Traditional Chinese medicine treatment composition for tumor-like calcaremia and preparation method of traditional Chinese medicine treatment composition
By developing a composition containing Chinese medicinal materials of white grass, coix seeds and abacus, the existing drugs for treating tumor-like calcification have been solved, and effective therapeutic effects and safety have been achieved.
Patent Information
- Application Number
- CN202311770886.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-12-20
- Publication Date
- 2025-06-20
AI Technical Summary
The current drugs for treating tumor-like calcification have no significant efficacy and obvious side effects. Surgical resection also has a risk of recurrence, which brings great pain to the patients.
A traditional Chinese medicine composition is developed, including the roots of white grass, the seeds or roots of coix seeds, and the roots, leaves or fruits of abacus, which are prepared by a certain proportion of combination and decoction with water to form an effective therapeutic composition.
This traditional Chinese medicine composition can effectively prevent and treat tumor-like calcification, significantly reduce calcified mass, and has no obvious side effects, avoiding the pain and risk of recurrence caused by surgery.
Smart Images
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Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating tumoral calcinosis and a preparation method thereof. Background Art
[0002] Tumoral calcinosis (TC) is a rare disease characterized by progressive calcified masses in the subcutaneous soft tissues, and the main component of its ectopic calcification is hydroxyapatite. TC can occur at any age, more commonly in the age group of 10 - 20 years. Patients usually present with masses caused by calcium deposition in the subcutaneous soft tissues of the buttocks, shoulders, elbows, hands, feet, knees and other parts, and in severe cases, chalky substances will flow out. In 1898, the French dermatologist Giard first described this disease, and it was first named by Inclan in 1943.
[0003] Familial genetic factors, abnormal calcium and phosphorus metabolism, reactive calcification of collagen fibers near joints in response to stimuli, trauma factors, immune system dysfunction, elevated erythropoietin, etc. may all cause TC. So far, various treatment means such as drug treatments with bisphosphonates, calcitonin, steroids, phenylbutazone, etc. have been tried, but there is no significant curative effect, and the side effects are obvious and it often recurs; surgical resection also has a recurrence risk and brings great pain to patients.
[0004] Therefore, there is an urgent need in this field to develop a pharmaceutical composition for treating tumoral calcinosis and a preparation method thereof. Summary of the Invention
[0005] The purpose of the present invention is to develop a pharmaceutical composition for treating tumoral calcinosis and a preparation method thereof. Specifically, the present invention develops a traditional Chinese medicine composition that can effectively treat tumoral calcinosis and a preparation method thereof.
[0006] In the first aspect of the present invention, there is provided a composition, which comprises (i) a first active ingredient A, a second active ingredient B and a third active ingredient C, and (ii) optionally a pharmaceutically acceptable carrier.
[0007] Wherein, the first active ingredient A is selected from the group consisting of the root of Imperata cylindrica Beauv. or an extract thereof;
[0008] The second active ingredient B is selected from the group consisting of the seed kernel, root of Coix lacryma-jobi L. or an extract thereof;
[0009] The third active ingredient C is selected from the group consisting of the root, leaf, fruit of Glochidion puberum (L.) Hutch. or an extract thereof.
[0010] In another preferred example, the composition is a traditional Chinese medicine composition, and the first active ingredient A, the second active ingredient B, and the third active ingredient C are traditional Chinese medicinal materials.
[0011] In another preferred example, when the active ingredient is an extract, the compatibility of the extract is calculated based on the dry weight of the corresponding medicinal materials.
[0012] In another preferred example, the medicinal materials include fresh traditional Chinese medicinal materials, partially dried traditional Chinese medicinal materials, dried traditional Chinese medicinal materials, or combinations thereof.
[0013] In another preferred example, the active ingredient A is the dried root of Imperata cylindrica; and / or
[0014] the active ingredient B is the dried root, dried semen, or a combination thereof of Coix lacryma-jobi; and / or
[0015] the active ingredient C is the dried root, dried leaf, dried fruit, or a combination thereof of Glochidion puberum.
[0016] In another preferred example, in the composition, the weight parts of the first active ingredient A are 0.5 - 35 parts; preferably 1 - 20 parts.
