CN112717052A - Traditional Chinese medicine composition and blood-clearing granules for preventing and treating radiation-therapy injury - Google Patents
Traditional Chinese medicine composition and blood-clearing granules for preventing and treating radiation-therapy injury Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition and blood-clearing granules for preventing and treating radiation-therapy injury, wherein the traditional Chinese medicine composition comprises the following raw material medicines: saviae Miltiorrhizae radix, rhizoma Ligustici Chuanxiong, radix Paeoniae Rubra, radix Angelicae sinensis, radix rehmanniae Preparata, semen Persicae, Carthami flos and rhizoma paridis. The preparation of the blood-cleaning particle comprises the following steps: extracting Saviae Miltiorrhizae radix with ethanol under reflux twice, mixing the extractive solutions, filtering, recovering ethanol from the filtrate until no ethanol smell exists to obtain Saviae Miltiorrhizae radix liquid medicine, and collecting the residue; mixing Saviae Miltiorrhizae radix residue with the rest materials, adding clear water, decocting twice, mixing the decoctions, filtering, and concentrating the filtrate to obtain viscous paste; adding Saviae Miltiorrhizae radix liquid into the paste, mixing, drying under reduced pressure, and pulverizing into fine powder; adding adjuvants into the fine powder, and adding ethanol to make into blood-clearing granule. The traditional Chinese medicine composition and the blood-clearing granules can promote the repair of radiation injury, regulate the immunologic function of organisms and relieve the radiation injury of patients caused by radiotherapy.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition and blood-clearing granules for preventing and treating radiation-induced injury.
Background
Radiotherapy is a common method for treating malignant tumors, and since energy of radiation penetrating substances is absorbed by the penetrated tissues and converted into heat energy, the radiation inevitably causes radiation damage to normal tissues and cells around the tumor before reaching the tumor focus, and modern researches show that the radiation can also generate radiation side effect damage through the gap connection between cells and the transmission of cytokines.
In the understanding of the etiology of traditional Chinese medicine, radiation injury belongs to the category of fire-heat toxin, radiotherapy is a local treatment method of attacking toxin with toxin, while eliminating the toxin, the body healthy qi is injured, fire (heat) is yang pathogen, the nature of the fire scorches and burns upwards, the body fluid and qi are injured, the wind is generated, the blood is moved, and sores and carbuncles are easily caused. The pathogenic fire and heat of the radiation act on the local parts of the human body, which leads to local stagnation of qi and blood in the body and formation of local blood stasis, which leads to the loss of healthy qi and regeneration of new blood in the whole body after a long time. The traditional Chinese medicine considers that after radiotherapy, a human body can have the symptoms of deficiency of both qi and yin, blood stasis, toxin accumulation and the like, so that the treatment principle of mainly supplementing qi, nourishing yin, promoting blood circulation and removing blood stasis is a general consensus aiming at radiation injury.
The radiotherapy injury is usually manifested as aseptic inflammation, and mainly takes inflammatory infiltration and exudation of irradiated tissues as the main pathological changes. At present, glucocorticoid is mostly adopted to relieve acute inflammation clinically aiming at radiation pneumonitis, esophagitis and enteritis caused by radiotherapy, however, the course of the radiation inflammation is more than half a year, and long-term application of the glucocorticoid inevitably causes severe adverse reactions such as cushing syndrome and the like.
At present, medicines matched with radiotherapy for whole-course intervention are relatively scarce in the market, so that the development of medicines for preventing and treating radiotherapy injury has very important medical value and market demand.
Disclosure of Invention
The invention aims to solve the technical problem of providing the traditional Chinese medicine composition and the blood-cleaning particles for preventing and treating radiation damage, and relieving the radiation damage of a patient caused by radiation therapy by promoting the repair of the radiation damage, regulating immunity and the like.
On one hand, the invention provides a traditional Chinese medicine composition for preventing and treating radiation damage, which consists of the following raw material medicines: saviae Miltiorrhizae radix, rhizoma Ligustici Chuanxiong, radix Paeoniae Rubra, radix Angelicae sinensis, radix rehmanniae Preparata, semen Persicae, Carthami flos and rhizoma paridis.
