Traditional Chinese medicine composition for treating liver and kidney cyst as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating liver and kidney cyst and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine. The composition comprises the following components in parts by weight: 1-15 parts of selfheal, 1-15 parts of tangerine seed, 5-20 parts of turtle shell, 1-10 parts of lychee seed, 10-30 parts of radix ranunculi ternati, 1-5 parts of leech, 5-15 parts of oldenlandia diffusa, 5-15 parts of dark plum, 1-10 parts of pericarpium citri reticulatae, 5-20 parts of radix actinidiae chinensis, 30-100 parts of chestnut shell, 10-20 parts of alhagi sparsifolia, 5-20 parts of rhizoma drynariae, 1-10 parts of horsetail, 5-15 parts of spina gleditsiae, 1-10 parts of liquorice, 1-15 parts of lithospermum and 1-15 parts of stiff silkworm. The traditional Chinese medicine composition has a good treatment effect on liver and kidney cyst caused by blood stasis and phlegm coagulation.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for treating liver and kidney cysts, and a preparation method and application thereof. Background Art

[0002] Liver cysts are a group of heterogeneous diseases with different etiologies, including sporadic simple liver cysts and hereditary polycystic liver diseases (PLD). Whether it is simple liver cysts or polycystic liver disease (PLD), most liver cysts are relatively small (<5cm) and most of them are asymptomatic. However, larger cysts may cause abdominal pain, bloating, loss of appetite, nausea, vomiting, abdominal mass or dyspnea due to the mass effect. Although most patients with this disease present with a benign course, some patients also have symptoms and complications related to cyst enlargement and subsequent compression of abdominal organs, such as abdominal pain, early satiety, esophageal reflux or intracystic bleeding, infection, and even cyst rupture. In very few patients, liver function is damaged or even liver failure occurs due to excessive cyst size and number. At present, the main treatments for this disease include conservative treatment, suction sclerotherapy, fenestration surgery, partial liver resection and liver transplantation.

[0003] Renal cysts often have no obvious symptoms, but a few cysts may cause symptoms. Low back pain is the most common, while hematuria, hypertension, gastrointestinal vagal symptoms, cyst rupture, and hydronephrosis are rare, and occasionally polycythemia may occur. In recent years, a series of studies have shown that simple renal cysts are associated with common medical diseases such as hypertension, diabetes, hyperuricemia, kidney stones, and abnormal renal function.

[0004] There are currently no better treatments for liver cysts and kidney cysts on the market. Therefore, it is extremely important to develop a drug that has a better therapeutic effect on liver cysts and kidney cysts. Summary of the invention

[0005] In view of the above-mentioned deficiencies in the prior art, the present invention provides a Chinese medicine composition for treating liver and kidney cysts, and a preparation method and application thereof. The Chinese medicine composition has a good therapeutic effect on blood stasis and phlegm coagulation type liver and kidney cysts.

[0006] To achieve the above purpose, the technical solution adopted by the present invention to solve the technical problem is:

[0007] A traditional Chinese medicine composition for treating liver and kidney cysts comprises the following components in parts by weight: 1-15 parts of Prunella Vulgaris, 1-15 parts of tangerine seeds, 5-20 parts of turtle shells, 1-10 parts of litchi seeds, 10-30 parts of cat's claw, 1-5 parts of leeches, 5-15 parts of oldenlandia diffusa, 5-15 parts of black plums, 1-10 parts of tangerine peels, 5-20 parts of iris root, 30-100 parts of chestnut shells, 10-20 parts of camel thorns, 5-20 parts of drynaria, 1-10 parts of horsetail, 5-15 parts of Gleditsia sinensis thorns, 1-10 parts of liquorice, 1-15 parts of lithospermum officinale and 1-15 parts of bombyx batryticatus.

[0008] Further, the invention comprises the following components in parts by weight: 5-10 parts of selfheal, 5-10 parts of tangerine seed, 10-15 parts of turtle shell, 4-8 parts of litchi seed, 15-25 parts of cat's claw, 2-4 parts of leech, 7-12 parts of oldenlandia diffusa, 7-12 parts of black plum, 4-8 parts of tangerine peel, 10-15 parts of rattan pear root, 50-70 parts of chestnut shell, 13-17 parts of camel thorn, 10-15 parts of drynaria, 4-8 parts of equisetum, 7-12 parts of gleditsia thorn, 4-8 parts of liquorice, 5-10 parts of lithospermum and 5-10 parts of bombyx batryticatus.

[0009] Further, the invention comprises the following components in parts by weight: 5 parts of Prunella Vulgaris, 10 parts of tangerine seed, 10 parts of turtle shell, 4 parts of litchi seed, 25 parts of cat's claw, 2 parts of leech, 12 parts of oldenlandia diffusa, 7 parts of black plum, 4 parts of tangerine peel, 15 parts of rattan pear root, 50 parts of chestnut shell, 17 parts of camel thorn, 10 parts of drynaria, 8 parts of equisetum, 7 parts of Gleditsia sinensis thorn, 8 parts of liquorice, 5 parts of lithospermum and 10 parts of bombyx batryticatus.

[0010] Further, the invention comprises the following components in parts by weight: 10 parts of Prunella Vulgaris, 5 parts of tangerine seed, 15 parts of turtle shell, 8 parts of litchi seed, 15 parts of cat's claw, 4 parts of leech, 7 parts of oldenlandia diffusa, 12 parts of black plum, 8 parts of tangerine peel, 10 parts of rattan pear root, 70 parts of chestnut shell, 13 parts of camel thorn, 15 parts of drynaria, 4 parts of equisetum, 12 parts of Gleditsia sinensis thorn, 4 parts of licorice, 10 parts of lithospermum and 5 parts of bombyx batryticatus.

