CN106728679B - Molecular traditional Chinese medicine sustained-release tablet for resisting bone mass loss and preparation method thereof - Google Patents
Molecular traditional Chinese medicine sustained-release tablet for resisting bone mass loss and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a molecular traditional Chinese medicine sustained-release tablet for resisting bone mass loss and a preparation method thereof, the molecular traditional Chinese medicine sustained-release tablet comprises molecular traditional Chinese medicine components and pharmaceutically-allowable auxiliary material components, wherein the molecular traditional Chinese medicine components comprise 1-5 parts of specnuezhenide (glossy privet fruit), 1-5 parts of wedelolactone (yerbadetajo herb), 0.5-3 parts of paeoniflorin (peony), 0.5-3 parts of psoralen (fructus psoraleae) and 1-5 parts of diosgenin (Chinese yam); the auxiliary material components comprise 10-50 parts of sodium alginate, 1-5 parts of carbomer (934), 10-30 parts of hydroxypropyl methyl cellulose, 10-40 parts of lactose and 1-5 parts of magnesium stearate. The invention is a molecular Chinese medicine slow-release tablet which is safe and reliable, has high bioavailability and obvious curative effect and is prepared by scientific compatibility according to the theory of Chinese medicines and the theory of slow-release preparations and aiming at the traditional Chinese medicine pathological characteristics of postmenopausal osteoporosis.
Description
Technical Field
The invention relates to a molecular traditional Chinese medicine sustained-release tablet for resisting bone mass loss and a preparation method thereof, belonging to the technical field of traditional Chinese medicines.
Background
Postmenopausal osteoporosis is a disease related to age increase, belongs to the field of 'flaccidity of bones' in traditional Chinese medicine, occurs in postmenopausal women, and is characterized in that bone metabolic diseases characterized by damaged bone strength caused by lack of estrogen cause increased fracture risk, and has the pathological characteristics of reduced bone mineral content and bone matrix components in equal proportion, thinned cortical bone and thinned and reduced trabecular bone. With the aging of population, the incidence rate is remarkably increased, which has become a public problem seriously affecting the health and life quality of the old people and is one of the hot problems concerned by the medical field.
Kidneys are the innate root, and essence is stored in bones to produce marrow, which is located in bones to nourish bones. The chapter entitled "Kidney essence governing the root of the sealed and stored book, Su Wen, Liu Zang Xiang Lun" (plain questions, six sections of Tibetan elephants treatises); it is mainly developed and filled in the bone, which is called kidney governing bone marrow in the treatise on West treatise on plain questions and essence and theory on explanation of marrow and bone filling in the treatise on kidney essence storing essence governing bone and generating marrow, i.e. kidney essence is sufficient and bone marrow is biochemically active to nourish bone. The theory of essence deficiency refers to that the kidney is stored in essence, … … refers to that the disease is known to be in the bone, the spirit refers to that the essence damages the bone and the atrophy is faint, and the theory of essence deficiency refers to that the kidney has heat, so that the waist and the spine are not lifted, the bone is withered and the marrow is reduced, and the bone atrophy is caused, so that the mutual influence of the kidney governing the bone on the pathogenesis, the kidney deficiency and the marrow depletion, the bone marrow is biochemical and poor in source, and the bone is nourished without the nutrition, so that the bone atrophy is caused; on the contrary, the pathological changes of the bone may damage the bone marrow and involve the kidney, which fully indicates that the physiological and pathological changes of the bone are governed by the kidney, and the abundance or insufficiency of the kidney essence determines the strength of the bone. The Su Wen, the Bin Yang congratulation treatise on the theory that the kidney generates marrow and the marrow is biochemically active when the kidney essence is sufficient, indicate that the kidney essence is sufficient and the marrow is actively generated and nourished; when kidney deficiency and marrow depletion, bone marrow is a source of biochemical exhaustion and bone nourishment, osteoblastic bone formation-osteoclastic bone resorption coupling imbalance is the pathological basis of postmenopausal osteoporosis flaccidity, wherein kidney yin deficiency is one of the common clinical syndromes.
