Preparation method of film-coated stone-like omphalia for cancer treatment

Abstract

The invention discloses a preparation method of film-coated stone-like omphalia for cancer treatment, which comprises the following steps: selecting fresh high-quality stone-like omphalia, putting the selected stone-like omphalia into a sodium bicarbonate solution for ultrasonic cleaning, putting the cleaned stone-like omphalia into a ventilation cabinet for drying, slicing the dried stone-like omphalia, putting the sliced stone-like omphalia into a container, adding a sodium chloride solution for soaking, and taking out the sliced stone-like omphalia; the preparation method comprises the following steps: crushing the omphalia to obtain omphalia fine powder, granulating the omphalia fine powder through some auxiliary materials by adopting a dynamic extraction and low-temperature concentration process, carrying out granule straightening and tabletting, and finally taking a medicinal film coating as a coating material. The traditional Chinese medicine stone-like omphalia is sclerotia of poriaceae plant stone-like omphalia, a large number of clinical tests prove that the stone-like omphalia has the effects of softening hard mass, resolving tumor and reducing lumps, promoting the human body to recover the synthetic ability of albumin, improving immunity, inducing diuresis, relaxing bowels and expelling toxins, the effect is good, and the stone-like omphalia is not dissolved in the stomach and dissolved and absorbed in the small intestine by using a coating material, so that the stone-like omphalia is not dissolved in the stomach. And meanwhile, the stomach is protected.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine preparations, and in particular to a method for preparing film-coated lei pills for cancer treatment. Background Art

[0002] At present, the incidence of cancer is increasing year by year around the world. Western medicine is generally used for clinical treatment, but the toxic side effects caused by Western medicine have become a problem that troubles clinical medical workers. When treating malignant tumors with Western medicine in clinical treatment, X-ray or Y-ray radiotherapy is also required. The treatment process is very painful, and the first thing to be damaged is the white blood cells in the hematopoietic system. White blood cells are important immune cells in the human body. When the white blood cell count in the human body is too low, it may be infected by other pathogens and cause serious consequences. Traditional Chinese medicine has accumulated rich experience in thousands of years of practice. When using traditional Chinese medicine to treat diseases, it pays attention to the adjustment of the functions of the internal organs of the human body and the yin and yang of qi and blood, and improves the body's resistance to diseases. It is safer to treat diseases with traditional Chinese medicine, with fewer toxic side effects and low prices, and patients are easy to accept. The traditional Chinese medicine Lei Wan is the sclerotium of the Lei Wan fungus of the Polyporaceae family. A large number of clinical trials have shown that Lei Wan is rich in Lei Wan polysaccharide S-4002, Lei Wansu, calcium, aluminum, magnesium, butyl benzoate, 4,6,8(14),22(23)-tetraen-3-one-ergostane, ergosta-7,22-diene-3p-ol, acetylfamonic acid, lfamonic acid, 3β-hydroxylanostane trienoic acid, chitin, protein, fat, sterol, lecithin, glucose, adenine, histidine, choline, β-lei Wan polysaccharide degrading enzyme, lipase, protease, ergoster- It contains more than 20 kinds of active ingredients, including 5,7,22-triene-3β-ol, ergosterol, ergosterol peroxide, etc. It has obvious effects of softening and reducing tumors; promoting the body's ability to restore albumin synthesis, inhibiting renal tubular reabsorption function, reducing globulin, having obvious diuretic effect, and improving immunity; moisturizing the intestines and inhibiting bacteria, facilitating bowel movements and detoxifying; relieving inflammation and enzymes, protecting the liver and relieving jaundice; benefiting the lungs and resolving phlegm, reducing fever and relieving cough; calming the nerves and improving sleep; dissolving protein and blocking the effect of recurrence and metastasis. Therefore, it is feasible to use Leiwan to make Chinese medicine preparations for cancer treatment.

[0003] Cancer patients in the hospital usually need to undergo routine treatments such as surgery, radiotherapy and chemotherapy, and they must also take a lot of Chinese or Western medicine as auxiliary treatments. Some therapeutic drugs are dissolved and absorbed in the stomach. Over time, these drugs will cause serious damage to the stomach. Summary of the invention

[0004] In order to solve the above problems, the present invention provides a method for preparing film-coated lei pills for cancer treatment.

