 1 , Figure 2 , Figure 3 .

[0100] 2.2 Effect of Chinese herbal medicine combination on 5-HT and 5-HIAA contents in dorsal raphe nucleus of rats

[0101] Compared with the 5-HIAA content (372.50±58.16) and 5-HIAA / 5-HT ratio (12.90±3.33) in the dorsal raphe nucleus of rats in group A, the 5-HIAA content (135.33±17.19) and 5-HIAA / 5-HT ratio (5.52±1.37) in group B were significantly decreased (both P=0.000). Compared with group B, the 5-HIAA content (338.50±49.35) and 5-HIAA / 5-HT ratio (12.43±3.30) in group C were significantly increased (both P=0.000), while the 5-HIAA content (198.17±17.01) in the dorsal raphe nucleus of rats in group D was significantly increased (P=0.013), and the 5-HIAA / 5-HT ratio (7.30±1.38) was not statistically significant. Figure 4 .

[0102] 2.3 Effect of Chinese herbal medicine combination on serum BDNF and GFAP levels in rats

[0103] Compared with the serum BDNF content (193.08±15.63) and GFAP content (9.42±1.73) of rats in group A, the serum BDNF content (152.33±14.52) of rats in group B was significantly decreased (P=0.000), and the GFAP content (18.83±1.64) was significantly increased (P=0.000); compared with group B, the serum BDNF content (186.75±14.81) of rats in group C was significantly increased (P=0.000), and the GFAP content (11.75±2.05) was significantly decreased (P=0.000), while there was no significant difference in the serum BDNF content (P=0.143) and GFAP content (P=0.075) of rats in group D. Figure 5 .

[0104] 2.4 Effect of Chinese herbal medicine combination on serum cytokine levels in rats

[0105] Compared with group A, the levels of TNF-α, IL-1β, and IL-6 in the serum of rats in group B were significantly increased (P<0.05); compared with group B, the levels of TNF-α, IL-1β, and IL-6 in the serum of rats in group C were significantly decreased (P<0.05); compared with the low-dose group of the Chinese medicine composition, the high-dose group of the Chinese medicine composition had significantly decreased levels of TNF-α, IL-1β, and IL-6 (P<0.05). Figure 6 .

[0106] The pathogenesis of insomnia is complex, affected by physical and mental factors, and the course of the disease is protracted. Central 5-HT plays a key role in the maintenance and regulation of sleep, and 5-HIAA is a metabolite of 5-HT. The central 5-HIAA / 5-HT ratio reflects the activity of central 5-HT neurons and the utilization of 5-HT. Increasing the utilization of 5-HT can promote and maintain sleep. The experimental results showed that high-dose Chinese medicine compositions can effectively upregulate the mRNA expression levels of central 5-HT synaptic signaling pathway genes TPH2 and SLC6A4 in insomnia model rats, and significantly increase 5-HIAA content and 5-HIAA / 5-HT ratio, indicating that the mechanism of Chinese medicine composition intervention in insomnia may be related to the increase in 5-HT neuron activity.

[0107] BDNF is an important member of the neurotrophic factor family, which has the function of promoting the growth and development of nerve cells and preventing nerve cell damage. The experimental results show that the Chinese medicine composition can effectively increase the BDNF content in the serum of insomnia model rats, indicating that the mechanism of Chinese medicine composition intervention in insomnia may be related to the increase of BDNF content. GFAP in the central nervous system has the functions of regulating the development of the nervous system, neuronal damage, repair, regeneration and plasticity, and participates in the formation of synaptic connections between neurons. The increase in GFAP content represents the increase in astrocyte activation, and neurons are in a state of stress damage, resulting in the upregulation of proinflammatory cells TNF-α, IL-1β and IL-6 expression. The experimental results show that after the intervention of high-dose Chinese medicine composition, the GFAP content and TNF-α, IL-1β, IL-6 cytokine levels in the serum of insomnia model rats were significantly reduced, indicating that the mechanism of Chinese medicine composition intervention in insomnia may be related to the protection of neuronal damage by increasing BDNF levels.