[0011] Further, the invention comprises the following components in parts by weight: 8 parts of Prunella Vulgaris, 8 parts of tangerine seed, 12 parts of turtle shell, 6 parts of litchi seed, 20 parts of cat's claw, 3 parts of leech, 10 parts of oldenlandia diffusa, 10 parts of black plum, 6 parts of tangerine peel, 13 parts of rattan pear root, 60 parts of chestnut shell, 15 parts of camel thorn, 13 parts of drynaria, 6 parts of equisetum, 10 parts of Gleditsia thorn, 6 parts of licorice, 8 parts of lithospermum and 8 parts of bombyx batryticatus.

[0012] Furthermore, the tangerine seed is salted tangerine seed, the turtle shell is vinegared turtle shell, the lychee seed is salted lychee seed, the drynaria is scalded drynaria, and the licorice is roasted licorice.

[0013] The preparation method of the above-mentioned traditional Chinese medicine composition for treating liver and kidney cysts comprises the following steps: the raw materials are crushed and then mixed; or the raw materials are mixed or extracted separately to obtain an extract; or the extract is further refined and purified to obtain an effective ingredient; or the extract / effective ingredient is added with pharmaceutically acceptable excipients.

[0014] Furthermore, the dosage form is one of pills, granules, capsules, powders, mixtures, tablets, granules or oral liquids.

[0015] Furthermore, the specific preparation method is as follows: seven of the above 18 ingredients, namely, turtle shell, leech, tangerine peel, horsetail, chestnut shell, camel thorn, and silkworm, are crushed into fine powder, sieved, mixed, and set aside; the remaining eleven ingredients, including selfheal, tangerine seed, litchi seed, cat's claw, black plum, oldenlandia diffusa, rattan pear wood, drynaria, sapodilla thorn, lithospermum and roasted licorice, are added with water, decocted, the filtrate is combined, filtered, the filtrate is concentrated into an extract, mixed with the above fine powder, dried, crushed into fine powder, made into pills, and dried to obtain the extract.

[0016] Application of the above Chinese medicine composition in preparing medicine for treating liver and kidney cysts.

[0017] The beneficial effects produced by the present invention are:

[0018] In the present invention, Prunella vulgaris has the effects of clearing liver fire and dispersing nodules, tangerine seed has the effects of regulating qi and dispersing nodules, and litchi seed has the effects of regulating qi and dispersing nodules. The three medicines are used together to play the effects of clearing liver fire, purging fire, regulating qi and dispersing nodules, and reducing swelling; turtle shell has the effects of nourishing yin and suppressing yang, softening hard masses and dispersing nodules, and cat's claw has the effects of resolving phlegm and dispersing nodules. The two medicines are used together to nourish yin and suppress yang, soften hard masses and dispersing nodules, and have a therapeutic effect on phlegm congealing caused by liver and kidney yin deficiency; Gleditsia sinensis has the effects of reducing swelling and discharging pus, and Bombyx batryticatus has the effects of reducing swelling, detoxifying, and dispersing pus. The two medicines are used together to have a therapeutic effect on resolving phlegm, unblocking meridians, dispersing pus, dispersing nodules, and reducing swelling; the above medicines are collectively monarch medicines;

[0019] Leeches have the effect of breaking blood and removing blood stasis, and can remove blood stasis in the veins and resolve blood stasis inside cysts; Hedyotis diffusa and Lithospermum officinale have the effects of clearing heat and detoxifying, cooling blood and dispersing blood stasis; Rhizoma Coptidis and Equisetum arvense have the effects of clearing heat and removing dampness, dispersing wind and unblocking collaterals, and can assist in eliminating damp-heat accumulation. The above drugs are all ministerial drugs;

[0020] Wumei has the effect of sourness and astringency, which can prevent the dispersing drugs from damaging the vital energy; Gusu Bu has the effect of strengthening the body and nourishing the essence; Chenpi has the effect of regulating qi and strengthening the spleen, drying dampness and resolving phlegm, and can transport and transform phlegm and dampness; Camel thorn has the effect of clearing heat and detoxifying, which can assist in removing blood stasis, clearing heat and eliminating blood stasis. The above drugs are adjuvant drugs.

[0021] Licorice has the function of harmonizing various medicines, alleviating the harsh nature of the medicines, and also invigorating qi and harmonizing the middle, promoting the health of the body; the medicines in this application are compatible with each other, and the medicinal materials complement each other. Through the combination of dispersing and collecting, attacking and supplementing, regulating qi and blood, clearing away dampness and heat, etc., it has a good therapeutic effect on liver cysts and kidney cysts with blood stasis and phlegm stagnation syndrome. DETAILED DESCRIPTION

[0022] In order to make the purpose, technical scheme and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention, that is, the embodiments described are only part of the embodiments of the present invention, rather than all of the embodiments.

[0023] Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative work are within the scope of protection of the present invention.

[0024] It should be noted that relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprises" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0025] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0026] Example 1

[0027] A traditional Chinese medicine composition for treating liver and kidney cysts is prepared from the following components in parts by weight: 1 part of Prunella Vulgaris, 15 parts of salt orange seeds, 5 parts of vinegar turtle shells, 10 parts of salt lychee seeds, 30 parts of cat's claw, 1 part of leech, 15 parts of oldenlandia diffusa, 5 parts of black plum, 1 part of tangerine peel, 20 parts of rattan pear root, 30 parts of chestnut shell, 20 parts of camel thorn, 5 parts of scalded drynaria, 10 parts of horsetail, 5 parts of Gleditsia sinensis thorn, 10 parts of roasted liquorice, 1 part of lithospermum officinale and 15 parts of bombyx batryticatus.