Preferably, the raw material medicines comprise the following components in parts by weight: 15-135 parts of the root of red-rooted salvia, 5-75 parts of the rhizome of chuanxiong, 5-45 parts of the root of common peony, 5-45 parts of the Chinese angelica, 5-45 parts of the prepared rehmannia root, 5-45 parts of the peach seed, 5-45 parts of the safflower and 5-75 parts of the rhizoma paridis.
Preferably, the raw material medicines comprise the following components in parts by weight: 25-135 parts of the root of red-rooted salvia, 15-75 parts of the rhizome of chuanxiong, 10-45 parts of the root of common peony, 10-45 parts of the Chinese angelica, 10-45 parts of the prepared rehmannia root, 10-45 parts of the peach seed, 10-45 parts of the safflower and 15-75 parts of the rhizoma paridis.
Preferably, the raw material medicines comprise the following components in parts by weight: 30-120 parts of the root of red-rooted salvia, 20-60 parts of the rhizome of chuanxiong, 15-40 parts of the root of common peony, 15-40 parts of the Chinese angelica, 15-40 parts of the prepared rehmannia root, 15-40 parts of the peach seed, 15-40 parts of the safflower and 20-60 parts of the rhizoma paridis.
Preferably, the raw material medicines comprise the following components in parts by weight: the traditional Chinese medicine composition comprises 75 parts of the root of red-rooted salvia, 40 parts of ligusticum wallichii, 25 parts of red paeony root, 25 parts of Chinese angelica, 25 parts of prepared rehmannia root, 25 parts of peach kernel, 25 parts of safflower and 40 parts of rhizoma paridis.
On the other hand, the invention also provides a blood-clearing granule which is prepared from the traditional Chinese medicine composition.
Preferably, the preparation process of the blood-clearing granules comprises the following steps:
step 1, performing reflux extraction on salvia miltiorrhiza with ethanol twice, combining extracting solutions of the two times, filtering, recovering ethanol from filtrate until no ethanol smell exists, obtaining salvia miltiorrhiza liquid medicine, and collecting salvia miltiorrhiza dregs obtained by filtering;
step 2, combining the salvia miltiorrhiza dregs with other raw materials, adding clear water, decocting twice, combining the liquid medicines decocted twice, filtering, and concentrating the filtrate to obtain a viscous paste;
step 3, adding the salvia miltiorrhiza medicinal liquid into the paste, uniformly mixing, drying under reduced pressure, and then crushing into fine powder;
and 4, adding auxiliary materials into the fine powder, and adding ethanol to prepare the blood-clearing granules.
Preferably, in the step 1, the concentration of the ethanol is 80%, the amount of the ethanol used in each reflux extraction is 6 times of the weight of the salvia miltiorrhiza, and the time of each reflux extraction is 2 hours.
Preferably, in the step 2, the amount of the clear water used in each decoction is 8 times of the total weight of the salvia miltiorrhiza residue and the rest raw materials, and the decoction time is 2 hours.
Preferably, the auxiliary materials are sucrose and dextrin.
The traditional Chinese medicine composition and the blood-clearing granules for preventing and treating radiation damage can promote the repair of radiation damage and adjust the immune function of an organism, thereby relieving the radiation damage to a patient caused by radiation treatment.
Detailed Description
The invention will be further described with reference to specific embodiments, and the advantages and features of the invention will become apparent as the description proceeds. It should be understood that the examples are illustrative only and are not limiting upon the scope of the invention. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be made without departing from the spirit and scope of the invention.
In the following description, all methods involved are conventional in the art unless otherwise specified. The starting materials mentioned are all those which are commercially available from the public unless otherwise specified.