[0017] In another preferred example, in the composition, the weight parts of the second active ingredient B are 0.5 - 35 parts; preferably 1 - 20 parts.
[0018] In another preferred example, in the composition, the weight parts of the third active ingredient C are 0.5 - 35 parts; preferably 1 - 20 parts.
[0019] In another preferred example, when the active ingredient is a traditional Chinese medicinal material, its weight parts are calculated based on the dry weight of the corresponding traditional Chinese medicinal material.
[0020] In another preferred example, when the active ingredient is an extract, its weight parts are calculated based on the dry weight of the corresponding traditional Chinese medicinal material.
[0021] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = (1 - 40):(1 - 45):(1 - 35), based on the weight of the composition.
[0022] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = (1 ± 0.2):(1 - 6):(1 - 5), based on the weight of the composition.
[0023] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = 1:4:3, based on the weight of the composition.
[0024] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = 2:6:4 (or 1:3:2), based on the weight of the composition.
[0025] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = 8:12:10 (1:1.5:1.25), based on the weight of the composition.
[0026] In another preferred example, the "based on the weight of the composition" means based on the dry weight of the composition.
[0027] In another preferred example, the composition is an oral preparation.
[0028] In another preferred example, the composition is a liquid preparation or a freeze-dried preparation.
[0029] In another preferred example, the dosage form of the composition is selected from the group consisting of oral liquid, tablets, granules, and capsules.
[0030] In another preferred example, the composition is the decoction of the Chinese medicinal materials.
[0031] In another preferred example, the composition is a water decoction.
[0032] In another preferred example, the decoction includes the decoction with unadjusted (or unchanged) concentration, the concentrated decoction, and the diluted decoction.
[0033] In another preferred example, the extract is an extract with water or an aqueous solvent.
[0034] In another preferred example, the aqueous solvent includes a water-alcohol mixed solvent, preferably with a volume ratio of water to alcohol of 20:80 - 100:0, more preferably 30:70 - 95:5.
[0035] In another preferred example, the alcohol is a C1-C4 alkyl alcohol, preferably ethanol or propanol.
[0036] The second aspect of the present invention provides a medicine box, which includes:
[0037] (a1) A first container, and the composition described in the first aspect of the present invention or a drug containing the composition described in the first aspect of the present invention located in the first container; and
[0038] (b) A pharmaceutically acceptable carrier.
[0039] In another preferred example, the drug in the first container is a single-agent preparation containing the composition described in the first aspect of the present invention.
[0040] In another preferred example, the dosage form of the drug is selected from the group consisting of capsules, tablets, granule preparations, liquid preparations, or a combination thereof.
[0041] In another preferred example, the dosage form of the drug is an oral dosage form.
[0042] In another preferred embodiment, the kit further contains an instruction manual.
[0043] In a third aspect of the present invention, there is provided a use of the composition as described in the first aspect, or a preparation containing the composition, or the kit as described in the second aspect of the present invention, for the preparation of a drug for preventing and / or treating and / or alleviating tumoral calcinosis.
[0044] In another preferred embodiment, the drug is further used for inhibiting calcified masses.
[0045] In another preferred embodiment, the active ingredient A is the dried root of Imperata cylindrica.
[0046] In another preferred embodiment, the active ingredient B is the dried root of Coix lacryma-jobi.
[0047] In another preferred embodiment, the active ingredient C is the dried root of Glochidion puberum.
[0048] In another preferred embodiment, the compatibility of the active ingredients A, B, and C is as described above.
[0049] In a third aspect of the present invention, there is provided a method for preparing the composition as described in the first aspect, comprising the steps of:
[0050] (1) Providing the active ingredient A, the active ingredient B, and the active ingredient C, and decocting with water;
[0051] (2) Obtaining the decoction, and the decoction is the composition.
[0052] In another preferred embodiment, the compatibility of the active ingredients A, B, and C is A:B:C = (1 - 40):(1 - 45):(1 - 35) by weight.
[0053] In another preferred embodiment, the compatibility of the active ingredients A, B, and C is A:B:C = 1:4:3 by weight.
