A traditional Chinese medicine composition for regulating heart and spleen, a traditional Chinese medicine preparation and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for regulating heart and spleen, a traditional Chinese medicine preparation and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises a whole spleen and intestine-rectifying compound and a heart and blood-nourishing compound. The whole spleen and intestine-rectifying compound is prepared from Huangqi, Baishao, Fangji, Chaihu, Zhishi, Paojiang, Fuling, Zexie, Huangqi, Huanglian, Jiangbanxia, Shashen, Maidan and Zhigancao, and the heart and blood-nourishing compound is prepared from Danshen, Kuanshen, Chuanqiong, Sanqi, Gualou, Xiebai, Taoren, Tingshengzi, Hongshen, Dangui, Guizhi, Maidong, Honghua, Wuyi and Zhigancao. The application further provides preparation methods of granules, oral liquid and ointment of the traditional Chinese medicine composition. The application establishes a quality control system of thin-layer chromatography identification, high performance liquid chromatography content determination, microbial limit test and physical and chemical stability evaluation. The application is scientific in prescription and compatibility, controllable in quality, suitable for long-term conditioning and clinical application of patients with chronic heart and spleen diseases.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition, preparation and preparation method for regulating the heart and spleen. Background Technology

[0002] Traditional Chinese medicine theory holds that the heart governs blood vessels and stores the spirit, while the spleen governs transformation and transportation and controls blood. There is a close relationship between the heart and spleen, characterized by mutual generation and support, shared origin of qi and blood, and corresponding ascending and descending functions. Physiologically, the heart and spleen are interdependent. The spleen is the source of qi and blood production, and the essence of food and water it transforms is delivered to the heart, providing the material basis for the heart's function of governing blood vessels. When the heart's function of governing blood vessels is normal, blood circulation is smooth, and the spleen, nourished by the heart's blood, functions robustly. In pathological states, the heart and spleen often suffer from concurrent diseases, exhibiting mixed deficiencies and excesses, imbalances in qi and blood, and disordered ascending and descending functions. Excessive thinking depletes heart blood, which can lead to spleen dysfunction; improper diet damages the spleen and stomach, resulting in insufficient qi and blood production, which can also lead to heart blood deficiency. Therefore, chronic cardiovascular diseases and spleen and stomach diseases are highly correlated in their pathogenesis, and treating only the heart or only the spleen is insufficient to fundamentally solve the problem.

[0003] Currently, although there are many types of traditional Chinese medicine preparations used clinically to regulate the heart and spleen, they have many shortcomings. On the one hand, most of the existing publicly available prescriptions are fixed formulas with weak targeting of the pathogenesis, making them difficult to adapt to complex syndromes such as comorbid heart and spleen diseases, mixed cold and heat patterns, and mixed deficiency and excess patterns. On the other hand, existing prescriptions tend to focus on single treatment methods and fail to fully reflect the comprehensive treatment concept of treating both the heart and spleen, regulating both qi and blood, and using both cold and heat methods, making it difficult to achieve synergistic regulation of multiple organs and multiple targets.

[0004] Existing traditional Chinese medicine (TCM) preparations are limited to single dosage forms, failing to meet the diverse needs of outpatient treatment, home care, and long-term tonification, as well as the individualized requirements of patients. Therefore, there is an urgent need to develop a scientifically formulated TCM composition with a variety of dosage forms suitable for long-term safe use to regulate the heart and spleen. Summary of the Invention

[0005] In view of this, the present invention provides a traditional Chinese medicine composition, a traditional Chinese medicine preparation and a method for preparing the same for regulating the heart and spleen. The traditional Chinese medicine composition includes a compound formula for regulating the spleen and intestines and a compound formula for nourishing the heart and blood. It also provides preparation processes and quality control methods for three dosage forms: granules, oral liquids and pastes, in order to solve the problems of fixed formulations, single treatment methods and lack of quality control in existing traditional Chinese medicine compositions.

[0006] The technical solution provided by this invention is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for regulating the heart and spleen, comprising two compound formulas, namely a spleen-regulating and intestinal-cleansing compound formula and a heart-nourishing and blood-nourishing compound formula; The spleen-regulating and bowel-cleansing compound is made from the following ingredients in parts by weight: Astragalus membranaceus 10-14 parts, Paeonia lactiflora 10-14 parts, Stephania tetrandra 5-7 parts, Bupleurum chinense 5-7 parts, Citrus aurantium 8-12 parts, Zingiber officinale (processed) 5-7 parts, Poria cocos 10-14 parts, Alisma plantago-aquatica 5-7 parts, Scutellaria baicalensis 5-7 parts, Coptis chinensis 2-4 parts, Pinellia ternata (processed) 5-7 parts, Adenophora stricta 10-14 parts, Hordeum vulgare 13-17 parts, Glycyrrhiza uralensis (processed) 5-7 parts; The nourishing blood and qi compound formula is made from the following ingredients in parts by weight: Salvia miltiorrhiza 13-17 parts, Sophora flavescens 5-7 parts, Ligusticum chuanxiong 8-12 parts, Panax notoginseng 5-7 parts, Trichosanthes kirilowii 8-12 parts, Allium macrostemon 5-7 parts, Prunus persica 5-7 parts, Lepidium apetalum 5-7 parts, Panax ginseng 5-7 parts, Angelica sinensis 5-7 parts, Cinnamomum cassia 5-7 parts, Ophiopogon japonicus 10-14 parts, Carthamus tinctorius 2-4 parts, Schisandra chinensis 5-7 parts, Glycyrrhiza uralensis (processed) 10-14 parts.

