AU2021102527A4 - A tonifying and balancing restorative paste - Google Patents

Abstract

The present disclosure belongs to the field of pharmaceutical technology, and pertains to a tonifying and balancing restorative paste, containing the ingredients: American Ginseng 15g, Astragalus 45g, Dry-fried Atractylodes macrocephala 45g, Poria cocos 45g, Angelica sinensis 45g, Raw Rehmannia glutinosa 22.5g, Prepared Rehmannia glutinosa 22.5g, Dendrobium 45g, Cortex Phellodendri 22.5g, Dioscorea japonica 30g, Semen Euryales 45g, Ganoderma 45g, Fructus Amomi 15g, Raw White Peony Root 45g, Dong-E-E-Jiao (donkey hide gelatin) 1.5 pieces, Fructus Citri sarcodactylis 15g, Citron Peel 15g, Cortex Moutan 30g, Turmeric Root 30g, Bulbus Fritillariae thunbergii 30g, Asparagus Tuber 30g, and Radix Ophiopogonis 30g. When combined properly, the traditional Chinese medicines in the present disclosure act synergistically, and their toxicity is reduced or eliminated. Its actions include strengthening the spleen and stomach, tonifying qi and blood, and nourishing the liver and kidney. Drawings Fig. 15 Fig. 16 7

Description

Drawings

Fig. 15

Fig. 16

Description

A tonifying and balancing restorative paste

Field of the Disclosure The present disclosure belongs to the field of pharmaceutical technology, and particularly relates to a tonifying and balancing restorative paste. Background of the Disclosure The treatment methodologies commonly employed within the industry are as follows: Functional dyspepsia (FD) refers to a group of clinical syndromes caused by gastric and duodenal dysfunction in the absence of organic disease. It is the most common clinical functional gastrointestinal disease. The main symptoms of FD include early satiety, postprandial fullness, epigastric pain, epigastric burning, loss of appetite, belching, and acid reflux. An epidemiological survey performed in Western countries showed that FD affects 19% to 41% of the total population. An epidemiological survey performed in China showed that FD patients account for about 10% of outpatient visits to general internal medicine clinics and about 50% of outpatient visits to gastroenterology specialists. Although FD is a benign disease, it frequently recurs and the course of the disease may be prolonged, impacting not only the routine life and work of patients and thus detracting from quality of life, but also consuming copious medical resources. As everyday life grows more fast-paced, dietary recommendations are modified, and work becomes increasingly stressful, the incidence of FD has likewise risen year after year. The pathogenesis of FD has not yet been fully elucidated. Western medicine attributes involvement to numerous factors, including gastrointestinal motility disorder, Helicobacter pylori infection, abnormal gastrointestinal hormone secretion, visceral hypersensitivity, abnormal gastric acid secretion, societal and psychological factors, diet, lifestyle, and genetics. As the pathogenesis remains unclear, Western

Description medicine has been unable to offer a very effective therapy or drug regimen. Treatment focuses mostly on promoting gastrointestinal motility, inhibiting gastric acid production, protecting the gastric mucosa, attacking Helicobacter pylori, administering digestive enzymes, and alleviating depression and anxiety. Treatment efficacy is inconsistent, the condition is likely to recur, and the cost of long-term pharmaceutical intervention is high. FD is among the conditions for which Traditional Chinese Medicine (TCM) is particularly suited. Many new advances have been made in recent years, both clinically and theoretically. "Functional dyspepsia" is not a TCM diagnosis, but based on the primary symptoms and clinical presentation, most cases are categorized under the conditions of "epigastric distension" or "stomach pain". In TCM terms, FD may be due to an external pathogen, internal injury caused by diet, emotional dysregulation, deficiency of the spleen and stomach, or a weak constitution, which has damaged the spleen and stomach. Deficiency of the spleen impairs its transportation and transformation functions, in turn engendering damp-heat, phlegm-damp, and food retention, which obstructs the Middle Jiao and impedes the flow of qi in the Middle Jiao, leading to an imbalance in the up- and down-bearing functions of the spleen and stomach, liver qi constraint, failure of liver qi to course freely, or Wood overacting on deficient Earth. Liver qi counterflow invades the stomach, which then fails in its function of down-bearing, resulting in disharmony of the Qi Mechanism. Any of these pathologies can cause postprandial fullness, epigastric distention, loss of appetite, belching, and other symptoms of FD. TCM treatment of FD usually focuses on the liver, spleen, and stomach, employing strategies such as strengthening the spleen to benefit the qi, regulating qi to harmonize the stomach, nourishing yin to moisturize dryness, and dredging the liver to regulate qi. Summary of issues with current techniques: Western medicine has been unable to offer a very effective therapy or drug regimen. Treatment focuses mostly on promoting gastrointestinal motility, inhibiting gastric acid production, protecting the gastric mucosa, attacking Helicobacter pylori,

Description administering digestive enzymes, and alleviating depression and anxiety. Treatment efficacy is inconsistent, the condition is likely to recur, and the cost of long-term pharmaceutical intervention is high.

Summary of the Disclosure This disclosure describes a tonifying and balancing restorative paste created in response to the above issues. The present disclosure, a tonifying and balancing restorative paste, is comprised of American Ginseng 15g, Astragalus 45g, Dry-fried Atractylodes macrocephala 45g, Poria cocos 45g, Angelica sinensis 45g, Raw Rehmannia glutinosa 22.5g, Prepared Rehmannia glutinosa 22.5g, Dendrobium 45g, Cortex Phellodendri 22.5g, Dioscorea japonica 30g, Semen Euryales 45g, Ganoderma 45g, Fructus Amomi 15g, Raw White Peony Root 45g, Dong-E-E-Jiao (donkey hide gelatin) 1.5 pieces, Fructus Citri sarcodactylis 15g, Citron Peel 15g, Cortex Moutan 30g, Turmeric Root 30g, Bulbus Fritillariae thunbergii 30g, Asparagus Tuber 30g, and Radix Ophiopogonis 30g. Each piece of Dong-E-E-Jiao is 31.25g. An additional purpose of the present disclosure is to provide a preparation of said tonifying and balancing restorative paste in pill form. An additional purpose of the present disclosure is to provide a preparation of said tonifying and balancing restorative paste in powder form. An additional purpose of the present disclosure is to provide a preparation of said tonifying and balancing restorative paste in bolus form. An additional purpose of the present disclosure is to provide a preparation of said tonifying and balancing restorative paste in tincture form. An additional purpose of the present disclosure is to provide a preparation of said tonifying and balancing restorative paste in distillate form. An additional purpose of the present disclosure is to provide a preparation of said tonifying and balancing restorative paste in decoction form. An additional purpose of the present disclosure is to provide a preparation of