[0005] According to one aspect of the present invention, a method for preparing a film-coated leptospira pill for cancer treatment is provided, the method comprising the following steps:

[0006] (1) Selecting thunder balls: Select fresh thunder balls and remove inferior ones and impurities;

[0007] (2) Cleaning the thunder balls: Place fresh and high-quality thunder balls in sodium bicarbonate solution and perform ultrasonic cleaning for 20 min;

[0008] (3) Drying the thunder balls: Place the cleaned thunder balls in a fume hood and dry them for 30-40 minutes;

[0009] (4) Slicing the thunder balls: Slice the dried thunder balls, and control the slice thickness to 2-4 mm;

[0010] (5) Soaking the thunder balls: placing the thunder balls obtained in step (4) in a container, adding a sodium chloride solution with a concentration of 1.5-2.8%, the weight ratio of the thunder balls to the sodium chloride solution being 1:0.5-1.2, soaking for 24-30 hours, and drying at 50-80° C. for 18-24 hours to obtain dry thunder balls for use;

[0011] (6) crushing the thunder balls: crushing the thunder balls obtained in step (5) and sieving them through a 100-mesh sieve to obtain thunder ball fine powder;

[0012] (7) Making thunder ball tablets: taking the thunder ball fine powder obtained in step (6), mixing it evenly with powdered sugar, dextrin, and sodium hydroxymethyl starch in a weight ratio of 30:7-10:1-2:1-2, granulating it with 50% syrup, and pressing the whole granules into tablets;

[0013] (8) Coating the thunder ball tablets: using the premixed auxiliary materials for the medicinal film coating as the coating material, the thunder ball tablets obtained in step (7) are coated with the medicinal film coating.

[0014] The beneficial effects are as follows: in step (4) of the preparation process, the dried thunder balls are sliced, so that time can be saved when soaking the thunder balls in step (5); in step (6), the thunder balls are crushed and sieved through 100 meshes to obtain fine thunder ball powder, so that the drug can be more thoroughly digested and absorbed; a medicinal film coating is used as a coating material, so that the thunder balls do not dissolve in the acidic liquid in the stomach, and are dissolved and absorbed only when they encounter alkaline liquid in the small intestine, thereby protecting the stomach.

[0015] In some embodiments, the pharmaceutical film coating is made of polyacrylic acid resin II or polyacrylic acid resin III as a coating material. Therefore, the pharmaceutical film coating uses polyacrylic acid resin II or polyacrylic acid resin III as a coating material, which can ensure that the thunder ball does not dissolve in the acidic liquid in the stomach.

[0016] In some embodiments, the thunder ball tablets obtained in step (7) are coated with a medicinal film coating in a solution of a premixed excipient for a medicinal film coating at a volume of 0.2-2 times the total weight of the thunder ball tablets according to conventional methods, and the medicinal film coating accounts for 5-15% of the total weight of the thunder ball tablets.

[0017] The advantages of the present invention are as follows: the main anti-cancer component of the thunder pill described in the present invention is thunder pill protein, which is thunder pill protease. The thunder pill protease is ineffective when heated, has the strongest effect in an alkaline (pH 8) solution, and is ineffective in an acidic solution. Based on the characteristic that the thunder pill is ineffective in gastric acid, the preparation method described in the present invention adopts a medicinal film coating as a coating material, prolongs the disintegration time of the drug, and makes the thunder pill insoluble in the acidic liquid in the stomach, and is dissolved and absorbed when it encounters an alkaline liquid in the small intestine, thereby making the drug effect better and protecting the stomach at the same time. DETAILED DESCRIPTION

[0018] The present invention will be further described below in conjunction with specific implementation modes.

[0019] Example 1

[0020] Select fresh thunder balls and remove inferior and impurities; put 300g of fresh and high-quality thunder balls into 1000g of 0.5% sodium bicarbonate solution for ultrasonic cleaning for 20min; put the cleaned thunder balls into a fume hood for drying for 30min;

[0021] The dried thunder balls are sliced, and the slice thickness is controlled to be 2-4mm; the sliced ​​thunder balls are placed in a container, 150 grams of sodium chloride solution with a concentration of 1.5% are added, soaked for 30 hours, and then dried for 24 hours at 60-80°C to obtain dried thunder balls for use; the thunder balls are crushed and sieved through 100 meshes to obtain thunder ball fine powder; the sieved thunder ball fine powder is mixed evenly with 70 grams of powdered sugar, 15 grams of dextrin, and 15 grams of sodium hydroxymethyl starch, and the dynamic extraction low-temperature concentration process is adopted. After granulation with 50% syrup, the whole granules are pressed into tablets; finally, the medicinal film coating premixed auxiliary material is used as the coating material, and the medicinal film coating is coated in the medicinal film coating premixed auxiliary material solution of 1 times the total weight of the thunder ball tablets according to the conventional method, and the medicinal film coating is controlled to account for 5-15% of the total mass of the thunder ball. In this embodiment, the medicinal film coating uses polyacrylic resin No. II as the coating material.