[0007] Furthermore, the spleen-regulating and intestinal-cleansing compound is made from the following raw materials in parts by weight: Astragalus membranaceus 12 parts, Paeonia lactiflora 12 parts, Stephania tetrandra 6 parts, Bupleurum chinense 6 parts, Citrus aurantium 10 parts, Zingiber officinale (processed) 6 parts, Poria cocos 12 parts, Alisma plantago-aquatica 6 parts, Scutellaria baicalensis 6 parts, Coptis chinensis 3 parts, Pinellia ternata (processed) 6 parts, Adenophora stricta 12 parts, Hordeum vulgare 15 parts, Glycyrrhiza uralensis (processed) 6 parts. The nourishing blood and qi compound formula is made from the following ingredients in parts by weight: Salvia miltiorrhiza 15 parts, Sophora flavescens 6 parts, Ligusticum chuanxiong 10 parts, Panax notoginseng 6 parts, Trichosanthes kirilowii 10 parts, Allium macrostemon 6 parts, Prunus persica 6 parts, Lepidium apetalum 6 parts, Panax ginseng 6 parts, Angelica sinensis 6 parts, Cinnamomum cassia 6 parts, Ophiopogon japonicus 12 parts, Carthamus tinctorius 3 parts, Schisandra chinensis 6 parts, Glycyrrhiza uralensis 12 parts.

[0008] Secondly, the present invention provides a traditional Chinese medicine preparation for regulating the heart and spleen, comprising the above-mentioned traditional Chinese medicine composition for regulating the heart and spleen and pharmaceutically acceptable excipients.

[0009] Furthermore, the dosage form of the traditional Chinese medicine preparation is granules, oral liquid, or paste.

[0010] Thirdly, the present invention provides a method for preparing a traditional Chinese medicine preparation for regulating the heart and spleen as described above, comprising the following steps: S1. Take each raw material, add 8 to 10 times the weight of the medicinal materials in purified water, soak at room temperature, then decoct for the first time, filter, add 6 to 7 times the weight of purified water to the residue for the second decoction, and combine the two decoctions. S2. The decoction is coarsely filtered through a 200-mesh filter and then finely filtered through a 0.45μm microporous membrane. The filtrate is concentrated under reduced pressure at a vacuum of 0.06–0.08 MPa and a temperature of 60–70℃ to obtain a thick paste with a relative density of 1.20–1.25. S3. Mix the thick paste with dextrin and lactose evenly, prepare a soft mass using 75% ethanol, and after granulation, drying, and sizing, package it to obtain granules.

[0011] Fourthly, the present invention provides a method for preparing a traditional Chinese medicine preparation for regulating the heart and spleen as described above, comprising the following steps: S1. Take each raw material, add 8 to 10 times the weight of the medicinal materials in purified water, soak at room temperature, then decoct for the first time, filter, add 6 to 7 times the weight of purified water to the residue for the second decoction, and combine the two decoctions. S2. The decoction is coarsely filtered through a 200-mesh filter and then finely filtered through a 0.45μm microporous membrane. The filtrate is concentrated under reduced pressure at a vacuum of 0.06–0.08 MPa and a temperature of 60–70℃ to obtain a clear extract with a relative density of 1.05–1.10. S3. Mix the extract with steviol glycosides and potassium sorbate evenly, then filter through a 0.45μm microporous membrane, sterilize with steam, and fill into bottles to obtain the oral liquid.

[0012] Fifthly, the present invention provides a method for preparing a traditional Chinese medicine preparation for regulating the heart and spleen, as described above, comprising the following steps: S1. Take each raw material, add 8 to 10 times the weight of the medicinal materials in purified water, soak at room temperature, then decoct for the first time, filter, add 6 to 7 times the weight of purified water to the residue for the second decoction, and combine the two decoctions. S2. The decoction is coarsely filtered through a 200-mesh filter and then finely filtered through a 0.45μm microporous membrane. The filtrate is concentrated under reduced pressure at a vacuum of 0.06–0.08 MPa and a temperature of 60–70℃ to obtain a thick paste with a relative density of 1.38–1.42. S3. Add rock sugar to the thick paste, heat and stir until the rock sugar is completely melted, cool down and add sodium benzoate, stir well, and fill into the paste while hot to obtain the paste formula.

[0013] The components and their main effects in the traditional Chinese medicine composition used in this invention are as follows: Explanation of the formula for regulating the spleen and cleansing the intestines: This formula uses Astragalus membranaceus as the chief ingredient to invigorate the spleen and replenish qi, raise yang and lift prolapse, and protect the spleen and stomach, the foundation of acquired constitution, thereby improving the symptoms of spleen deficiency, weakness and poor digestion from the source.

