Spleen-tonifying kidney-tonifying fat-regulating paste and preparation method thereof

Abstract

The invention discloses spleen-tonifying kidney-tonifying fat-regulating paste and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine compositions. The invention relates to spleen-tonifying kidney-tonifying fat-regulating paste. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8-12 parts of herba epimedii, 8-12 parts of fructus lycii, 8-12 parts of fructus psoraleae, 8-12 parts of semen cuscutae, 8-12 parts of cassia twig, 8-12 parts of herba cistanche, 8-12 parts of radix morindae officinalis, 8-12 parts of rhizoma zingiberis, 8-12 parts of ginseng, 8-12 parts of radix astragali, 6-8 parts of fiveleaf gynostemma herb, 8-12 parts of poria cocos, 8-12 parts of plantago asiatica, 8-12 parts of rhizoma alismatis, 8-12 parts of rhizoma dioscoreae, 8-12 parts of pericarpium citri reticulatae, 8-12 parts of prepared rhizoma polygonati, 8-12 parts of radix rehmanniae preparata and 8-12 parts of semen asteris. The traditional Chinese medicine is prepared from 8-12 parts of tortoise plastron, 8-12 parts of crude dragon bone, 8-12 parts of oyster, 8-12 parts of magnet, 8-12 parts of amethyst and 8-12 parts of golden cypress. Through precise compatibility of monarch, minister, assistant and guide (warming kidney yang, tonifying spleen soil, nourishing kidney yin, promoting diuresis and turbid dampness, securing essence and qi, clearing heat and drying dampness), the whole effects of tonifying kidney and spleen, supporting healthy qi, promoting gasification, restoring transportation and transformation and removing turbid dampness and fat paste are achieved, and relapse is not prone to occurring.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a spleen-tonifying, kidney-tonifying, and lipid-regulating ointment and its preparation method. Background Technology

[0002] With socioeconomic development and improved living standards, dietary structures have changed significantly, leading to a continuous rise in the incidence of hyperlipidemia, which has become a common and prevalent disease threatening public health. Hyperlipidemia is a significant independent risk factor for cardiovascular and cerebrovascular diseases such as atherosclerosis, coronary heart disease, fatty liver, and stroke. Therefore, effectively regulating blood lipid levels is crucial for the prevention and treatment of related cardiovascular and cerebrovascular diseases.

[0003] Currently, modern clinical medicine mainly uses chemical drugs such as statins and fibrates for lipid-lowering treatment. Although they can lower blood lipid levels relatively quickly, they have varying degrees of adverse reactions such as elevated liver enzymes, muscle soreness, and gastrointestinal reactions. Moreover, the lipids tend to rebound after discontinuation. The safety of long-term use and patient compliance are prominent issues.

[0004] In the field of Traditional Chinese Medicine (TCM), hyperlipidemia is often categorized under "phlegm turbidity," "blood stasis," and "fat accumulation." TCM theory holds that abnormal blood lipids are closely related to dysfunction of the liver, spleen, and kidneys. The spleen governs transportation and transformation, and is the source of phlegm. Spleen deficiency leads to impaired transportation and transformation, hindering the distribution of essential nutrients, resulting in dampness and phlegm accumulation. The kidneys govern water, are the foundation of innate constitution, store essence and regulate fluids. Kidney deficiency weakens qi transformation, leading to disordered fluid metabolism and impaired fat accumulation. The liver governs the free flow of qi; liver qi stagnation affects the distribution of body fluids and fats. The underlying pathogenesis is often a combination of deficiency and excess, with spleen and kidney deficiency as the root cause and phlegm turbidity and blood stasis as the manifestations.

[0005] Currently, there are many traditional Chinese medicine compound formulas for regulating lipids, mostly based on the principles of simply resolving phlegm and dampness, and promoting blood circulation and removing blood stasis. While these can achieve certain therapeutic effects, they often focus on "purging excess" while neglecting "tonifying deficiency," thus failing to address the fundamental pathogenesis of spleen and kidney deficiency. This results in unsustainable treatment effects and a high relapse rate after discontinuation of medication. In addition, traditional Chinese medicine decoctions have disadvantages such as being cumbersome to prepare, inconvenient to carry, and having an unpleasant taste, while common Chinese patent medicines such as pills and capsules sometimes fall short in their ability to exert the advantages of overall conditioning and strengthening the body's resistance.