Description said tonifying and balancing restorative paste in tablet form. An additional purpose of the present disclosure is to provide a preparation of said tonifying and balancing restorative paste in paste form. In summary, the advantages and positive effects of the present disclosure include: The paste formulation described herein is indicated for treatment of constitutional deficiency, fatigue syndromes, suboptimal health status, chronic diseases, and other pathological conditions related to spleen deficiency with qi stagnation. Spleen deficiency refers here to deficiency of spleen qi or spleen yin. In TCM theory, the spleen is called the "root of postnatal qi" and "the generative source of qi and blood", which are references to its functions of absorbing, utilizing, and distributing the dietary intake. The spleen makes use of ingested nutrients and conveys them within the body, thus supplying the material and energetic basis for growth, development, reproduction, and life activities. A maxim of TCM states that "a spleen that flourishes in all four seasons can stave off pathogenic qi". That is, if spleen function is exuberant, the Healthy Qi will dominate and pathogenic qi will be unable to assert itself; but if the spleen is deficient, a multitude of diseases can result. Pathological changes in the spleen are most commonly syndromes of deficiency, primarily presenting as physiological abnormalities. Specific syndromes are differentiated according to deficiency of spleen qi, yin, or yang, etc. Qi and yin deficiencies are the types for which the described paste formulation is most appropriate. Failure of the spleen to transform and transport is a pathology of dysfunction which inevitably disrupts the digestion, absorption, and utilization of ingested nutrients, and leads to diminished appetite, abdominal distention and pain, loose stools, weight loss, and fatigue. Dysfunctional transformation and transportation of fluids by the spleen causes fluid retention, which engenders dampness, phlegm-rheum, and other pathological factors. The spleen is referred to as the "mother of the five viscera". The Yellow

Description Emperor's Inner Classic states "the True Qi of the Five Viscera is moistened by the spleen." The spleen yin is the essence refined from ingested food and water; it keeps the internal organs moist and supple. The fluids of the internal organs likewise flow through the spleen; the spleen yin is the major wellspring of all the body's organs. Esteemed physician of the modern era, Pu Fuzhou, put forth the idea that spleen yin deficiency is characterized by "restlessness with sensation of heat and dry mouth but no desire to drink; irritability with bloating, fullness, and no desire to eat." When the spleen yin is deficient, the transformation and transportation functions are diminished, and so it presents as loss of appetite, postprandial abdominal distention, a red tongue with scanty fur, and a thin pulse. Insufficiency of the spleen yin depletes the source of qi and blood. If the blood is unable to nourish the heart, the presentation will include dizziness, spotty vision, palpitations or racing heart, dry mouth, or chapped lips, restless or dream-disturbed sleep, forgetfulness, and irritability with sensation of heat. Deficiency of both yin and blood leaves the Nutritive Qi unable to circulate around the entire body. Disharmony ensues and the limbs and bones are deprived of nourishment. Therefore, the presentation will include listlessness or lethargy, weight loss, lackluster complexion, red tongue with scanty fur, possibly peeling; pulse is thin and forceless, rapid, or choppy. Spleen yin insufficiency with qi deficiency presents with hemorrhoids or organ prolapse, listlessness or somnolence, shortness of breath that worsens on exertion, irritability with heat in the palms, soles and sternum, and pallid and lackluster complexion. Sweet medicines, either neutral or cooling, that have moistening, tonifying and nourishing properties, without being drying or cloying, should be used. Zhang Xichun wrote "Bland flavored medicines are able to nourish the spleen yin." When moistening the spleen yin, the spleen qi should always be tonified along with it. Gan's balancing restorative paste contains several types of tonifying traditional Chinese medicines, including raw astragalus, American ginseng, and atractylodes macrocephala, which supply the nutrients the body needs. While also strengthening the spleen and benefiting the kidney, tonifying qi and nourishing blood, and

Description harmonizing yin and yang, they also strengthen the constitution, improve immunity, promote absorption and exploitation of nutrients by the body, and ameliorate the clinical symptoms of spleen deficiency. The restorative paste described in the present disclosure can effectively alleviate symptoms of FD due to TCM syndromes of spleen deficiency and qi stagnation, as well as improve the quality of life. It is safe for clinical application, and shows efficacy reliable enough to be worthy of clinical recommendation. The effects of the most traditional Chinese medicines are relatively mild. When combined properly, they act synergistically, and their toxicity is reduced or eliminated. The restorative paste is properly formulated according to the natures of the ingredients, the meridians they enter, their effects, and their dosages. It functions to strengthen the spleen and stomach, tonify qi and blood, and moisten the liver and kidney. The restorative paste described in this disclosure has no acute toxicity, and is safe for oral administration at the clinically recommended daily dosage for adults. After beginning treatment with the restorative paste described in the present disclosure, quality of life in the treatment group improved in all areas as compared with before treatment, and the difference was statistically significant (P<0.05). In the control group, all areas except for stress showed improvement compared to before treatment, and the difference was statistically significant (P<0.05). Compared with the control group, the treatment group improved significantly in terms of daily life, sleep, feeling of well-being, stress, and total score, and the differences were statistically significant (P<0.05), but there was no statistical difference in anxiety, diet, malaise, or disease control (P> 0.05). According to the results of the pre-test, the acute toxicity test of the restorative paste described in the present disclosure could not determine the median lethal dose (LD50), so a maximum dose experiment (formal experiment) was carried out. During the 14-day observation period of the formal experiment, no abnormal reactions or obvious toxic side effects were observed in any mice, and there were no deaths. The blood analysis and liver and kidney functions of the mice in the experimental group

Description and the control group were all normal. The gross dissection results and the H&E stains of the liver, heart, spleen, lung, kidney, and stomach were all normal, with no obvious abnormal changes. The restorative paste described in the present disclosure can effectively alleviate symptoms of FD due to TCM syndromes of spleen deficiency and qi stagnation, as well as improve the quality of life, and is safe for clinical application. Compared with the Western medicine Mosapride Citrate Dispersible Tablets, the restorative paste herein described can more effectively relieve the symptoms of epigastric distension, poor appetite and fatigue in patients with FD due to spleen deficiency and qi stagnation, and exhibits more reliable efficacy in improving patients' daily life, sleep, feeling of well-being, and stress. The maximum dose given to mice by intragastric administration in the embodiments of the present disclosure is equivalent to 120 times the daily clinical dose for human adults, suggesting that the restorative paste has no acute toxicity and is safe for oral administration at the clinically recommended daily dose in adults. The restorative paste described in this disclosure follows the principle of "using a paste formulation for tonification in the wintertime". Paste is one of the eight types of medicinal preparation used in Traditional Chinese Medicine, i.e. pills, powders, pastes/creams, boluses, tinctures, distillates, decoctions, and tablets. Brief Description of the Drawings Fig. 1 is a flow chart of the method of preparing the tonifying and balancing restorative paste described in the embodiments of the present disclosure. Fig. 2 is a flow chart of the method for measuring the acute toxicity of the tonifying and balancing restorative paste described in the embodiments of the present disclosure in the treatment of FD due to spleen deficiency and qi stagnation. Fig. 3 is a flow chart of the method for constructing the animal model for verifying the efficacy in treating spleen deficiency and qi stagnation of the tonifying and balancing restorative paste described in the embodiments of the present disclosure.