[0014] The herbs are divided into two categories: liver-soothing and digestion-eliminating. White peony nourishes blood, softens the liver, and relieves pain; Bupleurum soothes the liver, relieves depression, and raises yang qi. The combination of the two harmonizes the liver and spleen, relieving abdominal distension and pain caused by liver stagnation. Fructus Aurantii Immaturus breaks up qi stagnation, eliminates stagnation, resolves phlegm, and disperses masses; Malt promotes qi circulation, aids digestion, strengthens the spleen, and stimulates appetite. The combination of the two helps to clear food stagnation and qi stagnation in the middle jiao, thus improving appetite.

[0015] The adjuvant herbs take into account four aspects: warming the middle jiao, clearing heat, promoting diuresis, and nourishing yin. Prepared ginger warms the middle jiao, strengthens the spleen, dispels cold, and stops diarrhea, thus dispelling cold pathogens from the spleen. Scutellaria baicalensis and Coptis chinensis clear heat, dry dampness, purge fire, and detoxify, clearing heat stagnation in the stomach and intestines. When combined with prepared ginger and ginger-processed Pinellia ternata, they form a pungent-opening and bitter-descending method to resolve the fullness and distension caused by the mixture of cold and heat. Ginger-processed Pinellia ternata dries dampness, resolves phlegm, descends rebellious qi, and harmonizes the stomach, eliminating nausea and fullness. Poria cocos strengthens the spleen, promotes diuresis, eliminates dampness, calms the mind, and soothes the nerves. Alisma plantago-aquatica promotes diuresis, eliminates dampness, and clears turbidity. Stephania tetrandra is bitter and cold, descends and drains, and promotes water metabolism and reduces swelling. The three herbs work together to eliminate dampness and guide pathogens downward, thus stopping loose stools. Adenophora stricta nourishes yin and clears heat, preventing the warming and drying herbs from consuming body fluids and restraining the bitter and cold herbs from damaging the yin, thus playing a protective and restraining role for yin.

[0016] Prepared licorice root is used as the guiding herb to tonify the spleen and replenish qi, harmonize the effects of other herbs, and ensure that the entire formula balances cold and heat, and combines tonification and purgation.

[0017] This formula combines tonification and purgation, cold and heat, and liver and spleen regulation, achieving the effects of strengthening the spleen and replenishing qi, soothing the liver and stomach, warming the middle jiao and clearing damp heat, regulating the middle jiao, and purifying the intestines and stopping diarrhea. It is mainly used to treat abdominal distension, poor appetite and weakness, irregular bowel movements, chronic intestinal dysfunction, and recurrent and persistent spleen and stomach weakness caused by spleen deficiency and qi stagnation, liver and spleen disharmony, and mixed cold and heat.

[0018] Explanation of the Formula for Nourishing Blood and Nourishing the Mind: This formula uses Danshen (Salvia miltiorrhiza) and red ginseng as the principal herbs. Danshen invigorates blood circulation, removes blood stasis, unblocks meridians, relieves pain, clears the heart and eliminates irritability, directly clearing blood stasis in the heart vessels to treat the symptoms. Red ginseng greatly replenishes vital energy, restores pulse, consolidates the body, and nourishes qi and blood to treat the root cause. The combination of the two herbs addresses both qi and blood, closely targeting the core pathogenesis of deficiency of both heart and spleen, and qi deficiency and blood stasis.

[0019] The main ingredients are divided into two categories: those that invigorate blood and remove blood stasis, and those that promote yang and resolve phlegm. Chuanxiong invigorates blood, promotes qi circulation, dispels wind and relieves pain, and removes blood stasis. Sanqi disperses blood stasis, stops bleeding, reduces swelling and relieves pain, and disperses blood stasis in the heart vessels. Taoren invigorates blood, removes blood stasis, moistens the intestines and promotes bowel movement. The three ingredients work together with Danshen to enhance the effect of promoting blood circulation and removing blood stasis. Gualou clears heat and eliminates phlegm, and relieves chest congestion. Xiebai promotes yang, disperses congestion, and promotes qi circulation and relieves stagnation. The two are a classic combination to promote chest yang and resolve phlegm and turbidity obstruction. Tinglizi drains the lungs and relieves asthma, promotes diuresis and reduces swelling, and eliminates phlegm and edema that is affecting the heart, relieving shortness of breath, wheezing and edema of the limbs. Guizhi warms and unblocks the meridians, assists yang and promotes qi transformation, warms and invigorates chest yang, and dispels cold stagnation, assisting Gualou and Xiebai in promoting yang and opening up obstruction.

[0020] The adjuvant herbs also nourish blood and yin, clear heat and calm the mind. Angelica sinensis replenishes blood, invigorates blood circulation, moistens the intestines and promotes bowel movements, thus assisting in the function of nourishing and promoting blood circulation. Safflower invigorates blood circulation, unblocks menstruation, disperses blood stasis and relieves pain, thus enhancing the ability to invigorate blood circulation and unblock the meridians. Sophora flavescens clears heat and dries dampness, clears stagnation of heat in the heart meridian, relieves irritability and calms the mind. Ophiopogon japonicus nourishes yin and generates fluids, moistens the lungs and clears the heart. Schisandra chinensis astringes and consolidates, invigorates qi and calms the mind, stops sweating and calms the mind. The combination of the two herbs nourishes yin and astringes heart qi, improving insomnia, palpitations and restlessness caused by the dissipation of heart qi.