According to the theory of traditional Chinese medicine, aiming at the symptoms of qi-yin deficiency and blood stasis and toxin accumulation of a human body after radiotherapy, the invention takes the treatment principles of supplementing qi and nourishing yin and promoting blood circulation to remove blood stasis, and combines eight raw material medicines of salvia miltiorrhiza, ligusticum wallichii, red paeony root, Chinese angelica, prepared rehmannia root, peach seed, safflower and rhizoma paridis into the traditional Chinese medicine composition for preventing and treating the radiotherapy injury. The traditional Chinese medicine composition takes the salvia miltiorrhiza as a monarch drug, is bitter and slightly cold in property, and has the effects of promoting blood circulation to remove blood stasis, cooling blood and soothing the nerves; the red paeony root, the angelica and the szechuan lovage rhizome are matched to be used as ministerial drugs and combined with monarch drug of the salvia miltiorrhiza, so that the effects of promoting blood circulation to remove blood stasis, nourishing blood and promoting qi circulation are realized; the prepared rehmannia root has the effects of nourishing yin and blood, harmonizing blood and astringing yin, the peach kernel and the safflower have the effects of activating blood and dissolving stasis, and the three medicines are used as adjuvant medicines and matched with monarch and minister medicines, so that the effect of dissolving stasis is enhanced, and the effects of nourishing blood and yin are taken into consideration; rhizoma paridis is bitter and cool, has the effects of clearing heat and removing toxicity, cooling blood and softening liver, and strengthening the efficacy of promoting blood circulation and cooling blood without over-warming the whole formula.
In the whole process of carrying out radiotherapy on a tumor patient, the traditional Chinese medicine composition and/or the blood-clearing granules are used in a matching way, so that the repairing of radiation injury can be promoted, and the immune function of an organism can be adjusted, thereby relieving the radiation injury of the patient caused by the radiotherapy.
The medicinal materials used for the traditional Chinese medicine composition are as follows:
red sage root: is dried root and rhizome of Salvia miltiorrhiza Bge (Salvia militaria Bge.) belonging to Labiatae.
Ligusticum wallichii: is dried rhizome of Ligusticum chuanxiong Hort (Ligusticum sinense cv. Chuanxiong) belonging to Umbelliferae.
Red peony root: is dried root of Paeonia lactiflora Pall or Paeonia veitchii Lynch.
Chinese angelica: is dried root of Angelica sinensis (Oliv.) Diels) belonging to Umbelliferae.
Prepared rehmannia root: is prepared from radix rehmanniae (Rehmannia glutinosa (Gaetn.) Libosch.ex Fisch.et Mey.) or rehmanniae radix (Rehmannia glutinosa (Gaertn.) Li-bosch.) by processing, steaming and sun drying.
Peach kernel: is dried mature seed of Prunus persica (L.) Batsch) or Prunus davidiana (Carr.) Franch) belonging to Rosaceae family.
Safflower: is dried flower of Carthamus tinctorius L of Compositae.
Rhizoma paridis: is Paris polyphylla (Paris polyphyta Smith var. yunnanensis (Franch.) hand-Mazz.) belonging to Liliaceae
Or dried rhizome of Parispyphyllia Smith var chinensis (Franch.) Hara.
In a specific embodiment of the invention, the traditional Chinese medicine composition for preventing and treating radiation damage is prepared from raw material medicines including salvia miltiorrhiza, ligusticum wallichii, red paeony root, angelica, prepared rehmannia root, peach kernel, safflower and rhizoma paridis. The preferred proportion of each raw material medicine by weight is as follows: 15-135 parts of salvia miltiorrhiza, 5-75 parts of ligusticum wallichii, 5-45 parts of red paeony root, 5-45 parts of angelica sinensis, 5-45 parts of prepared rehmannia root, 5-45 parts of peach kernel, 5-45 parts of safflower and 5-75 parts of rhizoma paridis.
The traditional Chinese medicine composition can be prepared into different preparation formulations, preferably granules, powder, oral liquid, tablets, pills, capsules and the like. Besides the effective pharmaceutical ingredients, the preparation can also comprise pharmaceutically acceptable carriers, such as excipients and auxiliary materials, so as to more effectively exert the curative effect of the medicament.