[0054] In another preferred embodiment, the compatibility of the active ingredients A, B, and C is A:B:C = 2:6:4 by weight.
[0055] In another preferred embodiment, the compatibility of the active ingredients A, B, and C is A:B:C = 8:12:10 by weight.
[0056] In another preferred embodiment, the specific steps of the water decoction include:
[0057] (c1) Soaking the first mixture for 0.5 - 1 hour;
[0058] (c1) Decocting 2 - 3 times to obtain a crude decoction.
[0059] In another preferred example, the amount of water added is such that the water just submerges the first mixture.
[0060] In another preferred example, the decoction obtained by filtering the thick decoction in step (c1) is the decoction in step (2), which is the composition.
[0061] In another preferred example, before step (1), there is also a step of taking the raw medicinal materials corresponding to active ingredients A, B, and C, washing, drying in the sun, pulverizing, and mixing to obtain the first mixture.
[0062] In another preferred example, the raw medicinal materials include (i) the roots of Imperata cylindrica, (ii) the seeds and / or roots of Coix lacryma-jobi, and (iii) the roots, leaves, and / or fruits of Glochidion puberum.
[0063] In the fourth aspect of the present invention, there is provided a method for preventing and / or treating and / or alleviating tumoral calcinosis diseases, which comprises administering a medicinally effective amount of the composition described in the first aspect to a patient in need.
[0064] In another preferred example, the patient is a patient with tumoral calcinosis.
[0065] It should be understood that within the scope of the present invention, the above technical features of the present invention and the technical features specifically described below (such as in the examples) can be combined with each other to form new or preferred technical solutions. Due to space limitations, they will not be elaborated one by one here. BRIEF DESCRIPTION OF THE DRAWINGS
[0066] Figure 1 It is a pedigree chart of the TC family. In the figure, the black filling represents the patient, the white filling represents the normal person, and the arrow indicates the proband. The TC proband IV:7, patient III:1, patient III:5, patient IV:1, and patient V:1 in the figure are the TC patients who took the traditional Chinese medicine of the present invention in Examples 1, 2, 3, 4, and 5 respectively.
[0067] Figure 2 It is a clinical symptom chart of the proband IV:7. As Figure 2 shown, (a) is a front upper body picture of the proband IV:7 taken at the age of 11. It can be seen that the obvious subcutaneous protruding mass is the calcified mass of the TC symptom; (b) is an X-ray film of the proband IV:7. It can be seen that there are white shadows in the soft tissues around the trunk, elbows and other parts, and this shadow position is the calcified mass; (c) is a HE staining picture of the pathological section of the skin lesion tissue of the proband IV:7, and the dark area is the calcified area; (d) is a silver staining picture of the pathological section of the skin lesion tissue of the proband IV:7, and the dark area is the granular calcium salt deposition; Figures (c) and (d) are taken under a 40-fold objective lens.
[0068] Figure 3Figure showing the gradual resolution of calcified masses in proband IV:7 at different times after taking the medicine. As Figure 3 shown, Figure (a) is a diagram showing the resolution of the calcified mass in proband IV:7 after taking the traditional Chinese medicine of the present invention for 3 years; Figure (b) is a diagram showing the resolution of the calcified mass in proband IV:7 after taking the traditional Chinese medicine of the present invention for 9 years; the position indicated by the white arrow in the figure is the position after the original calcified mass was resolved after taking the medicine.
[0069] Figure 4 Figure showing the resolution of the calcified mass in patient III:1 after taking the medicine. As Figure 4 shown, the position indicated by the white arrow is the body part after the original calcified mass in patient III:1 was resolved. Figure (a) is the buttocks, Figure (b) is the waist, Figure (c) is near the shoulder joint, and Figure (d) is near the elbow joint.
[0070] Figure 5 Figure showing the resolution of the calcified mass in patient IV:1 after taking the medicine. As Figure 5 shown, the position indicated by the white arrow is the neck and face after the original calcified mass in patient IV:1 was resolved. Detailed implementation mode
[0071] Through extensive and in-depth research, the inventor of the present invention unexpectedly discovered for the first time that a composition containing active ingredients A, B, and C can effectively prevent and / or treat and / or relieve tumoral calcinosis. Based on this, the present invention was completed.