[0021] Prepared licorice root is used as an adjuvant to tonify the spleen and replenish qi, and to harmonize the effects of other herbs. It can both moderate the harshness of blood-activating herbs and strengthen the spleen and consolidate the foundation.

[0022] The formula uses danshen and red ginseng to nourish both qi and blood, with herbs that invigorate blood circulation, clear phlegm, and promote yang. It also includes herbs that nourish blood and yin, clear heat, and calm the mind. The formula harmonizes the spleen and promotes the overall effects of invigorating qi and nourishing the heart, invigorating blood circulation and removing blood stasis, promoting yang and relieving pain, calming the mind and soothing the nerves, and harmonizing the qi and blood of the heart and spleen. It is mainly used to treat palpitations, shortness of breath, insomnia, dreaminess, physical weakness and fatigue, and restlessness caused by deficiency of both heart and spleen, qi deficiency and blood stasis, and obstruction of the heart vessels.

[0023] The beneficial effects of this invention are as follows: 1. This invention is based on the holistic treatment concept of the heart and spleen, and constructs two sets of traditional Chinese medicine compositions: a spleen-regulating and intestinal-cleansing compound and a heart-nourishing and blood-tonifying compound. The spleen-regulating and intestinal-cleansing compound uses Astragalus membranaceus as the chief herb to strengthen the spleen and consolidate its foundation, with Bupleurum chinense and Paeonia lactiflora as assistant herbs to harmonize the liver and spleen, Citrus aurantium and Hordeum vulgare to promote digestion and relieve stagnation, and pungent and bitter herbs to disperse dampness and protect yin as adjuvant herbs. Glycyrrhiza uralensis is used as the guiding herb to harmonize all the herbs. It combines tonification and purgation, cold and heat, and liver and spleen regulation, precisely targeting chronic gastrointestinal disorders caused by spleen deficiency and qi stagnation, liver and spleen disharmony, and mixed cold and heat, addressing both the root cause and symptoms, and achieving stable efficacy. The heart-nourishing and blood-tonifying compound uses Salvia miltiorrhiza and Panax ginseng as the chief herbs to tonify both qi and blood, with blood-activating, stasis-removing, yang-clearing, and phlegm-resolving herbs as assistant herbs, and blood-nourishing, yin-nourishing, heat-clearing, and heart-calming herbs as adjuvant herbs. Glycyrrhiza uralensis is used as the guiding herb to harmonize and strengthen the spleen, combining tonification and purgation, activating blood without harming the body's vital energy, targeting palpitations, insomnia, chest tightness, and shortness of breath caused by deficiency of both heart and spleen, qi deficiency, and blood stasis, tonifying without stagnation and purging without harming the body's vital energy. Both sets of compound prescriptions are scientifically formulated, achieving the therapeutic goals of treating both the heart and spleen, regulating both qi and blood, and synergistically regulating multiple organs, thus possessing good clinical application value.

[0024] 2. This invention provides three dosage forms: granules, oral liquids, and herbal pastes. All three dosage forms employ a standardized extraction process involving segmented soaking, secondary decoction, and vacuum low-temperature concentration, resulting in minimal batch-to-batch variation. Granules are convenient to carry and take, suitable for outpatient treatment and daily care; oral liquids are rapidly absorbed and have a quick onset of action, suitable for patients with acute exacerbations or those requiring rapid relief; herbal pastes have a pleasant taste and a mild, long-lasting effect, suitable for long-term tonification and conditioning during the recovery period of chronic diseases.

[0025] 3. This invention establishes a quality control system encompassing thin-layer chromatography (TLC) identification, high-performance liquid chromatography (HPLC) content determination, microbial limit testing, and physicochemical stability evaluation. TLC can specifically identify characteristic components such as Astragalus membranaceus, Paeonia lactiflora, Scutellaria baicalensis, Salvia miltiorrhiza, Ligusticum chuanxiong, and Schisandra chinensis. HPLC can quantify effective components such as baicalin, paeoniflorin, tanshinone IIA, ferulic acid, and schisandrol A. Combined with microbial limit testing and accelerated stability testing, this system ensures the safety, efficacy, and quality stability of the product. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with the embodiments of this invention. Obviously, the described embodiments are only a part of the embodiments of this invention, not all of them. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention. Experimental methods in the following embodiments that do not specify specific conditions are generally performed under conventional conditions or as recommended by the manufacturer. Unless otherwise stated, percentages and parts are weight percentages and parts by weight.

[0027] Unless otherwise specified, the technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. It should be noted that the terms used herein are for the purpose of describing particular embodiments only and are not intended to limit the exemplary embodiments of this application.