In another embodiment of the present invention, the above-mentioned Chinese medicinal composition is prepared into a blood-clearing granule, and the preparation process of the blood-clearing granule comprises the following steps:
step 1, adding the salvia miltiorrhiza raw material medicine in the formula into ethanol, carrying out reflux extraction twice, then merging and filtering extracting solutions, recovering ethanol from filtrate until no alcohol smell exists to obtain salvia miltiorrhiza liquid medicine, and collecting the salvia miltiorrhiza dregs obtained by filtering. The concentration of the ethanol is preferably 80%, each dosage of the ethanol is preferably 6 times of the weight of the salvia miltiorrhiza, and the time of each reflux purification is preferably 2 hours.
Step 2, mixing the salvia miltiorrhiza dregs with other raw materials (ligusticum wallichii, red paeony root, angelica, prepared rehmannia root, peach seed, safflower and rhizoma paridis) in the formula, then adding clear water for decocting twice, mixing the liquid medicines decocted twice, filtering, and concentrating the filtrate to obtain a viscous paste. The dosage of the clear water in each decoction is preferably 8 times of the sum of the weight of the salvia miltiorrhiza residue and the rest raw material medicines, and the time of each decoction is preferably 2 hours.
And 3, adding the salvia miltiorrhiza medicinal liquid prepared in the step 1 into the paste prepared in the step 2, uniformly mixing, drying under reduced pressure, and then crushing the dried product into fine powder.
And 4, adding auxiliary materials into the fine medicine powder prepared in the step 3, and adding ethanol to prepare blood-clearing granules, wherein the auxiliary materials are preferably sucrose and dextrin.
The administration dose of the Chinese medicinal composition or the blood-clearing granules of the present invention may vary depending on the age, body weight, health condition, individual difference and dosage form of the patient.
In order to help better understand the technical scheme of the invention, the following specific examples of preparing the traditional Chinese medicine composition and the curative effect of the traditional Chinese medicine composition on preventing and treating radiation injury are provided by taking the blood-cleaning granules as examples.
The first embodiment is as follows: preparation of blood-cleaning granules
The raw material medicines used in the embodiment include: 15 parts of salvia miltiorrhiza, 5 parts of ligusticum wallichii, 5 parts of red paeony root, 5 parts of angelica, 5 parts of prepared rehmannia root, 5 parts of peach kernel, 5 parts of safflower and 5 parts of rhizoma paridis.
Preparing blood-clearing granules by the following steps:
step 1, adding the salvia miltiorrhiza into 80% ethanol, wherein the amount of the ethanol is 6 times of the weight of the salvia miltiorrhiza each time, continuously carrying out secondary reflux extraction, wherein the reflux is carried out for 2 hours each time, then combining the two extracting solutions, filtering, recovering the ethanol from the filtrate until no ethanol smell exists to obtain salvia miltiorrhiza liquid medicine, and collecting the salvia miltiorrhiza dregs obtained by filtering for later use.
And 2, combining the salvia miltiorrhiza dregs with other raw materials (ligusticum wallichii, red paeony root, angelica sinensis, prepared rehmannia root, peach kernel, safflower and rhizoma paridis), then adding clear water for decoction twice, wherein the dosage of the clear water is 8 times of the sum of the weight of the salvia miltiorrhiza dregs and the other raw materials, the clear water is decocted for 2 hours each time, combining the liquid medicines decocted twice, filtering, and concentrating the filtrate to obtain a viscous paste.
And 3, adding the salvia miltiorrhiza medicinal liquid prepared in the step 1 into the paste prepared in the step 2, uniformly mixing, drying under reduced pressure, and then crushing the dried product into fine powder.
And 4, adding sucrose powder and a proper amount of dextrin into the medicine fine powder prepared in the step 3, uniformly mixing, and adding a proper amount of absolute ethyl alcohol to prepare the blood-clearing granules, wherein the addition amount of the sucrose powder is 13% of the mass of the blood-clearing granules.
Example two: preparation of blood-cleaning granules
The raw material medicines used in the embodiment include: 45 parts of salvia miltiorrhiza, 23 parts of ligusticum wallichii, 15 parts of red paeony root, 15 parts of angelica, 15 parts of prepared rehmannia root, 15 parts of peach kernel, 15 parts of safflower and 23 parts of rhizoma paridis.
The blood-cleaning granules of this example were prepared in the same manner as in example 1.
