CN106075008B - Selfheal granules and preparation method thereof - Google Patents

Selfheal granules and preparation method thereof Download PDF

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CN106075008B
CN106075008B CN201610417256.1A CN201610417256A CN106075008B CN 106075008 B CN106075008 B CN 106075008B CN 201610417256 A CN201610417256 A CN 201610417256A CN 106075008 B CN106075008 B CN 106075008B
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parts
selfheal
granules
weight
powder
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CN106075008A (en
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赵珂
刘维利
李鹏
刘丽
徐静
于建
李爱华
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SHANDONG XIANHE PHARMACEUTICAL CO Ltd
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/536Prunella or Brunella (selfheal)
    • AHUMAN NECESSITIES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/35Caprifoliaceae (Honeysuckle family)
    • A61K36/355Lonicera (honeysuckle)
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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    • A61K36/57Magnoliaceae (Magnolia family)
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • AHUMAN NECESSITIES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/79Schisandraceae (Schisandra family)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/86Violaceae (Violet family)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/894Dioscoreaceae (Yam family)
    • A61K36/8945Dioscorea, e.g. yam, Chinese yam or water yam
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    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8962Allium, e.g. garden onion, leek, garlic or chives
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    • A61K9/1629Organic macromolecular compounds
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    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
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Abstract

The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to selfheal granules and a preparation method thereof, wherein the granules are prepared from the following raw materials in parts by weight: 400 parts of common selfheal fruit-spike, 50-80 parts of honeysuckle, 30-60 parts of Chinese violet, 10-30 parts of lightyellow sophora root, 50-80 parts of muskroot-like semiaquilegia root, 50-80 parts of endive and 12-15 parts of Chinese magnoliavine fruit. The selfheal granules provided by the invention can cure lymphatic goiter, have high cure rate and small toxic and side effects, and improve the life quality of patients; according to the invention, different treatment methods are selected according to different raw materials, so that the extraction rate of effective components can be improved, the loss in the extraction process is avoided, and the prepared granules are convenient to drink and suitable for industrial production.