Description Fig. 4 is a roadmap of the experimental techniques described in the embodiments of the present disclosure. Fig. 5 is a schematic diagram of the liver tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 6 is a schematic diagram of the liver tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Fig. 7 is a schematic diagram of the heart tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 8 is a schematic diagram of the heart tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Fig. 9 is a schematic diagram of the spleen tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 10 is a schematic diagram of the spleen tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Fig. 11 is a schematic diagram of the stomach tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 12 is a schematic diagram of the stomach tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Fig. 13 is a schematic diagram of the lung tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 14 is a schematic diagram of the lung tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Fig. 15 is a schematic diagram of the kidney tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 16 is a schematic diagram of the kidney tissue of the control group described in the embodiments of the present disclosure as seen under a microscope.

Detailed Description of the Preferred Embodiments The disclosure will now be described in detail with reference to the

Description embodiments to more clearly clarify the purpose, technical solution and advantages of the disclosure. It should be understood that the preferred embodiments described herein are only to explain the disclosure and are not intended to limit the disclosure. The tonifying and balancing restorative paste described in the embodiments of the present disclosure contains: American Ginseng (sliced and ground) 15g, Astragalus 45g, Dry-fried Atractylodes macrocephala 45g, Poria 45g, Angelica sinensis 45g, Raw Rehmannia glutinosa 22.5g, Prepared Rehmannia glutinosa 22.5g, Dendrobium 45g, Cortex Phellodendri 22.5g, Dioscorea japonica 30g, Semen Euryales 45g, Ganoderma 45g, Fructus Amomi 15g, Raw White Peony Root 45g, Dong-E-E-Jiao (donkey hide gelatin) 1.5 pieces (8 pieces equals 250g), Fructus Citri sarcodactylis 15g, Citron Peel 15g, Cortex Moutan 30g, Turmeric Root 30g, Bulbus Fritillariae thunbergii 30g, Asparagus Tuber 30g, and Radix Ophiopogonis 30g. In combination with the attached drawings, the following contents provide the application principle of the disclosure in detail. As shown in Fig. 1, the method of preparing the tonifying and balancing restorative paste described in the embodiments of the present disclosure is as follows: S101: The traditional Chinese medicines were soaked in water for 24 hours, then decocted, pressed to extract the liquid, and filtered a total of 3 times. S102: The three decoctions were then mixed and concentrated. S103: Ejiao dissolved in water was added, and the mixture formed into a paste by adding honey over low heat. As shown in Fig. 2, the method for constructing the animal model for verifying efficacy in treating spleen deficiency and qi stagnation of the tonifying and balancing restorative paste described in the embodiments of the present disclosure, is as follows: S201: A randomized control method was adopted to randomly divide 62 patients who met the criteria and have FD due to spleen deficiency and qi stagnation into a treatment group and a control group with 31 cases each. S202: The treatment group was given the restorative paste by mouth, and the

Description control group was given the Western medicine Mosapride Citrate Dispersible Tablets by mouth, each for a course of 4 weeks. S203: The groups were observed, and compared made of their TCM syndrome scores before and after treatment, their functional digestive disorder quality of life scale (FDDQL) scores and any adverse reactions, then treatment efficacy was evaluated and compared. As shown in Fig. 3, the method for constructing the animal model for verifying efficacy in treating spleen deficiency and qi stagnation of Gan's tonifying and balancing restorative paste described in the embodiments of the present disclosure, utilized the following procedure: S301: Forty SPF Kunming mice, half males and half females, were stratified by sex and randomly divided by random number table into an experimental group and a control group, each with 20 mice. S302: The experimental group was administered two consecutive doses at the maximum concentration of 0.75g/ml and maximum volume of 0.4ml/lOg by intragastric administration. The control group was administered two consecutive isometric doses of normal saline by intragastric administration. S303: The mice were routinely reared and observed for 14 days. Records were kept of their food and water intake, body weight, appearance, behavior, excretion, mental state, and condition in general, as well as deaths and toxic reactions. S304: After conclusion of the experiment, blood samples were taken from some of the mice for the blood analysis and the measurement of liver and kidney markers. After gross dissection, the liver, heart, spleen, lung, stomach, and kidney were examined for pathological changes with the naked eye and under a light microscope. The pre-test described in the embodiments of the present disclosure was carried out prior to the formal maximum dose experiment. The following pharmacological analysis further explains the application principle of the present disclosure. Atractylodes macrocephala: The main pharmacological mechanism of

Description atractylodes macrocephala in the treatment of spleen and stomach diseases is in promoting gastrointestinal motility and protecting the gastric mucosa. Atractylodes macrocephala regulates gastrointestinal motility in both directions, while also reducing gastric acid secretion, promoting the proliferation of gastric mucosal cells, and protecting the gastric mucosa. It enhances immune regulation, promotes cellular immunity and white blood cells proliferate to a certain extent. It also plays a certain role in protecting the liver and promoting the flow of bile, regulating blood glucose and the physiological functions of the heart, as well as exhibiting antibacterial, and anti-tumor activity. Poria cocos: Poria decoctions, syrups, ether extracts, and other preparations function to protect the liver and promote urination, as well as lower blood lipids and have sedative, anti-inflammatory, anti-tumor, and anti-aging properties. Poria decreases stomach acid secretion and prevents ulcers. Poria cocos polysaccharides regulate immune function. Administering poria decoction, atractylodes decoction, and atractylodes-poria decoction to rats with spleen deficiency has shown that all three can decrease expression of vasoactive intestinal peptide receptor 2 (VIPR2) in the plasma and colon tissue of spleen deficient rats. Poria decoction and atractylodes-poria decoction can also down-regulate levels of vasoactive intestinal peptide (VIP) in rats with spleen deficiency. Atractylodes-poria decoction outperforms a decoction of poria alone. Astragalus: Astragalus increases metabolism, combats fatigue, promotes urination, regulates blood glucose, improves immunity, strengthens myocardial contractility, exerts antibacterial, and antiviral effects, lowers blood lipids, and protects the cardiovascular system and the liver. Existing experiments on rats have found that astragaloside, an active component of astragalus, can inhibit apoptosis in rat gastric mucosal cells, accelerate proliferation of these cells, and play a role in protecting the gastric mucosa. American ginseng: Regarding mainly the cardiovascular, digestive, nervous, endocrine, and immune systems, a large number of analyses show that American