[0006] Therefore, there is a need for a traditional Chinese medicine preparation that can invigorate the spleen and kidneys, strengthen the body's resistance, resolve phlegm and remove blood stasis, eliminate turbidity and regulate lipids, and has the characteristics of good taste, convenient administration and long-lasting effects. This is of great practical significance for meeting clinical needs and for the long-term conditioning of patients with hyperlipidemia. Summary of the Invention

[0007] In view of this, the purpose of this invention is to provide a spleen-tonifying and kidney-nourishing lipid-regulating ointment and its preparation method. This invention achieves the overall efficacy of "tonifying the kidney and spleen, supporting the body's vital energy, promoting qi transformation, restoring digestion and metabolism, and removing dampness and turbidity" through precise formulation of the principal, assistant, adjuvant, and guide herbs (warming kidney yang, tonifying spleen earth, nourishing kidney yin, eliminating dampness and turbidity, consolidating essence and qi, and clearing heat and drying dampness), and is not prone to recurrence.

[0008] To achieve the above objectives, the present invention provides the following technical solution:

[0009] This invention provides a spleen-strengthening, kidney-tonifying, and lipid-regulating paste, prepared from the following raw materials in parts by weight:

[0010] Epimedium 8-12 parts, Lycium barbarum 8-12 parts, Psoralea corylifolia 8-12 parts, Cuscuta chinensis 8-12 parts, Cinnamomum cassia 8-12 parts, Cistanche deserticola 8-12 parts, Morinda officinalis 8-12 parts, Zingiber officinale 8-12 parts, Panax ginseng 8-12 parts, Astragalus membranaceus 8-12 parts, Gynostemma pentaphyllum 6-8 parts, Poria cocos 8-12 parts, Plantago asiatica 8-12 parts, Alisma plantago-aquatica 8-12 parts, Dioscorea opposita 8-12 parts, Citrus reticulata 8-12 parts, Polygonatum sibiricum 8-12 parts, Rehmannia glutinosa 8-12 parts, Astragalus membranaceus 8-12 parts, Testudinis plastrum 8-12 parts, Raw dragon bone 8-12 parts, Ostrea gigas 8-12 parts, Magnetite 8-12 parts, Amethyst 8-12 parts, Phellodendron chinense 8-12 parts.

[0011] Preferably, the mass fraction of the raw material is:

[0012] Epimedium 10 parts, Lycium barbarum 10 parts, Psoralea corylifolia 10 parts, Cuscuta chinensis 10 parts, Cinnamomum cassia 10 parts, Cistanche deserticola 10 parts, Morinda officinalis 10 parts, Zingiber officinale 10 parts, Panax ginseng 10 parts, Astragalus membranaceus 10 parts, Gynostemma pentaphyllum 7 parts, Poria cocos 10 parts, Plantago asiatica 10 parts, Alisma plantago-aquatica 10 parts, Dioscorea opposita 10 parts, Citrus reticulata 10 parts, Polygonatum sibiricum 10 parts, Rehmannia glutinosa 10 parts, Astragalus membranaceus 10 parts, Testudinis plastrum 10 parts, Raw dragon bone 10 parts, Ostrea gigas 10 parts, Magnetite 10 parts, Amethyst 10 parts, Phellodendron chinense 10 parts.

[0013] This invention provides a method for preparing the above-mentioned spleen-strengthening, kidney-tonifying, and lipid-regulating paste, comprising the following steps:

[0014] Weigh the raw materials according to the stated weight proportions;

[0015] The tortoise shell, raw dragon bone, oyster shell, magnetite, amethyst, and other medicinal materials are finely pulverized and mixed together with water for soaking. Then, the mixture is decocted for the first time. After filtering, the dregs are added to water for the second decoction. After filtering, the dregs are added to water for the third decoction.