[0072] Specifically, the present invention discovers that a pharmaceutical composition containing a certain proportion of active ingredients A, B, and C prepared by a certain method can effectively prevent and / or treat and / or relieve tumoral calcinosis. The present invention provides the use of a composition containing active ingredients A, B, and C for preparing a drug for preventing and / or treating and / or relieving tumoral calcinosis. When the compatibility of active ingredients A, B, and C is A:B:C=(1 - 40):(1 - 45):(1 - 35), preferably A:B:C = 1:4:3, A:B:C = 2:6:4, A:B:C = 8:12:10, A:B:C = 8:12:10, by weight, the effect of the composition in treating the disease is better. The present invention also provides a method for preparing the implementation composition.
[0073] Imperata cylindrica
[0074] As used herein, the term "Imperata cylindrica" refers to the Chinese medicinal herb Imperata cylindrica or its active extract. Imperata cylindrica (L.) Beauv. is the rhizome of the grass Imperata cylindrica Beauv. Aliases: Imperata root, orchid root, and root of Imperata cylindrica. Preferably, it is the dried root of Imperata cylindrica (L.) Beauv. var. major (Nees) C.E. Hubb. The Chinese medicinal herb Imperata cylindrica functions to clear heat and promote the production of body fluid, etc. In the present invention, Imperata cylindrica is also referred to as the first active ingredient A.
[0075] As used herein, the term "Coix lacryma-jobi" refers to the Chinese medicinal herb Coix lacryma-jobi or its active extract. Coix lacryma-jobi L. is the root, seed kernel, or a combination thereof of the grass Coix lacryma-jobi L. Semen Coicis is the seed kernel of Coix lacryma-jobi, and its aliases include: Semen Coicis, Job's tears, Coix seed, Gouzi rice, Yi rice, etc. The functions of Coix lacryma-jobi root are basically the same as those of Semen Coicis. The Chinese medicinal herb Coix lacryma-jobi functions to strengthen the spleen and promote diuresis, dispel dampness, relieve arthralgia and stop diarrhea, clear heat, etc. In the present invention, Coix lacryma-jobi is also referred to as the second active ingredient B.
[0076] As used herein, the term "Glochidion puberum" refers to the Chinese medicinal herb Glochidion puberum or its active extract. Glochidion puberum (L.) Hutch. is the root, leaf, fruit, or a combination thereof of the plant Glochidion in the Euphorbiaceae family. Representative Glochidion plants include (but are not limited to): Glochidion puberum (L.) Hutch., Glochidion wilsonii Hutch., etc. The aliases of Glochidion puberum include: Li Jizi, wild pumpkin, persimmon pepper, abacus beads, etc. The Chinese medicinal herb Glochidion puberum functions to clear heat and promote diuresis, dispel wind and activate collaterals, etc. In the present invention, Glochidion puberum is also referred to as the third active ingredient C.
[0077] The composition of the present invention
[0078] As used herein, "composition", "traditional Chinese medicine composition", "traditional Chinese medicine composition of the present invention", and "composition of the present invention" refer to a composition that can effectively prevent and / or treat and / or relieve tumoral calcinosis obtained by mixing a certain proportion of active ingredients A, B, and C in a certain proportion according to a certain preparation method.
[0079] The composition of the present invention contains active ingredient A, active ingredient B, and active ingredient C.
[0080] In another preferred example, the active ingredient A is the dried root of Imperata cylindrica.
[0081] In another preferred example, the active ingredient B is the dried root of Coix lacryma-jobi L.
[0082] In another preferred example, the active ingredient C is the dried root of Glochidion puberum (L.) Hutch.
[0083] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = (1 - 40):(1 - 45):(1 - 35) by weight.
[0084] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = 1:4:3 by weight.
[0085] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = 2:6:4 by weight.
[0086] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = 8:12:10 by weight.