[0022] Example 2

[0023] Select fresh thunder balls and remove inferior and impurities; take 300 grams of fresh and high-quality thunder balls and put them into 1000 grams of 0.5% sodium bicarbonate solution for ultrasonic cleaning for 20 minutes; put the cleaned thunder balls into a fume hood for drying for 40 minutes; slice the dried thunder balls, and the slice thickness is controlled at 2-4 mm; put the sliced ​​thunder balls into a container, add 360 grams of 2.8% sodium chloride solution, soak for 24 hours, and then dry for 18 hours at 50-70°C to obtain The dried thunder balls are set aside; the thunder balls are crushed and sieved through 100 meshes to obtain thunder ball fine powder; the sieved thunder ball fine powder is evenly mixed with 100 grams of powdered sugar, 15 grams of dextrin, and 15 grams of sodium hydroxymethyl starch, and the dynamic extraction and low-temperature concentration process is adopted to granulate with 50% syrup, and the whole granules are pressed into tablets; finally, the medicinal film coating premixed auxiliary material is used as the coating material, and the medicinal film coating is coated in the medicinal film coating premixed auxiliary material solution of 1 times the total weight of the thunder ball tablets according to the conventional method, and the medicinal film coating accounts for 5-15% of the total mass of the thunder ball. In this embodiment, the medicinal film coating uses polyacrylic acid resin No. III as the coating material.

[0024] Example 3

[0025] Select fresh thunder balls and remove inferior and impurities; take 300 grams of fresh and high-quality thunder balls and put them into 1000 grams of 0.5% sodium bicarbonate solution for ultrasonic cleaning for 20 minutes; put the cleaned thunder balls into a fume hood for drying for 35 minutes; slice the dried thunder balls, and control the slice thickness to 2-4 mm; put the sliced ​​thunder balls into a container, add 240 grams of 2% sodium chloride solution, soak for 26 hours, and then dry for 22 hours at 60-80°C to obtain dry The dried thunder balls are set aside; the thunder balls are crushed and sieved through 100 meshes to obtain thunder ball fine powder; the sieved thunder ball fine powder is mixed evenly with 80 grams of powdered sugar, 15 grams of dextrin, and 15 grams of sodium hydroxymethyl starch, and the dynamic extraction and low-temperature concentration process is adopted, and after granulation with 50% syrup, the whole granules are pressed into tablets; finally, the medicinal film coating premixed auxiliary material is used as the coating material, and the medicinal film coating is coated in the medicinal film coating premixed auxiliary material solution of 1 times the total weight of the thunder ball tablets according to the conventional method, and the medicinal film coating is controlled to account for 5-15% of the total mass of the thunder ball. In this embodiment, the medicinal film coating uses polyacrylic acid resin No. III as the coating material.

[0026] The present invention adopts a unique film coating technology to prolong the drug disintegration time, allowing the tablets to dissolve less in the stomach, thereby achieving a zero-toxic effect without hurting the stomach.

[0027] The above are only some embodiments of the present invention. It should be pointed out that for ordinary technicians in this field, other modifications and improvements can be made without departing from the creative concept of the present invention, which all belong to the protection scope of the present invention.

Claims

1. A method for preparing a film-coated lei pill for cancer treatment, characterized in that: The method comprises the following steps: (1) Selecting thunder balls: Select fresh thunder balls and remove inferior ones and impurities; (2) Cleaning the thunder balls: Place fresh and high-quality thunder balls in sodium bicarbonate solution and perform ultrasonic cleaning for 20 min; (3) Drying the thunder balls: Place the cleaned thunder balls in a fume hood and dry them for 30-40 minutes; (4) Slicing the thunder balls: Slice the dried thunder balls, and control the slice thickness to 2-4 mm; (5) Soaking the thunder balls: placing the thunder balls obtained in step (4) in a container, adding a sodium chloride solution with a concentration of 1.5-2.8%, the weight ratio of the thunder balls to the sodium chloride solution being 1:0.5-1.2, soaking for 24-30 hours, and drying at 50-80° C. for 18-24 hours to obtain dry thunder balls for use; (6) crushing the thunder balls: crushing the thunder balls obtained in step (5) and sieving them through a 100-mesh sieve to obtain thunder ball fine powder; (7) Making thunder ball tablets: taking the thunder ball fine powder obtained in step (6), mixing it evenly with powdered sugar, dextrin, and sodium hydroxymethyl starch in a weight ratio of 30:7-10:1-2:1-2, granulating it with 50% syrup, and pressing the whole granules into tablets; (8) Coating the thunder ball tablets: using the premixed auxiliary materials for the medicinal film coating as the coating material, the thunder ball tablets obtained in step (7) are coated with the medicinal film coating.

2. The method for preparing a film-coated thunder pill for cancer treatment according to claim 1, characterized in that: The medicinal film coating is made of polyacrylic acid resin No. II or polyacrylic acid resin No. III as coating material.

3. The method for preparing a film-coated thunder pill for cancer treatment according to claim 2, characterized in that: Take the thunder ball tablets obtained in step (7) and coat them with a medicinal film coating in a solution of a premixed excipient for a medicinal film coating in an amount of 0.2-2 times the total weight of the thunder ball tablets according to a conventional method, and control the medicinal film coating to account for 5-15% of the total weight of the thunder ball.