[0016] The decoctions obtained from the three decoctions are mixed and concentrated to obtain a concentrated liquid. Honey is then added to the concentrated liquid to obtain a spleen-strengthening, kidney-tonifying, and lipid-regulating paste.

[0017] Preferably, the mesh size of the ultrafine pulverizer is 300-500 mesh.

[0018] Preferably, the amount of water added is 10cm above the medicinal materials.

[0019] Preferably, the soaking time is 10-15 hours.

[0020] Preferably, the first decoction time is 3 hours; the second decoction time is 2 hours; and the third decoction time is 1 hour.

[0021] As a preferred option, the volume is concentrated to 10% of the original volume.

[0022] Preferably, the concentration temperature is 60-80℃.

[0023] Preferably, the mass ratio of the concentrate to honey is 30:1.

[0024] It contains at least the following beneficial technical effects:

[0025] In Traditional Chinese Medicine (TCM), fatty liver is often associated with kidney yang deficiency (lack of vital energy) and spleen deficiency (insufficient digestive and absorptive capacity). Kidney yang deficiency leads to impaired qi transformation, while spleen yang deficiency leads to dysfunction in digestion and a failure to properly distribute the essence of food and water. This results in the accumulation of dampness, phlegm, turbidity, and fat, which then accumulate in the liver, forming fatty liver.

[0026] This compound formula, through the precise combination of principal, assistant, adjuvant, and guide herbs (warming kidney yang, tonifying spleen earth, nourishing kidney yin, eliminating dampness and turbidity, consolidating essence and qi, clearing heat and drying dampness), achieves the overall effect of "tonifying the kidney and strengthening the spleen, supporting vital energy, promoting qi transformation, restoring digestion and metabolism, and removing dampness and turbidity."

[0027] Therefore, this formula is based on warming and tonifying the spleen and kidney yang, enhancing the body's metabolic functions, and actively clearing away existing dampness and phlegm (fat). It works in two ways to prevent and treat fatty liver caused by spleen and kidney yang deficiency and internal retention of dampness and phlegm, and also has a certain effect on regulating blood lipids. It contains numerous herbs with distinct structures, and its formulation is mature and stable, embodying the essence of traditional Chinese medicine compound prescriptions. Detailed Implementation

[0028] Analysis of the principal, assistant, adjuvant, and guiding principles in this formula:

[0029] The principal herbs are Epimedium, which warms and tonifies kidney yang and strengthens tendons and bones; Psoralea corylifolia, which tonifies kidney yang, warms the spleen, and stops diarrhea; Cuscuta chinensis, which tonifies the liver and kidneys, benefits essence and blood, and consolidates essence and reduces urination; it tonifies kidney yang and slightly nourishes kidney yin; Cistanche deserticola, which tonifies kidney yang, benefits essence and blood, and moistens the intestines to relieve constipation; it is warm but not drying, and tonifying but not drastic; Morinda officinalis, which tonifies kidney yang, dispels wind and dampness; Cinnamomum cassia, which harmonizes ying and wei, disperses cold and relieves pain, warms and unblocks the meridians, and assists yang in qi transformation; and deer antler velvet, which tonifies kidney essence, strengthens kidney yang, and strengthens tendons and bones; it is a blood and flesh product with a strong essence-replenishing effect. (Warming and tonifying kidney yang is the foundation of this formula, together stimulating the fire of the gate of life and enhancing qi transformation function, targeting the core pathogenesis of "kidney yang deficiency")