[0087] Tumoral calcinosis
[0088] The disease related to the present invention is tumoral calcinosis (abbreviated as TC), which is a rare disease mainly characterized by progressive calcium deposition in subcutaneous soft tissues (especially in the perijoint tissues including the buttocks, shoulders, elbows, hands, feet, and knees).
[0089] Pharmaceutical composition
[0090] The present invention provides a pharmaceutical composition, which comprises:
[0091] (i) Active ingredients A, B, and C;
[0092] wherein the compatibility of the active ingredients A, B, and C is A:B:C = (1 - 40):(1 - 45):(1 - 35) by the weight of the composition;
[0093] (ii) Other pharmaceutically acceptable carriers or excipients.
[0094] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = 1:4:3 by the weight of the composition.
[0095] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = 2:6:4 by the weight of the composition.
[0096] In another preferred example, the compatibility of the active ingredients A, B, and C is A:B:C = 8:12:10 by the weight of the composition.
[0097] In another preferred embodiment, the pharmaceutical composition comprises a pharmaceutically acceptable carrier or excipient. Such carriers include (but are not limited to): saline, buffer solution, glucose, water, glycerol, ethanol, and combinations thereof. The pharmaceutical preparation should be compatible with the mode of administration. The pharmaceutical composition of the present invention can be made in the form of an injection, for example, prepared by conventional methods using physiological saline or an aqueous solution containing glucose and other adjuvants. Pharmaceutical compositions such as tablets and capsules can be prepared by conventional methods. Pharmaceutical compositions such as injections and solutions should be manufactured under sterile conditions. The dosage of the active ingredient is a therapeutically effective amount, for example, about 1 μg / kg body weight to about 5 mg / kg body weight per day. In addition, the present invention can also be used in combination with other therapeutic agents.
[0098] When using the pharmaceutical composition, a safe and effective amount of the composition of the present invention is administered to a mammal, wherein the dosage of the active ingredient of the present invention is generally 0.001 mg / kg to 1000000 mg / kg body weight.
[0099] Of course, the specific dosage should also consider factors such as the route of administration and the health status of the patient, which are within the scope of the skills of a skilled physician.
[0100] Preparation method
[0101] The present invention also provides a method for preparing the composition of the present invention, the method comprising the steps of:
[0102] (1) Providing a first mixture of active ingredients A, B, and C, and decocting with water;
[0103] (2) Obtaining the decoction, and the decoction is the composition.
[0104] In another preferred embodiment, the compatibility of the active ingredients A, B, and C is A:B:C = (1 - 40):(1 - 45):(1 - 35) by weight of the composition.
[0105] In another preferred embodiment, the compatibility of the active ingredients A, B, and C is A:B:C = 1:4:3 by weight of the composition.
[0106] In another preferred embodiment, the compatibility of the active ingredients A, B, and C is A:B:C = 2:6:4 by weight of the composition.
[0107] In another preferred embodiment, the compatibility of the active ingredients A, B, and C is A:B:C = 8:12:10 by weight of the composition.
[0108] In another preferred embodiment, the specific steps of the decocting with water include:
[0109] (c1) Soaking the first mixture for 0.5 - 1 hour;
[0110] (c1) Decoct 2 - 3 times to obtain a crude decoction.
[0111] In another preferred example, the amount of water added is such that the water just submerges the first mixture.
[0112] In another preferred example, filter the crude decoction in (c1) to obtain the decoction in step (2), which is the composition.
[0113] In another preferred example, before step (1), there is also a step: take the roots of raw medicinal materials A, B, and C, wash, dry in the sun, pulverize, and mix to obtain a first mixture.
[0114] The main advantages of the present invention are as follows:
[0115] (a) It is first discovered that a composition containing active ingredients A, B, and C in certain proportions can effectively prevent and / or treat tumoral calcinosis.
[0116] (b) The present invention provides a compatibility of a composition containing active ingredients A, B, and C that can effectively treat tumoral calcinosis. When the compatibility of active ingredients A, B, and C is A:B:C = (1 - 40):(1 - 45):(1 - 35), preferably A:B:C = 1:4:3, A:B:C = 2:6:4, A:B:C = 8:12:10, A:B:C = 8:12:1, the composition can effectively prevent and / or treat tumoral calcinosis.