[0108] Example 16

[0109] Clinical trials

[0110] 1. Materials and methods

[0111] 1.1 Clinical Data

[0112] Patients with insomnia who were hospitalized in Jiujiang Fifth People's Hospital from February 2021 to January 2023 were selected as the research subjects. According to the diagnostic criteria for insomnia and relevant inclusion and exclusion criteria, 159 patients with insomnia were screened and randomly assigned to alprazolam (A) group, Chinese medicine combination (B) group, and Chinese medicine combination combined with alprazolam (C) group using the random number table method. There were 53 cases in group A (3 cases dropped out due to unsatisfactory efficacy), including 23 males and 27 females; the age ranged from 25 to 65 years, with an average age of (44.08±14.40) years; the course of disease was 1 to 25 years, with an average course of disease of (10.86±6.95) years; 29 patients with college education or above, and 21 patients with high school education or below. Group B had 53 cases (2 cases dropped out due to unsatisfactory efficacy), including 25 males and 26 females; the age ranged from 26 to 65 years old, with an average age of (44.18±12.91) years; the course of disease ranged from 1 to 27 years, with an average course of disease of (11.04±7.38) years; 30 patients had college degree or above, and 21 patients had high school education or below. Group C had 53 cases (1 case dropped out due to unsatisfactory efficacy and 1 case was discharged voluntarily), including 23 males and 28 females; the age ranged from 23 to 65 years old, with an average age of (43.16±14.29) years; the course of disease ranged from 1 to 29 years, with an average course of disease of (11.53±6.45) years; 31 patients had college degree or above, and 20 patients had high school education or below. Gender of patients in the three groups (x 2 =0.173, P = 0.917), age (F = 0.88, P = 0.916), course of disease (F = 0.126, 0.881) and educational level (χ 2=0.086, P=0.958) were not statistically significant. Inclusion criteria: ① Western medicine diagnosis refers to the "Chinese Classification and Diagnostic Criteria for Mental Disorders, 3rd Edition" (CCMD-3): Insomnia is the only symptom, including difficulty falling asleep, shallow sleep, dreaming, early awakening, or difficulty falling asleep again after waking up, discomfort after waking up, fatigue, or daytime sleepiness; having a dominant concept of insomnia and extremely concerned about the consequences of insomnia; insomnia occurs at least 3 times a week and lasts for more than 1 month. ② TCM diagnostic criteria refer to the diagnostic criteria of the 2016 TCM Clinical Practice Guidelines for Insomnia and the diagnosis of spleen and stomach disharmony in the TCM Clinical Diagnosis and Treatment Terminology (GB / T 16751.2-1997). The diagnostic basis is as follows: Main symptoms: difficulty falling asleep, easy to wake up during sleep, or even sleepless all night. If one of the symptoms is met, it can be diagnosed as insomnia; Secondary symptoms: abdominal distension, stomach noise, loss of appetite, or abdominal distension after eating, loose stools, belching and bowel sounds; Tongue and pulse: red tongue, yellow greasy or slippery tongue coating, slippery or stringy pulse; If one of the main symptoms is met, plus 3 or more secondary symptoms, the tongue and pulse can be used for diagnosis. ③ PQSI score>8 points. ④ Insomnia patients with a course of 1 year or more who have not taken medication within 2 weeks before treatment; ⑤ Aged 18 to 65 years old; ⑥ Informed and voluntary signing of informed consent. Exclusion criteria: ① severe organic disease; ② pregnancy or lactation; ③ mental illness and drug factors. The clinical research ethics committee of Jiujiang Fifth People's Hospital approved the study before it started.

[0113] 1.2 Methods

[0114] 50 cases in group A were treated with alprazolam tablets (Jiangsu Enhua Pharmaceutical Co., Ltd., approval number: National Medicine Standard H32020215) 0.4-0.8 mg / d, 51 cases in group B were treated with Chinese medicine combination for regulating spleen and stomach, and 51 cases in group C were treated with Chinese medicine combination for regulating spleen and stomach combined with alprazolam tablets 0.4-0.8 mg / d. The prescription of Chinese medicine combination for regulating spleen and stomach: 15g of Ziziphus jujuba seed, 10g of Platycladus orientalis, 10g of Scutellaria baicalensis, 12g of Phellodendron chinense, 9g of Pinellia ternata, 3g of Cinnamon bark, 10g of Rhizoma Anemarrhenae, 9g of Polygonum multiflorum, 10g of Citrus reticulata, 10g of Coix seed, 10g of Chinese yam, 24g of Tortoise shell, and 30g of raw oyster. After mixing the above drugs, decoct them with 400 mL of water, take them twice a day on an empty stomach, warm, 1 dose / d, and 4 weeks as a course of treatment.