[0030] The herb used is ginseng, which greatly replenishes vital energy, strengthens the spleen and lungs, promotes the production of body fluids, and calms the mind. This formula strengthens the spleen and stomach, enhancing the body's ability to support the body's vital energy and consolidate its foundation. Astragalus membranaceus (Huangqi) tonifies Qi and raises Yang, benefits the defensive Qi and strengthens the exterior, promotes diuresis and reduces swelling; it strengthens the spleen and promotes diuresis, assisting the spleen in transforming and transporting fluids. Dioscorea opposita (Yanyao) tonifies the spleen and stomach, generates fluids and benefits the lungs, tonifies the kidneys and astringes essence; it tonifies both the spleen and kidneys and also has astringent properties. Rehmannia glutinosa (Shudihuang) tonifies blood and nourishes Yin, benefits essence and fills marrow; when combined with other Yang herbs, Yang is aided by Yin, generating endlessly, and its drying and pungent nature is restrained (tonifying both Yin and Yang, seeking Yang within Yin). Lycium barbarum (Gouqizi) tonifies the liver and kidneys, benefits essence and improves eyesight, nourishes kidney Yin, and assists the body's Yin-Yang balance. Astragalus complanatus (Shayuanzi) tonifies the kidneys and consolidates essence, nourishes the liver and improves eyesight, tonifies the kidneys and astringes. Tortoise shell (Guiban) nourishes Yin and subdues Yang, benefits the kidneys and strengthens bones, nourishes blood and replenishes the heart, nourishes kidney Yin, subdues deficient Yang, and assists the body in controlling the warming nature of the body's medicine, strengthening tendons and bones. Nine-times-processed Polygonatum sibiricum (Jiuzhihuangjing) tonifies Qi and nourishes Yin, benefits the kidneys, strengthens the spleen and moistens the lungs. Gynostemma pentaphyllum (Jiaogulan) tonifies Qi, strengthens the spleen and aids digestion, invigorates Qi and blood, and promotes detoxification. (These drugs work together to accomplish two tasks: ginseng, astragalus, yam, and gynostemma pentaphyllum mainly "tonify the spleen" to solve the problem of weak digestion; rehmannia, wolfberry, astragalus, jujube peel, tortoise shell, and polygonatum focus on "nourishing yin, replenishing essence and marrow", on the one hand, to solve the possible kidney yin deficiency or deficiency of essence and blood, and on the other hand, to provide the material basis for warming yang and prevent it from consuming yin essence.)

[0031] The adjuvant herbs include Poria cocos, which promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind; Alisma plantago-aquatica, which promotes diuresis and eliminates dampness, and clears heat (especially good at clearing turbid dampness from the kidneys); and Plantago asiatica, which promotes diuresis and relieves strangury, eliminates dampness and stops diarrhea, improves eyesight, and eliminates phlegm.

[0032] (These three herbs are specifically formulated to target the pathological products of fatty liver—dampness, turbidity, and fat. Through their diuretic and dampness-eliminating effects, they guide metabolic waste and dampness out through urination, making them a key group of herbs for directly regulating blood lipids and improving liver fat accumulation.) The astringent and consolidating group (consolidates essence, qi, and blood, preventing excessive diuresis from the principal herb). Raw dragon bone: calms the liver and subdues yang, calms the mind and spirit, astringes and consolidates; Oyster shell: heavily calms the mind and spirit, subdues yang and nourishes yin, softens hardness and dissipates nodules, astringes and consolidates (stops sweating, astringes semen); Amethyst: warms the kidneys and assists yang, calms the heart and spirit, descends rebellious qi, warms the uterus. (Combines warming kidney yang and heavily calming rebellious qi)

[0033] (While vigorously warming and tonifying the Yang and aiding digestion, using herbs with strong astringent and consolidating effects, such as dragon bone and oyster shell, can prevent excessive dissipation of vital energy or leakage of kidney essence, thus achieving a balance between tonification and consolidation.) The heat-clearing and dampness-drying, and counteracting ingredients (restrain the warming properties of all the herbs in the formula)

[0034] Phellodendron bark clears heat and dries dampness, drains fire and detoxifies, and reduces deficiency heat. This formula contains many warming herbs, which may exacerbate heat and dryness. Phellodendron bark, being bitter and cold, can clear deficiency heat in the lower burner or internally generated damp heat, and also acts as a counteracting herb to restrain excessive heat (especially when the formula may contain highly pungent and hot herbs such as ginger and cinnamon). It also forms part of the warming and dispersing cold-relieving exterior-releasing group (assisting warming yang herbs to reduce side effects).

[0035] Dried ginger warms the middle jiao and dispels cold, restores yang and unblocks the meridians, warms the lungs and resolves phlegm, and relieves exterior symptoms and dispels cold (fresh or dried ginger is commonly used).

