Traditional Chinese medicine composition for breaking blood and removing blood stasis and blood stasis breaking pill

Abstract

The invention discloses a traditional Chinese medicine composition for breaking blood and removing blood stasis and a blood stasis breaking pill. The traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 5-7 parts of centipede, 2-4 parts of scorpion, 0.5-1.5 parts of toad skin, 8-12 parts of pseudo-ginseng, 5-7 parts of gecko, 2-4 parts of myrrh, 0.5-1.5 parts of safflower, 0.5-1.5 parts of ligusticum wallichii and 5-7 parts of pig nail. Animal drugs including centipede, scorpion, gecko and toad skin are main drugs and belong to insect drugs, traditional Chinese medicine believes that the properties of the animal drugs are good, and the animal drugs can combat poison with poison and break blood to remove blood stasis; pseudo-ginseng, safflower, ligusticum wallichii and myrrh are classic medicines for promoting blood circulation to remove blood stasis, so that the effects of activating meridians to stop pain are enhanced, and the drasticality of insect medicines is alleviated.

Description

Background Technology

[0001] Traditional Chinese medicine (TCM) categorizes cancer as "abdominal masses," with core pathogenesis including: Qi stagnation and blood stasis: obstructed Qi and blood circulation, leading to internal blood stasis and the formation of masses (such as in liver cancer and breast cancer); Phlegm and blood stasis: the binding of phlegm and dampness with blood stasis, commonly seen in lung cancer and thyroid cancer; and Toxin and blood stasis: the coexistence of heat toxins and blood stasis, frequently seen in late-stage tumor metastasis. Currently available medications have unsatisfactory therapeutic effects, exhibiting multiple problems such as slow onset of action, numerous side effects, poor stability, and treating only the symptoms without addressing the root cause.

[0002] Traditional formulas for promoting blood circulation and removing blood stasis are based on insect-based drugs, but they have significant limitations: Limited efficacy: Although insect-based medicines are good at dispelling wind and clearing the meridians, they are difficult to use alone to meet the dual needs of breaking up blood stasis and dispersing nodules as well as strengthening the body's resistance, which leads to a prolonged course of disease. Insect-based medicines alone are also difficult to eradicate deep stagnation.

[0003] Toxicity risk: Overuse of insecticides can easily cause liver and kidney damage.

[0004] Therefore, how to provide a compound composition of cordyceps and other plant-based traditional Chinese medicines that can effectively break up blood stasis is a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0005] This invention addresses the problems existing in the prior art by providing a traditional Chinese medicine composition for breaking up blood stasis and removing blood stasis, as well as a pill for breaking up blood stasis and its preparation method.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A traditional Chinese medicine composition for breaking up blood stasis and removing blood stasis, the raw materials of the composition are: centipede, scorpion, toad skin, Panax notoginseng, gecko, myrrh, safflower, Ligusticum chuanxiong, and pig shell.

[0007] Preferably, the raw materials of the traditional Chinese medicine composition are: 5-7 parts by weight of centipede, 2-4 parts by weight of scorpion, 0.5-1.5 parts by weight of toad skin, 8-12 parts by weight of Panax notoginseng, 5-7 parts by weight of gecko, 2-4 parts by weight of myrrh, 0.5-1.5 parts by weight of safflower, 0.5-1.5 parts by weight of Ligusticum chuanxiong, and 5-7 parts by weight of pig shell.

[0008] Preferably, the raw materials of this traditional Chinese medicine composition are: 6 parts by weight of centipede, 3 parts by weight of scorpion, 1 part by weight of toad skin, 8 parts by weight of Panax notoginseng, 6 parts by weight of gecko, 3 parts by weight of myrrh, 1 part by weight of safflower, 1 part by weight of Ligusticum chuanxiong, and 6 parts by weight of pig shell.

[0009] Preferably, the centipede and scorpion are obtained by soaking in rice wine or salt water after removing their heads and feet, the toad skin is obtained by processing with wine, and the pig shell is obtained by processing with high-temperature calcination.