[0115] 1.3 Observation indicators

[0116] (1) Pittsburgh Sleep Quality Index (PSQI) table to assess sleep quality: PSQI table consists of 19 self-assessment items and 5 other-assessment items, of which the 19th self-assessment item and the 5 other-assessment items are not included in the scoring. The 18 self-assessment items are composed of 7 components, each component is scored on a scale of 0 to 3, and the cumulative scores of each component are the total PSQI score, which ranges from 0 to 21. The higher the score, the worse the sleep quality. (2) Clinical efficacy is evaluated based on PSQI scores: efficacy index = (pre-treatment score - post-treatment score) / pre-treatment score × 100%, and the PSOI total score reduction rate is represented by X: ① cured: X>75%; ② markedly effective: X between 51% and 75%; ③ effective: X between 25% and 50%; ④ ineffective: X<25%. (3) TCM syndrome efficacy evaluation criteria: According to the "Guidelines for Clinical Research of New Chinese Medicines", the TCM syndrome score of insomnia patients is evaluated. The items include: ① Difficulty falling asleep, frequent dreams and easy awakening, and difficulty falling asleep after waking up; ② Fatigue; ③ Pale complexion; ④ Palpitations and forgetfulness; ⑤ Loose stools; ⑥ Dizziness; ⑦ Fullness of the stomach; ⑧ Decreased appetite; ⑨ Pale tongue, thin or thin white fur; ⑩ Weak pulse. Scoring criteria: ① to ③, mild, moderate, and severe are scored as 2, 4, and 6 points respectively, and no score is 0; ④ to ⑧, mild, moderate, and severe are scored as 1, 2, and 3 points respectively, and no score is 0. Items 9 and 10, if yes, score 1 point, and if no score is 0. The sum of the scores of each item is the TCM syndrome evaluation score of the patient. (4) Conventional method: Lumbar puncture was performed to collect 3 ml of cerebrospinal fluid sample, which was centrifuged at 12,000 rpm for 10 min (25t, centrifugal radius 10 cm) to precipitate protein. The supernatant was injected and the contents of 5-HT and 5-HIAA were determined by HPLC-electrochemical detection using a Shimadzu LC-10A high-performance liquid chromatography system and a LECD6A electrochemical detector.

[0117] 1.4 Statistical methods

[0118] SPSS 27.0 was used to analyze the data. The measurement data were analyzed by χ2 test, and the count data were analyzed by analysis of variance and repeated measures analysis of variance. P < 0.05 was considered statistically significant. Dropout cases were not included in the statistical analysis.

[0119] 2 Results

[0120] 2.1 PSQI score

[0121] Before treatment, there was no significant difference in PSQI scores between the three groups (P>0.05). PSQI scores continued to decrease in the first, second, and fourth weeks after treatment. At the end of the fourth week of treatment, PSQI scores in group C were significantly lower than those in group A (P<0.05). PSQI scores in group B were not significantly different from those in group A (P>0.05). See Table 2.

[0122] Table 2 Comparison of PSQI scores among the three groups before and after treatment (points, )

[0123]

[0124] Note: Compared with group A, a P < 0.01; b P<0.001.

[0125] 2.2 Clinical efficacy of the three groups

[0126] The total effective rates of groups A, B, and C were 58%, 74.51%, and 86.27%, respectively, with significant differences (x 2 =10.33, P = 0.006), and group C was significantly higher than group A (x 2 =10.073, P=0.002).

[0127] Table 2 Comparison of clinical effects among the three groups [cases, (%)]

[0128]

[0129] Note: Compared with group A, a P<0.01.

[0130] 2.3 TCM syndrome scores of the three groups before and after treatment

[0131] At the treatment baseline, there was no significant difference in the TCM syndrome scores among the three groups (17.86±4.43), (17.58±4.89), (17.71±4.82) (F=0.042, P=0.959). At the fourth week of treatment, there was a significant difference in the TCM syndrome scores among the three groups (12.69±3.82), (9.85±3.46), (7.41±3.47) (F=5.365, P=0.005), and the total effective rate of group C was significantly higher than that of group A (P=0.001).

[0132] Table 32 Comparison of TCM syndrome scores among the three groups before and after treatment (points, )

[0133]

[0134]

[0135] Note: Compared with group A, a P < 0.001; b P<0.001.

[0136] 2.4 5-HT, 5-HIAA contents and 5-HIAA / 5-HT ratio among the three groups

[0137] There was no significant difference in the 5-HT, 5-HIAA content and 5-HIAA / 5-HT ratio among the three groups at the treatment baseline (P>0.05); at the end of the fourth week of treatment, the 5-HIAA content and 5-HIAA / 5-HT ratio of groups C and B were significantly higher than those of group A (P<0.05). See Table 3 for details.

[0138] Table 3 Comparison of 5-HT and 5-HIAA contents among three groups

[0139]

[0140] Note: Compared with group A, a P < 0.05; b P < 0.001; c P<0.01.