[0028] The preparation method of the above-mentioned traditional Chinese medicine composition for treating liver and kidney cysts comprises the following steps: the above 18 ingredients, including turtle shell with vinegar, leech, tangerine peel, horsetail, chestnut shell, camel thorn and silkworm, are crushed into fine powder, sieved, mixed and set aside; the remaining 11 ingredients, including selfheal, salt orange kernel, salt lychee kernel, cat's claw, black plum, oldenlandia diffusa, rattan pear wood, scalded bone drynaria, sapodilla thorn, lithospermum and roasted licorice, are added with 12 times the amount of water, boiled twice, each time for 1.5 hours, the filtrate is combined, filtered, the filtrate is concentrated into an extract with a relative density of 1.2 (60-65°C), mixed with the above-mentioned fine powder, dried, crushed into fine powder, made into pills, and dried to obtain the extract.

[0029] Example 2

[0030] A traditional Chinese medicine composition for treating liver and kidney cysts is prepared from the following components in parts by weight: 15 parts of Prunella Vulgaris, 1 part of salt orange kernel, 20 parts of vinegar turtle shell, 1 part of salt lychee kernel, 10 parts of cat's claw, 5 parts of leech, 5 parts of oldenlandia diffusa, 15 parts of black plum, 10 parts of tangerine peel, 5 parts of rattan pear root, 100 parts of chestnut shell, 10 parts of camel thorn, 20 parts of scalded drynaria, 1 part of horsetail, 15 parts of Gleditsia sinensis thorn, 1 part of roasted liquorice, 15 parts of lithospermum officinale and 1 part of bombyx batryticatus.

[0031] The preparation method of the above-mentioned traditional Chinese medicine composition for treating liver and kidney cysts comprises the following steps: the above 18 ingredients, including turtle shell with vinegar, leech, tangerine peel, horsetail, chestnut shell, camel thorn and silkworm, are crushed into fine powder, sieved, mixed and set aside; the remaining 11 ingredients, including selfheal, salt orange kernel, salt lychee kernel, cat's claw, black plum, oldenlandia diffusa, rattan pear wood, scalded bone drynaria, sapodilla thorn, lithospermum and roasted liquorice, are added with 12 times the amount of water, boiled twice, each time for 1.5 hours, the filtrate is combined, filtered, the filtrate is concentrated into an extract with a relative density of 1.3 (60-65°C), mixed with the above-mentioned fine powder, dried, crushed into fine powder, made into pills, and dried to obtain the extract.

[0032] Example 3

[0033] A traditional Chinese medicine composition for treating liver and kidney cysts is prepared from the following components in parts by weight: 5 parts of Prunella Vulgaris, 10 parts of tangerine seeds, 10 parts of turtle shells, 4 parts of litchi seeds, 25 parts of cat's claw, 2 parts of leeches, 12 parts of oldenlandia diffusa, 7 parts of black plums, 4 parts of tangerine peels, 15 parts of iris root, 50 parts of chestnut shells, 17 parts of camel thorns, 10 parts of drynaria, 8 parts of equisetum, 7 parts of Gleditsia sinensis thorns, 8 parts of liquorice, 5 parts of lithospermum and 10 parts of bombyx batryticatus.

[0034] The preparation method of the above-mentioned traditional Chinese medicine composition for treating liver and kidney cysts comprises the following steps: the above 18 ingredients, including turtle shell with vinegar, leech, tangerine peel, horsetail, chestnut shell, camel thorn and silkworm, are crushed into fine powder, sieved, mixed and set aside; the remaining 11 ingredients, including selfheal, salt orange kernel, salt lychee kernel, cat's claw, black plum, oldenlandia diffusa, rattan pear wood, scalded bone drynaria, sapodilla thorn, lithospermum and roasted liquorice, are added with 12 times the amount of water, boiled twice, each time for 1.5 hours, the filtrate is combined, filtered, the filtrate is concentrated into an extract with a relative density of 1.3 (60-65°C), mixed with the above-mentioned fine powder, dried, crushed into fine powder, made into pills, and dried to obtain the extract.

[0035] Example 4

[0036] A traditional Chinese medicine composition for treating liver and kidney cysts is prepared from the following components in parts by weight: 10 parts of Prunella Vulgaris, 5 parts of tangerine seeds, 15 parts of turtle shells, 8 parts of litchi seeds, 15 parts of cat's claws, 4 parts of leeches, 7 parts of oldenlandia diffusa, 12 parts of black plums, 8 parts of tangerine peels, 10 parts of iris root, 70 parts of chestnut shells, 13 parts of camel thorns, 15 parts of drynaria, 4 parts of equisetum, 12 parts of Gleditsia sinensis thorns, 4 parts of liquorice, 10 parts of lithospermum and 5 parts of bombyx batryticatus.

[0037] The preparation method of the above-mentioned traditional Chinese medicine composition for treating liver and kidney cysts comprises the following steps: the above 18 ingredients, including turtle shell with vinegar, leech, tangerine peel, horsetail, chestnut shell, camel thorn and silkworm, are crushed into fine powder, sieved, mixed and set aside; the remaining 11 ingredients, including selfheal, salt orange kernel, salt lychee kernel, cat's claw, black plum, oldenlandia diffusa, rattan pear wood, scalded bone drynaria, sapodilla thorn, lithospermum and roasted licorice, are added with 12 times the amount of water, boiled twice, each time for 1.5 hours, the filtrate is combined, filtered, the filtrate is concentrated into an extract with a relative density of 1.2 (60-65°C), mixed with the above-mentioned fine powder, dried, crushed into fine powder, made into pills, and dried to obtain the extract.