Description

Selfheal granules and preparation method thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to selfheal granules and a preparation method thereof.
Background
Prunellae Spica (Prunella vulgaris L) is a perennial herb, and has effects of clearing heat and purging fire, improving eyesight, resolving hard mass and relieving swelling.
Lymphoid goiter is an autoimmune disease, is mostly seen in women, mainly manifested as goiter, mostly diffuse, and rarely localized, and can be complicated with other various immune diseases. The clinical long-term application limits iodine intake and drug treatment such as thyroid preparation, thyroxine, immunoregulation and the like, patients mostly need to take hormone for life, the side effect is large, the effect on the autoimmune process of the organism is not achieved, the curative effect is poor, and the operation and the radioiodine treatment often cause hypocalcemia and other sequelae. The selfheal has a certain curative effect on the lymphatic goiter, but the existing selfheal particles have larger influence on liver and kidney and the like after being taken for a long time.
Disclosure of Invention
Aiming at the problems in the prior art, the invention provides selfheal granules, and the formula can effectively inhibit lymphocyte infiltration and lymphoid follicle proliferation, can protect liver and has small side effect.
The invention also provides a preparation method of the selfheal granules.
The technical scheme adopted by the invention for realizing the purpose is as follows:
the invention provides selfheal granules which are characterized by being prepared from the following raw materials in parts by weight: 500 parts of 400-portions of selfheal, 50-80 parts of honeysuckle, 30-60 parts of Chinese violet, 10-30 parts of lightyellow sophora root, 50-80 parts of muskroot-like semiaquilegia root, 50-80 parts of endive and 12-15 parts of Chinese magnoliavine fruit;
the weight parts of the raw materials are dry weight.
The formula provided by the invention also comprises 8-10 parts of onion and 10-12 parts of yam powder.
The invention also provides a preparation method of the selfheal granules, which comprises the following steps:
(1) coarsely crushing Prunellae Spica, flos Lonicerae, herba Violae, radix Sophorae Flavescentis, radix Semiaquilegiae, herba Sonchi arvensis and fructus Schisandrae chinensis in parts by weight to obtain mixed medicinal materials, adding 8-12 times of 50-70% ethanol aqueous solution containing 0.5-1.0% acetic acid, reflux-extracting for 2 times, filtering to obtain filtrate, adding 8-12 times of water into medicinal materials to the residue, heating and boiling for 1 hr, and filtering to obtain filtrate; mixing the filtrates, and concentrating to obtain soft extract with relative density of 1.2-1.3 (measured at 50 deg.C);
(2) slicing Bulbus Allii Cepae, steaming, adding phytic acid and cyclodextrin, pulping, oven drying Bulbus Allii Cepae pulp, grinding into 80 mesh powder to obtain Bulbus Allii Cepae powder;
(3) adding the obtained soft extract into rhizoma Dioscoreae powder and Bulbus Allii Cepae powder, adding adjuvants, mixing, granulating, and drying.
Further, in the step (1), the reflux extraction conditions are as follows: extracting at 80 deg.C for 1 h.
Further, in the step (2), the phytic acid is added in an amount which accounts for 0.2% of the weight of the onions; the addition amount of cyclodextrin is 5% of onion weight.
Further, in the step (3), the mass ratio of the formula to the auxiliary materials is 1: 1.2.
The auxiliary materials comprise dextrin, sucrose powder and mannitol according to a mass ratio of 1: 0.8: 0.2.
The onion used in the invention is fresh purple-skin onion, and the weight parts of the onion refer to fresh weight.
Through a large number of experiments and theoretical researches, the inventor discovers that the heat-clearing and detoxifying raw materials such as the Chinese violet and the like can enhance the drug effect of the selfheal granules; the prunella spike is compounded with schisandra fruit, sophora flavescens and the like, and the kurarinone and other components contained in the prunella spike can effectively inhibit the activity of serum alanine transferase; the compound endive can effectively inhibit the activity of the aspartate aminotransferase in serum, and can sooth liver, regulate qi, dissipate stagnation and reduce swelling by being supplemented with other raw materials, and warm and tonify spleen and kidney by being assisted with a liver softening method. In the process of preparing the onion powder, the pungent smell of the onion can be reduced, and the taste of the granule is improved.
The invention has the beneficial effects that:
(1) the selfheal granules provided by the invention can cure lymphatic goiter, have high cure rate and small toxic and side effects, and improve the life quality of patients;
(2) according to the invention, different treatment methods are selected according to different raw materials, so that the extraction rate of effective components can be improved, the loss in the extraction process is avoided, and the prepared granules are convenient to drink and suitable for industrial production.
Detailed Description
The present invention is further illustrated by the following examples, which should be understood as being merely illustrative and not limiting.
Example 1
A selfheal granule comprises the following components: 400 parts of selfheal, 62 parts of honeysuckle, 50 parts of Chinese violet, 10 parts of lightyellow sophora root, 72 parts of muskroot-like semiaquilegia root, 72 parts of endive, 12 parts of Chinese magnoliavine fruit, 10 parts of onion and 11 parts of yam powder;
the preparation method comprises the following steps:
(1) coarsely crushing Prunellae Spica, flos Lonicerae, herba Violae, radix Sophorae Flavescentis, radix Semiaquilegiae, herba Sonchi arvensis and fructus Schisandrae chinensis in parts by weight to obtain mixed medicinal materials, adding 12 times of 50-70% ethanol aqueous solution containing 0.5-1.0% acetic acid, reflux-extracting at 80 deg.C for 2 times, each time for 1 hr, filtering to obtain filtrate, adding 12 times of water into the residue, heating and boiling for 1 hr, and filtering to obtain filtrate; mixing the filtrates, and concentrating to obtain soft extract with relative density of 1.2-1.3 (measured at 50 deg.C);
(2) slicing Bulbus Allii Cepae, steaming, adding phytic acid 0.2% and cyclodextrin 5% of fresh weight of Bulbus Allii Cepae, pulping, oven drying Bulbus Allii Cepae pulp, grinding into 80 mesh powder to obtain Bulbus Allii Cepae powder;
(3) adding the obtained thick paste into the yam powder and the onion powder, adding the auxiliary materials into the mixed raw material medicine according to the ratio of 1:1.2, uniformly mixing to prepare a soft material, granulating, and drying;
the auxiliary materials comprise dextrin, sucrose powder and mannitol according to a mass ratio of 1: 0.8: 0.2.
Example 2
A selfheal granule comprises the following components: 425 parts of selfheal, 80 parts of honeysuckle, 45 parts of Chinese violet, 17 parts of lightyellow sophora root, 65 parts of muskroot-like semiaquilegia root, 65 parts of endive, 13 parts of Chinese magnoliavine fruit, 8 parts of onion and 10 parts of yam powder;
the preparation method is the same as example 1.
Example 3
A selfheal granule comprises the following components: 448 parts of selfheal, 70 parts of honeysuckle, 30 parts of Chinese violet, 20 parts of lightyellow sophora root, 55 parts of muskroot-like semiaquilegia root, 55 parts of endive, 14 parts of Chinese magnoliavine fruit, 9 parts of onion and 12 parts of yam powder;