Description ginseng can counter hemorrhagic shock, protect the heart, regulate blood glucose, protect the nerves, stop bleeding, and exert anti-hypoxic, anti-convulsant, anti-tumor, and other effects. The amino acids and peptides contained in American ginseng promote the gastrointestinal motility of rats and strengthen immunity. Rats with spleen deficiency were administered concentrated extract of American ginseng for 10 days, and the levels of gastrin and cortisol in the serum were tested. The results showed that the levels of gastrin and cortisol in the serum of the spleen deficient rats were significantly lower than in normal rats. When spleen deficient rats were administered concentrated extract of American ginseng, levels of gastrin and cortisol increased, and symptoms of spleen deficiency improved. Angelica sinensis: Angelica promotes hematopoiesis, regulates angiogenesis, enhances immune function, exerts anti-arrhythmic, anti-inflammatory, analgesic, anti-thrombotic, and anti-tumor effects, and protects damaged nerves. Angelica regulates gastrointestinal function by relaxing GI smooth muscle, regulating peristaltic movement, and combating peptic ulcers. It has a wide range of clinical applications in the treatment of digestive system diseases. Albizia julibrissin: Albizzia flower exerts antidepressant, anxiolytic, sedative, soporific, antibacterial, and anti-obesity effects Experimental analysis using rats has shown that the bioflavonoids in albizia flower can increase escape latency times and number of successes (that is, improve learning and memory) in depressed rats, as well as increase endogenous expression of BDNF and TrkB in the CA3 region of the hippocampus, thereby protecting hippocampal neurons. Using the established isolation rearing with chronic unpredictable stress model of depression, it was found that the bioflavonoids in albizia flower can increase the behavioral score of rats and reduce apoptosis in neurons in the CA3 region of the hippocampus of rats. Citrus sarcodactylis: Citrus sarcodactylis (Buddha's hand) stops cough and relieves wheezing, lowers blood pressure, dilates coronary blood vessels, and exerts antioxidant, immunoregulatory, anti-inflammatory, and anti-tumor effects. Experiments have shown that the volatile oil contained in Buddha's hand has a strong

Description antidepressant effect, the mechanism of which may be related to reducing the serum level of cortisol (CORT) in depressed rats and promoting expression of brain-derived neurotrophic factor (BDNF) in the hippocampus. Experiments in rabbits and mice have shown that an alcohol extract of Buddha's hand can promote movement of the small intestine in mice, enhance contraction frequency and contractility in isolated rabbit ileum, as well as reduce the frequency and contractility of spontaneous activities of the isolated ileum. Fructus Amomi: Amomum promotes gastrointestinal motility, and exerts anti-ulcer, analgesic, anti-inflammatory, antidiarrheal, immunoregulatory, vasodilatory, antioxidant, and anti-tumor effects. Experiments in rats have shown that the volatile oil contained in amomum can significantly reduce levels of gastric juice and pepsin in rats, reducing total acidity; as well as increase levels of prostaglandin E2 and vasoactive intestinal peptide in the gastric mucosa of rats, down-regulate gastrin, and inhibit the motor function of the small intestine in mice with diarrhea. Experiments on Wistar rats have shown that a water extract of amomum can significantly promote gastrointestinal motor function in rats. Tests with an amomum group of rats against control found that levels of motilin (MTL) and substance P (SP) in plasma, jejunal tissue and the gastric antrum were significantly higher in the amomum group, suggesting that amomum may promote gastrointestinal motility by increasing levels of MLT and SP in the blood and gastrointestinal tract. The amount of gastric acid and the concentration of pepsin collected from rat stomachs by ligation of the pylorus showed that amomum volatile oil can reduce levels of gastric acid and pepsin in rats, thereby exerting a protective effect on the gastric mucosa. White peony: White peony root promotes gastrointestinal motility and exerts sedative, analgesic, anticonvulsant, anti-inflammatory, immune-enhancing, hepatoprotective, and antihypertensive effects. Experiments on guinea pigs have shown that the glucosides contained in white peony root can prolong the contraction time of colonic smooth muscle, increase the contraction integral and the range of contraction, and regulate the motor function of the guinea pig colon, and that the

Description change in contractility has a certain relationship with the dose of total peony glucosides. Analysis of experimental colitis in rats has shown that peony glucosides can reduce levels of interleukin-6 (IL-6), interleukin-17 (IL-7) and interleukin-23 (IL-23) in the serum of rats with experimental colitis induced by TNBS, increase levels of transforming growth factor-pl (TGF-31) and forkhead box transcription factor 3 (FOXP3) in colon tissue, increase the expression of Treg cells, and reduce the activity of the Th17 cell population, thereby improving the symptoms of experimental colitis rats and inflammatory damage to colon tissue. Turmeric: Turmeric promotes liver cell regeneration, protects liver cells, and exerts antibacterial, anti-inflammatory, analgesic, anti-tumor, and anti-depressant effects. A decoction of turmeric can inhibit the formation and development of experimental ulcers in rats, and promote the expression of serum epidermal growth factor (EGF). Curcumin and volatile oil, the active ingredients in turmeric, promote the secretion and excretion of bile. Turmeric has been given to post-stroke depression (PSD) rats as intervention treatment. Analysis shows that a water extract of turmeric can significantly increase the behavioral score and sucrose water consumption of PSD rats, and promote the expression of VEGF and its receptor FLK-1 in the rat hippocampus. Dendrobium: Dendrobium exerts antioxidant and anti-inflammatory effects, improves liver function, lowers blood glucose, enhances immunity, lowers blood lipids, and promotes digestive function. Dendrobium promotes gastrointestinal motility and secretion of gastric juices, and aids with digestion. Accounts in ancient texts of its association with a robust GI tract show that dendrobium can protect the gastric mucosa, inhibit ulcers, promote the secretion of digestive juices and enzymes, regulate intestinal flora, enhance intestinal immunity, and promote excretion of feces. Euryales semen: Euryale seeds combat myocardial ischemia, counters fatigue, lowers blood glucose, and exerts antioxidant, anti-aging, and anti-tumor effects. Euryale extract has been administered to mice with acute gastric mucosal injury, and found to enhance superoxide dismutase (SOD) activity, reduce malondialdehyde