[0036] The guiding herbs are: Poria cocos, Alisma plantago-aquatica, Plantago asiatica, and Citrus reticulata peel. These herbs themselves have the function of guiding the medicine downwards, promoting urination, and regulating Qi, and can be used as "guiding herbs" to expel damp-heat and phlegm through urination. Although the formula contains many herbs, the combination is precise and the overall effect is strong.

[0037] Compatibility characteristics and mechanisms of action in preventing and treating fatty liver

[0038] 1. Focus on warming and tonifying: The core is to use a large amount of warming and tonifying kidney yang (chief herb + kidney-warming assistant herb) to invigorate the fire of the gate of life and enhance the qi transformation and warming functions of the whole body, especially the kidney and spleen.

[0039] 2. Balancing Yin and Yang: In addition to the heavy dose of yang-tonifying medicine, kidney-nourishing and essence-replenishing medicines (such as Rehmannia glutinosa, Lycium barbarum, tortoise shell, and nine-times-processed Polygonatum sibiricum) are added to reflect the idea of ​​"seeking yang within yin" and "using tonification as a function", so that warming yang will not harm yin or deplete essence (preventing the main medicine from being biased) and to solve the possible deficiency of essence and blood.

[0040] 3. Treating both the spleen and kidneys: Ginseng, astragalus, yam, and gynostemma pentaphyllum invigorate the spleen and replenish qi, directly addressing the problem of weak spleen function and cutting off the source of phlegm and dampness accumulation. Strengthening the spleen and tonifying the kidneys complement each other, forming a combined effect.

[0041] 4. Combining Tonification and Purgation (the most prominent feature): This formula, while vigorously tonifying the spleen and kidneys, uses a powerful diuretic and dampness-draining formula consisting of Poria cocos, Alisma plantago-aquatica, Plantago asiatica, and Citrus reticulata peel to dry dampness and resolve phlegm, specifically clearing away existing dampness and phlegm (fat in fatty liver is a typical example of "turbidity"). Tonification (tonifying the spleen and kidneys) aims to cut off the source of its formation, while purgation (draining dampness and clearing turbidity) aims to eliminate existing pathogenic factors. This is precisely the key to preventing and treating fatty liver—restoring the body's normal metabolic capacity (the root cause) while clearing away accumulated pathological products (the symptoms).

[0042] 5. Consolidation and prevention of dissipation: The combination of astringent herbs such as dragon bone, oyster shell, and amethyst with warming and tonifying herbs reflects the "consolidation" aspect of "combining tonification and purgation" to prevent dissipation.

[0043] 6. Harmonizing cold and heat: By utilizing the bitter and cold properties of Phellodendron bark to clear heat and dry dampness, it can counteract the excessive warming properties that may result from too many pungent and warm herbs in the whole formula, making it more suitable for fatty liver patients with complex constitutions (mixed with deficiency heat or dampness transforming into heat).

[0044] Protecting the middle burner: The use of ginger reduces the stimulation of hot medicines on the spleen and stomach.

[0045] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0046] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Every smaller range between any stated value or intermediate value within a stated range, and any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0047] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0048] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be obvious to those skilled in the art. This application specification and embodiments are merely exemplary.

[0049] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0050] Unless otherwise specified, "room temperature" and "normal temperature" in this invention refer to 25±2℃.

[0051] Unless otherwise specified, all raw materials or instruments used in the following embodiments of the present invention are commercially available.

[0052] Example 1

[0053] A spleen-strengthening, kidney-tonifying, and lipid-regulating paste, prepared as follows:

[0054] S1. Weigh out 10 parts of Epimedium, 10 parts of Lycium barbarum, 10 parts of Psoralea corylifolia, 10 parts of Cuscuta chinensis, 10 parts of Cinnamomum cassia, 10 parts of Cistanche deserticola, 10 parts of Morinda officinalis, 10 parts of Zingiber officinale, 10 parts of Panax ginseng, 10 parts of Astragalus membranaceus, 7 parts of Gynostemma pentaphyllum, 10 parts of Poria cocos, 10 parts of Plantago asiatica, 10 parts of Alisma plantago-aquatica, 10 parts of Dioscorea opposita, 10 parts of Citrus reticulata peel, 10 parts of Polygonatum sibiricum (processed), 10 parts of Rehmannia glutinosa (processed), 10 parts of Astragalus membranaceus, 10 parts of Testudinis plastrum, 10 parts of raw dragon bone, 10 parts of oyster shell, 10 parts of magnetite, 10 parts of amethyst, and 10 parts of Phellodendron chinense according to the stated weight proportions.