[0010] Preferably, the soaking time for centipedes is ≥2 hours and the soaking time for scorpions is ≥2 hours; after soaking, they are dried at the following temperatures: centipedes ≤60℃, scorpions ≤80℃, and moisture content ≤5%.

[0011] Preferably, the toad skin is cleaned of impurities, washed with water, cut into pieces, stir-fried with sand until it foams, the sand is removed, and then stir-fried with wine until the surface is golden brown and there is no burnt smell.

[0012] Preferably, the pig carcass is first cleaned, dried, and then placed in a high-temperature resistant container and calcined over a high flame until it is carbonized. The surface is charred black, the texture is brittle, the ash content is ≥90%, and the uncarbonized part is ≤2%.

[0013] The method of preparing geckos is to stir-fry them with sand. Place sand in a pot and heat it over high heat until it becomes flexible. Then, add clean geckos and stir-fry them continuously until they bulge slightly. Remove them, sift out the sand, and let them cool.

[0014] A preparation containing the above-mentioned traditional Chinese medicine composition for breaking up blood stasis and removing blood stasis, wherein the dosage form of the traditional Chinese medicine composition preparation is a decoction, granules, pills, tablets or capsules.

[0015] A method for preparing a blood-activating and stasis-removing pill, wherein the raw material for the blood-activating and stasis-removing pill is the above-mentioned traditional Chinese medicine composition, comprising the following steps: (1) Raw material pretreatment: Centipedes, scorpions, toad skin, geckos, and pig shells were cryogenically pulverized with liquid nitrogen until D90≤45μm; Panax notoginseng, myrrh, safflower, and Ligusticum chuanxiong were pulverized and passed through a 300-mesh sieve, with a residue of ≤5%; (2) Thoroughly mix the pulverized raw materials; (3) Refine honey to make pills.

[0016] Furthermore, in step (2), a three-dimensional mixer was used at a speed of 10 r / min for a mixing time of ≥90 minutes; 10 samples were taken, and safflower yellow pigment A was detected by HPLC with an RSD ≤3%; The honey refining temperature in step (3) is 116-118℃, the water content is 14-16%, and the specific gravity is 1.35-1.38; the filter pore size is ≤100μm. After pelleting in step (3), the pellets are dried at a temperature of 45℃±2℃ with a moisture content of ≤6%.

[0017] In this invention, the centipede is the dried body of *Scolopendra subspinipes*, an animal of the Scolopendra family. It mainly contains various active polypeptides, fatty acids, polysaccharides, amino acids, and other components. These components work synergistically to exert their medicinal effects.

[0018] The scorpion is the dried body of the East Asian scorpion, an animal belonging to the family Scorpionidae. Its main components include scorpion venom, trimethylamine, betaine, taurine, and lecithin. Scorpion venom is its main active ingredient and possesses various pharmacological effects.

[0019] Toad skin refers to the skin of animals such as the Chinese giant toad or the black-rimmed toad. It mainly contains bufotalide derivatives, cardiac sterols, indole alkaloids, polysaccharides, and other components, exhibiting a variety of pharmacological activities.

[0020] Gecko refers to the dried whole body of the gecko (Gecko schlegelii) or other species of geckos belonging to the Gekkonidae family. It mainly contains alkaloids, proteins, fats, and trace elements, with alkaloids being one of its main active ingredients.

[0021] Panax notoginseng is the dried root and rhizome of the Panax notoginseng plant, belonging to the Araliaceae family. It mainly contains various saponins, such as notoginsenoside R1, ginsenoside Rg1, and ginsenoside Rb1, as well as flavonoids, polysaccharides, amino acids, and other components.

[0022] Myrrh is the dried resin of the Ficus microcarpa or Ficus hirta, plants belonging to the Burseraceae family. It mainly contains volatile oil, resin, and gum. The main components of the volatile oil are myrrhene, eugenol, and m-phenylmethylphenol, which possess various pharmacological activities.