[0141] Insomnia patients often experience irritability, mental fatigue, memory loss, and physical illness, which bring troubles to their lives and work. Qin Jingming of the Ming Dynasty said in "Symptoms, Causes, and Pulse Treatment·On Not Being Able to Sleep" that "the stomach is strong and eats a lot, but the spleen is weak and cannot transport and transform, which stagnates in the stomach, forming fluid and phlegm, and the qi in the middle abdomen is blocked and uncomfortable, and the pulse of Yangming is reversed and does not go down, and the symptoms of not being able to sleep occur." Zhang Lu of the Qing Dynasty also said in "Zhang's Medical Guide·Not Being Able to Sleep" that "the pulse is rapid, slippery, and strong and those who cannot sleep have stagnant phlegm and fire in the body. This is because the stomach is not harmonious, so they cannot sleep well." The spleen and stomach have the functions of receiving and transporting water and grain, raising the clear and lowering the turbid, controlling qi and regulating blood. The spleen and stomach are the foundation of the acquired constitution, and the water and grain essences they transport and transform are the material basis for the transformation of qi, blood, and body fluids. The spleen fails to transport properly and phlegm and dampness block the body, leading to the positive pathological changes of restless sleep at night. The spleen and stomach are weak, qi and blood are deficient, the spirit and soul are not nourished, the Ying and Wei are not harmonious, and the heart and kidney are not connected, leading to the deficiency pathological changes of restless sleep at night. The spleen and stomach are important organs of the human body. Dysfunction of the spleen and stomach will cause abnormal function of the five internal organs, which will lead to insomnia in patients. Insomnia patients have dysfunction of the spleen and stomach, which is mainly manifested by abnormal qi movement, lack of source of qi and blood biochemistry, and qi and blood deficiency. Only a large amount of tranquilizers will cause damage to the spleen and stomach tissues, aggravate the dysfunction of the spleen and stomach, and the condition will be lingering. The mechanism of insomnia is complex and difficult to cure. The formula of this Chinese medicine composition, in which the Chinese jujube seeds, the Chinese cypress seeds and the Polygonum multiflorum are used to nourish the heart and tranquilize the mind, and the combination of tortoise shell and raw oyster nourishes yin and suppresses yang, increases the tranquilizing effect. Scutellaria baicalensis and Phellodendron chinense purge heat and eliminate lumps, clear the heart and eliminate restlessness; cinnamon leads fire back to the origin, and cooperates with Scutellaria baicalensis and Phellodendron chinense to communicate the heart and kidney. Clearing Pinellia ternata, drying dampness and resolving phlegm, harmonizing the stomach and reducing adverse reactions; bamboo shavings clear heat and resolve phlegm, eliminate restlessness and harmonize the stomach; tangerine peel and yam strengthen the spleen and regulate qi; coix seed eliminates dampness and calms the heart, and helps to clear Pinellia ternata, strengthen the spleen and resolve phlegm, and harmonize the stomach and tranquilize the mind. The combination of these medicines can strengthen the spleen and nourish blood, connect the heart and kidney, dry dampness and move the spleen, resolve phlegm and regulate qi, so that the spleen and stomach qi can rise and fall normally, qi and blood, yin and yang can return to their respective positions, and sleep and wakefulness can be peaceful. The experimental results showed that the PSQI score and TCM syndrome score of the Chinese medicine combination group and the Chinese medicine combination combined with alprazolam group were significantly lower than those of the alprazolam group alone, and the total effective rate of the Chinese medicine combination combined with alprazolam group was significantly higher than that of the alprazolam group alone, indicating that the effect of the Chinese medicine combination in treating insomnia is equivalent to or better than that of benzodiazepines.

[0142] The bidirectional neuroendocrine loop (brain-gut interaction) formed between the central nervous system and the enteric nervous system can regulate gastrointestinal function. The present invention's research shows that the Chinese medicine composition improves the central 5-HIAA content and 5-HIAA / 5-HT ratio of insomnia patients by regulating the stomach, indicating that the Chinese medicine composition may improve insomnia symptoms by protecting the central nervous system function and upregulating the activity of central 5-HT neurons.