[0055] S2. Grind the tortoise shell, raw dragon bone, oyster shell, magnetite, and amethyst into 300 mesh and mix with other medicinal materials. Add water to submerge the medicinal materials by 10 cm and soak for 13 hours. Then bring to a boil over high heat and simmer over low heat for the first decoction for 3 hours. Then filter and add water to the dregs for the second decoction for 2 hours. Then filter and add water to the dregs for the third decoction for 1 hour.

[0056] The decoctions obtained from the three decoctions are mixed and concentrated at 70°C to 10% of their original volume to obtain a concentrated liquid. Honey is then added to the concentrated liquid (the mass ratio of concentrated liquid to honey is 30:1) to obtain a spleen-strengthening, kidney-tonifying, and lipid-regulating paste.

[0057] Example 2

[0058] A spleen-strengthening, kidney-tonifying, and lipid-regulating paste, prepared as follows:

[0059] S1. Weigh out the following ingredients according to the stated weight proportions: Epimedium 8 parts, Lycium barbarum 8 parts, Psoralea corylifolia 8 parts, Cuscuta chinensis 8 parts, Cinnamomum cassia 8 parts, Cistanche deserticola 8 parts, Morinda officinalis 8 parts, Zingiber officinale 8 parts, Panax ginseng 8 parts, Astragalus membranaceus 8 parts, Gynostemma pentaphyllum 6 parts, Poria cocos 8 parts, Plantago asiatica 8 parts, Alisma plantago-aquatica 8 parts, Dioscorea opposita 8 parts, Citrus reticulata 8 parts, Polygonatum sibiricum 8 parts, Rehmannia glutinosa 8 parts, Astragalus membranaceus 8 parts, Testudinis plastrum 8 parts, raw dragon bone 8 parts, Ostrea gigas 8 parts, Magnetite 8 parts, Amethyst 8 parts, Phellodendron chinense 8 parts.

[0060] S2. Grind the tortoise shell, raw dragon bone, oyster shell, magnetite, and amethyst into 300 mesh and mix with other medicinal materials. Add water to submerge the medicinal materials by 10 cm and soak for 10 hours. Then bring to a boil over high heat and simmer over low heat for the first decoction for 3 hours. Then filter and add water to the dregs for the second decoction for 2 hours. Then filter and add water to the dregs for the third decoction for 1 hour.

[0061] The decoctions obtained from the three decoctions are mixed and concentrated at 60°C to 10% of their original volume to obtain a concentrated liquid. Honey is then added to the concentrated liquid (the mass ratio of concentrated liquid to honey is 30:1) to obtain a spleen-strengthening, kidney-tonifying, and lipid-regulating paste.

[0062] Example 3

[0063] A spleen-strengthening, kidney-tonifying, and lipid-regulating paste, prepared as follows:

[0064] S1. Weigh out the following ingredients according to the stated weight proportions: Epimedium 12 parts, Lycium barbarum 12 parts, Psoralea corylifolia 12 parts, Cuscuta chinensis 12 parts, Cinnamomum cassia 12 parts, Cistanche deserticola 12 parts, Morinda officinalis 12 parts, Zingiber officinale 12 parts, Panax ginseng 12 parts, Astragalus membranaceus 12 parts, Gynostemma pentaphyllum 6 parts, Poria cocos 12 parts, Plantago asiatica 12 parts, Alisma plantago-aquatica 12 parts, Dioscorea opposita 12 parts, Citrus reticulata 12 parts, Polygonatum sibiricum 12 parts, Rehmannia glutinosa 12 parts, Astragalus membranaceus 12 parts, Testudinis plastrum 12 parts, raw dragon bone 12 parts, Ostrea gigas 12 parts, Magnetite 12 parts, Amethyst 12 parts, Phellodendron chinense 12 parts.