Description (MDA) levels, and increase levels of prostaglandin E2 (PGE2) in mice following gastric mucosal injury, and thereby play a role in protecting the gastric mucosa. Dioscorea japonica: Dioscorea enhances immunity, promotes gastrointestinal motility, lowers blood glucose, protects the liver, lowers blood lipids, and exerts anti-inflammatory, anti-bacterial, and anti-tumor effects. Administration of different doses of a decoction of raw dioscorea to mice with spleen-deficiency constipation has shown that, in relation to certain doses, as the concentration increases, the defecation function and small intestinal propulsion rate of the mice are strengthened, which may be related to dioscorea's ability to lower levels of vasoactive intestinal peptide (VIP) and substance P (SP). Ophiopogon japonicus: Ophiopogon regulates blood glucose and immunity, protects the myocardium and gastric mucosa, and exerts anti-shock, anti-sedative, and antibacterial effects. Asparagus root: Asparagus root exerts antibacterial, immune-enhancing, and anti-tumor effects. The active ingredient asparagine has certain anti-asthmatic, anti-tussive and expectorant properties. It dilates peripheral blood vessels, lowers blood pressure, enhances cardiac contractility, reduces heart rate, and increases urine output. Radix Moutan: Moutan exerts anti-inflammatory, anti-coagulation, and antibacterial effects, and increases coronary blood flow. The active ingredient paeonol exerts inhibitory effects on the CNS such as sedation and analgesia, and combats peptic ulcers and atherosclerosis. Raw Rehmannia glutinosa: Rehmannia lowers blood pressure, strengthens the heart, and exerts sedative, anti-inflammatory, anti-allergic, diuretic, anti-tumor, and other effects. Honey: Honey enhances humoral immunity, inhibits bacteria, is detoxifying, promotes wound healing, protects the liver, and exerts anti-tumor effects. Honey also increases the peristaltic propulsion rate in laboratory animals and significantly accelerates the excretion of feces.

Description The application principle of the disclosure will be further described below in combination with specific embodiments. Traditional Chinese Medicine emphasizes the "correspondence between nature and humanity", that is, the life activities of the human body are closely related to changes in the natural world. After the human body has experienced the three seasons of spring birth, summer growth, and autumn harvest, its physical strength will have been consumed to a certain extent. The accounts of yin and yang, qi and blood, are "overdrawn". With winter, arrives a time of rest and recuperation, when the body refuels and recharges, and can avail itself of science to regain balance. One of TCM's methods for regaining balance is through the use of tonifying pastes. Most of these pastes are focused on tonification and nourishment, which treat diseases as well as replenish deficiency. Winter is the season when the Essential Qi retreats. The human body has higher energy and nutritional requirements due to the cold, so its digestion and absorption functions are enhanced. Ingesting tonifying medicines in wintertime helps to extract the maximum amount of energy from nutrients and store it maximally within the body. The season of winter is thus regarded as the most opportune for use of medicinal tonics. The tonifying and balancing restorative paste works in accordance with the dual purpose of "supporting tonification with harmonizing" based on the idea of "using a paste formulation for tonification in the wintertime". The medicinal formulation emphasizes tonifying the spleen and stomach. This "root of postnatal qi" must function robustly in order to promote absorption of nutrients. A strong spleen and stomach will generate ample qi and blood to nourish the internal organs, muscles, and bones. The formulation also boosts the functioning of the "root of prenatal qi", the kidney, as well as harmonizing the qi and blood, the liver and stomach, and yin and yang. It unblocks the meridians, promotes somatic self-regulation, and improves immunity, thus laying the foundation for health in the years to come.

Description The tonifying and balancing restorative paste is appropriate for the following groups: (1) People with fatigue syndromes or suboptimal health status; (2) People with reduced energy, low physical fitness, or constitutional deficiency; (3) Patients with stable chronic diseases; (4) People under mental strain or those with immune disorders; (5) People recovering from surgery, childbirth, serious illness or injury; (6) Women in menopause or men in andropause. The application principle of the present disclosure is further explained below in conjunction with specific experiments. Experiment 1: 1. A total of 62 cases were collected and randomly divided into a treatment group and a control group, each with 31 cases. The treatment group contained 13 males and 18 females, all of which successfully completed the analysis. The control group contained 11 males and 20 females, but during the analysis period, a male patient withdrew due to dissatisfaction with treatment efficacy. Therefore, 1 case was eliminated, and a total of 30 cases were completed. (1) Comparison of sexes between the two groups Sex composition ratio of the two groups: The treatment group contains 13 males (41.94%) and 18 females (58.06%). The control group contained 10 males (33.33%) and 20 females (66.7%). Chi-squared tests were performed for both groups, 7 2 =0. 4 8 0, P=0.488, P> 0.05; indicating that the difference was comparable and not statistically significant. (See table 1)

Table 1: Comparison of sexes between the two groups Sex Group Number of Cases (n) Male Female

Treatment Group 31 13(41.94%) 18(58.06%)

Control Group 30 10(33.33%) 20(66.7%)

Total 61 23 38

Description

(2) Comparison of ages between the two groups Age among the two groups: The youngest in the treatment group was 22 years old, the oldest was 65, and the average age was (39.26+11.40). The youngest in the control group was 23 years old, the oldest was 64, and the average age was (40.47+11.43). The two groups were t-tested using two independent samples, t=0.413, P=0.681, P> 0.05; indicating that the difference was comparable and not statistically significant. (See Table 2)

Table 2: Comparison of ages between the two groups Number of Cases Age (Years) Group (n) Minimum Maximum Average( xs)

Treatment 31 22 65 39.26+11.40 Group

Control 30 23 64 40.47+11.43 Group

(3) Comparison of course of disease between the two groups Course of disease of the two groups: The shortest course among the treatment group was 9 months, the longest was 72 months, and the average was (29.97+17.75) months. The shortest course among the control group was 9 months, the longest was months, and the average was (31.06 14.70) months. The two groups were t-tested using two independent samples, t=0.263, P=0.793, P> 0.05; indicating that the difference was comparable and not statistically significant. (See table 3)