[0023] Safflower is the dried flower of the safflower plant, belonging to the Asteraceae family. It mainly contains flavonoids, such as hydroxysafflower yellow A and kaempferol, as well as fatty acids and polysaccharides.

[0024] Ligusticum chuanxiong is the dried rhizome of the plant Ligusticum chuanxiong, belonging to the Apiaceae family. It mainly contains volatile oils, alkaloids, and phenolic substances, among which ferulic acid is one of its main active ingredients.

[0025] Hoof and hooves are the hooves of pigs, animals belonging to the Suidae family. They mainly contain protein components such as keratin and collagen, and can be hydrolyzed to obtain various amino acids, such as glycine, alanine, and proline.

[0026] The beneficial effects of this invention are: This invention's traditional Chinese medicine composition emphasizes both removing blood stasis and promoting blood circulation: animal-based medicines are the main component, including centipedes, scorpions, geckos, and toad skin, all of which are insect-based medicines. Traditional Chinese medicine believes that these insects are highly mobile and can "use poison to fight poison and break up blood stasis"; plant-based medicines are the auxiliary component, including Panax notoginseng, safflower, Ligusticum chuanxiong, and myrrh, which are classic blood-activating and stasis-removing medicines, enhancing the effects of unblocking the meridians and relieving pain, while also mitigating the harshness of insect-based medicines.

[0027] Toxicity Compatibility and Toxicity Reduction Design: When geckos, centipedes, and scorpions (all containing neurotoxins) are combined with toad skin (containing cardiac glycoside toxins), the toxicity needs to be mitigated through processing and the addition of herbs such as Panax notoginseng and myrrh. Pig hooves are rarely used in Han Chinese medicine, but are considered a medicinal material for promoting blood circulation and dispersing stagnation in some ethnic minorities (such as the Miao and Dong), reflecting the unique characteristics of their medicinal practices.

[0028] Each ingredient in the formula of this invention possesses unique pharmacological activity, and their synergistic effects, when combined, constitute the therapeutic efficacy of the Blood Stasis-Breaking Pill. Indications: Used for various cancers, including lung cancer, colorectal cancer, liver cancer, pancreatic cancer, cervical cancer, breast cancer, thyroid cancer, and gastric cancer. It can also be used in conjunction with radiotherapy, chemotherapy, and post-operative treatment. Attached Figure Description

[0029] Figure 1 This is the CT scan report of Xiao Moumou after taking the medication in clinical case 2. Figure 2 This is the MRI report of Zhang, a patient in clinical case 3, after taking the medication. Figure 3 This is the blood routine test report of Li, a clinical case 1, after taking the medication; Figure 4 This is the blood routine test report of Luo, a clinical case 4, after taking the medication. Detailed Implementation

[0030] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed in this application. Those skilled in the art can make various changes and modifications to the invention based on the disclosed content, and such changes should also fall within the scope of protection claimed in this application.

[0031] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention are obtained through conventional commercial channels. Reagents, active ingredients, and raw materials from different manufacturers do not significantly affect the technical effects.

[0032] In the embodiments of this invention, all raw materials are ordinary commercially available products, and their sources are not specifically limited. The quality standards and safety tests of raw materials, auxiliary materials, medicinal materials and processed products all comply with relevant national standards.

[0033] Example 1 A type of blood-stasis-removing pill, the raw materials are: centipede 30g, scorpion 15g, gecko 30g, toad skin 5g, Panax notoginseng 40g, myrrh 15g, safflower 5g, chuanxiong 5g, and pig shell 30g.

[0034] A method for preparing a blood-activating pill includes the following steps: 1. Pretreatment process Remove the head and legs from the centipede, soak it in rice wine for 3 hours until thoroughly moistened, then dry it at a low temperature (60℃ until crispy), with a moisture content ≤5%. Soak scorpions in salt water for 2 hours, rinse with clean water, and then dry (bake at 80℃ until firm), with a moisture content of ≤5%. Toad skin roasting method (spraying with 50° liquor and then stir-frying until slightly charred to destroy toad venom residue), bufotoxin lactone residue: HPLC method for sampling each batch, those exceeding national standards require rework.