The spleen governs four limbs and is the source of acquired root and generation of qi and blood. The spleen belongs to yin and earth, is located in the center, has the functions of tranquility and dryness, can transport and transform food essence, and also can ascend and descend the qi activity of the main body, and if the spleen qi is vigorous, the spleen qi can be used for mediating and rotating, transporting up and down, irrigating the four sides and keeping the vitality. The Su Wen & Sheng Qi Tong Tian Lun (Su Wen & Sheng Qi Tong Tian Lun) is to harmonize five flavors, so that bones are strong and soft, qi and blood flow in the same direction, and striae and interstice in the same direction, so that the bone qi is refined, the Kun Wai' ao is like the law, and the heaven Life is good, thus prompting that the growth of bones is closely related to the function of spleen and stomach. The spleen governs skeleton, transforms and generates qi, blood, essence and body fluid to nourish bone, and in lingshu, Benshen, "spleen qi deficiency and limbs deficiency" suggests spleen and stomach function exhaustion, qi transformation failing to control, pivot dysfunction, blood failing to transform essence, congenital kidney failing to nourish, kidney essence deficiency and bone failing to nourish.
The main medicines for treating postmenopausal osteoporosis in western medicine are medicines for inhibiting bone resorption (estrogen, calcitonin, isoflavone and the like), promoting bone formation (fluoride, parathyroid hormone and the like) and bone mineralization (calcium agent, vitamin D3), and the medicines have large side effect and are easy to cause complications after being taken for a long time. The traditional Chinese medicine has obvious characteristics and advantages for treating postmenopausal osteoporosis, and is mainly reflected in that (1) traditional Chinese medicine treatment methods mainly take regulation and pay attention to integral regulation and internal cause regulation; (2) the traditional Chinese medicine composition has obvious curative effect, and can relieve or eliminate symptoms by inhibiting bone resorption and improving the bone mass and the biomechanical property of bones; (3) the side effect is small, and the price is low; (4) the multi-target effect achieves the purpose of comprehensive treatment by regulating the functional states of a plurality of systems such as endocrine, immunity and the like, and the long-term curative effect is stable. At present, the results of clinical research, animal experiments and related pharmacological research preliminarily disclose the action mechanism of traditional Chinese medicine for treating postmenopausal osteoporosis.
The invention carries out scientific prescription according to the traditional Chinese medicine principle and the traditional Chinese medicine pathological characteristics of postmenopausal osteoporosis, and the glossy privet fruit is sweet, bitter and cool, enters liver and kidney channels, tonifies liver and kidney and clears deficiency heat, and the main component is specnuezhenide which is a monarch drug; the eclipta alba is sweet, sour and cool, belongs to kidney and liver channels, and is used for tonifying liver and kidney, and the wedelolactone is used as a ministerial drug as the main component; the peony root is bitter, sour and slightly cold, enters liver and spleen channels, nourishes blood and softens liver, relieves the middle-jiao to relieve pain, astringes yin and absorbs sweat, mainly comprises paeoniflorin, fructus psoraleae is pungent, bitter and warm, enters kidney, pericardium, spleen, stomach and lung channels, warms kidney and invigorates yang and receives qi, and mainly comprises psoralen which is an adjuvant drug; the yam is sweet and neutral, enters spleen, lung and kidney channels, tonifies spleen and stomach, promotes fluid production and benefits lung, and tonifies kidney and astringes essence, and the yam is diosgenin serving as a messenger drug as a main component. Develops a molecular Chinese medicinal sustained-release tablet which has the characteristics of the Chinese medicament and has good effect of resisting bone mass loss. The molecular Chinese medicine slow release tablet is used as a novel dosage form, can effectively control the release speed of the medicine, has high bioavailability, and maintains the blood concentration of the medicine for a long time, thereby improving the traditional dosage form.
Disclosure of Invention
The invention provides a molecular traditional Chinese medicine sustained-release tablet for resisting bone mass loss and a preparation method thereof. As a novel dosage form, the molecular Chinese medicinal sustained-release tablet has the advantages of readily available raw materials, simple and convenient preparation method, convenient use, no obvious adverse reaction, effective control of the release speed of the medicament, high bioavailability and long-term maintenance of the blood concentration of the medicament, thereby effectively relieving the bone mass loss of the postmenopausal osteoporosis.