[0028] Example 1: Preparation of Granules This embodiment provides a traditional Chinese medicine composition for regulating the heart and spleen, comprising two compound formulas: a spleen-regulating and intestinal-cleansing compound formula and a heart-nourishing and blood-nourishing compound formula. The spleen-regulating and bowel-cleansing compound is made from the following ingredients in parts by weight: Astragalus membranaceus 12 parts, Paeonia lactiflora 12 parts, Stephania tetrandra 6 parts, Bupleurum chinense 6 parts, Citrus aurantium 10 parts, Zingiber officinale (processed) 6 parts, Poria cocos 12 parts, Alisma plantago-aquatica 6 parts, Scutellaria baicalensis 6 parts, Coptis chinensis 3 parts, Pinellia ternata (processed) 6 parts, Adenophora stricta 12 parts, Hordeum vulgare 15 parts, Glycyrrhiza uralensis (processed) 6 parts. The nourishing blood and qi compound formula is made from the following ingredients in parts by weight: Salvia miltiorrhiza 15 parts, Sophora flavescens 6 parts, Ligusticum chuanxiong 10 parts, Panax notoginseng 6 parts, Trichosanthes kirilowii 10 parts, Allium macrostemon 6 parts, Prunus persica 6 parts, Lepidium apetalum 6 parts, Panax ginseng 6 parts, Angelica sinensis 6 parts, Cinnamomum cassia 6 parts, Ophiopogon japonicus 12 parts, Carthamus tinctorius 3 parts, Schisandra chinensis 6 parts, Glycyrrhiza uralensis 12 parts.

[0029] This embodiment provides a method for preparing a traditional Chinese medicine composition for regulating the heart and spleen, including the following steps: S1. Take the raw materials of the spleen-regulating and intestinal-cleansing compound and the heart-nourishing and blood-nourishing compound, add 9 times the weight of the medicinal materials in purified water, soak at room temperature for 60 minutes, then decoct for the first time for 45 minutes, filter, add 6 times the weight of purified water to the residue for the second decoction, decoct for 30 minutes, and combine the two decoctions. S2. The decoction was coarsely filtered through a 200-mesh filter and then finely filtered through a 0.45μm microporous membrane. The filtrate was concentrated under reduced pressure at a vacuum of 0.07MPa and a temperature of 65℃ to obtain a thick paste with a relative density of 1.22 at 60℃. S3. Mix the thick paste with dextrin and lactose in a mass ratio of 1:0.8:0.4, add 75% ethanol to prepare a soft mass, granulate by extrusion at 14 mesh, dry in a fluidized bed at 58℃, granulate through 10 mesh and 40 mesh sieves, control the moisture content of the granules to ≤5.0%, and package to obtain spleen-regulating and intestinal-cleansing granules and heart-nourishing and blood-nourishing granules.

[0030] Example 2: Preparation of oral liquid This embodiment provides a traditional Chinese medicine composition for regulating the heart and spleen, comprising two compound formulas: a spleen-regulating and intestinal-cleansing compound formula and a heart-nourishing and blood-nourishing compound formula. The spleen-regulating and bowel-cleansing compound is made from the following ingredients in parts by weight: Astragalus membranaceus 12 parts, Paeonia lactiflora 12 parts, Stephania tetrandra 6 parts, Bupleurum chinense 6 parts, Citrus aurantium 10 parts, Zingiber officinale (processed) 6 parts, Poria cocos 12 parts, Alisma plantago-aquatica 6 parts, Scutellaria baicalensis 6 parts, Coptis chinensis 3 parts, Pinellia ternata (processed) 6 parts, Adenophora stricta 12 parts, Hordeum vulgare 15 parts, Glycyrrhiza uralensis (processed) 6 parts. The nourishing blood and qi compound formula is made from the following ingredients in parts by weight: Salvia miltiorrhiza 15 parts, Sophora flavescens 6 parts, Ligusticum chuanxiong 10 parts, Panax notoginseng 6 parts, Trichosanthes kirilowii 10 parts, Allium macrostemon 6 parts, Prunus persica 6 parts, Lepidium apetalum 6 parts, Panax ginseng 6 parts, Angelica sinensis 6 parts, Cinnamomum cassia 6 parts, Ophiopogon japonicus 12 parts, Carthamus tinctorius 3 parts, Schisandra chinensis 6 parts, Glycyrrhiza uralensis 12 parts.

[0031] This embodiment provides a method for preparing a traditional Chinese medicine composition for regulating the heart and spleen, including the following steps: S1. Take the raw materials of the Spleen-Regulating and Intestine-Clearing Compound and the Heart-Nourishing and Blood-Nourishing Compound, add 9 times the weight of the medicinal materials in purified water, soak at room temperature for 50 minutes, then decoct for the first time for 50 minutes, filter, add 7 times the weight of purified water to the residue for the second decoction, decoct for 35 minutes, and combine the two decoctions. S2. The decoction was coarsely filtered through a 200-mesh filter and then finely filtered through a 0.45μm microporous membrane. The filtrate was concentrated under reduced pressure at a vacuum of 0.07MPa and a temperature of 65℃ to obtain a clear extract with a relative density of 1.08 at 60℃. S3. Cool the extract to below 40°C, add 0.1% potassium sorbate and 0.2% steviol glycosides by mass, stir evenly, filter through a 0.45μm microporous membrane, sterilize with flowing steam at 105°C for 30 minutes, and fill into bottles to obtain the Spleen-Regulating and Intestine-Clearing Oral Liquid and the Heart-Nourishing and Blood-Nourishing Oral Liquid.

