A medicinal ointment for treating qi deficiency and blood stasis syndrome and its preparation method

Abstract

This invention discloses a medicinal ointment for treating Qi deficiency and blood stasis syndrome and its preparation method. The raw materials of the medicinal ointment include: ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, dandelion, chuanxiong rhizome, costus root, turmeric, salvia miltiorrhiza, peucedanum praeruptorum, apricot kernel, sparganium rhizome, scutellaria barbata, oldenlandia diffusa, licorice, and gelatinous medicinal materials. The preparation method involves decocting the medicinal formula and then adding gelatinous materials to form the ointment. This invention improves the loss of appetite and fatigue in mice with non-small cell lung cancer syndrome caused by Qi deficiency and blood stasis syndrome by modifying the traditional Chinese medicine formula and preparing it as an ointment. It reduces whole blood and plasma viscosity by tonifying Qi, activating blood circulation, and removing blood stasis, thus promoting blood flow without damaging hepatocytes and reducing the toxic side effects of the formula on the liver. Furthermore, the ointment preparation makes it convenient for patients to carry and take.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparations, specifically to a medicinal ointment for treating qi deficiency and blood stasis syndrome and its preparation method. Background Technology

[0002] Traditional Chinese medicine believes that Qi and blood play a vital role in maintaining bodily functions. There is a relationship of interdependence, mutual nourishment, and yin-yang balance between Qi and blood. Blood, as the carrier of Qi, has the function of generating and carrying Qi, while Qi, in turn, propels the circulation of blood, having the effects of generating, circulating, and controlling blood. The combination of Qi and blood promotes metabolism and contributes to good health. However, if Qi deficiency occurs due to various reasons, its ability to propel blood circulation is reduced, leading to poor local Qi and blood flow, resulting in blood stasis and pain. The most common condition is Qi deficiency and blood stasis syndrome. Qi deficiency and blood stasis syndrome refers to the symptoms caused by Qi deficiency leading to insufficient blood circulation and stagnation. It is often caused by prolonged illness leading to Qi deficiency and gradual internal blood stasis. Clinically, it manifests as a pale or dull complexion, fatigue, weakness, shortness of breath, stabbing pain (commonly located in the chest and ribs, fixed in location, aggravated by pressure), a pale or dark tongue with purplish spots, and a deep, hesitant pulse.

[0003] Patients with advanced non-small cell lung cancer (NSCLC) often experience symptoms such as cough, sputum production, hemoptysis, and lung pain. These symptoms are similar to those of Qi deficiency and blood stasis syndrome, where Qi deficiency weakens blood circulation, leading to stagnation. Therefore, Qi deficiency and blood stasis syndrome is an important syndrome in advanced NSCLC. Prolonged illness and Qi deficiency result in slow blood flow or even a hypercoagulable state, leading to blood stasis at the affected site, causing hemoptysis, hemoptysis, and lung pain. While methods to treat Qi deficiency and blood stasis syndrome can alleviate these symptoms, it's important to remember that all medicines have some degree of toxicity. The liver, as the body's primary organ for detoxification and drug metabolism, is often the site of traditional Chinese medicine formulas used to alleviate Qi deficiency and blood stasis syndrome in NSCLC patients. These formulas can damage liver cells, causing elevated transaminase levels. This means that some medications are metabolized in the liver, overburdening it, and some medications are even hepatotoxic, potentially causing liver cell damage or necrosis. For non-small cell lung cancer patients who need to take medication for a long time, the burden on the liver is already heavy. If liver-damaging drugs are used, the patient's survival time will be further shortened. Therefore, reducing the liver damage caused by the medications taken by non-small cell lung cancer patients is particularly important for the patient's health.

[0004] The information disclosed in this background section is intended only to enhance the understanding of the overall background of the invention and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0005] The purpose of this invention is to provide a medicinal ointment for treating qi deficiency and blood stasis syndrome, aiming to overcome the significant toxic side effects of the formula on the human liver, which can cause serious liver damage during the treatment of lung cancer. At the same time, it aims to overcome the problems of spleen and stomach discomfort, loss of appetite, and physical weakness caused by long-term bed rest and medication in patients with chronic diseases.

[0006] The present invention also provides a method for preparing a medicinal ointment for treating qi deficiency and blood stasis syndrome, which aims to overcome the shortcomings of patients' lack of knowledge about preparation, improper decoction or decoction equipment leading to poor therapeutic effect of the prescription, and the moldy and difficult-to-carry medicinal materials after long-term storage.

[0007] To achieve the above objectives, the present invention provides a medicinal ointment for treating qi deficiency and blood stasis syndrome. The raw materials of the medicinal ointment include: ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, dandelion, chuanxiong rhizome, costus root, turmeric, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, scutellaria barbata, oldenlandia diffusa, licorice, and gelatinous medicinal materials.

[0008] The specific medicinal properties of the herbs are as follows:

[0009] Ginseng: It tastes sweet and slightly bitter, is neutral in nature, and enters the spleen, lung, and heart meridians. Ginseng contains chemical components such as ginsenosides, triterpenes, sesquiterpenes, and monoterpenes, and has the effects of greatly replenishing vital energy, consolidating the body and restoring pulse, tonifying the spleen and lungs, promoting body fluid production, and calming the mind.

[0010] Atractylodes macrocephala: bitter and sweet, warm in nature, and enters the spleen and stomach meridians. Its chemical components include atractylol, atractylone, volatile oil, and vitamin A, and it has the effects of regulating the stomach and intestines, promoting diuresis and relieving exterior syndromes, and nourishing blood and qi.