[0035] The pig cartilage must first be cleaned and dried, then placed in a high-temperature resistant container and calcined over a high flame until carbonized (the surface is charred black and the texture is brittle), with an ash content of ≥90% and an uncarbonized portion of ≤2%. During the calcination process, the container must be sealed to prevent the smoke from escaping and to ensure the stability of the medicinal properties. After washing, Panax notoginseng is dried at a low temperature of 60℃. Myrrh vinegar-processed (stir-fry over low heat until the surface is slightly charred, using 10% vinegar); Ligusticum striatum prepared with wine (soaked in rice wine for 4 hours, then stir-fried until brownish-yellow); 2. Crushing and mixing Fineness of grinding: Insect-based medicinal materials (centipedes, scorpions, toad skin, geckos, pig shells) are cryogenically pulverized to 300 mesh (D90≤45μm) using liquid nitrogen. The medicinal plants (Panax notoginseng, myrrh, safflower, and chuanxiong) are pulverized and passed through a 300-mesh sieve, with a residue of ≤5%.

[0036] Mixing uniformity: The three-dimensional mixer operates at a speed of 10 r / min and a mixing time of ≥90 minutes. Ten samples were taken, and safflower yellow pigment A was detected by HPLC. The RSD was ≤3%.

[0037] 3. Pelletizing process Honey Refining Control: Honey refining temperature: 116-118℃, water content 14-16% (specific gravity 1.35-1.38). Filter pore size: ≤100μm.

[0038] Formulation: Mix the medicinal powder and refined honey in a ratio of 1:0.8-1.2 to form pills of moderate firmness (they should clump together when squeezed in the hand but crumble easily when lightly pressed). Weight variation: 3g / pill, ±5%; Drying temperature: 45℃±2℃, moisture content ≤6%.

[0039] Usage and dosage: Oral administration: Take one pill with water, twice a day.

[0040] Clinical case of the blood-activating pills prepared in Example 1 Case 1: Patient Li, female, born in 1960, suffered from lung adenocarcinoma. She had been taking targeted drugs for many years without success, and her physical condition and immunity had declined across the board. After taking the Poyu Pill prepared in Example 1 for four months, her condition was controlled, the tumor did not grow or spread, and no toxic side effects were produced.

[0041] Case 2: Xiao XX, male, 62 years old, suffering from small cell lung cancer. After taking the Poyuan Pills prepared in Example 1 for 2 months, the tumor significantly shrank.

[0042] Case 3: Zhang XX, female, 49 years old, with glioma. After taking the Poyuan Pills for five years, the tumor has basically disappeared.

[0043] Case 4: Luo XX, male, 54 years old. After taking the Poyuan Pills for half a year, the lung cancer has basically been controlled, and no toxic or side effects have occurred.

[0044] Stability test of Poyuan Pills As a national medicine with unique curative effects, the stability of Poyuan Pills plays a decisive role in the safety and effectiveness of clinical applications.

[0045] Stress testing 1. High temperature test: Place the Poyuan Pills samples in an incubator at 60°C for 10 days. Take samples on the 5th and 10th days respectively for comprehensive testing. The results show that the appearance color of the samples gradually deepens, and some volatile components are lost, resulting in a slight change in smell; the moisture content decreases by about 3%, which may be due to the acceleration of water evaporation at high temperature; the content of active ingredients also changes to a certain extent. For example, the content of active polypeptides in centipedes decreases by about 8%, and the content of scorpion toxins in scorpions decreases by about 10%. This indicates that high temperature has a relatively obvious impact on the stability of the active ingredients of Poyuan Pills.