Example three: preparation of blood-cleaning granules
The raw material medicines used in the embodiment include: 75 parts of salvia miltiorrhiza, 40 parts of ligusticum wallichii, 25 parts of red paeony root, 25 parts of angelica, 25 parts of prepared rehmannia root, 25 parts of peach kernel, 25 parts of safflower and 40 parts of rhizoma paridis.
The blood-cleaning granules of this example were prepared in the same manner as in example 1.
Example four: preparation of blood-cleaning granules
The raw material medicines used in the embodiment include: 90 portions of salvia miltiorrhiza, 50 portions of rhizoma ligustici wallichii, 30 portions of red paeony root, 30 portions of angelica, 30 portions of prepared rehmannia root, 30 portions of peach kernel, 30 portions of safflower and 50 portions of rhizoma paridis.
The blood-cleaning granules of this example were prepared in the same manner as in example 1.
Example five: preparation of blood-cleaning granules
The raw material medicines used in the embodiment include: 135 parts of salvia miltiorrhiza, 75 parts of ligusticum wallichii, 45 parts of red paeony root, 45 parts of angelica, 45 parts of prepared rehmannia root, 45 parts of peach kernel, 45 parts of safflower and 75 parts of rhizoma paridis.
The blood-cleaning granules of this example were prepared in the same manner as in example 1.
Test example: the traditional Chinese medicine composition has the effect of preventing and treating radiation esophagitis of patients with esophageal cancer
In this test example, the blood-clearing granules prepared in example 2 were used as an example to evaluate the prevention and treatment effects of the traditional Chinese medicine composition on radiation esophagitis of patients with esophageal cancer.
44 patients with esophageal cancer who had not been treated by surgery were selected using a prospective, randomized, double-blind, control study protocol. Inclusion criteria included: (1) chest radiotherapy is proposed for esophageal cancer in pathological or cytological diagnosis; (2) the age must be 18 years or older and less than 80 years old; (3) can be drunk or orally taken; (4) general condition score (KPS) >50 points. Exclusion criteria included: (1) the primary focus of esophageal cancer is removed by operation; (2) intraesophageal stent placement angioplasty; (3) patients had completely failed to eat, swallowed or orally administered the test drug when enrolled in the study; (4) pregnant and lactating women; (5) those known or suspected to be allergic to the test drug.
Patients were randomized into two groups, including treatment and control groups, with 22 patients per group. The external irradiation treatment is carried out on a patient by adopting a three-dimensional conformal radiotherapy (3D-CRT) technology, specifically, 4-6 MV X-rays are adopted, the conventional segmentation is carried out, the fractional dose is 1.8-2.0 Gy/f and 5D/f, and the total dose is 50-70 Gy. The treatment group takes the blood-clearing granule 2 times a day, 0.08g each time. The medicine is taken for 5-7 weeks from the beginning of radiotherapy to the end of radiotherapy, and the medicine taking time after the occurrence of the radiation esophagitis is not less than 2 weeks. The control group is administered with placebo containing starch, plasticizer, pigment, bitter agent, etc.
The test result shows that the incidence rates of the radiation esophagitis of the patients in the treatment group and the patients in the control group are 86.36 percent and 90.91 percent respectively, and the Fisher exact probability method tests that the P is 1.000(P is more than 0.05) show that the incidence rates of the radiation esophagitis of the patients in the two groups have no significant difference. Meanwhile, the effective rate of the patients with radiation esophagitis in the treatment group after treatment is 73.68%, while the effective rate of the patients with radiation esophagitis in the control group after treatment is 35.00%, and the P is 0.025(P <0.05) by Fisher's exact probability method. The effective rate of the treatment group is obviously higher than that of the control group, and the traditional Chinese medicine composition has obvious effect of preventing and treating the radiation esophagitis of the patients.
In addition, anaphylactic reaction related to the treatment medicament does not occur in the period of medication of patients in a treatment group, and examination results of liver and kidney functions before and after treatment show that liver and kidney function damage does not occur in the period of treatment of the patients, so that the traditional Chinese medicine composition has no obvious toxic or side effect in preventing and treating the radiation esophagitis, and is safe and reliable.