[0038] Example 5

[0039] A traditional Chinese medicine composition for treating liver and kidney cysts is prepared from the following components in parts by weight: 8 parts of Prunella Vulgaris, 8 parts of tangerine seeds, 12 parts of turtle shells, 6 parts of litchi seeds, 20 parts of cat's claws, 3 parts of leeches, 10 parts of oldenlandia diffusa, 10 parts of black plums, 6 parts of tangerine peels, 13 parts of iris root, 60 parts of chestnut shells, 15 parts of camel thorns, 13 parts of drynaria, 6 parts of equisetum, 10 parts of Gleditsia sinensis thorns, 6 parts of liquorice, 8 parts of lithospermum and 8 parts of bombyx batryticatus.

[0040] The preparation method of the above-mentioned traditional Chinese medicine composition for treating liver and kidney cysts comprises the following steps: the above 18 ingredients, including turtle shell with vinegar, leech, tangerine peel, horsetail, chestnut shell, camel thorn and silkworm, are crushed into fine powder, sieved, mixed and set aside; the remaining 11 ingredients, including selfheal, salt orange kernel, salt lychee kernel, cat's claw, black plum, oldenlandia diffusa, rattan pear wood, scalded bone drynaria, sapodilla thorn, lithospermum and roasted liquorice, are added with 12 times the amount of water, boiled twice, each time for 1.5 hours, the filtrate is combined, filtered, the filtrate is concentrated into an extract with a relative density of 1.3 (60-65°C), mixed with the above-mentioned fine powder, dried, crushed into fine powder, made into pills, and dried to obtain the extract.

[0041] Comparative Example 1

[0042] A traditional Chinese medicine composition for treating liver and kidney cysts is prepared from the following components in parts by weight: 8 parts of gentian, 8 parts of trifoliate lanceolate, 12 parts of oyster, 6 parts of litchi seed, 20 parts of cat's claw, 3 parts of leech, 10 parts of oldenlandia diffusa, 10 parts of black plum, 6 parts of tangerine peel, 13 parts of iris root, 60 parts of chestnut shell, 15 parts of camel thorn, 13 parts of drynaria, 6 parts of equisetum, 10 parts of patrinia, 6 parts of liquorice, 8 parts of lithospermum and 8 parts of bombyx batryticatus.

[0043] The preparation method of the above-mentioned traditional Chinese medicine composition for treating liver and kidney cysts comprises the following steps: the above 18 ingredients, including oyster, leech, tangerine peel, horsetail, chestnut shell, camel thorn and silkworm, are crushed into fine powder, sieved, mixed and set aside; the remaining 11 ingredients, including gentian, trifoliate green, salt lychee kernel, cat's claw, black plum, oldenlandia diffusa, rattan pear wood, bone drynaria, patrinia, lithospermum and roasted liquorice, are added with 12 times the amount of water, boiled twice, each time for 1.5 hours, the filtrate is combined, filtered, and the filtrate is concentrated into an extract with a relative density of 1.3 (60-65°C), mixed with the above-mentioned fine powder, dried, crushed into fine powder, made into pills, and dried to obtain the extract.

[0044] Comparative Example 2

[0045] A traditional Chinese medicine composition for treating liver and kidney cysts is prepared from the following components in parts by weight: 8 parts of selfheal, 8 parts of tangerine seeds, 12 parts of turtle shells, 6 parts of litchi seeds, 20 parts of cat's claws, 3 parts of earthworms, 10 parts of dandelions, 6 parts of tangerine peels, 13 parts of iris root, 60 parts of chestnut shells, 15 parts of camel thorns, 6 parts of horsetail, 10 parts of gleditsia thorns, 6 parts of liquorice, 8 parts of lithospermum and 8 parts of bombyx batryticatus.

[0046] The preparation method of the above-mentioned traditional Chinese medicine composition for treating liver and kidney cysts comprises the following steps: the above 18 ingredients, including turtle shell, earthworm, tangerine peel, horsetail, chestnut shell, camel thorn and silkworm, are crushed into fine powder, sieved, mixed and set aside; the remaining 11 ingredients, including selfheal, salt orange kernel, salt lychee kernel, cat's claw, dandelion, rattan pear wood, scalded soapberry thorn, lithospermum and roasted licorice, are added with 12 times the amount of water, boiled twice, each time for 1.5 hours, the filtrate is combined, filtered, and the filtrate is concentrated into an extract with a relative density of 1.3 (60-65°C), mixed with the above-mentioned fine powder, dried, crushed into fine powder, made into pills, and dried to obtain the extract.

[0047] Test example

[0048] 1. Clinical Trials

[0049] Patients with liver cysts and kidney cysts who visited our hospital were collected.

[0050] 1. Diagnostic criteria

[0051] 1.1 Western medicine diagnostic criteria for liver cysts

[0052] The following is formulated with reference to the Clinical Diagnosis and Treatment Guidelines (Surgery) compiled by the Chinese Medical Association (published by the People's Medical Publishing House in 2006) and the 9th edition of Surgery:

[0053] ①Symptoms: The cyst compresses the adjacent organs, causing abdominal discomfort, dull pain, and obstructive jaundice; acute abdominal pain occurs when the cyst ruptures or the pedicle twists; and chills, fever, etc. occur when the cyst is infected.

[0054] ②Physical signs: Large cysts can be palpated as a mass and liver enlargement in the right upper abdomen. The mass can move with breathing, has a smooth surface, feels cystic, and has no obvious tenderness. Multiple liver cysts can be palpated as scattered nodules on the liver surface without obvious tenderness.

[0055] ③ Laboratory examination: Patients with combined bile duct stenosis, cholangitis, hepatitis and those in the late stage of the disease may have abnormal liver function tests, such as elevated transaminase, increased total bilirubin and direct bilirubin, hypoproteinemia, etc.; patients with intracystic infection may have increased white blood cell counts.

[0056] ④Imaging examinations: B-ultrasound, CT, abdominal plain film, radionuclide liver scan, etc. are all helpful in the diagnosis of liver cysts.

