Evidence map›Paper›PMID 25284988›Full record

ArticleDrug design, development and therapy2014

Bioactive protein fraction DLBS1033 containing lumbrokinase isolated from Lumbricus rubellus: ex vivo, in vivo, and pharmaceutic studies.

Raymond R Tjandrawinata, Jessica Trisina, Puji Rahayu, Lorentius Agung Prasetya, Aang Hanafiah, Heni Rachmawati

Registry-linked trialAbstract read
In one paragraph

Article in Drug design, development and therapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04425590 (The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04425590 phase2 / phase3unknown statusnot on this mapstarted 2020, after this paper: background citation

The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Study

TypeinterventionalSponsorDuta Wacana Christian UniversityRan2020 to 2020Enrolled180ConditionsIschemic StrokeArmsDLBS1033, Aspirin, Statin, Vit B12
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Bioevaluation ofMolecules (Basel, Switzerland) · 2021
    Article
  4. Tacorin, an extract fromFEBS open bio · 2017
    Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Raymond R TjandrawinataDexa Laboratories of Biomolecular Sciences, Dexa Medica, Cikarang, Indonesia.
Jessica TrisinaDexa Laboratories of Biomolecular Sciences, Dexa Medica, Cikarang, Indonesia.
Puji RahayuDexa Laboratories of Biomolecular Sciences, Dexa Medica, Cikarang, Indonesia.
Lorentius Agung PrasetyaDexa Laboratories of Biomolecular Sciences, Dexa Medica, Cikarang, Indonesia.
Aang HanafiahNational Nuclear Energy Agency, Bandung, Indonesia.
Heni RachmawatiSchool of Pharmacy, Bandung Institute of Technology, Bandung, Indonesia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

DLBS1033 is a bioactive protein fraction isolated from Lumbricus rubellus that tends to be unstable when exposed to the gastrointestinal environment. Accordingly, appropriate pharmaceutical development is needed to maximize absorption of the protein fraction in the gastrointestinal tract. In vitro, ex vivo, and in vivo stability assays were performed to study the stability of the bioactive protein fraction in gastric conditions. The bioactive protein fraction DLBS1033 was found to be unstable at low pH and in gastric fluid. The "enteric coating" formulation showed no leakage in gastric fluid-like medium and possessed a good release profile in simulated intestinal medium. DLBS1033 was absorbed through the small intestine in an intact protein form, confirmed by sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS PAGE) analysis. This result confirmed that an enteric coating formula using methacrylic acid copolymer could protect DLBS1033 from the acidic condition of the stomach by preventing the release of DLBS1033 in the stomach, while promoting its release when reaching the intestine. From the blood concentration-versus-time curve, (99m)Tc-DLBS1033 showed a circulation half-life of 70 minutes. This relatively long biological half-life supports its function as a thrombolytic protein. Thus, an enteric delivery system is considered the best approach for DLBS1033 as an oral thrombolytic agent.

Indexed as

AnimalsDrug StabilityEndopeptidasesFibrinolytic AgentsHydrogen-Ion ConcentrationInjections, IntramuscularMaleOligochaetaRatsRats, WistarSolubilityTissue ExtractsDLBS 1033EndopeptidasesFibrinolytic AgentslumbrokinaseTissue Extractsbioactive protein fractionenteric coated tabletpharmacodynamic

Identifiers

PMID25284988
PMCPMC4181543

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.