[0117] (c) The present invention provides a preparation method for the composition of the present invention, enabling it to be widely used in clinical applications.
[0118] The following further elaborates the present invention in combination with specific examples. It should be understood that these examples are only used to illustrate the present invention and not to limit the scope of the present invention. For the experimental methods without specific conditions noted in the following examples, they are usually carried out under conventional conditions, such as the conditions described in Sambrook et al., Molecular Cloning: A Laboratory Manual (New York: Cold Spring Harbor Laboratory Press, 1989), or the conditions recommended by the manufacturer. Unless otherwise stated, percentages and parts are calculated by weight.
[0119] Unless otherwise specified, the materials and reagents used in the examples of the present invention are all commercially available products.
[0120] In all the following examples, the raw medicinal material Imperata cylindrica is the root of Imperata cylindrica (dried), the raw medicinal material Coix lacryma - jobi is the root of Coix lacryma - jobi (dried), and the raw medicinal material Glochidion puberum is the root of Glochidion puberum (dried).
[0121] Example 1: The calcified mass of the proband with tumoral calcinosis in the family was effectively treated by the drug of the present invention
[0122] Method
[0123] In 2009, we collected and identified a large family with hereditary tumoral calcinosis with 7 patients ( Figure 1 ). First, the proband was clinically diagnosed. The specific methods are as follows: By examining the skin, a large number of hard and well-defined nodules and masses were found in the subcutaneous soft tissues of the whole body. Most of the masses showed no obvious pain when pressed ( Figure 2 (a)); By X-ray examination, obvious abnormal mass shadows were found in the soft tissues near the elbow joint and the trunk ( Figure 2 (b)); A small amount of subcutaneous nodule tissue from the abdomen was taken for biopsy and pathological section, and a large number of granular calcification foci were found in the dermis and subcutaneous tissues ( Figure 2 (c)). Silver nitrate staining showed brown granular substances indicating calcification foci ( Figure 2 (d)). The proband was pathologically diagnosed with cutaneous calcinosis. Further detection of various serum biochemical indexes showed that the phosphorus concentration was slightly too high at 2.01 mmol / L (normal range 0.96 - 1.62 mmol / L), while other components such as calcium ion, parathyroid hormone (PTH), procalcitonin, etc. were normal; other detection indexes such as blood routine, urine routine, fecal routine, renal function, liver function, etc. were all normal; no obvious abnormalities were found in the physical examination and other systems.
[0124] In summary, the final clinical diagnosis was tumoral calcinosis. Further investigation of this family found that the father of the proband ( Figure 1 , III:7, deceased), first cousin uncle ( Figure 1 , III:1), uncle ( Figure 1 , III:5), eldest cousin ( Figure 1 , IV:1), younger sister ( Figure 1 , IV:8) and the son of the eldest cousin ( Figure 1 , V:1) all had similar tumoral calcinosis on their skin.
[0125] The raw medicinal materials Imperata cylindrica, Coix lacryma-jobi and Glochidion puberum are the dried roots of the corresponding medicinal materials. Take 1 g of raw medicinal material Imperata cylindrica, 4 g of raw medicinal material Coix lacryma-jobi, and 3 g of raw medicinal material Glochidion puberum. Wash, dry and crush them, place them in a container, add water to cover the medicinal materials, soak for 1 hour, and decoct 3 times. The first decoction is for 60 minutes, and the second and third decoctions are each for 30 minutes. Filter the decoction liquid, and combine and mix the decoction liquid obtained each time to obtain a combined liquid, which is used as the dosage of one unit. Since 2009, the proband (IV:7) has taken 1 unit dosage daily, divided into three times, once in the morning, once at noon and once in the evening, and taken the medicine intermittently for 4 years. The total duration of taking the medicine each year is about 120 - 150 days.
[0126] Result
[0127] The proband (Hong, Figure 1 IV: 7, 11 years old) started taking medicine in 2009 and was followed up.