The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all equivalent structural changes made by using the contents of the present specification, or any other related technical fields directly or indirectly, are included in the scope of the present invention.
Claims (10)
1. A traditional Chinese medicine composition for preventing and treating radiation damage comprises the following raw material medicines: saviae Miltiorrhizae radix, rhizoma Ligustici Chuanxiong, radix Paeoniae Rubra, radix Angelicae sinensis, radix rehmanniae Preparata, semen Persicae, Carthami flos and rhizoma paridis.
2. The Chinese medicinal composition for preventing and treating radiation therapy injury according to claim 1,
the method is characterized in that: the raw material medicines are as follows by weight: 15-135 parts of the root of red-rooted salvia, 5-75 parts of the rhizome of chuanxiong, 5-45 parts of the root of common peony, 5-45 parts of the Chinese angelica, 5-45 parts of the prepared rehmannia root, 5-45 parts of the peach seed, 5-45 parts of the safflower and 5-75 parts of the rhizoma paridis.
3. The Chinese medicinal composition for preventing and treating radiation therapy injury according to claim 1,
the method is characterized in that: the raw material medicines are as follows by weight: 25-135 parts of the root of red-rooted salvia, 15-75 parts of the rhizome of chuanxiong, 10-45 parts of the root of common peony, 10-45 parts of the Chinese angelica, 10-45 parts of the prepared rehmannia root, 10-45 parts of the peach seed, 10-45 parts of the safflower and 15-75 parts of the rhizoma paridis.
4. The Chinese medicinal composition for preventing and treating radiation therapy injury according to claim 1,
the method is characterized in that: the raw material medicines are as follows by weight: 30-120 parts of the root of red-rooted salvia, 20-60 parts of the rhizome of chuanxiong, 15-40 parts of the root of common peony, 15-40 parts of the Chinese angelica, 15-40 parts of the prepared rehmannia root, 15-40 parts of the peach seed, 15-40 parts of the safflower and 20-60 parts of the rhizoma paridis.
5. The Chinese medicinal composition for preventing and treating radiation therapy injury according to claim 1,
the method is characterized in that: the raw material medicines are as follows by weight: the traditional Chinese medicine composition comprises 75 parts of the root of red-rooted salvia, 40 parts of ligusticum wallichii, 25 parts of red paeony root, 25 parts of Chinese angelica, 25 parts of prepared rehmannia root, 25 parts of peach kernel, 25 parts of safflower and 40 parts of rhizoma paridis.
6. A blood-clearing granule prepared from the traditional Chinese medicine composition of any one of claims 1 to 5.
7. The blood-cleaning particle according to claim 6, wherein: the preparation process of the blood-clearing granules comprises the following steps:
step 1, performing reflux extraction on salvia miltiorrhiza with ethanol twice, combining extracting solutions of the two times, filtering, recovering ethanol from filtrate until no ethanol smell exists, obtaining salvia miltiorrhiza liquid medicine, and collecting salvia miltiorrhiza dregs obtained by filtering;
step 2, combining the salvia miltiorrhiza dregs with other raw materials, adding clear water, decocting twice, combining the liquid medicines decocted twice, filtering, and concentrating the filtrate to obtain a viscous paste;
step 3, adding the salvia miltiorrhiza medicinal liquid into the paste, uniformly mixing, drying under reduced pressure, and then crushing into fine powder;
and 4, adding auxiliary materials into the fine powder, and adding ethanol to prepare the blood-clearing granules.
8. The blood-cleaning particle according to claim 7, wherein: in the step 1, the concentration of the ethanol is 80%, the dosage of the ethanol in each reflux extraction is 6 times of the weight of the salvia miltiorrhiza, and the reflux extraction time is 2 hours.
9. The blood-cleaning particle according to claim 7, wherein: in the step 2, the amount of clear water used in each decoction is 8 times of the sum of the weight of the salvia miltiorrhiza residue and the weight of the rest raw materials, and the decoction time is 2 hours.
10. The blood-cleaning particle according to claim 7, wherein: the auxiliary materials are sucrose and dextrin.
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