[0032] Example 3: Preparation of herbal paste This embodiment provides a traditional Chinese medicine composition for regulating the heart and spleen, comprising two compound formulas: a spleen-regulating and intestinal-cleansing compound formula and a heart-nourishing and blood-nourishing compound formula. The spleen-regulating and bowel-cleansing compound is made from the following ingredients in parts by weight: Astragalus membranaceus 12 parts, Paeonia lactiflora 12 parts, Stephania tetrandra 6 parts, Bupleurum chinense 6 parts, Citrus aurantium 10 parts, Zingiber officinale (processed) 6 parts, Poria cocos 12 parts, Alisma plantago-aquatica 6 parts, Scutellaria baicalensis 6 parts, Coptis chinensis 3 parts, Pinellia ternata (processed) 6 parts, Adenophora stricta 12 parts, Hordeum vulgare 15 parts, Glycyrrhiza uralensis (processed) 6 parts. The nourishing blood and qi compound formula is made from the following ingredients in parts by weight: Salvia miltiorrhiza 15 parts, Sophora flavescens 6 parts, Ligusticum chuanxiong 10 parts, Panax notoginseng 6 parts, Trichosanthes kirilowii 10 parts, Allium macrostemon 6 parts, Prunus persica 6 parts, Lepidium apetalum 6 parts, Panax ginseng 6 parts, Angelica sinensis 6 parts, Cinnamomum cassia 6 parts, Ophiopogon japonicus 12 parts, Carthamus tinctorius 3 parts, Schisandra chinensis 6 parts, Glycyrrhiza uralensis 12 parts.

[0033] This embodiment provides a method for preparing a traditional Chinese medicine composition for regulating the heart and spleen, including the following steps: S1. Take the raw materials of the Spleen-Regulating and Intestine-Clearing Compound and the Heart-Nourishing and Blood-Nourishing Compound, add 9 times the weight of the medicinal materials in purified water, soak at room temperature for 50 minutes, then decoct for the first time for 50 minutes, filter, add 7 times the weight of purified water to the residue for the second decoction, decoct for 35 minutes, and combine the two decoctions. S2. The decoction was coarsely filtered through a 200-mesh filter and then finely filtered through a 0.45μm microporous membrane. The filtrate was concentrated under reduced pressure at a vacuum of 0.07MPa and a temperature of 65℃ to obtain a thick paste with a relative density of 1.40 at 60℃. S3. Add 32% rock sugar by mass to the thick paste, heat and stir until the rock sugar is completely melted, cool to 60℃, add 0.08% sodium benzoate, stir evenly, and fill into containers while hot to obtain the spleen-regulating and intestinal-cleansing paste and the heart-nourishing and blood-nourishing paste.

[0034] Experiment Example 1: Thin-layer chromatography identification experiment The spleen-regulating and intestinal-clearing granules and the blood-nourishing and blood-nourishing granules prepared in Example 1 were identified by thin-layer chromatography.

[0035] Preparation of test sample: Take 1g of granules, add 50mL of methanol, extract with ultrasound for 30 minutes, cool and filter, evaporate the filtrate to dryness, dissolve the residue in 20mL of water, extract twice with 20mL of saturated n-butanol each time, combine the n-butanol solutions and evaporate to dryness, dissolve the residue in 1mL of methanol to obtain the test sample solution.

[0036] Preparation of reference standards: Take astragaloside A, paeoniflorin, baicalin, tanshinone IIA, ferulic acid, and schisandrol A reference standards respectively, and add methanol to prepare reference standard solutions containing 0.5 mg per 1 mL.

[0037] Development and inspection: Take 5 μL each of the test solution and the reference solution and spot them on the same silica gel G thin-layer plate. Develop using the developing solvent system. Pre-saturate the developing tank for 15 minutes, develop upwards 15 cm, remove and air dry; examine the fluorescent spots under a 365 nm UV lamp, then spray with 5% vanillin-sulfuric acid ethanol solution and heat at 105 °C until the spots are clear.

[0038] Experimental Results: In the chromatogram of the Zhengpi Suchang Granules test sample, characteristic spots of the same color, position, and good separation appeared at the corresponding positions as in the chromatograms of astragaloside A, paeoniflorin, and baicalin reference standards. Similarly, in the chromatogram of the Yangli Xue Granules test sample, characteristic spots of the same color, position, and good separation appeared at the corresponding positions as in the chromatograms of tanshinone IIA, ferulic acid, and schisandrol A reference standards. All test sample chromatograms showed no obvious tailing or interference from other spots, and the thin-layer identification results all met the requirements.

[0039] Experiment Example 2: High Performance Liquid Chromatography (HPLC) Content Determination Experiment The contents of the spleen-regulating and intestinal-clearing granules and the blood-nourishing and blood-nourishing granules prepared in Example 1 were determined by high performance liquid chromatography.