[0011] Astragalus: Sweet in taste and slightly warm in nature; it enters the spleen and lung meridians. The chemical components of astragalus include astragaloside, daidzein, choline, betaine, etc., and it has the effects of strengthening the spleen and replenishing the middle jiao, raising yang and lifting prolapse, benefiting wei qi and consolidating the exterior, and promoting diuresis.

[0012] Rehmannia glutinosa (processed): sweet in taste and slightly warm in nature; it enters the liver and kidney meridians. Its chemical components include verbascoside, monosaccharides, amino acids, and vitamin A, and it has the effects of nourishing blood deficiency, promoting blood circulation and invigorating qi, and tonifying the liver and kidneys.

[0013] Dandelion: Bitter and sweet in taste, cold in nature; enters the liver and stomach meridians. The chemical components of dandelion include taraxerol, taraxasterol, taraxasterol, β-amyrinol, stigmasterol, β-sitosterol, choline, etc., and it has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting diuresis and relieving strangury.

[0014] Chuanxiong (Ligusticum striatum): pungent in taste and warm in nature; it enters the liver, gallbladder, and pericardium meridians. Its chemical components include ligustrazine, tetramethylol, apigenin, tetramethylolamine, rye alkaloid, and trimethylamine, etc., and it has the effects of regulating qi and relieving stagnation, dispelling dampness and wind, promoting blood circulation and removing blood stasis, and relieving pain.

[0015] Costus root: pungent in taste and warm in nature; it enters the lung and spleen meridians. The chemical components of costus root include costunolide, dehydrocostunolide, costunolide, dihydrocostunolide, d-costunolic acid, α-costunol, salicylolide, costunolide, and dihydrocostunolide, etc., and it has the effects of resolving phlegm and relieving cough, strengthening the spleen and promoting digestion, soothing the liver and regulating qi, and relieving pain.

[0016] Turmeric: It has a pungent and bitter taste, and is cold in nature; it enters the liver, gallbladder, heart, and lung meridians. The chemical components of turmeric include curcumin, demethoxycurcumin, didemethoxycurcumin, curcuminone, aromatic-curcuminone, geranione, terpinene, curcumene, aromatic-curcumene, veratrum dione, turmeric alcohol, eucalyptol, caryophyllene, limonene, linalool, α-pinene, and β-pinene, etc. It has the effects of promoting blood circulation and relieving pain, clearing heat and cooling the blood, regulating qi and relieving depression, and alleviating pain caused by qi stagnation and blood stasis.

[0017] Peucedanum praeruptorum: bitter and pungent in taste, slightly cold in nature; enters the lung meridian. The chemical components of Peucedanum praeruptorum include praeruptoside, praeruptoside, praeruptoside, acinin, eugenol, and oxypraeruptoside, etc., and have the effects of lowering qi and resolving phlegm, dispelling wind and clearing heat.

[0018] Danshen (Salvia miltiorrhiza): Bitter and slightly spicy, warm in nature; it enters the heart, liver, and spleen meridians. The chemical components of Danshen include tanshinone, tanshinol, tanshinone, tanshinone-formone, tanshinaldehyde, water-soluble tanshinone, and tanshinone, etc., and it has the effects of promoting blood circulation and removing blood stasis, cooling blood and reducing swelling, and preventing liver damage.

[0019] Almonds: bitter in taste and slightly warm in nature; they enter the lung and large intestine meridians. The chemical components of almonds include amygdalin, amygdalin, benzaldehyde, linalool, 4-terpinenol, and α-terpineol, etc., and they have the effects of relieving cough and asthma, and moistening the intestines and promoting bowel movements.

[0020] Sparganium rhizome: It has a pungent and bitter taste, and is warm in nature; it enters the liver and spleen meridians. The chemical components of Sparganium rhizome include phenylethanol, hydroquinone, hexadecanoic acid, as well as dehydrocostinol, succinic acid, trisparganic acid, stigmasterol, β-sitosterol, and carotene, etc. It has the effects of reducing swelling and relieving pain, promoting blood circulation and removing blood stasis, and dispersing blood stasis and relieving pain.

[0021] Scutellaria barbata: pungent and bitter in taste, cold in nature; enters the lung, liver, and kidney meridians. The chemical components of Scutellaria barbata include safflowerin, isosafflowerin, baicalin, baicalin, β-sitosterol, stearic acid, baicalin, scutellarin, scutellarin seed extract, naringin, apigenin, ragweed extract, senna extract, luteolin, etc., and it has the effects of dispersing blood stasis, clearing heat and detoxifying, and promoting diuresis.

[0022] Hedyotis diffusa: It has a sweet and bland taste, and is slightly cold in nature; it enters the stomach, lung, large intestine, and bladder meridians. The chemical components of Hedyotis diffusa include ursolic acid, oleanolic acid, quercetin, kaempferol, cypermethrin, and cypermethrin acid, etc., and it has the effects of clearing heat and detoxifying, moistening the lungs and relieving cough.

[0023] Licorice: It has a sweet taste and neutral properties, and enters the heart, lung, spleen, and stomach meridians. The chemical components of licorice include glycyrrhizic acid, isoglycyrrhizin, glycyrrhizin alcohol, glycyrrhizin, and coumarin, etc. It has the effects of tonifying the spleen and replenishing qi, eliminating phlegm and relieving cough, clearing heat and detoxifying, relieving spasms and pain, and harmonizing other medicines.

[0024] Preferably, in the above technical solution, there are 100-150g of ginseng, 40-60g of atractylodes macrocephala, 65-85g of astragalus membranaceus, 65-85g of rehmannia glutinosa, 40-60g of dandelion, 40-60g of chuanxiong rhizome, 45-65g of costus root, 45-65g of turmeric, 40-60g of salvia miltiorrhiza, 40-60g of angelica dahurica, 40-60g of apricot kernel, 40-60g of sparganium rhizome, 40-60g of scutellaria barbata, 65-85g of oldenlandia diffusa, 20-40g of licorice root, and 65-85g of gelatinous medicinal materials.