the preparation method is the same as example 1.
Example 4
A selfheal granule comprises the following components: 470 parts of selfheal, 55 parts of honeysuckle, 60 parts of Chinese violet, 26 parts of radix sophorae flavescentis, 80 parts of muskroot-like semiaquilegia root, 60 parts of endive, 15 parts of Chinese magnoliavine fruit, 9 parts of onion and 11 parts of yam powder;
the preparation method is the same as example 1.
Example 5
A selfheal granule comprises the following components: 500 parts of selfheal, 50 parts of honeysuckle, 48 parts of Chinese violet, 30 parts of lightyellow sophora root, 50 parts of muskroot-like semiaquilegia root, 80 parts of endive, 15 parts of Chinese magnoliavine fruit, 10 parts of onion and 9 parts of yam powder;
the preparation method is the same as example 1.
Example 6
A selfheal granule comprises the following components: 470 parts of selfheal, 55 parts of honeysuckle, 60 parts of Chinese violet, 26 parts of lightyellow sophora root, 80 parts of muskroot-like semiaquilegia root, 60 parts of endive and 15 parts of Chinese magnoliavine fruit.
The preparation method comprises the following steps:
(1) coarsely crushing Prunellae Spica, flos Lonicerae, herba Violae, radix Sophorae Flavescentis, radix Semiaquilegiae, herba Sonchi arvensis and fructus Schisandrae chinensis in parts by weight to obtain mixed medicinal materials, adding 12 times of 50-70% ethanol aqueous solution containing 0.5-1.0% acetic acid, reflux-extracting at 80 deg.C for 2 times, each time for 1 hr, filtering to obtain filtrate, adding 12 times of water into the residue, heating and boiling for 1 hr, and filtering to obtain filtrate; mixing the filtrates, and concentrating to obtain soft extract with relative density of 1.2-1.3 (measured at 50 deg.C);
(2) adding adjuvants into the obtained soft extract at a ratio of 1:1.2, mixing to obtain soft material, granulating, and drying;
the auxiliary materials comprise dextrin, sucrose powder and mannitol according to a mass ratio of 1: 0.8: 0.2.
Example 7
A selfheal granule comprises the following components: 500 parts of selfheal, 50 parts of honeysuckle, 48 parts of Chinese violet, 30 parts of lightyellow sophora root, 50 parts of muskroot-like semiaquilegia root, 80 parts of endive and 15 parts of Chinese magnoliavine fruit
The preparation method is the same as example 6.
Comparative example 1
A selfheal granule comprises the following components: 400 parts of selfheal, 62 parts of honeysuckle, 50 parts of Chinese violet and 72 parts of muskroot-like semiaquilegia root;
the preparation method comprises the following steps: mixing the raw materials, adding water 8 times of the total weight of the raw materials, heating and boiling for 30min, filtering, adding water 8 times of the residue, heating and boiling for 30min, mixing the filtrates, concentrating to obtain soft extract with relative density of 1.2, adding adjuvants, making into soft material, granulating, drying, and packaging.
(I) clinical laboratory data
The cases are as follows: clinical observations were made on 102 patients who were clearly diagnosed with lymphoid goiter.
The syndrome of traditional Chinese medicine:
and (3) healing: the symptoms are completely disappeared, and the thyroid function activity is recovered to be normal;
remarkably: the main symptoms are eliminated, the physical signs are obviously improved, the thyroid function is basically recovered, and the function is recovered;
the method has the following advantages: the main symptoms basically disappear, and the physical signs are improved;
and (4) invalidation: compared with the pretreatment, the method has no progress in all aspects.
The invention carries out clinical tracking treatment on 102 patients, wherein 10 males and 92 females exist, and the age of the patients is 25-60 years, the application method of the selfheal granules provided by the invention is 1 bag each time, 1 day is twice, 21 days is one treatment course, 5 treatment courses are taken, and the effective rate (including recovery, remarkable and effective number) is 90%.
(II) pharmacodynamic test of the granules of the present invention
1. The test drugs are: the selfheal granules prepared by the embodiment of the invention.
2. Test animals: female Wistar rats, 5-6 weeks old, weighing 120-.
The specific operation method comprises the following steps:
at the beginning of the experiment, 100 ug of bovine thyroglobulin emulsified by complete Freund's adjuvant is injected subcutaneously into the foot pad part of the experimental rat as primary immunization, 100 ug of bovine thyroglobulin emulsified by incomplete Freund's adjuvant is boosted for 1 time at 2, 3 and 4 weeks respectively, and high iodine water (containing 500mg/L of sodium iodide) is drunk in large amount during the experiment period, and the modeling is successful at 6 weeks. The experimental groups were divided into 9 groups (5 rats per group) of S1-S7, D1, and blank group K1, and administered, wherein the Prunella vulgaris granules prepared in examples 1-7 were used in S1-S7, respectively, and the drug prepared in comparative example 1 was used in D1, and the administration was carried out by flushing with distilled water, feeding water to the blank group K1, gavaging at a weight of 0.5g/kg, and the administration was carried out once a day for 10 days, and then sacrificed. Detecting serum thyroglobulin antibody (TGAb), thyroid peroxidase antibody (TPOAb); thyroid tissue was taken, pathological sections were prepared, and morphological examination was performed, and the results are shown in table 1.
TABLE 1
After the selfheal granules prepared by the invention are used, most of follicular epithelial tissues are cubic, colloid is contained in a follicular cavity, and the infiltration of lymphocytes is obvious when the follicular structure of a model rat is moderately and severely damaged.
As can be seen from Table 1, the granules prepared by the method have a certain inhibiting effect on the lymphoid goiter, and compared with a blank group, after the granules are administered for 10 days, the hair color of a mouse appears glossy, the mental state is better, the diet is good, and data shows that the traditional Chinese medicine composition prepared by the method provided by the invention has a better effect than the traditional method of directly decocting.
(III) typical cases
Liu Yi, female, age 48, swelling in the front of the neck, local oppression, irritability, bitter taste in the mouth and dry mouth, and color Doppler ultrasound of the thyroid gland: goiter, multiple asymmetric nodules; by using the selfheal granules in the embodiment 1 of the invention, symptoms are relieved after 2 weeks of administration, clinical symptoms disappear after 3 months, thyroid antibodies are recovered obviously, swelling is relieved obviously, follow-up is carried out after 1 year, and no recurrence is caused, so that clinical cure is achieved.
In summer, female, 29 years old, 3 months after delivery, emaciation and hypodynamia, palpitation, fatigue intolerance, spontaneous sweating, anorexia, aversion to cold, abdominal distension, emotional silence, and color Doppler ultrasound: diffuse damage to the thyroid gland, uneven echo, multiple asymmetric nodules; by using the selfheal granules in the embodiment 3 of the invention, the symptoms are relieved after 3 weeks of administration, after 3 months, clinical symptoms disappear, thyroid antibodies are obviously recovered, thyroid function is recovered to be normal, follow-up is performed after 1 year, and no recurrence is caused, so that clinical cure is achieved.