[0040] Chromatographic conditions: A C18 reversed-phase column (4.6 mm × 250 mm, 5 μm) was used, with methanol-water-phosphoric acid gradient elution at a flow rate of 1.0 mL / min and a column temperature of 30 ℃. Detection wavelengths: baicalin 280 nm, paeoniflorin 230 nm, tanshinone IIA 270 nm, ferulic acid 320 nm, schisandrol A 250 nm.

[0041] Preparation of test sample: Take 1g of granules, add 50mL of methanol, extract by ultrasonication for 40 minutes, cool and make up to volume, filter through a 0.45μm filter membrane, and take the filtrate as the test sample solution.

[0042] Determination method: Inject the test solution into the liquid chromatograph separately, and calculate the content of each active ingredient using the external standard method.

[0043] Test results: The content of baicalin in Zhengpi Suchang Granules was ≥1.8mg / g, and the content of paeoniflorin was ≥1.2mg / g; the content of tanshinone IIA in Yangxinlixue Granules was ≥0.15mg / g, the content of ferulic acid was ≥0.08mg / g, and the content of schisandrol A was ≥0.10mg / g.

[0044] Experimental Example 3: Microbial Limit Test Experimental Procedure: Granules, oral liquids, and herbal pastes prepared in each example were added to sterile sodium chloride-peptone buffer (pH 7.0) under aseptic conditions to prepare 1:10 test solutions. Appropriate amounts of each test solution were inoculated into the corresponding culture media: bacterial counting was performed on nutrient agar medium, incubated at 30–35°C for 48 hours, followed by colony counting; mold and yeast counting was performed on rose rubric agar medium, incubated at 23–28°C for 5 days, followed by colony counting. Separately, appropriate amounts of the test solutions were inoculated into selective culture media, and Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Salmonella were tested according to the prescribed methods.

[0045] Limits: Total bacterial count in granules ≤1000 CFU / g, mold and yeast ≤100 CFU / g; Total bacterial count in oral liquids and ointments ≤100 CFU / mL, mold and yeast ≤10 CFU / mL; Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Salmonella must not be detected in any dosage form.

[0046] Experimental results: In the tested granule samples, the total bacterial count, as well as the total mold and yeast counts, did not exceed the above-mentioned limits; in the oral liquid and ointment samples, the total bacterial count, as well as the total mold and yeast counts, also met the requirements. None of the above four pathogenic bacteria were detected in any of the tested dosage forms, and all indicators met the hygienic requirements for oral Chinese medicine preparations.

[0047] Experiment Example 4: Physicochemical Indicators and Stability Experiment Experimental Procedure: The physicochemical properties of each dosage form were determined: pH values ​​of oral liquids and herbal pastes were measured using a pH meter, and moisture content of granules was determined using the toluene method. Granules prepared in Example 1, oral liquids prepared in Example 2, and herbal pastes prepared in Example 3 were also placed under constant temperature and humidity conditions of 40°C and 75% for 6 months. Samples were taken at the end of months 0, 1, 2, 3, and 6 to investigate the properties of the preparations, thin-layer chromatography identification, active ingredient content, and microbial limits.

[0048] Experimental Results: Regarding physicochemical indicators, the pH values ​​of the oral liquid were all between 4.0 and 6.0, the pH values ​​of the herbal paste were all between 4.2 and 6.5, and the moisture content of the granules did not exceed 5.0%. Accelerated stability testing results showed that during the 6-month observation period, the formulation properties of the samples at each time point did not change significantly. The granules showed no moisture absorption, clumping, or discoloration; the oral liquid showed no precipitation, turbidity, or off-odor; and the herbal paste showed no layering or mold growth. In thin-layer chromatography, the characteristic spots were clearly visible, showing the same color spots at the corresponding positions as the reference chromatogram, with good separation. The content of each active ingredient remained stable within the content limits, with fluctuations not exceeding ±8%. In microbiological limit tests, the total bacterial count, mold count, and yeast count all met the prescribed limits, and no pathogenic bacteria were detected.

[0049] The above descriptions are merely embodiments of the present invention, and common knowledge such as specific technical solutions and / or characteristics are not described in detail here. It should be noted that those skilled in the art can make various modifications and improvements without departing from the technical solutions of the present invention, and these should also be considered within the scope of protection of the present invention. These modifications and improvements will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. A traditional Chinese medicine composition for regulating the heart and spleen, characterized in that, It includes two compound formulas: one for regulating the spleen and intestines and the other for nourishing the mind and blood. The spleen-regulating and bowel-cleansing compound is made from the following ingredients in parts by weight: Astragalus membranaceus 10-14 parts, Paeonia lactiflora 10-14 parts, Stephania tetrandra 5-7 parts, Bupleurum chinense 5-7 parts, Citrus aurantium 8-12 parts, Zingiber officinale (processed) 5-7 parts, Poria cocos 10-14 parts, Alisma plantago-aquatica 5-7 parts, Scutellaria baicalensis 5-7 parts, Coptis chinensis 2-4 parts, Pinellia ternata (processed) 5-7 parts, Adenophora stricta 10-14 parts, Hordeum vulgare 13-17 parts, Glycyrrhiza uralensis (processed) 5-7 parts; The nourishing blood and qi compound formula is made from the following ingredients in parts by weight: Salvia miltiorrhiza 13-17 parts, Sophora flavescens 5-7 parts, Ligusticum chuanxiong 8-12 parts, Panax notoginseng 5-7 parts, Trichosanthes kirilowii 8-12 parts, Allium macrostemon 5-7 parts, Prunus persica 5-7 parts, Lepidium apetalum 5-7 parts, Panax ginseng 5-7 parts, Angelica sinensis 5-7 parts, Cinnamomum cassia 5-7 parts, Ophiopogon japonicus 10-14 parts, Carthamus tinctorius 2-4 parts, Schisandra chinensis 5-7 parts, Glycyrrhiza uralensis (processed) 10-14 parts.