[0025] Preferably, in the above technical solution, there are 120-130g of ginseng, 45-55g of atractylodes macrocephala, 70-80g of astragalus membranaceus, 70-80g of rehmannia glutinosa, 45-55g of dandelion, 45-55g of chuanxiong rhizome, 50-60g of costus root, 50-60g of turmeric, 45-55g of salvia miltiorrhiza, 45-55g of angelica dahurica, 45-55g of apricot kernel, 45-55g of sparganium rhizome, 45-55g of scutellaria barbata, 70-80g of oldenlandia diffusa, 25-35g of licorice root, and 70-80g of gelatinous medicinal materials.

[0026] Preferably, in the above technical solution, the gelatinous medicinal material is donkey-hide gelatin.

[0027] According to the above technical solution, donkey-hide gelatin is added to the ointment of the present invention. Donkey-hide gelatin mainly serves to thicken the ointment to make it semi-fluid. At the same time, donkey-hide gelatin has the effects of nourishing and health preservation, moisturizing the lungs, calming the mind and stabilizing the spirit, and acting on the lungs to enhance the vitality of lung cells.

[0028] Preferably, in the above technical solution, there are 125g of ginseng, 50g of atractylodes macrocephala, 75g of astragalus membranaceus, 75g of rehmannia glutinosa, 50g of dandelion, 50g of chuanxiong rhizome, 55g of costus root, 55g of turmeric, 50g of salvia miltiorrhiza, 50g of angelica dahurica, 50g of apricot kernel, 50g of sparganium rhizome, 50g of scutellaria barbata, 75g of oldenlandia diffusa, 30g of licorice root, and 75g of donkey-hide gelatin.

[0029] A method for preparing a medicinal ointment for treating qi deficiency and blood stasis syndrome as described in claim 1, wherein the preparation method is specifically as follows:

[0030] (1) Weigh out ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, dandelion, chuanxiong rhizome, costus root, turmeric, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, scutellaria barbata, oldenlandia diffusa and licorice according to the prescription. Take ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, chuanxiong rhizome, costus root, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome and licorice as the first group of drugs, and take turmeric, dandelion, scutellaria barbata and oldenlandia diffusa as the second group of drugs. Wash them clean.

[0031] (2) Soak the first group of drugs in 1000-1500mL of water for 60-120min using a pre-set decoction vessel, add 1500-2500mL of water, bring to a boil over high heat, add the second group of drugs, and decoct over low heat for 40-50min to obtain a first decoction. Add 2500-3000mL of water, bring to a boil over high heat, and decoct over low heat for 30-50min to obtain a second decoction.

[0032] (3) Mix the first decoction and the second decoction, precipitate and filter, take the filtrate to obtain the mixed decoction, add gelatinous medicinal materials to the mixed decoction, boil over high heat and then simmer over low heat to concentrate to a thick paste, divide into jars to obtain the paste for treating qi deficiency and blood stasis syndrome.

[0033] Preferably, in the above technical solution, the preset cooking vessel is a ceramic pot or a clay pot.

[0034] Preferably, in the above technical solution, in the steps of mixing, precipitating, and filtering the first decoction and the second decoction, taking the filtrate to obtain a mixed decoction, adding gelatinous medicinal materials to the mixed decoction, boiling it over high heat and then simmering it to concentrate it into a thick paste, dividing it into containers, and obtaining a paste for treating qi deficiency and blood stasis syndrome, the filtration is performed using a 150-mesh sieve and a 200-mesh sieve.

[0035] Compared with the prior art, the present invention has the following beneficial effects:

[0036] (1) The ointment for treating qi deficiency and blood stasis syndrome of this invention uses ginseng, prepared rehmannia root, atractylodes macrocephala, sparganium rhizome, turmeric, dandelion, and oldenlandia diffusa as the principal herbs, astragalus root, costus root, apricot kernel, angelica root, and scutellaria barbata as the assistant herbs, and licorice root, salvia miltiorrhiza root, chuanxiong rhizome, and donkey-hide gelatin as adjuvant herbs. Ginseng and prepared rehmannia root, as the principal herbs, replenish blood and qi, consolidate the body and restore the pulse, tonify the spleen and lungs, and tonify the liver and kidneys. Combined with the assistant herbs astragalus root to replenish qi and raise yang, strengthen the spleen and replenish the middle jiao, and salvia miltiorrhiza root to prevent liver damage, they together promote the production and flow of red blood cells, accelerate metabolism and protect the liver, so as to improve the symptoms of shortness of breath, blood stasis, fatigue and weakness caused by long-term illness. Turmeric invigorates blood and removes blood stasis, atractylodes macrocephala root generates blood and replenishes qi, and sparganium rhizome breaks up blood and promotes qi circulation, forming a blood-activating and meridian-restoring pathway for removing blood stasis, replenishing qi, and promoting qi circulation. Combined with the assistant herbs costus root to soothe the liver and regulate qi, and scutellaria barbata root... Lotus root promotes diuresis and removes blood stasis, while chuanxiong (Ligusticum striatum) invigorates blood circulation, removes blood stasis, and relieves stagnation. Together, they act on areas of blood stasis to clear blockages, restore blood flow, and promote smooth blood circulation. As the stasis is cleared, pain is relieved, alleviating pain and emotional distress. Dandelion clears heat and detoxifies, while Hedyotis diffusa moistens the lungs and relieves cough. Combined with apricot kernel to stop cough and relieve asthma, Peucedanum praeruptorum to lower qi and resolve phlegm, and donkey-hide gelatin to nourish the lungs, they work together on the affected areas of the lungs to reduce the stimulation of the respiratory tract by diseased cells, thus reducing tracheal spasms and contractions, thereby alleviating cough symptoms. Licorice is added to harmonize the effects of the other herbs. The principal herbs, Atractylodes macrocephala (Bai Zhu) to regulate the stomach and intestines, and ginseng to generate fluids, along with licorice to nourish the stomach, work together to promote gastric juice secretion and intestinal peristalsis, improve appetite in patients with chronic illnesses, increase nutrient intake, and strengthen the constitution of patients with chronic illnesses.