The molecular traditional Chinese medicine sustained-release tablet comprises molecular traditional Chinese medicine components and pharmaceutically-allowable auxiliary material components, wherein the molecular traditional Chinese medicine components comprise 1-5 parts of specnuezhenide (glossy privet fruit), 1-5 parts of wedelolactone (eclipta), 0.5-3 parts of paeoniflorin (peony), 0.5-3 parts of psoralen (fructus psoraleae) and 1-5 parts of diosgenin (Chinese yam).
The pharmaceutically acceptable auxiliary material components comprise 10-50 parts of sodium alginate, 1-5 parts of carbomer (934), 10-30 parts of hydroxypropyl methyl cellulose, 10-40 parts of lactose and 1-5 parts of magnesium stearate.
The preparation method comprises the following steps:
(1) weighing each molecule of Chinese medicinal components in proportion, and mixing uniformly;
(2) sodium alginate and hydroxypropyl methylcellulose are used as framework materials, carbomer (934) is added as an adhesive, the mixture is uniformly mixed with the molecular traditional Chinese medicine components in the step (1), and a proper amount of 95% ethanol is added to prepare a soft material;
(3) drying the soft material in (2) at low temperature, pulverizing into fine powder, adding lactose as diluent, adding magnesium stearate as lubricant, mixing, and tabletting.
The invention has the beneficial effects that:
(1) the molecular traditional Chinese medicine provided by the invention is reasonable in compatibility and better in curative effect. The molecular traditional Chinese medicine components are derived from an empirical prescription for clinically treating postmenopausal osteoporosis, glossy privet fruit which is sweet, bitter and cool, enters liver and kidney channels, tonifies liver and kidney and clears deficiency heat is adopted in the prescription, and the main component is specnuezhenide which is a monarch drug; the eclipta alba is sweet, sour and cool, belongs to kidney and liver channels, and is used for tonifying liver and kidney, and the wedelolactone is used as a ministerial drug as the main component; the peony root is bitter, sour and slightly cold, enters liver and spleen channels, nourishes blood and softens liver, relieves the middle-jiao to relieve pain, astringes yin and absorbs sweat, mainly comprises paeoniflorin, fructus psoraleae is pungent, bitter and warm, enters kidney, pericardium, spleen, stomach and lung channels, warms kidney and invigorates yang and receives qi, and mainly comprises psoralen which is an adjuvant drug; the yam is sweet and neutral, and has the effects of invigorating spleen and nourishing stomach, promoting the production of body fluid and benefiting lung, and tonifying kidney and arresting seminal emission, and the yam is mainly composed of diosgenin, is used as a messenger drug, is compatible with various medicines, and has the effects of tonifying kidney and softening liver, and nourishing yin and blood, and is obviously superior to the effects of single medicine.
(2) The molecular Chinese medicine sustained-release tablet has novel dosage form, convenient and safe use, high bioavailability and capability of effectively controlling the release speed of the medicine and maintaining the blood concentration of the medicine for a long time, thereby effectively resisting the bone loss.
(3) The mechanism of action of the present invention against bone mass loss is primarily elucidated. Experiments prove that: the molecular Chinese medicine slow-release tablet can increase bone mass and improve the biomechanical property of bones by inhibiting bone absorption.
Detailed Description
The technical solutions of the present invention are described in detail below by examples, and the following examples are only exemplary and are only used to explain and illustrate the technical solutions of the present invention, but not to limit the technical solutions of the present invention.
Example 1
A molecular Chinese medicinal sustained release tablet for resisting bone loss comprises molecular Chinese medicinal components and pharmaceutically acceptable adjuvant components, wherein the molecular Chinese medicinal components comprise 5 parts of specnuezhenide (fructus Ligustri Lucidi), 5 parts of wedelolactone (Ecliptae herba), 2 parts of penoniflorin (radix Paeoniae), 3 parts of psoralen (fructus Psoraleae), and 5 parts of diosgenin (rhizoma Dioscoreae); the auxiliary material components comprise 30 parts of sodium alginate, 1 part of carbomer (934), 25 parts of hydroxypropyl methyl cellulose, 20 parts of lactose and 4 parts of magnesium stearate.
The preparation method comprises the following steps:
(1) weighing each molecule of Chinese medicinal components in proportion, and mixing uniformly;
(2) sodium alginate and hydroxypropyl methylcellulose are used as framework materials, carbomer (934) is added as an adhesive, the mixture is uniformly mixed with the molecular traditional Chinese medicine components in the step (1), and a proper amount of 95% ethanol is added to prepare a soft material;
(3) drying the soft material in (2) at low temperature, pulverizing into fine powder, adding lactose as diluent, adding magnesium stearate as lubricant, mixing, and tabletting.