[0065] S2. Grind the tortoise shell, raw dragon bone, oyster shell, magnetite, and amethyst into 300 mesh and mix with other medicinal materials. Add water to submerge the medicinal materials by 10 cm and soak for 15 hours. Then bring to a boil over high heat and simmer over low heat for the first decoction for 3 hours. Then filter and add water to the dregs for the second decoction for 2 hours. Then filter and add water to the dregs for the third decoction for 1 hour.

[0066] The decoctions obtained from the three decoctions are mixed and concentrated at 80°C to 10% of their original volume to obtain a concentrated liquid. Honey is then added to the concentrated liquid (the mass ratio of concentrated liquid to honey is 30:1) to obtain a spleen-strengthening, kidney-tonifying, and lipid-regulating paste.

[0067] Experimental Example 1

[0068] Inclusion criteria for the experiment: Western medicine diagnosis: meeting the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese Adults", with serum total cholesterol (TC) ≥ 5.18 mmol / L and / or triglycerides (TG) ≥ 1.70 mmol / L.

[0069] Traditional Chinese Medicine Diagnosis:

[0070] Primary symptoms: fatigue and weakness, soreness and weakness in the lower back and knees; Secondary symptoms: dizziness and tinnitus, poor appetite, abdominal distension and loose stools. Two or more primary symptoms must be met, or one primary symptom plus two or more secondary symptoms.

[0071] Exclude individuals with severe heart, liver, or kidney disease, pregnant or breastfeeding women, and those allergic to this product.

[0072] Experimental grouping and treatment methods: Experimental group 1 took 15g of the spleen-tonifying, kidney-tonifying, and lipid-regulating paste prepared in Example 1 orally, twice a day (once in the morning and once in the evening), dissolved in warm water.

[0073] Control group 1 received oral administration of the commercially available positive control drug "Xuezhikang Capsules" at the recommended dosage (2 capsules each time, twice a day) according to the instructions.

[0074] 100 people per group.

[0075] Average efficacy evaluation indicators

[0076] Blood lipid levels: serum total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).

[0077] Testing time points: before treatment and week 8 of treatment.

[0078] Secondary efficacy endpoints:

[0079] Traditional Chinese Medicine syndrome score: The main symptoms (fatigue, weakness, soreness and weakness of the waist and knees, etc.) are graded as none, mild, moderate and severe (0, 1, 2 and 3 points respectively), and the total score is calculated.

[0080] Efficacy evaluation criteria:

[0081] Clinical cure: TCM syndrome score reduced by ≥95%, blood lipid indicators returned to normal.

[0082] Significant effect: TCM syndrome score decreased by ≥70%, and blood lipid indicators were significantly improved.

[0083] Effective: The TCM syndrome score decreased by ≥30%, and blood lipid indicators improved.

[0084] Ineffective: TCM syndrome score decreased by <30%, and blood lipid indicators showed no improvement.

[0085] Safety indicators: Complete blood count, routine urine count, liver function (ALT), and kidney function (BUN, Cr) were measured once before and after treatment, and adverse events were recorded.

[0086] Table 1 Blood lipid levels

[0087]

[0088] Table 2 Comparison of therapeutic effects of TCM syndromes

[0089]

[0090]

[0091] As shown in Tables 1-2, after 8 weeks of treatment, the blood lipid levels in both groups were significantly improved compared to before treatment (P<0.05). The spleen-tonifying and kidney-nourishing lipid-regulating paste prepared in Example 1 was significantly more effective than the control group "Xuezhikang capsules" in reducing TC, TG, LDL-C and increasing HDL-C, demonstrating superior comprehensive lipid-regulating ability.

[0092] In terms of improving symptoms of spleen and kidney deficiency (such as fatigue and lower back pain), the total effective rate of the treatment group was significantly higher than that of the control group, demonstrating a more comprehensive effect of strengthening the spleen and tonifying the kidney.