2. The traditional Chinese medicine composition for regulating the heart and spleen according to claim 1, characterized in that, The spleen-regulating and bowel-cleansing compound is made from the following ingredients in parts by weight: Astragalus membranaceus 12 parts, Paeonia lactiflora 12 parts, Stephania tetrandra 6 parts, Bupleurum chinense 6 parts, Citrus aurantium 10 parts, Zingiber officinale (processed) 6 parts, Poria cocos 12 parts, Alisma plantago-aquatica 6 parts, Scutellaria baicalensis 6 parts, Coptis chinensis 3 parts, Pinellia ternata (processed) 6 parts, Adenophora stricta 12 parts, Hordeum vulgare 15 parts, Glycyrrhiza uralensis (processed) 6 parts. The nourishing blood and qi compound formula is made from the following ingredients in parts by weight: Salvia miltiorrhiza 15 parts, Sophora flavescens 6 parts, Ligusticum chuanxiong 10 parts, Panax notoginseng 6 parts, Trichosanthes kirilowii 10 parts, Allium macrostemon 6 parts, Prunus persica 6 parts, Lepidium apetalum 6 parts, Panax ginseng 6 parts, Angelica sinensis 6 parts, Cinnamomum cassia 6 parts, Ophiopogon japonicus 12 parts, Carthamus tinctorius 3 parts, Schisandra chinensis 6 parts, Glycyrrhiza uralensis 12 parts.

3. A traditional Chinese medicine preparation for regulating the heart and spleen, characterized in that, It includes a traditional Chinese medicine composition for regulating the heart and spleen as described in claim 1 or 2, and pharmaceutically acceptable excipients.

4. A traditional Chinese medicine preparation for regulating the heart and spleen according to claim 3, characterized in that, The dosage form of the traditional Chinese medicine preparation is granules, oral liquid, or paste.

5. A method for preparing a traditional Chinese medicine preparation for regulating the heart and spleen as described in claim 3 or 4, characterized in that, Includes the following steps: S1. Take each raw material, add 8 to 10 times the weight of the medicinal materials in purified water, soak at room temperature, then decoct for the first time, filter, add 6 to 7 times the weight of purified water to the residue for the second decoction, and combine the two decoctions. S2. The decoction is coarsely filtered through a 200-mesh filter and then finely filtered through a 0.45μm microporous membrane. The filtrate is concentrated under reduced pressure at a vacuum of 0.06–0.08 MPa and a temperature of 60–70℃ to obtain a thick paste with a relative density of 1.20–1.

25. S3. Mix the thick paste with dextrin and lactose evenly, prepare a soft mass using 75% ethanol, and after granulation, drying, and sizing, package it to obtain granules.

6. A method for preparing a traditional Chinese medicine preparation for regulating the heart and spleen as described in claim 3 or 4, characterized in that, Includes the following steps: S1. Take each raw material, add 8 to 10 times the weight of the medicinal materials in purified water, soak at room temperature, then decoct for the first time, filter, add 6 to 7 times the weight of purified water to the residue for the second decoction, and combine the two decoctions. S2. The decoction is coarsely filtered through a 200-mesh filter and then finely filtered through a 0.45μm microporous membrane. The filtrate is concentrated under reduced pressure at a vacuum of 0.06–0.08 MPa and a temperature of 60–70℃ to obtain a clear extract with a relative density of 1.05–1.

10. S3. Mix the extract with steviol glycosides and potassium sorbate evenly, then filter through a 0.45μm microporous membrane, sterilize with steam, and fill into bottles to obtain the oral liquid.

7. A method for preparing a traditional Chinese medicine preparation for regulating the heart and spleen as described in claim 3 or 4, characterized in that, Includes the following steps: S1. Take each raw material, add 8 to 10 times the weight of the medicinal materials in purified water, soak at room temperature, then decoct for the first time, filter, add 6 to 7 times the weight of purified water to the residue for the second decoction, and combine the two decoctions. S2. The decoction is coarsely filtered through a 200-mesh filter and then finely filtered through a 0.45μm microporous membrane. The filtrate is concentrated under reduced pressure at a vacuum of 0.06–0.08 MPa and a temperature of 60–70℃ to obtain a thick paste with a relative density of 1.38–1.

42. S3. Add rock sugar to the thick paste, heat and stir until the rock sugar is completely melted, cool down and add sodium benzoate, stir well, and fill into the paste while hot to obtain the paste formula.