[0046] 2. High humidity test: Place the samples in a constant humidity closed container with a relative humidity of 90% ± 5% for 10 days. Take samples on the 5th and 10th days for testing. It is found that the samples absorb moisture and gain weight by about 8%, showing obvious caking phenomena, which seriously affects the appearance and physical properties of the medicine; the results of microbial limit testing show that the number of microorganisms exceeds the standard on the 10th day, indicating that a high humidity environment is prone to microbial growth and poses a threat to the safety of the medicine; at the same time, the content of some water-soluble active ingredients also fluctuates. For example, the content of hydroxysafflor yellow A in safflower decreases by about 12%, indicating that high humidity has a greater negative impact on the active ingredients and quality stability of Poyuan Pills.

[0047] 3. High light irradiation test: Place the samples in an illumination box equipped with fluorescent lamps (illuminance of 4500 lx ± 500 lx) with the openings facing up for 10 days. The test results show that the color of the samples becomes significantly lighter, which may be due to the decomposition of some pigment components caused by photochemical reactions; the content of some active ingredients decreases. For example, the total content of bufadienolides and cardenolide bufotoxins in toad skins decreases by about 15%, indicating that Poyuan Pills are relatively sensitive to strong light, and light will have a significant impact on its active ingredients and appearance quality.

[0048] Accelerated test The Pyruvic Blood-activating Pills samples were placed in a thermo-hygrostat at a temperature of 40°C ± 2°C and a relative humidity of 75% ± 5% for 6 months. Samples were taken at the end of 1, 2, 3, and 6 months respectively, and a comprehensive inspection was carried out in accordance with the finished product quality control standards. At 1 month, the moisture content of the samples began to gradually increase, and there was an upward trend in the microbial limit; at 2 months, the content of some active ingredients began to decrease, such as the content of notoginsenoside R1 decreased by about 5%; at 3 months, the moisture content approached the limit requirement, the microbial limit exceeded the standard, and the content of active ingredients decreased more significantly, the content of ginsenoside Rg1 decreased by about 8%; at 6 months, obvious changes appeared in the appearance of the samples, the color became darker and there was a slight adhesion phenomenon, the content of active ingredients decreased by about 18%, and the overall quality stability decreased significantly. This indicates that under the accelerated test conditions, the stability of the Pyruvic Blood-activating Pills is poor, and the storage conditions need to be strictly controlled.

[0049] Long-term test Under the conditions of a temperature of 30°C ± 2°C and a relative humidity of 65% ± 5%, the samples were placed for 24 months. Samples were taken every 3 months for a comprehensive inspection. At 3 months, all indicators were basically stable, and the content of active ingredients decreased slightly, such as the content of the main component of volatile oil in myrrh decreased by about 3%; at 6 months, the content of active ingredients decreased by about 5%, and the moisture content, microbial limit, etc. all met the standard requirements; at 12 months, the content of active ingredients decreased by about 8%, and there were no obvious changes in the sample properties and particle size; at 24 months, the content of active ingredients decreased to the edge of the specified lower limit, such as the content of ginsenoside Rb1 decreased by about 15%, but it was still within the acceptable range, the microbial limit met the standard, and the moisture content was stable. This indicates that under the conditions set for the long-term test, the Pyruvic Blood-activating Pills are basically stable within 24 months, but as time goes by, the content of active ingredients gradually decreases, and attention needs to be paid to its quality changes. <>

[0050] Conclusion Through this stability test, it can be concluded that the Pyruvic Blood-activating Pills are relatively sensitive to environmental factors such as high temperature, high humidity, and strong light. Under the accelerated test conditions, the stability performance is not good, indicating that the environmental conditions must be strictly controlled during production, storage, and transportation. Under the conditions of a temperature of 30°C ± 2°C and a relative humidity of 65% ± 5% set for the long-term test, it is basically stable within 24 months, but the content of active ingredients will gradually decrease over time. Based on the test results, it is recommended that the storage conditions be sealed and placed in a cool and dry place (temperature not exceeding 20°C, relative humidity 35% - 75%) to ensure the quality and efficacy of the drug within the validity period.