Example 2
A molecular Chinese medicinal sustained-release tablet for resisting bone loss comprises molecular Chinese medicinal components and pharmaceutically acceptable adjuvant components, wherein the molecular Chinese medicinal components comprise 2.5 parts of specnuezhenide (fructus Ligustri Lucidi), 2.5 parts of wedelolactone (Ecliptae herba), 1 part of paeoniflorin (radix Paeoniae), 2 parts of psoralen (fructus Psoraleae), and 2 parts of diosgenin (rhizoma Dioscoreae). The auxiliary materials comprise 40 parts of sodium alginate, 3 parts of carbomer (934), 15 parts of hydroxypropyl methyl cellulose, 30 parts of lactose and 2 parts of magnesium stearate.
The preparation method comprises the following steps:
(1) weighing each molecule of Chinese medicinal components in proportion, and mixing uniformly;
(2) sodium alginate and hydroxypropyl methylcellulose are used as framework materials, carbomer (934) is added as an adhesive, the mixture is uniformly mixed with the molecular traditional Chinese medicine components in the step (1), and a proper amount of 95% ethanol is added to prepare a soft material;
(3) drying the soft material in (2) at low temperature, pulverizing into fine powder, adding lactose as diluent, adding magnesium stearate as lubricant, mixing, and tabletting.
Example 3
A molecular Chinese medicinal sustained release tablet for resisting bone loss comprises molecular Chinese medicinal components and pharmaceutically acceptable adjuvant components, wherein the molecular Chinese medicinal components comprise 1.5 parts of specnuezhenide (fructus Ligustri Lucidi), 1.5 parts of wedelolactone (Ecliptae herba), 0.5 parts of paeoniflorin (radix Paeoniae), 0.5 parts of psoralen (fructus Psoraleae), and 1 part of diosgenin (rhizoma Dioscoreae). The auxiliary materials comprise 45 parts of sodium alginate, 2 parts of carbomer (934), 20 parts of hydroxypropyl methyl cellulose, 25 parts of lactose and 3 parts of magnesium stearate.
The preparation method comprises the following steps:
(1) weighing each molecule of Chinese medicinal components in proportion, and mixing uniformly;
(2) sodium alginate and hydroxypropyl methylcellulose are used as framework materials, carbomer (934) is added as an adhesive, the mixture is uniformly mixed with the molecular traditional Chinese medicine components in the step (1), and a proper amount of 95% ethanol is added to prepare a soft material;
(3) drying the soft material in (2) at low temperature, pulverizing into fine powder, adding lactose as diluent, adding magnesium stearate as lubricant, mixing, and tabletting.
Example 4
Molecular traditional Chinese medicine sustained-release tablet for inhibiting bone metabolic disorder of postmenopausal osteoporosis animal model
The method comprises the following steps: 45 SD rats of 2 months old cleaning grade, female, the random number table method is divided into 2 groups, blank group 15 and model group 30. The blank group only removes part of fat beside ovaries by adopting a pseudo-operation, the model group establishes a postmenopausal osteoporosis animal model by removing bilateral ovaries, and the random digital table method is divided into 2 groups, 15 model groups and 15 experimental groups. The blank group is fed regularly, the model group is irrigated with equivalent physiological saline, the experimental group is irrigated with 60mg/kg/d molecular traditional Chinese medicine sustained-release tablets (prepared in example 2) for 12 weeks 1 time every day, and changes of serum bone alkaline phosphatase (BALP), Osteocalcin (OC) and Osteoprotegerin (OPG) related indexes of post-menopausal osteoporosis animal models bone metabolic disorder are detected by an ELISA method.