[0128] The results of the disease tracking 3 years (2012) and 9 years (2018) after the proband started taking medicine showed that most of the calcified masses in the subcutaneous soft tissues of the proband disappeared, leaving scars. According to the description of the proband, no discomfort was felt during and after taking the medicine, indicating that the traditional Chinese medicine composition of the present invention has obvious therapeutic effects on tumoral calcinosis, has no obvious side effects, and there is no recurrence of the calcified mass after treatment ( Figure 3 , a - b).
[0129] In December 2019, the proband (IV: 7, weight about 40 kg) still had a small amount of calcified masses that did not disappear. The raw medicinal materials Imperata cylindrica, Coix lacryma - jobi, and Glochidion puberum were the dried roots of the corresponding medicinal materials. 2 grams of Imperata cylindrica, 6 grams of Coix lacryma - jobi, and 4 grams of Glochidion puberum were taken, washed, dried, and pulverized, placed in a container, added with water to cover the medicinal materials, soaked for 1 hour, decocted 3 times, the first decoction for 60 minutes, and the second and third decoctions for 30 minutes each. The decoction liquid was filtered, and the decoction liquid obtained from each decoction was combined and mixed to obtain a combined liquid, which was used as the dosage of one unit. One unit dosage was taken daily, divided into three times, once in the morning, once at noon, and once in the evening, for 21 consecutive days. According to the description of the patient, no discomfort was felt during and after taking the medicine.
[0130] Result: After the second round of taking medicine, the small amount of calcified masses further significantly shrank or disappeared.
[0131] Example 2 Treatment of calcified masses in patients with tumoral calcinosis in a family by the drug of the present invention
[0132] Method
[0133] The drug used in this example for treating tumoral calcinosis is: The raw medicinal materials Imperata cylindrica, Coix lacryma - jobi, and Glochidion puberum are the dried roots of the corresponding medicinal materials. 8 grams of the raw medicinal material Imperata cylindrica, 12 grams of the raw medicinal material Coix lacryma - jobi, and 10 grams of the raw medicinal material Glochidion puberum are taken, washed, dried, and pulverized, placed in a container, added with water to cover the medicinal materials, soaked for 1 hour, decocted 3 times, the first decoction for 60 minutes, and the second and third decoctions for 30 minutes each. The decoction liquid was filtered, and the decoction liquid obtained from each decoction was combined and mixed to obtain a combined liquid, which was used as the dosage of one unit.
[0134] Result
[0135] Patient (Cai) developed calcified masses in subcutaneous soft tissues at the age of 6 - 7. When the condition became severe at the age of 31, the patient began taking the drug of this embodiment, taking 1 unit dose per day, divided into three times, once in the morning, once at noon, and once in the evening. After 1 year of continuous medication, the drug was discontinued, and the calcified masses in subcutaneous soft tissues completely disappeared ( Figure 4 , a - d). According to the patient's description, no discomfort was felt during and after the medication process. This shows that the traditional Chinese medicine of the present invention has obvious therapeutic effects on tumoral calcinosis, has no obvious side effects, and there is no recurrence of calcified masses after treatment.
[0136] Example 3 Treatment of calcified masses in a patient with tumoral calcinosis in a family by the drug of the present invention
[0137] Method
[0138] The drug used to treat tumoral calcinosis in this embodiment is: the raw medicinal materials Imperata cylindrica, Coix lacryma - jobi, and Glochidion puberum are the dried roots of the corresponding medicinal materials. Take 2 grams of raw medicinal material Imperata cylindrica, 6 grams of raw medicinal material Coix lacryma - jobi, and 4 grams of raw medicinal material Glochidion puberum. Wash, dry, and crush them, place them in a container, add water to cover the medicinal materials, soak for 1 hour, and decoct 3 times. The first decoction is for 60 minutes, and the second and third decoctions are each for 30 minutes. Filter the decoction liquid, and combine and mix the decoction liquid obtained from each decoction to obtain a combined liquid, which is used as one unit dose.
[0139] Result
[0140] Patient (Cai XX, son of patient Cai in Example 2) developed multiple calcified masses in subcutaneous soft tissues at the age of 10 and then began taking the drug, taking 1 unit dose per day, divided into three times, once in the morning, once at noon, and once in the evening. After taking the drug for more than half a year, the drug was discontinued, and the calcified masses in subcutaneous soft tissues completely disappeared and have not recurred so far ( Figure 5 ).