[0037] (2) The method for preparing the ointment for treating qi deficiency and blood stasis syndrome of the present invention is to first decoct the medicine and then filter it through multiple sieves to remove impurities to avoid gritty texture or poor taste. Then, add gelatinous medicinal materials and boil it into an ointment to prepare multiple courses of treatment. This avoids the patient's improper decoction, which may lead to poor efficacy, and is convenient for the patient to carry and take. Attached Figure Description

[0038] Figure 1 This is a graph showing the rate of change in body weight for the blank group, the no-drug group, Example 1, and Comparative Examples 1-4 of this invention;

[0039] Figure 2 This is a graph showing the differences in aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin levels between the untreated group, Example 1, and Comparative Examples 1-4 of this invention and the blank group.

[0040] Figure 3 These are TUNEL staining images of tumor tissue sections from the drug-free group, Example 1, and Comparative Example 1 of this invention;

[0041] Figure 4 These are TUNEL staining images of tumor tissue sections from Comparative Examples 2, 3, and 4 of this invention. Detailed Implementation

[0042] The specific embodiments of the present invention will be described in detail below with reference to specific examples, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments.

[0043] Example 1

[0044] A medicinal ointment for treating qi deficiency and blood stasis syndrome, comprising, by weight: 125g ginseng, 50g atractylodes macrocephala, 75g astragalus membranaceus, 75g rehmannia glutinosa, 50g dandelion, 50g chuanxiong rhizome, 55g costus root, 55g turmeric, 50g salvia miltiorrhiza, 50g peucedanum praeruptorum, 50g apricot kernel, 50g sparganium rhizome, 50g scutellaria barbata, 75g oldenlandia diffusa, 30g licorice root, and 75g donkey-hide gelatin.

[0045] A method for preparing a medicinal ointment for treating qi deficiency and blood stasis syndrome as described above, wherein the preparation method is as follows:

[0046] (1) Weigh out ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, dandelion, chuanxiong rhizome, costus root, turmeric, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, scutellaria barbata, oldenlandia diffusa, and licorice according to the above prescription. Take ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, chuanxiong rhizome, costus root, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, and licorice as the first group of drugs, and take turmeric, dandelion, scutellaria barbata, and oldenlandia diffusa as the second group of drugs. Wash them clean.

[0047] (2) Soak the first group of drugs in 1000mL of water for 90 minutes in a ceramic pot, add 1500mL of water, bring to a boil over high heat, add the second group of drugs, simmer over low heat for 50 minutes to obtain a first decoction, add 2500mL of water, bring to a boil over high heat, simmer over low heat for 50 minutes to obtain a second decoction.

[0048] (3) Mix the first decoction and the second decoction, precipitate and filter, take the filtrate to obtain the mixed decoction, add donkey-hide gelatin to the mixed decoction, boil over high heat and then simmer over low heat to concentrate to a thick paste, divide into jars to obtain the paste for treating qi deficiency and blood stasis syndrome.

[0049] The method of use is as follows: Using the medicine spoon prepared with the above-mentioned ointment for treating qi deficiency and blood stasis, take 1-2 spoonfuls of the ointment directly for consumption, or dissolve 1-2 spoonfuls of the ointment in about 100mL of warm water and drink it, 1-2 times a day.

[0050] Example 2

[0051] A medicinal ointment for treating qi deficiency and blood stasis syndrome, comprising, by weight: 120g ginseng, 45g atractylodes macrocephala, 70g astragalus membranaceus, 70g rehmannia glutinosa, 45g dandelion, 45g chuanxiong rhizome, 50g costus root, 50g turmeric, 45g salvia miltiorrhiza, 45g peucedanum praeruptorum, 45g apricot kernel, 45g sparganium rhizome, 45g scutellaria barbata, 70g oldenlandia diffusa, 25g licorice root, and 70g donkey-hide gelatin.

[0052] A method for preparing a medicinal ointment for treating qi deficiency and blood stasis syndrome as described above, wherein the preparation method is as follows:

[0053] (1) Weigh out ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, dandelion, chuanxiong rhizome, costus root, turmeric, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, scutellaria barbata, oldenlandia diffusa, and licorice according to the above prescription. Take ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, chuanxiong rhizome, costus root, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, and licorice as the first group of drugs, and take turmeric, dandelion, scutellaria barbata, and oldenlandia diffusa as the second group of drugs. Wash them clean.

[0054] (2) Soak the first group of drugs in 1500mL of water for 120 minutes in a ceramic pot, add 1500mL of water, bring to a boil over high heat, add the second group of drugs, simmer over low heat for 40 minutes to obtain a first decoction, add 2500mL of water, bring to a boil over high heat, simmer over low heat for 30 minutes to obtain a second decoction.

[0055] (3) Mix the first decoction and the second decoction, precipitate and filter, take the filtrate to obtain the mixed decoction, add donkey-hide gelatin to the mixed decoction, boil over high heat and then simmer over low heat to concentrate to a thick paste, divide into jars to obtain the paste for treating qi deficiency and blood stasis syndrome.