[0057] 1.2 Western medicine diagnosis of renal cysts

[0058] Drafted with reference to the relevant contents of the 9th edition of Surgery:

[0059] Generally, the diagnosis can be made based on the patient's symptoms such as pain in the affected side of the abdomen or back, hematuria, etc., combined with the results of auxiliary examinations such as B-ultrasound and CT.

[0060] ① Symptoms: Simple kidney swelling generally has no symptoms. Only when the swelling compresses the surrounding tissues will corresponding manifestations appear, such as low back and abdominal pain, abdominal masses, hematuria, etc.; there are usually no symptoms in the early stages, and most symptoms only appear around the age of 40, such as flank and back pain, macroscopic hematuria, and impaired renal function.

[0061] ②Physical signs: When palpating the abdomen of a large cyst, an abdominal mass may be felt.

[0062] ③ Laboratory examination: If the cyst compresses the renal parenchyma or is accompanied by intracystic infection, a small amount of red blood cells and white blood cells will appear in the urine.

[0063] ④ Imaging examination: B-ultrasound and CT are helpful for the diagnosis of renal cysts. The typical sonographic features of B-ultrasound are round or oval liquid-free echo-free areas in the renal parenchyma or under the capsule, with thin walls and smooth edges, and enhanced echoes in the back. Even very small cysts can be found. CT can accurately reflect the positional relationship between the cyst and the surrounding structures. The imaging shows that the cyst is a uniform, round, low-density area with sharp boundaries, and has a clear boundary with the adjacent renal parenchyma.

[0064] 1.3 TCM syndrome diagnostic criteria

[0065] Refer to "Chinese Medicine Surgery" edited by Chen Hongfeng of China Traditional Chinese Medicine Press, "Chinese Medicine Internal Medicine" (11th edition), a planned textbook for national colleges of traditional Chinese medicine, and "Clinical Guidance for New Chinese Medicines" (2002 edition):

[0066] Main symptoms: dull abdominal pain, backache, distension and pain, irritability and restlessness;

[0067] Secondary symptoms: fullness, nausea, and vomiting after eating;

[0068] Tongue and pulse: dark red tongue, thin and greasy coating, stringy or slippery pulse;

[0069] The diagnosis can be made based on 2 main symptoms and 2 or more secondary symptoms combined with tongue and pulse.

[0070] 1.4 Quantitative Standards for TCM Syndrome Symptom Scoring

[0071] Table 1:

[0072]

[0073] 4 Inclusion criteria

[0074] ⑴ Those who meet the diagnostic criteria for liver cysts and kidney cysts.

[0075] ⑵ Those who meet the syndrome of blood stasis and phlegm coagulation.

[0076] ⑶Age: 18-70 years old.

[0077] 5. Criteria for exclusion of cases

[0078] (1) Patients with liver and kidney malignancies confirmed by examination.

[0079] (2) Women who are pregnant, planning to become pregnant or breastfeeding within six months.

[0080] (3) People with allergic constitution or allergies to multiple drugs.

[0081] (4) Patients have other complications that may affect the observation of therapeutic efficacy or have contraindications to the trial drugs.

[0082] (5) Those who take contraceptive pills and sex hormone drugs.

[0083] (6) Patients with serious primary diseases of the cardiovascular, liver, kidney and hematopoietic systems, or mental illness.

[0084] 6 Treatments

[0085] Patients with liver cysts and kidney cysts were randomly divided into 3 groups, each with 20 patients. The patients in each group were respectively given the drugs in Example 5 and Comparative Examples 1-2, once in the morning and evening each day, 6 g each time (each g is equivalent to 1.77 g of crude drug), for 30 consecutive days, and the recovery status of each group of patients was observed and counted.

[0086] 7 Observation indicators

[0087] 7.1 Safety Observation

[0088] (1) Vital signs: such as blood pressure, respiration, heart rate, etc. (before and after the test).

[0089] (2) Routine blood, urine and stool examinations (before and after the test).

[0090] (3) Electrocardiogram, liver function (ALT, AST), and renal function (BUN, Cr, TBIL, TP, ALP) (before and after the test).

[0091] (4) Adverse events (record in detail at any time).

[0092] 7.2 Efficacy Observations

[0093] 7.2.1 Background information observation (before experiment)

[0094] (1) Demographic data: age, height, weight, etc.

[0095] (2) General clinical information: comorbidities and medications, etc.

[0096] 7.2.2 Diagnostic indicators (before the test)

[0097] (1) Specialized examination: B-ultrasound, CT scan, etc.

[0098] (2) Traditional Chinese medicine syndrome.

[0099] (3) Related symptoms and signs (before and after the test).

[0100] 7.2.3 Efficacy Observation

[0101] (1) TCM symptoms (before and after the test);

[0102] (2) Related symptoms and signs (before and after the test).

[0103] 8. Efficacy evaluation criteria

[0104] 8.1 Criteria for determining the efficacy of TCM symptoms

[0105] Formulated with reference to the "Standards for Diagnosis and Efficacy of TCM Diseases" and the "Guidelines for Clinical Research of New Chinese Medicines". Clinical control: clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by N≥95%. Significant effect: clinical symptoms and signs are significantly improved, and the syndrome score decreases by N≥70%, <95%.

[0106] Effective: Clinical symptoms and signs are improved, and the syndrome score is reduced by N≥30%, <70%.

[0107] Ineffective: clinical symptoms and signs have no significant improvement, or even worsen, and the syndrome score decreases by N < 30%. Note: Therapeutic effect index N = (total score before treatment - total score after treatment) ÷ total score before treatment × 100%.

[0108] Total effective rate (%) = (number of clinically controlled patients + number of significantly effective patients + number of effective patients) ÷ total number of patients × 100%.