TABLE 1 Change in bone metabolism index after intervention
| Group of | BLAP（U/L） | OC（μg/L） | OPG（ng/L） |
| Blank group | 69.40±9.47 | 47.81±10.82 | 19.64±3.45 |
| Model set | 96.56±9.87* | 71.61±9.70* | 9.69±2.73* |
| Experimental group | 75.65±10.00▽ | 51.70±8.29▽ | 16.23±2.51▽ |
Note: p <0.05 compared to blank; in comparison with the set of models,▽P＜0.05。
as a result: after the intervention of the molecular traditional Chinese medicine sustained-release tablets for 12 weeks, the contents of serum BALP and OC are obviously higher than those of a blank group (P < 0.05), and an experimental group is obviously lower than that of a model group (P < 0.05); the serum OPG content was significantly lower in the model group than in the blank group (P < 0.05) and significantly higher in the experimental group than in the model group (P < 0.05) (Table 1).
And (4) conclusion: the molecular Chinese medicinal sustained-release tablet can reduce the content of serum BALP and OC, increase the content of serum OPG, and inhibit bone metabolism disorder of postmenopausal osteoporosis.
Example 5
Molecular traditional Chinese medicine sustained-release tablets for inhibiting hormone level disorder of postmenopausal osteoporosis animal model
The method comprises the following steps: 45 SD rats of 2 months old cleaning grade, female, the random number table method is divided into 2 groups, blank group 15 and model group 30. The blank group only removes part of fat beside ovaries by adopting a pseudo-operation, the model group establishes a postmenopausal osteoporosis animal model by removing bilateral ovaries, and the random digital table method is divided into 2 groups, 15 model groups and 15 experimental groups. Feeding the blank group regularly, performing intragastric administration on the model group by using equivalent physiological saline, performing intragastric administration on the experimental group by using 60mg/kg/d molecular traditional Chinese medicine sustained-release tablets (prepared in example 2) 1 time a day for 12 weeks, and detecting changes of indexes related to bone metabolic disorder of the post-menopausal osteoporosis animal model by using an ELISA method, namely serum E2, FSH and LH.
As a result: after the molecular traditional Chinese medicine sustained-release tablet intervenes for 12 weeks, the content of serum E2 is obviously lower than that of a blank group (P is less than 0.01), and an experimental group is obviously higher than that of a model group (P is less than 0.05); serum FSH and LH contents, model group and experimental group are obviously higher than those of blank group (P < 0.05), and experimental group is obviously lower than that of model group (P < 0.05) (Table 2).
TABLE 2 Change in hormone levels in each group after intervention
| Group of | E2（ng/L） | FSH（IU/L） | LH（ng/L） |
| Blank group | 4.50±0.89 | 0.94±0.40 | 1.74±0.75 |
| Model set | 2.43±0.55* | 2.58±0.67* | 5.02±1.74* |
| Experimental group | 3.89±0.56▽ | 1.37±0.54▽ | 2.62±0.73▽ |
Note: andblank group comparison, P < 0.05; in comparison with the set of models,▽P＜0.05。
and (4) conclusion: the molecular Chinese medicinal sustained-release tablet can inhibit hormone level disorder of postmenopausal osteoporosis by reducing serum FSH and LH content and increasing serum E2 content.
Example 6
Expression of molecular Chinese medicine slow-release tablet for inhibiting postmenopausal osteoporosis bone mass loss
The method comprises the following steps: 45 SD rats of 2 months old cleaning grade, female, the random number table method is divided into 2 groups, blank group 15 and model group 30. The blank group only removes part of fat beside ovaries by adopting a pseudo-operation, the model group establishes a postmenopausal osteoporosis animal model by removing bilateral ovaries, and the random digital table method is divided into 2 groups, 15 model groups and 15 experimental groups. The blank group is fed conventionally, the model group is perfused with equivalent physiological saline, the experimental group is perfused with 60mg/kg/d molecular traditional Chinese medicine sustained-release tablets (prepared in example 2) for 12 weeks 1 time per day, the femoral neck bone density and the bone trabecular structure are detected by adopting the mico CT, and the maximum load force of the femoral shaft is detected by adopting an IG-A1000N universal material testing machine.