[0141] Example 4 Treatment of calcified masses in patient V:1 with tumoral calcinosis in a family by the drug of the present invention
[0142] Method
[0143] The drug used to treat tumoral calcinosis in this embodiment is: the raw medicinal materials Imperata cylindrica, Coix lacryma - jobi, and Glochidion puberum are the dried roots of the corresponding medicinal materials. Take 1 gram of raw medicinal material Imperata cylindrica, 4 grams of raw medicinal material Coix lacryma - jobi, and 3 grams of raw medicinal material Glochidion puberum. Wash, dry, and crush them, place them in a container, add water to cover the medicinal materials, soak for 1 hour, and decoct 3 times. The first decoction is for 60 minutes, and the second and third decoctions are each for 30 minutes. Filter the decoction liquid, and combine and mix the decoction liquid obtained from each decoction to obtain a combined liquid, which is used as one unit dose.
[0144] Result
[0145] Patient V:1 started taking medicine when the symptoms of tumoral calcinosis first appeared at the age of 7-8. 1 unit of the medicine was taken daily, divided into three doses, once in the morning, once at noon, and once in the evening. After taking 10 units of the medicine continuously, the calcified mass in the subcutaneous soft tissue completely disappeared and there has been no recurrence so far.
[0146] All documents mentioned in this invention are cited in this application as references, as if each document was cited separately as a reference. In addition, it should be understood that after reading the above teachings of this invention, those skilled in the art can make various changes or modifications to this invention, and these equivalent forms also fall within the scope defined by the appended claims of this application.
Claims
1. A composition, characterized in that, The composition comprises (i) a first active ingredient A, a second active ingredient B and a third active ingredient C, and (ii) an optional pharmaceutically acceptable carrier, wherein the first active ingredient A is selected from the group consisting of the root of Imperata cylindrica Beauv. or its extract; the second active ingredient B is selected from the group consisting of the seed, root of Coix lacryma-jobi L. or its extract; the third active ingredient C is selected from the group consisting of the root, leaf, fruit of Glochidion puberum (L.) Hutch. or its extract.
2. The composition according to claim 1, characterized in that, The active ingredient A is the dried root of Imperata cylindrica Beauv.; and / or the active ingredient B is the dried root, dried seed of Coix lacryma-jobi L. or a combination thereof; and / or the active ingredient C is the dried root, dried leaf, dried fruit of Glochidion puberum (L.) Hutch. or a combination thereof.
3. The composition according to claim 1, characterized in that, In the composition, the weight parts of the first active ingredient A are 0.5 - 35 parts; preferably 1 - 20 parts.
4. The composition according to claim 1, characterized in that, In the composition, the weight parts of the second active ingredient B are 0.5 - 35 parts; preferably 1 - 20 parts.
5. The composition according to claim 1, characterized in that, In the composition, the weight parts of the third active ingredient C are 0.5 - 35 parts; preferably 1 - 20 parts.
6. A medicine box, characterized in that, The medicine box comprises: (a1) a first container, and the composition as claimed in claim 1 or a drug containing the composition as claimed in claim 1 located in the first container; and (b) a pharmaceutically acceptable carrier.
7. The use of a composition according to claim 1, or a preparation containing the composition, or the medicine box according to claim 6, characterized in that, It is used for preparing a drug for preventing and / or treating and / or alleviating tumoral calcinosis.
8. The use according to claim 7, characterized in that, The drug is also used for inhibiting calcified masses.
9. A method for preparing the composition according to claim 1, characterized in that, It includes steps: (1) providing the active ingredient A, the active ingredient B and the active ingredient C, and decocting with water; (2) obtaining a decoction, and the decoction is the composition.
10. The method according to claim 9, characterized in that, Before the step (1), there is also a step of taking the raw medicinal materials corresponding to the active ingredients A, B and C, washing, drying in the sun, pulverizing and mixing to obtain a first mixture.