[0143] In summary, the formula of the Chinese medicine composition of the present invention, the Chinese date seed, the Chinese cypress seed and the Polygonum multiflorum vine in the prescription have the effect of nourishing the heart and calming the mind, and the combination of tortoise shell and raw oyster nourishes yin and suppresses yang, and increases the calming effect. Scutellaria baicalensis and Phellodendron chinense purge heat and eliminate lumps, clear the heart and relieve restlessness; cinnamon bark leads fire back to the origin, and cooperates with Scutellaria baicalensis and Phellodendron chinense to communicate the heart and kidney. Qing Banxia dries dampness and resolves phlegm, harmonizes the stomach and reduces adverse reactions; bamboo shavings clear heat and resolve phlegm, relieve restlessness and harmonize the stomach; tangerine peel and Chinese yam strengthen the spleen and regulate qi; coix seed resolves dampness and calms the mind and helps Qing Banxia drenches the spleen and resolves phlegm, harmonizes the stomach and calms the mind. All the medicines are used together to strengthen the spleen and nourish blood, communicate the heart and kidney, dry dampness and move the spleen, resolve phlegm and regulate qi, so that the spleen and stomach qi mechanism rises and falls normally, qi, blood, yin and yang return to their respective positions, and sleep peacefully.

[0144] The present invention studies the effect of the above-mentioned Chinese medicine composition on the mRNA expression of tryptophan hydroxylase 2 (TPH2), a key protein of the central 5-HT synaptic signaling pathway, and the 5-HIAA content and the 5-HIAA / 5-HT ratio of the 5-HIAA transporter (Slc6a4) in the rat model of insomnia with spleen deficiency syndrome caused by complex factors. The results show that the Chinese medicine composition can up-regulate the mRNA expression of TPH2 and Slc6a4 in the dorsal raphe nucleus of the rat model of insomnia with spleen deficiency syndrome, and up-regulate the 5-HIAA content and the 5-HIAA / 5-HT ratio, thereby finally improving the insomnia symptoms.

[0145] The above-mentioned implementation cases only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis, characterized in that: The lotus jelly is formed by mixing a medicinal liquid made from a traditional Chinese medicine composition and konjac powder in a preset ratio. The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 1-5 parts of small-leaf lotus, 0.5-2.5 parts of spiny jujube seeds, 0.5-2.5 parts of astragalus, 0.5-2.5 parts of longan pulp, 16-20 parts of gelling agent, 2-10 parts of sweetener, and 0.9-1.4 parts of acidulant.

2. The small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis according to claim 1, characterized in that: The Chinese medicine composition is made from the following raw materials in parts by weight: 2-2.6 parts of small-leaf lotus, 1.3-1.9 parts of sour jujube seeds, 1.3-1.9 parts of astragalus, 1.3-1.9 parts of longan pulp, 17-19 parts of gelling agent, 3.5-5.5 parts of sweetener, and 1-1.2 parts of sour agent.

3. The small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis according to claim 1, characterized in that: The Chinese medicine composition is made of the following raw materials in parts by weight: 2.3 parts of microphylla, 1.6 parts of spiny jujube seeds, 1.6 parts of astragalus, 1.6 parts of longan pulp, 1 part of gelling agent, 4.6 parts of sweeteners, and 1.15 parts of sour agents.

4. The lotus jelly with the effect of improving qi deficiency and blood stasis according to claim 1, characterized in that: The medicinal liquid prepared from the traditional Chinese medicine composition and the konjac powder are prepared in a preset ratio of (4.5-7):

1.

5. The small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis according to claim 1, characterized in that: The sweetener comprises white sugar, honey or erythritol, the gelling agent comprises konjac flour, and the acidulant comprises citric acid, malic acid or lactic acid.

6. The method for preparing the small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis according to any one of claims 1 to 5, characterized in that: The following steps are involved: Put the medicinal materials into the pot, and add appropriate amount of water to completely immerse the medicinal materials, wherein the medicinal materials include small leaf lotus, spiny jujube seeds, longan pulp and astragalus; Soaking the medicinal material for a first preset time to ensure that the active ingredient in the medicinal material can be dissolved; Using a first preset fire power to boil the mixture formed by the medicinal materials and clean water; After boiling, switching to a second preset fire and continuing to stew for a second preset time to obtain a mixed solution containing the medicinal material extract; Filtering the mixed solution to remove the drug residue to obtain a clarified drug solution; Adding the pre-prepared konjac powder, sweetener and acidulant to the clarified medicinal solution; Continue stewing for a third preset time under the second preset fire condition until a uniform and stable gel is formed; The formed gel is transferred into a mold, placed in a suitable environment for shaping and cooling, and finally a finished product of lotus jelly is obtained.

7. The method for preparing the small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis according to claim 6, characterized in that: The temperature of the first preset firepower is 150-160°C, and the temperature of the second preset firepower is 100-120°C.

8. The method for preparing the small-leaf lotus jelly having the effect of improving qi deficiency and blood stasis according to claim 6, characterized in that: The first preset time is 20-40 minutes, the second preset time is 20-40 minutes, and the third preset time is 2-5 minutes.

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