[0109] 8.2 Criteria for determining disease efficacy

[0110] Significantly effective: The diameter of the cyst is reduced by more than 1 / 2;

[0111] Effective: The diameter of the cyst is reduced by more than 1 / 3;

[0112] Ineffective: no significant change in cyst diameter or cyst enlargement;

[0113] Recurrence: The cyst diameter increases or new cysts appear.

[0114] Total effective rate % = (number of effective patients + number of effective patients) ÷ total number of patients × 100%

[0115] 9. Treatment results

[0116] TCM syndrome efficacy: The results of liver cyst treatment are shown in Table 2, and the results of kidney cyst treatment are shown in Table 3;

[0117] Table 2: Treatment results of liver cysts

[0118] Group Clinical control (people) Significantly effective (people) Effective (person) Invalid (person) Effectiveness (%) Example 5 5 9 4 2 90％ Comparative Example 1 0 5 4 11 45％ Comparative Example 2 0 4 3 13 35％

[0119] Table 3: Treatment outcomes of renal cysts

[0120] Group Clinical control (people) Significantly effective (people) Effective (person) Invalid (person) Total effective rate (%) Example 5 5 8 5 2 90％ Comparative Example 1 0 4 6 10 50％ Comparative Example 2 0 3 6 11 45％

[0121] Disease efficacy: The treatment results of liver cysts are shown in Table 4, and the treatment results of kidney cysts are shown in Table 5;

[0122] Table 4: Treatment results of liver cysts

[0123] Group Significantly effective (people) Effective (person) Invalid (person) Relapse (person) Total effective rate (%) Example 5 6 9 2 3 85％ Comparative Example 1 0 8 8 4 40％ Comparative Example 2 0 6 11 3 30％

[0124] Table 5: Treatment results of renal cysts

[0125] Group Significantly effective (people) Effective (person) Invalid (person) Relapse (person) Total effective rate (%) Example 5 5 10 3 2 75％ Comparative Example 1 0 6 10 4 30％ Comparative Example 2 0 5 12 3 25％

[0126] It can be seen from the results in Tables 2-5 that the drugs in Example 5 have good therapeutic effects on liver cysts and kidney cysts, with a total effective rate of more than 85%, while the drug formula in Comparative Example 1-2 was adjusted, and the total effective rate of the drugs after the adjustment was lower than 50%. It is speculated that after the adjustment of the formula, the interaction relationship between the drugs disappeared, thereby affecting the final therapeutic effect.

[0127] 2. Animal Experiments

[0128] 1. Experimental Materials

[0129] Test drugs: drugs in Example 5 and Comparative Examples 1-2

[0130] Positive drugs: Enteric-coated aspirin tablets, Metoclopramide tablets

[0131] Animals: KM mice, 100, half male and half female;

[0132] 2. Drug preparation method

[0133] Taking the drugs in Example 5 and Comparative Examples 1-2 as examples, the drugs were converted into a mouse intragastric administration dose of 2.73 g / Kg. Since the administration volume was 20 ml / Kg, the converted administration concentrations were 14% respectively;

[0134] The preparation method is as follows: take 1.4g of the drug, add the drug to pure water and place in a refrigerator for refrigeration, soak for 12 hours, add pure water to make the volume 10ml, and mix evenly with a glass rod and glue stick to obtain the drug solution for intragastric administration;

[0135] Enteric-coated aspirin tablets were selected as the microcirculation-positive drug. The oral administration dose for mice was 72.8 mg / Kg after conversion. Since the administration volume was 20 ml / Kg, the converted administration concentration was 3.64 mg / ml.

[0136] The preparation method is as follows: grind 1 enteric-coated aspirin tablet into powder, weigh 36.4 mg of aspirin powder, add purified water to make up to 10 ml, stir evenly, and obtain;

[0137] Metoclopramide tablets were selected as the positive drug for gastric emptying and small intestinal propulsion test. The oral administration dose for mice was 91 mg / Kg. Since the administration volume was 20 ml / Kg, the converted administration concentration was 4.55 mg / ml.

[0138] The preparation method is as follows: grind 1 metoclopramide tablet into powder, weigh 45.5 mg of drug powder, add purified water to make up to 10 ml, stir and mix well, and the product is obtained.

[0139] Preparation of nutritional semi-solid paste: Take 15g of feed, grind it into powder, add water to 100ml, add 5g of activated carbon and stir evenly to prepare 100ml of a mixture of nutritional paste and activated carbon 1.125g / ml.

[0140] 3. Experimental methods of mouse auricle microcirculation

[0141] 3.1 Animal grouping

[0142] 50 healthy KM mice, half of which were male and half were female, weighing 18-22 g, were selected and evenly divided into 5 groups according to their weight, with 10 mice in each group, half of which were male and half were female, namely, blank group, positive group, Example 5 group, Comparative Example 1 group and Comparative Example 2 group.

[0143] 3.2 Determination of mouse auricle microcirculation before administration

[0144] The mice were anesthetized with 0.17 mL / 10 g of 10% ulanose injected intraperitoneally (strictly disinfected), and fixed on the mouse observation platform with the abdomen facing downward, so that the auricle was flat on the ear tray, and a small amount of cedar oil was dripped on the ear tray and the surface of the auricle. The observation platform was placed on the microscope stage of the BI-2000 Bio-Acuity Experiment System, and the brightness of the floodlight was adjusted to an appropriate level. The mice were observed under a 4x microscope, the microcirculation software was started, and the field of view under the microscope was adjusted to make the image transmitted by the camera to the computer screen clear. A certain boundary was selected near the marked point, and a blood vessel distribution sketch was drawn (in order to find the original measured blood vessel site during the next observation), and the capillary opening volume, blood flow velocity (μm / s), blood vessel input caliber (μm) and blood vessel output caliber (μm) were measured.