Table 3: Comparison of course of disease between the two groups Number of Cases Course of Disease (Month) Group (n) Shortest Longest Average( xs)

Treatment 31 9 72 29.97±17.75 Group

Control 30 9 60 31.06+14.70 Group

Description 2. Comparison of TCM syndrome total scores between the two groups Comparison was made within each group. The total TCM syndrome scores of both groups were lower than that before treatment. A paired t-test was performed for the treatment group before and after treatment, t=15.657, P=0.000, P<0.05; and for the control group before and after treatment, t =9.302, P=0.000, P<0.05; all suggesting that the differences were statistically significant. Comparison was made between the two groups. The total TCM syndrome scores of the treatment group and the control group were t-tested before treatment using two independent samples, t=0.212, P=0.833, P> 0.05; indicating that the difference was comparable and not statistically significant. After treatment, the total TCM syndrome score of the treatment group was significantly lower than that of the control group. Both groups were t-tested using two independent samples, t=-3.765, P=0.000, and P<0.05; indicating that the difference was statistically significant. (See table 4) Table 4: Comparison of TCM syndrome total scores between the two groups( x+s)

Group Number of Cases (n) Before Treatment After Treatment

Treatment Group 31 13.00±2.72 4.68±2.73

Control Group 30 12.83+3.40 7.60+3.32 3. Comparison of TCM syndrome treatment efficacy between the two groups After treatment, of the treatment group, 3 cases were clinically cured, 10 cases showed marked efficacy, 16 cases showed some efficacy, and 2 cases showed no efficacy. In the control group, 1 case was clinically cured, 4 cases showed marked efficacy, 20 cases showed some efficacy, and 5 cases showed no efficacy. The respective total effective rates of the two groups were 93.55% and 83.33%. The total effective rate of TCM syndromes in the treatment group was higher than in the control group. Rank sum test of the two groups: P=0.003 (P<0.05), suggesting that the difference was statistically significant. (See Table 5)

Table 5: Comparison of TCM syndrome treatment efficacy between the two groups

Description

Number Efficacy Total

of Effective Group Clinically Markedly Cases Effective Ineffective Rate Cured Effective (n) (%)

Treatment 31 3 10 16 2 93.55% Group

Control 30 1 4 20 5 83.33% Group 4. Comparison of individual symptom scores

Table 6: Comparison of individual symptom scores Treatment Group (n = 31) Control Group (n=30) Symptoms Before Treatment After Treatment Before Treatment After Treatment

Epigastric 3.10+1.99 0.97±1.25^* 3.00±1.88 1.80±1.69A* distention

Epigastric pain 2.71±2.04 1.19±1.68^ 2.40+2.06 1.47±1.74A

Poor appetite 3.55+1.61 1.03+1.45^* 3.33+1.52 2.00 .89A*

Belching 1.48+0.96 0.74±0.86^ 1.60+0.93 0.90±0.88A

Fatigue 1.06+1.00 0.45+0.68^* 1.27+1.01 0.97+0.96*

Loose stools 1.10+1.08 0.29±0.59A 1.23+1.07 0.47±0.63A

Note: (1) ^ means P<0.05 for comparison of the treatment group before and after drug administration; (2)

Ameans P<0.05 for comparison of the control group before and after drug administration; (3) * means

P<0.05 for comparison of the treatment group and control group after drug administration.

Comparison of the individual symptom scores of the treatment group and the control group before treatment were all P> 0.05, and the differences were comparable and not statistically significant. Comparison of the two groups after treatment showed the individual symptom scores of the treatment group were lower than that before treatment. The paired t-test showed that the difference was statistically significant (P<0.05). The control group's individual symptom scores after treatment were higher

Description than those before treatment except for fatigue. The scores of other symptoms showed statistically significant differences from those before treatment (P<0.05). Comparison of the two groups after treatment showed the individual symptom scores of the treatment group were significantly lower than those of the control group. After testing, the two groups had statistically significant differences in the three symptoms of epigastric distension, poor appetite, and fatigue (P <0.05). There was no statistically significant difference in the three symptoms of epigastric pain, belching, and loose stools (P> 0.05). (See Table 6) 5. Functional Digestive Disorder Quality of Life Scale (FDDQL) score comparison

Table 7: Functional Digestive Disorder Quality of Life Scale (FDDQL) score comparison Treatment Group (n = 31) Control Group (n=30) Area Before After Before After Treatment Treatment Treatment Treatment Daily life 68.06+9.07 83.51+4.85^ 69.00+10.12 79.03+6.50*

Worry 54.19+10.97 77.81+8.14^ 53.53+11.34 76.57+7.34A

Diet 52.58+12.43 78.52+8.33^ 50.57+12.42 75.33+7.85A

Sleep 60.55+16.37 83.35+6.88A 59.13+15.99 80.45+8.73*

Malaise 62.45+11.01 83.71+7.43^ 64.40+10.29 82.37+6.07A

Feeling of 52.58±12.13 82.90±8.08^ 51.70±13.21 78.37±8.42* well-being Disease 49.26±16.60 80.81±8.38^ 50.13±15.48 79.37±8.95A control Stress 46.16+14.02 63.84+10.35L 47.00+13.84 49.10+12.49*

Total score 55.73+7.35 79.31+5.76^ 55.68+8.07 74.29+5.02*

Note: (1) ^ means P<0.05 for comparison of the treatment group before and after drug administration; (2)A

means P<0.05 for comparison of the control group before and after drug administration; (3) * means

Description

P<0.05 for comparison of the treatment group and control group after drug administration.

Comparisons of the FDDQL scores of the treatment group and the control group before treatment were P> 0.05 in all areas, and the differences were comparable and not statistically significant. Comparison within the two groups after treatment showed all areas of the treatment group were improved compared with before treatment, and the difference was statistically significant (P<0.05). All areas except stress, improved in the control group compared with before treatment, and the difference was statistically significant (P<0.05). Comparison of the two groups after treatment showed the treatment group improved significantly in terms of daily life, sleep, feeling of well-being, stress, and total score, and the differences were statistically significant (P<0.05), but there was no statistical difference in anxiety, diet, malaise, or disease control (P> 0.05). (See Table 7) 6. Comparison of adverse reactions between the two groups During the treatment period, 1 person in the treatment group developed mild dizziness on the 16th day of treatment, which was not treated, and resolved on its own after 2 hours. An interview and medical history showed it may be related to a missed dose of an antihypertensive drug on the same day. In the control group, 1 person developed mild diarrhea on the 2nd and 3 rd days of treatment, with loose, runny stools twice a day and returned to normal without treatment. 1 person developed nausea and discomfort on the 6th day of treatment, which was relieved on its own. The remainder did not have any adverse reaction. (See Table 8)