[0056] Example 3

[0057] A medicinal ointment for treating qi deficiency and blood stasis syndrome, comprising, by weight: 130g ginseng, 55g atractylodes macrocephala, 80g astragalus membranaceus, 80g rehmannia glutinosa, 55g dandelion, 55g chuanxiong rhizome, 60g costus root, 60g turmeric, 55g salvia miltiorrhiza, 55g angelica dahurica, 55g apricot kernel, 55g sparganium rhizome, 55g scutellaria barbata, 80g oldenlandia diffusa, 35g licorice root, and 80g donkey-hide gelatin.

[0058] A method for preparing a medicinal ointment for treating qi deficiency and blood stasis syndrome as described above, wherein the preparation method is as follows:

[0059] (1) Weigh out ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, dandelion, chuanxiong rhizome, costus root, turmeric, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, scutellaria barbata, oldenlandia diffusa, and licorice according to the above prescription. Take ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, chuanxiong rhizome, costus root, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, and licorice as the first group of drugs, and take turmeric, dandelion, scutellaria barbata, and oldenlandia diffusa as the second group of drugs. Wash them clean.

[0060] (2) Soak the first group of drugs in 1000mL of water for 120 minutes in a ceramic pot, add 1500mL of water, bring to a boil over high heat, add the second group of drugs, simmer over low heat for 45 minutes to obtain a first decoction, add 2500mL of water, bring to a boil over high heat, simmer over low heat for 40 minutes to obtain a second decoction.

[0061] (3) Mix the first decoction and the second decoction, precipitate and filter, take the filtrate to obtain the mixed decoction, add donkey-hide gelatin to the mixed decoction, boil over high heat and then simmer over low heat to concentrate to a thick paste, divide into jars to obtain the paste for treating qi deficiency and blood stasis syndrome.

[0062] Example 4

[0063] A medicinal ointment for treating qi deficiency and blood stasis syndrome, comprising, by weight: 100g ginseng, 40g atractylodes macrocephala, 65g astragalus membranaceus, 65g rehmannia glutinosa, 40g dandelion, 40g chuanxiong rhizome, 45g costus root, 45g turmeric, 40g salvia miltiorrhiza, 40g peucedanum praeruptorum, 40g apricot kernel, 40g sparganium rhizome, 40g scutellaria barbata, 65g oldenlandia diffusa, 20g licorice root, and 65g donkey-hide gelatin.

[0064] A method for preparing a medicinal ointment for treating qi deficiency and blood stasis syndrome as described above, wherein the preparation method is as follows:

[0065] (1) Weigh out ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, dandelion, chuanxiong rhizome, costus root, turmeric, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, scutellaria barbata, oldenlandia diffusa, and licorice according to the above prescription. Take ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, chuanxiong rhizome, costus root, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, and licorice as the first group of drugs, and take turmeric, dandelion, scutellaria barbata, and oldenlandia diffusa as the second group of drugs. Wash them clean.

[0066] (2) Soak the first group of drugs in 1000-1500mL of water in a clay pot for 60-120 minutes, add 1500-2500mL of water, bring to a boil over high heat, add the second group of drugs, simmer over low heat for 40-50 minutes to obtain the first decoction, add 2500-3000mL of water, bring to a boil over high heat, simmer over low heat for 30-50 minutes to obtain the second decoction;

[0067] (3) Mix the first decoction and the second decoction, precipitate and filter, take the filtrate to obtain the mixed decoction, add donkey-hide gelatin to the mixed decoction, boil over high heat and then simmer over low heat to concentrate to a thick paste, divide into jars to obtain the paste for treating qi deficiency and blood stasis syndrome.

[0068] Example 5

[0069] A medicinal ointment for treating qi deficiency and blood stasis syndrome, comprising, by weight: 150g ginseng, 60g atractylodes macrocephala, 85g astragalus membranaceus, 85g rehmannia glutinosa, 60g dandelion, 60g chuanxiong rhizome, 65g costus root, 65g turmeric, 60g salvia miltiorrhiza, 60g peucedanum praeruptorum, 60g apricot kernel, 60g sparganium rhizome, 60g scutellaria barbata, 85g oldenlandia diffusa, 40g licorice root, and 85g donkey-hide gelatin.

[0070] A method for preparing a medicinal ointment for treating qi deficiency and blood stasis syndrome as described above, wherein the preparation method is as follows:

[0071] (1) Weigh out ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, dandelion, chuanxiong rhizome, costus root, turmeric, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, scutellaria barbata, oldenlandia diffusa, and licorice according to the above prescription. Take ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, chuanxiong rhizome, costus root, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, and licorice as the first group of drugs, and take turmeric, dandelion, scutellaria barbata, and oldenlandia diffusa as the second group of drugs. Wash them clean.

[0072] (2) Soak the first group of drugs in 1000-1500mL of water for 60-120 minutes in a ceramic pot, add 1500-2500mL of water, bring to a boil over high heat, add the second group of drugs, simmer over low heat for 40-50 minutes to obtain the first decoction, add 2500-3000mL of water, bring to a boil over high heat, simmer over low heat for 30-50 minutes to obtain the second decoction;

[0073] (3) Mix the first decoction and the second decoction, precipitate and filter, take the filtrate to obtain the mixed decoction, add donkey-hide gelatin to the mixed decoction, boil over high heat and then simmer over low heat to concentrate to a thick paste, divide into jars to obtain the paste for treating qi deficiency and blood stasis syndrome.