[0093] No serious adverse drug reactions were observed in either group, indicating good safety. Most importantly, during the 6-month follow-up, the recurrence rate in the treatment group was significantly lower than that in the control group, reflecting the "strengthening the body's resistance and consolidating its foundation" characteristic of traditional Chinese medicine plasters.

[0094] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A spleen-strengthening, kidney-tonifying, and lipid-regulating ointment, characterized in that, It is prepared from the following raw materials in parts by weight: Epimedium 8-12 parts, Lycium barbarum 8-12 parts, Psoralea corylifolia 8-12 parts, Cuscuta chinensis 8-12 parts, Cinnamomum cassia 8-12 parts, Cistanche deserticola 8-12 parts, Morinda officinalis 8-12 parts, Zingiber officinale 8-12 parts, Panax ginseng 8-12 parts, Astragalus membranaceus 8-12 parts, Gynostemma pentaphyllum 6-8 parts, Poria cocos 8-12 parts, Plantago asiatica 8-12 parts, Alisma plantago-aquatica 8-12 parts, Dioscorea opposita 8-12 parts, Citrus reticulata 8-12 parts, Polygonatum sibiricum 8-12 parts, Rehmannia glutinosa 8-12 parts, Astragalus membranaceus 8-12 parts, Testudinis plastrum 8-12 parts, Raw dragon bone 8-12 parts, Ostrea gigas 8-12 parts, Magnetite 8-12 parts, Amethyst 8-12 parts, Phellodendron chinense 8-12 parts.

2. The spleen-tonifying, kidney-nourishing, and lipid-regulating ointment according to claim 1, characterized in that, The mass fraction of the raw material is: Epimedium 10 parts, Lycium barbarum 10 parts, Psoralea corylifolia 10 parts, Cuscuta chinensis 10 parts, Cinnamomum cassia 10 parts, Cistanche deserticola 10 parts, Morinda officinalis 10 parts, Zingiber officinale 10 parts, Panax ginseng 10 parts, Astragalus membranaceus 10 parts, Gynostemma pentaphyllum 7 parts, Poria cocos 10 parts, Plantago asiatica 10 parts, Alisma plantago-aquatica 10 parts, Dioscorea opposita 10 parts, Citrus reticulata 10 parts, Polygonatum sibiricum 10 parts, Rehmannia glutinosa 10 parts, Astragalus membranaceus 10 parts, Testudinis plastrum 10 parts, Raw dragon bone 10 parts, Ostrea gigas 10 parts, Magnetite 10 parts, Amethyst 10 parts, Phellodendron chinense 10 parts.

3. The preparation method of the spleen-tonifying, kidney-tonifying, and lipid-regulating ointment according to claim 1, characterized in that, Includes the following steps: Weigh the raw materials according to the stated weight proportions; The tortoise shell, raw dragon bone, oyster shell, magnetite, amethyst, and other medicinal materials are finely pulverized and mixed together with water for soaking. Then, the mixture is decocted for the first time. After filtering, the dregs are added to water for the second decoction. After filtering, the dregs are added to water for the third decoction. The decoctions obtained from the three decoctions are mixed and concentrated to obtain a concentrated liquid. Honey is then added to the concentrated liquid to obtain a spleen-strengthening, kidney-tonifying, and lipid-regulating paste.

4. The preparation method according to claim 3, characterized in that, The mesh size of the ultrafine pulverizer is 300-500 mesh.

5. The preparation method according to claim 3, characterized in that, The amount of water added is 10cm above the medicinal materials.

6. The preparation method according to claim 3, characterized in that, The soaking time is 10-15 hours.

7. The preparation method according to claim 3, characterized in that, The first decoction time is 3 hours; the second decoction time is 2 hours; and the third decoction time is 1 hour.

8. The preparation method according to claim 3, characterized in that, Concentrate to 10% of the original volume.

9. The preparation method according to claim 3, characterized in that, The concentration temperature is 60-80℃.

10. The preparation method according to claim 3, characterized in that, The mass ratio of the concentrate to honey is 30:1.

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