Table 8 Comparison of adverse reactions between the two groups Number of Adverse Group Number of Cases (n) Rate of Adverse Reactions Reactions

Treatment Group 31 1 3.23%

Control Group 30 2 6.67% The adverse reaction rate of the treatment group was lower than that of the control group. A Chi-squared test was performed, y 2=0.333, P=0.564, P> 0.05; the

Description difference was not statistically significant. Experiment 2: 1. Test Materials (1) Laboratory Animal 46 healthy SPF Kunming mice, weighing 18-22g, half males and half females, purchased from Hubei Provincial Laboratory Animal Analysis Center, license number: SCXK (Hubei) 2015-0018, animal quality certificate number: NO.42000600026224 Animal experimentation conducted at: Animal Analysis Center of Hubei Provincial Hospital of Traditional Chinese Medicine, experimentation unit license number: SYXK (Hubei) 2017-0095. Food, litter and sterile water for the mice were provided in the experimentation unit. During the experiment, the mouse enclosures were cleaned regularly and the litter was changed twice each week. The sterile drinking water was changed once a day, and sufficient food was provided for the mice every day. Experimental environment temperature: 20-26°C; Humidity: 40-70%. (2) Preparation of experimental drug The restorative paste is composed of more than 20 medicines, including dry-fried atractylodes, poria, astragalus, raw white peony, ginseng, dendrobium, ganoderma, American ginseng, cortex moutan, ophiopogon, asparagus root, turmeric, citrus sarcodactylis, and citron peel. The traditional Chinese medicines were soaked in water for 24 hours, then decocted, pressed to extract the liquid, and filtered a total of 3 times. The 3 decoctions were then mixed and concentrated. Ejiao dissolved in water was added, and the mixture formed into a paste by adding honey over low heat. One gram of paste is equivalent to 1.95 grams of crude ingredients. The daily adult dosage is one spoonful (~15g) twice daily in the morning and evening taken with warm water. 2. Test Method (1) Pre-test Six SPF Kunming mice weighing 18-22g, half females and half males, were adaptively reared in the Animal Analysis Center of Hubei Provincial Hospital of

Description Traditional Chinese Medicine for 3 days before the experiment, and then stratified by sex and randomly divided into a low-dose group, a medium-dose group, and a high-dose group, with 2 mice each. Before the experiment, the mice of both groups were fasted for 12 hours but were allowed water, and the mice were respectively given low dose 0.25g/ml, medium dose 0.45g/ml and high dose 0.75g/ml of tonifying and balancing restorative paste-i by intragastric administration. The mice were given a single dose according to their maximum tolerable volume (0.4ml/10g), and were allowed to resume eating and drinking freely after 4 hours. The mice were routinely reared and continuously observed for 7 days. Records were kept of their food and water intake, body weight, appearance, behavior, excretion, mental state, and other general conditions, as well as deaths and toxic reactions. After conclusion of the experiment, all mice were sacrificed by cervical dislocation, and gross dissection was performed to observe whether their livers, hearts, spleens, lungs, kidneys, stomachs, and other major organs had abnormal changes. Tissue or organs that exhibited abnormal changes in color, volume, or texture were subjected to histopathological examination 101. (2) Formal experiment (maximum dosage test) The pre-test was unable to determine the median lethal dose (LD50), so a formal maximum dose experiment was carried out. 1) Grouping Forty healthy SPF Kunming mice, half males and half females, weighing 18-22g, were stratified by sex and randomly divided by random number table into an experimental group and a control group, each with 20 mice. 2) Routes of drug administration and methods Before the experiment, the mice of both groups were fasted for 12 hours but were allowed water. The mice of the experimental group were administered two consecutive doses of No. 1 tonifying and balancing restorative paste by intragastric administration at the maximum concentration for intragastric administration (0.75g/ml) and the maximum volume (0.4ml/10g), spaced 6 hours apart. The control

Description group was administered two consecutive isometric doses of normal saline, spaced 6 hours apart. Neither group was given food or water during the spacing interval, but were allowed to resume eating and drinking freely 4 hours after the last dose. Afterwards, they were routinely reared for 14 days, given food and water each day at 8:30 a.m. 3) Observation Indicators The mice of both groups were observed for 14 days, noting their food and water intake, body weight, appearance, behavior, excretion, mental state, and other general conditions. They were closely observed for toxic reactions (time of onset, specific symptoms, duration, severity, and reversibility) and deaths. Special attention was paid to the condition of the mice on the day of intragastric administration. All mice were weighed on days 1, 7 and 14. After the 14 days, some of the mice were selected for orbital enucleation and the blood subjected to the hematology (WBC, RBC, HGB, PL) and analyzed for liver and kidney function (ALT, AST, BUN, CREA, UA). All mice were sacrificed by cervical dislocation. Their livers, hearts, spleens, lungs, kidneys, stomachs and other major organs were dissected and examined visually for abnormalities in color, volume, texture, and other signs of abnormality. The liver, heart, spleen, lung, stomach, and kidney tissues of some mice were fixed with 4% of paraformaldehyde at room temperature for 24 hours, and dehydrated, made transparent, waxed, embedded in paraffin, trimmed, sectioned, H&E stained, and examined under a light microscope. (3) Fig. 4 is a roadmap of the experimental techniques described in the embodiments of the present disclosure. 3 Statistical Methods The method used to translate the maximum dosage in mice to the clinically recommended daily dosage for human adults is as follows:

Maximum dosage for Average human adults body

Maximum each mouse (g) weight (60000g) (times) x dosage multiple= Average mouse body Recommended daily dosage

Description

weight (g) for human adults (g)

All experimental data were statistically analyzed using SPSS19.0 data analysis software. Measurement data are expressed as mean standard deviation( x+s). The t-test was used for the normal distribution, and the non-parametric rank sum test was used for the non-normal distribution. P<0.05 was taken as indicative of statistically significant difference. 4. Test Result (1) General Observation After intragastric administration, mice in the control group exhibited huddling behavior, reduced activity, quiescence with closed eyes, and delayed responsiveness. The mice in experimental group also exhibited reduced activity, quiescence with closed eyes, and delayed responsiveness, but their distribution was more scattered than that of the control group. The mice gradually returned to normal. During the experimental observation period, both groups of mice exhibited normal dietary and watering habits, were breathing evenly, had lustrous fur, were adeptly responsive, and had normal bowel movements and urination. No dyspnea, convulsions, vomiting, salivation, dyskinesia, biting, loose stools, restlessness, abnormal abnormalities, or other obvious side effects were observed. There were no deaths. (2) Changes in mouse body weight between the two groups The body weights of female and male mice were tallied separately. Before drug administration, the body weights of mice of the two groups were t-tested using two independent samples, and the difference was comparable and not statistically significant (P> 0.05). The weights were again measured on days 1, 7 and 14 after administration. The body weights of both female and male mice showed an increasing trend, and there was no statistically significant difference in body weight changes between the two groups of mice (P> 0.05). (See Table 9)