[0145] 3.3 Administration

[0146] After measuring the microcirculation of the mouse auricle before administration, the mice in each group were gavaged on the second day. The control group was gavaged with purified water, the positive group was gavaged with aspirin 72.8 mg / kg, and the Example 5 group, the Comparative Example 1 group and the Comparative Example 2 group were gavaged with 2.73 g / kg, respectively. The gavage volume of each group was 20 mL / kg, and the administration was continued for 7 days.

[0147] 3.4 Determination of auricular microcirculation in mice after drug administration

[0148] Each group of mice was gavaged for 7 days. The blood vessel opening volume, blood flow velocity, blood vessel input diameter and blood vessel output diameter of the original part of the mice were measured 30 and 60 minutes after the administration on the 7th day. The change values ​​of blood vessel opening volume, blood flow velocity, blood vessel input and output diameter were obtained by subtracting the corresponding values ​​before administration. The inter-group comparison was performed by t test. The test results are shown in Tables 6-10.

[0149] 3.5 Results

[0150] As shown in Table 6, the positive drug group, Example 5 group, Comparative Example 1 group and Comparative Example 2 group can increase the number of open capillaries in the auricle of mice, among which, the Example 5 group increases the number of open capillaries in the auricle of mice significantly, which is higher than the positive drug group (P<0.05 or P<0.01);

[0151] As shown in Table 7, the positive drug group, Example 5 group, Comparative Example 1 group and Comparative Example 2 group can all accelerate the blood flow velocity of the auricular capillary arteries of mice, among which, Example 5 group significantly accelerates the blood flow velocity of the auricular capillary arteries of mice, but not as much as the positive drug group (P<0.05 or P<0.01);

[0152] As shown in Table 8, the positive drug group, Example 5 group, Comparative Example 1 group and Comparative Example 2 group can all accelerate the blood flow velocity of the auricular capillary veins of mice, among which, Example 5 group significantly accelerates the blood flow velocity of the auricular capillary veins of mice, but not as much as the positive drug group (P < 0.05 or P < 0.01);

[0153] As shown in Table 9, the positive drug group, Example 5 group, Comparative Example 1 group and Comparative Example 2 group can all increase the capillary input caliber of mice, among which, Example 5 group increases the capillary input caliber of mice ear pinna most significantly, which is higher than the positive drug group (P<0.05 or P<0.01);

[0154] As shown in Table 10, the positive drug group, Example 5 group, Comparative Example 1 group and Comparative Example 2 group can all increase the output caliber of mouse capillaries, among which Example 5 group significantly increased the output caliber of mouse auricle capillaries, but was lower than the positive drug group (P < 0.05 or P < 0.01).

[0155] Table 6: Effect on the number of capillaries opened in mice

[0156]

[0157] Table 7: Effects on mouse capillary arterial blood flow velocity (μm / s)

[0158]

[0159] Table 8: Effects on mouse capillary venous blood flow velocity (μm / s)

[0160]

[0161] Table 9: Effects on the capillary input caliber (micrometers) of mice

[0162]

[0163]

[0164] Table 10: Effects on the capillary output caliber (micrometers) of mice

[0165]

[0166] 4. Mouse gastric emptying and intestinal propulsion test

[0167] 4.1 Grouping and Dosing

[0168] 50 healthy KM mice were evenly divided into five groups according to body weight: blank group, positive group, Example 5 group, Comparative Example 1 group and Comparative Example 2 group, 10 mice in each group, half male and half female. The control group was gavaged with purified water, the positive group was gavaged with 91 mg / kg of metoclopramide, and the Example 5 group, Comparative Example 1 group and Comparative Example 2 group were gavaged with 2.73 g / kg of the corresponding drug.

[0169] 4.2 Gastric emptying measurement

[0170] After the last administration, the animals were fasted but not watered for 18 hours, and then gavaged with 0.8 mL of nutrient semisolid paste per rat. After 20 minutes, the animals were killed by dislocating the cervical vertebrae, the abdominal cavity was opened, the gastric cardia and hilum were ligated, the stomach was taken out, and the total weight was weighed after wiping it dry with filter paper. Then the stomach body was cut open along the greater curvature of the stomach, the stomach contents were washed out, wiped dry, and the net weight was weighed. The difference between the total weight of the stomach and the net weight of the stomach was taken as the weight of the stomach contents, and the gastric residual rate was calculated.

[0171] 4.3 Intestinal propulsion assay

[0172] In the above 4.2, the small intestine is quickly taken out while the abdominal cavity is opened, and the mesentery is gently peeled off and laid directly on the tray. The distance from the pylorus to the ileocecum is the total length of the small intestine, and the distance from the pylorus to the front edge of the nutrient semi-solid paste is the advancement distance of the nutrient semi-solid paste in the small intestine. The small intestine advancement rate is calculated.

[0173] 4.4 Observation indicators

[0174] 1) Gastric residual rate (%) = gastric content weight (g) / nutritional semi-solid charcoal paste weight (g) × 100%.

[0175] 2) Small intestine propulsion rate (%) = distance of semisolid paste propagated in the small intestine (cm) / total length of small intestine (cm) × 100%.

[0176] 4.5 Results

[0177] As can be seen from Table 11, compared with the blank group, the positive group, Example 5 group, Comparative Example 1 group and Comparative Example 2 group can all reduce the gastric residual rate of mice and increase the small intestinal propulsion rate of mice, among which the gastric residual rate of Example 5 group was significantly reduced (P < 0.01), and the small intestinal propulsion rate was significantly increased (P < 0.01), indicating that this product has the effect of promoting gastrointestinal motility and increasing the small intestinal propulsion rate.