[0074] Comparative Example 1

[0075] Similar to Example 1, except that Rehmannia glutinosa, Atractylodes macrocephala, and Salvia miltiorrhiza are missing. A medicinal ointment for treating Qi deficiency and blood stasis syndrome, by weight, comprises the following ingredients: 125g ginseng, 75g Astragalus membranaceus, 50g Taraxacum mongolicum, 50g Ligusticum chuanxiong, 55g Aucklandia lappa, 55g Curcuma longa, 50g Peucedanum praeruptorum, 50g Prunus armeniaca, 50g Sparganium stoloniferum, 50g Scutellaria barbata, 75g Hedyotis diffusa, 30g Glycyrrhiza uralensis, and 75g donkey-hide gelatin.

[0076] Comparative Example 2

[0077] It is basically similar to Example 1, except that it lacks Atractylodes macrocephala, Curcuma longa, and Aucklandia lappa.

[0078] A medicinal ointment for treating qi deficiency and blood stasis syndrome, wherein the ingredients of the medicinal ointment by weight include: 125g ginseng, 75g astragalus, 50g dandelion, 50g chuanxiong, 50g qianhu, 50g apricot kernel, 50g sanleng, 50g scutellaria barbata, 75g oldenlandia diffusa, 30g licorice and 75g donkey-hide gelatin.

[0079] Comparative Example 3

[0080] It is basically similar to Example 1, except that it lacks dandelion and Peucedanum praeruptorum.

[0081] A medicinal ointment for treating qi deficiency and blood stasis syndrome, wherein the ingredients of the medicinal ointment, by weight, include: 125g ginseng, 50g atractylodes macrocephala, 75g astragalus membranaceus, 50g chuanxiong rhizome, 55g costus root, 55g turmeric, 50g apricot kernel, 50g sparganium rhizome, 50g scutellaria barbata, 75g oldenlandia diffusa, 30g licorice root, and 75g donkey-hide gelatin.

[0082] Comparative Example 4

[0083] It is basically similar to Example 1, except that it lacks ginseng, atractylodes macrocephala and licorice.

[0084] A medicinal ointment for treating qi deficiency and blood stasis syndrome, wherein the ingredients of the medicinal ointment, by weight, include: 75g of Astragalus membranaceus, 50g of Taraxacum mongolicum, 50g of Ligusticum chuanxiong, 55g of Aucklandia lappa, 55g of Curcuma longa, 50g of Peucedanum praeruptorum, 50g of Prunus armeniaca, 50g of Sparganium stoloniferum, 50g of Scutellaria barbata, 75g of Hedyotis diffusa, and 75g of donkey-hide gelatin.

[0085] 1. Experimental subjects

[0086] The experimental animals were SPF-grade male C57BL / 6 mice, 5 weeks old, weighing 20-22g. The C57BL / 6 mice were purchased from Beijing Huafukang Technology Co., Ltd., and were housed in a temperature- and humidity-controlled animal room. Feed and water were sterilized by autoclaving.

[0087] 2. Experimental Design

[0088] C57BL / 6 mice were randomly divided into a blank group (n=10), a control group (n=10), Example 1 (n=10), and comparative examples 1-4 (n=10 in each group). In this experiment, a mouse model of non-small cell lung cancer with Qi deficiency and blood stasis syndrome was created based on existing technology. The method of syndrome-first and disease-later was adopted, that is, the non-small cell lung cancer model was replicated on the basis of the Qi deficiency and blood stasis syndrome model, and the disease-syndrome combined animal model was completed. Mice from the control group (no medication), Example 1, and Comparative Examples 1-4 were subjected to a high-fat, high-sugar diet and chronic sleep deprivation to simulate Qi deficiency and blood stasis syndrome. Specifically, the mice's diet was replaced with a high-fat, high-sugar diet, consisting of 84.5% basal diet plus 5% egg yolk powder, 0.5% cholesterol, 5% lard, and 5% sucrose. Mice were fed this high-fat, high-sugar diet daily, and an unpredictable chronic sleep deprivation method was used to stimulate them. The treatment involved four phases: normal light (8:00-20:00 light, 20:00-8:00 darkness), reverse light (8:00-20:00 darkness, 20:00-8:00 light), continuous light, and continuous darkness (each phase lasting 7 days, repeated for 6 weeks). Within each phase, the four phases were randomly assigned. Mice underwent 48 hours of sleep deprivation in each phase, with low-voltage stimulation keeping them awake and preventing them from entering a sleep state. The model was considered successfully established if any of the following three signs were present: ① fatigue and weakness, decreased response to external stimuli, or lethargy; ② slow or no weight gain; ③ one or more areas of blood stasis in the veins. Mice with qi deficiency and blood stasis syndrome in the control group, Example 1, and Comparative Examples 1-4 were subcutaneously injected with 0.2 mg / mouse at a concentration of 1×10⁻⁶. 7 Lewis lung cancer cell suspension at / mL. After successful establishment of the rat model, each drug-treated group was administered the corresponding drug to the rats by gavage once daily, while the untreated control group and blank group were administered an equal volume of 0.9% physiological saline by gavage. The experiment continued for 2 weeks, and the experimental data collected after 2 weeks were recorded, statistically analyzed and compiled.

[0089] 3. Determination of the rate of change in body weight of rats in each group

[0090] Mice body weight was recorded before modeling and on the day after treatment. Food intake after treatment was also recorded. Mice were placed in a transparent fish tank after treatment, and swimming time was calculated. The relevant results are shown in Table 1 below. Based on the recorded mouse body weight, the rate of change in mouse body weight was calculated as follows: Figure 1 As shown, the formula for calculating the rate of change in body weight is:

[0091] Weight change rate (%) = {(Weight on the day of modeling - Weight before modeling) / Weight before modeling} * 100%.

[0092] Table 1. Relevant Indicators of Non-Small Cell Lung Cancer Mice with Qi Deficiency and Blood Stasis Syndrome

[0093]

[0094]

[0095] Note: Compared with the no-drug group * P < 0.05 ** P < 0.01.