Table 9: Changes in body weight of mice( xs, n=10)

Body Weight (g) Group Sex Id 7d 14d

Description

Female 20.50±0.82 27.29+3.56 32.5±2.24 Control Group Male 21.58±2.63 34.17+3.37 40.08±3.15

Experimental Female 20.33+0.98 29.41+1.63 33.58+1.11

Group Male 21.81+1.79 33.56+2.44 39.63+3.94 (3) Murine blood test index results On 14 days after intragastric administration, the mice were subjected to orbital enucleation and the blood and biochemical markers analyzed. The results showed that WBC, RBC, HGB, and PLT of the experimental group and the control group were compared with no statistically significant differences (P> 0.05). Hepatic and renal function tests were compared, while ALT, AST, BUN, Crea, and UA showed no statistically significant differences (P> 0.05). (See Tables 10, 11)

Table 10: Murine blood analysis results (xs)

Index WBC(*1I09/L) RBC(*1012/L) HGB(g/L) PLT(*1I09/L) Group

Experimental 4.34+1.20 8.34+0.73 154.14+11.32 997.14±160.51 Group

Control 5.20±0.77 8.16±0.59 156.88±13.49 1077.38+163.76 Group

Table 11: Murine blood biochemistry results( xs)

Index BUN Crea ALT(U/L) AST(U/L) BUTN/CR UA(ptmol/L) Group (mmol/L) (ptmol/L)

Experimental 45.33+17.8 124.8+16.69 7.34+2.08 11.29+2.81 6.66+0.84 97.33+19.16 Group 0

Control 41.00+12.8 117.13+19.97 6.66+0.84 10.63+2.72 7.06+1.58 80.25+17.38 Group 8

(4) Gross dissection and pathology results of mice Gross dissection results: No abnormalities were seen on visual examination in

Description the color, volume or texture of the liver, heart, spleen, lungs, kidneys, stomach, large intestine, small intestine, bladder, or other major organs of the two groups of mice. There were no signs of swelling or atrophy, edema, adhesion, or sclerosis. As shown in Figs. 5-17, the livers, hearts, spleens, lungs, kidneys, and stomachs of some mice were sampled for paraffin-embedded sections and H&E staining. The tissue structures of both the experimental group and control group appeared normal under light microscopy, and no obvious abnormal changes were observed. Fig. 5 is a schematic diagram of the liver tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 6 is a schematic diagram of the liver tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Fig. 7 is a schematic diagram of the heart tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 8 is a schematic diagram of the heart tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Fig. 9 is a schematic diagram of the spleen tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 10 is a schematic diagram of the spleen tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Fig. 11 is a schematic diagram of the stomach tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 12 is a schematic diagram of the stomach tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Fig. 13 is a schematic diagram of the lung tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope. Fig. 14 is a schematic diagram of the lung tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Fig. 15 is a schematic diagram of the kidney tissue of the experimental group described in the embodiments of the present disclosure as seen under a microscope.

Description Fig. 16 is a schematic diagram of the kidney tissue of the control group described in the embodiments of the present disclosure as seen under a microscope. Note: All images are stained with H&E, and magnified x200. The applications of the present disclosure will be further described below in conjunction with the effects. (1) The restorative paste described in the present disclosure can effectively alleviate symptoms of FD due to TCM syndromes of spleen deficiency and qi stagnation, as well as improve their quality of life, and is safe for clinical application. (2) Compared with the Western medicine Mosapride Citrate Dispersible Tablets, the restorative paste herein described can more effectively relieve the symptoms of epigastric distension, poor appetite and fatigue in patients with FD due to spleen deficiency and qi stagnation, and exhibits more reliable efficacy in improving patients' daily life, sleep, feeling of well-being, and stress. (3) The maximum intragastric dose in mice in this experimental design was equivalent to 120 times the clinical daily dose for human adults, suggesting that the restorative paste has no acute toxicity and is safe for oral administration at the clinically recommended daily dose for adults. Although the disclosure has been illustrated and described herein with reference to preferred embodiments, it should not be construed as limiting the scope of the disclosure. Any modifications, equivalent substitutions and improvements that are within the spirit and principle of the disclosure are intended to be covered by the protection scope of the disclosure.

Claims (10)

Claims

1. A tonifying and balancing restorative paste, characterized in that the said tonifying and balancing restorative paste (by mass) consists of American Ginseng 15g, Astragalus 45g, Dry-fried Atractylodes macrocephala 45g, Poria 45g, Angelica sinensis 45g, Raw Rehmannia glutinosa 22.5g, Prepared Rehmannia glutinosa 22.5g, Dendrobium 45g, Cortex Phellodendri 22.5g, Dioscorea japonica 30g, Semen Euryales 45g, Ganoderma 45g, Fructus Amomi 15g, Raw White Peony Root 45g, Dong-E-E-Jiao (donkey hide gelatin) 1.5 pieces, Fructus Citri sarcodactylis 15g, Citron Peel 15g, Cortex Moutan 30g, Turmeric Root 30g, Bulbus Fritillariae thunbergii 30g, Asparagus Tuber 30g, and Radix Ophiopogonis 30g.

2. The tonifying and balancing restorative paste as claimed in claim 1, characterized in that each piece of Dong-E-E-Jiao is 31.25 g.

3. A tonifying and balancing restorative paste, as claimed in claim 1, prepared in pill form.

4. A tonifying and balancing restorative paste, as claimed in claim 1, prepared in powder form.

5. A tonifying and balancing restorative paste, as claimed in claim 1, prepared in bolus form.

6. A tonifying and balancing restorative paste, as claimed in claim 1, prepared in tincture form.

7. A tonifying and balancing restorative paste, as claimed in claim 1, prepared in distillate form.

8. A tonifying and balancing restorative paste, as claimed in claim 1, prepared in decoction form.

9. A tonifying and balancing restorative paste, as claimed in claim 1, prepared in tablet form.

10. A tonifying and balancing restorative paste, as claimed in claim 1, prepared in paste form.