[0178] Table 11: Effects on gastric emptying and intestinal propulsion in mice

[0179] Group Number of animals dose Gastric residual rate (%) Small intestinal propulsion rate (%) Blank Group 10 - 64.19±0.09 69.44±0.08 Positive group 10 91mg / kg <![CDATA[53.41±0.07 ** ]]> <![CDATA[78.27±0.05 ** ]]> Example 5 Group 10 2.73g / kg <![CDATA[54.14±0.04 ** ]]> <![CDATA[77.65±0.04 ** ]]> Comparative Example 1 10 2.73g / kg 60.25±0.08 73.12±0.07 Comparative Example 2 10 2.73g / kg 61.35±0.06 72.43±0.08

Claims

1. A Chinese medicine composition for treating liver and kidney cysts, characterized in that: The invention comprises the following components in parts by weight: 1-15 parts of selfheal, 1-15 parts of tangerine seeds, 5-20 parts of turtle shells, 1-10 parts of litchi seeds, 10-30 parts of cat's claws, 1-5 parts of leeches, 5-15 parts of oldenlandia diffusa, 5-15 parts of black plums, 1-10 parts of tangerine peels, 5-20 parts of vine pear roots, 30-100 parts of chestnut shells, 10-20 parts of camel thorns, 5-20 parts of drynaria, 1-10 parts of horsetail, 5-15 parts of sapodilla thorns, 1-10 parts of liquorice, 1-15 parts of lithospermum and 1-15 parts of bombyx batryticatus.

2. The Chinese medicine composition for treating liver and kidney cysts according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 5-10 parts of selfheal, 5-10 parts of tangerine seeds, 10-15 parts of turtle shells, 4-8 parts of litchi seeds, 15-25 parts of cat's claws, 2-4 parts of leeches, 7-12 parts of oldenlandia diffusa, 7-12 parts of black plums, 4-8 parts of tangerine peels, 10-15 parts of vine pear roots, 50-70 parts of chestnut shells, 13-17 parts of camel thorns, 10-15 parts of drynaria, 4-8 parts of equisetum, 7-12 parts of gleditsia thorns, 4-8 parts of liquorice, 5-10 parts of lithospermum and 5-10 parts of bombyx batryticatus.

3. The Chinese medicine composition for treating liver and kidney cysts according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 5 parts of selfheal, 10 parts of tangerine seeds, 10 parts of turtle shells, 4 parts of litchi seeds, 25 parts of cat's claws, 2 parts of leeches, 12 parts of oldenlandia diffusa, 7 parts of black plums, 4 parts of tangerine peels, 15 parts of rattan pear roots, 50 parts of chestnut shells, 17 parts of camel thorns, 10 parts of drynaria, 8 parts of equisetum, 7 parts of gleditsia thorns, 8 parts of liquorice, 5 parts of lithospermum and 10 parts of bombyx batryticatus.

4. The Chinese medicine composition for treating liver and kidney cysts according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 10 parts of Prunella Vulgaris, 5 parts of tangerine seeds, 15 parts of turtle shells, 8 parts of litchi seeds, 15 parts of cat's claws, 4 parts of leeches, 7 parts of oldenlandia diffusa, 12 parts of black plums, 8 parts of tangerine peels, 10 parts of iris root, 70 parts of chestnut shells, 13 parts of camel thorns, 15 parts of drynaria, 4 parts of equisetum, 12 parts of gleditsia thorns, 4 parts of liquorice, 10 parts of lithospermum and 5 parts of bombyx batryticatus.

5. The Chinese medicine composition for treating liver and kidney cysts according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 8 parts of selfheal, 8 parts of tangerine seeds, 12 parts of turtle shells, 6 parts of litchi seeds, 20 parts of cat's claws, 3 parts of leeches, 10 parts of oldenlandia diffusa, 10 parts of black plums, 6 parts of tangerine peels, 13 parts of vine pear roots, 60 parts of chestnut shells, 15 parts of camel thorns, 13 parts of drynaria, 6 parts of equisetum, 10 parts of gleditsia thorns, 6 parts of liquorice, 8 parts of lithospermum and 8 parts of bombyx batryticatus.

6. The Chinese medicine composition for treating liver and kidney cysts according to claim 1, characterized in that: The tangerine seed is a salted tangerine seed, the turtle shell is a vinegared turtle shell, the lychee seed is a salted lychee seed, the drynaria is a scalded drynaria, and the licorice is roasted licorice.

7. The method for preparing the Chinese medicine composition for treating liver and kidney cysts according to any one of claims 1 to 6, characterized in that: The following steps are involved: It is made by mixing the raw materials after pulverizing them; or by extracting the raw materials after mixing or extracting them separately; or by further refining and purifying the extract to obtain the active ingredient; or by adding pharmaceutically acceptable excipients to the extract / active ingredient.

8. The method for preparing the Chinese medicine composition for treating liver and kidney cysts according to claim 7, characterized in that: The prepared dosage form is one of pills, granules, capsules, powders, mixtures, tablets, granules or oral liquids.

9. The method for preparing the Chinese medicine composition for treating liver and kidney cysts according to claim 7 or 8, characterized in that: The specific preparation method is as follows: seven of the above 18 ingredients, including turtle shell, leech, tangerine peel, horsetail, chestnut shell, camel thorn and silkworm, are crushed into fine powder, sieved, mixed and set aside; the remaining 11 ingredients, including selfheal, tangerine seed, litchi seed, cat's claw, black plum, oldenlandia diffusa, rattan pear wood, drynaria, sapodilla thorn, lithospermum officinale and roasted licorice, are added with water, decocted, the filtrate is combined, filtered, and the filtrate is concentrated into an extract, mixed with the above fine powder, dried, crushed into fine powder, made into pills, and dried to obtain the extract.

10. Use of the Chinese medicine composition according to claims 1-6 in the preparation of medicines for treating liver and kidney cysts.

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