[0096] The results are shown in Table 1 and... Figure 1 As shown, the body weight, swimming time, and food intake of rats in each drug-treated group were significantly different from those in the untreated group (P < 0.05). Compared with the control group, the untreated group showed significantly reduced body weight, swimming time, and food intake, indicating that mice with non-small cell lung cancer suffering from qi deficiency and blood stasis syndrome exhibited obvious symptoms of loss of appetite, fatigue, and weight loss. Compared with the untreated and control groups, the mice in Example 1 fed the drug ointment obtained by the method of this invention had a better appetite, reaching normal food intake, with less weight loss and normal swimming time, indicating that the drug ointment of this invention can alleviate the symptoms of fatigue, loss of appetite, and significant weight loss in model mice caused by qi deficiency and blood stasis syndrome and non-small cell lung cancer. After mice were given the ointment for treating qi deficiency and blood stasis obtained in Example 1 of this invention, compared with Comparative Examples 1-4, the mice showed better weight, activity, and appetite. This indicates that the ointment of this invention promotes blood circulation, relieves pain, and improves gastrointestinal motility by replenishing qi and blood, protecting the liver, and promoting blood circulation. It helps to increase the food intake of model mice, alleviate symptoms of blood stasis, depression, qi deficiency, fatigue, and lethargy, and improve appetite, energy, and vitality. This is helpful for the weight loss and fatigue caused by prolonged illness and qi and blood deficiency.

[0097] 4. Influence of blood rheological parameters

[0098] Blood rheological parameters include whole blood viscosity, plasma viscosity, plasma prothrombin time (PT), activated partial thromboplastin time (APTT), and plasma fibrinogen (FIB). Among these, whole blood viscosity is an important parameter reflecting the basic characteristics of blood rheology and a key indicator for assessing the degree of blood viscosity. Excessively high viscosity in both whole blood and plasma can easily lead to embolism. The results of blood rheological parameters in a non-small cell lung cancer model mouse with Qi deficiency and blood stasis syndrome are shown in Table 2.

[0099] Table 2. Hemorheological parameters of non-small cell lung cancer model mice with Qi deficiency and blood stasis syndrome in each group.

[0100]

[0101] Note: Compared with the no-drug group * P < 0.05 ** P < 0.01.

[0102] As can be seen from Table 2, compared with the no-drug group, the P values ​​for whole blood viscosity, plasma viscosity, PT, APTT, and FIB in Example 1, Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4 were all less than 0.05, and even less than 0.01. That is, the whole blood viscosity, plasma viscosity, PT, APTT, and FIB data of Example 1 were statistically significant compared with those of Comparative Examples 1-4. Compared with Comparative Examples 2 and 4, the ointment obtained by the method of this invention was used on mice with non-small cell lung cancer (NSCLC) of Qi deficiency and blood stasis syndrome. The mice treated with Example 1 had lower whole blood viscosity and plasma viscosity, faster PT and APTT, and higher FIB concentration. This indicates that the ointment obtained by this invention for treating Qi deficiency and blood stasis syndrome can reduce the viscosity of whole blood and plasma in mice with NSCLC of Qi deficiency and blood stasis syndrome. Excessive blood viscosity can easily cause blood coagulation and blockage, making it difficult to disperse local blood stasis. The method of this invention utilizes Atractylodes macrocephala, Curcuma longa, and Aucklandia lappa to promote blood circulation, remove blood stasis, replenish Qi, and regulate Qi. It also utilizes Ginseng, Atractylodes macrocephala, and Glycyrrhiza uralensis to replenish Qi and benefit Qi. By promoting blood circulation through Qi, the activation time of thrombin is increased, effectively reducing the viscosity of whole blood and plasma and promoting smooth blood flow.

[0103] 5. Liver function test

[0104] Mice in each group were fasted for 8-12 hours. Venous blood was drawn from each group of mice, and aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin were measured. The results are shown in Table 3. Figure 2 As shown, where Figure 2 The formula for the difference is: Difference = Values ​​of each group - Values ​​of the blank group.

[0105] Table 3. Detection results of transaminase and bilirubin in mice of each group.

[0106] Aspartate aminotransferase (U / L) Alanine aminotransferase (U / L) Bilirubin (Umol / L) Blank group 36.5±6.15 13.7±4.91 12.3±2.43 No medication group 35.9±5.45 13.2±4.48 12.6±2.69 Example 1 36.2±6.37 14.1±4.73 12.7±2.74 Comparative Example 1 46.4±5.68 24.3±4.73 18.4±3.21 Comparative Example 2 41.0±6.12 20.8±5.13 14.8±4.16 Comparative Example 3 35.9±5.75 14.1±4.59 12.9±1.53 Comparative Example 4 36.8±6.74 13.6±4.31 12.3±2.48

[0107] Mice in each group were dissected to examine whether their livers showed signs of enlargement, hardening, abnormal proliferation, spots, or rupture and hemorrhage. The results are shown in Table 4.

[0108] Table 4. Liver condition in mice with Qi deficiency and blood stasis syndrome in each group of non-small cell lung cancer models.

[0109]

[0110]

[0111] From Table 3, Table 4 and Figure 2It can be seen that the levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin in the model mice treated with drugs from Comparative Examples 1 and 2 were significantly elevated. ALT is one of the most sensitive indicators of normal liver function; specifically, when hepatocytes are damaged, ALT levels rise. AST is an indicator of liver function and is used to determine whether the liver is damaged. Comparing the formulation in Example 1 with Comparative Examples 1 and 2, it is evident that the addition of Rehmannia glutinosa, Atractylodes macrocephala, and Salvia miltiorrhiza to the formulation has a liver-protective effect and reduces hepatocyte damage.