Claims

1. A traditional Chinese medicine composition for breaking up blood stasis and removing blood stasis, characterized in that, The raw materials of this traditional Chinese medicine composition are: centipede, scorpion, toad skin, Panax notoginseng, gecko, myrrh, safflower, Ligusticum chuanxiong, and pig shell.

2. The traditional Chinese medicine composition for breaking up blood stasis and removing blood stasis according to claim 1, characterized in that, The raw materials of this traditional Chinese medicine composition are: centipede 5-7 parts by weight, scorpion 2-4 parts by weight, toad skin 0.5-1.5 parts by weight, Panax notoginseng 8-12 parts by weight, gecko 5-7 parts by weight, myrrh 2-4 parts by weight, safflower 0.5-1.5 parts by weight, Ligusticum chuanxiong 0.5-1.5 parts by weight, and pig shell 5-7 parts by weight.

3. The traditional Chinese medicine composition for breaking up blood stasis and removing blood stasis according to claim 1, characterized in that, The raw materials of this traditional Chinese medicine composition are: 6 parts by weight of centipede, 3 parts by weight of scorpion, 1 part by weight of toad skin, 8 parts by weight of Panax notoginseng, 6 parts by weight of gecko, 3 parts by weight of myrrh, 1 part by weight of safflower, 1 part by weight of Ligusticum chuanxiong, and 6 parts by weight of pig shell.

4. The traditional Chinese medicine composition for breaking up blood stasis and removing blood stasis according to claim 1, characterized in that, The centipedes and scorpions were prepared by removing their heads and feet and then soaking them in rice wine or salt water. The toad skin was prepared by roasting with wine. The pig armor was prepared by calcining with charcoal at high temperature.

5. The traditional Chinese medicine composition for breaking up blood stasis and removing blood stasis according to claim 4, characterized in that, Centipedes should be soaked for ≥2 hours, and scorpions for ≥2 hours; after soaking, they should be dried at the following temperatures: centipedes ≤60℃, scorpions ≤80℃, and moisture content ≤5%.

6. The traditional Chinese medicine composition for breaking up blood stasis and removing blood stasis according to claim 4, characterized in that, Remove impurities from the toad skin, wash it with clean water, cut it into pieces, stir-fry it with sand until it foams, remove the sand, and then stir-fry it with wine until the surface is golden brown and there is no burnt smell.

7. The traditional Chinese medicine composition for breaking up blood stasis and removing blood stasis according to claim 4, characterized in that, First, clean the pig carcass, dry it in the sun, and then put it into a high-temperature resistant container. Then, calcine it with a high flame until it is carbonized. The surface is charred black, the texture is brittle, the ash content is ≥90%, and the uncarbonized part is ≤2%.

8. A traditional Chinese medicine composition preparation for breaking up blood stasis and removing blood stasis according to any one of claims 1-7, characterized in that, The dosage forms of the traditional Chinese medicine composition are decoctions, granules, pills, tablets, or capsules.

9. A method for preparing a blood-activating pill, characterized in that, The raw material for the Blood Stasis-Clearing Pill is the traditional Chinese medicine composition according to any one of claims 1-7, comprising the following steps: (1) Raw material pretreatment: Centipedes, scorpions, toad skin, geckos, and pig shells were cryogenically pulverized with liquid nitrogen until D90≤45μm; Panax notoginseng, myrrh, safflower, and Ligusticum chuanxiong were pulverized and passed through a 300-mesh sieve, with a residue of ≤5%; (2) Thoroughly mix the pulverized raw materials; (3) Refine honey to make pills.

10. The method for preparing a blood-activating pill according to claim 9, characterized in that, In step (2), a three-dimensional mixer was used at a speed of 10 r / min for a mixing time of ≥90 minutes; 10 samples were taken, and safflower yellow pigment A was detected by HPLC with an RSD ≤3%; The honey refining temperature in step (3) is 116-118℃, the water content is 14-16%, and the specific gravity is 1.35-1.38; the filter pore size is ≤100μm. After pelleting in step (3), the pellets are dried at a temperature of 45℃±2℃ with a moisture content of ≤6%.

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