Claims (5)

1. The selfheal granules are characterized by being prepared from the following raw materials in parts by weight: 500 parts of 400-portions of selfheal, 50-80 parts of honeysuckle, 30-60 parts of Chinese violet, 10-30 parts of lightyellow sophora root, 50-80 parts of muskroot-like semiaquilegia root, 50-80 parts of endive and 12-15 parts of Chinese magnoliavine fruit;
the weight parts of the raw materials are dry weight;
8-10 parts of onion and 10-12 parts of yam powder;
the preparation method specifically comprises the following steps:
(1) coarsely crushing Prunellae Spica, flos Lonicerae, herba Violae, radix Sophorae Flavescentis, radix Semiaquilegiae, herba Sonchi arvensis and fructus Schisandrae chinensis in parts by weight to obtain mixed medicinal materials, adding 8-12 times of 50-70% ethanol aqueous solution containing 0.5-1.0% acetic acid, reflux-extracting for 2 times, filtering to obtain filtrate, adding 8-12 times of water into medicinal materials to the residue, heating and boiling for 1 hr, and filtering to obtain filtrate; mixing the filtrates, concentrating to obtain soft extract with relative density of 1.2-1.3, and measuring the density of the soft extract at 50 deg.C;
(2) slicing Bulbus Allii Cepae, steaming, adding phytic acid and cyclodextrin, pulping, oven drying Bulbus Allii Cepae pulp, grinding into 80 mesh powder to obtain Bulbus Allii Cepae powder;
(3) adding the obtained soft extract into rhizoma Dioscoreae powder and Bulbus Allii Cepae powder, adding adjuvants, mixing, granulating, and drying.
2. The selfheal granules according to claim 1, wherein in the step (1), the reflux extraction conditions are as follows: extracting at 80 deg.C for 1 h.
3. The selfheal granules according to claim 1, wherein in the step (2), the phytic acid is added in an amount of 0.2% by weight of the onion; the addition amount of cyclodextrin is 5% of onion weight.
4. The selfheal granules according to any one of claims 1 to 3, wherein in the step (3), the mass ratio of the formula to the auxiliary materials is 1: 1.22.
5. The selfheal granules according to claim 1, wherein the auxiliary materials comprise dextrin, sucrose powder and mannitol in a mass ratio of 1: 0.8: 0.2.
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