[0112] 6. Effects of different treatments on tumor cell apoptosis in mice with Qi deficiency and blood stasis syndrome of non-small cell lung cancer

[0113] Tumor tissue sections from mice in the untreated group, Example 1, and Comparative Examples 1-4 were stained with TUNEL and the effect of Bufei Huayu Decoction on tumor tissue apoptosis was investigated using an inverted optical microscope. Figure 3 and Figure 4 As shown.

[0114] from Figure 3 and Figure 4 It can be seen that the tumor cells in the untreated group were of varying sizes and had a higher distribution density. The mice treated with the drugs prepared by Comparative Examples 1, 2, 3 and 4 had fewer tumor cells than the untreated group, but more than those in Example 1. This indicates that Example 1 has the best apoptosis effect on tumor cells in mice with non-small cell lung cancer and qi deficiency and blood stasis syndrome.

[0115] The foregoing description of specific exemplary embodiments of the invention is for illustrative and explanatory purposes. These descriptions are not intended to limit the invention to the precise forms disclosed, and it will be apparent that many changes and variations can be made in accordance with the foregoing teachings. The exemplary embodiments were chosen and described in order to explain the specific principles of the invention and its practical application, thereby enabling those skilled in the art to implement and utilize various different exemplary embodiments of the invention, as well as various different choices and variations. The scope of the invention is intended to be defined by the claims and their equivalents.

Claims

1. A medicinal ointment for treating qi deficiency and blood stasis syndrome, characterized in that, The raw materials for the medicinal ointment consist of 100-150g of ginseng, 40-60g of Atractylodes macrocephala, 65-85g of Astragalus membranaceus, 65-85g of Rehmannia glutinosa, 40-60g of Taraxacum mongolicum, 40-60g of Ligusticum chuanxiong, 45-65g of Aucklandia lappa, 45-65g of Curcuma longa, 40-60g of Salvia miltiorrhiza, 40-60g of Peucedanum praeruptorum, 40-60g of Prunus armeniaca, 40-60g of Sparganium stoloniferum, 40-60g of Scutellaria barbata, 65-85g of Hedyotis diffusa, 20-40g of Glycyrrhiza uralensis, and 65-85g of donkey-hide gelatin. The specific method for preparing the drug ointment is as follows: (1) Weigh out ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, dandelion, chuanxiong rhizome, costus root, turmeric, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome, scutellaria barbata, oldenlandia diffusa and licorice according to the prescription. Take ginseng, atractylodes macrocephala, astragalus membranaceus, rehmannia glutinosa, chuanxiong rhizome, costus root, salvia miltiorrhiza, angelica dahurica, apricot kernel, sparganium rhizome and licorice as the first group of drugs, and take turmeric, dandelion, scutellaria barbata and oldenlandia diffusa as the second group of drugs. Wash them clean. (2) Soak the first group of drugs in 1000-1500 mL of water for 60-120 min using a pre-set decoction vessel, add 1500-2500 mL of water, bring to a boil over high heat, add the second group of drugs, and decoct over low heat for 40-50 min to obtain a first decoction. Add 2500-3000 mL of water, bring to a boil over high heat, and decoct over low heat for 30-50 min to obtain a second decoction. (3) Mix the first decoction and the second decoction, precipitate and filter, take the filtrate to obtain the mixed decoction, add donkey-hide gelatin to the mixed decoction, boil over high heat and then simmer over low heat to concentrate to a thick paste, divide into jars to obtain the ointment for treating qi deficiency and blood stasis syndrome.

2. The ointment for treating qi deficiency and blood stasis syndrome according to claim 1, characterized in that, The raw materials for the medicinal ointment consist of 120-130 g of ginseng, 45-55 g of Atractylodes macrocephala, 70-80 g of Astragalus membranaceus, 70-80 g of Rehmannia glutinosa, 45-55 g of Taraxacum mongolicum, 45-55 g of Ligusticum chuanxiong, 50-60 g of Aucklandia lappa, 50-60 g of Curcuma longa, 45-55 g of Salvia miltiorrhiza, 45-55 g of Peucedanum praeruptorum, 45-55 g of Prunus armeniaca, 45-55 g of Sparganium stoloniferum, 45-55 g of Scutellaria barbata, 70-80 g of Hedyotis diffusa, 25-35 g of Glycyrrhiza uralensis, and 70-80 g of donkey-hide gelatin.

3. The ointment for treating qi deficiency and blood stasis syndrome according to claim 2, characterized in that... The raw materials for the medicinal ointment consist of 125 g of ginseng, 50 g of atractylodes macrocephala, 75 g of astragalus membranaceus, 75 g of rehmannia glutinosa, 50 g of dandelion, 50 g of chuanxiong rhizome, 55 g of costus root, 55 g of turmeric, 50 g of salvia miltiorrhiza, 50 g of angelica dahurica, 50 g of apricot kernel, 50 g of sparganium rhizome, 50 g of scutellaria barbata, 75 g of oldenlandia diffusa, 30 g of licorice root, and 75 g of donkey-hide gelatin.

4. The ointment for treating qi deficiency and blood stasis syndrome according to claim 1, characterized in that, The pre-set cooking vessel is a ceramic pot or a clay pot.

5. The ointment for treating qi deficiency and blood stasis syndrome according to claim 1, characterized in that, In the steps of mixing and precipitating the first decoction and the second decoction, filtering the filtrate to obtain a mixed decoction, adding gelatinous medicinal materials to the mixed decoction, boiling it over high heat and then simmering it to concentrate it into a thick paste, dividing it into containers to obtain a paste for treating qi deficiency and blood stasis syndrome, the filtration is performed using a 150-mesh sieve and a 200-mesh sieve.

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