TABLE 3 Dry prognosis for various groups of bone Density changes
| Group of | BMD(mg/cc) | BV/TV(%) | Tb.Sp(μm) | Tb.Th(μm) |
| Blank group | 821.76±39.45 | 84.09±3.84 | 15.83±0.86 | 348.16±16.73 |
| Model set | 568.62±33.54☆ | 50.12±2.56☆ | 53.89±3.43☆ | 117.63±7.86☆ |
| Experimental group | 681.45±32.66☆△ | 62.55±3.32☆△ | 26.12±1.86☆△ | 163.46±8.22☆△ |
Note:☆comparison with blank group P<0.01，△Comparison with model group P<0.01。
As a result: after the intervention of the molecular traditional Chinese medicine sustained-release tablets for 12 weeks, the detection results of femoral neck bone density (BMD), cancellous bone and cortical bone volume fraction (BV/TV), trabecular bone width (Tb.Th) and maximum load force (N) born by femoral shaft show that the model group and the experimental group are obviously lower than the blank group (P is less than 0.01); the experimental group was significantly higher than the model group (P < 0.01) (table 3, table 4). The detection result of the separation degree (Tb.Sp) of the femoral neck trabecula shows that the model group and the experimental group are obviously higher than the blank group (P is less than 0.01); the experimental group was significantly lower than the model group (P < 0.01) (table 3).
TABLE 4 changes in biomechanical Properties of femoral shafts in groups after intervention
| Group of | N |
| Blank group | 1085.34±46.78 |
| Model set | 782.27±57.85☆ |
| Experimental group | 903.96±47.67☆△ |
Note:☆comparison with blank group P<0.01，△Comparison with model group P<0.01。
And (4) conclusion: the molecular traditional Chinese medicine sustained-release tablet promotes the reconstruction of the three-dimensional structure of the trabecular bone by inhibiting the reduction of bone mass, and enhances the structural strength and mechanical strength of the bone, thereby relieving the clinical symptoms of postmenopausal osteoporosis.
Claims (2)
1. The drug sustained-release tablet for resisting osteoporosis is prepared from an active ingredient and pharmaceutically-allowable auxiliary material ingredients, wherein the active ingredient comprises 1-5 parts of specnuezhenide, 1-5 parts of wedelolactone, 0.5-3 parts of paeoniflorin, 0.5-3 parts of psoralen and 1-5 parts of diosgenin, and the pharmaceutically-allowable auxiliary material ingredients comprise 10-50 parts of sodium alginate, 9341-5 parts of carbomer, 10-30 parts of hydroxypropyl methyl cellulose, 10-40 parts of lactose and 1-5 parts of magnesium stearate.
2. The sustained-release tablet for an anti-osteoporosis drug according to claim 1, wherein: the preparation method comprises the following steps:
(1) weighing the active ingredients in proportion, and mixing uniformly;
(2) sodium alginate and hydroxypropyl methylcellulose are used as framework materials, carbomer 934 is added as an adhesive, the mixture is uniformly mixed with the active ingredients in the step (1), and a proper amount of 95% ethanol is added to prepare a soft material;
(3) drying the soft material in (2) at low temperature, pulverizing into fine powder, adding lactose as diluent, adding magnesium stearate as lubricant, mixing, and tabletting.
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| CN108619101A (en) * | 2018-04-23 | 2018-10-09 | 常德职业技术学院 | A kind of anti-inflammatory sustained release preparation and preparation method thereof |
| KR101918206B1 (en) * | 2018-08-13 | 2018-11-13 | 단국대학교 천안캠퍼스 산학협력단 | Composition for preventing or treating osteoporosis comprising compound isolated from Paeonia lactiflora extract as effective component |
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| CN101057885B (en) * | 2006-04-20 | 2012-12-12 | 周亚伟 | Medicinal composition for treating osteoporosis and preparations and application thereof |
| CN102389440B (en) * | 2011-12-09 | 2014-08-20 | 四川浩源生物科技有限公司 | Application of iridoid in preparation of anti-osteoporosis medicines |
| CN104415031A (en) * | 2013-09-10 | 2015-03-18 | 中国科学院大连化学物理研究所 | Application of wedelolactone in preparation of medicaments or healthcare products for treating osteoporosis |
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Non-Patent Citations (2)
| Title |
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| Ligustrum lucidum and its Constituents : A Mini-Review on the Anti-Osteoporosis Potential;Chun-Tao Chea et al；;《Natural Product Communications》;20151231;第10卷(第12期);第2189-2194页 * |
| Paeoniflorin isolated from Paeonia lactiflora attenuates osteoblast cytotoxicity induced by antimycin A;Eun Mi Choi et al；;《Food & Function》;20131231(第4期);第1332–1338页 * |
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